const BRCGS_DATA_EXT = [{"section":1,"title":"Senior management commitment","clauses":[{"id":"1.1.1","requirement":"The site shall have a documented policy which states the site’s intention to meet its obligation to produce safe, legal and authentic products to the specified quality, and its responsibility to its customers. • be signed by the person with overall responsibility for the site. • be communicated to all staff. • include commitment to continuously improve the site’s food safety and quality culture.","interpretation":"The site’s policy must clearly state the overall aims to meet customer requirements,\nincluding the provision of safe, authentic products of the quality desired by the customer.\nThe policy will also highlight the site’s intention to improve product safety and quality\nculture on a continuous basis, which, as discussed (for example, in the interpretation for\nthe statement of intent and importantly in clause 1. 1.2), is fundamental in the consistent\napplication of product safety practices. The policy is designed to show the site’s intention,\nso that all staff can work towards this common goal.\nAuthenticity of products means ensuring that all products sold or purchased are of\nthe nature, substance and quality expected. This applies not just to product claims, but\nincludes all products and raw materials with the assurance that they meet the specification.\nAuthenticity is defined in the glossary.\nThe policy must be signed by the person with overall responsibility for the audited site,\nto demonstrate the commitment at senior management at site level. Where the policy is a\ngroup- or company-wide statement, the site management should endorse it; for example, by\ncountersigning it.\nThe policy statement is only a summary and can usually be expressed in a single page.\nAlthough it does not need to be dated, it must be current and should therefore be updated\nwhen significant policies or senior management change. The policy forms the foundation\nfor the site’s ways of working and the auditor will expect to see how the site management\nensure staff understanding and engagement. This may include:\n• communication to staff (e. g. through display on noticeboards, inclusion in the induction\nprocess, availability on the company intranet, and the use of appropriate languages where\nthe local language is not the first language of all employees. The use of dual languages\nmay improve and speed up understanding and action)\n• inclusion of all staff, including temporary and contract staff, in the communication and\nengagement processes."},{"id":"1.1.2","requirement":"The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a food safety and quality culture. The plan shall include measures needed to achieve a positive culture change. • defined activities involving all sections of the site that have an impact on product safety. As a minimum, these activities shall be designed around: clear and open communication on product safety, training, feedback from employees, the behaviours required to maintain and improve product safety processes, performance measurement of activities related to the safety, authenticity, legality and quality of products. • an action plan indicating how the activities will be undertaken and measured, and the intended timescales. • a review of the effectiveness of completed activities.","interpretation":"Analysis of the root causes of many non-conformities shows that a proactive, positive\nproduct safety and quality culture (hereafter referred to as culture) within a company can\nmake all the difference in the effectiveness of the food safety and quality plan and its\nconsistent implementation throughout the site. Culture must be led by senior management\nand ‘felt’ throughout the organisation, so that all aspects of the business are informed and\ninvolved. It is important to understand that the culture plan is unlikely to be successful if\nit is viewed as simply a technical function. It will require the input and commitment of the\nsite’s senior leadership team and may also align with several teams around the business; for\nexample, with human resources (HR) or personnel management activities.\nCulture can be challenging. It relies not just on measurables and specifics but an ethos and\nvalues felt by people at all levels of the site. The size and complexity (or simplicity) of the\nsite should not be a barrier to a successful culture.\nThe site is required to develop, implement and maintain a clear plan or programme for\ndeveloping and improving its culture. Such a plan should be based on the nature of the\norganisation, and dependent on its size, seasonality and the overall aims it has identified\nas important for its own culture. The clause does not prescribe the exact mechanisms that\nmust be used; this is to allow the site flexibility to develop systems that are effective within\nits specific ways of working, and its current prevailing culture. It does, however, highlight the\nminimum scope of the plan.\nThe plan will need to consider the measures needed to achieve the intended positive\nculture change.\nThe plan does not need to be annual. A strategic plan could, for example, cover 5 years, with\nactivities designed to measure current culture, implement changes and assess improvements\n(or where improvement was not evident, a review of why). Some aspects of the plan may\noccur more frequently than others. However, for the plan to be effective, the development\nand improvement of culture will need to be treated as an ongoing and continuous process,\nand the auditor will expect to see evidence that activities are being completed each year\nduring which the plan is designed to operate. It is not acceptable to design a 5-year plan\nwhere all of the activities are completed within the final year.\nRegardless of the intended length or lifetime of the plan, it is important that it remains\nrelevant and up to date. The site will therefore need to ensure that it is regularly reviewed\nand updated. At a minimum there must be an annual review.\nA wide range of activities could be incorporated into a culture development plan, some of\nwhich the company may already be conducting. As a minimum the Standard requires:\n• a clear and open communication on product safety\n• training\n• feedback from employees\n• behaviour changes required to maintain and improve product safety processes\n• performance measurement on product safety, authenticity, legality and quality related\nactivities.\nHowever, note that culture is not simply a matter of introducing another policy, but on\ndeveloping attitudes and a positive approach to product safety and product safety processes.\nFor example:\n• Ease of movement of product safety information between different levels and sections of\nthe site can be an indication of a good culture. However, a formal communication policy is\nnot likely to affect company culture, unless the site has considered what is communicated,\nin what format. For example, if all communication is finance-related and lacks information\non product safety, then staff may mistakenly believe that product safety is not important,\ndue to its lack of communication. Instead, regular, open and clear communication,\ninvolving all personnel, is needed, including expectations, benefits, product safety\nsuccesses as well as deviations from what is expected or acceptable.\n• Training and staff development (e. g. the use of annual staff reviews and one-to-ones)\nshould have a number of aims beyond just training the process or procedure (e. g.\nawareness of food safety issues, management techniques, and development of positive\nbehaviours and staff development).\n• Feedback from employees (e. g. staff surveys), focusing on values and culture, can provide\nuseful information on current mindset and culture, impact of recent initiatives and\npreferred direction of travel. Feedback mechanisms also provide an opportunity to identify\nand address staff concerns.\nchoose relevant behaviours that will have a positive impact on product safety. These\nrelevant behaviours may be identified simply by a manager’s knowledge of the site, or\nidentified through the results of a site survey (such as the BRCGS Culture Excellence\nModule), or by considering the many indicators (or artefacts) of the behaviours, beliefs or\nattitudes that exist at a site. These can provide an indication of the prevailing culture and\ncould be used in this part of the plan. An artefact of culture is described as an existing\nproduct safety activity that is not culture itself, but is indicative of the site’s prevailing\nculture (i. e. the site’s attitudes towards the value or importance of a specific product\nsafety activity, and its compliance with that activity, is often indicative of the culture of\nthe site). These behaviours or attitudes are often identifiable by the site and useful in\nthe maintenance and improvement of product safety culture and can therefore be built\ninto the culture improvement plan. Many fundamental product safety processes could be\nconsidered artefacts of the culture; for example:\n• food safety policy\n• objective setting and management review\n• food safety in management meetings\n• food safety resources\n• risk awareness (e. g. for HACCP development)\n• effectiveness of corrective and preventive actions\n• internal audits\n• training.\nRemember that these activities are not the culture themselves; they are artefacts –\nindicators of the prevalent product safety behaviours at the site.\n• Performance measurement – this is different from clause 1. 1.3. There, the objectives are\nused to directly improve food safety, whereas the aim of this clause is to consider the\nimpact of the results and learnings on product safety culture. For example, if an objective\nis always met, or always missed, or the objective remains unchanged every year, this may\nindicate a site attitude towards the objectives and provides site leadership with an attitude\nto focus on. In other words, is the site attitude to develop and continuously improve food\nsafety using the objectives as one of the tools, or are the objectives set only to meet the\nrequirements of the Standard?\nAlong with the activities, the culture plan must also include information indicating how\nactivities will be undertaken, the intended timescales for completion, plans for measurement\n(including results from previous activities) and a review of the effectiveness of completed\nactivities.\nThis information should be used to review the plan to ensure it remains up to date and\nrelevant for the site. It also has the bonus of creating a history of improvements and impacts.\nThis information can be used, for example, to train new employees, inspire existing staff and\nfurther inform the types of activity/implementation that are most effective at the site and\nthose which are more likely to struggle.\nCulture is often considered to be subjective and therefore difficult to audit. It must be\nemphasised that auditors are not expected to audit ‘food safety culture’ of the site, but the\nevidence of compliance with the requirements of the clause. The auditor will therefore\nexamine evidence of conformity with this requirement during both the audit of the facilities\nand the documentation audit. This will be achieved using a number of auditing techniques;\nfor example:\n• a review of the documented plan and records – is it complete, does it contain all the\nrelevant information, how were the activities and objectives set, are the monitoring and\nreview processes operating correctly and have they been used to review and update the\nplan to ensure it remains relevant for the site?\n• discussion with senior management on the development and implementation of the plan\n(refer to clause 1. 1.11).\n• discussions may be conducted across all levels of personnel on an informal basis. The\nauditor would expect to find an awareness of food safety culture, how individuals can\nimpact it, and the company’s objectives.\n• evidence of the site completing the activities in its action plan.\n• timescales and evidence that they have been met.\n• monitoring and review processes, and results from previous activities.\nBRCGS provides a number of services that can support a site’s development of its culture\nplan, including:\n• an additional voluntary module in product safety culture excellence which helps sites\nmeasure the current culture and identify areas for improvement.\n• a guideline on product safety culture which may be purchased from the BRCGS Store or\nviewed online at BRCGS Participate.\n• a training course explaining culture and its implementation.\nNon-conformities To ensure expectations are understood relating to compliance with clause 1. 1.2, its consistent\napplication at certificated sites, and assessment during audits, BRCGS has trained auditors\nand certification bodies to apply the following non-conformities, where sites are non-\ncompliant:\n• Major non-conformity Where the site does not have a documented plan for food safety\nand quality culture. In this context a plan is more than a short statement of intent, but is\ndocumentation incorporating all of the requirements of the clause.\n• Minor non-conformity Where a documented plan exists, but:\n• is of poor quality (e. g. lacks detail such as timescales for completion or clear action\nplans)\n• does not cover all the relevant areas or staff\n• is not fully implemented (e. g. some activities are not implemented or are not completed\nto a predefined schedule).\nThe final bullet point in the clause requires sites to undertake a review of the effectiveness\nof completed activities. However, it is possible that this review of the success of the\nprogramme would not always be implemented in year 1 (since a review cannot be completed\nuntil there are activities to review). Therefore non-compliance with this bullet point is not\nconsidered a non-conformity at the site’s initial audit, but will be assessed from the site’s\nsecond audit to the Standard onwards.\nThe site is expected to complete corrective action, root cause analysis and preventive action\nplans in accordance with section 2. 3 of the audit protocol prior to certification, and any non-\nconformity will be included in the calculation of the site’s grade.\nExample Food safety and quality culture plan\nThe company decides to implement a culture plan. Based on the requirements of the\nStandard it identifies six key areas to include:\n• Enhanced training Beyond just managing critical control points (CCPs), to an\nunderstanding of the reasons for the current product safety processes and involving staff\nin corrective actions.\n• Communications Regular staff updates in addition to the traditional internal message\nboards. Updates are used to communicate production, incidences of non-conforming\nproduct, customer complaints and their corrective actions, and improvements in product\nquality. They also focus on company strategy and product safety objectives.\n• A clear feedback process To initiate communication ‘up’ to management, so that\ncommunication is not seen just as management ‘telling staff’.\n• Recognition Management instigates ‘employee of the month’ awards as rewards for\nsuccessful process improvement ideas.\n• Behaviours to maintain and improve product safety The site identifies two areas it would\nlike to focus on:\n• Previously the site had developed reporting and whistleblowing systems which allow\nstaff to feed back concerns relating to product safety, in accordance with clauses 1. 1.\nand 1. 2.3 of the Standard. However, staff feedback has identified a lack of use of the\nsystems due to:\n• a lack of encouragement to report errors and product safety concerns\n• a lack of trust, and a feeling that it is not safe or comfortable to report problems\n• a belief that problems will not be taken seriously or that nothing will improve.\nSenior management therefore decides to include staff reporting and concerns about\nthe current system in the culture improvement plan, and look for ways to build trust and\nencourage use.\n• Internal audits are an extremely useful site-based tool for monitoring and improving\nsystems. However, the site notices that many departments undervalue the audit\nprogramme, with several reports reflecting a negative attitude towards the programme.\nSenior management also notes that internal audits require effort and resource to\ncomplete robustly and effectively, which have not always been available. In fact, at a\nprevious management meeting the senior leadership had considered the potential to\nfurther minimise the internal audit programme (e. g. by resorting to tick-box exercises,\nreducing the number of audits or auditors, and completing the minimum activity\npossible, rather than reviewing the actual risks).\nThe culture plan therefore includes activities to build belief in, and use of, the internal\naudit programme, starting with education about the programme and its importance,\ntraining for new internal auditors, communication of audit results (positives as well as\nnon-conformity), using the management review programme to consider learnings from\nthe programme which can further benefit the site.\n• KPIs The site’s quality KPIs have remained constant for a prolonged period. The site\ndecides to use its annual customer reviews as an opportunity to review the quality KPIs to\nestablish their continuing appropriateness.\nExample\nTo ensure that the activities proceed according to the plan (and in accordance with the\nStandard), the site management:\n• assigns timescales for the start of each activity\n• nominates leaders for each activity with responsibility to lead the activities identified\n• makes progress against the product safety culture plan an agenda item at the quarterly\nsenior management team meetings\n• schedules a follow-up staff survey for 12 months’ time which will specifically be used to\nassess the effectiveness of the planned activities\n• sets a review date for the complete plan."},{"id":"1.1.3","requirement":"The site’s senior management shall ensure that clear objectives are defined to maintain and improve the safety, authenticity, legality and quality of products manufactured, in accordance with the food safety and quality policy and this Standard. • documented and include targets or clear measures of success. • clearly communicated to all staff. • monitored and results reported at least quarterly to site senior management and all staff.","interpretation":"Senior management must set objectives concerning food safety, authenticity, legality and\nquality that help to achieve the stated policy (see clause 1. 1.1).\nThe objectives must be communicated so that staff understand what is required from\nthem. The setting of these objectives also helps the allocation of suitable budgets and\nresources. Auditors will look for evidence that the objectives are in place and have been\ncommunicated.\nGood objectives are usually:\n• Specific Objectives should be clear and directly related to the site’s aims or goals for\nproduct safety and quality.\n• Measurable Objectives should be measurable so that the site can assess progress.\n• Achievable Targets that stretch the company are acceptable but it is important that they\nare realistic and that sufficient resources will be available.\n• Relevant Objectives should be designed to maintain and improve product safety and\nquality.\n• Time-bound Objectives can be long-term (e. g. throughout the period of certification) or\nshorter-term (e. g. within the next 3 months); however, the timescales or deadlines should\nbe clear to enable the site to review progress and, if necessary, amend activities.\nThere are many examples of objectives that could be included. For example:\n• reductions in customer complaints, non-conforming products and/or customer rejections\nor returns\n• reductions in audit failures or audit non-conformities – include both internal and external\naudits, but ensure that all audits are still completed to a thorough, rigorous quality\n• improved product safety training\n• improvements to the management of product authenticity\n• increases to product testing.\nIn each of these examples it would be necessary for the site to consider how to make the\nobjective specific and measurable (as discussed above); for example, 10% fewer customer\ncomplaints to be achieved by year end.\nObjectives associated with product authenticity are likely to be formed differently; for\nexample, they may be linked to:\n• improvements to the traceability systems or traceability testing (section 3. 9)\n• evolution of product monitoring processes such as product testing (section 5. 6)\n• outcomes from the vulnerability assessment (section 5. 4)\n• updates to the supplier approval mechanisms and the ongoing monitoring of suppliers\n(section 3. 5).\nA similar situation exists for objectives associated with legality, as these will also need to be\nformed differently from those commonly used for product safety. For example, where there\nis proposed legislation in the region where the company operates, then possible targets may\nrelate to ensuring that relevant staff are trained in a timely manner.\nProgress against targets must be reviewed and reported to senior management at least\nquarterly. It may, for example, be included in management meetings (e. g. those scheduled\nfor clause 1. 1.4), or it may be the subject of a separate review or included in a report to\nmanagement. Auditors will look for documented evidence of communication and the\nquarterly progress review.\nThe Standard also requires communication to staff (including all employees and agency-\nsupplied staff). The Standard is not prescriptive on the methods of communication used\nto meet this clause. For example, any of the following could be used: meetings, briefings,\ncascades, huddles, electronic media (e. g. email), and company noticeboards.\nIndependent sites or facilities that are part of a large group with company-wide objectives\ncan adopt the company-wide objectives, but are required to ‘own’ the objectives and carry\nout the implementation, monitoring, review etc. at site level."},{"id":"1.1.4","requirement":"Management review meetings attended by the site’s senior management shall be undertaken at appropriate planned intervals, annually at a minimum, to review the site performance against the Standard and objectives set in clause 1.1.3. • previous management review action plans and timeframes. • the results of internal, second-party and/or third-party audits. • any objectives that have not been met, to understand the underlying reasons. This information shall be used when setting future objectives and to facilitate continual improvement. • any customer complaints and the results of any customer feedback. • any incidents (including both recalls and withdrawals), corrective actions, out-of-specification results and non-conforming materials. • the effectiveness of the systems for HACCP, food defence and authenticity, and the food safety and quality culture plan. • resource requirements.","interpretation":"The purpose of the management review meeting is to take an overview of the food safety\nsystems. It should therefore be a full and detailed examination of what has happened and\nwhat should happen in future. It is not the ongoing management of an issue or concern\n(although the agenda may include a review of any such concerns) and it is not just incident/\nnon-conforming product management (processes for these activities are covered in the\nrelevant sections of the Standard; for example, in sections 3. 8 and 3. 11).\nThe format of the meeting should reflect company size.\nThe Standard identifies specific agenda items that must be included within the meeting;\nhowever, additional relevant subjects should also be included where appropriate. As a\nminimum the meeting agenda should therefore consider:\n• minutes of the previous management reviews and actions agreed. For example, the\nprevious meeting may have set actions and timescales for their completion; however,\nif actions were not completed on schedule or have failed to be effective, further\ninvestigation and actions will be required\n• what has been achieved or not been achieved and progress against objectives (see\nclause 1. 1.3); for example:\n• if an objective has been met the site can consider future targets based on achievements\nto date\n• if an objective has not been met the site can consider why. This can be very informative\nand allows future objectives (or other actions such as the product safety culture plan)\nto focus on areas where relevant, achievable actions can take place. This review need\nnot be exhaustive (such as a full root cause analysis) but the site should be able to\nunderstand why objectives were not met. The outcome would not be preventive action\nbut continual improvement, allowing the site to refine its future targets\n• internal, second-party and/or third-party audits, and subsequent actions. As a minimum\nthe Standard requires a summary of the results from the internal audit programme to be\nreviewed at these meetings (see clause 3. 4.3). This provides two opportunities for the\nsenior management team:\n• a review of non-conformities, corrective actions, root causes and preventive actions,\nwith a focus on any outstanding concerns or additional actions required (individual\nissues should have been identified and acted upon at the time they were identified and\nwhere necessary, escalated to the management team during the year)\n• review of the overall performance and key trends should facilitate continuous\nimprovement (e. g. changes to the frequency of auditing particular areas, training needs or\nsuggestions for improvements or further developments of the internal audit programme)\nSimilarly, second- or third-party activities (including customer audits, regulatory authority\nvisits) could be summarised to facilitate further discussion and identify any actions or\nimprovements that need to be made\n• progress against the product safety and quality culture plan and the effectiveness of\ncompleted actions\n• product safety incidents, complaints, out-of-specification results or non-conforming\nproducts, to ensure these have been fully actioned, to assess any trends and identify any\nadditional follow-up actions or improvements needed as a result of these incidents and\nnon-conforming situations\n• the management and effectiveness of product safety systems such as HACCP, food\ndefence and product authenticity, along with any existing or emerging issues relating to\nthese topics\n• identification of targets and areas of improvement for the coming year\n• changes to resource requirements.\nIt is important that sufficient information is presented to the meeting to enable a full and\nmeaningful discussion and, where appropriate, actions to be agreed.\nSenior management is considered to consist of managers who have the authority to\nmake decisions on food safety objectives and/or the provision of adequate human and\nfinancial resources. The management team would usually include the site manager and\nthose managers responsible for production, technical operations, purchasing, engineering\nand human resources. For large, multi-site organisations the management review meeting\nmay include head office representatives, but this decision should be driven by the senior\nmanagement on site. It may also include representatives from any departments responsible\nfor specific product safety activities or for specific agenda items.\nGood practice is to ensure that the meeting is put into all attendees’ diaries sufficiently early\nto maximise attendance and that agendas and papers are circulated in advance.\nThe auditor will be looking for evidence that, for each agenda item, sufficient information\nhas been provided to allow an informed discussion to take place leading to appropriate\naction plans. This may be demonstrated through a review of the inputs to the meeting,\nminutes of the discussion of the items and, where necessary, agreed action plans. To\ndemonstrate that, for example, senior management has reviewed the management of the\nHACCP system, the minutes should contain a general summary of the HACCP review\nmeeting (see section 2. 12. 3) and a record of its outcomes (these would be inputs into\nthe management review meeting), together with any actions requested during the senior\nmanagement meeting (i. e. outputs of management review meeting).\nOne of the outputs from the meeting is a review of performance against the objectives\n(clause 1. 1.3) and the establishment of new or amended targets and objectives for the\nfollowing year. This should be clearly documented within the minutes of the meeting.\nThe outcomes from the review meeting must be communicated to the relevant staff to\nensure implementation. It should be evident to the auditor how this has been achieved\n(e. g. cascaded through staff briefings or posted on noticeboards). It should also be evident\nthat actions are followed up and completed. For example, evidence of completion could\nbe added to meeting records, or assessment of actions could be added to the internal audit\nprogramme.\nThe Standard requires an annual review, such as a regular annual management review\nmeeting. However, it is important that meetings are scheduled correctly and of sufficient\nfrequency to maximise the value of the meeting and allow timely actions. Many companies\nopt to make a review or partial review more frequently (e. g. every 6 months or each quarter),\neither addressing all the points in summary (after other review meetings) or addressing\none or two points in depth in each meeting. The number of meetings and the individual\nagendas should be based on company need, providing all relevant topics are covered within\nthe 12-month period. Where meetings are scheduled with a large intervening period (e. g.\nannually) the site needs a process to ensure that any matters needing consideration can\nbe completed in a timely fashion; for example, by incorporating them into management\nmeeting agendas (see clause 1. 1.5).\nSpecial consideration should be given to seasonal and temporary sites to ensure meetings\noccur at an appropriate point in the season and that actions, targets or objectives can be\ncompleted. Some sites therefore opt for two meetings; for example, one at the start of the\nseason, to allow objective setting, and one at the end of the season, when the season’s\ninformation can be assessed. Alternatively, a management meeting shortly after an external\naudit allows any non-conformities to be included in the discussion and relevant corrective\nactions to be agreed.\nAll sites should have a predefined schedule so all participants are aware, in advance, of when\nthe meetings will take place."},{"id":"1.1.5","requirement":"The site shall have a demonstrable meeting programme which enables food safety, authenticity, legality and quality issues to be brought to the attention of senior management. These meetings shall occur at least monthly.","interpretation":"The objective of this clause is to ensure that there is a mechanism that enables the site to\nlearn and react to available information from both internal (within the site and/or company)\nand external sources (e. g. wider industry, media, etc), allowing food safety, authenticity,\nlegality and quality issues to be raised and discussed at a senior management level within\nthe site. The meeting could include, for example:\n• review of successes/failures relating to product safety, authenticity, legality and quality and\nthe lessons that can be learnt from these\n• any ongoing concerns\n• review of corrective actions, root causes, preventive actions and the effectiveness of these\n• review of information relating to publications, known recalls of similar products,\ninformation from regulatory authorities, media stories and potential implications/learnings\nfor the site. This could include information obtained as a result of activities to comply with\nclause 1. 1.\n• overview of KPIs, complaint levels or other relevant metrics.\nMeetings will need to include management of a seniority to make decisions, and where\nappropriate, take actions.\nMost sites have weekly or monthly management meetings and the inclusion of safety,\nauthenticity, legality and quality as an agenda item within this meeting is one way to meet\nthe requirements of this clause.\nA schedule for the meetings needs to be in place.\nSeasonal sites are not expected to have monthly meetings when the site is closed and not\noperating, but scheduling should consider the length of the season and processes to ensure\nthat food safety, authenticity, legality and quality issues can be discussed in a timely manner.\nFor example, the first meeting could take place shortly before the season begins, with further\nmeetings monthly or even weekly throughout the season, and a final meeting at the end of\nthe season.\nThe audit will confirm whether:\n• the meetings occur at a defined frequency (e. g. a schedule, diary bookings or agendas)\n• previous meetings contained relevant discussions (e. g. agenda and minutes for the\nmeetings which clearly state conclusions and any additional actions).\nGood practice is to ensure that any decisions and actions agreed are communicated to\nappropriate staff, and that there is a system to check that actions are implemented within\nagreed timescales."},{"id":"1.1.6","requirement":"The company shall have a confidential reporting system to enable staff to report concerns relating to product safety, authenticity, legality and quality. The mechanism (e.g. the relevant telephone number) for reporting concerns shall be clearly communicated to staff. The company’s senior management shall have a process for assessing any concerns raised. Records of the assessment and, where appropriate, actions taken, shall be documented.","interpretation":"In 2018 a report from the Association of Certified Fraud Examiners found that reports\nfrom employees and outside parties are by far the most common method of detecting\nwrongdoing. It is therefore vital that all sites facilitate effective communication methods\nallowing staff to report any concerns. Ideally, this will be achievable using procedures\ndeveloped to meet clause 1. 2.3. However, from time to time it may be necessary for\nindividuals to report on hazards or infractions anonymously and confidentially (e. g. if a\nstaff member felt that a genuine concern raised through other mechanisms, such as those\ncovered in clause 1. 2.3, had not been adequately addressed), so the site (or company) should\nhave a system in place to manage this. Although the aim of the Standard is to ensure these\nreporting systems relate to product safety, authenticity, quality and legality, the company\nmay choose to incorporate all staff concerns into the system, and not limit it to concerns\nrelated to the scope of the Standard.\nAs a minimum, the system used must ensure that the confidentiality of the employee\nreporting the concern is maintained (i. e. the employee’s identity is not known or released\nto the site or company management) to protect any staff using it, and the confidential and\nanonymous nature of the system should be clear to all staff. An email or telephone call to an\non-site manager, for example, is unlikely to be anonymous or confidential as the manager is\nlikely to know the employee’s email address or recognise their voice. Therefore this would\nnot be considered a confidential system.\nMany food processors will also have whistleblowing systems established by the brand\nowners and retailers for which it produces. Where this is the case, the site is still required\nto have its own system as affected products may not relate to the specific brand owner.\nAdditionally, in some areas, local relevant regulatory authorities will have facilities for\nconfidential reports about a site but this also does not mitigate the need for a site (or\ncompany) to have a system.\nAs well as gathering information, the site is required to collate and act on it. The auditor\nwill expect to see a system in place, and transparency about the content of any reports and\nactions, although not the source of the original concern.\nWhere possible, sites might consider an independent system that receives and processes\nany concerns raised with appropriate promptness. For example, where quality, safety or\nconformity of the product is at risk, action should be immediate. This might be by using an\nindependent consultant or a professional organisation that can act as an intermediary.\nWhere local legal requirements prohibit certain activities around confidentiality or such\nreports, the site will need to ensure the system employed meets these legal requirements.\nThis will also be acknowledged by the auditor and compliance with this clause noted within\nthe context of the legal framework.\nIt is not uncommon for larger companies to base the management of their confidential\nreporting systems at head office, rather than at each individual site. This is acceptable and\nthe audit process is explained in Appendix 4 of the Standard.\nBRCGS operates the independent ‘Tell BRCGS’ facility (available online). This has been\ndesigned so that BRCGS can receive information from any interested party about the status\nof certificated sites or the certification process. Therefore, when feedback is received, it will\nbe investigated and this may, for example, identify the need for a compliance audit at the\nimplicated site to ensure that it is operating legally and in compliance with the Standard.\nThis is different from the aim of this whistleblowing clause, which is to provide the site/\ncompany management with an opportunity to receive and address any concerns raised\nby employees without the site being subject to an external review. Therefore, a site using\nthe Tell BRCGS system without its own confidential reporting system will not achieve the\nintended aim of the clause, although it could be used for situations where an employee has\ntried other site-specific options and is still sufficiently concerned to raise the matter with\nBRCGS."},{"id":"1.1.7","requirement":"The company’s senior management shall provide the human and financial resources required to produce safe, authentic, legal products to the specified quality and in compliance with the requirements of this Standard.","interpretation":"Sites must have sufficient financial and human resources to be able to maintain the food\nsafety, authenticity, legality and quality systems.\nAlthough a review of resources forms part of the management review process (clause 1. 1.4),\nit should not be restricted to a single annual discussion if there is a need to make changes to\nresource allocation during the course of the year.\nAs well as looking at the minutes of the management review meeting, auditors will also\nlook at the type, number and root causes of non-conformities identified at the audit, as the\nability of the site to meet the requirements of the Standard will partly demonstrate that the\nappropriate resources and skills are available.\nThe auditor will examine this requirement during both the audit of the facilities and\ndocumentation. The auditor will expect the site to demonstrate that it is adequately\nresourcing its product safety, authenticity, legality and quality activities, which may include\ncapital expenditure (e. g. for repairs or new equipment), staff levels and staff training."},{"id":"1.1.8","requirement":"The company’s senior management shall have a system in place to ensure that the site is kept informed of and reviews: • scientific and technical developments. • industry codes of practice. • new risks to authenticity of raw materials. • all relevant legislation in the country where the product will be sold (where known).","interpretation":"Food safety issues and legislative requirements are constantly changing. The objective of\nthis clause is to ensure that sites remain up to date, are able to meet legislation and can\nadapt their food safety systems to protect against new threats. The company must be able\nto demonstrate that it maintains up-to-date knowledge of relevant legislation, scientific and\ntechnical developments, potential risks to raw materials (e. g. to the authenticity of the raw\nmaterial) and industry codes of practice, such as Codex Alimentarius. Activities to achieve\nthis may include:\n• membership of a trade association that provides this service\n• subscription to a service provider supplying legal updates\n• help from government officials or local enforcement offices\n• regular review of identified websites covering legislation and standards.\nIn addition to information relating to food safety, the site must also have a system to obtain\nand review information relating to the authenticity of raw materials and the potential for\nsubstitution or dilution of the ingredients. This information will, for example, be required to\ndemonstrate compliance with clause 5. 4.2.\nThe company needs to demonstrate that it can readily access, either directly or through\na third party, legislation relating to the product in the country, state or territory where the\nproduct is sold to the ultimate consumer (if known, or where it can reasonably be expected\nto be sold). Good practice is also to consider the country where the product is manufactured.\nThe auditor will therefore look for evidence of systematic checking and of the process for\nensuring the information is transferred into action as necessary."},{"id":"1.1.9","requirement":"The site shall have a genuine, original hard copy or electronic version of the current Standard available and be aware of any changes to the Standard or protocol that are published on the BRCGS website.","interpretation":"The aim of this clause is to ensure the site has easy access to all the relevant requirements\nfor compliance and certification to the Standard. The site must therefore have an official\ncopy of the Standard available in either paper or electronic form. Either a free or paid-for\nPDF copy of the Standard demonstrates compliance with this requirement. A subscription to\nBRCGS Participate provides an online version of the Standard (and interpretation and other\nguidelines) and therefore also meets this requirement.\nThe site will also need copies of any additional voluntary modules to which they are\ncertificated.\nIn addition, during the lifetime of the Standard, the BRCGS technical advisory committee\n(TAC) may be asked to:\n• review the wording of a requirement in the Standard or audit protocol\n• provide an interpretation for a requirement\n• rule on the grading of a non-conformity against a clause.\nPublished TAC opinions are defined as ‘position statements’. Position statements are binding\non the way that the audit and certification process is carried out and are considered to\nbe an extension to the Standard. Sites must therefore be aware of any published position\nstatements and, where necessary, ensure the information is transferred into action. Position\nstatements are published on the ‘Food Safety Help and Guidance’ page of the BRCGS\nwebsite and available on BRCGS Participate. They are communicated via the BRCGS\nnewsletter. This newsletter is sent to all certificated companies. Position statements are also\ncommunicated to certification bodies via the bulletin."},{"id":"1.1.10","requirement":"Where the site is certificated to the Standard, it shall ensure that announced or blended announced recertification audits occur on or before the audit due date indicated on the certificate.","interpretation":"The audit due date is indicated on both the audit report and the certificate issued to all\ncertificated sites. The responsibility for scheduling the next audit rests with the site.\nAnnounced audits may be taken in the 28 calendar days up to and including the audit due\ndate. Blended audits may commence within the 56 calendar days prior to the audit due date.\nLate audits are likely to result in a gap in certification and a major non-conformity will be\nawarded unless exceptional circumstances occur as identified in the audit protocol section\nof the Standard (II, section 2. 7.2). This includes situations where the site is:\n• situated in a specific country, or an area within a specific country, where there is\ngovernment advice not to visit and there is no suitable local auditor\n• within a statutory exclusion zone that could compromise food safety or animal welfare\n• in an area that has suffered a natural or unnatural disaster, rendering the site unable to\nproduce or the auditor unable to visit\n• affected by conditions that do not allow access to the site or restrict travel (e. g. heavy\nsnow)\n• producing seasonal products where production is delayed by a late start to the seasons\n(e. g. due to weather or product availability).\nLack of personnel is not an acceptable reason for adjusting the audit date. It is expected that\nthe site will appoint adequate deputies and established systems of working to ensure the\nsmooth operation of the site in the absence of individual managers. Nor is the undertaking\nof building work an acceptable reason for delay unless the site is not in production while the\nbuilding work is carried out.\nWhere a site has an unannounced audit, either by opting into the voluntary unannounced\nscheme or due to the requirement for a mandatory unannounced audit, it becomes the\nresponsibility of the certification body to ensure this requirement is met."},{"id":"1.1.11","requirement":"The most senior production or operations manager on site shall participate in the opening and closing meetings of the audit for certification to the Standard. Relevant departmental managers or their deputies shall be available as required during the audit. A member of the senior management team on site shall be available during the audit for a discussion on effective implementation of the food safety and quality culture plan.","interpretation":"For a site to successfully complete a BRCGS audit, it will be necessary to involve a range of\ndifferent site colleagues, including senior managers, section heads and staff responsible for\ncompleting specific activities. Involving a range of site colleagues in this way has a number\nof advantages, including:\n• It allows the individuals that are responsible for, or who complete, specific activities to\nexplain them and discuss any questions the auditor may have, ensuring that the auditor\nreceives detailed, up-to-date information, and can observe the activity in action.\n• It allows members of the team who are not currently needed for the audit to complete\nother duties, either as part of their normal work or preparation for other parts of the audit;\nfor example, compiling the information for the vertical audit.\n• It indicates a positive product safety culture, where management encourages staff of all\nlevels to be involved in the audit process.\nAs a minimum the most senior production or operations managers on site (i. e. those who\nare responsible for the hands-on, daily running of the site) must participate in the opening\nand closing meetings of the audit. The objective is to ensure that non-conformities are\neffectively understood and agreed; therefore this site representative will need to be\nsufficiently senior to make decisions regarding any non-conformities and the corrective\naction to be taken.\nThe auditor will also need to discuss food safety and quality culture and the site’s\nimplementation of its plan to improve the culture with this manager or an appropriate\nmember of the senior management team.\nIt may be the case that the most senior operations managers within the company are\nabsent on the day of the audit because of other commitments, especially where an audit is\nunannounced; however, there must always be a nominated deputy available (clause 1. 2.1)."},{"id":"1.1.12","requirement":"The site’s senior management shall ensure that the root causes of any non-conformities against the Standard identified at the previous audit have been effectively addressed to prevent recurrence.","interpretation":"An important aspect of the Standard is to encourage continual improvement of product\nsafety processes (e. g. see the statement of intent for section 1. 1) and the prevention of non-\nconforming situations is one aspect of this. Therefore, non-conformities identified in the\nprevious certification audit must have been fully and effectively rectified (i. e. corrective and\npreventive actions completed) and these will be checked during the current audit. Therefore,\nfor each non-conformity at the last audit, the auditor will expect to see:\n• Corrective action The site will have completed its corrective action within 28 days of the\nlast audit. The auditor will therefore expect to see this action in operation (e. g. that the\nupdated procedure submitted to the certification body as evidence of corrective action is\nin use, or that repairs have been completed and remain effective).\n• Preventive action At the time when the certificate was awarded, the site will have\nsubmitted a preventive action plan, but may not have completed all of the preventive\naction. The auditor will therefore expect to see evidence that the site implemented\npreventive action and that recurrence of the non-conformity has therefore been\neffectively prevented.\n• Root cause analysis Root cause analysis is used to identify the fundamental or root cause\nof a non-conformity, and is therefore a key activity in establishing appropriate preventive\naction. Although the site submitted the root cause analysis following the previous audit,\nthe auditor may need to review this; for example, if preventive action has been ineffective\nat preventing the non-conformity.\nThis process is detailed in II of the Standard, section 2. 3.2.\nMany sites have found it useful to retain copies of records and documents implicated by\nnon-conformities with the audit records. This allows quick and easy reference to the specific\ndocument while reviewing, investigating and correcting the non-conformity. (The original\ncopy of the document, should, of course, be returned to the appropriate place in the site’s\nquality system.)\nNote that additional information on preventive action and root cause analysis, and non-\nconforming situations which require their use, is detailed in I, section 3. 7 of the\nStandard, and especially clause 3. 7.2.\nA site’s attitude towards preventive action may also indicate its product safety culture. For\nexample, minimal follow-up, or preventive action that is just seen as a necessary document\nto pass an audit, may be a sign of a poor culture.\nBRCGS has published a guideline to understanding preventive action and root cause\nanalysis which explains some of the techniques available for identifying the cause of\nnon-conformities and preventing them from recurring. The guideline is available from the\nBRCGS Store or viewed online at BRCGS Participate.\nIf effective corrective or preventive action has not been introduced (e. g. it has been\nineffective at preventing recurrence), a non-conformity may be raised against this clause, in\naddition to a non-conformity against the clause that has the recurring issue."},{"id":"1.1.13","requirement":"The BRCGS logo and references to certification status shall be used only in accordance with the conditions of use detailed in the audit protocol section (Part III, section 6.7) of the Standard.","interpretation":"Sites that have gained certification against any of the BRCGS Standards are entitled to\ndemonstrate their pride in their achievement and use the BRCGS certification logo for\nmarketing purposes. This means the logo can be used on websites, letter headers, business\ncards, etc.\nHowever, the logo is not a product certification mark, so it (or words stating that the product\nwas produced in a BRCGS-certificated site) cannot be used on product packaging. The rules\naround logo use are highlighted in the protocol of the Standard (II, section 6. 7) and\nfurther guidance is available in the Brand Guidelines on the BRCGS website.\nWhere an auditor finds consumer-facing packaging with any BRCGS logo or wording during\nan audit, they will raise a non-conformity."},{"id":"1.1.14","requirement":"Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.","interpretation":"In countries, states or territories where there is a legal requirement to register premises as\nfood production sites, there must be documentary proof that the site has been appropriately\nregistered.\nThe clause is not limited to food defence, but to all requirements for food manufacturing,\nfood safety, authenticity, food defence, etc. However, the clause does not cover other legal\nregistrations related to personnel, health and safety (such as fire regulations) or employment\nlaw, as these are outside the scope of the Standard. Examples of registration include:\n• EU requirements detailed in EC Regulations No. 852/2004 on the Hygiene of Foodstuffs,\nArticle 6(2) and No. 853/2004 for animal products processing\n• FDA registration requirements in the US\n• registration with the local authority in the UK.\n1. 2 Organisational structure, responsibilities and management authority\nThe company shall have a clear organisational structure and lines of communication to enable effective\nmanagement of product safety, authenticity, legality and quality.\nThis section has three key objectives, to:\n• facilitate clear communication of the roles and responsibilities for food safety, authenticity, legality and quality,\nand ensure that staff are aware who has these responsibilities\n• ensure responsible individuals have the knowledge and ability to fulfil the role\n• empower staff to communicate any concerns relating to product safety, authenticity, legality or quality to the\nrelevant individuals, to facilitate a timely response where action is required."},{"id":"1.2.1","requirement":"The company shall have an organisation chart demonstrating the management structure of the company. The responsibilities for the management of activities which ensure food safety, authenticity, legality and quality shall be clearly allocated and understood by the managers responsible. It shall be clearly documented who deputises in the absence of the responsible person.","interpretation":"An organisational chart must be available, clearly indicating reporting lines for all managers\non the site and, where applicable, relationships to the company head office roles. The chart\nwould normally be expected to show both a position and the named person occupying that\nposition. Where the chart shows job titles only, other documents must indicate the person\noccupying each position.\nThe chart or associated documentation needs to clearly indicate the responsibilities of each\nrelevant member of staff with responsibility for the management of food safety, authenticity,\nlegality or quality. Examples include technical managers, quality assurance staff, section\nheads/managers (e. g. those accountable for overseeing production and cleaning activities (i. e.\nthose responsible for ensuring the correct standards are maintained)), any on-site laboratory\nstaff and product development teams.\nResponsibilities must be defined for key aspects of the food safety and quality management\nsystem, including, for example, decisions on corrective actions, non-conforming products,\nprocess deviations, finished product release, document control and customer complaints.\nIt is usual for specific responsibilities to be defined within the job descriptions of key staff\n(especially for management and supervisors); however, they may instead be described within\nsite procedures (e. g. responsibility for decisions on corrective action may be incorporated\ninto the site’s corrective action procedure).\nIt must be clearly documented who is expected to deputise in the absence of a manager.\nDeputies would usually be identified on the organisational chart and/or in job descriptions,\nbut documentation could also be in the form of an additional table. The responsibility\nmay be assigned to either a more senior or more junior person, as long as the deputy has\nthe knowledge and ability to adequately cover for the absent manager. Deputies may be\nappointed for the whole role or particular responsibilities may be deputised to different\npeople; as long as this is clearly defined.\nThe auditor will be looking for both documented responsibilities and evidence that the\nresponsible person is able to fulfil the role (clause 7. 1.7 requires the company to review the\ncompetencies of staff and ensure that any necessary training, mentoring or experience is\nprovided)."},{"id":"1.2.2","requirement":"The site’s senior management shall ensure that all staff are aware of their responsibilities and demonstrate that work is carried out in accordance with documented site policies, procedures, work instructions and existing practices for activities undertaken. All staff shall have access to relevant documentation.","interpretation":"The objective of this clause is to ensure that all staff, including temporary staff and\nemployment agency staff, are able to work effectively and ensure that food safety,\nauthenticity, legality and quality are maintained.\nConsistent application of these systems relies on the correct and established processes\nbeing documented, accessible by relevant staff and used in practice. This will usually be\nestablished by the auditor discussing roles with the employees themselves during the audit.\nThere is no requirement for a detailed job description; however, staff should be aware of\ntheir particular responsibilities. Where the role or an activity that makes up part of the role\ncovers a food safety, authenticity, legality or quality issue described within a procedure (e. g. a\nCCP or prerequisite programme), the staff must understand what is expected and be able to\naccess the relevant procedure."},{"id":"1.2.3","requirement":"Staff shall be aware of the need to report any risks or any evidence of unsafe or out-of-specification product, equipment, packaging or raw materials, to a designated manager to enable the resolution of issues requiring immediate action.","interpretation":"Where a food safety risk is identified by a staff member, the reporting function and\nsubsequent activity should be sufficiently rapid and effective to mitigate any food safety\nrisks.\nIdentified risks may be associated with, for example, raw materials, work in progress, final\nproduct, packaging or equipment. Good practice is to encourage staff to report as wide a\nrange of situations as possible, including out-of-specification results, damage, errors or when\nthe staff member is concerned that something does not look right or as it normally does.\nThe transfer of information from staff to senior management regarding unsafe or out-of-\nspecification situations is an example of a good food safety culture. If staff feel supported\nand empowered to identify and report issues and make positive changes, this will typically\nbe reflected in the effectiveness of the site’s product safety management systems."},{"id":"1.2.4","requirement":"If the site does not have the appropriate in-house knowledge of food safety, authenticity, legality or quality, external expertise (e.g. food safety consultants) may be used; however, the day-to-day management of the food safety systems shall remain the responsibility of the company.","interpretation":"Where external food safety consultants have been used as the main source of technical\nknowledge for a specific activity (e. g. to lead the development of the food safety plan or\nHACCP plan) it is essential that day-to-day responsibilities are under the control of the site\nand that it has personnel in place with working knowledge of the product safety systems,\nwho can operate effectively even when the consultant is not available.\nFor example, the requirements of clause 1. 2.1, regarding deputies and documented\nprocedures, apply even where a food safety consultant is used.\nA food safety consultant is seen as a service provider to the site and is therefore subject to\nthe requirements of section 3. 5.3.\n2 The food safety plan – HACCP\nFundamental\nThe company shall have a fully implemented and effective food safety plan incorporating the Codex\nAlimentarius HACCP principles.\nThe purpose of these requirements is to create a food safety plan to mitigate food safety hazards. The foundation of\nthis food safety plan is a hazard and risk analysis. In order to be effective this analysis must be systematic, science-\nbased, thorough, fully implemented and kept up to date.\nIn the food industry, the principles for assessing hazard and risk are commonly referred to as HACCP. However, the\nspecific terminology used in the Standard, such as prerequisites and critical control points (CCPs), are drawn from\nglobal terminology used to describe expectations. Sites are not required to use the specific terminology used in\nthe Standard; alternative terminology is acceptable, providing it is evident that all the requirements have been fully\nmet. For example, legislative requirements in the US (detailed in the Food Safety Modernization Act) use different\nterminology but still incorporate all the requirements of the Standard.\nSites are advised to avoid having multiple plans with different terminology as this is administratively complex\nand unnecessary. (It may, of course, be appropriate to have multiple plans where a site produces different types of\nproducts with different product safety hazards, but common terminology should be used throughout.)\nRegardless of the terminology used the food safety plan must incorporate all of the Codex Alimentarius HACCP\nprinciples. The clauses in Issue 9 have been updated to reflect the latest publication of the Codex Alimentarius\nHACCP principles, therefore where it is evident that all the requirements in section 2 have been fully met, a site will\nnot be expected to undertake additional activities to meet the Codex Alimentarius principles.\nThe plan must be specific to the products manufactured, processed or packed on site and the production processes\nused.\nCodex Alimentarius has published background information and extensive guidance on the HACCP principles which\ncan be found in the General Principles of Food Hygiene (CXC1-1969) last updated in 2020. It can be downloaded\nfrom the Codex Alimentarius page on the FAO’s website.\nBRCGS offers training on HACCP implementation. Details are available from the BRCGS website.\n2. 1 The HACCP food safety team (equivalent to Codex Alimentarius Step 1)"}],"statement_of_intent":"The site’s senior management shall demonstrate that they are fully committed to the implementation of the requirements of the Global Standard Food Safety and to processes which facilitate continual improvement of food safety, quality management, and the site’s food safety and quality culture."},{"section":2,"title":"The food safety plan – HACCP","clauses":[{"id":"2.1.1","requirement":"The HACCP or food safety plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality assurance, technical management, production operations and other relevant functions (e.g. engineering, hygiene). The team leader shall have an in-depth knowledge of Codex HACCP principles (or equivalent) and be able to demonstrate competence, experience and training.","interpretation":"For a comprehensive HACCP or food safety plan to be established, maintained and kept up\nto date it needs to be managed by a nominated team with suitable training, relevant skills\nand experience.\nThe number of HACCP food safety team members needs to be appropriate to the size and\nstructure of the company, as the team will include representatives of each department with\nresponsibility for the operation of the Standard (e. g. technical, quality assurance, purchasing,\nengineering, new product development, hygiene/sanitation and senior leadership team).\nThere will always be more than one person, since a single person does not constitute a\n‘team’. The team needs knowledge of the types of operations that are carried out at the site\nand the hazards these operations may present to the product.\nIt is good practice to document the team members within the study, with a summary of\ntheir roles, experience and areas of responsibility within the company. Membership of the\nHACCP food safety team needs to be reviewed and, when necessary, updated (e. g. when job\nresponsibilities change or personnel leave or join the company).\nThe team leader must be able to demonstrate competency and experience in HACCP/food\nsafety processes. This can be shown by:\n• the quality of the plan\n• documented evidence of their qualification (e. g. successful completion of an industry-\nrecognised HACCP training course)\n• demonstrable, extensive experience in implementing or training HACCP.\nThe team will need sufficient knowledge of HACCP processes, products manufactured on\nsite, production processes and relevant hazards, to facilitate a thorough hazard and risk\nanalysis and the creation of an appropriate food safety plan. This may be demonstrated by,\nfor example, training records (see clause 7. 1.6) that show adequate training (e. g. through an\nindustry-recognised training course or good quality internal training) has been given to all\nHACCP food safety team members. Any format or delivery method of training is permitted;\nhowever, the outcome should be a suitably trained individual capable of executing a HACCP\nor food safety plan as part of their team.\nWhere there is a legal requirement for specific training the site is expected to ensure this\nhas been completed.\nWhere external expertise has been used in developing the HACCP or food safety plan, the\nsite must demonstrate ownership of the identified requirements by ensuring that the day-\nto-day management of the food safety system remains the responsibility of the site (see\nclause 1. 2.4).\nAt the audit, the competency and understanding of the HACCP/food safety plan team will\nbe assessed, as well as the quality of the resultant HACCP or food safety plan. The site\nshould also be able to establish the training and competence of any external consultant in\nHACCP/food safety principles (see section 3. 5.3).\nSenior management commitment (clauses 1. 1.1 to 1. 1.14) is required to support the HACCP\nfood safety team. This may be demonstrated by the presence of senior management\nwithin the team, policy statements referring to HACCP or food safety, or evidence within\nmanagement review meetings that HACCP/food safety issues are discussed and reviewed.\nThe existence of a food safety plan does not, in itself, guarantee product safety, and it is vital\nthat the results of the HACCP or food safety plan are implemented, applied correctly and\nintegrated into the food safety and quality management system."},{"id":"2.1.2","requirement":"The scope of each HACCP or food safety plan, including the products and processes covered, shall be defined.","interpretation":"The scope of the HACCP or food safety plan must be identified. The scope should describe\nall the products and processes to be included within the study. In sites with a small range\nof similar products, it may be possible to incorporate all of the products and processes\ninto a single HACCP or food safety plan; however, where there is a wide range of different\nproducts or processes with different hazards, it is likely that the site will need to use more\nthan one plan.\nThe format of these plans is not prescribed by the Standard; various formats are acceptable\nas long as the scope for each plan is clearly defined and all activities and products are\ncovered within the processes. For example, a HACCP or food safety plan may cover each\ngroup of products with similar process characteristics, or the plan may be split into ‘modules’\nwhich cover specific process steps; these modules can then be used in a ‘mix and match’\nstructure to create a HACCP or food safety plan for any given product.\n2. 2 Prerequisite programmes"},{"id":"2.2.1","requirement":"The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). • cleaning and disinfection. • pest management. • maintenance programmes for equipment and buildings. • personal hygiene requirements. • staff training. • supplier approval and purchasing. • transportation arrangements. • processes to prevent cross-contamination. • allergen management","interpretation":"The prerequisites are the basic environmental and production conditions necessary for the\nmanufacture of safe food and the control of generic hazards. Note that the list of examples\nin the Standard is not exhaustive, and others will exist in some sites; for example, utilities,\nair and general aspects of the production environment. Sites must therefore define the full\nrange of prerequisites applicable to their site and operations.\nAlthough the prerequisites are usually covered by day-to-day activities such as good\nmanufacturing or hygiene practices, it is vital that they work effectively and to the correct\nstandards as:\n• The prerequisite programme needs to provide a solid base on which the rest of the\nHACCP or food safety plan can be developed.\n• The company is relying on the prerequisite activities to mitigate the identified hazards and\ndeliver safe product (e. g. if a site identifies cleaning as a prerequisite, then it relies on the\ncleaning activities to adequately remove food residues and dirt that might otherwise result\nin hazards such as allergen cross-contamination or microbiological contamination).\nTherefore there should be a whole work stream behind each identified prerequisite to\nensure that the relevant activity, procedures and policies are in place, that they are working\ncorrectly and that they continue to deliver the level of control required.\nAlthough the prerequisite programme is expected to be effective in achieving the level of\ncontrol required to ensure food safety, it is not a requirement that a documented validation\nof every prerequisite is undertaken, as prerequisite programmes typically cover a wide range\nof general environmental controls, often with results that are not quantifiable. However,\nwhere a prerequisite programme is used to manage a specific hazard (e. g. cleaning regimes\nused to prevent allergen cross-contamination), there needs to be a documented validation\nthat the prerequisite controls the identified hazard (see clause 2. 7.4 for further details\nregarding the validation). Some companies prefer to differentiate prerequisites that manage\nspecific hazards from other prerequisites by referring to them as operational prerequisites\n(oPRPs).\nSites that need to meet the requirements of the US Food Safety Modernization Act (FSMA)\nshould note that they must ensure that preventive controls are subject to validation and\nverification. Some of these controls may cover activities that have traditionally formed part\nof the prerequisite programme.\nThe clause contains references to later sections of the Standard which provide detail\non the requirements for effective management of some specific prerequisites, including\ncleaning (section 4. 11), pest management (section 4. 14) and training (section 7. 1). These are\nnot intended to be an exhaustive list of all prerequisites or all the relevant sections of the\nStandard.\nThe prerequisite programmes are often dependent on the production risk zoning (see clause 4. 3.1); for example, cleaning within a high-risk zone. Therefore it may be necessary to place\ngreater attention on some prerequisites that are particularly important for food safety in\nthose specific zones.\nGood practice is to review the prerequisite programmes and their management. The\nfrequency of this review should be based on risk, but it could be included, for example, in\nthe annual review of the HACCP or food safety plan.\n2. 3 Describe the product (equivalent to Codex Alimentarius Step 2)"},{"id":"2.3.1","requirement":"A full description for each product or group of products shall be developed, which includes all relevant information on food safety. • composition (e.g. raw materials, ingredients, allergens, recipe). • origin of ingredients. • physical or chemical properties that impact food safety (e.g. pH, aw). • treatment and processing (e.g. cooking, cooling). • packaging system (e.g. modified atmosphere, vacuum). • storage and distribution conditions (e.g. chilled, ambient). • maximum safe shelf life under prescribed storage and usage conditions","interpretation":"A full description of the product is required to ensure that all aspects that could potentially\naffect food safety are considered. The Standard gives guidance on the factors that may be\nconsidered:\n• composition (e. g. raw materials or ingredients used, allergens, recipes)\n• origin of the ingredients (e. g. climatic conditions, culture or food safety standards may\nmake some countries a greater risk than others)\n• physical or chemical properties that impact food safety (e. g. pH, aw)\n• treatment and processing conditions (e. g. cooking, chilling)\n• product packaging system (e. g. modified atmosphere, vacuum packing or canning)\n• storage and distribution conditions (e. g. chilled, frozen or ambient)\n• maximum safe shelf life under prescribed storage and usage conditions.\nGood practice is not to simply describe the product, but to consider the possible\nimplications of what will be needed later in the HACCP study. For example, when\nconsidering the origin of ingredients, rather than just stating the material comes from a\nspecific country or region, it may be useful to consider whether the potential climatic\nconditions, culture or food safety standards in the country change the hazards.\nProduct groups can be used where the products are similar (e. g. different pack sizes).\nHowever, where significantly different products (e. g. coated and non-coated meat products)\nare manufactured, these are to be treated as separate products or groups."},{"id":"2.3.2","requirement":"All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. • the latest scientific literature. • historical and known hazards associated with specific food products. • relevant codes of practice. • recognised guidelines. • food safety legislation relevant for the production and sale of products. • customer requirements. • a copy of any existing site HACCP plans. • a map of the premises and equipment layout. • a water distribution diagram for the site. • indication of any areas (zones) where high-risk, high-care or ambient high-care production facilities are required","interpretation":"Up-to-date background information must be taken into account when preparing the HACCP\nor food safety plan. Therefore, suitable information must be collated and maintained.\nThere are many sources of information, particularly on the internet; for example, Codex\nAlimentarius, European Food Safety Authority, US Food and Drug Administration, or\nthe Rapid Alert System for Food and Feed (RASFF). Sources of information must be\nreferenced in the HACCP or food safety plan and be recoverable or available on request\n(using an internet search engine to find the information during an audit is not acceptable,\nas this implies that the information was not collected and maintained for use during the\ndevelopment of the HACCP or food safety plan). A list of legislation and codes of practice\nreferenced may be helpful.\nMany membership organisations also provide useful information. Where membership\ninformation is referenced, this also needs to be available on site (either electronically or as\nhard copy).\nThe Standard gives some guidance on the types of information that may be considered in\ndeveloping the HACCP or food safety plan. These include:\n• the latest scientific literature (good practice is to understand the source of the material;\nfor example, peer-reviewed science may have greater validity and usefulness)\n• historical and known hazards associated with specific food products (good practice is to\nbe as specific as possible, giving, for example, the name of the micro-organism(s) that are\nknown hazards to the product, rather than just listing ‘bacteria’)\n• relevant codes of practice\n• recognised guidelines – for example:\n• material provided on BRCGS Participate\n• publication by regulatory authorities\n• publications available from industry experts, trade associations, etc.\n• food safety legislation relevant for the production and sale of products in destination\ncountries, states or territories\n• customer requirements\n• existing HACCP plans; i. e. plans from products that are already in production. There are\ntwo uses for the existing plan:\n• learnings from previous plans may provide a useful reference\n• existing products, ingredients or processes within the same manufacturing area may\nresult in additional risks that need to be managed\n• a map of the premises and equipment layout\n• a water distribution diagram\n• indication of any production risk zoning.\n2. 4 Identify intended use (equivalent to Codex Alimentarius Step 3)"},{"id":"2.4.1","requirement":"The intended use of the product by the customer, and expected alternative uses, shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers).","interpretation":"The HACCP food safety team needs to consider and document the intended use of the\nproducts by the customer and the ultimate consumer to ensure all the risks have been\nassessed. For example, the team should consider:\n• the target population (e. g. does this include high-risk groups such as infants, elderly\npeople or allergy sufferers?)\n• handling and preparation (e. g. will the product be consumed without further cooking?)\n• the customer supply chain\n• storage (e. g. frozen, or the requirement for chilled storage after opening the pack).\nWhere there is an expected alternative food use for a product, including the potential\nfor a customer or consumer to misuse or mistreat the product in a way not intended by\nthe manufacturer, this information should be included in the description in the HACCP\nassessment so that any implications can be considered as part of the subsequent hazard\nanalysis. This alternative use may occur in the consumer’s home (e. g. consumption of a\nproduct that looks ready to eat without completing the correct cooking) or elsewhere in the\nsupply chain (e. g. an unintended use of a raw material). A number of product recalls have\noccurred, for example, with frozen raw vegetables and coated/battered poultry products due\nto unintended use of the product. Inclusion of intended and expected alternative uses of a\nproduct can also provide a useful due diligence reference demonstrating to a customer or\nregulatory authority the scope of hazards that have been considered.\n2. 5 Construct a process flow diagram (equivalent to Codex Alimentarius Step 4)"},{"id":"2.5.1","requirement":"A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope. • plan of premises and equipment layout. • raw materials, including introduction of utilities and other contact materials. • sequence and interaction of all process steps. • outsourced processes and subcontracted work. • potential for process delay. • rework and recycling. • low-risk/high-risk/high-care area segregation. • finished products, intermediate/semi-processed products, by-products and waste","interpretation":"The process flow diagram provides the site with an important tool, allowing it to evaluate the\npossible introduction, occurrence or change of hazards at each step of the process. It should\ntherefore be used when identifying hazards (see clause 2. 7.1) and conducting hazard analysis\n(see clause 2. 7.2).\nTherefore, an accurate flow diagram indicating all the process steps, including all inputs and\noutputs, needs to be constructed for each HACCP or food safety plan. This may be achieved\nwith a single diagram, or it could be in a modular form with several documents compiled to\nprovide the complete information (in this situation it must clearly identify the interaction\nbetween the process steps). The Standard lists guidance on the points to consider and\ninclude when developing the flow diagram; for example:\n• a plan of the premises and equipment layout to facilitate consideration of cross-\ncontamination risks (e. g. allergen control)\n• raw materials – it should be clear where raw materials are stored and the routes they take\ninto the production area; this includes the introduction of utilities and other contact\nmaterials (e. g. water or packaging)\n• sequence and interaction of all process steps (e. g. method of transportation between each\nstep)\n• outsourced processes and subcontracted work, including, for example, off-site processing,\nstorage, packing or transport\n• potential for process delay (i. e. how products or ingredients will be handled if a delay\noccurs)\n• rework and recycling\n• low-risk/high-risk/high-care segregation (i. e. clearly indicating where the different\nproduction zones are located)\n• finished products, intermediate/semi-processed products, by-products and waste (e. g.\nwhere waste products leave the production process, and the storage of intermediates and\nfinished products).\nclause 3. 2.1 of the Standard requires the site to have an effective document control system.\nSigning and dating the approved process flow diagram is one method of demonstrating that\nthis is occurring.\nExamples There is no set pattern or format for the diagram. However, it is important to show all the\nsteps in the process, from raw materials through to final products, as shown in \nRaw Materials\nAll Process Stages\nProduct\nAll products must be covered in the diagram, so if your site has a wide range of similar\nproducts or processes, a modular option may be preferable; Figures 2 and 3 show examples.\nOtherwise a separate linear diagram is needed for each product; i. e. 20 products would need\n20 linear process flow diagrams.\nRaw Materials\nAll Process Stages\nProduct B\nAll Process Stages\nProduct C\nAll Process Stages\nProduct A\nExamples\nAll Process Stages\nSteamed Ingredients\n(See HACCP Study B1) Final Products\nDeep Fat Frying\n(See HACCP Study A1)\nRaw Ingredients\nIf you use a modular or generic diagram, take care to ensure that it includes all steps and\nall products. If your site manufactures multiple products that are considerably different or\nrequire different processes, you will need to have several separate diagrams.\nIn addition to the process steps, the diagram needs to contain:\n• all raw materials used in the manufacture of the product(s), including the introduction of\nutilities and other contact materials (e. g. water or packaging)\n• details of any outsourced or subcontracted process (i. e. any activity that is part of the\nproduction process but does not occur on site)\n• rework or recycling\n• low-risk, high-care and high-risk segregation\n• routes taken by waste products\n• all finished products, intermediates, semi-processed products or by-products.\nExamples of completed process flow diagrams are shown in Figures 4 and 5.\nExamples\n8. Sieving (Xμm) 9. Tempering\n(Ambient ≤X hours)\n5. Bulk Storage (Ambient)\n1. Flour 2. Sugar\n7. Chilled Storage (X-Yo\nC)\n11. Weighing Up\n12. Mixing\n13. Forming\n17. Baking\n(≥X C, Y minutes)\n18. Cooling\n(Ambient, X minutes)\n21. Packing\n23. Date Coding\n24. Metal Detection\n25. Ambient Storage\n16. Waste\n15. Rework\n6. Ambient Storage\n3. Walnuts\n10. Water\n26. Dispatch\n22. Waste\t20. Packaging Store\n19. Pre-Printed\nPlastic Wrap\nExamples\n7. Curing Brine\nPreparation\n6. Water 8. Injection 9. Thaw (X C for Y-Z hours)\n4. Ambient Storage\n1. Salt (NaCl) 2. Nitrite Curing Salt\n5. Frozen Storage (<Xo\nC)\n3. Trimmed Pork Joints\n10. Tumbling 11. Waste (Brine)\n12. Cooking\n(≥Xo\nC for Y minutes)\n13. Cooling Blast Chill\n(<Xo\nC within Y hours)\n14. Chilled Storage (X-Yo\n(if required due to delay\n)\n20. Packing & Labelling\n21. Date Coding\n22. Metal Detection\n23. Chilled Storage\n(X-Yo\nC)\n24. Chilled Dispatch\n(X-Y C)\n16. Waste\n19. Disinfection\t18. Packaging Store\n17. Plastic Trays, Film\nLids & Labels\nLOW RISK\nHIGH RISK\nHIGH RISK\nENCLOSED\nPRODUCT AREA\n2. 6 Verify process flow diagram (equivalent to Codex Alimentarius Step 5)"},{"id":"2.6.1","requirement":"The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit at least annually, and whenever there are changes to the process.","interpretation":"The flow diagram shall be verified as accurate. A member of the HACCP food safety team\nwho is based at the site, part of the team, or the whole team must check that the flow\ndiagram is accurate by on-site audit. This may be achieved using a physical walk-through of\nthe process within the production area. A report of the activity and any findings will help to\ndemonstrate that this has been completed.\nDuring the BRCGS audit, the auditor will confirm the accuracy of the documented process\nflow diagram by following the process in production.\nIt is vital that the process flow diagram remains up to date; therefore verification should\noccur whenever there is a review of the HACCP or food safety plan (e. g. whenever there\nis a change to the plan or operational activity) and at least once per year. For example, the\nmanufacture of a new product (see clause 5. 1.2) should result in a HACCP review to confirm\nthat any hazards to existing products have been managed appropriately, as well as ensuring\nthat any hazards affecting the new product are controlled.\nIt is important that any daily (e. g. different shifts, including any night or weekend shifts) or\nseasonal variations are considered during the verification process (e. g. the production of a\nChristmas range that uses ingredients or processes not used during the rest of the year or\nsignificant changes in production volume).\nThe site must retain records of the diagrams and verification activities. For example, a\nverification record could include an annotated diagram showing:\n• the date and time of the verification\n• the product(s) being manufactured at the time the activity was observed\n• any amendments or alterations that were noted.\nAlternatively, a separate report could be produced in the format of an internal audit.\nThe records should also be signed to confirm who completed the verification.\n2. 7 List all potential hazards associated with each process step, conduct a hazard\nanalysis and consider any measures to control identified hazards (equivalent to\nCodex Alimentarius Step 6, Principle 1)"},{"id":"2.7.1","requirement":"The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. • microbiological. • physical contamination. • chemical and radiological contamination. • fraud (e.g. substitution or deliberate/intentional adulteration). • malicious contamination of products. • allergen risks","interpretation":"It is expected that the list will include specific hazards. The Standard provides examples of\nthose that should be considered, including:\n• specific micro-organisms (e. g. E. coli or Salmonella)\n• specific chemicals (e. g. veterinary residues, pesticides or radiological contaminants)\n• cleaning chemicals\n• machinery lubricants\n• specific foreign bodies (e. g. glass, metal or plastic)\n• specific allergens (e. g. peanuts or egg); i. e. those identified by the company, materials that\nare considered allergens in the country of intended sale and any customer requirements\n• the potential for fraud and/or adulteration\n• malicious tampering with the product or processes.\nIt is important that the company considers all relevant potential hazards from all relevant\nsources. These could include raw materials, processes and the factory environment. The\nprocess flow diagram is a useful tool in considering the potential risks at each stage of\nproduction. Some sites find it useful to consider each hazard, at each step, in terms of:\n• whether the hazard is likely to be present in, for example, the raw material or the\nprocessing environment\n• whether there is the potential to introduce or create a specific hazard at the step in the\nprocess being considered\n• if there is the potential for growth of micro-organisms\n• whether the hazard will survive the processing step; for example, whether a pathogen\ncan survive in the product, or whether the contaminant is stable to the process being\ncompleted (e. g. heat stable).\nThere must be a description of each hazard and its sources – one hazard may have several\npotential sources and occur at more than one point in the process. This is important to\nensure that effective controls for each source of hazard are established in the subsequent\nsteps of the process.\nThe Standard has referenced food fraud and malicious contamination (food defence) in\nthe list of hazards in this clause to draw attention to the need to include these within\nsite assessments. However, later sections of the Standard (sections 4. 2 and 5. 4) provide\ngreater detail on the expected activity in these areas. This clause does not require\nthose assessments to be repeated or duplicated (as part of the HACCP plan, and then in\ncompliance with sections 4. 2 and 5. 4) – separate assessment processes are acceptable and\nthe site can reference the additional assessment within the HACCP plan. However, the\noutputs from those separate assessments must be considered as part of this process, to\nensure that the correct controls, monitoring, verification, etc. are in place.\nThe aim of including radiological hazards within the clause is to consider potential\ncontamination by radioactive isotopes (a legal requirement in some countries) which\nmay be present in water or soil (either from a naturally occurring source or resulting from\ncontamination caused by humans). A number of authorities produce reports on known\nradiological hazards; for example:\nIn the UK:\n• FSA: Radioactivity in Food and the Environment (RIFE)\n• UK Health Security Agency:\nThree Steps to Manage Radon in Buildings – Check, Measure, Act\n• UK government: Radioactivity in Food and the Environment (RIFE) Reports.\nIn the US:\n• FDA: FDA Response to the Fukushima Daiichi Nuclear Power Facility Incident.\nIn Ireland:\n• EPA: National Radiation Monitoring Network"},{"id":"2.7.2","requirement":"The HACCP food safety team shall conduct a hazard analysis to identify the significant hazards (i.e. those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented, eliminated or reduced to acceptable levels. • likely occurrence of hazard. • severity of the effects on consumer safety. • vulnerability of those exposed. • survival and multiplication of micro-organisms of specific concern to the product. • presence or production of toxins, chemicals or foreign bodies. • contamination of raw materials, intermediate/semi-processed product, or finished product","interpretation":"Any hazards identified in clause 2. 7.1 must be evaluated against the criteria detailed in this\nclause to identify those which are significant. For the purposes of the Standard a significant\nhazard is a hazard identified by the hazard analysis, which is reasonably likely to occur in the\nabsence of a control, at an unacceptable level (i. e. a level that would be considered unsafe or\nillegal), and therefore control is essential for the production of a safe product. The HACCP\nfood safety team must therefore take into account:\n• the likely occurrence of the hazard, taking into consideration existing prerequisite\nprogrammes, the nature of the facility and the equipment used\n• the severity of the effects on consumer safety\n• the vulnerability of those exposed\n• the survival and growth of micro-organisms (i. e. those of concern to the product(s) within\nthe scope of the HACCP or food safety plan)\n• the presence or production of toxins, chemicals or foreign bodies\n• contamination of raw materials, intermediates, semi-processed product or finished\nproduct.\nEvidence of the decisions, along with the justification for the decision and the decision-\nmaking process, must be kept within the HACCP or food safety plan.\nThere are a range of tools that may assist with the evaluation of hazards (e. g. quadrant\ngraphs, scoring systems, logic tables or decision trees). The team may choose to use these\ntools but should keep a record of any that are deployed. Such tools may also help in\nestablishing CCPs.\nIt is useful to remember that the quality of the output from the assessment depends on\nthe quality of the data or evidence used. The hazard analysis should, wherever possible, be\nbased on demonstrable evidence such as documented validation studies, trend analysis\nand science-based literature. Where this information is not available at the site, it may be\nnecessary for the site to obtain it from suppliers or reputable external sources to establish\nthe likelihood or severity of the specific hazards.\nWhere elimination of a hazard is not possible, acceptable levels need to be defined.\nReference should be made to legal requirements or scientific evidence to justify the\nacceptable levels (e. g. microbiological standards or presence of mycotoxins)."},{"id":"2.7.3","requirement":"The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level.","interpretation":"Control measures required to reduce or eliminate the specific hazards (i. e. each hazard\nidentified in clause 2. 7.1) must be established. Any hazard that cannot be eliminated must\nhave control measures designed to reduce it to an acceptable level of presence. This\nacceptable level (e. g. setting a target of <100 cfu/g of Staphylococcus aureus in finished\nproduct) needs to be justified; in other words the site should understand the potential\nconsequences of the hazard and be able to demonstrate that the acceptable level will\nadequately protect the consumer.\nIndustry guidelines, codes of practice, legislation etc. can help to establish and justify these\nlevels."},{"id":"2.7.4","requirement":"Where the control of a specific food safety hazard is achieved through prerequisite programmes or control measures other than critical control points (CCPs), this shall be stated and the adequacy of the programme to control the specific hazard validated.","interpretation":"It is important that all controls are effective and consistently prevent identified hazards from\noccurring. Therefore where specific hazards are controlled by mechanisms other than CCPs\n(e. g. by prerequisite programmes or other control measures) these also need to be validated.\nIt is not a requirement that a documented validation of every prerequisite is undertaken, as\nprerequisite programmes typically cover a wide range of general environmental controls,\noften with results that are not quantifiable. However, where a prerequisite programme is\nused to manage a specific hazard (e. g. cleaning regimes used to prevent allergen cross-\ncontamination), there needs to be a documented validation that the prerequisite controls\nthe identified hazard. Some companies prefer to differentiate these prerequisites that\nmanage specific hazards from other prerequisites, by referring to them as operational\nprerequisites (oPRPs).\nExamples of prerequisites that require validation include:\n• control of allergen cross-contamination by cleaning the production equipment. Evidence\nis required that the cleaning regime can effectively and consistently remove the allergen\n(examples of how this might be achieved are given in the guidance to clause 5. 3.8).\n• chilled storage conditions for product safety. The defined storage temperature must be\nvalidated by reference to technical literature, confirming the control of growth of relevant\nspoilage or food poisoning organisms. The storage facility must be validated as being\ncapable of consistently delivering the defined temperature.\nPrerequisites used to control specific hazards must also be subject to routine verification\nand monitoring, and records should detail the control measures and monitoring procedures\nused (see clause 2. 12. 2 for full details of this requirement).\n2. 8 Determine the CCPs (equivalent to Codex Alimentarius Step 7, Principle 2)"},{"id":"2.8.1","requirement":"For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. CCPs shall be those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level.","interpretation":"Each control measure must be examined to identify which are critical (i. e. to identify the\npoints at which control can be applied). This is essential to prevent or eliminate a food\nsafety hazard or reduce it to an acceptable level.\nRecords must be available showing how this has been conducted and how decisions have\nbeen reached.\nThe Standard is not prescriptive on the tools used to facilitate this process; for example,\na two- or four-question decision tree may be useful. The site must, however, be able to\ndemonstrate that it has used a logical approach and, therefore, a copy of any decision-\nmaking tools used and the results (e. g. the results of the questions from the decision tree)\nmust be recorded.\nIf a hazard has been identified as critical but there is no control measure at that step or any\nother, the product or process should be modified so that a suitable control measure can be\nincorporated either at this step or at an earlier point in the process.\nSites working in accordance with the US Food Safety Modernization Act (FSMA) are likely to\nfind that the preventive controls required by that legislation include all of the controls that\nwould normally be identified as CCPs using a HACCP system. For example, CCPs are known\nas process preventive controls (PPCs) in an FSMA-compliant food safety plan. For\ncertification purposes, it does not matter which terms are referenced as their management\n(for certification purposes) would be the same. Other preventive controls are historically\ntreated as PRPs (prerequisite programmes) in many sites. In some cases, parts of them are\nelevated to preventive controls; these include food allergen, sanitation, supply chain, based\non known or reasonably foreseeable risk of a serious adverse health consequence or death\nto humans or animals (SAHCODHA) hazard.\nWhere the management components of those preventive controls do not contain all the\nsame elements of the CCPs/PPCs it is expected that the site would combine the most\nstringent requirements of FSMA and the Standard together. For example, a sanitation\npreventive control does not require validation for allergen cleaning under FSMA but it\nis required by the Standard (see clause 2. 7.4), therefore the Standard expects additional\ncompliance with this requirement.\nAuditors shall be looking to confirm that the site has identified the correct points at which\ncontrol should be exercised by the appropriate control mechanisms.\n2. 9 Establish validated critical limits for each CCP (equivalent to Codex Alimentarius\nStep 8, Principle 3)\nOnce the HACCP or food safety team has identified all the relevant CCPs, it must then identify critical limits. The\ncritical limit is the point that separates safe from unsafe or acceptable from unacceptable product.\nSome critical limits are defined by legislation; however, many will require experimental results, the advice of\nappropriate industry specialists or consideration of customer requirements."},{"id":"2.9.1","requirement":"For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be: • measurable wherever possible (e.g. time, temperature, pH). • supported by clear guidance or examples where measures are subjective (e.g. photographs)","interpretation":"All identified CCPs must have defined critical limits – the point that, if properly and\nconsistently implemented, separates safe from unsafe or acceptable from unacceptable\nproduct.\nWherever possible the criteria used should be objective (i. e. measurable), such as the\ntemperature, time, moisture level, pH and aw.\nWhere objective criteria are not available, subjective parameters can be used. These\nmay include sensory parameters such as visual appearance and texture, but they must be\nsupported by clear guidance or examples. Photographs of acceptable and unacceptable\nlimits or product samples for comparison could be shown as examples to staff at process\ncontrol points.\nGood practice is often to identify action limits as well as critical limits with the aim of\nensuring the measured parameter remains controlled; i. e. to identify a point at which action\ncan be taken or a review completed, when the product or process is approaching the critical\nlimit, but prior to it actually exceeding the critical limit.\nDetails on how the critical limits have been determined must be documented; these may\ninclude industry best practice, legislation or validation studies undertaken by the company."},{"id":"2.9.2","requirement":"The HACCP food safety team shall validate each CCP, including critical limits. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.","interpretation":"Documented evidence must be available showing how the control measures for CCPs and\ncritical limits have been validated to ensure they control, reduce or eliminate the hazard to\nan acceptable level.\nValidation must be specific and demonstrate that if the control measures are followed as\nspecified and the critical limits are met (at minimum and maximum levels where a range\nis indicated), a consistently safe product will be produced. Evidence could come from\nprofessional bodies, trade associations, historical processing data, scientific and technical\nliterature or legislation. In addition, scientifically valid experimental or pilot plant trial data\nor exercises, such as challenge testing, may be required to confirm the capability of the\nprocess.\n2. 10 Establish a monitoring system for each CCP (equivalent to Codex Alimentarius\nStep 9, Principle 4)\nMonitoring is a planned set of checks or measurements for each CCP to ensure it is consistently meeting the\nidentified critical limit. Monitoring must be recorded in terms of both the procedures to be followed and the results\nobtained."},{"id":"2.10.1","requirement":"A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and, wherever possible, provide information in time for corrective action to be taken. • online measurement. • offline measurement. • continuous measurement (e.g. thermographs, pH meters)","interpretation":"Each CCP needs to be monitored to ensure the established limits are not exceeded. This\ncan be achieved by observing or measuring the CCP at scheduled intervals or by the use of\nautomated continuous measurement systems.\nA monitoring procedure must be established for each CCP. At a minimum, this should\ninclude:\n• the CCP to which the procedure relates\n• the staff (or staff role) responsible for monitoring the CCP (clause 1. 2.1 requires the staff\nresponsible for product safety activities to be documented)\n• training requirements for responsible staff (see clause 7. 1.2)\n• the frequency at which the monitoring is completed\n• instructions on how the monitoring is completed\n• the requirements for record-keeping (clause 2. 10. 2)\n• the critical limit(s).\nIt is often useful for the procedure to include the action to be taken if the specified limit is\nexceeded (e. g. who to inform).\nMonitoring must be able to detect variation, which may result in limits being broken if no\nremedial action is taken. Wherever possible, monitoring must be sufficiently frequent to\nensure that any necessary remedial action can be taken in adequate time so that there is no\nrisk to the product and that no potentially affected product is released for sale or dispatched\nto the customer.\nMethods used may include online or offline measurements and may be continuous or\ndiscontinuous."},{"id":"2.10.2","requirement":"Records associated with the monitoring of each CCP shall include the date, time and result of measurement, and shall be signed by the person responsible for the monitoring and verified, when appropriate, by a suitably competent and authorised person.","interpretation":"The results of monitoring activities must be recorded. At a minimum, these records must\ninclude:\n• date and time when the measurement was made\n• the result\n• the signature of the individual conducting the monitoring\n• the signature of the individual (e. g. the line manager) checking and verifying the record.\nRecords of the monitoring should be evaluated by a designated person with knowledge to\nconfirm the acceptability (or otherwise) of the results and authority to carry out corrective\nactions when necessary. It is often valuable for the verification to be completed by a\ndifferent individual rather than the staff member who completed the monitoring, however,\nthis is not always possible in very small sites. This verification should be completed at\nappropriate frequencies which, depending on working practices, may be at identified points\nduring the day (e. g. at the end of the shift) rather than every time a measurement is made.\n2. 11 Establish a corrective action plan (equivalent to Codex Alimentarius Step 10,\nPrinciple 5)"},{"id":"2.11.1","requirement":"The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control.","interpretation":"A documented procedure needs to be established, detailing the actions to be taken when\nmonitoring indicates that limits have been exceeded or when trends suggest they may be\nexceeded if no remedial action is taken.\nThe site will need to ensure that all CCPs are covered by corrective action plans. This may be\nachieved by having a single corrective action document or by individual documents for each\nCCP. However, it is important that the identified actions are specific to each CCP and not\nsimply generic statements.\nThe procedure must include:\n• Authorised personnel – identify who can make decisions about product produced where\nlimits have been exceeded and the corrective actions to be taken.\n• Immediate remedial action to be taken – for example, to bring the process back within\ncritical limits.\n• Quarantine procedures – instructions on how implicated products (those that have passed\nthrough the process and may therefore have exceeded the limits) are identified, handled,\nisolated and/or stored until their safety status is established (e. g. products that have been\nmetal-detected since the last satisfactory metal detector check). The handling and storage\nprocedure must ensure that implicated product cannot enter production or be distributed\nto customers unless it has been confirmed as safe and released by the authorised staff.\n• Disposal procedures for unsafe products.\n• Additional actions that may be required (e. g. alternative processing, increased monitoring,\netc.).\nGood practice is to use root cause analysis, where possible, to identify and correct the\nfundamental cause of the out-of-specification result.\nAll actions should be recorded.\nWhen investigation shows that the implicated product is safe and can be released to\ncustomers it may be necessary to review the critical limit, as the ‘safe’ product implies that\nthe critical limit has not been set at the correct value.\n2. 12 Validate the HACCP plan and establish verification procedures (equivalent to\nCodex Alimentarius Step 11, Principle 6)\nValidation is defined as obtaining evidence through the provision of objective evidence that a control or measure,\nif properly implemented, is capable of delivering the specified outcome. In other words, it is objectively confirming\nthat the plan will perform, effectively, as intended.\nSimilarly, verification is the application of methods, procedures, tests and other evaluations, in addition to\nmonitoring, to determine whether a control or measure is or has been operating as intended. In other words,\nverification seeks to answer the question, ‘Has it been operating effectively, as intended?’ Codex Alimentarius has\npublished guidelines for the validation of food safety control measures (CXG 69-2008) which can be downloaded\nfrom the Codex Alimentarius guidelines page of the FAO’s website."},{"id":"2.12.1","requirement":"HACCP or food safety plans shall be validated prior to any changes which may affect product safety, to ensure that the plan will effectively control the identified hazards before implementation.","interpretation":"It is important that the site validates the food safety plan to confirm it will perform,\neffectively, as intended, and therefore prevent food safety hazards from occurring. In other\nwords, the site should assess whether what it intends to put in place will actually work in\npractice.\nObviously, to be effective this validation needs to be completed before the plan is\nimplemented and before any changes are made (e. g. in production) that could affect food\nsafety.\nIn some countries (e. g. the US), there is an additional legal requirement for a revalidation\nafter implementation, which must occur within a specified timescale, such as 90 days. This\nis good practice as it allows sites to consider the effects of upscaling (i. e. moving from trial\nsystems to full production) or any other changes that may have occurred during the first few\nweeks of production, and therefore ensure that the plan still accurately reflects the actual\nproduction. Sites operating in countries where this is not a legal requirement may also find\nthis a useful good-practice addition to their ways of working.\nThere are a number of aspects of the plan that should be validated, including:\n• production process flow\n• identification of the correct hazards at the correct steps of the process\n• identification of the correct CCPs\n• the establishment of monitoring and verification activities, including what to monitor and\nhow frequently\n• critical limits and the corrective actions associated with each CCP.\nValidation in this context could include a range of activities, depending on the relevant\nhazards, such as:\n• review of literature\n• mathematical modelling\n• validation studies\n• guidance from authoritative sources (e. g. legislation).\nIt is important that the site has a mechanism to ensure that every subsequent change is\ncaptured and reviewed. This might include changes to processes or seasonality.\nWhere a HACCP plan already exists and has been operating effectively for a period of\ntime the validation may be achieved using established verification and review processes\ndeveloped in accordance with clauses 2. 12. 2 and 2. 12. 3."},{"id":"2.12.2","requirement":"Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective. • internal audits. • review of records where acceptable limits have been exceeded. • review of complaints by enforcement authorities or customers. • review of incidents of product withdrawal or recall","interpretation":"The HACCP or food safety plan, including controls managed by prerequisites, must be\nverified to ensure that it remains effective.\nVerification requires objective evidence that the specified requirements are being met.\nThis may include verification that monitoring has been completed correctly, that results\nare understood and that appropriate corrective actions have been completed. Examples of\nactivity that can be included in verification studies are:\n• internal audits (e. g. to ensure the correct procedures and work instructions are in use and\nthat monitoring frequencies are correct)\n• review and trending of records (e. g. CCP monitoring records)\n• review of complaints by enforcement authorities or customers\n• review of incidents (e. g. product withdrawal or recall).\nThe results of this verification must be documented and communicated to the HACCP or\nfood safety team as part of the review process.\nVerification should be completed to a planned schedule."},{"id":"2.12.3","requirement":"The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety. • change in raw materials or supplier of raw materials. • change in ingredients/recipe. • change in processing conditions, cleaning and disinfection procedures, process flow or equipment. • change in packaging, storage or distribution conditions. • change in consumer use. • emergence of a new risk. • review following a significant product safety incident. • new developments in scientific information","interpretation":"The HACCP or food safety plan and associated prerequisite programmes must be reviewed\nregularly, at a minimum of once a year, even if there have been no changes to the product\nrange or processing methods. Some or all of the plan should be reviewed whenever there is\na significant change.\nChanges that may affect product safety, such as those listed in this clause, need to be\nevaluated in the context of the plan before they are introduced, and the plan amended as\nnecessary.\nA procedure could be documented that lists the activities or changes which trigger a\nHACCP review, but this would have to be backed up by documented evidence that the\nreview has actually been carried out (e. g. by documenting minutes of the meeting or an\nagreed action plan).\nIn the case of published incidents (e. g. recalls or media stories), it is good practice to\nconsider whether the product involved is similar to those produced at the site, and therefore\nwhether a similar problem could occur with the site’s products. Where a genuine risk is\nidentified, the site should complete a review of the existing HACCP controls to establish\nwhether they remain sufficient or whether amendments are required. However, it is not a\nrequirement of the Standard to complete an in-depth analysis of every recall that occurs\nwhere no similarity or risk exists.\n2. 13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius\nStep 12, Principle 7)"},{"id":"2.13.1","requirement":"Documentation and record-keeping shall be sufficient to enable the site to verify that the HACCP and food safety controls, including controls managed by prerequisite programmes, are in place and maintained.","interpretation":"Records must be kept to demonstrate that the HACCP or food safety plan, including the\nprerequisite programmes, is fully implemented. This must include all the steps in creating\nand reviewing the plan, records of control and monitoring procedures, and training records\nof staff.\nFurther details on record-keeping are available in the requirements in section 3. 3 of the\nStandard and its interpretation.\n3 Food safety and quality management system\n3. 1 Food safety and quality manual\nThe company’s processes and procedures to meet the requirements of this Standard shall be documented to\nallow effective, consistent application, facilitate training, and support due diligence in the production of a safe\nproduct.\nA well-documented, systematic management system forms the basis for the product and process controls necessary\nto produce safe products, meet the requirements of the Standard, meet customer specifications and enable staff to\nbe trained and informed.\nIn many instances, the Standard specifically states that requirements shall be satisfied by documented procedures;\nin others, this is implied as the company needs to ensure consistent application throughout the site and show that\nsystems are in place to demonstrate food safety to external stakeholders (including regulatory authorities, customers\nand the BRCGS auditor). The Standard therefore requires policies, procedures, records, risk assessments, etc. , to be\ndocumented in sufficient detail to achieve these aims.\nThe Standard does not prescribe a review frequency for the food safety and quality manual, or the documents within\nit; however, good practice is to update the manual, or relevant parts of it, whenever there is a change to processes or\nprocedures."}],"statement_of_intent":null},{"section":3,"title":"Food safety and quality management system","clauses":[{"id":"3.1.1","requirement":"The site’s procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual.","interpretation":"Policies, procedures and work instructions must be in place, easily retrievable and available\nwhere needed, and must cover the requirements of the Standard. These documents must be\ncollated into one or more quality manuals which form the reference point for all documents\nincluded in the food safety and quality system.\nThese documents may exist on paper (i. e. as hard copy) or may be controlled on an\nelectronic system. In either case, they should be easy to follow and kept up to date.\nIn a small, simple operation, the manual may contain the majority of the procedures\ncontrolling the processes. In a complex operation it may contain the headline policies and\nindicate where more detailed operating instructions can be found.\nThe manual should include an overview of how the company’s policies and procedures are\norganised. This organisation should be understood by those using the documents and easily\ndemonstrated. Where the site is part of a company governed by a head office, the interaction\nbetween the site’s documented system and that of the other sites and the head office\nshould be clear. All policies and procedures necessary for the operation of the site being\nassessed must be available at that site.\nThere is no requirement for sites to have a quality manual that is numbered in accordance\nwith the Standard’s numbering system."},{"id":"3.1.2","requirement":"The food safety and quality manual shall be fully implemented and the manual or relevant components shall be readily available to relevant staff.","interpretation":"The objective of this requirement is to ensure that key staff have access to up-to-date\npolicies and procedures at all times and in the most appropriate format. For example, the\nincident management procedure should be available to the relevant team members via\ninternet link, hard copy or other off-site format.\nStaff needing such documents as part of their role within the company must always\nhave access to them. During the audit the procedures documented in the manual will\nbe evaluated against the actual practices on the site, with the expectation that they are\nfollowed correctly."},{"id":"3.1.3","requirement":"All procedures and work instructions shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by appropriate staff.","interpretation":"Procedures and work instructions must be documented in a clear and unambiguous format.\nAnyone using an authorised document must be able to understand its relevance, what it is\nfor and how to use it. Evidence is required to demonstrate that staff clearly understand the\nprocedures as this will be challenged by the auditor.\nConsideration may be given to providing procedures in appropriate languages, either written\nor oral, to ensure staff understand the documents and their role. Where translations are\nused, a record should be kept of who translated the information into which language(s). Both\nthe translator and the recipient staff should sign the training record to indicate that the\ntranslated version has been understood.\nDocumentation should include the use of photographs, diagrams or other pictorial\ninstructions where written communication alone is not sufficient. For example, diagrams\nadded to cleaning instructions can show clearly which pieces of equipment to remove or\nfocus on. Signs and pictures can be particularly useful for communicating personal hygiene\nand protective clothing requirements.\n3. 2 Document control\nThe company shall operate an effective document control system to ensure that only the correct versions of\ndocuments, including recording forms, are available and in use.\nDocuments must be effectively controlled to ensure that staff are working with the most up-to-date information\nand to minimise the potential for mistakes. Documents include policies, procedures, work instructions, records,\nforms, specifications, data lists and any information that is written down and defined. They may be available on paper\n(i. e. as hard copy) or in electronic format.\nKey documents found to be in use during the audit that have not been properly authorised or are not the correct\nversion may lead to a non-conformity."},{"id":"3.2.1","requirement":"The company shall have a procedure to manage documents which form part of the food safety and quality system. • a list of all controlled documents indicating the latest version number. • the method for the identification and authorisation of controlled documents. • a record of the reason for any changes or amendments to documents. • the system for the replacement of existing documents when these are updated. • stored securely (e.g. with authorised access, control of amendments, or password protection). • backed up to prevent loss","interpretation":"The control of all documents within the food safety and quality system (for both external\nand internal use) is important for several reasons, including:\n• the documents are kept up to date\n• staff are working with the correct version\n• the potential for mistakes caused by multiple versions of a document is minimised.\nTherefore all documents in use need to be properly authorised and must be the correct\nversion.\nThe Standard requires the site to have a documented procedure that describes the method by\nwhich documents are controlled and managed. This procedure needs to include instructions\non how the following features of the document management system are controlled:\n• responsibilities for the management of the system\n• list of all controlled documents, indicating the current version number and the allocation\nof controlled copies of the document (see below)\n• identification of controlled documents (e. g. document ID, issue date, version number)\n• records of the reason for any change(s) (see below)\n• method of rescinding and replacing documents.\nIn order to demonstrate the control of document issue, it is necessary to maintain a\nregister of all controlled documents, their allocation and issue status. Where the controlled\ndocuments are all contained on an electronic system, it is usual for printed versions to be\nmarked as uncontrolled. Each copy must be authorised (e. g. with a signature or stamp) to\nshow it is for use, and each must be given a version number so that out-of-date documents\ncan be identified and removed. This must be evidenced by the fact that all documents in use\nare the most up-to-date versions.\nWhere documents are maintained electronically, the site is required to ensure that they are\nstored securely and cannot be amended by unauthorised persons; for example, by using\nindividual passwords or security swipe cards. This includes backing them up appropriately to\nensure no data is lost. The auditor will ask to see evidence (e. g. a procedure) that the site has\nan effective backup process, rather than auditing that the backup contains all the relevant\nfiles.\nThe methodology or type of electronic storage is not specified. The site may choose to use\nan internal server to store data; or it may use cloud services, which are generally considered\nto be secure and backed up, providing there is control of authorised/authenticated users.\nWhen a document is changed, a record needs to be made of the change and the reason for\nit. This can be achieved by keeping a copy of the previous version with the reason for the\nchange written on it, or by keeping a history of amendments. Consideration should also be\ngiven to the most effective method of communicating the changes to staff; for example, by\nhighlighting the change within the new document or training relevant staff.\nFurther guidance How to put a document control procedure in place\nFirstly, ensure there is a single, clear, documented system that operates across all documents\nwithin the food safety and quality management system and that it includes the minimum\nrequirements highlighted in the Standard:\n• identification of the individual(s) responsible for management of the system (i. e. who is\nauthorised to issue or amend documents). This might be someone with the authority to\ninstigate and maintain the system\n• the list of all controlled documents\n• methods of identification of controlled documents\n• records regarding the reasons for any changes\n• the method of collecting and replacing documents.\nList of documents\nYour site needs a list of all the documents within the food safety and quality system.\nTypically this will include:\n• the document identification or number. The Standard does not set out how you should\nidentify your documents, but an example format would be using sequentially numbered\ndocuments or an initial letter (often representing a department or activity) followed by a\nnumber (e. g. P0123);\n• the document title. Use a concise title that clearly explains the purpose or content of the\ndocument (e. g. ‘metal detector check procedure’)\n• the current issue or version number. Each time the document is updated, amended or\nreplaced, a new version number should be used\n• the issue date. Include the date when the current version of the document first came into\nforce\n• withdrawal date (if applicable)\n• review date (if applicable). Documents may require periodic review to ensure the\ninformation remains applicable and up to date\n• the allocation of controlled copies (i. e. who has a copy of the document).\nFurther guidance\nREFERENCE\nNUMBER\nTITLE VERSION\nNUMBER\nISSUE\nDATE\nWITHDRAWAL REVIEW\nDATE\nALLOCATED\nCOPIES\nCheck\nProcedure\n1 1 June\n1 January\nN/A J Jones\nB Brown\nS Smith\nCheck\nProcedure\n2 1 January\nN/A J Jones\nB Brown\nS Smith\nCheck Weight\nProcedure\n1 1 January\nN/A S Smith\nG Green\nIdentification and authorisation of your documents\nThe simplest way to identify your document is to include a footer on each page that\ncontains the relevant information, as shown in\n• document reference\n• issue or version number\n• title of the document\n• date of issue\n• page number and total number of pages.\nREFERENCE: \nVersion Number: 2 Issue Date: 1st January 2020\tPage: 1 of \nAcceptance of Raw Materials Version 1 Page 3 of 4 Issued: 1/1/20\tG001\nYou will need to include a method of authorisation too (e. g. a signature or a stamp that\nidentifies genuine copies of the document). Where these are held electronically, it may be\nmore convenient to label printed copies as uncontrolled copies.\nMaking changes to your documents\nWhen a document is changed, you will need to make a note of the change and the reason for\nit. You can do this by:\n• keeping a copy of the previous version with the reason for the change written on it, or\n• keeping a ‘history of amendments’ log within each document; \nFurther guidance\nNew metal detector purchased which needed to be reflected in this procedure\nDATE CHANGES\n1 Jan \n28 Sept 21 Frequency of checks updated to reflect requirements of a new customer\nA new issue or revision always replaces an existing document. You must not have two\ndifferent issues or revisions of the same document at any time.\nYou will also need to ensure that any policy or procedure changes are communicated to the\nrelevant staff. This can be done by highlighting the change within the new document or by\nspecific training prior to the issue of the new version.\nReplacing your documents\nYou will need to keep a record of all controlled documents and their allocation. This will\nmean that whenever a document is updated or replaced, the person responsible can ensure\neach old copy is returned when the new version is issued. The easiest way to do this is by\nusing a sign-off sheet where staff sign to indicate that they have returned the previous\nversion and collected the new one.\n3. 3 Record completion and maintenance\nThe site shall maintain genuine records to demonstrate the effective control of product safety, legality and\nquality.\nRecords are documented information that provide permanent evidence about past events – particularly events\nconcerning product safety, quality and legality. Records must therefore be maintained in an appropriate way to\nensure they demonstrate control of systems and operations.\nWhere records are kept electronically, it is good practice to ensure that the IT management system facilitates good\nquality, secure, accurate record-keeping. For example, it should:\n• include suitable systems for storing and backup of data (it may be useful to check the effectiveness of the system\nto restore data, e. g. as part of the incident management procedures detailed in section 3. 11)\n• define access and IT management responsibilities\n• set a frequency of backup based on risk\n• confirm the security of data storage."},{"id":"3.3.1","requirement":"Records shall be legible, maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for the alteration shall be recorded. • stored securely (e.g. with authorised access, control of amendments, or password protection). • suitably backed up to prevent loss","interpretation":"Records must be legible and genuine; for example, they must be completed at the time of\nthe checks (i. e. not before or after the event) and in an appropriate manner (e. g. using a pen,\nas pencil could be altered after the event). Records should be appropriately authorised; this\nmay include the initials or signature of the operator or supervisor verifying the records.\nAny alterations to records need to be justified and authorised. A suitable procedure must be\nin place to manage any mistakes that are made (e. g. neatly crossing through the ‘inaccurate’\ninformation, noting the reason for the error and giving the initials of the person making\nthe change). Note that the use of correction fluid is not acceptable as this makes the initial\ninformation illegible.\nRecords must be retrievable when required (e. g. during an audit or the investigation of a\ncustomer complaint), and must therefore be maintained and stored to allow this (e. g. by\nbeing appropriately filed by date or \nlegible within the specified storage timeframe). They must be created in such a manner that\nthey accurately transmit the intended information (e. g. they can be read by others and are\ntraceable to the creator of the record via initials or signature).\nWhere records are stored electronically, this storage must be secure. The site should\nensure that passwords or other mechanisms required to access records are known only by\nthe people who need to use them. When using electronic systems, it may also be useful to\nassign different access levels; for example, for staff who can view records, and for those who\ncan also add or amend existing data.\nElectronic documents must be suitably backed up to prevent loss. Consideration should be\ngiven to testing electronic retrieval systems, and records of these tests should be retained."},{"id":"3.3.2","requirement":"Records shall be retained for a defined period with consideration given to: any legal or customer requirements, the shelf life of the product. At a minimum, records shall be retained for the shelf life of the product plus 12 months.","interpretation":"The retention time for records must be established by the company, and procedures put in\nplace for appropriate handling, so that records are retained in good condition for this period\nand are retrievable. Consideration should be given to the potential for degradation during\nstorage (e. g. due to fading ink, degradation of thermal paper or breakdown of electronic\nmedia).\nRecords that may be called upon to demonstrate the safety, authenticity or legality of\nthe product must be kept for an appropriate period. Examples of appropriate periods for\nproducts or ingredients are as follows:\n• Final products A period not less than the indicated shelf life plus 1 year.\n• Ingredients (i. e. where the site sells an ingredient that will be used in the manufacture of a\nfinal product) The shelf life of the final product plus 1 year. Where the final-product shelf\nlife is not reasonably known, records should be kept for 3 years or a period agreed with\ncustomers.\n• Products of an undefined shelf life (e. g. some wines and alcoholic drinks) The company\nshould define a reasonable record retention period based on experience of customer\nusage, time for complaints and any legal precedents. It would be usual for records to be\nkept for at least 3 years in these situations.\nAdditional retention time may be required by legislation, by customers or because of\nthe nature of the product (e. g. extension beyond the normal shelf life by the inclusion of\ncustomer freezing instructions on the product packaging must be observed).\nAs records may be called upon by a customer as part of a legal defence, consideration\nshould be given to the length of time that may pass from production of a product to\nnotification of impending legal action in the country of sale.\nSome regions have specific legal requirements. FSMA legislation, for example, requires a\nstorage period of a minimum of 2 years for all documents and records relating to the food\nsafety plan, and records must be retrievable within 24 hours, even when stored off site.\n3. 4 Internal audits\nFundamental\nThe company shall be able to demonstrate that it verifies the effective application of the food safety\nplan, and the implementation of the requirements of the Global Standard Food Safety and the site’s\nfood safety and quality management system.\nAn internal audit is any audit completed by or on behalf of the company rather than by a second or third party. In\nsecond-party audits, the company carrying out the audit may have a commercial interest (e. g. a customer audit), while\na third-party audit is generally conducted by an independent organisation (e. g. a certification body).\nInternal audits are one of the most powerful self-assessment tools that a site has available; they are a key factor\nin ensuring compliance with the requirements of the Standard, and the operation of its food safety and\nquality management systems. They must therefore be regarded by the management of the company as critical to its\noperation, and this section of the Standard is listed as fundamental to food safety and compliance with the Standard.\nThe internal audit programme can be used to:\n• confirm that the product safety and quality management systems are correct and effective\n• verify that product safety, authenticity, legality and quality activities and processes are being completed correctly\n(i. e. the actual work completed)\n• monitor and confirm that products are manufactured correctly\n• provide early identification of potential risks or potential non-conformities (sometimes referred to as near-misses),\nallowing timely correction such that they do not become actual non-conformities\n• identify areas for improvement\n• undertake verification of systems (a crucial step within the control of the HACCP or food safety plan; e. g. see\nclause 2. 12. 2).\nThe site’s attitude towards its internal audit programme is also likely to indicate its food safety and quality culture.\nFor example, a site with a poor food safety culture may be tempted to:\n• reduce the number of internal audits and inspections to the minimum, rather than the level indicated by thorough\nrisk assessment\n• under-report non-conformity and near-misses (i. e. find less than exist in reality)\n• not follow up on non-conformities (e. g. corrective, preventive actions and root cause analysis).\nThe scope of the internal audit programme must cover all areas of the food safety and quality management system,\nincluding all the requirements of the Standard, implementation of the HACCP or food safety plan, prerequisite\nprogrammes and procedures, food defence and prevention of food fraud. It must also cover both the systems in\nplace and the work practices.\nIt is not a requirement of the Standard that all of the internal audits in the programme are completed prior to the\nsite’s BRCGS audit. However, the Standard does require the site to have a planned schedule, with audit dates spread\nthroughout the year, and for the site to complete the individual audits according to this schedule (see details below).\nFor sites that are already certificated the auditor may review the internal audits from the previous year, if the BRCGS\naudit occurs early in the year, and little of the current year’s schedule has been completed.\nThe Standard is not prescriptive on the type of auditing techniques used during internal audits, and the site may\ntherefore choose the most applicable techniques for the activity being audited. For example, there are some areas\nthat may be auditable remotely, while others are likely to require physical, on-site auditing techniques. Whichever\ntechniques the site uses, it is still expected to have an effective audit programme. That means being able to\ndemonstrate that the systems associated with the food safety plan, the Standard and the food safety and quality\nmanagement system are operating effectively and as intended."},{"id":"3.4.1","requirement":"There shall be a scheduled programme of internal audits. At a minimum, the programme shall include at least four different audit dates spread throughout the year. The frequency at which each activity is audited shall be established in relation to the risks associated with the activity and previous audit performance. The scope of the internal audit programme shall include: • HACCP or food safety plan, including the activities to implement it. • prerequisite programmes (e.g. hygiene, pest management). • food defence and food fraud prevention plans. • procedures implemented to achieve the Standard","interpretation":"The scope of internal audits needs to be established and must ensure that all aspects\nof the food safety and quality management systems (including the HACCP programme,\nprerequisite programmes, policies, documentation, hygiene and production), the product\nsafety and quality culture plan, and systems associated with authenticity, product legality\nand quality management are audited at least annually.\nAll the internal audits should not be conducted on a single day; nor should every internal\naudit attempt to cover all aspects of the food safety and quality management system or\nthe Standard. A once-a-year check against all the requirements of the Standard may be of\nvalue as a gap analysis when preparing for an audit or confirming the contents of the food\nsafety and quality management systems, but is insufficient to cover the full requirements\nof an internal audit programme as it will not provide the depth of assessment or level of\nconfidence required.\nDevelopment of the internal audit schedule should begin with a risk assessment. The aim of\nthis is to identify:\n• all the areas or activities that need to be audited\n• the frequency with which each part of the product safety and quality management system\nneeds to be audited. This will be dependent on the risk inherent in each activity or section\nof the food safety and quality management system. For example, the site should be aware\nof the consequences of not complying with its own systems, which could lead to hazards\nnot being identified in a timely manner. Therefore internal audits of CCPs are likely to be\nmore frequent than those for less critical activities.\nFrequency may also be influenced by known issues within the company or customer\nrequirements. This may result in a site needing to audit an activity multiple times\nthroughout the year, or developing a programme with more than four internal audit dates\n(see below)\n• the most relevant dates for each internal audit; for example, if activities or processes are\nseasonal (see below) or if specific activities need to be completed more than once a year.\nSites may also find it useful to consider completing internal audits during different shifts,\nincluding, for example, nights or weekends.\nThe majority of sites are likely to benefit from a programme of audit dates spread diversely\nthroughout the year, as this maximises the opportunity to identify any non-conforming\nprocesses in a timely manner, allowing correction and minimising the potential for standards\nto fall between audits. The Standard promotes this concept by requiring a minimum of\nfour audit dates spread throughout the year. However, it does not require all audits to be\ncompleted quarterly, as there may be genuine situations where risk assessment shows an\nalternative frequency. Seasonality is an example; if a site is open only for part of the year,\nthen there is little value in completing internal audits while the site is shut. For seasonal\nproduction, the site is not expected to complete a series of internal audits when the site is\nnot operating; however, there must be a system for the management of start-up processes,\nand internal audits are therefore expected to start before the season commences to ensure\nthe site is ready to start production. For example, the HACCP programme should be audited\nto ensure that it is up to date and appropriate for the forthcoming production; that hygiene\nand fabrication are correct; and that staff are appropriately trained. The remaining areas of\nthe internal audit programme should be covered throughout the season. Further information\nis available in the BRCGS Fresh Produce Guideline available from BRCGS Participate or the\nBRCGS Store.\nEven where a site is open throughout the year, seasonality can affect the internal audit\ndates; for example, if certain activities, such as the harvest of grapes or bottling of wine, are\nonly completed at certain times, or if there are seasonal changes in production volumes\nwhich apply a greater burden on the product safety systems at certain times of year. Where\na site is part of a multi-site company, and the company conducts annual corporate food\nsafety audits, it is acceptable for this annual audit to be incorporated into the internal audit\nschedule. However, additional internal audits that look at specific parts of the food safety\nand quality system, and compliance with the Standard, should be scheduled throughout the\nrest of the year.\nThe most common way of completing an internal audit is by taking documented procedures\nand work instructions and comparing them with the actual working practices and records.\nNote that a tick-box exercise is not sufficient, as it does not provide the rigour or depth that\nan effective internal audit programme requires.\nThe use of an external consultant (e. g. by small sites) is acceptable, providing the internal\naudit programme is scheduled throughout the year and not in a single block of activity.\nSee clause 1. 2.4 and section 3. 5.3 for details relating to the requirements for product safety\nconsultants.\nBRCGS has produced a guideline to internal auditing which is available on\nBRCGS Participate or from the BRCGS Store."},{"id":"3.4.2","requirement":"Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (i.e. not audit their own work).","interpretation":"Good auditing is a thorough, evidence-based assessment of an activity or system, completed\nby an independent auditor. It should ultimately contribute towards the site’s continuous\nimprovement.\nAuditing is therefore an acquired skill and auditors need to be trained and competent to\nensure they are carrying out this function effectively. Training should include:\n• auditing skills, such as how to complete an effective audit\n• relevant technical knowledge of the activity to be audited, such as HACCP or appropriate\nproduct technical knowledge. This may be by work experience in the sector or specific\ntraining\n• soft skills associated with auditing.\nInternal auditors must be able to show via training records (clause 7. 1.6) that they have\nreceived formal training on internal auditing, via either attendance at an external course or\ntraining within the company.\nTraining should also cover the planning and scheduling of the internal audits, preparing\naudit reports in the company’s agreed format, the correct use of audit techniques (e. g.\ndocumentation and process auditing, audit trails and discussions with colleagues) and\nfollow-up of audit findings (see clause 3. 4.3).\nTraining must be of sufficient duration and depth to ensure that auditors can complete\nrobust, consistent audits.\nExternal auditors may be used where internal resources are insufficient, providing the\nrequirements of clause 3. 4.1 can be met (for scheduling audits throughout the year). The site\nshould refer to clause 1. 2.4 and section 3. 5.3 for the requirements for the management of\nfood safety consultants.\nInternal auditors must be independent of the process being audited. This is to ensure that\nthere is no conflict of interest (i. e. that the audit is rigorous and thorough) and that any work\nneeded to make corrections or improvements can be identified by an auditor who is not\nbiased or influenced by working in the area. Internal auditors may not audit their own work\nor any programmes for which they are immediately responsible. It is not acceptable, for\nexample, for workers on one shift to audit the work of another shift completing the same\nwork, as they are not independent of the operation.\nDuring the BRCGS audit, the auditor may discuss the process with internal auditors to\nestablish their level of competence.\nSites may find it useful to calibrate their internal auditor team (e. g. at the beginning of the\nyear, before a new schedule of internal audits begins) to ensure that there is a consistent\napproach across the company.\nA number of sources of further guidance and training for internal auditors are available\nincluding:\n• BRCGS guideline on internal auditing (see BRCGS Participate or BRCGS Store)\n• BRCGS internal auditor training\n• ISO 19011 Guidelines for auditing management systems."},{"id":"3.4.3","requirement":"The internal audit programme shall be fully implemented. Internal audit reports shall identify conformity as well as non-conformity and include objective evidence of the findings. The results shall be reported to the personnel responsible for the activity audited. Corrective and preventive actions, and timescales for their implementation, shall be agreed and their completion verified.","interpretation":"The management review processes (see clause 1. 1.4) must ensure that the internal audit\nprogramme operates effectively and that necessary corrective or preventive actions are\nappropriately completed. As a result, the internal audit process will often contain a number\nof steps. For example:\n• internal audit completed\n• corrective actions agreed\n• corrective actions completed and signed off\n• completion verified\n• root cause analysis used to identify any necessary preventive actions\n• preventive actions completed and reviewed\n• overall management review completed.\nEach internal audit must examine the process or activity in detail and will usually include a\nnumber of activities such as:\n• observing how activities are completed\n• asking relevant staff how an activity is completed or why it is completed in a specific way\n• reviewing procedures and records to confirm whether the activity has been completed and\nrecorded correctly.\nIn addition to the actual internal audit, it is important that appropriate reports are\ncompleted, clearly indicating what was audited, the actions that are agreed and the review of\nthese actions.\nReports must show evidence of conformity as well as non-conformity, with objective\nsupporting evidence (e. g. what documents or actions were observed). Some sites have also\nfound it useful to include recommendations for improvement, where the audit can highlight\nany that are noted during the audit.\nTick lists showing that items have been assessed will not normally be accepted as the\nonly form of evidence; information showing how the audited items have fulfilled the\nrequirements, or how they are non-compliant, is required. This is important, as recording\nconformity is documenting evidence that due diligence is taking place; in other words,\nthat required procedures are taking place, and have been observed by auditors who are\nindependent of the process. This may subsequently be useful, for example, in the event of\nan incident, or for answering questions from regulatory authorities or customers.\nNotes, references or copies of the documents and records should be kept as evidence of\naspects that have been examined, to allow an independent reviewer to reach the same\nconclusion as the internal auditor. For example, the dates and titles of records that were\ninspected should be noted in sufficient detail to allow them to be traced; if any records are\nnon-compliant, precise details of the non-compliance should be given. The listing of records\nreviewed also ensures that a wide range of records are considered (e. g. training records of\na variety of staff rather than repeated audits of the same records). Records will also confirm\nwhether anything has changed since the last audit.\nThe Standard is not prescriptive regarding the format of the internal audit reports; for\nexample, they may be hand-written, stand-alone electronic documents or uploaded into a\ncompany database. Good practice is to retain any auditor notes that are completed during\nthe audit, as well as the final report. \nreport.\nThe results of audits need to be communicated to the relevant staff; i. e. those who are\nresponsible for the area or activity, and corrective actions, root cause and preventive\nactions and timescales for their completion agreed. This may be achieved via operational\nor review meetings, or via an update at the end of the audit combined with documentation\nsuch as a memo or a copy of the audit report. Responsibility for corrective actions must be\ndocumented – for example, by being recorded on the audit record sheet. Full details for\nhandling non-conformities, including corrective and preventive actions, are provided in\nsection 3. 7.\nNote that finding a non-conformity during an internal audit should not necessarily be\nviewed as a negative, since it allows the site to implement action before the non-conformity\nbecomes a more serious problem.\nWhere non-conformities have been identified, effective completion of corrective and\npreventive action must be verified. Good practice is to ensure that a nominated member\nof staff with the appropriate authority checks that the action has been taken within the\nagreed timescale, and that this has rectified the problem sufficiently to prevent recurrence.\nThe nominated staff member should not be the person responsible for completion of the\nactions; ideally this should be the original auditor.\nGood practice is to complete a review of the internal audit programme; for example, looking\nat the outputs and trends, and any insight these provide. A summary of the programme and\nresults will also be required for the management review meeting (see clause 1. 1.4).\nA non-conformity will be raised against clause 3. 4.3 if there is a non-conformity in the\noperation of the internal audit programme itself. Examples include if the audit schedule is\nnot properly implemented or if corrective and preventive actions are not completed within\nthe agreed timescales.\nWhere the site consistently obtains negative results (i. e. no non-conformities are identified\nthroughout the scheduled programme) good practice is to review the programme to ensure\nit is operating robustly; for example, to:\n• consider if all activities are correctly incorporated into the programme\n• review rigour, robustness and consistency of the internal audits.\nFull records of all internal audits and the results, including conformities and non-\nconformities and verification of corrective and preventive actions, must be kept for a defined\nperiod, typically 2 years.\nBRC REQUIREMENT SITE POLICY EVIDENCE COMPLIES\nThe site shall ensure that any\nout of specification product is\neffectively managed to prevent\nunauthorised release.\nProcedure QM11 & form QRec11. All non-conformities trended for inclusion in management\nreview meetings (log reviewed and management report for\n1/9/21)\nY\nWaste disposal records checked (Sept – Dec 21) against\nrecords of non-conformities – disposal of outer packaging\non 1/1/22 unaccounted for.\nN\nThere shall be documented\nprocedures for managing\nnon-conforming products.\nProcedure QM11 – specifies all\nrequirements – non-conforming products\nare stored in identified area and labelled\n‘on hold’, ‘reject’ or ‘QC pass’. Form to be\ncompleted and\nspecified management. Sign off approved\nstaff only.\nForm QRec11 for recording information.\nProcedure QM11 version 3 dated 1/2/22 in use. Y\nRecords for Aug 21 – Dec 21 checked and indicated correct\nsign off. Y\nRandom staff check on staff numbers 94, 157 & \n– queried what they should do with incorrectly baked\nproduct. N\nRecords of the decision on\nuse or disposal and records\nof destruction where product\nis destroyed for food safety\nreasons.\nForm QRec11 for recording information. Records comply with disposals instructions. Y\nOne pallet of product (failed customer quality checks)\nsegregated for disposal, correctly labelled and authorised\nfor disposal.\nY\nRecords for 12/1/22 reviewed – correctly completed. Y\nAREA REQUIREMENT: Control of Non-Conforming Product DATE: 14 February 22 AUDITOR: A Checker\nNON-CONFORMITIES IDENTIFIED:\nNON-CONFORMITY ACTION RESPONSIBILITY DUE BY VERIFIED AS\nCOMPLETE\nStaff numbers 157 & 196 were unclear of procedure. Retraining to be completed against\nQM11.\nProduction\nManager\n21/2/22 A Checker 22/2/\nWaste disposal records checked (Sept – Dec 21)\nagainst records of non-conformities – disposal of\nouter packaging on 1/1/22 unaccounted for.\nInvestigate cause and introduce\ncorrective action.\nEnsure staff aware of procedure.\nProduction\nManager\n24/2/22 A Checker 25/2/\nBRCGS has produced a guideline to preventive action and root cause analysis which may be\npurchased from the BRCGS Store or viewed online at BRCGS Participate."},{"id":"3.4.4","requirement":"In addition to the internal audit programme, there shall be a separate programme of documented inspections to ensure that the factory environment and processing equipment are maintained in a suitable condition for food production. At a minimum, these inspections shall include: hygiene inspections, fabrication inspections.","interpretation":"In addition to the internal audit programme the Standard requires a programme of\ndocumented inspections to ensure that the factory environment and processing equipment\nare maintained in a suitable condition. These inspections are different from the internal\naudit programme specified in clauses 3. 4.1 to 3. 4.3, which examines practices against\ndocumented procedures. Audits are an in-depth challenge to the systems and procedures\nthat a site has put in place to manage hazards, to confirm that the site is effectively\nmitigating identified risks. A documented inspection, however, is a simpler approach to\nassessing the conditions present, so an entirely separate inspection plan should be in place.\nThese hygiene- and fabrication-based inspections assess standards of cleaning, equipment,\nbuilding fabrication and personal hygiene to ensure that high standards are maintained and\nthat a safe, hygienic production environment is in place. For example, inspections should\ninclude:\n• appropriateness, status, state of repair and cleaning of doors, walls, floors and other\nfabrication and facilities (e. g. those detailed in section 4. 4)\n• hygiene inspection to confirm equipment and facilities have been suitably cleaned\n• equipment inspection to identify and control potential foreign bodies (e. g. from worn or\ndamaged equipment) before they have the opportunity to contaminate a product.\nThe frequency of the inspections should be based on risk. For open product areas,\ninspections need to be at least monthly, whereas inspections in high-care and high-risk areas\nare likely to be more frequent (e. g. daily or weekly); seasonal products or activities should be\nincluded where appropriate. Line start-up checks, which may occur daily or at shift changes\nin many operations, can form part of this inspection programme.\nIt is also good practice to complete inspections after any activities that potentially change\nthe risk to products; for example, after maintenance.\nA review of the inspection programme should be completed prior to any changes which may\naffect food safety; for example:\n• introducing new equipment or facilities\n• changes to products\n• changes to processing conditions or process flow\n• following a non-conformity in an audit (e. g. internal, BRCGS, customer, or regulatory audit)\nor an independent inspection (e. g. following recommendations for improvement from the\npest control in-depth survey).\nThe individuals responsible for completing these inspections should be suitably trained\nfor the systems they are checking. However, staff completing hygiene and fabrication\ninspections do not need the same level of training as internal auditors.\nThe absolute requirements for independence identified in clause 3. 4.2 do not always apply\nto these inspections; for example, it would be acceptable for line start-up checks to be\ncarried out by line supervisors or managers. External agencies may be used to carry out\ninspections.\nIt is important that issues identified at the inspections are corrected as soon as possible so\nthat product risk is minimised. The records of inspections and corrective actions must be\nretained.\nInspection records can provide useful information to identify trends and drive\nimprovements (e. g. through the use of scored inspection results). To facilitate this, and to\npromote discussions about improvements to hygiene and fabrication, a summary of the\nresults will be discussed at the management review meetings (see clause 1. 1.4).\n3. 5 Supplier and raw material approval and performance monitoring"},{"id":"3.6.1","requirement":"Specifications for raw materials and primary packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements.","interpretation":"Specifications for all raw materials, including primary packaging materials, must be provided\nand adequately detailed. They must include the defined limits for all parameters critical to\nthe safety, legality and quality of the product. They must also include details of packaging.\nThe specifications may be in the format provided by the supplier or in the company’s own\nformat, as long as the information controlling the product’s quality and safety are clearly\ndefined."},{"id":"3.6.2","requirement":"Accurate, up-to-date specifications shall be available for all finished products.","interpretation":"Specifications must be in place detailing all finished products. These specifications must be\nup to date (i. e. they must accurately represent the current version of the product) and should\nbe reviewed whenever changes occur to the product, process or formulation. Good practice\nis therefore to ensure that the company has a system of change control where changes in\nproducts are identified before manufacture commences, that relevant amendments are made\nto the specification in a timely manner and that only the correct version of the specification\nis available to staff (see clause 3. 6.4 for further details).\nThe format of the specifications should be agreed with the customer to ensure that\nall relevant customer requirements are incorporated. This may, for example, be printed\ndocuments, electronic files or an online database. In the case of the company’s branded\nproducts, it is acceptable to have an internal specification setting parameters for the\nmanufacture of a product and a technical data sheet for customer use containing the key\ninformation for the safe use of the product, including but not limited to:\n• ingredients, including the presence of allergens\n• nutritional information\n• preparation or cooking instructions\n• storage instructions\n• shelf-life/code information\n• quantity.\nSpecifications must be accurate and the control of amendments and approval of\nspecifications should therefore be laid down in a documented procedure. This procedure\nshould also detail who can approve the amendments."},{"id":"3.6.3","requirement":"Where the company is manufacturing customer-branded products, it shall seek formal agreement of the finished product specifications.","interpretation":"Customer-branded, finished product specifications must be formally agreed with the\nrelevant customer and must, wherever possible, be signed by both parties. However, where\nthe customer’s signature or approval is not formally available, proof that specifications\nhave been issued (such as an email request for formal acknowledgement or specifications\non customer IT specification systems) is required. In this situation the site must be able to\ndemonstrate it is following a formal process agreed with the customer."},{"id":"3.6.4","requirement":"Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years.","interpretation":"Specifications must be reviewed whenever changes occur to the product, process or\nformulation. Where no known changes have occurred, the specifications must be reviewed\nat least every 3 years, or more frequently if required by a specific customer, to ensure they\nremain completely up to date and accurate. Evidence that a review has been completed\nneeds to be available and this should be achieved through the addition of a signature and\ndate to the specification or through the use of a matrix showing specifications and the latest\nreview date and reviewer.\nThe control of the amendment and approval of specifications should be laid down\nin a documented procedure. The procedure should also detail who can approve the\namendments.\nSome sites, companies or customers use cloud-based services which are able to notify\nthe user when there has been a change to the data. In these cases, the site should have\na mechanism to review the specification or change to understand whether there is any\nimpact to product safety, the HACCP or food safety plan, or the production processes. This\nrequirement is also reflected in clause 2. 12. 3, which explains how the HACCP or food safety\nplan needs to be reviewed whenever raw materials change.\n3. 7 Corrective and preventive actions\nFundamental\nThe site shall be able to demonstrate that it uses the information from identified issues in the food\nsafety and quality management system (e. g. non-conforming products, internal audits, complaints,\nproduct recalls, product testing, second- and third-party audits and online reviews) to complete\nnecessary corrective actions and prevent recurrence.\nThe objective is to ensure there are clear procedures to deal with problems that have the potential to affect safety,\nauthenticity, legality or quality, ensuring that the finished product and consumer safety are not compromised.\nCorrective and preventive actions are applicable to a wide range of non-conforming situations; they are not limited\nto BRCGS audit results, non-conforming products and complaints. The statement of intent therefore includes some\nexamples of situations in which corrective and preventive actions are required, but this list is by no means definitive.\nThe aim is for information from all issues associated with the safety and quality management system to be used to\nmake improvements, not just those requiring immediate action."},{"id":"3.7.1","requirement":"The site shall have a procedure for handling and correcting issues identified in the food safety and quality management system. The site procedures shall include the completion of root cause analysis and implementation of preventive action.","interpretation":"There must be a documented procedure for handling issues in the food safety and quality\nsystem which have a potential adverse effect on product safety, authenticity, legality or\nquality. All issues or non-conformities generated by the site (e. g. non-conforming product,\ninternal audits and site inspections, third-party audits or customer complaints, product\nrecalls, product testing (including inspections, quality assurance tests and laboratory\ntesting)) must be subject to corrective action.\nGood practice is for corrective action to be completed as soon after detecting the non-\nconformity as possible (this is particularly important where the non-conformity could affect\nproduct safety, legality or quality – see clause 3. 7.2).\nAn important part of an effective corrective action process is the identification of the root\nor underlying cause of the non-conformity and the implementation of suitable action to\nprevent recurrence. Root cause analysis is a process of conducting an investigation into an\nidentified problem to allow the investigator(s) to understand the fundamental cause and put\nit right. While there are a number of techniques for undertaking root cause analysis, one of\nthe most common and simplest to use is the ‘five whys’ technique. The technique is based\non repeatedly digging deeper into the cause of a problem by asking ‘Why …?’ to get to the\nroot of the issue. Usually, the root cause becomes evident after five steps, but this is not\nfixed and further investigation should be completed where required. This is described in\nmore detail in the example in clause 3. 7.2.\nSome clauses in the Standard specifically require root cause analysis but it is up to the site\nto establish a procedure for its completion. Root cause analysis procedures should include:\n• a set of parameters that will initiate the use of an appropriate tool (i. e. the site must define\nwhen the analysis will be completed if it is not already prescribed by the Standard)\n• who is trained and/or authorised to complete the analysis\n• the methods that the site will use to conduct the analysis\n• the records which detail the analysis and any subsequent preventive actions\n• the methods for the verification of the completed actions.\nThe auditor will expect to see a documented procedure that includes this information, as\nwell as evidence of any root cause analysis and preventive action that the site has carried\nout.\nIt is worth noting that in some geographies the analysis of trends may be a legal\nrequirement. For example, in the EU, the Microbiological Criteria for Foodstuffs (EC) No\n2073/2005 states that food business operators (FBOs) shall analyse trends in test results.\nWhen they observe a trend towards unsatisfactory results, they shall take appropriate\nactions without undue delay to remedy the situation in order to prevent the occurrence of\nmicrobiological risks."},{"id":"3.7.2","requirement":"Where a non-conformity places the safety, authenticity or legality of a product at risk, or where there is an adverse trend in quality, this shall be investigated and recorded. • clear documentation of the non-conformity. • assessment of consequences. • the corrective action to address the immediate issue. • completion of root cause analysis to identify the fundamental cause (root cause) of the non-conformity. • appropriate timescales for corrective and preventive actions. • the person(s) responsible for corrective and preventive actions. • verification that the corrective and preventive actions have been implemented and are effective.","interpretation":"Non-conformities with the potential to affect product safety, authenticity, legality or\nquality must be recorded, and the responsibility for investigating the cause of problems and\nensuring that an adequate response is taken must be assigned to specified personnel.\nAction needs to be undertaken as soon as possible after the detection of the non-\nconformity, but there may also be a need for long-term action to prevent further occurrence\nof the non-conformity. All actions undertaken must be documented.\nThe records will include:\n• details of the non-conformity and when it occurred or was identified\n• assessment of the potential consequences of the non-conformity by a suitably competent\nand authorised person\n• details of the action taken to address the immediate issue and dates or timescales for\ncompletion of the actions (i. e. corrective action)\n• root cause analysis to identify the fundamental or root cause of the non-conformity\n• details of the preventive action taken to address the root cause and dates or timescales for\ncompletion of the actions\n• identification of who is authorised and responsible for the actions\n• details of the verification checks to ensure the action has been implemented and is\neffective.\nWhere there is a significant trend in a specific type of non-conformity, root cause analysis\nmust be used to investigate the trend and implement action to prevent recurrence.\nAll corrective actions should be completed in a timely fashion. In practice this will depend\non the nature of the activity and the potential consequences of a delay. For example,\nstopping the production line would happen immediately but receiving and fitting a new or\nreplacement part may be a prolonged process.\nThe actions should be included in a regular review of activities and systems.\nThe site must assess the consequences of any delay in action and ensure that product\nintegrity and safety are not jeopardised. Where set timescales are not met, the reason for\nthe delay should be recorded and reviewed by the appropriate site management to ensure\nongoing product safety and, where necessary, provide appropriate resources.\nExample Root cause analysis using the ‘five whys’ technique\nAn operator is instructed to perform a simple action, ‘Weigh out ingredient A’. However, the\noperator inadvertently uses ingredient B instead. The immediate reaction would probably be\nthat this was operator error. Although this may be accurate, it does not establish the reason\nwhy the error occurred or prevent it from happening in the future. Using the five whys\ntechnique, the root cause analysis should ask and answer a series of questions:\n• Why did the operator make the error? The operator was unfamiliar with the procedure.\n• Why was an operator who was unfamiliar with the procedure asked to complete it? He\nhad been trained but there was no supervision or sign-off of the training to confirm it was\nsatisfactory.\n• Why was the training not satisfactory? The two ingredients looked identical.\n• Why weren’t the ingredients clearly labelled? The labels had been removed during\ncleaning and not replaced.\n• Why weren’t the labels replaced? The cleaning staff did not consider the significance of\nthe delay or the potential for an error.\n• Why were the ingredient containers being used if they had not been set up correctly for\nmanufacture? Checking the labels did not form part of anyone’s duties.\nThe conclusion of a root cause analysis should be to identify what should be changed to\nprevent recurrence of the error. In this example, the conclusion might be to:\n• update the training procedure\n• introduce a training sign-off procedure to ensure training is understood\n• replace labels – if practical, with ones that cannot be removed. Where labels must be\nremoved occasionally, ensure that post-maintenance line checks include a check of\nsignage\n• ensure that an individual (e. g. the production manager) is authorised and responsible for\npost-cleaning line sign-off\n• ensure that cleaning staff fully understand and are trained in the need to return labelling\n(and all equipment) to a fully operational state.\nNow that the root cause analysis has been completed, it is easy to see how this incident\noccurred. The causes were:\n• an incomplete training procedure\n• a faulty cleaning process\n• lack of post-cleaning check procedures.\nThe next step of the process is for the site to identify and implement suitable preventive\naction to ensure the problem does not occur again (where a non-conformity has multiple\ncauses it is important that the preventive action addresses all of these). For example:\n• update the training procedure to ensure sign-off ( and possibly a supervision step)\n• replace ingredient labels ideally with ones that cannot be removed\n• if labels must occasionally be removed, ensure that post-cleaning line checks include a\nsignage check\n• ensure an individual is authorised and responsible for post-cleaning line sign-off\n• ensure cleaners fully understand and are trained in the need to return labelling (and all\nequipment) in a fully operational state.\nBRCGS has produced a guideline on root cause analysis which may be purchased from the\nBRCGS Store or viewed online at BRCGS Participate.\n3. 8 Control of non-conforming product\nThe site shall ensure that any out-of-specification product is effectively managed to prevent unauthorised\nrelease.\nThe objective is to ensure there are clear documented procedures to deal efficiently with any non-conformity that\nhas the potential to affect product safety or quality. There is also a need to ensure that any non-conforming product\nor raw material is physically removed from the production process."},{"id":"3.8.1","requirement":"There shall be procedures for managing non-conforming products. • the requirement for staff to identify and report a potentially non-conforming product. • clear identification of a non-conforming product. • secure storage to prevent accidental release. • management of any product returned to the site. • referral to the brand owner where required. • defined responsibilities for decision-making on the use or disposal of products. • records of the decision on the use or disposal of the product. • records of destruction where a product is destroyed for food safety reasons.","interpretation":"The control of non-conforming product must be described in a documented procedure\n(in this context the implicated product could be any material, such as an ingredient, final\nproduct, packaging, or a combination of these). Procedures must include:\n• ensuring that all staff are aware of the need to report issues that may affect product safety,\nauthenticity, legality or quality, and to whom. This may be covered as part of the induction\nprocess for production staff\n• the system for labelling and identification of non-conforming product. This may include\nboth direct labelling and computer-based records.\n• segregation or isolation of non-conforming product. Ideally, the product must be\nphysically segregated by moving it to an identified area within the production site, or\nclearly marked so that it cannot be confused with in-process material or finished product.\nThe use of electronic inventory systems to ‘electronically isolate’ the material is also\nacceptable. It is often good practice to confirm the effective control of remaining product\nby completing a documented inventory; i. e. verifying the amount of non-conforming\nproduct that has been isolated with the quantities recorded in the production and\ndispatch records.\n• procedures for handling returned product; for example, goods receipt actions, secure\nstorage and notifications of returned product to relevant managers.\n• referral to the brand owner where required. The brand owner may need to be notified\nof quality issues and would expect to be contacted where issues affect product safety.\nAgreement may need to be reached before the held products are released for sale.\nContacting brand owners is not usually necessary where the decision is to destroy,\ndowngrade or rework product, unless this notification is a contractual requirement of the\nbrand owner\n• details of staff responsibilities, including which staff are authorised and responsible for\ndecisions relating to non-conforming products. The final decision on what to do with\nheld product should be taken by an experienced, technically competent manager. Only\na limited number of personnel must have the authority to lift the hold notice or remove\nproduct from the isolation area\n• records of all products placed on hold. These must include:\n• details of the product quantity and code\n• the reason for isolation\n• action taken or required to assess the suitability of the product\n• the final decision on what to do with the product; for example, rework, downgrading or\ndestruction of the product\n• the name of the person authorising the decision and date\n• confirmation of the action taken\n• any further actions required to prevent recurrence (this may link to an investigation of\ncorrective actions; see section 3. 7)\n• the ‘on hold’ procedure employed while an investigation is completed\n• procedures for the effective safe disposal of product.\nIt is usual to maintain a log of products which are on hold and to undertake periodic physical\nchecks of held stock to ensure that accidental release has not occurred. The summary of\nproducts held and actions taken must be reviewed as part of the management review process.\nNon-conforming product is a key prompt to initiate root cause analysis, particularly when\nthere has been an increase in incidents of the same type (e. g. mis-packing).\n3. 9 Traceability\nFundamental\nThe site shall be able to trace all raw material product lots (including primary packaging) from its\nsuppliers through all stages of processing and dispatch to its customers and vice versa.\nAs well as being a legislative requirement, traceability is a risk management tool, allowing food businesses and\nauthorities to withdraw or recall products that have been identified as unsafe. It is therefore a fundamental\nrequirement. A traceability system needs to be established at all stages of production, processing and distribution,\nidentifying from whom raw materials have been obtained and to which customers finished product has been\nsupplied. Note that the Standard requires forward and backward traceability throughout the production process. This\nmeans that the site should know where the material has come from (i. e. the direct supplier) and to whom finished\nproduct is dispatched.\nThere is no requirement for the site to trace raw materials all the way back to the source (e. g. farm) unless the source\nis the direct supplier to the site.\nThe system must ensure that products supplied to customers are adequately labelled or identified to facilitate\ntraceability. Traceability details need to be retained in a format that allows access in a timely manner.\nBRCGS has published a traceability guideline which may be purchased from the BRCGS Store or viewed online at\nBRCGS Participate."},{"id":"3.9.1","requirement":"The site shall have a documented traceability procedure designed to maintain traceability throughout the site’s processes. At a minimum this shall include: how the traceability system works, the labelling and records required.","interpretation":"Sites are free to utilise their own traceability systems; no specific tool or technique\nis required by the Standard. Nevertheless, it is imperative that the site documents its\ntraceability procedure so that it can be used and understood by the relevant personnel. This\nis particularly important at times of stress, when it is likely that the procedure will be relied\nupon to ensure at-risk product is identified and recalled or withdrawn in a timely manner.\nSome countries have specific legislation relating to traceability. The site will therefore need\nto ensure that any legislative traceability requirements in the country of sale or intended use\nare met."},{"id":"3.9.2","requirement":"Identification of raw materials (including primary packaging), intermediate/semi-processed products, part-used materials, finished products and materials pending investigation shall be adequate to ensure traceability.","interpretation":"Products and materials may be identified by physical labelling, by recording systems\nidentifying the allocation of materials to production or mixing areas, or through the use\nof computerised bar-coding systems. The level of traceability may need to be agreed\nbetween the company and its customers, but the system used must be capable of linking\nall raw material lot codes to finished product codes. This will enable finished product to be\nidentified if a particular batch of raw material needs to be recalled.\nThe limitations of any system must be recognised, as can be demonstrated by the problems\nassociated with bulk storage. Products such as sugar may be delivered with clear batch\nidentification; however, if they are emptied into a single storage tank that is mixed with\nearlier deliveries, the reduction in accurate traceability is compounded by the potential\nfor product to be trapped in dead zones during filling and emptying. If a particular delivery\nis identified as being contaminated, the entire product in the storage tank would need to\nbe disposed of, as well as several lot codes of finished product, as the company would not\nbe able to identify the specific batch of finished product that contained the contaminated\nmaterial. A similar limitation will exist if recyclable packaging is collected from several\nsources and combined to form a single batch.\nThe traceability system needs to include primary packaging (a full definition of primary\npackaging is available in the glossary, Appendix 1). Note that processing aids (i. e. substances\nthat are used within the process but are not required to be declared as an ingredient, such as\nsodium alginate for the clarification of beer) are included in the definition of raw materials\n(see glossary, Appendix 1) and therefore need to be included in the traceability system.\nAll test results (clause 3. 9.3) must be traceable to specific batches of product or ingredient.\nConsider how the traceability system operates in practice (with the effective physical\nidentification of ingredients and products). For example, if bulk containers are labelled,\nconsider how the information is presented to ensure it is legible and accurate. Common\nnon-conformities include the ineffective labelling of part-used packs in production, work in\nprogress, and storage areas leading to potential errors.\nStrict controls on material identification, traceability and segregation are also required to\npreserve the integrity of any claims made, such as organic status. Where logos are used that\nmake specific claims about production systems (e. g. farm assurance), full traceability must be\ndemonstrated (see also section 5. 4).\nApart from batch or lot codes, traceability information will usually include date codes to\nensure that only ingredients, intermediates and products within the appropriate shelf-life\nperiod are used. Particular care is needed for decanted ingredients, work in progress and\nproducts stored in bulk where the packaging has been removed."},{"id":"3.9.3","requirement":"The site shall test the traceability system across the range of product groups to ensure traceability can be determined from the supplier of raw material to the finished product and vice versa. For food raw materials and finished products, the test of the traceability system shall include a quantity check/mass balance. Traceability should be achievable within 4 hours.","interpretation":"Good practice is for the site to have a procedure or document that highlights the traceability\nsystem that is used at each step in the production process. It could include, for example,\nhow incoming raw material batch numbers are captured, and how the outgoing product is\ntraced and labelled. The process flow diagram developed as part of the HACCP plan (see\nclause 2. 5.1) may be useful to ensure all steps are captured.\nThe site’s traceability system must be tested at least annually, or more frequently if required\nby a customer. (Note that the frequency of traceability tests relating to provenance and\norigin claims is covered separately in clause 5. 4.5.)\nWhere traceability for all products manufactured by the site is the same or similar, then a\nminimum of one traceability test a year must be completed. However, if there are significant\ndifferences or specific traceability challenges relating to one product or group of products,\nadditional tests specifically related to that product or group of products may be needed.\nTraceability testing may be completed as part of a real product recall or withdrawal\nscenario if one has occurred, since the objective is to test the system and identify areas for\nimprovement, rather than supply records of a ‘test’ for its own sake.\nThe system must provide traceability forwards and backwards; therefore the system should\nbe tested in both directions. For example, a raw material could be selected and traced\nforwards to show in which finished products it was used. A finished product should also\nbe selected and traced backwards to show all the raw material batch codes (including\nprimary packaging) that were used to produce it. The tests should include identifying\nwhich customers received the finished products and which suppliers provided the raw\nmaterials. The traceability test must also include the traceability of the primary packaging\nmaterials. Although there are many benefits to complete supply chain traceability (i. e. from\nthe farm through all stages of processing, distribution and storage, through to the retailer\nor food service company), this clause does not require sites to complete full supply chain\ntraceability tests. The scope of the traceability test required here is from the suppliers of the\nraw material, through the site’s processes, to the site’s customers.\nThe site is also expected to compile a summary of the documents that should be referenced\nduring the test, and clearly show the links between them. This is of benefit to both the\nsite and the auditor, as it ensures all relevant documents are retrieved, and explains the\ntraceability system.\nThe test of traceability should be timed and full traceability would be expected to be\nachieved within 4 hours. This is to reflect the need for rapid traceability in the event of a\nrecall. Where traceability takes longer than 4 hours, review the areas where the retrieval of\ninformation is slow in order to identify improvements.\nFor all food products, and printed packaging and labels which have product safety\ninformation, the tests must also include a quantity check or mass balance exercise. It is not\nexpected that the full mass balance exercise would always be achievable within 4 hours. The\nobjective is to be able to account for the usage of a full batch of a raw material. This helps\nto ensure that the traceability systems are capable of operating effectively should a product\nrecall be required based on the recall of an ingredient.\nThe mass balance exercise is usually undertaken as follows:\n• Select a batch code of a particular specific raw material.\n• Identify the quantity of the raw material supplied under that batch code.\n• Identify the recipes in which the ingredient is used.\n• Use production schedules and batch make-up sheets to calculate the quantities of the\nselected batch of ingredient used in each product.\n• Calculate the quantity of any unused part of the batch in the warehouse.\n• Reconcile the quantity delivered against the amounts used plus any residual unused stock.\nIn some instances quantity checks may take a great deal of time and resource to complete\nsuccessfully.\nIt is unlikely that the mass balance exercise will be able to account for all materials to\n100% accuracy. However, the company needs to justify any discrepancies and demonstrate\nunderstanding of the nature of the variance. This may be inherent in the product\ncharacteristics (e. g. dehydration of fresh ingredients), or be ascribed to typical wastage on\nequipment or portion variances. Where the site adds subsequent deliveries to a bulk silo,\nthe test should clearly show how this has been managed. The principle is to ensure that\nthe traceability system is effective. Mass balance is a key measure of its workability and\nhighlights areas for improvement.\nDuring the BRCGS audit, the auditor will ask the site to complete at least one ‘vertical’ audit.\nAt a minimum this will include the traceability of a specific batch of product or ingredient\nthrough the site’s production, processing and distribution processes, and a review of the\nsite records related to the product or ingredient. Records will include, for example, supplier\napproval, goods receipt, process records (such as temperature monitoring), metal detector\nchecks and dispatch records.\nHowever, the vertical audit is not expected to include records that would only be held at\nother points in the supply chain (e. g. the raw material supplier’s processing records). This\nvertical audit is in addition to the review of the site’s own traceability tests. The final audit\nreport will include a summary of the vertical audit results.\nThe vertical audit will also include a mass balance exercise and a review of the systems\nrelating to the accuracy of labelling (clause 5. 2.1). Further information on the content of\nthe audit, including the vertical audit, can be obtained from BRCGS’ auditing techniques\ndocument. This may be viewed online at BRCGS Participate.\nBRCGS publishes a separate best-practice guideline on traceability, which may be purchased\nfrom the BRCGS Store or viewed online at BRCGS Participate."},{"id":"3.9.4","requirement":"Where rework or any reworking operation is performed, traceability shall be maintained.","interpretation":"Many sites undertake rework or recycling activities, where raw materials, work in progress or\nfinal product that has left the normal production but is still safe, legal and of the appropriate\nquality, is reprocessed. There may be several reasons for completing rework, including to:\n• reincorporate the material into a batch of the same product (either the batch currently\nbeing manufactured or to enable the materials to be stored for inclusion in a future\nproduction)\n• incorporate the material into a batch of another product with similar ingredients\n• process the material to meet the requirements of an alternative customer.\nWhere rework is undertaken, procedures must be in place to ensure that traceability is\nmaintained.\n3. 10 Complaint-handling\nCustomer complaints shall be handled effectively and information used to reduce recurring complaint levels.\nComplaints are key sources of information, informing the site of potential concerns and providing the opportunity\nfor continual improvement; for example:\n• in the event of a complaint relating to product safety, authenticity, legality or quality, they may require escalation\ninto emergency plans such as a product withdrawal or recall\n• the company’s attitude to complaints and complaint-handling processes may indicate the company’s product\nsafety and quality culture; for example, the timeliness and robustness of complaint investigation and the\nappropriateness of any actions.\nTherefore, an effective complaint-handling system needs to be operated by the company. The objective of the\ncomplaint investigation process should be to identify and correct causes of complaints, and one measure of an\neffective system should be a reduction in the number of complaints as a proportion of production volume."},{"id":"3.10.1","requirement":"All complaints shall be recorded and investigated, and the results of the investigation of the issue recorded where sufficient information is provided.","interpretation":"The company should ensure there is a clear process for customers (and potentially\nconsumers) to raise legitimate complaints about the products. This is usually via the contact\ninformation on product labels. Where products are supplied into food service or through\nintermediaries, every effort should be made to ensure that complaints raised are relayed to\nthe complaints department of the site.\nAll complaints need to be captured to a specified location to ensure they are adequately\nassessed and investigated, and the results of this investigation recorded. A documented\ncomplaints procedure is therefore required and the inclusion of a standardised complaint\nform may be useful.\nComplaints must be handled by appropriately trained staff to ensure that a proactive\nsystem identifies the severity, and therefore the significance, of any complaints received.\nActions must be appropriate to the seriousness of the complaint. A rapid response would be\nrequired for serious issues (such as a glass complaint) or where a number of complaints are\nreceived, suggesting a widespread problem.\nInvestigation must be completed within a defined timeframe and feedback provided to the\ncomplainant wherever contact details are provided."},{"id":"3.10.2","requirement":"Complaint data shall be analysed for significant trends. Where there has been a significant increase in a complaint, or a serious complaint, root cause analysis shall be used to implement ongoing improvements to product safety, legality and quality, and to avoid recurrence.","interpretation":"Data on customer complaints must be analysed to identify trends. A root cause analysis\nmust be carried out where there is evidence of an emerging trend or a serious complaint.\nThis is to help ensure problems are identified and improvements made to prevent\nrecurrence as far as practicable.\nThis may include, for example, an analysis of foreign-body complaint types as complaint\nnumbers per number of units produced, with data by shift or by production line. This\ndata must be communicated to relevant staff and may include graphical displays on staff\nnoticeboards or discussion at routine operations meetings.\nTrend analysis may demonstrate that certain complaints are associated with customer\nabuse of the product (e. g. not following cooking instructions). A root cause analysis of these\ncomplaints should be undertaken to establish whether the underlying cause can be managed\nby the company. For example, could on-pack instructions be made clearer to reduce\ncustomer abuse and therefore the number of complaints?\nBRCGS publishes a separate best-practice guide to complaint-handling, which may be\npurchased from the BRCGS Store or viewed online at BRCGS Participate.\n3. 11 Management of incidents, product withdrawal and product recall\nThe company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and\nrecall of products should this be required.\nIncidents are events that may result in the production of unsafe, illegal, non-conforming product or products that\nare not authentic, and risks to consumer safety. An emergency situation may also occur as a result of a sudden,\nunforeseen crisis that requires immediate action. An effective emergency plan must be in place so that if at any\nstage an incident occurs that impacts food safety, authenticity, legality or quality, it will be managed effectively.\nThe incident may be directly related to the product, the disruption of key services such as power and water, or\nenvironmental influences such as fire or flood.\nThe plan must be understood by relevant staff and must be routinely tested so that it can readily be put into\npractice, as incidents occur when least expected. The importance of a tried and tested procedure, ensuring that\npersonnel know who does what and when, cannot be underestimated."},{"id":"3.11.1","requirement":"The company shall have procedures designed to report and effectively manage incidents and potential emergency situations that impact food safety, authenticity, legality or quality. • disruption to key services. • events such as fire, flood or natural disaster. • malicious contamination or sabotage. • product contamination indicating a product may be unsafe or illegal. • failure of, or attacks against, digital cyber-security","interpretation":"In the event of an incident or emergency situation, the company must be ready to instigate\nactions as promptly and efficiently as possible. Therefore the site must have a documented\nincident management plan. The objective of the plan must be to minimise risk to consumers\nand potential disruption to business. Systems must be in place and used to ensure that\ninformation is collated and quickly assessed by staff who understand its significance and\nwho can develop an appropriate action plan. The site might establish a crisis management\nplan that could address the points listed here, and any additional risks which are outside the\nscope of the Standard.\nA documented incident management procedure is required. Although it may not be possible\nto detail exactly what action will be taken, as this will depend on individual circumstances,\nthe company should consider:\n• standard responses to a range of potential disasters, such as fire, flood or the loss of\nessential services\n• the provision of alternative resources for energy, water, transport and any potential options\nfor subcontracting production\n• how to handle acts of potential malicious contamination or extortion\n• management of unsafe or illegal products; for example, due to contamination or\nauthenticity concerns\n• details of staff responsibilities, including which staff are authorised and responsible\nfor making decisions relating to non-conforming products. The number of incident\nmanagement team members should be appropriate for the size of the business\n• a plan to handle the logistics of product traceability and the recovery or disposal of\naffected product and stock reconciliation (i. e. comparing the amount of implicated\nproduct with the amounts known to have been destroyed, returned or retained in storage)\n• methods to communicate with key contacts, both internal and external, such as telephone\nand email contact details (including office hours and out-of-hours details)\n• the communication process, and the way in which enquiries from customers and the media\nare handled (this can be critical to the effective management of the situation and ultimate\nbusiness recovery)\n• corrective action that needs to be taken before production can recommence\n• root cause analysis and preventive actions. Sites should reference their root cause\nprocedure (clause 3. 7.1), so that relevant preventive actions can be completed\n• procedures to withdraw or recall affected products.\nThese details must be kept up to date by periodic verification. Customers and suppliers may\nneed to be involved in the development of documented procedures as they may have their\nown requirements for crisis planning.\nWith more data being stored digitally and in cloud services, the site needs to be aware that\nsuch data is valuable to those who might extort or blackmail companies. Even though cloud\nservices can be relatively secure, digital attacks and failures of systems pose a significant\nrisk and the site needs to ensure that digital data is secure by using, for example, password\nprotection, anti-virus software, firewalls and/or data backup systems.\nSome organisations have published advice on cyber-security; for example, the National\nCyber Security Centre’s 10 Steps to Cyber Security.\nGood practice following an actual recall is to assess the effectiveness of the plan to identify\nand implement any appropriate learning or improvements. This process can form part of the\nevidence of compliance with clause 3. 11. 3."},{"id":"3.11.2","requirement":"The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum: • identification of key personnel constituting the recall management team. • guidelines for deciding whether a product needs to be recalled or withdrawn. • an up-to-date list of key contacts. • a communication plan. • details of external agencies providing advice and support. • a plan to handle the logistics of product traceability, recovery or disposal. • a plan to record timings of key activities. • a plan to conduct root cause analysis and to implement ongoing improvements","interpretation":"A product recall is defined as any activity that involves the return of an unfit product from\ncustomers and final consumers, whereas a withdrawal is the return of out-of-specification\nor unfit products from customers, but not from final consumers (see glossary for full\ndefinitions).\nThe site must have a documented recall and withdrawal procedure. At a minimum, it must\ninclude:\n• details of the recall management team members, including their roles, responsibilities\nand contact details. In larger businesses the recall team will involve head office personnel\nand it may be run from the head office. In this case the links between the production-site\nmanagement and the recall team need to be clear\n• guidelines for deciding whether a product needs to be recalled or withdrawn and the\nrecords to be maintained. Although causes for recall are often unpredictable, defined\nresponses to known risks (e. g. identification of pathogens in routine product sampling)\ncould be documented\n• an up-to-date list of key contacts (e. g. recall management team, suppliers, customers, the\ncertification body and regulatory authorities). A recall may occur at any time; therefore\noffice hours and out-of-hours contact details must be provided\n• a communication plan including the provision of information to customers, consumers\nand regulatory authorities in a timely manner. The communication process and the way in\nwhich enquiries from customers and the media are handled can be critical to the effective\nmanagement of the situation and ultimate business recovery. The use of professional\nresources to assist in communication management may sometimes be advisable\n• details of external agencies providing advice and support as necessary (e. g. specialist\nlaboratories, regulatory authorities and legal expertise)\n• a plan to handle the logistics of product traceability, recovery or disposal of affected\nproduct and stock reconciliation\n• a log of activities created as the event unfolds and real-time observations, which could,\nfor example, be used in discussions with customers or regulatory authorities. This may be\nvaluable during a post-incident review to consider improvements to incident management\nprocesses\n• reference to the root cause analysis procedure, so that relevant preventive actions can be\nintroduced.\nIn the event of a product recall, it is obviously important that actions are completed in a\ntimely fashion. Therefore, the aim of noting key times in the plan is to ensure that this will\nhappen during both tests of the system and during any actual incident. There are various\ntimes that should be recorded, including:\n• when the incident or test started\n• times of internal communications and key decisions\n• when traceability and mass balance exercises were started and completed\n• communication to customers or regulatory authorities."},{"id":"3.11.3","requirement":"The incident management procedures (including those for product recall and withdrawal) shall be tested, at least annually, in a way that ensures their effective operation.","interpretation":"The incident management procedure must be tested at least annually. This test must include\na test of the product withdrawal and recall processes which form part of the incident\nmanagement procedure.\nIt should be emphasised that traceability is only part of this procedure and therefore a\nrepeat test of the traceability will not, on its own, be sufficient to demonstrate that the site is\nmeeting this requirement. The aims of testing the full procedure are to:\n• demonstrate that the system works\n• highlight any gaps and where the system requires improvement\n• demonstrate how quickly the required information can be collated, and thereby corrective\naction taken, such as materials being isolated and quarantined\n• act as a training exercise for personnel to ensure that clear roles and responsibilities are\nundertaken in the event of a real withdrawal situation.\nThe test of the recall and withdrawal procedure must include verification of the decision-\nmaking process, traceability of raw materials through to finished product, verification of\ncontacts, and timings of key activities.\nRecords must be kept of tests of the recall and withdrawal procedure and must include a\nreview of the result of the test and any action taken for improvement.\nIf the site has had an actual withdrawal or recall which fully tested its recall procedures, then\nthis would be a substitute for a recall test as long as records are maintained, an analysis of\nthe effectiveness of the recall procedure is carried out, and any areas for improvement are\nidentified and acted upon.\nIn larger businesses the recall team may involve head office personnel and the test may be\nrun from the head office. In this case the links between the production site management and\nthe head office recall team need to be clear."},{"id":"3.11.4","requirement":"In the event of a significant food safety, authenticity or legality incident, including a product recall, regulatory food safety non-conformity (e.g. a regulatory enforcement notice) or food safety-related withdrawal, the certification body issuing the current certificate for the site against this Standard shall be notified within 3 working days.","interpretation":"Where there is a significant incident related to product safety, authenticity or legality\nthe site manufacturing or processing the implicated product is required to notify their\ncertification body of the situation. The types of situation that should be notified include:\n• all product recalls\n• any situation where the regulatory authority insists on action (e. g. an enforcement notice)\ndue to product safety or legality concerns\n• legal proceedings with respect to product safety or legality\n• adverse media attention relating to product safety\n• any food safety incident with the potential to harm a consumer\n• any food safety-related product withdrawal (it is worth noting that only product safety-\nrelated withdrawals need to be notified to the certification body; other types of product\nwithdrawal, such as those related to product quality, do not need to be notified).\nThe aim of this notification is to ensure that the integrity of the certificate is maintained by\nallowing the certification body to assess whether the incident affects the certification status\nof the site.\nIt is important that action is taken in a timely manner; therefore this initial notification, that\na notifiable incident has occurred, must be completed within 3 working days of the recall or\nother action taking place.\nThe company must also provide sufficient information to enable the certification body\nto assess any effects of the incident on the ongoing validity of the current certificate.\nTherefore, as a minimum, the company must forward copies of its corrective action, root\ncause analysis and preventive action plan. Note that this additional information may\ntake some time to collate and evaluate prior to communication to the certification body,\nespecially in the case of a complex incident. Therefore, it is not expected that this will be\navailable at the time of the initial notification, but may be submitted to the certification body\nat a later date. It must, however, be submitted within 21 days of the incident.\nWhere appropriate, the certification body can request further information or conduct a full\nor partial re-audit of the site to confirm certification.\n4 Site standards\n4. 1 External standards and site security\nThe production site shall be of suitable size, location and construction, and be maintained to reduce the risk of\ncontamination and facilitate the production of safe and legal finished products.\nThis part of the Standard is one of the most straightforward. It requires that the manufacturing facility is fit for\npurpose, both externally and internally, and that operations are conducted in an orderly fashion so as not to\njeopardise the safety, legality or quality of the product.\nThis section also includes the security systems that must be in place to control access to both external and internal\nareas of the site, buildings and product, including the records of all visitors to the site."}],"statement_of_intent":"The company’s processes and procedures to meet the requirements of this Standard shall be documented to allow effective, consistent application, facilitate training, and support due diligence in the production of a safe product."},{"section":4,"title":"Site standards","clauses":[{"id":"4.1.1","requirement":"Consideration shall be given to local activities and the site environment, which may have an adverse impact on finished product integrity, and measures shall be taken to prevent contamination.","interpretation":"Local activities and the site environment must not have an adverse impact on finished\nproduct integrity. (A site plan or map that indicates neighbouring activities may be useful.)\nPoints to consider may include:\n• derelict buildings, rubbish dumps, wasteland, etc. which could harbour pests\n• adjacent watercourses at risk of flooding\n• neighbouring companies and the nature of their business (e. g. presenting air or odour taint\npotential).\nAppropriate measures, such as additional pest or flood control, must be put in place and\nreviewed to ensure they are continually effective (e. g. by inclusion in internal audit schedules)."},{"id":"4.1.2","requirement":"The external areas shall be maintained in good order. Where grassed or planted areas are located near buildings, they shall be regularly tended and well maintained. External traffic routes under site control shall be suitably surfaced and maintained in good repair.","interpretation":"External areas must be maintained in good order and the condition of the site included in\naudit procedures. Overgrown areas can harbour pests; therefore, where areas are planted,\nthey must be tended regularly. For example, good practice is to have a 0. 5 m clear zone\nbetween the bottom of vegetation and external walls.\nDrainage in external areas is expected to deal with normal quantities of rainfall without\nlong-term pooling of water. If natural drainage is inadequate, external drainage must be\ninstalled.\nTo prevent potential contamination by dust, mud etc. , all traffic routes under the control of\nthe company must be suitably surfaced and maintained in good order. It is recognised that\ntraffic routes may have a variety of surfaces, and contamination risk to products will be\ninfluenced by other factors, such as weather conditions. The principle is to ensure that\nproducts are not placed at additional risk of contamination through the inappropriate\nsurfacing of routes where products are transferred. Risk may also be reduced by a\ncombination of procedures, such as the suitable protection of products while in transit, or\nwash-down of transit vessels prior to entering production areas."},{"id":"4.1.3","requirement":"The building fabric shall be maintained to minimise potential for product contamination (e.g. elimination of bird-roosting sites, sealing gaps around pipes to prevent pest entry, ingress of water and other contaminants).","interpretation":"The outsides of buildings must be monitored and maintained in a condition such that they\ndo not present a risk of product contamination. For example, pipework must be appropriately\nsealed to prevent pest entry, bird nesting sites must be eliminated (e. g. by using appropriate\nnetting), and ingress of water and other contaminants must be prevented."},{"id":"4.1.4","requirement":"Policies and systems shall be in place to ensure that access to the site by staff, contractors and visitors is controlled. A visitor recording system shall be in place. • Contractors and visitors, including drivers, shall be made aware of the procedures for access to the site. • Only authorised personnel shall have access to production and storage areas. • Staff shall be trained in site security procedures","interpretation":"There must be a visitor-reporting or monitoring procedure. When visitors or contractors\ncome on site, they should not be able to enter production areas without first reporting to\nsite representatives, who will:\n• make them aware of site rules; for example, relating to access\n• issue them with any protective clothing necessary for the areas they are visiting.\nGood practice is to include details of the name, company, date, time of entry and exit, as well\nas the purpose of the visit.\nOnly authorised personnel should have access to production and storage areas. Therefore,\nthese areas should have designated access points, which should be directly monitored or\nlocked with, for example, keys issued to nominated personnel, key-code locks or alarmed.\nContractors or visitors working in these areas must be the responsibility of a nominated\nmember of staff. It is normally good practice for them to be accompanied by the nominated\nstaff while in production and storage areas.\nAll staff must be trained in the company security procedures and form part of the security\narrangements. They should be encouraged to make enquiries on or report unknown persons\nin the facility. They must not compromise their personal safety; suspicious activities should\nalways be referred to security staff (where they are available).\n4. 2 Food defence\nSystems shall protect products, premises and brands from malicious actions while under the control of the site.\nThe objective is to ensure that the safety of finished products is not jeopardised through malicious actions,\ntampering or unauthorised persons.\nThe following clauses mirror those concerning food fraud (section 5. 4), so the site can choose to consider food\ndefence and food fraud together, if that is a more effective use of time and resource, or separately if the company\nprefers, providing both food authenticity and food defence are robustly assessed and managed.\nGood practice, especially in larger companies, is to use a multi-disciplinary team that includes different roles within\nthe company; for example, quality assurance, technical management, production, security and human resources.\nIn smaller companies this may not be possible, but consideration should be given to the inclusion of all relevant\ncolleagues or expertise.\nIn companies with multiple sites, some or all of the food defence threat assessment may be developed in one of two\nways:\n• centrally; for example, by a head office; or\n• locally at each individual office.\nWhere it is completed centrally it is important to ensure that the assessment and resultant food defence plan\nremain relevant to the specific sites and their activities. This may be achieved by, for example:\n• including members from the relevant sites in the food defence team\n• ensuring that the study is reviewed by senior members of staff located at the relevant sites\n• including the assessment and plan in the scope of the internal audit programme.\nThe BRCGS auditor will look for evidence of checks against local site activities and sign-off of the completeness and\naccuracy of the study.\nBRCGS will publish additional guidance on food defence, which may be purchased from the BRCGS Store or viewed\nonline at BRCGS Participate."},{"id":"4.2.1","requirement":"Where personnel are engaged in threat assessments and food defence plans, the individual or team responsible shall understand potential food defence risks at the site.","interpretation":"It is important that personnel completing food defence threat assessments are competent\nto develop the plan; they need to understand the risks they are trying to prevent. Therefore,\nit is expected that within the team there will be knowledge of the principles of food defence\nand the site.\nThe Standard is not prescriptive regarding how this knowledge is demonstrated and may\ninclude, for example:\n• training (e. g. a training course in food defence)\n• experience (e. g. demonstrable knowledge of the site such as security-related duties, or\nlength of service at the site)\n• other competency (e. g. the completeness and effectiveness of the threat assessment and\nits implementation).\nWhere there is a legal requirement for specific training, for example, in the US FSMA, the\nsite is expected to be able to demonstrate that this has been appropriately completed.\nIn the event of the site not having the appropriate in-house knowledge, external expertise\n(e. g. food safety consultants) may be used; however, reference should be made to clause"},{"id":"4.2.2","requirement":"The company shall undertake a documented risk assessment (threat assessment) of the potential risks to products from any deliberate attempt to inflict contamination or damage. The output shall be a documented food defence plan. • a new risk emerges. • an incident occurs where product security or food defence is implicated","interpretation":"The company must undertake a threat assessment of the risks inherent to the operation\nto prevent malicious intervention. The threat assessment needs to consider both external\nthreats (e. g. individuals or organisations gaining unauthorised access to the site, building or\nproducts) and internal threats, such as malicious tampering by staff who are authorised to be\non site.\nEach area (e. g. warehouses, processing areas and external storage areas) needs to be assessed\nin terms of how vulnerable the product is to contamination. Sensitive or restricted areas,\nsuch as open product areas, are likely to be the most vulnerable; the vulnerability of the\npackaged product will depend on the nature of the packaging. Details of IT systems and data\nprotection should also be included in the assessment.\nThe output of the threat assessment must be a food defence plan, which details:\n• the identified risks\n• the mitigation strategy; i. e. the steps or mechanisms used to avoid or mitigate the\nidentified risks (see clauses 4. 2.3 and 4. 2.4).\nThe food defence plan must be reviewed periodically; for example:\n• when there is a change to the site or buildings\n• when new market intelligence or supply chain information indicates a new or changed\nthreat\n• following an incident where product security or food defence systems are implicated.\nThis may include all forms of incident, as well as any customer complaints indicating that\ncurrent food defence measures are not effective\n• at least annually.\nRecords of the review need to be available for the audit.\nWhere there are legal requirements relating to food defence (e. g. in the US FSMA), the site\nmust be able to demonstrate that its food defence plan meets these requirements."},{"id":"4.2.3","requirement":"Where raw materials or products are identified as being at particular risk, the food defence plan shall include controls to mitigate these risks.","interpretation":"The site’s food defence plan may result in the need to take additional measures to mitigate\nrisks to raw materials or product. This may include extra verification or testing when raw\nmaterials are delivered, or additional wrapping with tamper evidence on pallets. Whatever\nthe measure, it should be appropriate and validated to ensure that it is effective.\nThe auditor will expect to see the documented plan (clause 4. 2.2) and the methodology of\ndetermining which products, materials or areas require additional control. The additional\nmeasures and procedures should be documented and the auditor will expect to see these\nmeasures in action at the time of the audit.\nIdeally the controls used should prevent the threat from occurring; however, where this is\nnot possible, the controls should mitigate risk and use tamper evidence so that malicious\nactivity can be seen and addressed in a timely manner, before it becomes a product safety\nissue.\nThe systems must be reviewed at least annually, including the controls identified in the plan,\nto check whether they are still effective and relevant."},{"id":"4.2.4","requirement":"Areas where a significant risk is identified shall be defined in the food defence plan, monitored and controlled. These shall include external storage and intake points.","interpretation":"The basic principle is that only authorised staff should have access to production and\nstorage areas. Levels of access for various areas at the site may differ between employees.\nRestriction of access to areas where sensitive materials are stored (e. g. laboratories,\nmaintenance areas or document storage areas) should also be in place. Where appropriate,\nareas should be locked when not in use.\nAll staff must be trained in the company food defence procedures. This is not the same as\nthe training described in clause 4. 2.1. There, the staff involved in the threat assessment and\ndevelopment of the site’s food defence plan must have knowledge of the principles of food\ndefence and the site, whereas this clause requires all staff to be trained in the relevant food\ndefence procedures; i. e. in the relevant site procedures that have been developed as a result\nof the food defence threat assessment.\nWhere a site wishes to combine this training with the security training described in clause 4. 1.4, this is acceptable providing both topics are sufficiently covered.\n4. 3 Layout, product flow and segregation\nFundamental\nThe factory layout, flow of processes and movement of personnel shall be sufficient to prevent the\nrisk of product contamination and to comply with relevant legislation.\nThe physical layout and flow of processes, materials and personnel must be identified, designed, managed and\nmaintained to protect product integrity and prevent contamination, whether physical, chemical or microbiological."},{"id":"4.3.1","requirement":"The site shall assess the production risk zones required for the products manufactured, processed or packed at the site, using the definitions in Appendix 2 of the Standard.","interpretation":"All sites need to ensure that the production facilities are suitable for the types of products\nthey are manufacturing, processing or packing. This includes an assessment of the\nproduction risk zones needed for the prevention of microbiological contamination.\nFull details of the definitions of the production risk zones recognised by the Standard are\ngiven in Appendix 2 of the Standard. However, in summary, the Standard recognises six\nzones:\n• high-risk and high-care zones for chilled or frozen and ready-to-eat products where there\nis a risk of contamination\n• ambient high care for products where there is a risk of contamination with vegetative\nmicro-organisms originating from raw materials and the products are stored in ambient\nconditions (rather than chilled or frozen)\n• low-risk areas\n• enclosed product areas (e. g. storage areas where products are fully enclosed within\npackaging and production areas where the product is fully enclosed within the equipment\nor pipework)\n• non-product areas (i. e. areas such as offices, where products are not taken at any stage in\ntheir manufacture or storage).\nIt is important to note that the high-risk, high-care and ambient high-care production zones\nusually only apply to part of a factory’s production processes. These zones typically start\nwhen products exit a microbiological kill step and include all the processes and steps until\nthe products are enclosed in packaging.\nThe auditor will expect to see a documented assessment comparing the products\nmanufactured, processed or packed on site with the definitions within Appendix 2 of the\nStandard.\nWhere a site identifies the need for a high-risk, high-care or ambient high-care production\nzone, the relevant clauses from section 8 will apply to those areas."},{"id":"4.3.2","requirement":"There shall be a map of the site. At a minimum, this map shall define: • production risk zones. • access points for personnel. • access points for raw materials, semi-finished products and open products. • routes of movement for personnel. • routes of movement for raw materials. • routes for the removal of waste. • routes for the movement of rework. • location of any staff facilities. • production process flows. • any areas where time segregation is used","interpretation":"The aim of the site map is to provide an overview of all the locations within the site, areas\nwhere the product is at different levels of risk from the general environment and the\nmovements of products, materials and people. It can then be used to support the site’s risk\nassessments and subsequent prevention of contamination; for example, by identifying the\nlocations where potential hazards (e. g. allergen cross-contamination) can occur.\nThe site map will be expected to illustrate the locations of critical facilities and activities, as\ndetailed in the requirement, including:\n• production risk zones (e. g. high-risk areas, high-care areas, low-risk areas, and enclosed\nproduct areas; see clause 4. 3.1). The object of identifying the production risk zones is\nto ensure that the standards of environmental hygiene, particularly those concerning\nequipment, buildings, cleaning and personnel hygiene, are appropriate for the work being\nundertaken. It also allows the product and personnel flows to be reviewed, to ensure they\ndo not compromise product safety\n• access points for personnel clearly showing the routes into, and out of the site and\nproduction areas\n• access points for raw materials, semi-finished products and open products\n• routes of movement for personnel. If it is necessary to allow access through production\nareas, good practice is to identify designated walkways that ensure there is adequate\nseparation from materials. Wherever possible, all facilities should be designed and\npositioned so that the movement of personnel is by simple, logical routes\n• routes of movement for raw materials\n• routes of movement for the removal of waste\n• routes of movement for rework\n• the location of staff facilities, including changing rooms, toilets, canteens and smoking\nareas\n• areas where time segregation is used; in other words, where the same production area\nis used as both a high-care and a low-risk production zone at different times, with time\nsegregation being used to separate the products with different risks (see Appendix 1 for\ndefinitions).\nSites which have identified the need for high-risk, high-care or ambient high-care areas (see\nclause 4. 3.1) will also need to include the location of the pathogen control step(s) on the\nmap (see clause 8. 1.1).\nThe Standard is not prescriptive on the format of the map, providing all of the relevant\ninformation is available. For example:\n• It is often useful to put the required information on several overlapping maps rather than a\nsingle diagram.\n• In complex sites a schematic diagram may be of greater benefit than a map."},{"id":"4.3.3","requirement":"Contractors and visitors, including drivers, shall be made aware of the requirements of the areas they are visiting, with special reference to hazards and potential product contamination.","interpretation":"Contractors and visitors (including drivers) must be made aware of all access restrictions and\nprocedures related to them. Visitors should be told when they sign in and the information\nshould be specific to the areas they will be visiting.\nContractors who visit regularly should be trained to a similar level as employees, and a\nrecord of the training retained."},{"id":"4.3.4","requirement":"The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products.","interpretation":"The HACCP or food safety plan must identify the potential risks associated with all\nproduction risk zones and the appropriate controls (including the level of prerequisite\nprogrammes) for the safe production of the products.\nA combination of process flow and procedures (e. g. the prerequisite programme and\nwork instructions) will be used to minimise risk to raw materials, packaging and products.\nParticular attention needs to be paid to the movement of personnel, raw materials,\npackaging, rework and waste, to ensure that the routes taken are defined and product safety\nis not compromised. For example, the removal of unnecessary packaging, such as debagging\nor removing outer boxes, should take place in a designated area, usually prior to transfer to\nproduction areas, in order to avoid potential foreign-body risks from discarded packaging.\nThe procedures developed to ensure product safety must be documented and validated as\neffective, and the appropriate staff must be trained. For example, where sites are receiving\npackaging through ‘hole in the wall’ operations, suitable controls should be in place to\nensure that there is no risk to the product and the materials are treated appropriately. For\nexample, an adjacent factory might deliver packaging materials on a conveyor or belt, as is\noften the case in dairy packing and carbonated beverages."},{"id":"4.3.5","requirement":"Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.","interpretation":"Premises must be designed to allow sufficient working space and storage capacity so that\nall operations are carried out properly under safe, hygienic conditions, thereby reducing\nthe potential for cross-contamination between activities because of close proximity. For\nexample, overfull refrigerated storage may lead to doors being left open for extended\nlengths of time because of difficulties in accessing required materials. This would lead to a\nnon-conformity.\nConsideration should be given to all activities, including inspection, cleaning, pest control\nand maintenance, as well as manufacturing operations."},{"id":"4.3.6","requirement":"Temporary structures constructed during building work or refurbishment etc. shall be designed and located to avoid pest harbourage and ensure the safety and quality of products.","interpretation":"Temporary structures (e. g. those constructed during building work or refurbishment) must\nbe designed and located to avoid pest harbourage, unsanitary conditions and potential\ncontamination of products. For example, where walls have to be knocked through during\ninstallation or expansion work, the integrity of the unit must be preserved to avoid pest\nentry, and scaffolding used in open product areas must be of the appropriate hygienic\nstandard.\nRisk assessment of temporary activities or structures should be completed prior to their\nintroduction.\n4. 4 Building fabric, raw material-handling, preparation, processing, packing and storage\nareas\nThe fabrication of the site, buildings and facilities shall be suitable for the intended purpose.\nThe design, construction and maintenance of the interior of the facility must support effective cleaning and protect\nproducts from contamination.\nThe type of finish to walls, floors and ceilings must, at a minimum, meet the requirements laid down in any applicable\nlegislation for the industry, and be suitable for the intended purpose.\nWhere a site has different production risk zones (see clause 4. 3.1), good practice is to consider whether there are\ndifferent facility requirements for each zone."},{"id":"4.4.1","requirement":"Walls shall be finished and maintained to prevent the accumulation of dirt, minimise condensation and mould growth, and facilitate cleaning.","interpretation":"This clause refers to the condition of the internal surfaces of the walls (other aspects of the\nwall’s condition are covered separately in clause 4. 1.3).\nThe walls in areas handling raw materials and preparing, processing, packing or storing\nproduct must be kept in a sound condition and must be easy to clean and, where necessary,\nto disinfect. For example, walls must have a smooth, impervious finish with sealed surfaces,\nbe in a good state of repair and be free from flaking paint.\nTiling of walls is best avoided but, if present, must be in good condition, with no cracks or\nloose tiles. Ledges (e. g. from ducting or piping) should be kept to a minimum or designed to\nfacilitate cleaning (e. g. with a slope to avoid dust collection).\nVulnerable wall surfaces or corners (e. g. where vehicles pass in close proximity) should\nbe protected from damage (e. g. with properly sealed metal plating or barriers). Junctions\n(including ‘wall to floor’, ‘wall to ceiling’ and ‘wall to wall’) should be maintained in good\ncondition to facilitate cleaning (e. g. by being appropriately sealed)."},{"id":"4.4.2","requirement":"Floors shall be suitably hard-wearing, impervious, maintained in good repair and facilitate cleaning.","interpretation":"The floors in areas handling raw materials and preparing, processing, packing or storing\nproduct must be kept in a sound condition and be easy to clean and, where necessary,\nto disinfect. Floors must be constructed of materials that are impervious, hard-wearing,\nrepairable and resistant to chemical attack so that they can withstand appropriate cleaning\nprocedures."},{"id":"4.4.3","requirement":"Drainage shall be sited, designed and maintained to minimise risk of product contamination. Machinery and piping shall be arranged so that process waste water goes directly to drain where feasible.","interpretation":"Drainage must be designed and maintained to ensure that product contamination risks are\nminimised. For example, drainage design might include methods to prevent flow back and\npest ingress, and routeing of waste systems to prevent dripping on products, packaging or\ningredients.\nDue consideration must be given to drainage from any internal laboratories or other\nhazardous operations undertaken on site to ensure that blockages or the presence of micro-\norganisms could not result in the contamination of processing areas.\nDrainage systems must not constitute a potential risk to product (e. g. from potential leakage)\nwhen passing through or over production areas. Where feasible, the design of equipment\nmust ensure that process waste water (e. g. condensate drainage from refrigeration or\ntemperature-controlled areas, or sink waste water) goes directly to a drain to minimise\ncontamination risk.\nWhere significant amounts of water are used (e. g. where wet cleaning is carried out) and\ndirect piping to a drain is not possible, floors must have adequate falls to cope with the flow\nof effluent (i. e. pooling of water should not occur) as this constitutes a splash hazard and,\ntherefore, a contamination risk.\nNote that the additional requirements for drainage in high-risk and high-care areas are\ncovered in section 8. 2."},{"id":"4.4.4","requirement":"Ceilings and overheads shall be constructed, finished and maintained to prevent the risk of product contamination.","interpretation":"Ceilings and overheads in areas handling raw materials and preparing, processing, packing\nor storing product must be appropriately designed and kept in a sound condition to avoid\nthe risk of contamination to product. Prevention of the accumulation of dirt, minimising\ncondensation and mould growth, and facilitating cleaning should all be considered.\nIn rooms with high ceilings that are difficult to clean or maintain, line covers over open\nproduct could reduce the risk of contamination."},{"id":"4.4.5","requirement":"Where suspended ceilings or roof voids are present, adequate access to the void shall be provided to facilitate inspection for pest activity, unless the void is fully sealed.","interpretation":"Where suspended ceilings are used (or roof voids are present), access must be available\nfor pest control purposes, even if this roof void is not normally used, unless it can be\ndemonstrated that the void is entirely sealed.\nRefrigeration equipment is often located in the roof void, and access will be required for\nmaintenance."},{"id":"4.4.6","requirement":"Where elevated walkways, access steps or mezzanine floors are adjacent to or pass over production lines which have open products, they shall be designed to prevent contamination, easy to clean and correctly maintained.","interpretation":"Mezzanine floors, access steps and suspended or elevated walkways (for example, in\nproduction areas or over production lines) should be safeguarded to ensure they do not\npresent a contamination risk to products below. This is particularly necessary where open\nproducts or open raw materials are handled and any contamination could have an immediate\nimpact on the product (e. g. walkways over a production line where open products are\nprocessed).\nTheir design could include features such as solid treads (rather than perforated material),\nback plates and enclosed sides to prevent items from falling into the production area below,\nfor example, from footwear.\nThe cleaning methods for these floors, steps and walkways should not allow waste materials\nor cleaning materials (e. g. wash water) to fall onto equipment or the production line below;\nfor example, by using minimal amounts of water to reduce the likelihood of splashing or\ndripping onto materials below.\nSites should include any elevated walkways, access steps and mezzanine floors in the\nprocedures concerning installation and maintenance activities with the express intention of\nensuring that they (and their use) do not pose a hazard to the product both:\n• when initially designed and installed, and\n• during use (e. g. due to erosion or ‘wear and tear’).\nFor example, by including the mezzanine floor, access steps or elevated walkway in the\nprogramme of documented inspections of the factory environment (see clause 3. 4.4), the\nsite should be able to facilitate prompt corrective action in the event of any problems."},{"id":"4.4.7","requirement":"Where there is a risk to product, windows and roof glazing which are designed to be opened for ventilation purposes shall be adequately screened to prevent the ingress of pests.","interpretation":"Where there is a risk to product, such as in production or storage areas, windows and\nroof glazing that are designed to be opened for ventilation purposes must be adequately\nscreened to prevent ingress of hazards such as pests or dust (e. g. by the use of mesh of an\nappropriate size to cover the windows)."},{"id":"4.4.8","requirement":"Doors (both internal and external) shall be maintained in good condition. External doors and dock levellers shall be close fitting or adequately proofed.","interpretation":"Doors and doorway equipment must be maintained in good condition, be easy to clean and\nkept clean, and provide an adequate level of pest proofing for the site. They should re-\nestablish continuous contact with the floor when lowered.\nDoors through which vehicles (such as forklift trucks) travel should be inspected and door\nframes should be fitted with close-fitting metal plates for protection. External doors to open\nproduct areas where activities such as raw-material handling, preparation, processing and\npacking occur must not be opened during production, except in emergencies.\nWhere external doors to enclosed product areas are opened, suitable precautions must be\ntaken to prevent pest ingress (e. g. strip curtains – see clause 4. 4.11 for further details).\nSites should be aware that the doors themselves can be a source of physical contamination,\nparticularly where they are designed to rise from floor contact to above the product as it\nis carried through (e. g. the potential for drip and therefore contamination of product as it\npasses through the doorway). It is not necessary to remove such doors, but sites should\nassess whether it is necessary to carry out mitigating steps, such as covering the product\nbefore it goes through the doorway.\nMechanical and electronic doors should be included in any planned or condition-based\nmaintenance programmes (i. e. they should be maintained and repaired in a timely fashion)."},{"id":"4.4.9","requirement":"Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of product and effective cleaning.","interpretation":"Adequate lighting must be provided to allow:\n• staff to be able to monitor quality and defects\n• the correct operation of processes\n• effective cleaning\n• a safe working environment.\nNote that some countries have specific legislation relating to minimal standards of lighting\nwithin the workplace. The site will need to be aware of these legislative requirements if it is\nlocated in a relevant country or region.\nIn the absence of specific legislation, industry guidelines state that preparation, processing\nand packing areas should generally be illuminated to a minimum intensity of 200 lux, with\ninspection areas requiring higher illumination such as 500 or 750 lux. All areas need to be\nconsidered; for example, poor lighting in storage areas may hinder effective cleaning or\ninspection."},{"id":"4.4.10","requirement":"Adequate ventilation and extraction shall be provided in product storage and processing environments to prevent condensation or excessive dust.","interpretation":"Adequate ventilation and extraction must be provided, particularly in areas where very dusty\noperations are carried out (e. g. in dry-ingredient handling areas) or where there is potential\nfor condensation build-up (e. g. in cooking areas).\nWhere air socks are used, the need for them to be cleaned and maintained should be\nconsidered. The frequency of this cleaning should be based on risk."},{"id":"4.4.11","requirement":"Where plastic strip curtains are present, these shall be maintained in good condition, clean, fitted correctly, and shall not pose a food safety risk.","interpretation":"Strip curtains are a common way of providing protection from hazards, or to facilitate\nenvironmental controls; for example, to:\n• prevent ingress of pests or dirt (e. g. where there are external doors into production or\nstorage areas)\n• help regulate temperature, air pressure or air flow\n• provide a hygiene barrier (i. e. preventing activities in one area from posing a risk to\nproducts or materials in neighbouring areas).\nWhere strip curtains are used, they must be controlled to ensure they achieve the intended\npurpose and do not pose a food safety risk. For example, they must be:\n• well fitting (usually defined as ‘as close to the floor as possible’, with no missing strips or\ngaps)\n• repaired or replaced in a timely manner when damage does occur (while slight scratches\nare unlikely to pose a food safety risk and therefore may not require immediate action,\nmissing strips or gaps caused by damage may allow pest ingress or contamination and will\nrequire timely action)\n• in use whenever relevant site activities are occurring, and not tied back when they should\nbe operational\n• kept clean (to ensure they are not a source of product or raw material contamination; for\nexample, to prevent microbiological, physical, chemical or allergen contamination). Ideally,\nstrip curtains will be designed to be easy to clean.\nGood practice is to include strip curtains in the inspection and maintenance programmes\n(see clauses 3. 4.4 and 4. 7.1) to facilitate timely identification of any concerns and the timely\nimplementation of corrective action.\n4. 5 Utilities – water, ice, air and other gases\nUtilities used within the production and storage areas shall be monitored to effectively control the risk of\nproduct contamination.\nThe utilities included within this requirement are specifically water, steam, ice, air and other gases that need to be\ncontrolled to ensure they do not constitute a contamination risk to product. Other commonly considered utilities,\nsuch as electricity, natural gas or fuel, are not included within these requirements."},{"id":"4.5.1","requirement":"All water used as a raw material, in preparation, hand-washing or cleaning shall be potable at point of use. The microbiological and chemical quality of water shall be analysed at least annually.","interpretation":"Water used must be provided in sufficient quantities (e. g. for cleaning operations), pose\nno contamination risk (e. g. be potable), be fit for the intended purpose and conform to\nrelevant legislation by being suitably treated or drawn from mains supply. Where required\nby legislation, private water supplies and treatment plants should be approved by local or\nnational authorities.\nThe frequency of water analysis must be based on risk, including:\n• legislative requirements for testing\n• historical information\n• the source of the water (e. g. mains supply or bore-hole)\n• specific site concerns (e. g. duration of water storage or the use of lead pipes)\n• treatments given to the water\n• its usage.\nThe water is expected to comply with national legislation (e. g. EU directive 98/83/EC and its\nsubsequent amendments) or, in the absence of this, with World Health Organization (WHO)\nstandards for drinking water. The scope of testing completed by the site should be based on\nrisk; for example:\n• if the site has lead pipes, then tests should include the presence and concentration of lead\n• if historical or published information indicates that the supply in the region has high levels\nof nitrate, then tests should incorporate this information.\nWater quality tests must be completed at least annually and be based on a risk assessment.\nIf the water is supplied by a water supply company, a chemical analysis from the water\ncompany will suffice for the chemical requirements, unless there are other risks identified\nin the delivery system (e. g. lead pipes). Alternatively, testing should be carried out at the\nsite to ensure that the water is tested and approved at the point of use. Where water is\nextracted from bore-holes and/or sites have on-site treatment facilities, additional checks\nwill be required to ensure that the water is not contaminated either at the bore-hole or\nduring treatment and that the treatment remains effective. The water should be sampled\nat appropriate points of use and this should be documented in a sampling plan (see clause 4. 5.2).\nWhere water is stored and handled on site (e. g. in storage or holding tanks), the site must\nassess any additional controls or testing needed to maintain food safety; for example, any\nlimitation on the maximum storage time, operational controls to prevent microbiological\ncontamination, or any monitoring of the condition of the tanks themselves (e. g. to ensure\ncorrosion cannot become a source of product contamination).\nWhere ice or steam is used in production or is in contact with food, it must be produced\nfrom potable water or pose no risk of contamination according to applicable legislation,\nand must be included within the sampling plan. Where legislation specifically allows the\nuse of non-potable water (e. g. in the washing of raw fish or livestock), the water must meet\nall legislative requirements for that process. The site will also need to have established\nthrough the HACCP process that the water does not present a risk to the final products\n(e. g. by introduction of chemical contaminants) or to other products within the processing\nenvironment."},{"id":"4.5.2","requirement":"An up-to-date schematic diagram shall be available of the water distribution system on site.","interpretation":"The aim of this requirement is to identify the key components of the water distribution\nsystem and how the components interconnect, particularly where potable and non-\npotable water are present. A fully detailed architect’s diagram showing the complete\npipework system is not required; a general plan, map or schematic diagram is sufficient.\nThe plan should enable the site management and auditor to assess potential hazards in the\ndistribution system and ensure that adequate management systems are in place to negate\nthe hazards. For example, water-holding tanks may present a microbiological hazard if not\ncovered; water pooling may occur if the water flow is not controlled; and where water is\nrecycled (e. g. for can cooling), the water may need to be treated and sometimes filtered to\nensure a satisfactory water quality.\nThe source of the water shall be included in the diagram (e. g. a bore-hole, an on-site\nreservoir or the mains supply), along with any on-site water-treatment processes. The best\nwater sampling points to assess the quality of water should be deduced from this plan."},{"id":"4.5.3","requirement":"Air and other gases used as an ingredient or that are in direct contact with products shall be monitored to ensure this does not represent a contamination risk.","interpretation":"Compressed air, steam or gases used as an ingredient or directly in contact with food\nmust be monitored to ensure they do not contaminate the product. The main risks to\nconsider are: the carry-over of boiler water-treatment chemicals in steam; dust particles in\ncompressed air; and oil used as a lubricant in compressed-air systems.\nThe level of monitoring needs to be based on an assessment of potential risk. Steam\ngenerated from potable water free from additives, for instance, is not likely to present a risk.\nCompressed air in direct contact with products needs to be filtered prior to use, and the\nfilters checked and maintained to ensure they remain effective. The gauge of filtration (e. g.\nmesh size) and frequency of checks should be documented and based on risk assessment,\ntaking into account the source of the air, the type of compressors used and the condition\nof the pipework (e. g. evidence of corrosion). The compressor suppliers or experts should\nbe consulted to establish any potential risks and any necessary testing. The objective of\nusing filters is to prevent dust particles and lubricating oil from the compression system\ncontaminating the products. Therefore a single central filter, in close proximity to the\ncompressor, but remote from the food-related use of the compressed air, is unlikely to\nprovide sufficient product protection. The site must be able to justify the effectiveness of\nthe filtration system employed.\nIf gases are used, such as in modified atmosphere packing, they must be demonstrated\nas being of an appropriate quality. Usually such gases are supplied in a compressed\nform in metal cylinders and the supplier management process (approved suppliers and\nspecifications, with certificates of conformance if required) would be sufficient. In these\ncircumstances, the site would not be expected to undertake its own checks. Compressed\ngases are generally considered to be microbiologically safe and the Standard does not\nrequire routine testing of such gases unless a specific risk has been identified.\nThere may be additional risks where gases are produced on site and these would need to\nbe evaluated through a risk assessment. Additional information can be obtained from the\nBritish Compressed Air Society and the European Industrial Gases Association.\n4. 6 Equipment\nAll production and product-handling equipment shall be suitable for the intended purpose and shall be used to\nminimise the risk of contamination of product.\n‘Suitability of equipment for its intended purpose’ includes the condition of the equipment, so that it does not pose a\nproduct contamination hazard; its ability to be effectively cleaned; and its capability of producing safe food products.\nThe site will need to consider the requirements:\n• when purchasing new equipment or equipment that is new to the site (for example, second-hand or reconditioned\nequipment)\n• when hiring equipment for a designated period\n• where equipment is stored (storage conditions must ensure the safety and integrity of the equipment so that it\ncannot become a source of contamination; for example, equipment should be stored clean and in such a way that\nit does not harbour pests)\n• when designing equipment that will be built by the company, e. g. by on-site engineers.\nMovable equipment needs to be controlled to ensure that it cannot be a source of product contamination; for\nexample, by restricting its use to designated areas, or using documented procedures to prevent contamination when\nmoving it between areas.\nRisk assessments and resultant controls must be proportionate to the likely risk to the product; for example,\nthe equipment’s proximity to product (e. g. use in production areas or open product areas), its significance to the\nproduction process, and its complexity (for example, a new production line or part of a production line will need\nsignificantly more consideration than a small item such as a plastic scoop).\nThere are a number of clauses within the Standard that may need to be considered in conjunction with this section;\nfor example:\n• Equipment maintenance and condition monitoring is covered in section 4. 7.\n• New equipment that includes measuring devices should be calibrated according to the requirements in section\n6. 4.\n• Risks associated with new products or new production processes are covered in section 5. 1; this will include the\nequipment associated with these new products and production processes.\nThere are a number of standards and industry guidelines that provide detailed recommendations for equipment; for\nexample:\n• EN 1672-2:2009 – Food Processing Machinery – Basic Concepts – Hygiene and Cleanability Requirements\n• ISO 14159:2002 – Safety of Machinery — Hygiene Requirements for the Design of Machinery\n• GFSI Benchmark JI (for building and equipment manufacturers) and JII (for building and equipment users).\nSites will need to ensure any applicable legislative requirements (for example, in the EU, the Machinery Directive\n2006/42/EC) are met."},{"id":"4.6.1","requirement":"There shall be a documented purchase specification for any new equipment detailing the site requirements for the equipment. • any relevant legislation. • where applicable, requirements for food contact surfaces. • details of intended use","interpretation":"The process for the purchase of new equipment must start prior to the actual purchase\nof the equipment, with an equipment purchase specification (sometimes referred to as\nuser requirements). The aim of the clause is not to introduce onerous documentation for\nall equipment, but to ensure that new equipment meets the site’s needs; for example, it\nis suitable for its intended use and is designed to eliminate or manage any identified food\nsafety hazards.\nFor the purposes of the Standard, new equipment can be defined as equipment bought\ndirectly from a manufacturer, second-hand equipment bought by the site (therefore new to\nthe site) or equipment that has been refurbished externally. It does not include small parts\nsuch as screws or other non-food contact fixings.\nPurchase specifications need to contain sufficient information to ensure product safety\nand suitability of the equipment. This means that the actual amount of detail in the\npurchase specification will be dependent on the type of equipment being purchased. For\nexample, a simple plastic scoop is only likely to need a very simple set of user requirements,\nwith minimal food hazards identified, whereas a new production line is likely to require\nsignificantly more details regarding, for example, product types, production rates and food\ncontact requirements.\nPurchase specifications usually include:\n• reference to any relevant legislation\n• requirements for food contact surfaces (i. e. where product will be in contact with the\nequipment)\n• intended use of the equipment\n• types of materials that will be used (this is particularly important for food contact surfaces,\nsince potential migration from equipment may be affected by the composition of the food\nmaterial, e. g. high fat or acidic materials can increase potential for migration).\nGood practice is to consider who within the company can authorise the purchase of\nnew equipment. For re-purchases of simple equipment, this may be simply a case of\nidentifying who is authorised to order the product; however, for complex machinery (such\nas a new production line), there may need to be input from multiple departments, such as\nengineering, technical, hygiene and finance. This is to ensure that all critical food safety\nrequirements have been considered and included within the specification.\nNote that where equipment is purchased from suppliers in other regions or countries,\nlegislative requirements may vary, and additional communication of requirements may\nfacilitate the purchasing process.\nThe site should retain evidence of the specification developed, and evidence provided from\nthe supplier demonstrating that the equipment meets these requirements, as this provides\nevidence of due diligence in the event of a challenge or incident.\nDuring the BRCGS audit, the auditor will expect to see evidence of the purchase\nspecification for any new equipment, the specification’s suitability for the specific\nequipment, equipment purchase matching the specification, and, as detailed in clauses\n4. 6.2–4. 6.7, commissioning of equipment, hygiene requirements, routine maintenance, etc.\nNote that the clause relates to the purchase of new equipment. It does not require a site\nto retrospectively develop specifications for equipment that was purchased prior to the\npublication of the Standard, or prior to its decision to become certificated for the first time."},{"id":"4.6.2","requirement":"The design and construction of equipment shall be based on risk, to prevent product contamination. Equipment in direct contact with food shall be suitable for food contact.","interpretation":"The aim of this requirement is to ensure that equipment is not a source of product\ncontamination, and that it complies with relevant food contact legislation where such\nlegislation exists (for example, in the EU, the Food Contact Materials – Regulation (EC)\n1935/2004 and its subsequent amendments).\nThe clause provides some examples of potential issues, including:\n• Food contact surfaces should be smooth and impervious; for example, to prevent\naccumulation of material that could lead to microbiological or allergen contamination of\nthe product.\n• Welds and joints should form a flat surface (again to prevent microbiological or allergen\ncontamination).\nOther well-documented issues have included the purchase of equipment (especially plastic\nitems) not designed for food use leading to the migration of chemicals into food products.\nThe company must consider the risks associated with the equipment (including any risks\nassociated with its design, construction and installation) and ensure that significant risks\nhave been controlled. This can, for example, be achieved by use of a hygienic design risk\nassessment, which uses hygienic design principles to consider the risks of foreign-body,\nmicrobiological, allergen or chemical contamination of the product.\nBefore using the equipment, the company will need to have evidence that the risks have\nbeen considered, and of the suitability of the equipment, and must confirm its acceptability\nfor food contact surfaces. For new equipment, this will usually form part of the purchase\nspecification process (see clause 4. 6.1). Where such evidence is not available (for example,\nwhen purchasing second-hand equipment) and the contact material is not a recognised\nfood-safe material (such as certain grades of stainless steel), an additional assessment should\nbe carried out to ensure safe use and to prevent food safety risks. The risk assessment\nshould consider factors such as:\n• the nature of the food contact surface and its known characteristics\n• the length of contact time with the food\n• the nature of the food and its potential for contamination (e. g. fatty or acidic foods are\noften at increased risk from migration of contaminants from plastic materials).\nDuring the BRCGS audit, the auditor will not inspect every seal, bolt or food contact surface,\nbut will:\n• need to understand the site processes; for example, they may review the documented\nprocess and their suitability, whether they have been used in practice, and the\ncompleteness of relevant records\n• inspect a small number of relevant examples of equipment where there is a food safety\nor quality implication; this may, for example, be completed during the inspection of\nequipment hygiene (see clause 4. 11. 1)."},{"id":"4.6.3","requirement":"A documented, risk-based commissioning procedure shall be in place for new equipment. Installation work shall be followed by a documented hygiene clearance procedure.","interpretation":"The aim of this clause is to ensure there is a formal process for the introduction of\nequipment that is new to the site (see the interpretation for the statement of intent for this\nsection), which ensures that product safety and integrity is maintained, when the equipment\nis introduced into and used within the production and storage areas.\nThe hazards associated with any specific item of equipment will vary considerably\ndependent on the nature of the equipment and its intended use. Using the previous\nexample, a new plastic scoop is likely to require minimal commissioning, whereas a\ncompletely new production line is likely to require an extensive commissioning process.\nTherefore the commissioning procedure should be risk-based, allowing the site the\nflexibility to complete the appropriate activities for the specific equipment. Examples of\ncommissioning activity might include installation and sign-off of equipment, trials operating\nthe equipment, cleaning validation and maintenance checks.\nIn order to facilitate routine cleaning, operation, inspection and servicing, equipment\nmust be appropriately positioned (e. g. access provided under, inside and around it). Where\nequipment is permanently sited, it should be properly secured and sealed to the floor to\nprevent the accumulation of food debris underneath, where it cannot be cleaned. It has been\nwell documented that, where equipment or fixtures allow organic matter and/or pathogens\nto collect and survive, this can subsequently cause product contamination as pathogens\nsuch as Salmonella or Listeria can survive for prolonged periods in these conditions if left\nundisturbed.\nThe site must ensure that the safety and integrity of product is not jeopardised during\ninstallation (e. g. equipment is not contaminated either by products used during installation\nsuch as sealants, nuts and bolts; by lubricants; or by packaging that has been removed\nfrom the equipment). Good practice is to schedule installation of larger or more complex\nequipment outside production hours. Where this is not practicable, suitable precautions\nmust be taken to prevent contamination of products; for example, the use of screening to\nprotect adjacent production lines.\nFollowing installation, equipment must be cleaned and inspected prior to use. An authorised\nmember of staff (e. g. the production manager) is required to formally accept equipment into\noperation following this inspection, to confirm that all relevant installation, commissioning\nand cleaning activities have been completed satisfactorily. Records need to be maintained\n(e. g. signing the appropriate engineering record or line start-up check sheet) to demonstrate\nthat the equipment has been inspected and is acceptable for use.\nThe commissioning procedure must include the updating of any other relevant site\nprocedures that are affected by the new equipment; for example, training, operating\nprocedures, cleaning, environmental monitoring, maintenance schedules or internal audits.\nThis is to ensure that all staff have access to the relevant procedures and understand how to\ncomplete their activities correctly.\nNote that the auditor will not stop equipment operating or the production flow in order to\ninspect equipment."},{"id":"4.6.4","requirement":"A procedure shall be in place to manage the movement of static equipment in production areas.","interpretation":"Static equipment is defined as pieces of equipment that are not ordinarily moved or are\nmoved only in exceptional circumstances; for example, due to redesign of the production\narea, relocation to another site or necessary maintenance that cannot be completed in situ.\nThere must be a documented procedure which covers how food safety and equipment\nintegrity will be maintained during movement of the equipment.\nGood practice is to complete a risk assessment to determine the specific risks and controls\nneeded.\nThe procedure may include:\n• the type of equipment to be moved\n• how the movement will occur (e. g. whether specialist equipment or contractors are\nrequired)\n• requirements for re-installation\n• authorisation (which staff are authorised to permit movement)\n• responsibility (which staff will be responsible for managing the movement)\n• staff training (e. g. on the procedure to ensure they understand the risks involved)\n• records required to demonstrate all necessary controls were completed\n• post-movement cleaning (see, for example, clause 4. 7.4)."},{"id":"4.6.5","requirement":"Equipment that is not used or is taken out of service shall be cleaned and stored in a manner that does not pose a risk to the product.","interpretation":"Appropriate precautions must be put in place to prevent product contamination resulting\nfrom storage of equipment; for example, dirt or dust accumulation, harbourage of micro-\norganisms, and potential pest activity if the equipment has not been fully cleaned before\nbeing stored.\nWhere equipment is stored within production or storage areas, it must be kept in a clean and\nhygienic condition (see clause 4. 11. 1). This might, for example, include:\n• a documented cleaning procedure (see clause 4. 11. 2)\n• periodic inspections, checks or condition monitoring (see clause 3. 4.4)\n• labelling to indicate that the equipment cannot be used without cleaning or sign-off\n• management through the food safety plan or HACCP (e. g. clause 5. 1.2).\nWhere equipment is intended for food contact, the equipment must be cleaned and, where\nnecessary, disinfected prior to next use. It is good practice to inspect the equipment once\nout of storage to ensure it is fit for purpose."},{"id":"4.6.6","requirement":"Mobile equipment used in open product areas shall not pose a risk to the product.","interpretation":"The aim of this requirement is to ensure that mobile equipment does not pose a risk to the\nproduct, including, for example, microbiological, allergen, chemical or foreign-body risks.\nThe site will therefore need defined procedures to ensure that any mobile equipment used\nin open product areas is used in such a way as to maintain product safety. This could, for\nexample, include:\n• a log of all mobile equipment\n• approved users and training for users\n• dedicated equipment: only used in designated open product areas\n• condition monitoring, to ensure items remain suitable for use in an open product area\n• cleaning and maintenance schedules.\nWhere the use of equipment in external areas cannot be avoided, and there is a risk of\nproduct contamination, additional procedures are required to ensure this risk is minimised.\nThese may include:\n• completing a risk assessment to identify areas/products where there is a risk of product\ncontamination (the Standard does not require cleaning and disinfection of every piece\nof equipment every time it is used in an external area, but that the site should identify\nwhen there will be a risk to product, and ensure that appropriate cleaning is completed to\nprevent this risk)\n• defining where equipment can be used\n• specific cleaning and disinfection procedures prior to re-entry into production areas\nwhere a product contamination risk exists. In addition to explaining how the cleaning will\nbe completed, it may be useful to identify the parts of the equipment that need to be\ncleaned (for example, tyres, wheels and the underbody may be a greater risk than other\nareas of the equipment).\nNote that where a site operates multiple production risk zones (see Appendix 2 of\nthe Standard), the additional requirements in section 8 of the Standard relating to the\nmovement of equipment between production risk zones will also need to be considered."},{"id":"4.6.7","requirement":"Battery-charging equipment shall not be stored in open product areas (unless fully sealed) or where there is a risk to products.","interpretation":"Mobile equipment may require battery-charging equipment. Where required, the battery-\ncharging equipment must not be stored or used in an open product area, unless the batteries\nare fully sealed and maintenance-free, to prevent the risk of chemical contamination of food\nproducts due to battery leakages or gases being emitted.\nGood practice is to identify locations where battery-charging is permitted.\n4. 7 Maintenance\nAn effective maintenance programme shall be in operation for plant and equipment, to prevent contamination\nand reduce the potential for breakdowns.\nTo ensure that all equipment (including fixtures, fittings, cleaning tools and utensils), is suitably maintained and does\nnot pose a product contamination risk (for example, due to foreign bodies created by the equipment), it must be\ncontrolled by a documented and effective maintenance system.\nPlanned maintenance may be completed internally or via contracted services. Maintenance undertaken internally\nmust be documented (e. g. in the form of a plan or schedule) and records of the maintenance activity kept. For\nequipment that is maintained under external contracts, evidence of contractual agreements must be available."},{"id":"4.7.1","requirement":"There shall be a planned preventive maintenance schedule or condition monitoring system which includes all plant, processing equipment and mobile equipment.","interpretation":"All plant, processing equipment and mobile equipment must be included in a planned\npreventive maintenance schedule or condition monitoring system.\nPlanned preventive maintenance is simply a schedule of proactive maintenance or servicing\ndesigned to prevent product contamination and reduce the potential for breakdowns.\nThe identified maintenance tasks are completed at defined frequencies based on a risk\nassessment. This can be supported by condition monitoring where equipment is inspected\nat a set frequency for problems. The aim is to identify and correct any problem before\nproduct contamination or equipment breakdown occurs.\nThe frequency of preventive maintenance or condition monitoring should be based on\nrisk assessment; for example, considering the likelihood of occurrence of a problem (e. g.\nprevious occurrences of the problem or equipment manufacturer’s recommendations)\nand the likely risk of product contamination if the equipment fails (e. g. proximity to open\nproduct).\nActivities should be documented, and appropriate corrective action taken where issues are\nhighlighted.\nMaintenance and condition monitoring requirements must be:\n• established as part of the commissioning process for new equipment\n• reviewed after repairs to equipment, to ensure that current monitoring and preventive\nmaintenance activities remain appropriate."},{"id":"4.7.2","requirement":"In addition to any planned maintenance programme, where there is a risk of product contamination by foreign bodies arising from equipment damage, the equipment shall be inspected at predetermined intervals.","interpretation":"Where there is a risk of foreign bodies contaminating product – for example, due to wear,\nerosion, loose or missing parts, or damage to equipment or pieces of machinery (e. g. sieves,\nmills, equipment covers) – there must be a periodic check of the equipment.\nA documented check procedure must be carried out at defined intervals (e. g. at process\nstart-up, at start of shift, during product changeover, and after cleaning or maintenance).\nInspection results must be documented and, where appropriate, action taken."},{"id":"4.7.3","requirement":"Where temporary repairs are made, these shall be documented and controlled to ensure that the safety or legality of products is not jeopardised.","interpretation":"Temporary repairs must be suitable, kept to a minimum and used only in an emergency. They\nmust be controlled (i. e. documented and notified to a shift leader) to ensure that the safety\nor legality of product is not jeopardised, and a system must be in place to demonstrate that\na permanent repair (or replacement of the equipment) is planned within a defined timescale\n(e. g. a works order).\nThe Standard is not prescriptive regarding the timescales for permanent repairs, as what\nis practicable will vary from site to site and according to the nature of the repair and any\nassociated product safety risks. Typically, a full permanent repair is expected as soon as\na replacement piece is available, or as soon as the line can be shut down. In all cases, the\nexpectation is that the safety and legality of the product will be maintained in the interim.\nIn an organisation with a strong food safety culture, production staff should be\nknowledgeable about food safety, be empowered and feel ownership of compliance with the\nStandard, so that they feel confident about informing the relevant individual or department\nwhen a repair or adjustment needs to be made."},{"id":"4.7.4","requirement":"The site shall ensure that the safety or legality of products is not jeopardised during maintenance and subsequent cleaning operations. Maintenance work shall be followed by a documented hygiene clearance procedure.","interpretation":"The site must ensure that the safety and legality of product is not jeopardised during\nmaintenance and cleaning operations. There are a number of ways that products can be\ncontaminated during maintenance activities; for example, by:\n• products or materials used during maintenance, such as sealants, nuts and bolts that are\neither not used correctly or not removed from the line after maintenance (for example,\nspare bolts, containers of lubricant, etc. need to be removed from the area when\nmaintenance is complete)\n• machinery parts that have broken or disintegrated and have not been adequately removed\n• maintenance tools that have not been stored in a suitably clean condition.\nGood practice is to schedule maintenance work outside production hours. Where this is\nnot practical, suitable precautions must be taken to prevent the contamination of products;\nfor example, by removing the item to be maintained from the production area, or by using\nsuitable screening to protect both the production line and any adjacent equipment or\nproduction lines.\nA procedure must be in place to ensure that, following maintenance work, equipment is\ncleaned and inspected prior to use. An authorised member of staff (e. g. the production\nmanager) is required to formally accept equipment back into operation following this\ninspection to confirm that maintenance and associated cleaning have been completed\nsatisfactorily. Records need to be maintained (e. g. by signing the appropriate engineering\nrecord or line start-up check sheet) to demonstrate that the equipment has been inspected\nand is acceptable for use."},{"id":"4.7.5","requirement":"Materials and parts used for equipment and plant maintenance shall be of an appropriate grade or quality. Lubricating oil in direct or indirect contact with products shall be food grade.","interpretation":"Materials used for equipment and plant maintenance that pose a risk of direct or indirect\ncontact with raw material, intermediates or final product must be of food grade and the\npresence of any allergens must be known and managed accordingly. Documentary evidence\nof the food-grade status must be held (for example, in a declaration by the supplier, on\nproduct data sheets or by demonstrable compliance to a recognised standard such as\nISO 21469 for lubricants, or the US Code of Federal Regulations, e. g. 21 CFR 178. 3570)."},{"id":"4.7.6","requirement":"Engineering workshops shall be kept clean and tidy.","interpretation":"The engineering workshop must be controlled to minimise the potential for contamination\nof product. Consideration should be given to location and design, as well as procedures\nfor control. For example, where it is not possible to avoid having an entrance directly from\nthe engineering workshop to the production area, procedures must be in place to avoid\ncontamination risks (e. g. by debris being carried inadvertently into the production or storage\nareas). These procedures may include changes of footwear and protective clothing, or matting\nspecifically designed to collect any small pieces of debris from footwear (e. g. swarf mats).\nWorkshops need to be kept clean and tidy, operated in a controlled manner, and included\nin the housekeeping and cleaning procedures. The provision and location of hand-washing\nfacilities for engineers entering the factory should be considered.\n4. 8 Staff facilities\nStaff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and\noperated to minimise the risk of product contamination. The facilities shall be maintained in good and clean\ncondition.\nThis section focuses on staff facilities from the perspective of eliminating product contamination.\nAppropriate staff facilities must be provided to enable staff to adhere to company policies (e. g. the correct storage\nof protective clothing and personal belongings) to ensure the risk of product contamination is kept to a minimum.\nThis must include adequate facilities to accommodate staff fluctuations, such as high production times, seasonal\nvariations or the use of agency staff.\nWashing, changing and toilet facilities provided for visitors and contractors must be of a standard that allows non-\nstaff members to meet suitable levels of hygiene. Best practice is that visitors and contractors follow exactly the\nsame changing routine as staff (e. g. change in changing areas and not in management offices)."},{"id":"4.8.1","requirement":"Designated changing facilities shall be provided for all personnel. These shall be sited to allow direct access to the production areas without recourse to any external area where possible.","interpretation":"Designated changing facilities must be provided for all staff (including visitors and\ncontractors). The location and position of facilities is an important consideration, and this\nmust be the subject of a risk assessment to ensure the protection of protective clothing\nfrom contamination before entering the production areas.\nThe size of the facilities needs to be adequate for the number of staff working at the factory\nand at times of peak staff numbers (e. g. at the start and end of shifts or when there are\nseasonal fluctuations).\nWhere changing facilities cannot be located with direct access to the production, packing or\nstorage areas without recourse to an external area, a risk assessment must be used to identify\nwhere additional procedures need to be implemented (e. g. providing cleaning facilities for\nfootwear where footwear is worn outside, or the donning of additional protective clothing\non entry to production areas)."},{"id":"4.8.2","requirement":"Storage facilities of sufficient size to accommodate personal items shall be provided for all personnel.","interpretation":"To prevent staff from bringing personal items (e. g. keys, mobile phones or coins) into\nproduction and storage areas where they could contaminate products (e. g. as foreign bodies),\nthere must be sufficient and suitably secure storage for employees’ belongings. Storage\nfor bulky items such as motorbike leathers and helmets should be provided, as well as for\nsmaller items such as jewellery and food.\nStorage areas should be designed to facilitate good practice and cleaning (e. g. lockers with\nsloping tops to prevent the accumulation of rubbish and raised off the floor to facilitate\ncleaning)."},{"id":"4.8.3","requirement":"Outdoor clothing and other personal items shall be stored separately from production clothing.","interpretation":"Separate storage facilities for personal items and work clothing are necessary to prevent\ncross-contamination of clothing via the locker. This can be achieved by:\n• using a locker with a divider to separate work clothing from personal clothing\n• enclosing protective clothing in a bag, such as a laundry bag, before use\n• providing a separate area for the hanging of work clothing.\nBecause of the potential for cross-contamination, clean protective clothing must be\nsegregated from dirty protective clothing (e. g. through the provision of separate locker areas\nor a dedicated collection point for dirty laundry)."},{"id":"4.8.4","requirement":"Suitable and sufficient hand-washing facilities shall be provided at access to, and at other appropriate points within, production areas. • advisory signs. • sufficient quantity of water at suitable temperature. • hands-free taps. • liquid/foam soap. • single-use towels or air driers","interpretation":"Dedicated hand-washing facilities must be provided at entrances to production areas and,\nwhere appropriate, at additional points within production areas. This is to ensure that hands\nare physically washed, rather than just sanitised, before starting work and as necessary during\nthe working day. In some low-risk operations, the hand-wash prior to entry to the production\narea may be in a changing facility or toilet rather than within the entrance to the actual\nproduction area. In some dry environments where water is avoided, gel or alcohol sanitisers\nmay be used in the production areas in place of hand-washing facilities, although staff will\nstill be required to wash their hands before entering the production area.\nThe hand-washing facilities must be equipped with the following:\n• hand-washing signage to prompt hand-washing at the relevant points in the process\n• appropriate instructions for use, considering the language needs of staff (e. g. including\npictorial instructions). For example, good practice is to instruct staff on how to wash in a\nthorough and appropriate manner and for the correct length of time (usually at least \nseconds)\n• water in sufficient quantities and at a suitable temperature. The publication WHO\nGuidelines on Hand Hygiene in Health Care (recommended by Codex Alimentarius)\nhighlights that warm water is more effective at cleaning than cooler water, with 40°C\nbeing demonstrably more effective than 20°C. It also notes that warm water is preferable\nto hot water because repeated exposure to hot water increases the risk of dermatitis\n(comfortably warm is generally considered to be about 45°C)\n• taps that have hands-free operation (e. g. knee- or foot-operated taps or those with\nmovement sensors)\n• liquid or foam soap solution\n• suitable hygienic hand-drying facilities (either single-use hand towels or suitably designed\nand located hand driers; roller towels are not acceptable as they are not single use). Where\nsingle-use towels are used, suitably designed and located bins should also be provided.\nGood practice is that hand sanitiser is also provided at all hand-washing facilities. (Hand\nsanitiser is always required for high-risk and high-care operations – see clause 8. 4.1.)\nThe provision and location of hand-wash basins are expected to follow industry best practice\nwithin that sector, including a risk assessment for breakage or damage. For some low-risk\noperations where hand-washing facilities are only provided within toilets before re-entering\nproduction, the requirements for hand-washing facilities will also apply to toilet areas."},{"id":"4.8.5","requirement":"Toilets shall be adequately segregated and shall not open directly into production or packing areas. Hand-washing facilities shall be provided within toilets.","interpretation":"Toilets must be adequately segregated from production areas and must not open directly\ninto production or packing areas. There should be an intermediate ventilated space between\nthe toilet cubicle and any production area to prevent foul odours from entering production\nareas.\nThe hand-washing facilities provided in toilets must be equipped with:\n• appropriate instructions for use, considering the language needs of staff\n• sufficient water at a suitable temperature (clause 4. 8.4)\n• soap (in any format)\n• suitable hand-drying facilities (in any format).\nWhere hand-washing facilities within toilet facilities are the only ones provided before\nre-entering production, the requirements of clause 4. 8.4 apply, including suitable signage to\ndirect staff to wash their hands prior to entering production areas."},{"id":"4.8.6","requirement":"Where smoking is allowed, designated controlled smoking areas shall be provided. Electronic cigarettes shall not be permitted in production or storage areas.","interpretation":"Facilities in line with national legislation must be provided for those staff wishing to smoke.\nThese facilities must not be located within the packing or production areas where there\nis open food or ingredients, or where smoke could reach product or ingredients. Indoor\nfacilities must have sufficient extraction to the exterior of the building.\nProcedures for protective clothing and hand-washing must be in place whenever staff enter\nor leave production and packing areas (clause 7. 4.1); therefore suitable facilities for staff to\nremove their protective clothing before smoking and for washing their hands afterwards\nmust be provided. Signs must direct them to the hand-washing facilities.\nThere must be sufficient and appropriately positioned facilities for the waste generated by\nthose persons smoking.\nWhere electronic cigarettes (e-cigs) are permitted on site, instructions for use must comply\nwith national and local legislation. Electronic cigarettes must not be taken into storage,\nprocessing or production areas."},{"id":"4.8.7","requirement":"All food brought into manufacturing premises by staff shall be appropriately stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas.","interpretation":"Suitable storage facilities must be provided for food brought on site by staff, enabling it to\nbe stored in a hygienic manner. Where refrigerators are provided for staff food, they should\nbe kept clean, maintained and operated at an appropriate temperature. Refrigerators used for\nproduction materials and shelf-life samples must not be used for storing staff foodstuffs.\nFood (including sweets and chewing gum) must not be taken into storage, processing\nor production areas, as it may constitute a risk to the product. Food must be adequately\ncontrolled when stored in other areas.\nAll food and drink must be consumed in designated areas away from food-handling,\nproduction and storage areas. Where appropriate, designated outside areas can be provided\nfor staff to eat food; where provided, these must have an appropriate control of waste.\nDrinking of water from purpose-made dispensers by using disposable conical cups or spill-\nproof containers may be allowed, provided it is confined to a designated area, minimising the\nrisk to product, and suitable disposal facilities are provided."},{"id":"4.8.8","requirement":"Where catering facilities are provided, they shall be suitably controlled to prevent contamination of products.","interpretation":"Where the company provides a canteen or other food service (including food vending\nservices) for members of staff, the kitchens and cold-storage areas need to be suitably\ncontrolled to prevent the contamination of products (e. g. by microbiological or allergen\ncontamination).\nIn the absence of specific legislative requirements and assessments for the control of\nhazards in catering facilities, a study based on HACCP principles should have been carried\nout on any catering facilities provided for the staff. The risks identified should be effectively\ncontrolled – in particular, those associated with staff hygiene, cleaning, cross-contamination\nbetween raw and cooked foods, and storage conditions.\nWhere hot food is prepared within a site’s facilities, additional safe food-handling may be\nrequired; for example, the WHO’s Five Keys to Safer Food Manual promoting safe food-\nhandling highlights the need to:\n• keep clean – wash hands and keep kitchens and food preparation areas washed and\nsanitised\n• separate raw and cooked foodstuffs, and keep the utensils or equipment used for handling\nthem separated\n• cook or reheat products thoroughly\n• store food at appropriate temperatures to maintain food safety; for example, using fridges\nand freezers, and keeping cooked food hot before serving\n• use water of an appropriate quality to ensure that it is not the source of a food safety hazard.\nThe Standard requires sites to consider whether there are risks of product contamination\nfrom catering activities and vending machines, and, where appropriate, ensure that suitable\ncompany policies are in place to manage these risks. For example, in some operations (e. g.\nsites manufacturing a product with an allergen-free claim), specific allergens may present a\nparticular risk. These sites should specify any relevant company policies to confectionery\nvending suppliers and catering facilities.\nAt the BRCGS audit, there will be a basic inspection of the kitchen facilities. Catering\nfacilities should be part of the site’s own internal audit or hygiene inspection programme.\n4. 9 Chemical and physical product contamination control: raw material-handling,\npreparation, processing, packing and storage areas\nAppropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination\nof product.\nThe risk of foreign-body and chemical contamination must be minimised through the consideration of potential\nsources and the implementation of control procedures within the HACCP or food safety plan. Areas to consider\ninclude storage, processing, equipment, maintenance, building structures, cleaning operations and personnel.\nStaff facilities and communal areas such as entrance corridors also need to be considered to ensure that their design\nand the processes carried out within them do not pose a risk to products (e. g. the presence of staples or drawing\npins on open noticeboards). Regular documented inspections (clause 3. 4.4) must be carried out to verify that these\ncontrols are in place.\nIt is often useful for sites to consider physical contamination controls in three tiers, as shown in \nWhere possible, eliminate the hazard. For example:\n• remove unnecessary glass and wood\n• ban staples in raw material packaging.\nWhere necessary, use control procedures to prevent the\nrisk. For example:\n• debagging and deboxing procedures that avoid\n• creating fragments of packaging.\nWhere the above are not possible, use materials that are\neasy to detect. For example:\n• metal detectable closures\n• plastic liners with contrasting colours\n• plasters that are both coloured and metal detectable.\nDetect\nPrevent\nEliminate"},{"id":"4.12.1","requirement":"Where licensing is required by law for the removal of waste, it shall be removed by licensed contractors and records maintained.","interpretation":"Waste contractors must be appropriately licensed and/or approved where this is required by\nlocal law.\nWhere legislation exists for specific waste streams (e. g. disposal of meat products), this must\nbe complied with; such legislation may include requirements for segregation of waste or\nspecific methods of disposal.\nRecords of removal must be maintained and available for audit."},{"id":"4.12.2","requirement":"Internal and external waste collection containers and rooms housing waste facilities shall be managed to minimise risk (clearly identified, easy to clean, emptied appropriately).","interpretation":"Waste collection containers and rooms housing waste facilities must be managed to\nminimise the risk of contamination of products. Particular consideration must be given to:\n• identification of waste containers and storage areas to ensure waste is collected only in\ndesignated containers/areas\n• ease and effectiveness of cleaning (see section 4. 11)\n• keeping facilities well maintained\n• emptying at appropriate frequencies\n• keeping external waste containers covered or room doors closed, thus ensuring that waste\ncannot fall out of containers or stray out of designated rooms to cause a contamination\nrisk\n• the pest control implications of external waste collection areas."},{"id":"4.12.3","requirement":"Waste removal from open product areas shall be managed to ensure that it does not compromise product safety.","interpretation":"Waste should be removed from open product areas to minimise the risk of product\ncontamination (for example, from allergens, pathogens, taint, non-compliance with claims).\nA number of considerations may be needed when planning waste handling, including:\n• risk assessment – to identify the risks associated with specific products or production\nareas\n• process flow – for example, the movement of product, waste and staff\n• identification of suitable equipment – for example, are lidded or sealed containers\nneeded; are there different types of waste that need to be segregated or handled\ndifferently?\n• scheduling of waste removal – for example, how frequently is waste removed; is removal\ncompleted during or after the production run?"},{"id":"4.12.4","requirement":"If unsafe products or substandard trademarked materials are transferred to a third party for destruction, that third party shall be a specialist and provide records.","interpretation":"Requirements for the disposal of trademarked waste must be defined within a contract with\nthe waste disposal contractor. Records of destruction or disposal must be maintained. The\nobjective is to ensure that waste products do not re-enter the food supply chain once sent\nfor disposal. If unsafe products are transferred to a third party for destruction, the third party\nmust be a specialist in secure product or waste disposal and must provide records which\ninclude the quantity of waste collected.\n4. 13 Management of surplus food and products for animal feed\nEffective processes shall be in place to ensure the safety and legality of by-products of the primary processing\nactivity of the site.\nAll products intended for the human food chain must not be injurious to health, and must be fit for human\nconsumption. Therefore the site’s procedures to control the handling and storage of surplus food and by-products\nmust ensure that safety and legality are maintained.\nSimilarly, by-products or other materials intended for animal feed must meet the relevant requirements for safety\nand legality pertaining to those supply chains."},{"id":"4.13.1","requirement":"Surplus customer-branded products shall be disposed of in accordance with customer-specific requirements. Customer brand names shall be removed unless otherwise authorised.","interpretation":"This clause covers the situation where surplus product is not required by the intended\ncustomer (e. g. because of a fall in predicted orders), but is still suitable for sale to alternative\ncustomers. It does not include sales to staff or donations to charity, which are covered\nseparately in clause 4. 13. 2.\nThe release of surplus product to alternative customers must only take place in accordance\nwith the original brand owner’s specific requirements. For example, in many cases the\nproduct packaging (or associated documentation) will refer to the brand owner and these\nbrand names will need to be removed before the product leaves the site."},{"id":"4.13.2","requirement":"Where customer-branded products which do not meet specifications are sold to staff or charities, this shall be with the prior consent of the brand owner.","interpretation":"Many companies sell products to staff or donate them to charity when they are not required\nby the intended customer (e. g. because of a fall in predicted orders, minor cosmetic damage\nto packaging, or failure to meet the brand owner’s specification).\nIn many cases the product packaging (or associated documentation) will refer to the brand\nowner and therefore release to charity or staff must only take place with the prior consent\nof the brand owner. It is not necessary for the site to obtain this consent for each individual\nbatch of product or on each occasion that the product is sent to a charity; however, the\nbrand owner’s policy or permission must be defined (e. g. in a policy document or within the\ncompany’s contract).\nAll products (customer-branded and own brand) must still be safe, be legal (e. g. meet legal\nrequirements for labelling), maintain traceability and be fit for consumption; therefore the\nsite should have documented procedures which detail the product assessment and release\nprocess. Staff responsibilities, including which staff have authorisation to release products\nfor staff sale or charitable donation, should also be made clear."},{"id":"4.13.3","requirement":"By-products and downgraded/surplus products intended for animal feed shall be segregated from waste and protected from contamination.","interpretation":"In many parts of the world, there are specific regulations relating to the suitability of\nproducts and by-products for inclusion in animal feed (e. g. EU legislation on animal by-\nproducts and the control of transmissible spongiform encephalopathies). It is essential\nthat, where products and by-products are supplied for animal feed, the site is aware of, and\ncomplies with, the relevant legislation. There are several recognised feed schemes and,\nwhere applicable, certification to such a scheme may be required. The animal feed contractor\nmust also be appropriately licensed.\nMaterials for inclusion in animal feed must be segregated from other waste streams and\nmanaged to prevent contamination, and should be labelled accordingly.\n4. 14 Pest management\nThe whole site shall have an effective preventive pest management programme in place to minimise the risk of\npest presence, and resources shall be available to respond rapidly to any issues which occur to prevent risk to\nproducts.\nPest management programmes shall comply with all applicable legislation.\nManagement of pests must be undertaken at a level commensurate with the needs of the whole site, including\ntemporary or seasonal facilities and all storage units, based on the:\n• nature of identified potential pests, including rodents, insects and birds\n• characteristics of raw materials (regarding their potential for stored insect pests)\n• equipment\n• finished products\n• process\n• site and environment (e. g. prevention of ingress and the removal of potential pest harbourage)\n• potential for future pest risks\n• legal requirements in the country or region where the site is located.\nWhere instances of pest ingress (i. e. single occasion or low numbers) occur, these need to be appropriately\ninvestigated and actioned but must not be deemed as loss of control. However, where there is pest presence (i. e.\nevidence of large numbers of pests breeding within the building or site over a period of time), this must be regarded\nas loss of control and a lack of maintenance of the pest management programme, and will lead to a major non-\nconformity being awarded.\nWhere a site uses pest management contractors or suppliers, the relevant clauses from sections 3. 5.3, 4. 1 and 7.\napply.\nBRCGS publishes a separate best-practice guideline on pest management, which may be purchased from the\nBRCGS Store or viewed online at BRCGS Participate."},{"id":"4.14.1","requirement":"If pest activity is identified, it shall not present a risk of contamination to products, raw materials or packaging.","interpretation":"Where pest activity is identified (for example, during site inspections (clauses 4. 14. 2 and\n4. 14. 10) or reported by staff (clause 4. 14. 12)), actions must be taken to ensure the risk of\ncontamination of products, raw materials or packaging is avoided. The site will therefore\nneed to record and assess any reported pest activity in a timely manner to ensure\nappropriate action can be taken. This may include action by the site (e. g. isolation of at-risk\nproduct) or by its approved pest management contractor (clause 4. 14. 2).\nWhere an infestation occurs, this must be clearly documented and effectively managed\n(clause 4. 14. 8).\nAny products, raw materials or packaging implicated by pest activity should be subject to the\nsite’s non-conforming product processes (see section 3. 8)."},{"id":"4.14.2","requirement":"The site shall either contract the services of a competent pest management organisation or have appropriately trained staff for regular inspection and treatment. The frequency of inspections shall be determined by risk assessment.","interpretation":"There must be regular inspection and, where appropriate, treatment of the site to deter\nand eradicate infestation. The frequency of inspection and treatment of the premises must\nbe based on the product risk, including the age, design and location of the buildings and\nequipment.\nPest management is often contracted to external companies, which may need to be licensed\nor approved by local or national authorities. The contractor must demonstrate competence\n(evidence could, for example, include membership of a national trade association, training\nrecords, licence or CEPA certification to EN 16636 for pest management services). Section"},{"id":"4.14.3","requirement":"Where a site undertakes its own pest management, it shall be able to effectively demonstrate that operations are undertaken by trained and competent staff, resources are sufficient, and legislation is complied with.","interpretation":"With regard to the need for pest management to be undertaken by trained staff, the auditor\nwill check the appropriate training records for proof of adequate training. Suitable training\nwould be expected to cover all relevant activities that the staff member is responsible for,\nincluding, for example, legislation, pest management techniques, correct use of monitoring\nand control devices, or permitted baits.\nAccess to specialist technical knowledge can be obtained by engaging the services of an\nexternal contractor or via trade association membership.\nIn some geographic regions legislation governing the use of pest control products is\nupdated frequently and the appointed staff will need to keep abreast of any changes."},{"id":"4.14.4","requirement":"Pest management documentation and records shall be maintained. • up-to-date plan of the site identifying devices. • identification of baits/monitoring devices. • clearly defined responsibilities. • details of pest control products used. • any observed pest activity. • details of treatments undertaken","interpretation":"Written procedures and inspection documentation must be maintained. These must include:\n• an up-to-date site plan identifying the locations of pest monitoring and control devices.\nThis plan should be reviewed periodically, for instance annually or when there are site\nchanges\n• identification (e. g. a numbered list) of the types of bait and monitoring devices on site\n• clearly defined responsibilities for site management and the contractor. This should\ninclude methods of communication, contact details for the nominated site and contractor\npersonnel, and dates for when review meetings will take place\n• details of the pest control products used and instructions for their safe and effective use\n• records of any pest activity observed\n• details of pest control activities undertaken.\nAll pest management inspections must be recorded, even when there are only negative\nfindings to report. This is important for due diligence: in the event of an incident, these\nrecords can confirm when the site or area was last inspected and confirmed as satisfactory,\nand demonstrate this to regulatory authorities and customers. Records can be in any format\nas long as they are accessible by the site. For example, during an audit the auditor may review\npaper-based pest management records or, where records are online, ask the site to access\nthe records and demonstrate use of the online system."},{"id":"4.14.5","requirement":"Bait stations or other rodent monitoring or control devices shall be appropriately located and maintained. Toxic rodent baits shall not be used within production areas where open product is present except when treating an active infestation.","interpretation":"Bait stations and other rodent monitoring or control devices must be appropriately\ndesigned, located and maintained to limit the potential for contamination of products. This\ncan be achieved by:\n• making them tamper-resistant\n• securing them in place or locating them in positions where accidental movement is\nunlikely\n• using non-spill formulations\n• inspecting them routinely at a frequency based on risk assessment or local legislation (this\nis particularly important for areas where live catch, break-back traps or spring-powered\ntraps are permitted because of the potential for secondary pests, if the caught pests are\nnot removed sufficiently quickly).\nThe pest management specialist should advise on the quantity and siting of the monitoring\ndevices; their locations might be risk-based rather than evenly distributed. When an active\ninfestation is being treated, the location of additional monitoring or control devices should\nbe considered.\nRodent bait is generally toxic, so must be controlled to avoid contamination of product.\nToxic rodent bait must not be used within production or storage areas where open product\nis present, except when treating an active infestation. Where this occurs, the bait must be\nsecured to ensure product cannot be contaminated.\nAny missing bait stations or missing rodent control devices should be recorded and\ninvestigated. Additional action may be required depending on the reason for the absent bait\nstation; for example, to ensure that there is no risk to product and that any pest activity has\nbeen appropriately managed."},{"id":"4.14.6","requirement":"Insect-killing devices, pheromone traps and/or other insect-monitoring devices shall be appropriately sited and operational.","interpretation":"Where insect-killing devices, pheromone traps or other insect-monitoring devices are used,\nthey must be correctly sited and operational. If insects could be expelled from an insect-\nkilling device and contaminate the product, alternative systems and equipment must be\nused (e. g. those based on sticky-board technology) or the devices must be moved to a more\nappropriate position.\nEquipment must be fully operational. For example, bulbs on insect-killing devices must be\nchanged at regular intervals (in accordance with the manufacturer’s instructions) to maintain\noptimal luminosity performance (there is no minimum frequency for changing the bulbs, as\nthis will depend on a number of factors, including the brand of bulb used), and pheromone\ntraps must be replenished quarterly or in accordance with the manufacturer’s instructions.\nDocumentation must provide evidence of this maintenance."},{"id":"4.14.7","requirement":"The site shall have adequate measures in place to prevent birds from entering buildings or roosting above loading or unloading areas.","interpretation":"The site (or its pest management contractor) should use a risk assessment approach to\nestablish whether there is any potential for the ingress of birds, or for roosting and nesting at\nloading or unloading areas, and to assess the measures required to mitigate the risk.\nThe expectation here is not necessarily to rebuild or reconfigure facilities; instead, the\nintention is to recognise any potential problems and take steps to remove or mitigate these\nrisks from birds roosting and nesting."},{"id":"4.14.8","requirement":"In the event of infestation, immediate action shall be taken to identify at-risk products and to minimise the risk of product contamination.","interpretation":"In the event of infestation (clause 4. 14. 1), immediate action must be taken to eliminate the\nhazard. This will include identifying and quarantining any potentially affected product so\nthat it can be evaluated in accordance with the site’s non-conforming product procedures.\nAction may also include steps to protect other products, and inspection by the pest\nmanagement specialist. Any such infestation and corrective actions taken must be recorded;\nsee section 3. 8 for the non-conforming product procedure."},{"id":"4.14.9","requirement":"Records of pest management inspections, pest proofing and hygiene recommendations and actions taken shall be maintained.","interpretation":"Records of pest management will include any recommendations made by the pest\nmanagement specialist (e. g. changes to inspection frequency or pest proofing).\nIt is the responsibility of the company to ensure that all relevant recommendations made by\nthe pest management specialist are carried out within a suitable timescale and verified for\neffectiveness. Records of these changes must be maintained."},{"id":"4.14.10","requirement":"An in-depth, documented pest management assessment shall be undertaken at a frequency based on risk, but at least annually, by a pest management expert.","interpretation":"In-depth pest management assessments are in addition to the regular inspections (e. g. monthly\nchecks of bait and traps) conducted as part of the pest management programme (clause 4. 14. 2).\nThe aim of these assessments is to:\n• ensure an in-depth inspection of the site, equipment and facilities for evidence of pest\nactivity and to determine the current levels of pest activity throughout the site. This\nshould not be a matter of mere bait checking, but should include an audit of the whole of\nthe site, especially in less accessible areas such as voids and cable runs, stores and silos\n(see below), where established pests are less easy to detect\n• review existing measures to provide a critical appraisal of the site’s pest management\nactivities to ensure they remain appropriate\n• where appropriate, liaise with the technician who completes the routine pest management\nactivities, to agree changes to the pest management programme\n• review pest management-related records\n• suggest alternative approaches to resolving problems\n• liaise with senior site or group management.\nWhere insects in stored product represent a potential hazard, the visits should be scheduled\nfor a time when access to equipment for inspection purposes is available, so that the\ngreatest value can be gained from the survey. Where pest activity is seasonal in nature, the\nsurvey may be timed to coincide with the period of greatest risk.\nThe assessment will be completed by a pest management expert (e. g. the pest management\ncontractor’s field biologist or a senior technician with a qualification in pest management\nand many years of experience). Many countries have formal qualifications for those working\nin pest management; for example, by operating a legally backed licensing system. Anyone\nworking as a field biologist should at least have a recognised basic pest management\nqualification, available in the country concerned, irrespective of whether it is a legal\nrequirement. Few countries have formal higher-level pest management qualifications.\nHowever, a field biologist should be a senior, competent technician with a number of years\nof practical pest management experience. Other desirable qualifications, knowledge and\nskills may include:\n• possession of a recognised food safety qualification. Field biologists work closely with\nfood, so should be trained to at least the same level as a food-handling employee\n• membership of a relevant continuing professional development (CPD) scheme, if such\na scheme exists in the country of operation. At the very least, they should be able to\ndemonstrate that they keep up to date with technical and regulatory developments in pest\nmanagement\n• knowledge of the scope and content of the food industry standards the site is working to.\nFor example, do they understand the requirements of the Standard and whether the site\nhas to meet any customer-specific requirements?\n• knowledge and understanding of the food manufacturing processes operating at the site,\nparticularly when commodities vulnerable to infestation by stored-product insects are\nbeing handled or processed\n• how to use pest monitoring data to effectively target and measure the success of control\nmeasures. For example, using monitoring data to generate trend analyses (as opposed to\njust counts) is key.\nThis highlights an important difference between the in-depth audit and the practical,\nroutine pest management service completed by the pest management technician. It is not\nsimply a second tier of inspection, adding complexity and costs to the contract. The pest\nmanagement field biologist is on hand to lead the pest management programme, and should\nuse the in-depth audit to guide the efforts of both site personnel and the pest management\ntechnician to eliminate problems and maintain pest-free conditions. In pest management\nterms, the field biologist is the most important person working on behalf of the pest\nmanagement contractor in any food site. It is therefore important that the site is satisfied\nthat this expert is fully competent and has sufficient knowledge and experience to conduct\nthe audit and produce meaningful results.\nGood practice is to separate the in-depth audit and routine inspections, rather than\ncomplete them at the same time. It is also often useful for the in-depth assessment to be\nconducted by an alternative consultant rather than the staff responsible for the regular\ninspections, as this has the benefit of a second expert examining the site and the current\npest management programme.\nIt is expected that the audits will be completed at least annually; however, risk assessment\nmay indicate that a different frequency is required (e. g. where pest issues are seasonal in\nnature then the frequency may need to increase). The BRCGS auditor will expect to see the\nrisk assessment that the site has used to determine the appropriate frequency. The results of\nthe surveys should be incorporated into the company management review (clause 1. 1.4).\nThis clause applies to all sites, not just those carrying out their own pest management.\nBRCGS has produced a separate best-practice guideline to pest management which may be\npurchased from the BRCGS Store or viewed online at BRCGS Participate.\nFurther guidance In-depth report format and content\nThe Standard does not prescribe the format of the report, and each pest management\nspecialist is likely to have their own preferred format. However, it is the content and not the\nformat that is all-important. As a minimum, the report should include:\nAreas inspected\nThe audit report should include reference to the areas inspected, even where no problems\nhave been found. A list of issues requiring attention without any additional detail is unlikely\nto provide the depth of information that the site requires to improve. If an area has been\ninspected and found clear, it is important that this is recorded: it is the contractor’s evidence\nthat the area has been inspected, and the food manufacturer’s evidence that there are no\nproblems there.\nAny problems\nProblems relating to, for example, sanitation and building fabrication should be highlighted.\nThese observations should have as their objective either the eradication of an existing\ninfestation, or the prevention of a new one. Where it is not immediately obvious, the reasons\nwhy the observation points to a problem should also be stated, and practical and appropriate\nrecommendations should be made to address these matters.\nFurther guidance\nCurrent system review\nThere should be a review of whether the pest management system is suitable; and, if it\nis found to be inadequate or inappropriate, recommendations should be made regarding\nalternative proactive pest management practices and strategies.\nSome pest contractors include useful information in addition to the on-site audit; for\nexample, a summary of the pest inspections and trend analysis, as discussed in clause 4. 14. 11.\nThis is acceptable; however, note that this information cannot form a substitute for an on-\nsite visit, or for the audit described above."},{"id":"4.14.11","requirement":"Results of pest management inspections shall be assessed and analysed for trends on a regular basis (annually or in the event of infestation).","interpretation":"There must be a periodic assessment of pest management inspection results and trends. The\nreview will consider:\n• pest control measures\n• bait takes\n• analysis from trapping and monitoring devices\n• identification of any trends\n• action taken\n• recommendations for changes or improvement.\nAt a minimum, this periodic assessment must be conducted annually (or sooner in the event\nof an infestation)."},{"id":"4.14.12","requirement":"Staff shall understand the signs of pest activity and be aware of the need to report any evidence of such activity.","interpretation":"Any member of staff on the site should be trained to recognise pest activity in production or\nstorage areas, and this can form part of the site’s induction and refresher training programme.\nThe content might address typical pests, different types of evidence of pest activity, and the\nfood safety implications. Subsequently, any pest activity witnessed by any member of staff\nneeds to be reported to the designated person.\nThe identification of the designated person and the process by which information should\nbe reported also need to be communicated to the staff. The designated person will need to\nrecord the evidence and assess whether additional action is required.\n4. 15 Storage facilities\nAll facilities used for the storage of raw materials, packaging, in-process products and finished products shall be\nsuitable for purpose.\nThe site’s procedures for storage must be controlled to ensure they do not pose a risk to products. This includes all\nraw materials and packaging, intermediates and finished products. Storage facilities must be suitable for all products\nstored and take into consideration the requirements for specific products; for example:\n• the temperature at which the product must be stored\n• allergen management\n• segregation, where required; for example, food and non-food storage."},{"id":"4.15.1","requirement":"Procedures to maintain product safety and quality during storage shall be developed on the basis of risk assessment. • managing chilled and frozen product transfer. • segregation of products. • storing materials off the floor and away from walls. • specific handling or stacking requirements","interpretation":"The company must consider the potential risks to product safety and quality that may\ndevelop during storage. For example, if a product is temperature-controlled, the specified\ntemperature must be maintained throughout the storage of the product.\nIn addition to the points listed in the requirement, the company should also maintain the\ncleanliness of the storage areas (e. g. with appropriate cleaning procedures and identified\nfrequencies, as evidenced by documented records), in accordance with the requirements in\nsection 4. 11."},{"id":"4.15.2","requirement":"Where appropriate, packaging shall be stored away from other raw materials and finished product.","interpretation":"In order to avoid product contamination risks from packaging (such as glass) or\ncontamination of unused packaging by-products, packaging should be stored away from\nraw materials and finished product. This may be achieved by use of a dedicated packaging\nstore or a dedicated area of a raw material store. Only packaging required for immediate use\nshould be stored in the actual packing area (clause 6. 2.1).\nThe storage of packaging outside is acceptable only where the packaging material:\n• is not at risk of deterioration (e. g. rusting of cans)\n• is protected from contamination\n• is cleaned effectively before filling.\nOnce packing has finished, controls must be in place to ensure that any leftover packaging\nis still suitable for use before its return to storage (e. g. it has not been contaminated or\nprinted with code information preventing reuse). Any open containers must be appropriately\nresealed or rewrapped and returned to appropriate storage to minimise the potential for\ncontamination (such as splashing during cleaning operations) or mis-packs. The traceability\nof packaging should be retained (i. e. the coding is retained on the outer packs on return to\nstorage)."},{"id":"4.15.3","requirement":"Where temperature control is required, the storage area shall be capable of maintaining product temperature within specification. Temperature recording equipment with alarms shall be fitted or manual checks recorded.","interpretation":"Where temperature control is required for the appropriate storage of products, the storage\narea must be capable of maintaining the required temperature. Good practice is for doors to\nclose automatically or be alarmed to ensure they cannot be inadvertently left open.\nTemperature management is usually carried out through the use of automatic temperature\nrecording systems, which raise an alarm when temperatures fall outside a set range for a\ndefined period (to allow for the usual defrost cycles). The alarm must be capable of notifying\na responsible person outside of normal working hours, either by notification to on-site\nsecurity, by a home call or by ringing through to a service centre.\nWhere such automatic systems are not in use, the same level of safeguard to product\ntemperature control needs to be instigated through manual temperature checks. To achieve\na similar level of control, manual temperature checks should be carried out on a 4-hourly\nbasis, including during nights and weekends. The frequency of checks could be reduced\nwhere the nature of the product and the insulating capability of the unit are such that the\nproduct would remain unaffected by a refrigeration failure of longer than 4 hours (e. g. some\nfrozen products). Ongoing temperature records must demonstrate that product temperature\nrequirements are being met.\nProcedures must specify the frequency of manual checks or the use of automatic continual\nmonitoring systems. All temperature monitoring must allow intervention before product\ntemperatures exceed defined limits for the safety, legality or quality of products. Procedures\nshould therefore identify the action to be taken in the event that:\n• temperature monitoring indicates temperatures outside of the permitted levels\n• there is a failure of the temperature control systems (e. g. a breakdown of the chiller or\nfreezer).\nIn regions where ambient temperatures may fluctuate considerably (e. g. large seasonal\ndifferences, or considerable variation from day to day), the site should be aware that this may\nhave an adverse effect on ambient storage as well as chilled and frozen facilities. Depending\non the product type, the site may need to consider emergency contingency monitoring or\ncontrol to ensure product safety or quality."},{"id":"4.15.4","requirement":"Where controlled atmosphere storage is required, the storage conditions shall be specified and effectively controlled.","interpretation":"Where storage conditions include other parameters (e. g. modified atmosphere storage of\nfruit and vegetables), the mix of gases needs to be defined and monitored to ensure the\nquality of the product is maintained.\nTests are required to ensure that the correct composition of gases is present. They are\ndifferent from the tests identified in clause 4. 5.3, which relate to contamination and food\nsafety. Test results must be recorded."},{"id":"4.15.5","requirement":"Where storage outside is necessary, items shall be protected from contamination and deterioration.","interpretation":"Where it is necessary to store product and equipment outside, they must be protected from\npests and the elements. Therefore storage of products and equipment outside is normally\nappropriate only where the site can demonstrate that the material:\n• is not at risk of deterioration\n• is protected from contamination\n• is cleaned effectively before being brought into the factory.\nParticular attention must be paid to cleaning and inspection of the materials before they are\nbrought into the factory and used, to prevent contamination."},{"id":"4.15.6","requirement":"The site shall facilitate correct stock rotation of raw materials, intermediate products and finished products.","interpretation":"Stock, whether raw materials, intermediates (including rework) or finished products, must be\ncontrolled to ensure that materials are used in an appropriate order and do not exceed their\nshelf life. This control is generally operated on a ‘first in, first out’ basis.\nProduct identification, such as labelling, and inventory systems can help to facilitate the\ncorrect order in relation to the materials’ manufacturing dates and prescribed shelf life.\n4. 16 Dispatch and transport\nProcedures shall be in place to ensure that the management of dispatch and of the vehicles and containers used\nfor transporting products from the site do not present a risk to the safety, security or quality of the products.\nThe site’s procedures for dispatch and transport must be controlled to ensure they do not pose a risk to final\nproducts.\nWhere transport or distribution is subcontracted, the requirements for suppliers of services also apply (see\nsection 3. 5.3)."},{"id":"4.16.1","requirement":"Procedures to maintain product safety and quality during loading and transportation shall be developed and implemented. • controlling temperature. • use of covered bays. • securing loads on pallets. • inspection of loads","interpretation":"The site must consider the potential risks to product safety and quality that may develop\nduring dispatch and transport. In addition to the points listed in the requirement, vehicles\nshould also be inspected prior to loading and unloading (clause 4. 16. 2)."},{"id":"4.16.2","requirement":"All vehicles or containers used for the transport of raw materials and the dispatch of products shall be fit for purpose (clean, free from odours, suitable condition, equipped for temperature requirements).","interpretation":"Inspection of vehicles should be a site’s responsibility even where the vehicles and\ndistribution are subcontracted. At a minimum, the inspection will cover whether vehicles\nhave the correct levels of cleanliness and are free from evidence of pests and strong odours\n(which could taint a product), and have been maintained to prevent product damage during\ntransit.\nThe site should ensure that the correct operating temperatures are capable of being\nmaintained throughout transportation (i. e. that the refrigeration temperature ranges remain\nwithin the permitted parameters). This may include pre-cooling trailers for temperature-\nsensitive products prior to loading, to maintain correct temperatures.\nVehicle inspection records must be maintained."},{"id":"4.16.3","requirement":"Where temperature control is required, the transport shall be capable of maintaining product temperature within specification. Temperature data-logging devices or monitoring systems shall be used.","interpretation":"Vehicles that are temperature-controlled must demonstrate the control of temperature\nunder both minimum and maximum loads. This can be achieved through the use of\ntemperature recorders, data loggers or manual recorded checks. Where manual checks are\nused, the frequency of checking must ensure that the safety and quality of the product\nare maintained. The use of data loggers may be considered as a monitoring method; data\nreceived should be analysed to ensure that the temperature of products transported is\nmaintained."},{"id":"4.16.4","requirement":"Maintenance systems and documented cleaning procedures shall be available for all vehicles and equipment used for loading/unloading.","interpretation":"Documented hygiene and maintenance procedures for all vehicles (e. g. forklift trucks, pallet\ntrucks) and equipment (e. g. loading hoses for silos) must be in place. They must include:\n• the method(s) of cleaning\n• the frequency at which the cleaning must be completed\n• records that the cleaning has been completed."},{"id":"4.16.5","requirement":"The company shall have procedures for the transport of products, including restrictions on mixed loads, security requirements and instructions for vehicle breakdown.","interpretation":"The site must have procedures for the transport of products. The procedures must include:\n• the identification of any restrictions for mixed loads (e. g. specifying where allergen-free\nmaterials are to be stored or transported) to avoid cross-contamination or taint uptake\n• the security of all finished products in transport to ensure that they cannot be\ncontaminated, either accidentally or deliberately. This may include tamper-evident\npacking, vehicle seals or contractual handling arrangements with transport providers (such\nas not leaving vehicles unattended in insecure situations)\n• breakdown procedures for temperature-controlled vehicles (in case of, for example,\nvehicle breakdown or failure of the refrigeration system). These should consider:\n• facilities for vehicle drivers to easily contact the company or haulier for assistance\n• provision of a backup vehicle or rapid-repair facility\n• guidelines to evaluate the acceptability of product affected by the breakdown.\nThe appropriate staff must be trained in these procedures."},{"id":"4.16.6","requirement":"Where the company uses contractors, it shall have a documented supplier approval procedure to ensure risks to food quality and safety are effectively managed.","interpretation":"Where the company uses third-party contractors for transport of products, it must have a\ndocumented supplier approval procedure to ensure food safety and quality of products\nduring these activities. As a minimum, the approval procedure will include either:\n• certification to a BRCGS Standard (e. g. Global Standard Storage and Distribution) or\nstandard benchmarked by GFSI\nor\n• a contract with terms and conditions, verified and reviewed by a competent person. As a\nminimum, this contract must include terms and conditions to meet all the requirements of\nclauses 4. 16. 1 to 4. 16. 5.\nThe use of a contract or terms and conditions for defining the requirements may also be an\noption where other forms of transport are used (e. g. couriers or larger-scale carriage such as\nrail transport).\nThe requirements in section 3. 5.3 relating to suppliers of services also apply to dispatch and\ntransport contractors.\n5 Product control\n5. 1 Product design/development\nProduct design and development procedures shall be in place for new products or processes and any changes to\nproduct, packaging or manufacturing processes to ensure that safe and legal products are produced.\nProcedures must be in place to ensure that all new product development and amendments to existing products\nresult in safe products.\nNew product development or the introduction of new ingredients must not compromise existing activities or\nproducts handled in the same area; for example, the introduction of an allergen or microbiological risk that does not\nalready exist in the area would need to be risk-assessed and managed to prevent contamination of existing products."}],"statement_of_intent":"The production site shall be of suitable size, location and construction, and be maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products."},{"section":5,"title":"Product control","clauses":[{"id":"5.1.1","requirement":"The company shall have a procedure for new product development and changes to existing product, packaging and manufacturing processes.","interpretation":"The aim of this clause is to formalise processes for new product development, and changes\nto existing products, processes and packaging, to ensure the design, development and\nintroduction into production areas does not adversely affect the safety and legality of either\nthe existing products manufactured on site or the new products themselves.\nTherefore the company must have a new product development procedure which ensures\nthat product development activities are aligned with other site policies on the types of\nproduct or hazards handled on site, to prevent the unintended introduction of these hazards\n– for example, where a company has an existing policy to exclude a particular allergen from\nthe site, or where an existing product claim will be adversely affected.\nThis requirement must operate in conjunction with the food safety plan (HACCP processes);\nfor example, see clause 5. 1.2 and section 2. 12.\nAny such restrictions must be documented. Where no restrictions apply, this need not be\ndocumented."},{"id":"5.1.2","requirement":"All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or an authorised HACCP team member.","interpretation":"It is important that the site understands the product safety rationale for all new products\n(i. e. the criteria that make a product safe for consumption). This may, for example, include\nprocessing conditions such as cooking or temperature control; intrinsic properties of\nthe product such as pH or water activity; control of shelf life; or the effect of specific\ningredients such as preservatives.\nExperience has shown that sometimes even minor changes to ingredients, packaging or\nprocessing conditions can have a significant effect on the safety of products. The sign-off of\nchanges by the HACCP team leader or an authorised HACCP team member is designed to\nensure that the consequences of any change are understood. Therefore a full description of\neach proposed change to a product, raw material or process must be made available to the\nHACCP team. This can be demonstrated by a record of the sign-off of product changes (e. g.\na change authorisation form).\nRecords should be available even where the change does not result in any modification to\nthe existing HACCP or food safety plan.\nThe assessment of any potential impact on product safety and subsequent sign-off must\noccur before the products are introduced into the factory; i. e. sign-off must be completed\nbefore production trials begin to ensure that new risks (e. g. from allergens) are not\nintroduced into the factory without suitable controls approved by the HACCP team."},{"id":"5.1.3","requirement":"Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality.","interpretation":"Documented evidence of production trials (i. e. not kitchen-scale trials) need to be available,\ntogether with test results validating that the product formulation and manufacturing\nprocesses are capable of producing a safe product of the desired quality.\nProduction trials may not be required where new products are very closely based on existing\nproducts. Where production trials are not undertaken, the reason must be documented."},{"id":"5.1.4","requirement":"Initial shelf-life trials shall be undertaken using documented protocols. Results shall be recorded and retained and shall confirm compliance with the relevant microbiological, chemical and organoleptic criteria.","interpretation":"Incorrect product shelf life can result in serious food safety or quality consequences,\nunnecessary waste and production costs. For example:\n• an incorrect shelf life that is too long could result in:\n• the growth of pathogens to unacceptable levels\n• product spoilage\n• an incorrect shelf life that is too short can result in:\n• unnecessary waste, as unused product will be disposed of (either in the supply chain or\nby the consumer) before it actually needs to be\n• increased manufacturing costs (e. g. more frequent production or smaller batch size).\nIt is therefore important to assign shelf life in a systematic and scientific way. The company\nmust establish a documented procedure detailing how initial shelf-life trials are undertaken\nfor new products and changes to existing products. This procedure must consider the\nhandling conditions throughout the supply chain (e. g. chilled products are often subject\nto 2 hours at an ambient temperature mid-life to mimic the conditions during retail\nshopping). The aim of shelf-life trials is to confirm that product safety, legality and quality are\nacceptable throughout the expected shelf life.\nSamples to determine the shelf life should be taken from the trials detailed in clause 5. 1.3.\nWhere long-shelf-life products (e. g. some canned or frozen products) are developed, it may\nnot be possible to complete full shelf-life trials. The justification for the declared shelf life\nmust be documented and based on experience from similar products and science-based\nevidence.\nWhere rework is used or work in progress is stored, shelf life of the material should be\nestablished to ensure it is used within the correct period.\nOngoing verification of shelf life is covered separately in clause 5. 6.3.\n5. 2 Product labelling\nProduct labelling shall comply with the appropriate legal requirements and contain information to enable the safe\nhandling, display, storage and preparation of the product within the food supply chain or by the customer.\nErrors in product labelling remain a significant cause of product recalls. Site processes must therefore have robust\nprocesses, capable of consistently developing accurate and legal labels.\nThe labelling of products must meet all of the legal requirements for the designated country of use. The site must\ntherefore have processes to ensure it remains up to date with labelling requirements in that country (or countries)\nand that these requirements are accurately transferred onto the packaging and labels.\nFor the purposes of the Standard, the following definitions apply:\n• label – any tag, mark, picture or other descriptive matter, whether it is written, printed or otherwise marked, on or\nattached to the packaging of the product\n• labelling – any words, picture or symbol relating to the food and placed on any packaging or label accompanying\nthe product.\nNote that activities relating to labelling and packing are located in several sections of the Standard. An effective\nsystem of label design and packing of products will therefore require these sections to interact and operate together\nwithin the company. For example:\n• Section 5. 1 – product design and development\n• Section 5. 2 – design of labelling\n• Section 5. 5 – design and purchase of packaging\n• Section 6. 2 – labelling and packing processes (i. e. packing products and applying labels to products)."},{"id":"5.2.1","requirement":"All products shall be labelled to meet legal requirements for the designated country of use. There shall be a process to verify that ingredient and allergen labelling is correct.","interpretation":"The site’s procedures must include the completion of a legality check and sign-off of\nthe proofs (or draft designs) of new labels to ensure their compliance; this will include\nverification of ingredient and allergen information, based on both the product recipe\nand ingredient specifications. The appropriate legislative requirements in the country (or\ncountries) in which the products will be used must be considered.\nWhere the company is manufacturing customer-branded products, the customer or brand\nowner will normally have specific policies for the completion of the final artwork; for\nexample, the site may need to seek formal agreement of the finished product artwork. Where\nartwork is not formally agreed, the company shall be able to demonstrate that it has taken\nsteps to complete the artwork in accordance with the brand owner’s policies.\nWhere the company is the brand owner, sign-off may be undertaken by an experienced and\nauthorised manager or staff member.\nDuring the vertical audit, the auditor will assess the site’s processes for ensuring the\naccuracy of labelling and verify that the systems are operating correctly. The auditor will\nnot check every aspect of the labelling to confirm its legality, nor validate the label, but will\nselect samples of on-pack information for the site to substantiate and demonstrate the\nrobustness of procedures and compliance with this clause. For example:\n• for a product which claims ‘10% meat’, the auditor may ask for the evidence that\ndemonstrates this claim. This may include the product recipe, the mass balance exercise\nfor the specific batch, etc.\n• for a product which claims to be a ‘product of the UK’, demonstration of the accuracy of\nthe claim could include evidence of the origin of the materials purchased from suppliers\n• the auditor may compare the on-pack ingredient information with the recipe and\nspecification."},{"id":"5.2.2","requirement":"There shall be effective processes in place to ensure that labelling information is reviewed whenever changes occur to: the product recipe, raw materials, supplier, country of origin, legislation.","interpretation":"The accuracy of product labelling is of primary importance for the legality, consumer safety\nand the maintenance of product authenticity. It is therefore important that whenever a\nchange occurs to the product, its formulation or the ingredients, there is a review of the\nlabel information to ensure it remains correct and up to date. Where it is not, this must lead\nto a change in the labelling. Reviews, for example, will be required when there are changes to\nthe:\n• product recipe (e. g. reformulation of an existing product)\n• composition of the raw materials. For example, when the recipe of a bought-in compound\nraw material changes, good practice is for the supplier to notify the site of the proposed\nchange before it actually occurs. This should be documented in the supplier approval\nprocess (section 3. 5)\n• supply chain (e. g. the introduction of new suppliers of raw materials)\n• country of origin of the product or ingredients\n• legislation (in the country/ies in which the product is manufactured and sold)."},{"id":"5.2.3","requirement":"Where the label information is the responsibility of a customer, the company shall provide information to enable the label to be accurately created.","interpretation":"This clause is applicable wherever the decision on pack copy is not controlled by the\ncompany but is the responsibility of the customer or a nominated second or third party.\nIn these circumstances, the site is responsible for supplying accurate and reliable\ninformation on which to base the label creation. A system must therefore be in place to\ntransfer all the relevant initial information to the relevant customer or nominated party and\nfor ensuring that any changes are communicated in a timely manner.\nclause 5. 2.1 also applies where the customer or a nominated second or third party completes\nthis activity, and therefore there is an expectation that artwork approval and sign-off will be\ncompleted."},{"id":"5.2.4","requirement":"Where cooking instructions are provided to ensure product safety, they shall be fully validated.","interpretation":"This clause is concerned with cooking instructions that are required to make a product safe\nto eat when cooked (e. g. products containing raw chicken), and applies to both own-brand\nand customer-branded products. The site must validate that the cooking instructions will\nresult in a product that is consistently safe to eat when the instructions are followed. Sites\nshould also consider the potential for instructions to be deviated from.\nWhere the cooking instructions are completed by a third party, the site is still responsible\nfor demonstrating that validation is in place. This may be done by completing the validation\nitself, by management of the service provider (section 3. 5.3) or by having the information\navailable (e. g. a copy of the validation report from the third party). If the site is using cooking\ninstructions in connection with products assessed as high risk or high care, it should refer to\nAppendix 2 of the Standard.\nThe Standard is not prescriptive on the cooking methods that must be used, as this will\nbe dependent on the product type. However, the site should consider any limitations or\nchallenges in completing the validation for the chosen cooking method(s). For example,\nmicrowave ovens provide some additional challenges for the validation of cooking\ninstructions. To ensure validation of microwave cooking instructions (ready to heat/cook),\ntheir power and efficiency must be considered.\n5. 3 Management of allergens\nPet food and animal feed manufacturers certificated to the Standard are required to meet the appropriate allergen\nmanagement legislation in the country of intended sale of the products. Therefore, if there is no legislation relating\nto allergens in pet food/animal feed, this section of the Standard may be considered ‘not applicable’ for pet food or\nanimal feed destined for those countries.\nIn some parts of the world, allergen claims (e g. gluten- or dairy-free) are made on pet food or animal feed products.\nTherefore, where a site makes an allergen claim on a pet food or animal feed, it is required to meet all of the\nrequirements within section 5. 3.\nFundamental\nThe site shall have a system for the management of allergenic materials which minimises the risk of\nallergen contamination (cross-contact) of products and meets legal requirements for labelling in the\ncountry of sale.\nLegislation in many countries requires that the presence of food allergens, when deliberately present in a product,\nmust be declared on the pack.\nIt is important to note that the substances recognised as allergens differ from country to country, and at a minimum\nthe company will need to consider the allergens identified as appropriate to its own business, applicable legislation\n(in both the country in which its products are manufactured and the intended country of sale) and customer\nrequirements.\nThere are a number of organisations that provide useful information on allergens and allergen legislation; for\nexample, the Food Allergy Research and Resource Programme (FARRP) provides a table of allergens by country,\navailable on its Food Allergens – International Regulatory Chart web page. Leaving aside the deliberate use of\nallergenic ingredients in a food, there are occasions when a product can be cross-contaminated (cross-contact)\nbecause of the supply chain or manufacturing environments. Where there is a genuine risk of cross-contamination\n(cross-contact) with an allergen, this must be managed by implementing effective allergen management procedures\nto prevent or minimise (to an acceptable level) both its likelihood and the levels of allergen that are likely to be\npresent.\nThe specific legislative requirements in the geographic origin of the raw material, in the country of manufacture and\nin the country of sale must be considered. This is necessary to ensure that all the relevant allergens are managed and\nnone is inadvertently omitted because of differences in the legislation. For example, the list of substances that are\nconsidered to be allergenic is different in Europe, the US, Australia and Japan.\nWhere products are both produced and sold in countries where there are no legal requirements for the labelling\nof allergens, the list of allergens as defined in the Codex General Standard for the Labelling of Prepackaged Foods\n(Codex Stan 1-1985, paragraph 4. 2.1. 4) should be used as the basis for assessing compliance with the Standard.\nResearch is continuing to be conducted in a number of countries, including the UK and Australia, to identify allergen\nthresholds (i. e. the minimum amount of an allergen that will cause a reaction in the majority of allergic customers).\nSome of this research has now outlined allergen thresholds for a number of allergens, with the aim of assisting in\nthe more appropriate application of precautionary allergen labelling. However, this information must only be used\nfollowing a meaningful risk assessment applied to a well-managed operation. The values are very low (e. g. a few\nmilligrams), therefore factories must continue to use the full range of risk assessment, risk management and risk\ncommunication tools to ensure they produce products that are safe for allergic consumers.\nBRCGS publishes a separate guideline on allergen management, which may be purchased from the BRCGS Store or\nviewed online at BRCGS Participate."},{"id":"5.3.1","requirement":"The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination (cross-contact) by allergens.","interpretation":"Raw materials are a potential source of allergens and of cross-contamination. Therefore, the\nsupplier approval and raw material risk assessment procedures (section 3. 5.1) must include\nan assessment of raw materials for the presence of allergens and the potential for cross-\ncontamination.\nRaw material specifications (including flavourings, additives, carriers and processing aids)\nmust be agreed with each raw material supplier and include the allergen status (both content\nand risk of cross-contamination) of the materials.\nWhere required, additional allergen information must be obtained (e. g. through the use of\nsupplier questionnaires or audits).\nWhere a compound raw material (i. e. one manufactured from a number of ingredients) is\npurchased, the risk assessment must consider the risks associated with the raw material, its\ningredients and the manufacturing sites of the ingredients. The assessment process and the\noutcome of the assessment must be documented.\nIt is good practice for allergen risk assessments to be reviewed, as part of the review\nprocesses for the food safety plan (e. g. see clause 2. 12. 3); for example, when there is a\nchange in raw materials or the supply chain."},{"id":"5.3.2","requirement":"The company shall identify and list allergen-containing materials handled on site.","interpretation":"The aim of this clause is to ensure that the site maintains up-to-date knowledge of the\nallergens that are handled on the site. It is therefore important that the allergen statuses\nof all raw materials, additives, processing aids, intermediates and final products are\nknown, in terms of both the deliberate presence of allergens and the potential for cross-\ncontamination.\nAll materials that contain allergenic substances (ingredients, processing aids, intermediates\nand finished products) must be listed in a single reference document or database. It is not a\nrequirement for this list to be a separate document just for allergen information. Provided\nthat all the relevant information is available in a timely fashion (for example, if an allergen\nlist can be pulled from the company’s raw material database and clearly identifies which\nallergens are used on site, in which raw materials or finished product), this list or database\nwould fulfil the requirements of this clause. This might also include non-food materials used\nin production areas (e. g. pest control baits that are wheat-based).\nThe need to maintain an up-to-date list should be communicated to all areas of the\ncompany that can introduce new allergens onto the site or is responsible for allergen risk\nassessment (e. g. the HACCP team, new product development or engineering)."},{"id":"5.3.3","requirement":"A documented risk assessment shall be carried out to identify routes of contamination (cross-contact) and establish documented policies and procedures. • physical state of the allergenic material. • potential points of cross-contamination. • assessment of risk at each process step. • identification of suitable controls","interpretation":"A risk assessment process must be completed to identify potential routes of cross-\ncontamination (cross-contact). Consideration must be given to\n• the physical state of the allergen. For example:\n• powdered ingredients represent a greater risk of aerial cross-contamination than those\nin liquid form\n• sticky or fatty ingredients are likely to adhere to surfaces should cleaning be ineffective\n• particulates (such as pieces of nut) may result in significant heterogeneous\ncontamination\n• the identification of potential points of cross-contamination (cross-contact). An\n‘allergen process flow diagram’ or ‘allergen map’ can be useful in understanding where\nallergenic ingredients and foods exist in the plant and where they are introduced into\nthe process. This usually takes the form of a site plan on which are highlighted all the\nroutes each allergenic material can take. This map can subsequently be used to identify\nareas where cross-contamination between allergenic and non-allergenic materials\n(ingredients, intermediates or products) can occur. (The map should consider process flow,\nenvironmental factors, production activities, shared equipment and people.)\n• an assessment of the risk at each stage identified in the previous step\n• the identification and implementation of all reasonable controls to reduce or eliminate\ncross-contamination (e. g. segregation, the use of dedicated lines or equipment, enhanced\ncleaning schedules).\nThe risk assessment process, the assessments and any resulting procedures and/or factory\ncontrols must be documented."},{"id":"5.3.4","requirement":"Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination. • physical or time segregation. • use of separate protective overclothing. • use of identified, dedicated equipment. • scheduling of production. • systems to restrict airborne dust. • waste handling and spillage controls","interpretation":"The risk assessment (clause 5. 3.3) must be used to develop the factory controls and\nprocedures for handling raw materials, intermediates and finished products to reduce (and,\nwhere possible, remove) the risk of allergen cross-contact. All allergens present on site\nmust be considered so that procedures can be designed to prevent allergen cross-contact\nwith each specific allergen. For example, contaminating an allergen-containing product with\nanother allergen-containing product (such as contaminating a nut-containing product with\na milk-containing product) is just as significant as contaminating a product with no allergens\nwith that allergen.\nEffective allergen management procedures must be implemented even where on-pack\nwarning labels (clause 5. 3.6) are used. Particular attention should be given to:\n• physical segregation. Ideally, allergenic ingredients and products will be totally segregated\nfrom non-allergenic ingredients and products. This could involve, for example, dedicated\nstorage areas, dedicated (and colour-coded) production equipment, and the use of\ndedicated production lines\n• time segregation. Where products must be handled in the same factory areas or on the\nsame production lines, consideration should be given to the use of time segregation. For\nexample, all non-allergenic products could be produced first and allergenic materials\nintroduced subsequently, or the use of allergenic materials could be confined to the end\nof a day/shift and only before a full clean. Production scheduling could also be used to\nminimise the frequency of changeovers between allergen-containing and non-allergen-\ncontaining products. For example, in some factories it is possible to limit the use of nuts\nto a defined period or shift, rather than producing nut-containing products throughout the\nweek\n• the potential for protective clothing to be a source of allergen contamination. The use of\nseparate clothing or overalls for handling allergenic materials should be considered. It is\nnormally useful to colour-code protective clothing to prevent confusion\n• the use of dedicated equipment or utensils. These should be clearly identifiable (e. g. by\ncolour-coding)\n• allergens that can form fine powders (e. g. flour, milk powder and soya isolates). The\nmovement of airborne dust should be minimised by, for example, using physical barriers\n(such as shrouds, lids or segregated areas) for dispensing and mixing operations. The\nlocation of air-conditioning outlets or the use of fans should also be considered to ensure\nthese do not distribute airborne allergens\n• waste handling and spillage controls. Allergens should be removed efficiently, ensuring\nthat the removal process does not become the source of allergen contamination in other\nareas of the factory\n• the allergens that may be handled in non-production areas of the site (e. g. in canteens or\nin new product development). A policy for food brought on site by staff, or used in vending\nmachines or catering facilities, should be developed. The policy may ban certain allergens\nor restrict them to certain areas of the site.\nWhere colour-coding is used, consideration must be given to the choice of colours to\nensure that colour-blind staff are able to identify the correct items."},{"id":"5.3.5","requirement":"Where rework is used, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.","interpretation":"Specific documented procedures must operate to prevent rework containing allergens from\nbeing used in products or processes that do not contain those allergens. Best practice is for\nrework to be used on a ‘like-for-like’ basis (i. e. it is used only in exactly the same product).\nThe use of rework must be documented."},{"id":"5.3.6","requirement":"Where a justified, risk-based assessment demonstrates that cross-contamination cannot be prevented, a warning should be included on the label.","interpretation":"Where well-implemented and managed allergen management controls cannot prevent\ncross-contamination (cross-contact) and there is a significant and genuine risk of the\npresence of an allergen that would not otherwise be present and is therefore not mentioned\nelsewhere on the product (e. g. in the ingredients list), the use of on-pack advisory warning\nlabels should be considered – i. e. an on-pack, advisory, consumer-facing warning label\nstating that there is a risk of cross-contact from an allergen, which cannot be prevented.\nWhile different wording may be used in different countries (see below), such warnings are\noften referred to as ‘may contain’ labels, as they refer to unpreventable cross-contact rather\nthan to the deliberate inclusion of the allergen in the product.\nThe use of a warning label should be justifiable on the basis of the risk assessment\nand procedure (clauses 5. 3.3 and 5. 3.4) and should not be a substitute for effective\nimplementation of good manufacturing practices. Reference must be made to national\nlegislation, guidelines or codes of practice when making such a statement to ensure that\nbest practice is followed. For example, consideration should be given to:\n• the location of the warning (preferably in close proximity to the ingredients list)\n• the visibility of the statement – colour, highlighting, location and font size can all aid\nconsumers\n• the choice of the warning phrase used, so that the meaning is clear to consumers.\nThe site should consider:\n• the allergens identified as important by the company, i. e. from the risk assessments and\ncontrols described above\n• legislation in the country of intended sale (relating to both which allergens need to be\nlabelled and the permitted warnings)\n• customer requirements."},{"id":"5.3.7","requirement":"Where a claim is made regarding the suitability of a food for individuals with a food allergy or sensitivity, the site shall ensure that the production process is fully validated.","interpretation":"Allergic, food-intolerant and other food-hypersensitive individuals are likely to actively\nseek and choose products that claim to be suitable for them to consume (e. g. ‘gluten-free’\nproducts). It is therefore essential that any allergen claim is based on rigorous controls to\nensure its validity and continuous implementation to prevent adverse health consequences.\nWhere a claim is made regarding the suitability of a food, full validation and verification\nactivities will be required to ensure that the claim is consistently met. Typically, this will\ninclude:\n• reference to legislation or national guidelines on the permitted claims and the\nmanufacturing requirements to make the claim. For example, some countries have been\ndiscussing tolerances or acceptable limits for allergen labelling\n• demonstration that production processes are in place to ensure the product does not\ncontain unacceptable traces of the allergen\n• analysis of the final product\n• assessment of the adequacy of cleaning, as detailed in clause 5. 3.8 (where the site also\nproduces products containing the allergen about which the claim is made, additional\nverification controls will be required)\n• raw material controls. In addition to the normal requirements listed in clause 5. 3.1,\nadditional validation/verification requirements are likely to be needed (e. g. raw material\ntesting, additional supplier questionnaires, site audits).\nThe validation and verification activities must be recorded."},{"id":"5.3.8","requirement":"Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination by allergens. Cleaning methods shall be validated.","interpretation":"Some standard cleaning regimes will be insufficient to ensure the removal of all allergenic\nmaterial. Therefore, specific cleaning procedures must be present on site where allergen-\ncontaining materials require control.\nCleaning procedures must be designed to remove or reduce to acceptable levels any\nallergenic material. They must consider:\n• cleaning schedules (i. e. when cleaning will be completed)\n• scheduling sufficient time to fully complete the clean to the required standard\n• ensuring that cleaning instructions contain all the information required\n• the order in which cleaning must be performed (to ensure that cleaning does not move an\nallergen into a previously cleaned area)\n• the cleaning equipment used for cleaning allergenic materials, which must not be a source\nof contamination and must therefore be either dedicated for the removal of that allergen,\nsingle use or effectively cleaned after use.\nThere is no internationally recognised definition of acceptable allergen levels; this would\nbe dependent on the intended country of sale. For example, reference doses are being\ndiscussed in the EU (further information can be found on the German Federal Institute for\nRisk Assessment’s website).\nWhere multiple allergens are handled on site, consider whether all allergens could be\nmanaged by the same cleaning/validation/verification activities. For example, peanuts,\nmilk and sesame seeds may need different controls because of their different physical\ncharacteristics. They may also be used on different equipment and production lines, again\nrequiring separate consideration.\nThe effectiveness of the procedures must be validated. The validation must be documented\nand evidence will typically include:\n• worst-case production/cleaning trials, where all equipment, processes and allergens need\nto be considered\n• targeted test locations, such as food contact surfaces, difficult-to-clean areas, deadlegs etc.\n• targeted samples, where worst-case samples are identified for laboratory testing using\nsuitably sensitive test methods. (Validation tests should be accredited methods and,\nwherever possible, quantifiable. Rapid tests, ATP and lateral flow devices are good for\nverification activities but are not suitable for validation.) Possible samples include the\nfirst product manufactured in the next production run, rinse water from cleaning systems,\nswabs etc.\n• assessment of new equipment for ease of cleaning prior to purchase\n• positive testing of the test method used, to confirm that it will detect the allergen if it is\npresent in a real sample (i. e. confirmation that product matrix will not interfere with the\ntest).\nIt is likely that validation data will need to be collected from several\nproduction runs to ensure it is representative and complete. A number of best-\npractice guidelines have been published on the validation of cleaning (e. g.\nCampden BRI Guideline 59 – Validation of Cleaning to Remove Food Allergens).\nThe cleaning procedures must be routinely verified by, for example:\n• visual inspections and documented sign-off\n• inclusion in internal audits\n• the use of swabs or testing (e. g. rapid tests, ATP, lateral flow devices or laboratory tests).\nRecords must be maintained of validation and verification tests and activities. Any corrective\nactions must also be recorded and completed.\nBRCGS has a training course on validation and verification. Further information is available\non the BRCGS website.\n5. 4 Product authenticity, claims and chain of custody\nSystems shall be in place to minimise the risk of purchasing fraudulent or adulterated food raw materials and to\nensure that all product descriptions and claims are legal, accurate and verified.\nThe objectives of this section of the Standard are to ensure:\n• the site has assessed its raw materials and supply chain for vulnerability to food fraud activities such as the\ndilution, substitution or misrepresentation of ingredients prior to delivery to the site, all of which could lead to the\nsale of unfit, illegal or potentially harmful products\n• the site has appropriate controls in place (based on the assessment) to minimise the risk of purchasing fraudulent\nor adulterated raw materials\n• all claims relating to raw materials used in products can be substantiated and that the audit provides a suitable\nevaluation of the site’s management of the chain of custody, where claims are made relating to primary agricultural\nschemes such as GLOBALG. A.P.\nNote that the security of products, while under the management control of the company, is also an important aspect\nof fraud prevention. Security of products is covered in section 4. 1 and food defence in section 4. 2; this section\nfocuses on the sourcing of raw materials and their vulnerability within the supply chain.\nSection 1 of the Standard deals with senior management commitment in relation to product authenticity; for\nexample, operating processes and objectives that facilitate product authenticity, and the importance of keeping\nup to date with emerging issues and relevant legislation. These activities complement this section; for example,\nknowledge of an emerging risk (clause 1. 1.8) could be added to the information relating to potential fraud (clause 5. 4.2), instigating a review of the vulnerability assessment (clause 5. 4.3).\nThis section applies to food raw materials and ingredients; therefore packaging does not need to be considered\nunder this section.\nProduct claims are also covered in this section in clauses 5. 4.5 (raw material status), 5. 4.6 (certification and methods\nof production) and 5. 4.7 (validation of claims, formulation, and methods of production)."},{"id":"5.4.1","requirement":"Where personnel are engaged in vulnerability assessments, the individual or team responsible shall understand potential food fraud risks.","interpretation":"It is important that personnel completing vulnerability assessments for food fraud are\ncompetent to develop the plan; they need to understand the risk they are trying to prevent.\nTherefore, it is expected that within the team there will be knowledge of:\n• the principles of food fraud (e. g. what food fraud is, why its management is important)\n• risk assessment or vulnerability assessment techniques\n• the risks associated with the raw material, product, supply chain or process being assessed.\nThe Standard is not prescriptive regarding how this knowledge is demonstrated and may, for\nexample, include:\n• formal training (e. g. a training course in food fraud, vulnerability assessment or VACCP)\n• internal training, development and experience (e. g. demonstrable knowledge of the site)\n• other competency (e. g. the completeness and effectiveness of the vulnerability\nassessment and its implementation).\nRisk assessments may be completed either by responsible individuals or by a team. The\nadvantage of a team is that every company has several departments that are likely to possess\nuseful information; for example:\n• technical or QA staff are often subject matter experts\n• supplier approval will see information relating to specific raw materials, suppliers and\nsupply chains\n• purchasing departments are usually well informed about availability or pricing concerns\n• goods receipt and production teams see the materials actually delivered to the site.\nWhere a team is used to complete assessments, it is important to consider the overall\ncapability of the team.\nIf the site does not have the appropriate in-house knowledge, external expertise (e. g. food\nsafety consultants) may be used; however, reference should be made to clause 1. 2.4 and\nsection 3. 5.3."},{"id":"5.4.2","requirement":"The company shall have processes in place to access information on historical and developing threats to the supply chain.","interpretation":"Information relating to the adulteration or substitution of raw materials constantly changes\nas new risks are identified and existing ones are managed. The objective of this clause is\ntherefore to ensure that sites remain up to date with emerging issues and are able to adapt\ntheir systems to protect their products against new and existing risks to the authenticity of\ntheir products.\nThe company must be able to demonstrate that it maintains up-to-date knowledge of\nrelevant scientific and technical developments, emerging issues and known risks relating\nto the authenticity of the raw materials it purchases and the potential for food fraud in the\nsupply chain. The company’s systems therefore must ensure that information is reliably\nobtained and reviewed in a timely manner. Ideally the company should be proactive, looking\nfor and reviewing information, rather than reacting to situations that have already occurred.\nMechanisms to achieve this may include:\n• membership of a trade association which provides this service\n• help from government officials or local enforcement offices\n• subscription to a service provider supplying updates on food fraud\n• regular review of reputable, quality information sources such as websites covering food\nfraud.\nThe auditor will look for evidence of systematic checking and a process for ensuring the\ninformation is transferred into action as necessary (clause 5. 4.3).\nInformation may be obtained and collated as part of the provision of technical knowledge\n(clause 1. 1.8) or as a separate exercise, providing it is clear that relevant information is\nbeing obtained. Good practice is to reference data sources, as this allows later reference;\nfor example, if further details are required or an update occurs. There are many different\ntypes of information that may indicate fraud and are useful when completing or updating a\nvulnerability assessment; examples are listed in clause 5. 4.3 and its interpretation.\nA number of organisations provide information and updates on food fraud risks; for\nexample:\n• European Commission Knowledge Centre for Food Fraud and Quality\n• Reports from Operation OPSON."},{"id":"5.4.3","requirement":"A documented vulnerability assessment shall be carried out on all food raw materials to assess the potential risk of adulteration or substitution. The output shall be a documented vulnerability assessment plan. • historical evidence of substitution. • economic factors. • ease of access to raw materials. • sophistication of routine testing. • nature of the raw material","interpretation":"A vulnerability assessment is a search for potential weaknesses in the supply chain in order\nto prevent food fraud (i. e. to prevent the adulteration or substitution of raw materials before\nthey arrive at the site). It is a specialised form of risk assessment, and needs a systematic and\nstructured approach to ensure data gathering, identification of significant food fraud hazards,\nassessment of likelihood of occurrence, and identification and implementation of controls\nto mitigate genuine risks. The aim of the assessment is not to assess the potential for fraud\nat the site, but to examine the supply chain for potential concerns or weaknesses, thereby\nidentifying those raw materials that are at particular risk of adulteration or substitution, so\nthat appropriate controls can be put in place (clause 5. 4.4).\nThe vulnerability assessment will consider information relating to each ingredient in order\nto assess whether there is a potential for food fraud. Where a site purchases a number of\nsimilar raw materials, it may be possible to consider these as a group rather than each raw\nmaterial individually, providing the risks are similar. The company will need to ensure that all\nfood materials are subject to a vulnerability assessment.\nTypical information to incorporate into the assessment includes:\n• any emerging issues and information identified in clause 5. 4.\n• historical evidence of substitution or adulteration of the ingredient\n• cost/value of the material\n• availability (e. g. a poor harvest may restrict availability and may increase the potential for\nadulteration)\n• sophistication of routine testing to identify adulterants. If testing within the supply chain\nis comprehensive and specifically focused on potential fraud issues, then the likelihood\nof adulteration is reduced (e. g. fruit juice is often tested for a comprehensive range of\nparameters, including DNA, isotopic analysis, added sugars and added water to prevent\npotential fraud)\n• country of origin\n• length and complexity of the supply chain\n• supply chain model\n• controls that are already in the supply chain. For example, if the raw material supplier\nis certificated to the Standard, then as part of that certification the supplier must have\ncompleted its own vulnerability assessment, and there is no requirement in the Standard\nfor the site to duplicate its supplier’s vulnerability assessment.\nThe nature of the raw material may change the potential for food fraud. For example, if a\nslaughterhouse is purchasing cattle, horses and pigs for slaughter, it will be obvious if there\nis an issue with the live animals; however, if the slaughterhouse intends to make a claim\nsuch as organic, Aberdeen Angus or specified country of origin, then greater controls of\nraw materials will be required to ensure only those which meet the claim are purchased.\nSimilarly, prepared ingredients such as beef mince or ground spices are likely to have a\ngreater risk than the whole ingredient.\nThe Standard does not define the exact process that the site must follow when completing\nthe vulnerability assessment; however, it is likely to incorporate the following steps:\n• draw up a list of raw materials (or groups of raw materials) and the controls (e. g. product\ntesting, traceability systems or supply chain audits) that are already in operation\n• consider the information obtained from clause 5. 4.2 for each ingredient\n• complete a risk assessment on the vulnerability of each ingredient.\nNote that the Standard does not require full supply chain mapping for all raw materials,\nalthough this may be a useful tool where a risk assessment indicates that a genuine risk\nexists and there is a need to identify the point in the supply chain where an effective control\ncan be applied.\nThe output of the vulnerability assessment must include a documented vulnerability\nassessment plan which should rank or score the materials to identify those which need\nadditional controls. The ranking and actions required could, for example, be as follows:\n• Very high A high-profile raw material with recent reports of adulteration published by\nregulatory authorities. Action or monitoring is required to ensure only genuine materials\nare purchased\n• High A high-profile material that provides an attractive target for potential adulteration.\nSome action and/or monitoring is required to ensure only genuine materials are purchased\n• Low This material is unlikely to be a target for substitution or adulteration; however a re-\nassessment may be necessary if new information becomes available\n• Negligible No further action required as the material is extremely unlikely to be a target\nfor food fraud.\nAs mentioned earlier in this interpretation, situations relating to food fraud change, and it\nis therefore important that the company has a dynamic system that can react to and assess\nnew information as it becomes available, thereby ensuring the vulnerability assessment\nremains up to date. At a minimum, the vulnerability assessment must be reviewed at least\nannually and when there is a significant change to the ingredient. As a guide, a review may be\ntriggered by the following, although this is not an exhaustive list:\n• a change in the country of origin or the supplier of raw materials\n• a change in the financial situation of raw material suppliers or countries of origin\n• a change in cost of raw materials, either upwards or downwards\n• a change in the supply chain, logistics and delivery of materials\n• a change in material availability (e. g. because of seasonal shortages)\n• emergence of a new risk (e. g. known adulteration of an ingredient)\n• developments in scientific information associated with ingredients, process or product\n• information received as part of a supplier approval or raw material risk assessment (e. g.\nclause 3. 5.1. 1) which highlights new or evolving risks.\nA number of risk assessment tools have been published. These include some specialist\nvulnerability assessment tools such as CARVER + Shock and TACCP (threat assessment\nand critical control points), which may be used to achieve a structured approach to the\nassessment process.\nBRCGS has published a number of items to assist with vulnerability assessments. These\ninclude a specific vulnerability assessment guideline that can be obtained from the\nBRCGS Store or viewed online at BRCGS Participate, and a training course available through\nBRCGS Performance Enhancement and its global network of approved training providers.\nA number of organisations have produced tools to assist with food fraud and vulnerability\nassessments, including, for example, the Food Fraud Resilience Self-Assessment Tool\navailable on the UK FSA website."},{"id":"5.4.4","requirement":"Where raw materials are identified as being at particular risk of adulteration or substitution, the vulnerability assessment plan shall include appropriate assurance and/or testing processes.","interpretation":"Where raw materials are identified as being of particular risk of adulteration or substitution,\nappropriate assurance controls need to be in place to ensure that only genuine materials are\npurchased. Depending on the perceived risk, assurance controls may include:\n• certificates of analysis from raw material suppliers\n• raw material testing\n• supply chain audits\n• use of tamper evidence or seals on incoming raw materials\n• enhanced supplier approval checks\n• mass balance exercises at the raw material supplier\n• changes to the supply chain (e. g. a change of supplier or a move to a shorter supply chain).\nIt is worth noting that the best controls are proactive and continuous as these are the most\nlikely to prevent an incident from occurring. For example, product testing is a useful tool but\nit is reactive (i. e. it can only tell you if something has happened; it cannot prevent it from\noccurring or recurring in future)."},{"id":"5.4.5","requirement":"Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. • provenance or origin. • breed/varietal claims. • assured status. • GMO status. • identity preserved. • named specific trademarked ingredients","interpretation":"The types of claim covered by this clause relate to the provenance of ingredients used\nin a product that differentiates those ingredients or product from the norm. Such a claim\nmay be made either on the product label for the consumer or in business-to-business\ncommunication. The types of claim include:\n• varietal claims (e. g. basmati rice, Aberdeen Angus beef, Bramley apples and cod fish cakes)\n• origin claims (e. g. Madagascan vanilla and Florida grapefruit)\n• assurance claims (e. g. GLOBALG. A.P. , Red Tractor, Marine Stewardship, dolphin-friendly\ntuna and sustainable palm oil)\n• identity-preserved claims (e. g. GMO-free).\nClaims which relate to the composition of the product (e. g. nutritional claims, fat-free,\nreduced sugar, free-from) are covered in clauses 5. 3.7 and 5. 4.7.\nIt is the responsibility of the site to make reasonable checks to ensure that the raw materials\nsupplied are genuine and that claims made about ingredients are proven.\nFor many assurance schemes, such as GLOBALG. A.P. , it is possible to check the assurance\nstatus and the scope of products of the supplier on a database. Reliance solely on a\ndeclaration from a supplier will not be sufficient. Where claims relate to variety or species\n(e. g. varieties of fruit), examination of visual characteristics may suffice. However, for claims\nwhere visual analysis is not possible (e. g. block frozen fish), certificates of analysis and\nperiodic sample analysis will be required.\nFull traceability records must be maintained, as required in section 3. 9. The records must\nalso include details of the quantities purchased and amounts used at each step to enable a\nmass balance exercise to be undertaken.\nIn the absence of more frequent requirements relating to a particular scheme, the site must\nundertake a mass balance traceability exercise on typical products for which a claim is made\nat least every 6 months. This must ensure that the system of records maintained enables\nall finished product batches to be identified for a particular batch of raw materials and that,\nfor a given finished product, the batch(es) of raw materials used for its production can be\nidentified. The test must be carried out in both directions.\nThe ingredients selected for the mass balance exercise must include the ingredient for\nwhich a claim is made. The objective is to test the systems and, where necessary, make\nimprovements to information recording to allow claims to be substantiated should they be\nchallenged by a customer or legal authority.\nIt follows that, where very different traceability systems are used within, for example, a\ncomplex or multi-product site, more than one mass balance traceability exercise may be\nrequired every 6 months to ensure that all systems are working effectively. However, where\na site has multiple claims, it is not intended that every claim be mass balance tested every\n6 months but that a representative selection of claims are chosen. In this situation, good\npractice would be to choose different claims or products each time the test is conducted.\nThe use of a third-party mass balance exercise (e. g. by an organic certifier or by the Fairtrade\nFoundation) would be acceptable evidence of a test, providing that records of the test,\nthe results and evidence of any necessary improvements made as a result of the test are\nmaintained.\nWhere the third-party scheme measures the mass balance over a period (e. g. 1 month)\nrather than for a single batch code this is considered acceptable providing the requirements\ndiscussed above are met. If, as part of the requirements for a particular scheme or to use a\nlogo, there is a requirement for more frequent mass balance traceability exercises, then that\nscheme’s requirements must be met."},{"id":"5.4.6","requirement":"Where claims are made about the methods of production (e.g. organic, halal, kosher), the site shall maintain the necessary certification status.","interpretation":"Where a site wishes to make claims relating to specific production methods, such as organic,\nHalal or Kosher, the site is responsible for maintaining the appropriate certification to those\nstandards.\nWhile the accuracy of the production methods relating to these third-party certification\nstandards will not be assessed during a BRCGS audit, the auditor will require evidence that\nthe appropriate certification is in place (e. g. by reviewing the certificate or an online database\nof certificated sites)."},{"id":"5.4.7","requirement":"Where a product is designed to enable a claim to be made, the company shall ensure that all claims are substantiated and fully validated.","interpretation":"Where a particular claim about the formulation of a product has been made, procedures\nmust be in place to:\n• validate that the claim is correct (this should include all steps in the process including, for\nexample, label design, raw material sourcing and production)\n• ensure legal requirements relating to the claim in the country of intended sale are met; for\nexample, in the EU, nutritional claims are defined\n• identify and prevent potential sources of contamination, loss of identity or variation which\nadversely affects the claim; for example, by using the process flow diagram to identify\nsteps in the manufacturing process where product may be located in shared production\nareas or on shared lines.\nFor example, an on-pack claim that a product is plant-based or vegetarian would need to be\nvalidated, and this may include:\n• inclusion of the claim in raw material risk assessment, supplier approval and specifications\n• inclusion of the claim in the food safety plan, e. g. use of the process flow (see below)\nleading to specific controls such as segregation and dedicated equipment, or validated\ncleaning regimes\n• review of the production processes, equipment segregation etc.\nGood practice is to ensure that a programme of ongoing verification and monitoring is in\nplace to demonstrate that claims are consistently met.\nClaims such as ‘free from allergen’ and ‘allergen-free’ need particular care to ensure that\ncross-contamination cannot occur during processing. This is covered separately in clause 5. 3.7.\nThe process flow diagram used within the food safety plan (or HACCP process) may be used\nas the basis for demonstrating compliance with this clause (the requirement may already\nbe covered within the HACCP or food safety plan). The site must identify (e. g. as a list or on\nthe process flow) potential areas where mixing of products or loss of identity may occur.\nProcedures of working or changes in process flow must be introduced to reduce the risk of\nmistakes and false claims being made. For example, in a large packhouse packing both farm-\nassured and non-farm-assured fruit, the farm-assured fruit is always stored separately within\ndedicated cold stores. Grading and packing operations are organised so that the packing of\nfarm-assured product occurs first or on particular packing lines.\n5. 5 Product packaging\nProduct packaging and processes for the purchase of product packaging shall be appropriate for the intended use.\nPackaging shall be stored under conditions to prevent contamination and minimise deterioration.\nConsideration of packaging and the process for the purchase of product packaging is crucial for ensuring the\nongoing integrity of the product (i. e. ensuring it is clean, is of the appropriate quality and minimises product\ndeterioration), and in maintaining product safety and legality (e. g. preventing product contamination)."},{"id":"5.5.1","requirement":"When purchasing or specifying primary packaging, the supplier shall be made aware of particular characteristics. Certificates of conformity shall be available.","interpretation":"There have been incidences of product recalls which have resulted from a lack of\ncommunication between the supplier of the packaging materials and the food manufacturer,\ntypically where a packaging material has been used in extreme product conditions or where\npackaging not designed for direct food contact has been used (e. g. a plastic liner of a carton\nis removed or changed to reduce costs).\nThe company must be able to demonstrate that each item of product packaging meets legal\nrequirements for its use (e. g. compliance with food contact regulations in the country of\nsale). This may be in the form of specifications, migration data or a certificate of conformity.\nWhere a declaration of conformity is used, any limitations on usage must be stated (e. g. the\nfood types or storage conditions: ambient, chilled or frozen).\nThe supplier of the packaging must be made aware of the conditions under which the\npackaging is going to be used, so that the suitability of the packaging materials can be\nconfirmed. This may take the form of a specification provided to the packaging supplier and\nwould include, as appropriate:\n• contact with food – direct food contact or, where not used for direct food contact, the\nnature of the barrier layer\n• characteristics of the food – any adverse characteristics of the food which may increase\nmigration of chemicals from the packaging (e. g. high fat content, or low or high product\npH)\n• conditions of processing (e. g. high-temperature fill, thermal processing in pack, or freezing)\n• expected customer usage (e. g. microwave in pack, cooking in pack, or freezing)\n• use of recyclable or reusable packaging materials\n• other packaging, especially where the components will be supplied by different companies\nand there is a need for compatibility between the component parts (e. g. a bottle and cap\nmanufactured and supplied by different suppliers).\nDirect food contact materials are of most concern as these have the greatest potential\nfor harm and many geographical regions have specific legislation around direct contact\npackaging. However, there may be risk associated with the additional layers of packaging,\nparticularly labelling which often comprises the primary pack (consumer unit) and also\nsecondary packaging such as corrugated cases. Physical or chemical contamination can\noccur from these packaging components.\nDiscussions with the provider of packaging materials are imperative to ensure that the right\nmaterials in the right configurations are used (e. g. it may be necessary to use lower levels\nof recycled content in a corrugated case for products that are susceptible to chemical\nmigration). Extensive work at the start of the process is incredibly valuable and can prevent\ncostly errors from being made in specifications.\nIt is also vital to consider the product supply chain to establish the most appropriate\npackaging, given the storage and distribution conditions that the product will be subjected\nto.\nThe requirement allows some flexibility in the approach used; for example, a site could use\nrisk assessment to identify the appropriate controls, and establish the level of evidence that\nis satisfactory for the level of risk (although the site would need to ensure that any legal\nrequirements were addressed). For example, in the EU the site may decide that it needs\nto review an EU Declaration of Compliance (DoC) for Food Contact Materials due to a\nperceived risk of migration.\nThe site would need to demonstrate that the evidence available is appropriate for the\nlevel of risk associated with the packaging – it would not be acceptable to list the clause\nas ‘not applicable’, as there should also be evidence that the matter has been adequately\ncommunicated/discussed with the packaging supplier.\nBRCGS has published a guideline on migration from packaging materials into food, which\nmay be purchased from the BRCGS Store or viewed online at BRCGS Participate."},{"id":"5.5.2","requirement":"Product liners and bags purchased by the company for use in direct contact with ingredients shall be appropriately coloured and resistant to tearing.","interpretation":"Materials used as liners for containers, as covers for work in progress or as bags for prepared\ningredients may themselves be a source of contamination. Such packaging materials must be\nvisually distinct from the product (e. g. blue or red) and of a sufficient thickness to reduce the\npotential for ripping or being damaged. Good practice is to ensure that bag and film gauges\nare documented and communicated to suppliers to ensure that only suitable materials are\npurchased.\nThe requirement applies only to materials purchased by the site and used on site; it does\nnot apply to finished product packing. However, suppliers of raw materials should be\nstrongly encouraged to supply ingredients in accordance with this requirement to reduce\nthe risk of packaging contaminating products.\nWhere companies are producing products for further processing, clear liners should not be\nused as they present a potential hazard for the next manufacturer.\nThis clause does not apply to packaging used for sale to the final consumer."},{"id":"5.5.3","requirement":"The company shall have a procedure to manage obsolete packaging (including labels).","interpretation":"Mis-labelling and mis-packing of product is a common cause of product recall. This is of\nparticular concern when, for example, allergens are introduced which are not accurately\nreflected on the labelling. Effective management of packaging materials, particularly those\nthat are printed, can minimise the risk of these incidents.\nOne of the key aspects of this management is the effective control of obsolete packaging\n(i. e. items that are no longer required) such as those that are out of date because of a change\nin the ingredients used in the product. At a minimum sites should have:\n• mechanisms to prevent the accidental use of obsolete packaging (e. g. physical segregation\nin storage areas, clear ‘do not use’ labelling, blocks in electronic inventory systems)\n• controls for the disposal of obsolete packaging (e. g. timescales for the disposal of\nmaterials; how accidental use will be prevented while waiting for disposal; and how\nmaterials will be disposed of)\n• appropriate procedures for the disposal of obsolete printed materials (e. g. rendering\ntrademarked materials such as out-of-date labels unusable).\n5. 6 Product inspection, on-site product testing and laboratory analysis\nThe company shall undertake or subcontract inspection and analyses which are critical to confirm product safety,\nauthenticity, legality and quality, using appropriate procedures, facilities and standards.\nThe company needs to identify and schedule the inspection and analyses which are critical for the products it\nproduces. For example, critical analyses may include:\n• known product safety risks associated with the product type or identified during the HACCP risk assessment\n• legal requirements, particularly those associated with the country of intended sale (where this is known)\n• product authenticity (e. g. where a genuine risk of adulteration, substitution or fraud has been identified during the\nvulnerability assessment described in section 5. 4)\n• quality attributes (e. g. where these form part of a specification agreed with the customer).\nThe frequency and type of inspection and tests are not prescribed by the Standard as these should be risk-based\nand specific to the type of products (see clause 5. 6.1)."},{"id":"5.6.1","requirement":"There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk.","interpretation":"The company needs to have a documented schedule of tests which are carried out on\nthe products. The objective of these tests is to ensure that products are manufactured to\nspecification and in compliance with safety and legislative requirements. The HACCP or\nfood safety plan is likely to identify some of the tests required and their frequency. However,\nother tests which ensure the quality of the product and which may not have been included\nin assessments of product safety must be considered. For example, tests may be identified\nto:\n• monitor for a potential contaminant (e. g. pesticides, heavy metals or microbiological\ncontamination)\n• test for conformity to a specification or claim (e. g. nutritional content)\n• monitor trends (e. g. environmental monitoring of the site environment – see section 4. 11.\nfor full details)\n• confirm compliance with a customer’s quality requirements\n• monitor potential food fraud or food defence concerns (e. g. as an output from food\ndefence or food fraud assessments – see sections 4. 2 and 5. 4).\nThe processes for obtaining product samples, including, where necessary, their delivery\nto a laboratory, must be considered and will be dependent on the production process, the\ntype of product, and whether the test is completed on site or at an external laboratory. For\nexample:\n• how the sample is removed from the production flow – identifying the correct product,\npreventing contamination of the rest of the production, confirming the correct quantity is\ntaken\n• sample integrity – to ensure that the sample is fit for analysis; for example, protecting\nit from contamination or adverse treatment (e. g. maintaining appropriate product\ntemperature and respecting any time limitations for chilled or frozen products prior to\nmicrobiological testing)\n• clear labelling of samples with relevant information, including traceability\n• where required, procedures for:\n• storage of samples before testing\n• delivery to a laboratory\n• clear communication with the laboratory.\nThe frequency and type of product tests should be based on risk and on any particular\ncustomer requirements. The site is expected to be able to explain and justify the basis for\nthe frequency of tests with reference to historical or scientific information as appropriate.\nThe test method and specifications for each test must be documented. Where the results\nof a test include subjective criteria (e. g. bake colour, texture or organoleptic tests), colour\nstandards or reference samples must be used to provide a reference point for the test results\n(i. e. to define pass/fail criteria).\nWhere tests are completed on site, the location of the testing should be considered; for\nexample, laboratory facilities will need appropriate siting and controls (clause 5. 6.5) and\norganoleptic tests should be completed in a designated area and not on the production line."},{"id":"5.6.2","requirement":"Test and inspection results shall be recorded and reviewed regularly to identify trends.","interpretation":"Systems of recording and review must be formalised and must include evidence of actions\ntaken on identified trends, or where unsatisfactory results have been recorded. The use of\ngraphs or charts of test results provides a good method of identifying trends and anomalous\nresults.\nWherever testing is carried out, criteria (e. g. acceptable limits, action limits or legal limits)\nshall be established and documented, so results can be interpreted.\nIt is important that the receiving site understands the test results and the content of any test\nreport and can interpret their significance.\nWhere test results are found to be outside established limits, there must be clear protocols\non the actions to be taken (e. g. product hold, additional testing, customer notification,\nproduct withdrawal or recall). Appropriate actions should be implemented promptly to\naddress unsatisfactory results or trends and thus protect consumer safety, product quality,\nlegality and brand reputation.\nRecords of the results, review and any actions taken should be maintained.\nThe site must agree with the laboratory on how the measurement uncertainty shall be\napplied to results (for some tests, in some countries, this may be defined by legislation).\nMeasurement\nuncertainty\nMeasurement uncertainty (sometimes simply referred to as ‘uncertainty’) is a parameter\nassociated with the result of a quantitative measurement. It is defined as the range of the\nvalues that could reasonably be expected for the attribute (e. g. the micro-organism, allergen\nor chemical) being measured. It is sometimes known as the ‘margin of doubt’ of the result.\nMeasurement uncertainty is important when making conformity decisions (i. e. assessing\nwhether a test result is within legal, safety or acceptable limits), as the range of probable\nvalues may cross one of these limits.\nNo matter what method is used, it will be subject to challenges inherent in taking the\nmeasurements accurately, day-to-day variations (e. g. in equipment, reagents, personnel\nor environmental conditions), and any systematic errors, random errors or corrections\nassociated with the test; therefore the result obtained is the best estimate of the value.\nRandom errors are errors that fluctuate due to the unpredictability or uncertainty inherent\nin the measuring process, or the variation in the quantity being measured (i. e. variation\nthroughout the sample or product being tested, and this is often demonstrated by the\nnormal variation seen in replicate measurements of the same material). A systematic\nerror is one that originates from a persistent issue and leads to a consistent error in the\nmeasurements; for example, recovery.\nMeasurement\nuncertainty\nProduct testing is often completed to establish compliance with limits; i. e. to demonstrate\nthat a product meets the requirements defined in its specification, by regulations and\nby customers. Knowing the measurement uncertainty is important when making these\nconformity decisions. For illustrative purposes only, in \nrepresents the target value or limit; values above this fall outside the permitted range, and\nvalues below it are within the permitted range.\nA\nB\nC\nD\nResults A and D are well above or well below the limit, and thus applying the measurement\nuncertainty value will not change the conformity statement made (e. g. A is still outside the\nlimit and D is still in specification). It is in results B and C where measurement uncertainty\nwould impact on the conformity.\nThe value obtained for C is within the limit. However, if the result and measurement\nuncertainty are combined, the value represented by C may fall above the limit and thus be\nout of specification.\nThe value obtained for B is above the limit and therefore would be out of specification, but\ntaking measurement uncertainty into consideration, there is a potential that B could fall\nbelow the threshold (i. e. be within specification).\nApplying measurement uncertainty in this manner needs careful consideration and\njustification depending on the risk, applicable legislation or customer requirements. Where\nthe test is of a critical parameter (e. g. product safety or legality), measurement uncertainty\nmust not be used to prevent taking the correct action to protect consumers and/or maintain\nlegality."},{"id":"5.6.3","requirement":"The site shall ensure that a system of validation and ongoing verification of the shelf life is in place.","interpretation":"Shelf-life testing may be critical to product safety; for example, where the product is\nsusceptible to the growth of pathogens. Therefore, after the initial shelf life is determined\n(see clause 5. 1.4), the site is expected to have a programme of ongoing shelf-life validation\nand verification across its range of products or product types. To achieve this, samples\nshould be retained from some or all production runs.\nRecords must be available supporting the declared shelf life for each product or group of\nsimilar products. These may include microbiological and sensory analyses, as well as relevant\nchemical factors such as pH and aw. Shelf-life trials extending beyond the stated life of the\nproduct, to ensure a margin of safety, may be required for some product types."},{"id":"5.6.4","requirement":"Pathogen testing shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated.","interpretation":"The requirements apply specifically to the testing of pathogens, and not to general\nmicrobiological tests such as those for yeasts and moulds, total viable count (TVC), coliforms\nor Enterobacteriaceae (while these need to be carefully controlled, they present a lower\nlevel of risk).\nIf pathogen-testing facilities are not carefully managed, they could present a risk to\nproducts. Pathogen testing also tends to be a specialised activity requiring specific facilities,\nand consequently it is usually outsourced to a specialist laboratory.\nWhere pathogen testing is carried out on the production site, the laboratory facility must\nbe physically segregated (ideally in a separate building) from production, food-handling\nand storage areas. The company must have documented procedures to prevent product\ncontamination and must be able to justify the controls in place. Consideration of the design\nof the laboratory is covered in clause 5. 6.5.\nFacilities for testing pathogens, their location (in relation to production and food-storage/\nhandling operations) and containment arrangements may be subject to legislation and/or\nguidelines, which the site will need to comply with.\nAllergens and other contaminant tests, for example, will also require suitable facilities, with\nprocedures for the delivery and removal of samples from the laboratory (i. e. this should not\nbe done via production or food-handling areas).\nFor environmental monitoring testing methods and use of rapid testing kits and ATP\nswabbing, see section 4. 11. 8."},{"id":"5.6.5","requirement":"Where testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety.","interpretation":"If a laboratory is present within the site, documented control procedures are required to\neliminate potential risks to product safety. These include:\n• appropriate containment of the work, i. e. design and operating procedures that ensure that\nproduct and production areas cannot be contaminated by laboratory samples or laboratory\nactivities\n• drainage and ventilation systems; for example, by ensuring the drainage does not flow\nthrough the production areas\n• restricted or controlled access for authorised personnel only\n• procedures which ensure that protective clothing arrangements are suitable (e. g. not\nwearing laboratory clothing in other areas of the site, especially in production and storage\nareas) and coat change procedures\n• movement of materials to and from the laboratory (e. g. laboratory consumables, chemicals,\nreference materials, equipment and laboratory waste)\n• hygiene procedures such as hand-washing on entry to the area.\nWhere at-line testing is undertaken, measures shall be in place to protect the integrity of\ntesting and production activities (e. g. by locating them in designated areas away from the\nproduction line, and allowing them to be completed only by trained and authorised staff).\nAccreditation to ISO/IEC 17025, or a similar recognised national standard with equivalent\nrequirements, will demonstrate that the laboratory meets these requirements."},{"id":"5.6.6","requirement":"Where the company undertakes or subcontracts analyses which are critical to product safety, authenticity or legality, the laboratory shall have gained recognised laboratory accreditation (ISO/IEC 17025).","interpretation":"This clause applies to tests which are critical to product safety or legality. Results from such\ntests must be credible and may be called upon in a court of law.\nThe company needs to identify which tests are critical to product safety, authenticity or\nlegality, such as compliance with label claims or declarations (e. g. nutritional claims, alcohol\ncontent) and tests for contamination (e. g. pesticides, aflatoxins), and verify that they are fit\nfor purpose; for example, by confirming that the laboratory and method is covered by the\nlaboratory’s accreditation to ISO/IEC 17025 for the product/material in question.\nNote that while the laboratory itself may have accreditation, the actual test methods must\nalso be accredited, as laboratory accreditation will relate to specific testing activities, and\nmay not cover all of the services that the laboratory provides. The specific tests should\nbe defined within the laboratory’s schedule of accreditation. Any method of analysis\nthat is not accredited needs justification as to why it was used (e. g. it may be a method\nfor which no accreditation is yet available). Where critical tests are carried out by non-\naccredited laboratories or with non-accredited methods (either contracted or on-site\nlaboratories), there must be suitable documented evidence that the laboratory is working\nto the requirements and principles of ISO/IEC 17025. This must include confirmation of the\nlaboratory’s procedures to meet the following general principles:\n• document control\n• defined responsibilities and authority\n• staff competency and documented training\n• documented test methodology based on accepted standards\n• equipment that is fit for purpose and appropriately calibrated\n• a documented quality assurance programme, including proficiency testing (this is\ninterlaboratory analysis, where multiple laboratories test the same material to allow\na comparison of the results. A site or laboratory can therefore demonstrate that the\ntest procedures used are working effectively and equivalent to those used in other\nlaboratories)\n• completion of internal audits of the laboratory’s operation.\nOther good practices include:\n• equipment control (e. g. maintenance, calibration, traceability to recognised standards,\nmonitoring and result appraisal)\n• validation of methods and materials to confirm fitness for purpose (e. g. test methods,\nequipment, test kits, reagents, chemicals)\n• quality-monitoring processes (e. g. proficiency tests, reference materials)\n• appropriate monitoring of environmental conditions\n• communication systems between the site and laboratory\n• completeness of record-keeping\n• management of non-conforming laboratory work\n• review of laboratory performance and operations."},{"id":"5.6.7","requirement":"Procedures shall be in place to ensure reliability of laboratory results other than those critical to safety and legality.","interpretation":"This requirement applies to non-critical product testing. While such tests need not be\ncarried out by a laboratory accredited to ISO/IEC 17025, it is nonetheless important that the\nresults can be relied upon. The clause sets out the documented procedures which must be\nin place to provide confidence in reliability.\nIn accordance with good laboratory practice, all laboratory testing should be suitability-\ncontrolled irrespective of the nature of the tests. clause 5. 6.6 clarifies the requirements for\ntests relating to product safety, authenticity and legality.\n5. 7 Product release\nThe site shall ensure that finished product is not released unless all agreed procedures have been followed.\nThe site must have a process to ensure that finished product is not released from its control until all production\nchecks have been completed and reviewed. Completion of end-product testing may not be applicable prior to\nthe release of all products. (An example would be microbiological checks on short-shelf-life products such as\nsandwiches.) However, there must be appropriate checks on the CCPs to ensure that the process was within\nspecification before product is released from the company’s control. This allows product to be held when a review\nof the process checks identifies a potential problem."},{"id":"5.7.1","requirement":"Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.","interpretation":"Where products are held either on or off site awaiting positive release, there need to be\ndocumented procedures describing the process for release and who authorises it. The\nprocedures need to be sufficiently robust so that accidental release cannot occur; for\nexample, having password control on a computerised system to prevent unauthorised\npicking of held product, or using the physical identification of pallets in the warehouse.\n5. 8 Pet food and animal feed\nWhere a site produces pet food or animal feed, all the relevant requirements from sections 1–7 of the Standard must\nbe fulfilled in addition to the requirements in this section.\nFor example, pet food and animal feed need to be considered as part of the food safety plan (HACCP), as detailed\nwithin section 2 of the Standard.\nWhere a site produces by-products of the food manufacturing process or sells downgraded/surplus products for\nanimal feed, the requirements for this process are detailed in section 4. 13, especially clause 4. 13. 3.\nWhere a site does not manufacture pet food/animal feed, this section can be marked as not applicable (n/a).\nThe site shall ensure that pet food and animal feed products are safe and fit for intended use.\nPet food and/or animal feed is manufactured in the same type of environment as food for human consumption, but\nthere are some specific additional requirements that reflect the nature of pet food and animal feed manufacture."},{"id":"5.8.1","requirement":"The site shall ensure that pet food and animal feed is formulated/designed for the intended use.","interpretation":"Pet food and animal feed are unique in that a product can be designed for complete diet (i. e.\na pet may eat the same product at every meal, often without other additions to the diet) or\nas a complementary product (e. g. as an addition to certain meals or as an occasional treat).\nThe formulation and design (e. g. nutritional composition, portion size etc.) is therefore\nlikely to be different depending on the intended frequency of consumption (complete or\ncomplementary).\nAuditors will expect to see documented evidence that this formulation requirement\nhas been considered (e. g. in new product development processes, recipe design and/or\nspecifications)."},{"id":"5.8.2","requirement":"Where a site’s product range includes pet food or animal feed products for different animal species, the site shall have specific procedures for the management of ingredients/products.","interpretation":"Sites that produce pet food and/or animal feed for many different animal species (e. g. cats,\ndogs, fish) must be aware that some ingredients cannot be safely eaten by all species without\ndeleterious effect. For example, there are foods that can be fed to cats but not dogs because\nof their different dietary requirements. Therefore, sites should consider:\n• a system to identify materials that could potentially be harmful to unintended recipients\n(i. e. to other species of pets). This shall include raw materials, processing aids, intermediate\nand finished products, and any new product development ingredients or products\n• a system to ensure incorrect ingredients cannot be used\n• procedures (e. g. cleaning procedures) to prevent cross-contamination from the production\nof one type of pet food into the subsequent pet food for a different species\n• specific procedures to ensure correct labelling of intended animal species and any\nlimitations on use."},{"id":"5.8.3","requirement":"Where the site manufactures pet food or animal feed products that contain medicinal substances, the site shall have specific procedures for the management of the medicated raw materials and finished products.","interpretation":"If a site manufactures pet food and/or animal feed which contains medicinal substances, it is\nvital that these materials (both the raw materials and the finished products) are controlled to\nensure correct doses and prevent cross-contamination. At a minimum, procedures must:\n• ensure clear identification of medicated materials (raw materials, processing aids,\nintermediate products, rework and finished products) throughout the receipt, storage and\nmanufacturing processes, so that all staff are aware that the material is medicated and of\nthe nature of the medication. This is important where multiple medicated substances are\nhandled on site\n• include supplier approval in accordance with section 3. 5.1 for all medicated raw materials\n(in addition to the other feed ingredients which are already covered in section 3. 5.1); for\nexample, raw material risk assessments, supplier approval and monitoring procedures\n• ensure relevant product safety training, as required by section 7. 1 of the Standard. If\nthe site handles medicated materials, training must provide specific information on\nthe handling of these materials and any relevant procedures specifically related to the\nmedicated substances\n• include processes to evaluate the correct doses of medicated substances for new product\ndevelopment, recipes and specifications\n• ensure that only the correct amounts of medicated substances are added to the batch\nduring manufacture. Any features of the manufacturing process that could affect these\nconcentrations (e. g. uneven distribution through the batch or a production process that\neffectively concentrates the medication such as a cooking process that causes water loss)\nmust be considered\n• prevent cross-contamination from the production of medicated pet food into subsequent\npet food which should not contain the medication. This applies principally to cleaning\nprocedures.\nMedicated substances and products containing them are likely to be subject to additional\nprocedures and legal requirements; for example:\n• specific storage requirements\n• segregation between medicated and non-medicated materials and products (both in\nstorage and during production)\n• handling of waste materials in a way that is legal and prevents product contamination\n(as already highlighted in section 4. 12). Medicated substances, and products containing\nthem, are likely to require specific procedures to ensure safe and legal waste disposal;\nfor example, controlled disposal, licensed contractors, prevention of environmental\ncontamination."},{"id":"5.8.4","requirement":"Site procedures shall be designed and implemented to meet the relevant pet food and animal feed product safety legislation.","interpretation":"Different parts of the world have different legislative requirements relating to pet food and\nanimal feed. For example, in the UK, the production of pet food using materials of animal\norigin and animal by-products needs to be registered with the Animal and Plant Health\nAgency (APHA), and the EU Animal Feed Regulations apply, such as the regulation regarding\nthe placing of animal feed on the market.\nclause 1. 1.8 requires sites to have systems in place to ensure that they remain up to date with\nproduct safety legislation (as well as other aspects of good practice). clause 5. 8.4 requires\nthat legislation is converted into practice, such that site procedures are designed and\nimplemented to meet the legislative requirements in both the country of manufacture and\nthe country where the product is sold.\n5. 9 Animal primary conversion\nWhere a site completes animal primary conversion (e. g. for red meat, poultry or fish), the following requirements\napply, in addition to those within the rest of the Standard.\nAnimal primary conversion is defined as completing the slaughter and/or evisceration of animals (including red meat,\npoultry and game) or the slaughter and/or gutting of fish. Applicable sites will therefore fall within BRCGS product\ncategories 1, 2 or 4.\nFor animal primary conversion, the site shall operate controlled processes that ensure products are safe and fit for\nintended use.\nSpecific controls are required to ensure that food remains safe, authentic and legal during animal primary conversion.\nThe clauses in this section are closely linked to clauses in other sections of the Standard and the interpretation\nprovided with them."},{"id":"5.9.1","requirement":"The company shall undertake a risk assessment for potential prohibited substances (e.g. pharmaceuticals, veterinary medicines, heavy metals).","interpretation":"Many countries have legislation relating to substances that are prohibited in food, and\nspecifically meat and products of animal origin. A risk assessment is therefore required to\nassess the risk of raw materials containing these substances.\nThe Standard does not provide a definitive list of prohibited substances, as this will depend\non the location of the site and the countries where the products will be sold; however,\nexamples include pharmaceuticals, veterinary medicines (such as growth hormones), specific\nheavy metals and pesticides.\nThis activity may form part of the larger risk assessment completed on all raw materials (see\nclause 3. 5.1. 1), be completed as part of the HACCP process (see clause 2. 7.1) or be completed\nas a separate activity.\nSection 3. 5.1 requires the company to have supplier approval and monitoring processes, and\nthe output from this risk assessment must be included in those activities."},{"id":"5.9.2","requirement":"Where the site is in receipt of live animals, there shall be an inspection by a suitably competent individual at lairage and post-mortem.","interpretation":"This requirement relates only to sites that are in receipt of live animals, such as\nslaughterhouses and sites receiving live fish.\nThe purpose of the inspection is to ensure that the animals are not diseased and are fit for\nslaughter for human consumption.\nThe inspection must be carried out both before and after slaughter. It should also identify\nany live animals that may present an increased risk of cross-contamination in the plant; for\nexample, excessively dirty or salmonella-positive flocks. Such animals require extra actions,\nsuch as cleaning or slaughter at the end of production, to prevent cross-contamination of\nunaffected animals or products.\nIn most countries, official veterinary inspections occur before and after slaughter. This fulfils\nthe primary requirements of the clause. In the absence of an official veterinary inspection,\nthe checks must be carried out by site staff who understand the signs of disease that present\na risk to human consumption and any legislative requirements, and who have the authority\nto reject animals or organs.\nWhere an animal is found to be unfit for human consumption, the site would be expected to\nhave procedures in place for the segregation of unfit meat or animals to prevent them from\nentering the human food chain.\nRecords should be kept of the inspections."},{"id":"5.9.3","requirement":"The site shall operate procedures to ensure that the traceability of all edible parts of the carcass is maintained.","interpretation":"The site must operate appropriate procedures to ensure that the traceability of all edible\nparts of the carcass (i. e. those intended for the human food chain) is maintained, including\nblood or other by-products for human consumption.\nSimilarly to clause 3. 9.1, the Standard is not prescriptive on the traceability system used.\nHowever, the site must be aware of any limitations of the traceability systems used. If a\ncarcass is deemed unfit for consumption, all edible parts associated with that carcass need to\nbe removed from the product flow. If traceability is to the day or batch rather than to specific\ncarcasses, in the event of a product withdrawal or recall, the whole day of production or\nbatch may need to be recalled for each edible part.\nThe site must document its traceability procedure, and ensure relevant personnel are trained\nin it and it is fully implemented.\nNote that for the purposes of this clause, edible parts include any part of the carcass which\nenters the human food chain (including offal, animal by-products for human food chain, and\nblood for human consumption; e. g. in the UK, blood is incorporated into the manufacture of\nblack pudding).\nThe site should be aware that in addition to a documented procedure, traceability requires a\nnumber of activities including identification of raw materials, intermediate/semi-processed\nproducts, part-used materials, and finished products in accordance with clause 3. 9.2."},{"id":"5.9.4","requirement":"The site shall establish defined time and temperature requirements for all post-slaughter processes.","interpretation":"clause 6. 1.1 requires the site to have documented process specifications and work\ninstructions for all key processes that may adversely affect product safety, legality and\nquality. This requirement specifically focuses on the need for post-slaughter times and\ntemperatures to ensure product safety. These must be available for:\n• all edible parts intended for the human food chain\n• all parts of the post-slaughter process including, for example, initial cooling (and time to\nreach intended carcass temperature), any processing stage, storage and distribution.\n6 Process control\n6. 1 Control of operations\nFundamental\nThe site shall operate to process specifications and work instructions/procedures that ensure the\nproduction of consistently safe and legal product with the desired quality characteristics, in full\ncompliance with the HACCP or food safety plan.\nThe principle of these requirements is to ensure that the documented HACCP or food safety plan is put into\noperation on a day-to-day basis, together with effective procedures to ensure that the product can be produced:\n• to food safety and legality requirements\n• consistently to the specified quality.\nNote that this section of the Standard covers production facilities. In conjunction with these requirements, sites may\nfind it useful to consider sections 4. 15 (product storage) and 4. 16 (management of transportation/distribution of the\nproduct)."}],"statement_of_intent":"Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing processes to ensure that safe and legal products are produced."},{"section":6,"title":"Process control","clauses":[{"id":"6.1.1","requirement":"Documented process specifications and work instructions/procedures shall be available for the key processes in the production of products to ensure product safety, legality and quality. • recipes – including identification of any allergens. • mixing instructions, speed, time. • equipment process settings. • cooking times and temperatures. • cooling times and temperatures. • labelling instructions. • coding and shelf-life marking. • storage conditions. • any additional critical control points identified in the HACCP or food safety plan","interpretation":"Documented process specifications, procedures or work instructions must be available for\nall key stages of the operation. These documents must be readily available to staff in the\narea in which the activity is undertaken. The documents must be sufficient to ensure that\nall key process parameters are specified and controlled, thereby ensuring that manufactured\nproduct consistently meets safety, legality and quality specifications.\nNote that while some of these key processes are likely to be CCPs or equivalent, they are\nunlikely to be limited to just CCPs, and sites may need to consider other control points\nand prerequisites to ensure all relevant parameters are captured. The Standard lists some\nexamples including (although this is not an exhaustive list):\n• recipes – including identification of any allergens\n• mixing instructions such as speed and time\n• equipment process settings; for example, line speed, which may in turn affect other online\nfood safety and quality activities such as:\n• the performance of metal detectors, check weighers and automated packaging accuracy\nchecks\n• manual inspection for quality\n• cooking, chilling and freezing where this is completed using a continuous production\nline\n• cooking times and temperatures\n• cooling times and temperatures\n• labelling instructions\n• coding and shelf-life marking – it is worth noting that product recalls have occurred when\ndate codes are incorrectly calculated and incorrect information printed on the pack\n• storage conditions (e. g. storage temperatures) for raw materials, intermediates and final\nproducts\n• any additional critical control points identified in the HACCP or food safety plan.\nStaff must be trained in the work instructions relevant to their role (section 7. 1).\nManufacturing instructions and process specifications must correctly reflect customer\nrequirements, such as final product specifications. The equipment settings must be checked\nto ensure that the equipment is set up correctly for the specific product in production, and\nlabelling instructions (such as particular requirements for label positioning on the pack)\nmust be followed.\nSpecifications for work in progress are not applicable to all products. For example, when a\nproduct is manufactured in several stages and combined to form the final product, or when\na product is partially processed and retained for future processing, a separate specification\nfor that product may be required. It must detail the important criteria that affect the finished\nproduct quality or safety parameters (e. g. brix, weight, colour, shelf life or storage conditions)\nand must include the acceptable range of each parameter.\nSimple photographic specifications, including minimum, target and maximum grading levels\nfor parameters such as size and colour, may be appropriate for production staff.\nThe site must ensure that process specifications and work instructions remain up to date,\nand therefore needs a review process that ensures that documents are updated prior to any\nchanges."},{"id":"6.1.2","requirement":"Where equipment settings are critical to the safety or legality of the product, changes to the equipment settings shall only be completed by trained and authorised staff.","interpretation":"As with any electronically stored data or records, equipment settings for product safety and/\nor legality should be adjusted only by trained and competent members of staff, and controls\nshould be in place to ensure that this remains the case.\nWhere equipment has the capacity for password protection or other restrictions such as\nlocked controls, these should be used to ensure that only trained and authorised staff can\nmake the amendments. Where equipment does not include these functions, the site will\nneed to identify alternative mechanisms of control."},{"id":"6.1.3","requirement":"Process monitoring, such as temperature, time, pressure and chemical properties, shall be implemented, adequately controlled and recorded.","interpretation":"Processes must be adequately controlled and monitored to ensure that product is produced\nwithin specification. These processes may include CCPs or prerequisite programmes\naddressing issues such as temperature, time, pressure and chemical properties.\nMonitoring must be carried out at suitable frequencies based on experience of the\nreliability of equipment, frequency of process changes, and risk to product safety and\nquality. The frequency of checks should be included on recording forms and/or in procedure\ndocumentation. A record of all monitoring must be maintained.\nWhere processes are shown to have exceeded defined limits, corrective actions must be\ntaken and this action must be recorded (clause 6. 1.6)."},{"id":"6.1.4","requirement":"In circumstances where process parameters or product quality are controlled by in-line monitoring devices, these shall be linked to a suitable failure alert system that is routinely tested.","interpretation":"Where process parameters or product quality are controlled by in-line monitoring devices\n(e. g. automatic temperature or pH loggers), they must be linked to a suitable failure alert\nsystem (e. g. audible/visual alarm, machine stop function or product divert system) which is\nactivated when defined parameters are exceeded. This alarm must be tested routinely to\nensure that it functions properly, and records must be maintained."},{"id":"6.1.5","requirement":"Where variation in processing conditions may occur within equipment critical to the safety or quality of products, the processing characteristics shall be validated and verified at a frequency based on risk.","interpretation":"The objective is to ensure that products can be consistently produced and stored within\nclearly defined parameters (e. g. within defined temperatures). It is recognised that process\nconditions are often not uniform throughout a chill store or an oven. It is important,\ntherefore, to identify hot or cold spots, both to try to improve uniformity and to identify\nworst-case scenarios to ensure that all products meet at least the minimum process\nconditions.\nThe Standard includes some common examples of equipment parameters such as:\n• heat distribution in retorts, ovens and processing vessels – the Standard expects heat-\ndistribution studies to be carried out on cooking equipment wherever small variations in\nprocess temperature may affect the safety of the products. Heat-distribution studies of a\nstatic oven may identify cold spots. If it is not possible to make adjustments to eliminate\nthese cold spots, the areas should be used as the worst-case scenarios when completing\nheat-distribution studies\n• temperature distribution in freezers and cold stores – when assessing whether to\nundertake temperature distribution studies on chill or freezer facilities, the level of\nrisk will depend on the product, the time spent in store and any margin allowed by the\ntemperature settings (e. g. setting the temperature at −20°C to ensure achievement of\n−18°C). Temperature distribution studies would not normally be necessary for small chill\nor cold stores where product is stored only for short periods.\nHowever, this is not a prescriptive list, and the site should consider all situations where\nvariations in processing conditions may occur in equipment critical to the safety or quality\nof products. For example, if pH is identified as critical, it may be necessary to validate the\npH distribution in a mixing vessel, and consider the thoroughness of the mixing process to\nachieve the desired pH throughout the batch.\nWhen testing equipment, any seasonal variations in performance must be considered,\nespecially when trying to assess worst-case scenarios. For example, a chiller evaluated\nin winter may not give the same results in summer, especially if there are large seasonal\ndifferences in the ambient temperatures. Some refrigeration equipment may be at the\nlimit of their performance on especially hot days if temperature parameters have not been\nproperly specified."},{"id":"6.1.6","requirement":"In the event of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status and quality of the product.","interpretation":"In cases of equipment failure or deviation from process or specification (e. g. outside the\ncritical limit), the company must have defined procedures in place to ensure that the product\nis safe prior to its release. At a minimum, this should include:\n• identification of all products at risk (i. e. product produced since the last satisfactory check)\n• how the affected product will be assessed for suitability/safety (this may include sensory\ntesting, microbiological sampling, reference to thermal process data or the use of\nmathematical modelling techniques, depending on the product and issue)\n• who is authorised to undertake action and make a final decision on the affected product.\nWhere product safety, authenticity, legality or quality is implicated, the site may need to\napply its non-conforming product procedures (see section 3. 8).\nRecords must be kept of any deviation and the action taken."},{"id":"6.1.7","requirement":"Where a site handles products or materials that are outside the scope of the audit, these shall be controlled to ensure that they do not create a product safety, authenticity or legality risk.","interpretation":"This aim of this requirement is to ensure that the site has considered and managed any\npotential product safety, authenticity and legality risks associated with products or materials\nthat are outside of the scope of the BRCGS audit.\nDuring the audit, the auditor may request information or watch the process, to ensure\nprocedures are in place and completed appropriately, and therefore do not represent a risk\nto the products within scope.\nExamples of products outside of scope include, but are not limited to:\n• by-products of the manufacturing process, which are not permitted to be included in the\nscope of the Standard (e. g. materials taken for non-food use)\n• exclusions from scope (in accordance with section 1. 6.2 of the audit protocol).\n6. 2 Labelling and pack control\nFundamental\nThe management controls of product-labelling activities shall ensure that products will be correctly\nlabelled and coded.\nOne of the common causes of withdrawals and recalls is incorrectly packed products and labelling (e. g. allergen\nlabelling) that does not reflect the actual content of the product. Therefore the aim of this section is to ensure that\nthe site has effective procedures to manage packing operations and to pack products in the correct packaging.\nPackaging controls must be in place which ensure the whole packing process is documented and working effectively.\nThese controls must be managed by nominated staff who have received specific labelling and packing process\ntraining (see clause 7. 1.5).\nSites may find it beneficial to consider this section in conjunction with sections 5. 2 (product labelling) and 5.\n(product packaging), which detail requirements on the design and purchase of packaging and labels."},{"id":"6.2.1","requirement":"There shall be a formal process for the allocation of packaging materials to packing lines and control in the packing area which ensures that only the packaging for immediate use is available. • setting and amendments to the printer parameters shall only be completed by an authorised member of staff. • controls shall be in place to ensure that only correctly printed material is available","interpretation":"Packaging for each production run must be brought to the line in a formal and controlled\nmanner following a documented process.\nOnly the packaging required for immediate use should be available to the packing line at\nany one time. Ideally, this will be achieved by only releasing new packaging from the store\nwhen all packaging from the previous run has been removed from the area. Where this is not\npossible (e. g. because of off-site packaging stores), a mechanism must be in place to ensure\nthat only the relevant packaging can be released to the packing line (e. g. by storing packaging\nin a designated, secure location with authorised access).\nWhere multiple component packaging is used (e. g. pots with separate lids, multi-packs or\npackaging with separate labels), then the controls will need to apply to all the individual\nparts, to ensure they all match the product being produced.\nThe integrity of date codes is vital to ensure product safety is maintained. Where date codes\n(or other information) are applied to packaging or product on site (e. g. on the trays, sleeves\nor flow wraps), this must be controlled so that only authorised (and competent) personnel\ncan set or make the changes to printers (e. g. inputting the required date code).\nProcesses must be in place to ensure that, after the product run, any unused labels are\nremoved from the packaging line.\nChecks must be in place to monitor that actual label use matches expected label use (i. e. the\nactual and expected uses are reconciled). The aim is to confirm correct usage, and therefore\nprovide an opportunity for any inconsistencies or unexpected results to be investigated. The\nStandard is not prescriptive on how this is completed; however, the site may find it useful to\nconsider:\n• the typical waste tolerance, i. e. how many labels are typically wasted or destroyed during a\nproduction run (this allows normal waste figures to be included in the reconciliation)\n• the number of labels received, issued, used or restocked, along with any obsolete,\nmisprinted or destroyed labels that need to be accounted for\n• systems for recording packing information; for example, when new reels or new batches of\nlabels are added to the line\n• the frequency of the checks – for most sites, this is likely to be at the end of each\nproduction run, as this allows investigation of any inconsistences while the product is still\nwithin the site’s control. However, there may be situations, for example, with very long\nproduction runs, where an alternative frequency is justified\n• the system to be used to complete the check; for example, an automated label check and\naccounting system or a manual check system could be used, either of which might take the\nform of a formal mass balance at the end of each production run, or of a stock take.\nAny inconsistencies or unexpected results must be investigated to ensure correct label use.\nWhere appropriate, non-conforming product procedures (see section 3. 8), corrective action,\nroot cause analysis and preventive actions may be required (see section 3. 7)."},{"id":"6.2.2","requirement":"Documented checks of the production line shall be carried out before commencing production and following changes of product. These shall ensure that lines have been suitably cleared.","interpretation":"Sites are required to manage product changeovers and line start-ups to ensure the line is\nready and correctly set for the next production run. If changeover is completed incorrectly,\nthis represents a weakness at a key point in the production process, which could result in\nthe production of non-conforming products; for example:\n• incorrect products being packed\n• incorrect labels being used (a major cause of product withdrawals and recalls in several\nparts of the world)\n• insufficient cleaning between products, resulting in:\n• the potential for microbiological or allergen cross-contamination\n• quality issues related to the product being contaminated or tainted with previous\nproducts\n• incorrect process parameters being used, e. g. cooking times and temperatures, or incorrect\ndate coding.\nDocumented checks carried out on the production line before production commences\nmust therefore ensure that systems are correctly set and running. Checks must include\nconfirmation that:\n• lines have been suitably cleaned\n• lines have been cleared of any packaging from previous production runs\n• lines are ready for production, with CCPs and quality parameters correctly set (e. g.\nmetal detector checks completed satisfactorily, cookers set to the correct temperature\nprogramme, correct packaging selected).\nIf the line is set up with equipment that has not been used for some time, there may be a\nneed to re-disinfect food contact surfaces immediately prior to use, or undertake additional\nline checks, to ensure appropriate set-up (for example, that condition monitoring has been\ncompleted and the correct operating settings selected).\nChecks are also required following changes of product to ensure that all product, packaging\nand labels from the previous production have been removed and, where appropriate, to\nensure that both cleaning and line set-up have been completed correctly for the new\nproduct. Line checks are usually the responsibility of the line manager or supervisor.\nEvidence that checks have been carried out (e. g. line check sheets) and guidelines on the\nchecks to complete should be available.\nDuring the audit, the auditor will normally expect to witness at least one product\nchangeover, and wherever practical at least one line start-up. There may be exceptional\ncircumstances where a site has very long production runs, or situations where there are no\nscheduled product changeovers during the audit (as when the length of the production run\nis longer than the number of days that the auditor is on site), and therefore the inclusion of\na product changeover or a line start-up is not possible; however, this must be considered\nexceptional, and any exceptions or omissions will be detailed in the audit report."},{"id":"6.2.3","requirement":"Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled. • at the start of packing. • during the packing run. • when changing batches of packaging materials. • date coding. • batch coding. • quantity indication. • pricing information. • bar coding. • country of origin. • allergen information","interpretation":"A high proportion of product withdrawals/recalls are because of products being packed\ninto incorrect packaging or incorrectly labelled. Therefore, specific documented packaging\ncontrols must be in place. Particular care is required where:\n• a number of similar-looking products are manufactured\n• a standard product may be packed into different types of packaging\n• there is a family of very similar labels for a product range, each containing different\ninformation (e. g. the presence of different allergens or different use-by/best-before dates).\nProcedures must be in place to verify that adequate checks have been carried out to\nminimise potential errors. The frequency of checks must be predefined, based on risk\nassessment, but at a minimum those checks specified in the requirement must be included:\n• at the start of packing – this is especially useful to confirm the correct packaging and\nlabels are being used, and that line changeover procedures (clause 6. 2.2) have effectively\nremoved all labels from the previous run\n• during the packing run (i. e. at predefined intervals); for example, the risk assessment\nmay have identified a maximum frequency based on previous experience, or a maximum\namount of product based on the site’s ability to recover and check product in the event of\na failure\n• when changing batches of packaging materials; for example, when each new reel of labels\nor new batch of packaging is added to the line\n• at the end of each production run.\nThe packing run can be defined as a batch or lot (e. g. each time a new reel is used), or\nanother distinct period. The intention is to ensure that the site is maintaining control over\npre-printed packaging materials and their packing.\nThe procedures must also include verification of any code information or other printing\ncarried out at the packing stage (i. e. applied by the site). This verification shall include those\nchecks as specified in the requirement.\nPackaging and label checks should be recorded."},{"id":"6.2.4","requirement":"Where online verification equipment is used to check product labels and printing, the site shall establish and implement procedures for the operation and testing of the equipment.","interpretation":"Some sites have found that the use of automated online vision equipment (e. g. bar code\nscanners or cameras) provides a beneficial check of the accuracy of the packing operation.\nThis equipment is able to check that the correct packaging has been consistently used\nthroughout the packing run and that the correct date code has been applied. Any out-\nof-specification information (as when the wrong packaging is used) is identified by this\nequipment, and staff are either alerted or the product is rejected out of the product flow.\nWhere a company chooses to use this type of equipment, it is important that procedures are\nin place to ensure that it is correctly set up and operates effectively throughout the packing\nrun. At a minimum this will include checks:\n• at the beginning of the packing run, so that the equipment is confirmed to be set up\ncorrectly before packing commences\n• at the end of the packing run, to confirm that the equipment is still operating effectively\nwhen packing is completed\n• during the packing run, at a frequency based on risk (i. e. based on the site’s ability to take\nappropriate action in the event of an adverse test result, before the implicated materials\nare released from the site).\nDepending on the function of the vision system, incorrect packaging might include the\nwrong packaging, an incorrect date code or an obscured label.\nDue to the variations in the different types of online vision equipment, the testing\nprocedures are not prescribed in the Standard. However, where the verification equipment\nexists as a separate item of equipment (situated, for example, towards the end of a\nproduction line, similar to the common placement of metal detectors), good practice is to\ntest the system using incorrect packs to ensure that the equipment identifies and rejects\nthose packs. It is important that these test packs are clearly marked so that they cannot\ninadvertently enter the process flow. The method can be used to check each function of the\nequipment (e. g. detection system, rejection mechanism or line stop, authorised restart and\nmis-read/non-read alarm).\nHowever, where the verification equipment is integral to another piece of equipment on\nthe packing line (e. g. based on cameras or scanners built into the printer, or printed film\nroll dispensers), or is situated where packaging is constructed (e. g. where cardboard boxes\nare glued immediately prior to the camera), it may not be possible, or practical, to insert\nincorrect packaging as a means of testing. In these situations, the site may devise alternative\ntesting solutions. For example, before the packing run begins, a test programme could check\neach function of the verification equipment by causing the instrument to reject the existing/\ncorrect packaging.\nThe site must consider the procedures it would follow in the event of an equipment failure\n(e. g. a backup plan).\n6. 3 Quantity – weight, volume and number control\nThe site shall operate a quantity control system which conforms to legal requirements in the country where the\nproduct is sold and any additional industry sector codes or specified customer requirements.\nThe site must ensure that products meet the requirements of customers and the legislation of the country, state or\nterritory where the product is sold."},{"id":"6.3.1","requirement":"The frequency and methodology of quantity checking shall meet the requirements of the appropriate legislation governing quantity verification, and records of checks shall be retained.","interpretation":"The type of quantity control used (e. g. average weights, catch weight, minimum weight or\ncount) may be determined by the company in conjunction with the requirements of the\ncustomer.\nThe system used must operate to the legal requirements in the country, state or territory in\nwhich the product is sold.\nPotential changes during transport and shelf life (e. g. weight loss during transport or water\nloss (desiccation) during storage) may need to be factored in, so that the weight at the end of\nshelf life continues to meet statutory and customer requirements.\nAdequate records must be kept or, where automatic check-weighing equipment is used,\nthis must be properly set up and the rejection system tested according to industry-sector\nguidelines. Checks of automatic reject systems must be carried out using representative\npacks of the product being produced.\nThe colour-coding of the clause indicates that it should be audited during on-site audits of\nproduction areas where the equipment is located, as the auditor will normally expect to see\nthe process in operation, and not just a review of records."},{"id":"6.3.2","requirement":"Where the quantity of the product is not governed by legislative requirements, the product shall conform to customer requirements.","interpretation":"Where there are no legislative requirements (e. g. where bulk quantities are supplied to the\ncustomer), procedures must be in place to ensure that customer requirements are met (e. g.\nmonitoring by flow meter or calibrated weighbridge for tanker loads).\nGood practice is to ensure that the customer requirements are clearly defined; for example,\nin a specification or buying contract.\nRecords must be maintained."},{"id":"6.3.3","requirement":"Where used, the site shall establish procedures for the operation and testing of online check weighers. • consideration of any legal requirements. • responsibilities for testing. • operating effectiveness. • methods and frequency of testing. • processes for handling rejected packs. • records of test results","interpretation":"A check weigher is defined as automated equipment for checking that the weight of\nproducts is correct and within relevant limits (e. g. it meets legislative and customer limits).\nThe equipment must be sufficiently rigorous for the intended purpose. For example, a check\nweigher that is simply used to provide a rough check during production is likely to be less\ncritical to product legality than one used to verify legal compliance of a final product.\nThe effective operation of a check weigher must be verified within the context of legal\nrequirements (e. g. minimum fill weights against declaration), and its function must be assured\nthrough testing and operation.\nThe Standard lists the minimum items that the site procedures will need to include:\n• consideration of any legal requirements – depending on the product and the legislation in\nthe country of sale, this might include minimum weight, average weight, maximum weight\n(for example, if large portion size affects minimum cooking times for food safety) etc.\n• methods, frequency and responsibilities for testing the equipment – the method of testing\nthe check weigher; the actions to take if it fails the test; how frequently the tests are\ncompleted and the staff responsible for completing them. In accordance with section 7. 1,\nstaff will need to be trained in the correct procedures\n• operating effectiveness and any variations for particular products (e. g. any known and\npermitted variations)\n• processes for handling rejected packs; for example, ensuring underweight packs are\nremoved and do not re-enter the product flow, procedures indicating whether packs can\nbe opened and the content returned to the product flow, any investigation needed as a\nresult of rejected packs\n• records of the test results.\nclause 6. 4.1 details the requirement for calibration of measuring equipment, which includes\ncheck weighers.\nThe methodology of testing should be documented, and the operator or person with\nresponsibility for the check weigher should understand the expected output and frequency.\nParticular consideration should be given to the location of the check weigher to ensure\nthat results accurately reflect the batch of product leaving the site. For example, if the site\nlocates metal detectors, or sampling points after the check weigher, it may need to consider\nthe implications of the removal of product by those systems on, for example, average weight\ncalculations.\n6. 4 Calibration and control of measuring and monitoring devices\nThe site shall be able to demonstrate that measuring equipment is sufficiently accurate and reliable to provide\nconfidence in measurement results.\nThe site must ensure that key pieces of equipment that control and monitor processes are themselves confirmed\nas operating effectively and accurately. This is routinely confirmed by measurement against recognised standards.\nWhere national or international standards do not exist, the company needs to demonstrate how the equipment is\nadequately monitored."},{"id":"6.4.1","requirement":"The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. • documented list of equipment. • identification code and calibration due date. • prevention from adjustment by unauthorised staff. • protection from damage, deterioration or misuse","interpretation":"The site needs to identify the measuring equipment (e. g. scales, thermometers and pH\nmeters) that is used to monitor CCPs, product safety, legality and quality.\nAt a minimum, this equipment must be:\n• documented in a list which details the location of each item of equipment\n• marked in accordance with its calibration requirements; for example, with an identification\ncode and the calibration due date. This may be achieved by engraving the piece of\nequipment with a number that cross-references to the documented list, or labelling the\nequipment with its calibration due date. Where equipment (e. g. a pH meter) is calibrated\ndaily or more frequently, this could be addressed by a procedure that clearly states the\nfrequency of calibration and a record of the daily calibration activities\n• protected against unauthorised adjustment (e. g. through the use of programme ID codes\nor locking keys)\n• protected from damage or misuse through good design or the training of staff."},{"id":"6.4.2","requirement":"All identified measuring devices shall be checked and, where necessary, adjusted at a predetermined frequency based on risk.","interpretation":"The site needs to establish the method by which the precision and accuracy of equipment is\nverified. This must include:\n• a predefined check frequency, based on a risk assessment (e. g. historical reliability, nature\nof use, manufacturer’s recommendations)\n• who is authorised to complete the checks (e. g. trained staff)\n• the method to be used (which must, where possible, be traceable to a recognised standard,\ne. g. use of a master calibration thermometer that has a certified test certificate traceable to\na national standard).\nEquipment must be of a suitable accuracy for the measurements it is required to perform.\nFor example, where temperature is critical to the safety of a product (as in pasteurisation or\nthe canning process), the measuring thermometer requires an accuracy of ±0. 5°C, whereas a\nthermometer used to check vehicle temperatures may only need an accuracy of ±1°C."},{"id":"6.4.3","requirement":"Reference measuring equipment shall be calibrated and traceable to a recognised national or international standard.","interpretation":"All reference equipment (e. g. a master thermometer) must be calibrated and traceable to a\nnational or international standard.\nWhere equipment is used to measure or monitor a critical limit, it is important that the\ntolerance (or uncertainty) of the calibration is considered. For example, if a thermometer\nis required to measure a critical limit of 72°C, but the calibration shows an uncertainty\nof 0. 5°C, then a thermometer reading of exactly 72°C could in fact represent a true\ntemperature of anywhere between 71. 5 and 72. 5°C (i. e. the temperature could be lower or\nhigher than the critical limit). In this situation, to guarantee a minimum temperature of 72°C,\nit would be necessary for the reading on the thermometer to always be 72. 5°C or higher.\nRecords must be kept."},{"id":"6.4.4","requirement":"Procedures shall be in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits.","interpretation":"Documented procedures must detail the action to be taken when equipment is found to be\noutside specified limits. The documentation must specify what will be done and by whom,\nand must include what will happen to products that have been monitored by this equipment\nsince the last successful check (to prevent at-risk products from being offered for sale).\nRecords must be kept of the actions taken.\n7 Personnel\n7. 1 Training: raw material-handling, preparation, processing, packing and storage areas\nFundamental\nThe company shall ensure that all personnel performing work that affects product safety, legality and\nquality are demonstrably competent to carry out their activity, through training, work experience or\nqualification.\nTraining is a fundamental requirement of the Standard, as without properly trained and competent staff, it is unlikely\nthat product safety, authenticity, legality or quality procedures can be completed in a rigorous and consistent\nmanner. Staff must therefore have the knowledge and skills to undertake their role, and must understand the impact\ntheir actions will make.\nCompanies must ensure that all training is up to date, covering relevant product safety, legality and quality\nrequirements.\nSeasonal/temporary personnel and contractors must be included. Where employment agencies are used for the\nprovision of staff, all the requirements in this section need to be adequately met and evidenced. This may include:\n• specifying company policies within any supply contract\n• obtaining evidence of staff training records from the agency prior to a staff member commencing work\n• using a risk-based system to challenge staff understanding and ensure competence in carrying out roles.\nEmployment agencies are subcontracted service providers whose business is to assist companies in filling vacant\npositions. Agency staff are often used to fill temporary positions, such as those caused by seasonal variations in\nproduction."}],"statement_of_intent":"The site shall operate to process specifications and work instructions/procedures that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP or food safety plan."},{"section":7,"title":"Personnel","clauses":[{"id":"7.1.1","requirement":"All personnel, including agency-supplied staff, temporary staff and contractors, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period.","interpretation":"The company must ensure that all staff, including temporary staff, agency-supplied staff (see\nstatement of intent) and contractors, receive training.\nAll staff will need some level of training; this should be proportional to their responsibility\nand the type of work or activity they perform. The company is responsible for defining the\ntraining requirements appropriate for each specific role (see clause 7. 1.3).\nFor example, the following training options may be considered:\n• induction training for all staff, covering company policies on hygiene, allergen awareness\n(see clause 7. 1.4), quality requirements, entry and exit procedures, pest control, a basic\nintroduction to HACCP, etc.\n• obtaining a qualification in ‘basic food hygiene’ for food handlers\n• training in areas that impact food safety, such as cleaning, machine operation, quality\ninspections and sampling\n• CCP monitoring (see clause 7. 1.2).\nAll personnel must be adequately supervised throughout the working period. Particular\nattention should be paid to identifying the needs of temporary/seasonal workers and\ncontractors. Good practice is for new starters to have additional supervision for a defined\nperiod. This additional supervision can be reduced or removed at the end of the period\nfollowing a review of the employee’s competency to complete the role (see clause 7. 1.7)."},{"id":"7.1.2","requirement":"Where personnel are engaged in activities relating to control measures and critical control points, relevant training and competency assessment shall be in place.","interpretation":"To ensure that activities identified as either control measures or critical control points\n(CCPs) within the food safety plan or HACCP are managed correctly, personnel involved\nin these areas must be appropriately trained in the relevant procedure. This includes the\noperation of the control and monitoring activities and the implementation of corrective\naction. Clear, documented instructions must be available, detailing:\n• how to carry out the tasks\n• when the tasks are to be completed\n• records to be maintained\n• action to be taken in the event of a non-conforming result.\nA competency assessment must take place on completion of the training and at predefined\nintervals (see clause 7. 1.7) (e. g. during internal audits of CCPs). The assessment needs to\nconfirm that the procedure is being followed correctly, test knowledge of the corrective\nactions, and check for the completion of any relevant training."},{"id":"7.1.3","requirement":"The site shall put in place documented programmes covering the training needs of personnel. • identifying the necessary competencies for specific roles. • providing training or other action to ensure staff have the necessary competencies. • reviewing the effectiveness of training. • delivery of training in the appropriate language of trainees","interpretation":"The site must have a documented training programme showing what job role competencies\nare required, including activities related to food safety, authenticity, legality and quality;\nthe actions taken to ensure that staff obtain these competencies; and a review of the\neffectiveness of these actions. For example, a job training matrix could list all of the site\nroles, with details of which procedures and work instructions are required for each role.\nTraining must be delivered in an appropriate language for the trainee (e. g. by providing\neither written or oral translation where it is required). It is not a requirement for all\ndocumentation to be translated into every language of the workforce, but all staff must be\nable to understand the instructions necessary for their job. For example, hygiene rules may\nbe provided in written translations or in pictorial format, while CCP monitoring instructions\nmay be translated into the languages spoken by the staff involved in these areas.\nThe Standard is not prescriptive on the format of the training, and may, for example, include:\n• internal training provided by the site\n• one-to-one training\n• on-the-job training\n• external training courses\n• computer-based training (CBT)\n• training provided by employment agencies, prior to the agency-supplied staff commencing\nroles at the site. (In this situation, the site will need to ensure that the agency has the\nnecessary knowledge and training in order to subsequently train staff supplied to the site.)\nTraining may be delivered internally or externally, but the company needs to ensure that the\ntraining has been effective. This can be achieved through assessment of the staff’s ability\nto undertake the tasks they need to perform, by testing their knowledge or by on-the-job\nassessment.\nA review of training and assessment of its effectiveness is an important part of the process,\nto ensure that it has achieved the level of learning, understanding or competency required.\nWhere tests of knowledge are used, good practice is to follow these with a review of any\nareas that were not answered correctly, to ensure that the trainee understands these areas.\nThis is particularly important where product safety or legality could be implicated if the\nactivity was completed incorrectly."},{"id":"7.1.4","requirement":"All personnel, including engineers, agency-supplied staff, temporary staff and contractors, shall have received general allergen awareness training and be trained in the site’s allergen-handling procedures.","interpretation":"All personnel, including all agency-supplied staff, temporary staff and contractors, involved\nin handling materials (ingredients, equipment, utensils, packaging and products), must have\nreceived training to raise awareness of food allergens and the specific allergen measures\nused by the company.\nThe level of training should be appropriate to the individual’s role. For example:\n• Personnel who do not actively handle allergens may require only a general understanding\nof the importance of allergens (for example, simple allergen awareness training, which\ncould be included as part of the induction process).\n• Those involved in tasks critical to the safety of the product need additional training on\nspecific procedures in which they are involved.\n• The management team responsible for incidents require a more in-depth knowledge.\n• Personnel who develop the allergen management system, and therefore are the site’s\nsubject matter experts, require the highest level of training.\nAll training records must be kept."},{"id":"7.1.5","requirement":"All relevant personnel shall have received training on the site’s labelling and packing processes which are designed to ensure the correct labelling and packing of products.","interpretation":"Mis-packed and mis-labelled goods are the leading cause of product recalls across the\nworld.\nThis clause requires any personnel linked to the packing or labelling of raw materials,\nintermediates or finished product to be trained in, and kept up to date with, proper\nprocedures. It is also useful for these staff to understand the implications of mis-packed or\nmis-labelled product."},{"id":"7.1.6","requirement":"Records of all training shall be available. • the name of the trainee and confirmation of attendance. • the date and duration of the training. • the title or course contents. • the training provider. • for internal courses, a reference to the material, work instruction or procedure that is used in the training","interpretation":"Evidence of all training needs to be kept and must include all the details as listed in the\nrequirement.\nThese details may be included in the certificate of attendance provided at an external or\ninternal course, or the course contents may be included in a personnel induction booklet\nthat is cross-referenced with a record of the training completed (with trainee name, date and\nname of trainer, together with the name of any translator).\nWhere training is internal, the site should retain reference to the material used (e. g. to\nthe company procedure and its version number). Where the site has used ‘on-the-job’ or\ninformal training methods (e. g. toolbox talks), a summary of the content could be used and\nmade available for reference.\nTraining records for any temporary agency-supplied staff and/or external consultants must\nalso be available."},{"id":"7.1.7","requirement":"The company shall routinely review the competencies of its staff and provide relevant training (refresher training, coaching, mentoring).","interpretation":"The company must ensure there is ongoing assessment of staff competencies in their roles\n(e. g. through one-to-one appraisals, team performance monitoring by line managers, review\nof the results of internal audits, or review of records).\nWhere the need is identified (e. g. when a job role changes; following performance issues;\nor when there are changes in operating procedures such as a change in the requirements\nfor a CCP), there must be appropriate refresher training (supplied internally or externally),\ncoaching, mentoring or on-the-job experience to improve skills and understanding.\nThe site should determine the appropriate frequency for reviews of competency and training\nneeds. There are likely to be several different scenarios; for example:\n• a routine review process (e. g. linked to annual performance reviews)\n• change management (e. g. when a procedure is amended or updated)\n• whenever there is evidence that an update would be beneficial.\n7. 2 Personal hygiene: raw material-handling, preparation, processing, packing and\nstorage areas\nThe site’s personal hygiene standards shall be developed to minimise the risk of product contamination from\npersonnel, be appropriate to the products produced and be adopted by all personnel, including agency-supplied\nstaff, contractors and visitors to the production facility.\nThe site must have documented personal hygiene rules designed to prevent product contamination from personnel.\nThese should be based on risk and may take into account different requirements for different production risk zones,\nand any national or regional legislation.\nAll personnel, including agency-supplied staff, contractors and visitors entering production areas (including raw\nmaterial storage, preparation, processing, packing and storage areas), must adhere to the company’s documented\npersonal hygiene rules, including those regarding personal belongings, hand-washing, injuries, illness and medication."},{"id":"7.2.1","requirement":"The requirements for personal hygiene shall be documented and communicated to all personnel. • watches and similar wearable devices shall not be worn. • jewellery shall not be worn (exception: plain wedding ring/wristband/medical alert). • rings and studs in exposed parts of the body shall not be worn. • fingernails shall be kept short, clean and unvarnished. • false fingernails and nail art shall not be permitted. • excessive perfume or aftershave shall not be worn","interpretation":"This clause is designed to ensure that personal items are not a source of product\ncontamination; for example, small parts that may fall off and become foreign-body hazards,\nor a source of microbiological or allergen contamination (e. g. if the items were previously\nworn in an area that was contaminated and the contaminant was transferred into the\nproduction area).\nThe site must document its personal hygiene requirements. At a minimum, these must include:\n• Watches are not permitted in open product areas (including devices used for fitness\nmonitoring and tracking). It is good practice to include details for all portable personal\nitems within site policies; for example, mobile phones and tablet devices (e. g. the site\nmight exclude all individuals’ personal mobile phones, but have specific rules relating to\ncompany-issued equipment, which could, for example, include instructions for cleaning on\nentry to production areas).\n• Jewellery must not be worn apart from plain, smooth rings or wristbands (i. e. without\nstones that may fall out), such as wedding rings. Exceptions must be minimal and must\nnot constitute a risk to product (e. g. wristbands identifying a particular medical condition,\nsuch as epilepsy or an allergy, may be worn where product is not at risk of contamination).\nWhere religious reasons prevent the removal of an item of jewellery, it must be covered\nand the site must complete a risk assessment to determine how this will be achieved (e. g.\nby totally covering the item with the wearer’s clothing, or by wearing overalls that are\nbuttoned up to cover the item).\n• The potential for broken, damaged or lost glasses and contact lenses to become a foreign-\nbody risk should be considered.\n• Rings and studs must not be worn in exposed parts of the body such as ears, noses,\neyebrows and tongues.\n• Long fingernails are not permitted, as they are a contamination hazard since they\nmay break off; nor are nail varnish, nail art or false nails. Fingernails must be kept\nclean, commensurate with the level of hygiene expected within a food manufacturing\nenvironment. Where visitors cannot comply with these rules, other controls (such as\nlimiting where visitors may enter and what they may touch, and the obligatory use of\ngloves) must be implemented to minimise the risk of contamination.\n• Excessive perfume or aftershave must not be worn, as this has the potential to taint foods.\nThese requirements are applicable to raw-material handling, preparation, processing, packing\nand storage areas. The requirements for staff working solely in enclosed product areas may\nbe relaxed where no risk is presented to the products.\nThe requirements must be communicated to all personnel (e. g. through induction training\nand sign-in procedures for visitors and contractors). Consideration must be given to the\nlanguage in which the training is completed; for example, where employees will be working\nin their second or third language. Appropriate methods of training (e. g. use of translators)\nmust be provided for them.\nCompliance with requirements must be checked regularly; for example, by incorporating\nchecks into daily or weekly good manufacturing practice audits (see clause 3. 4.4), or through\nthe questioning of personnel at regular intervals."},{"id":"7.2.2","requirement":"Hand-washing shall be performed on entry to the production areas and at a frequency that is appropriate to minimise the risk of product contamination.","interpretation":"Hand-washing must be conducted at a frequency appropriate to the level of risk to the\nproduct being produced and in line with good industry practice. At a minimum, hands must\nbe washed before staff enter the production area and whenever an activity is undertaken\nthat could potentially be a risk to products (e. g. after going to the toilet, eating, smoking,\nblowing noses, sneezing or handling shoes).\nAppropriate instructions for hand-washing, considering the language needs of staff (e. g.\nincluding pictorial instructions), must be provided (clause 4. 8.4).\nFurther guidance Introduction to hand-washing techniques\nHand-washing is recognised as an effective way to reduce the risk of contaminating food\nwith micro-organisms such as E. coli, Salmonella and Staphylococcus aureus. However, a\nnumber of studies have shown that people either do not wash their hands or fail to clean\nthem effectively. So it is vital that food companies not only provide staff with appropriate\nfacilities to wash their hands but also ensure staff are aware of the correct procedure to\nfollow.\nWhat makes a good hand-washing procedure?\nFrequency\nHand-washing should be carried out as often as is appropriate for the level of risk to the\nproduct. At a minimum hands should be washed:\n• before entering production areas\n• after any break which involves leaving the production area\n• after going to the toilet\n• after eating or smoking\n• after blowing your nose.\nSee also clause 8. 4.1 for hand-washing facilities and procedures in high-risk and high-care\nzones.\nMethod\nThere are a number of steps in an effective hand-washing procedure:\n• wet hands with water\n• apply soap\n• rub the hands so that all the parts of the hands are cleaned, including palms, backs of\nhands, between fingers, backs of fingers, thumbs and fingertips\n• rinse hands to remove soap\n• dry hands thoroughly, as careful drying is a vital step in preventing the contamination of\nfood products.\nFor a pictorial example of best practice for hand-washing, visit the World Health\nOrganization’s ‘How to Handwash?’ page.\nIn addition to the above routine, good practice is to apply a sanitiser such as an anti-\nbacterial hand gel after the hands have been washed and dried. An effective hand-washing\nroutine should take approximately 40–60 seconds to complete.\nTraining\nIt is important that a good hygiene culture operates within the site so that an effective\nhand-washing routine becomes normal, everyday behaviour. This means that all new staff\nshould be trained (e. g. during induction training) in the site’s hand-cleaning procedures\nand understand the importance of them. Regular updates can help ensure the information\nremains fresh in people’s minds.\nFacilities\nFor a description of hand-washing facilities, see the guidance for clause 4. 8.4."},{"id":"7.2.3","requirement":"All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster that is different from the product colour (preferably blue) and contains a metal detectable strip.","interpretation":"Cuts and grazes on exposed areas of skin must be covered to prevent contamination of\nproduct. To minimise the potential for plasters or band-aids to contaminate product, they\nmust be controlled by the site (e. g. through the use of an issue procedure, where numbered\nplasters or band-aids are documented in a log, stating when and to whom they were issued).\nThe site may consider the need for an audit of plasters at the end of the shift, and for staff to\nimmediately inform supervisors of any loss.\nPlasters or band-aids must be visually distinct (preferably blue) and include a metal\ndetectable strip. This applies even where the site does not use metal detectors, as many\nproducts are sold for further processing and the plaster or band-aid could therefore be\ndetected at a later stage in the supply chain. Where appropriate, in addition to the plaster or\nband-aid, a glove must be worn."},{"id":"7.2.4","requirement":"Where metal detection equipment is used, a sample from each batch of plasters shall be successfully tested through the equipment and records shall be kept.","interpretation":"To ensure that each batch of plasters purchased fulfils the metal detectable requirement,\na sample from each batch must be tested to confirm that it is successfully rejected by the\nmetal detector in use.\nIf multiple metal detectors are used on site, it is good practice to use a risk assessment\nto identify the least sensitive detector, as using this will ensure that a lost plaster can be\ndetected by all of the detectors on site.\nRecords must be kept.\nWhere the site does not use metal detectors, this requirement (for keeping a sample of the\nbatch of plasters) will not apply."},{"id":"7.2.5","requirement":"Processes and written instructions for staff shall be in place to control the use and storage of personal medicines.","interpretation":"Personal medicines need to be controlled to ensure they do not constitute a risk to product.\nThe site must have a documented procedure on the control and storage of medicines.\nWherever possible, medicines should not be taken into production areas (e. g. they could be\nstored in lockers along with other personal items). However, where staff have a medical need\nto keep personal medicines with them (e. g. they have asthma or diabetes), procedures must\nbe in place to control these medicines (such as a requirement to notify the company of the\ndefined medical need). Consideration should be given to the format and packaging of the\nmedicines (e. g. glass bottles) to minimise the potential risk of product contamination.\n7. 3 Medical screening\nThe company shall have procedures in place to ensure that staff, agency staff, contractors or visitors are not a\nsource of transmission of infections, diseases (including food-borne diseases) or conditions to products.\nTo ensure that all persons who will come into contact with food production and storage areas are not the source\nof a hazard, the company must have procedures in place by which staff and visitors are fully informed of the health\nconditions and symptoms which prevent them from working in food production and storage areas."},{"id":"7.3.1","requirement":"The site shall make staff aware of the symptoms of infection, disease or condition which would prevent a person working with open food.","interpretation":"Personnel need to receive, as part of their training, clear instructions on the potential risks of\nfood-borne disease and the site’s procedures for illness notification. Staff who are suffering\nfrom symptoms which may place products at risk must be prevented from working with open\nfood.\nThe site must be expected to define the symptoms, infections or conditions of concern, as\nadvised by local legislation (e. g. a list of communicable diseases). These policies must be\ndocumented.\nThis requirement covers all personnel on site, including temporary staff and those employed\nvia an employment agency. The site may consider the use of a pre-employment and/\nor return-to-work medical questionnaire or medical examination (e. g. stool testing), as\nappropriate to the risk.\nThe use of suitably trained and competent persons and external medical experts may be\nrequired, particularly where privacy laws exist.\nSome countries have legislation relating to fitness to work with food or the handling of\npersonal information. Sites are therefore expected to operate in accordance with these\nlegislative requirements. For example, in the UK, guidance can be found in the FSA guide\n‘Food Handlers: Fitness to Work – Regulatory Guidance and Best Practice Advice For Food\nBusiness Operators’."},{"id":"7.3.2","requirement":"Where permitted by law, visitors shall be required to complete a health questionnaire or otherwise confirm that they are not suffering from any symptoms which may put product safety at risk.","interpretation":"The site must ensure that visitors and contractors who enter areas where there may be a risk\nto product safety, or who undertake work that may constitute a risk to product, are informed\nof the site’s policies and the medical conditions (e. g. the symptoms) that would prevent\nentry into production, storage or open product areas.\nWhere permitted by legislation, visitors must be screened by use of a health questionnaire.\nThe site must ensure that regular visitors and contractors, such as external company staff or\npest control providers, are included. Where questionnaires are used, these must be reviewed\nby a competent person.\nA site with live animals (see clause 5. 9.2) may need to include the prevention of transmission\nof animal diseases; for example, by establishing whether the visitor has been to an area\nwithin the last 48 hours, where there has been a known outbreak or other risk to the animals\nthat are on site.\nThe procedure must be documented."},{"id":"7.3.3","requirement":"There shall be procedures for staff, contractors and visitors relating to action to be taken where they may be suffering from or have been in contact with an infectious disease.","interpretation":"Where staff, visitors or contractors declare they are suffering from, or have been in contact\nwith, the identified diseases, infections etc. , they must be subject to, and informed of, the\nprocedures to prevent product contamination. This will usually include relocation to a role\nwhere they are not in contact with open products.\n7. 4 Protective clothing: staff or visitors to production areas\nSuitable site-issued protective clothing shall be worn by staff, contractors or visitors working in or entering\nproduction areas.\nThe purpose of protective clothing is to protect the products from contamination. Therefore protective clothing\nincludes uniforms, overalls, head coverings (such as hats and hairnets), shoes and boots, aprons and gloves\n(whether disposable or washable). A suitable design of protective clothing must be provided to all staff, visitors and\ncontractors working in or visiting production areas."},{"id":"7.4.1","requirement":"The company shall document and communicate to all staff, contractors and visitors the rules regarding the wearing of protective clothing in specified work areas.","interpretation":"The company is required to determine and document the procedures for application and\nuse of protective clothing based on a risk assessment. The risk assessment must consider\nforeign-body, microbiological and allergen risks as appropriate, as well as general good-\npractice principles. It must document:\n• what must be worn (e. g. footwear, overalls and hair covering) and the design of each\n• where clothing must be put on and taken off, including designated area(s) for changing\n• the order in which clothing is applied (e. g. hairnet, footwear, wash hands and then overall\nor coat)\n• where protective clothing will be stored when not in use\n• special requirements for specific areas\n• instructions for the removal of protective clothing when moving away from the production\narea. Good practice is to include details on what should happen to protective clothing\nafter removal; for example, the correct disposal of disposable clothing, correct storage of\nreusable clothing or where to put clothing that requires laundering\n• removal of protective clothing before entering toilets\n• procedures for the removal of protective clothes in canteens and smoking areas\n• areas where the product is fully enclosed and has no or very little risk of contamination\nfrom the factory environment during normal production.\nThe wearing of full company-issued protective clothing is not an absolute requirement if all\nof the following criteria apply:\n• all products are fully enclosed\n• the product would, if it were not fully enclosed, be classed as a low-risk product\n• the area is separate from areas containing open product\n• staff do not need to pass through open product areas to access the area.\nThe wearing of a company uniform is preferred. Where personal clothing is allowed, sites\nmust provide guidance on the standards of clothing which are acceptable.\nWherever product lines are entered (e. g. adjustments at the filler), protective clothing and\nhair coverings must be worn."},{"id":"7.4.2","requirement":"Protective clothing shall be available that is provided in sufficient numbers, of suitable design (no external pockets above waist), contains all scalp hair, and includes snoods for beards where required.","interpretation":"Clothing must be available for all staff working in production and storage areas (including\nemployment agency staff, temporary staff and contractors). Items must be provided in\nsufficient numbers so that they may be maintained in an acceptable condition during\nworking (e. g. to allow for washing).\nThe company needs to consider the design of protective clothing and ensure that it is\nsuitable for the production processes. At a minimum:\n• the clothing must not include external pockets above the waist (e. g. no pockets in coats)\nand must not have sewn-on buttons\n• the company must consider the design of protective footwear for production areas and\nmust provide footwear that can be kept clean\n• staff and visitors must wear headwear (such as mob caps or hairnets) that completely\ncovers head hair to minimise potential contamination\n• snoods must be provided for staff or visitors who have beards or moustaches where\nprotection is needed to prevent product contamination. Clear rules must be in place and\nunderstood by staff, based on an assessment by the company."},{"id":"7.4.3","requirement":"Protective clothing shall be laundered by an approved contracted or in-house laundry using defined criteria to validate the effectiveness of the laundering process. • adequate segregation between dirty and cleaned clothes. • effective cleaning of the protective clothing. • cleaned clothes are supplied protected from contamination until use","interpretation":"Protective clothing may be cleaned by contracting the services of a specialised laundry, by\nlaundering in-house or, in exceptional circumstances, by employees laundering their own\nclothes.\nExternal contracted services must be incorporated within the company’s purchasing supplier\napproval programme (clause 3. 5.3. 1) and have systems of approval and continual assessment\nto ensure that the process is under control. This should be based on risk assessment and\nmay include self-audit questionnaires where low-risk products are manufactured. The\nmonitoring of the effectiveness of cleaning is likely to consist of visual assessment and the\nmonitoring of complaints.\nIn-house laundering carried out on the company premises must be controlled. This is likely\nto be via HACCP-style principles, controls and validation data, such as monitoring of the\ntemperature and detergent, specifying items not to be washed together, overseeing drying\nprocesses and visual inspection. The laundry will also be included in the programme of\ninternal audits (clause 3. 4.1).\nLaundries (both in-house and contracted) must ensure that:\n• dirty and clean clothing is adequately segregated to ensure that recently laundered items\nare not re-contaminated\n• the protective clothing is effectively cleaned (e. g. by the completion of microbiological\nvalidation and verification tests)\n• cleaned clothes are protected from contamination until delivered to the site (e. g. through\nthe use of covers or bags).\nThe Standard allows home laundering of protective clothing by employees, but only in\nexceptional circumstances, where both of the following conditions are met:\n• protective clothing is not used for product safety purposes, but is instead used to protect\nthe employee from the products handled; for example, in the produce industry, raw\nvegetables arriving from the fields may be covered in mud or dirt, and employees wear\noveralls to protect their personal clothing\nand\n• it is used only in low-risk or enclosed product areas (these are both defined in Appendix \nof the Standard).\nIt is important that where a site wishes to approve home laundering, both of these\nrequirements are satisfied. For example, home laundering would not be permitted in bakeries\nbecause although the protective clothing is being used in a low-risk area, it is an open\nproduct area where the clothing is needed to protect the product, not the employee.\nHome laundering still requires appropriate care and attention to ensure that potential\npathogens are removed or killed. Therefore, where approved, home laundering needs to be\ncontrolled by written instructions, including, for example:\n• how garments are to be washed (temperature, detergent, specifying items not to be\nwashed together, and drying instructions such as the use of a hot iron to further heat-\ndisinfect the clothes)\n• procedures for transporting clean protective clothing to the workplace; for example,\nprovision of sealable plastic bags or similar, which allow washed garments to be\ntransported from home to the workplace without becoming contaminated\n• on-site procedures; for example, defined responsibility within the company for monitoring\nthe effectiveness of the system (typically achieved by visual inspection). There must\nalso be a procedure and system for effectively dealing with any case where employees\nare unable to perform self-laundry, either through lack of diligence or through lack of\nfacilities. This system must be capable of being brought into immediate effect once a\nproblem has been identified."},{"id":"7.4.4","requirement":"Protective clothing shall be changed at an appropriate frequency, based on risk.","interpretation":"Protective clothing needs to be changed at an appropriate frequency to ensure that clothing\ncannot become a source of product contamination. The frequency of changes must be\nbased on risk (e. g. using visual inspections, swabbing or contact plates). For example, hairnets\nare changed daily or whenever they are removed."},{"id":"7.4.5","requirement":"If gloves are used, they shall be replaced regularly. Where appropriate, gloves shall be suitable for food use, of a disposable type, of a distinctive colour and intact.","interpretation":"Gloves are a potential source of foreign bodies; therefore, sufficient control procedures\n(such as regular inspection and replacement) need to be put in place to ensure they are\nintact and do not shed loose fibres. The company needs to consider the design of gloves and\nwhether they need to be disposable, of food grade and of a visually distinct colour from the\nproduct (preferably blue)."},{"id":"7.4.6","requirement":"Where items of protective clothing that are not suitable for laundering are provided (such as chain mail, gloves and aprons), these shall be cleaned and disinfected at a frequency based on risk.","interpretation":"A documented procedure must be developed for protective items that cannot be laundered,\nsuch as shoes, chain mail (cut-resistant, metallic PPE), gloves and aprons. The frequency of\ncleaning and disinfection must be defined based on risk.\n8 Production risk zones – high risk, high care and ambient high care\nWhere a site produces products where the production process, or part of it, requires high-risk, high-care and/or\nambient high-care production zones (see clause 4. 3.1 for this assessment and Appendix 2 of the Standard for the\ndefinition of these production zones), all the relevant requirements from sections 1–7 of the Standard must be\nfulfilled in addition to the requirements in this section.\nThe site shall be able to demonstrate that production facilities and controls are suitable to prevent pathogen\ncontamination of products.\nPrevention of potential contamination with pathogens is of paramount importance in the production of safe food.\nOne of the key ways of achieving this is to ensure the correct design (e. g. segregation) and control (e. g. restricted\naccess) of areas of the site where open products, susceptible to contamination, are handled. The Standard defines\nthese areas as production risk zones.\nThe main principle of the production risk zones in the Standard is to ensure that the environmental conditions\nand controls in open product areas are appropriate for the products being handled. Therefore the expectations for\nfactory hygiene, finish of buildings, equipment, protective clothing and staff hygiene should reflect the potential\nrisks to the product.\nWhere a site produces products that require handling in high-risk, high-care and/or ambient high-care production\nfacilities (see Appendix 2 of the Standard for the definition of products that require these facilities), equivalent\ncontrols are expected for any subsequent handling or re-packing operation where the product is open to the factory\nenvironment (i. e. the re-packing site is expected to have equivalent facilities).\nBRCGS has produced a specific guideline on high risk, high care and ambient high care, which explains the\nrequirements and provides details of good practice. It may be purchased from the BRCGS Store or viewed online at\nBRCGS Participate.\n8. 1 Layout, product flow and segregation in high-risk, high-care and ambient high-care\nzones\nThe requirements in this section are in addition to those in section 4. 3. Sites are therefore recommended to review\nthe two sections together, rather than separately."}],"statement_of_intent":"The company shall ensure that all personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification."},{"section":8,"title":"Production risk zones – high risk, high care and ambient high care","clauses":[{"id":"8.1.1","requirement":"The map of the site (see clause 4.3.2) shall include the location of the pathogen control step(s).","interpretation":"clause 4. 3.2 of the Standard requires the site to construct a site map, and this will include\nreference to the production risk zones appropriate to the site.\nIt is important to note that the high-care, high-risk and ambient high-care production\nzones usually apply to only part of a factory’s production processes; they typically follow\na microbiological kill step or pathogen control step, where any pathogens are removed or\nreduced to an acceptable level. For example, this could be a microbiological kill step such\nas heat treatment or cooking, or a process to reduce the pathogen levels such as a chlorine\nwash of fruit or vegetables. The production risk zone needs to be maintained until the\nproducts are enclosed in packaging.\nFor high-risk, high-care and ambient high-care areas, the location of the site’s pathogen\ncontrol step(s) must be included on the site map.\nAs explained in the interpretation for clause 4. 3.2, the site map must also include an\nindication of any areas where time segregation is used; for example, which areas apply time\nsegregation between high care and low risk. The boundaries of this segregation must be\nclearly detailed.\nThe Standard is not prescriptive on the format of the site plan; however, good practice is to\ninclude all the information in an easy-to-use form. Examples include:\n• use of schematic diagrams\n• overlaying several maps to form a complete picture, which allows both an overview of the\nsite and a focus into the specific features detailed on individual layers."},{"id":"8.1.2","requirement":"Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site.","interpretation":"High-risk areas require the highest levels of hygiene, working practices, and design\nand fabrication of facilities and equipment, to prevent product contamination from\nmicrobiological hazards.\nHigh-risk areas must be fully separated areas, with physical segregation in place between\nthem and other parts of the facility. The purpose of the physical segregation is to provide a\nself-contained area where uncovered (i. e. unprotected) high-risk products are handled after\nthe microbiological kill step (e. g. heat treatment or cooking) until they are fully protected,\nusually by means of final packaging. The segregating barrier must be capable of minimising\nthe risk of cross-contamination from:\n• pathogens which may be present in a low-risk environment or on products or ingredients\nthat have not received a full cook\n• all people moving between the high-risk area and other areas, except through designated\nchanging areas\n• the movement of all equipment, cleaning chemicals, utensils or materials into the high-risk\narea, except through designated ports with sanitising controls in place\n• water or other liquids (e. g. cleaning chemicals) on the floor, washing into the high-risk area\n• airborne contaminants (e. g. dust particles or water droplets).\nThe ideal barrier is a full wall (e. g. a separate room) separating the high-risk area from other\nareas. In assessing the suitability of a segregating barrier, a risk assessment should be carried\nout and documented.\nTime segregation is not an acceptable alternative for high-risk areas, except for the transfer\nareas noted below. The location and operation of all transfer points must not compromise\nhigh-risk and low-risk segregation. For example, where raw materials or staff move into a\nhigh-risk area, consideration must be given to whether this introduces a contamination\nhazard; it may therefore require measures that involve:\n• use of disinfection\n• removal of outer packaging\n• double-door ovens, blast chillers or freezers (i. e. those with a separate entrance and exit)\n• controlled air flow (clause 8. 2.2)\n• changing the design of entrances and exits (e. g. roller lifting doors may represent a risk\nwhen raised, due to the fact they have been in contact with the floor and the difficulty in\ncleaning them effectively).\nHigh-risk areas are expected to be self-contained and fully segregated. Best practice is that,\nwhere there is a cook step in the production of high-risk products, the cooker becomes\nthe transfer point into the high-risk area via a double-door system (i. e. the cooker is loaded\nin the low-risk area and unloaded directly into the high-risk area). While new cooker\ninstallations and new-build sites must incorporate double-door cooking systems, many\nexisting plants are equipped with single-door cookers and have established risk-based\nprocedures for the loading and unloading of the cookers to prevent cross-contamination\nof cooked products. The Standard will, therefore, accept the use of single-door cooking\nsystems where a thorough risk assessment has been completed as an interim measure\nprior to the eventual upgrading. Operating practices must be consistently achievable and\neffective, and prevent cross-contamination of cooked products.\nThe risk assessment must consider, and control potential risk, from:\n• crossover between cooked and raw products in the unloading area\n• operators and their clothing (e. g. handling of cooked products by operators who have\npreviously worked with raw products)\n• hand-contamination resulting from touching surfaces such as common equipment, cooker\ncontrol panels and cooker door handles\n• equipment used for transferring product into and out of cookers\n• airborne contamination from low-risk processes (e. g. the loading and unloading area\nshould be separate from the main low-risk processing area)\n• the floor (e. g. contamination of the wheels of trolleys transferring cooked products to the\nhigh-risk area).\nWhen cooked products are unloaded from the cooker, they must be moved immediately\nto a designated high-risk area to meet the requirements of the Standard. The auditor will\nassess the procedures in operation where single-door cookers are in use to ensure they\nare adequate, effective and understood by operators. The audit report will describe the\nprocedures in place to protect the cooked products from contamination.\nHigh-risk areas contain only components and foods which have undergone a cook or similar\nprocess to achieve, typically, a 6-log reduction for Listeria. Where a single area includes, by\nnecessity, some components which have received a lesser kill, together with fully cooked\ncomponents (e. g. in a sandwich preparation area), this will be classed as high care.\nExample Cooked crustacea – a product requiring a high-risk production zone\nWhere crustacea are cooked as part of the production process, or were cooked at an earlier\nstep in the production process (including at another site), the site will need to ensure the\ncorrect production risk zones are used.\nAccording to the definitions in Appendix 2 of the Standard, cooked crustacea fit into the\ndefinition of a product requiring a high-risk production zone because:\n• finished product is chilled or frozen to preserve food safety\n• all components have received a full cook (equivalent to a 6 log reduction in Listeria\nmonocytogenes)\n• finished product is vulnerable to growth of pathogens or survival of pathogens that could\nsubsequently grow during normal storage and use\n• finished product is ready to eat or ready to heat or, on the basis of known consumer use, is\nlikely to be eaten without adequate cooking.\nAlthough the Standard recognises that some food products can be effectively managed\nusing consumer cooking instructions, these instructions are not considered a valid\njustification for using a different production zone for cooked crustacea, as known consumer\nuse in many countries is to eat the product cold without any heating, and therefore without\na full cook by the consumer. Furthermore, the product appearance could lead consumers to\nbelieve the product is already fully cooked, and that no additional cooking is required.\nWhere a site is partially heating a crustacean (i. e. less than a 6-log reduction in Listeria\nmonocytogenes), a high-care area will be appropriate."},{"id":"8.1.3","requirement":"Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and other parts of the site. Where physical barriers are not in place, the site shall have undertaken a documented risk assessment.","interpretation":"This clause is applicable to high-care areas (i. e. areas designed to a high standard, where\npractices are in place to minimise product contamination by pathogenic micro-organisms;\nsee Appendix 2 of the Standard).\nVulnerable products and ingredients have, before entry to the high-care area, undergone a\nprocess to reduce any contamination by pathogenic bacteria (e. g. a chlorine wash of salad\nmaterials, or an early cook step as in the pasteurisation of cream). It is important that the\nhigh-care area is effectively protected from contamination by low-risk zones. This is most\neffectively achieved through full physical segregation by means of walls which separate the\nhigh-care area from other factory areas.\nWhere a separate, fully walled-off area is not available, alternative procedures must be in\nplace to segregate the high-care area. The segregating barrier must be capable of preventing\nthe risk of cross-contamination from:\n• unauthorised access and movement between high-care and other areas of the factory,\nexcept through designated changing areas\n• transfer of materials, cleaning chemicals, utensils or equipment, except through designated\nports with sanitising controls in place\n• microbiological contamination which may be present in a low-risk environment\n• airborne contaminants (e. g. dust particles or water droplets).\nThe segregating barrier may include time or space separation, control of movement or\nother restrictions. In assessing its suitability, a risk assessment must be carried out and\ndocumented. The method employed must be validated to demonstrate that the controls\nare effective in preventing cross-contamination. The auditor will critically examine the\narrangements to ensure that potential risks for contamination have been addressed, and\nthat the alternative controls are consistently workable before the solution is considered\nacceptable. (This will be recorded in the audit report.)\nWhere the solution is time segregation (i. e. a time separation between low-risk and high-\ncare products being produced in the same area, to allow the area to be converted from\na low-risk zone to a high-care zone (e. g. by cleaning, changes of protective clothing, or\nenvironmental monitoring)):\n• The changeover between low-risk and high-care operations should be as infrequent as\npossible, as it is unlikely that a sufficient standard of cleaning could be reached if changes\noccur frequently during the day.\n• Fully validated procedures to change the area from low risk to high care are required.\nThese activities need to be taken into account when scheduling production, to ensure\neffective transformation of the area, including personnel. If the same personnel are\nresponsible for the area during low-risk and high-care operations, they must undergo a\ncomplete change of protective clothing.\n• The shared area must be designed to meet the requirements of the high-care zone.\nTherefore all the facilities must be appropriate for a high-care production zone; for\nexample, drainage is appropriate and meets the requirements of clause 8. 2.1.\nWhere product characteristics meet the description of high care but the systems are fully\nenclosed (e. g. dairies filling cartons with milk), the production area is considered an enclosed\nproduct area. However, additional precautions are required when breaking into the lines or\nentering filler equipment (e. g. for maintenance, to free product blockage or for cleaning).\nWherever equipment is entered, the necessary hygiene requirements must be completed\nbefore operations can recommence.\nIt is expected that newly built factories will employ full wall segregation where high-care\nfacilities are required."},{"id":"8.1.4","requirement":"Where ambient high-care areas are required, a documented risk assessment shall be completed to determine the risk of cross-contamination with pathogens.","interpretation":"This clause is applicable to ambient high-care areas (i. e. areas designed to a high standard,\nwhere practices are in place to minimise product contamination by pathogenic micro-\norganisms).\nAmbient products that are handled in these areas are vulnerable, as vegetative pathogens\nare known to survive adverse conditions and may subsequently represent a potential food\npoisoning risk.\nProducts which require handling in ambient high-care areas are those which meet all of the\nfollowing criteria:\n• they contain a raw material that is prone to contamination with vegetative pathogens (e. g.\nSalmonella species)\n• the production process includes a process step which removes or reduces the pathogen\n(e. g. a microbiological kill step). (Where there is no effective step in the on-site processes,\nit is assumed that any risk associated with the raw material is controlled as part of the raw\nmaterial risk assessment and goods receipt processes.)\n• the finished products are stored at ambient temperatures (i. e. above 5°C)\n• the finished products are ready to eat or ready to heat or, on the basis of known consumer\nuse, are likely to be eaten without adequate cooking\n• the finished products are such that vegetative pathogens could survive and grow in normal\nuse, subsequently causing food poisoning, or are of a nature (e. g. fatty foods) that enables\nfood poisoning to result from a very low level of contamination with a pathogen.\nWhere products fall into the ambient high care category, the site should conduct a risk\nassessment to identify the potential risks of cross-contamination (e. g. locations where\ncross-contamination could occur) and introduce procedures and processes to manage these\npotential risks.\nThe procedures required will be dependent on the level of risk, but could, for example,\ninclude:\n• segregation – normally this would be physical separation; however, time segregation\nwould be permitted where the site can demonstrate that processes effectively minimise\nthe risk of contamination\n• cleaning and disinfection processes which ensure that areas where at-risk materials are\nlocated are maintained at a suitably high level of cleanliness\n• management of the process flow – ensuring a logical (and usually linear process) so that\nimplicated raw materials are not in the same area/zone as final product (or intermediates\nthat have been through the process to remove or reduce micro-organisms)\n• enhanced environmental monitoring.\nAdditional information on ambient high-care areas can be found in Appendix 2 of the\nStandard.\n8. 2 Building fabric in high-risk and high-care zones\nThe requirements in this section are in addition to those in section 4. 4. Sites are therefore recommended to review\nthe two sections together, rather than separately."},{"id":"8.2.1","requirement":"Where sites include high-risk or high-care facilities, there shall be a map of the drains for these areas which shows the direction of flow and the location of any equipment fitted to prevent the backup of waste water.","interpretation":"The flow of drains must not present a risk of contamination of the high-risk or high-care\nareas. There must be a plan of the drains for these areas which shows the direction of flow\nand location of any equipment fitted to prevent the backing-up of waste water. For example,\ndrains should flow from high-risk to low-risk areas and include suitable barriers, such as\nseparate drains that are not connected to other areas of the site. They should also feature\nnon-return or anti-syphon valves, and one-way traps or a sufficient drop to ensure flow in\nthe correct direction.\nThe map of the drains does not need to be a separate document – it can be incorporated\ninto the site map (see clauses 8. 1.1 and 4. 3.2) if this is more convenient. The direction of flow\nof the drains must be included on the map.\nGood practice is for the site to have procedures in place for the action to be taken in the\nevent of a failure of the drain traps or if water backs up into the high-risk or high-care areas.\nThis should be more than just mopping up and then continuing production, as the clause\nrequires that drains must not become a risk of contamination. A full clean, microbiological\nswabbing etc. may be required to reinstate and confirm the status of the high-risk area."},{"id":"8.2.2","requirement":"High-risk areas shall be supplied with sufficient changes of filtered air.","interpretation":"High-risk areas must be supplied with sufficient changes of filtered air. Therefore a risk\nassessment must be completed, with the aim of ensuring that the air introduced will not\ncontain micro-organisms of concern and will not be a source of additional contamination\n(e. g. through the formation of airborne water droplets). The following criteria should be\nconsidered:\n• the source of air. The air inlet needs to be located to minimise intake of contaminated air\n(at a minimum, it should be upwind of potential contaminants such as dust and chemical\nvapours)\n• the frequency of air changes\n• the specification of filter used. There is no absolute global standard for the filters used in\nspecific food industry applications; the grade required will depend on the source of the air\nand the length of time of exposure of high-risk products/ingredients\n• the frequency of replacement of filters\n• the need to maintain positive pressure compared with adjacent areas, particularly where\nthere is an interface with low-risk areas.\nThe effectiveness of the system employed should be checked using periodic sampling of air\nmicrobiological quality.\nWhile there is no specific requirement for an over-pressure of air in high-risk areas, good\npractice is for the ventilation system to be in balance, so that there is no large movement of\nair from low-risk into high-risk areas.\nWhere air socks are used for high-risk areas, they should be identifiable and kept separate\nfrom those for other areas."},{"id":"8.2.3","requirement":"Where sites include removable walls as part of the design of the high-risk or high-care area, procedures shall be in place to ensure they are tight fitting and their use is managed.","interpretation":"Production risk zones may have removable walls or removable wall panels, to allow the\nmovement of large items or specialist equipment between areas.\nSites must have documented procedures for the use of removable walls. As a minimum, the\nStandard expects:\n• these walls are tight fitting (e. g. to ensure pathogen contamination cannot occur through\nany gaps; for example, if air or water movement occurs between the two areas)\n• use of the removable wall is managed correctly and in a controlled manner (e. g. its\nremoval must be authorised and is only completed by trained and authorised personnel,\nat approved times when there is no production, and in accordance with documented\nprocedures)\n• cleaning and reconditioning are completed prior to the next production (i. e. to ensure\nthat any contamination that has occurred has been removed, and that the area is reliably\nreturned to its high-risk or high-care status).\nGood practice is to update the site map to show the walls which can be moved.\n8. 3 Equipment and maintenance in high-risk and high-care zones\nThe requirements in this section are in addition to those in sections 4. 6 and 4. 7. Sites are therefore recommended to\nreview these sections together, rather than separately."},{"id":"8.3.1","requirement":"Maintenance activities undertaken in high-risk and high-care areas shall respect the segregation requirements of the area. Tools and equipment shall be dedicated for use in that area where possible.","interpretation":"It is important that maintenance activities do not result in microbiological contamination\nof high-risk or high-care areas. Tools that are frequently needed in the area (e. g. spanners)\nshould be dedicated to the area and not removed from there. Where specialist tools or\nequipment need to be brought into an area for a specific task, then mechanisms should be\nin place to ensure that this does not result in contamination (e. g. cleaning equipment before\nentry and post-maintenance cleaning of the high-risk or high-care area)."},{"id":"8.3.2","requirement":"Where equipment is removed from the high-risk or high-care area, the site shall have a procedure to ensure the cleanliness and removal of contamination hazards before acceptance back into the area.","interpretation":"Some equipment is moved from place to place in order to be used in different areas. Where\nthis occurs, the site must take steps to ensure that re-introduction to those areas does not\ncompromise the conditions (i. e. the equipment is suitably clean and will not be a source of\ncontamination).\nThe auditor will expect to see a procedure that addresses the re-introduction of equipment\nto a high-risk or high-care area, as well as evidence of adherence to this procedure where\nequipment has been moved."},{"id":"8.3.3","requirement":"Where portable equipment and battery-charging equipment is used in high-risk or high-care areas, these items shall either be visually distinctive and dedicated, or have specific cleaning procedures.","interpretation":"Systems must ensure that the use or transportation of small portable equipment, such as\nhandheld devices (e. g. pH meter, temperature probe) and battery-charging, cannot become\nthe source of pathogen contamination.\nGood practice is for these items to be dedicated to the designated area. Where this is\nnot practical, then specific procedures must be in place to prevent contamination (e. g.\nmovement only through designated routes with associated cleaning or sanitising controls).\n8. 4 Staff facilities for high-risk and high-care zones\nThe requirements in this section are in addition to those in section 4. 8. Sites are therefore recommended to review\nboth of these sections together, rather than separately."},{"id":"8.4.1","requirement":"Where an operation includes a high-risk or high-care area, personnel shall enter via a specially designated changing facility at the entrance to the area. • clear instructions for the order of changing. • protective clothing that is visually distinct. • hand-washing routine during the changing procedure. • dedicated site footwear. • effective control of footwear (barrier/bench or boot-wash)","interpretation":"The objective of this clause is to ensure that protective clothing, once applied, is not\ncontaminated before entry into the high-risk or high-care area.\nIn facilities with high-risk or high-care areas, personnel must enter these areas via a specific,\ndesignated changing facility (i. e. separate from other, lower-risk changing areas) and must\nfollow documented instructions to:\n• apply specific dedicated protective clothing which is visually distinct (e. g. a different\ncolour or style), including clean overalls, headwear and footwear\n• apply clothing in a given order; for example:\n• put on hair covering\n• remove shoes\n• step over barrier (see below)\n• put on dedicated footwear\n• wash hands\n• put on coat or overalls\n• wash and sanitise hands\n• wash hands during the changing procedure.\nWhen personnel leave the high-risk or high-care area, there must be clear instructions\nfor changing out of protective clothing to ensure that they remove their overalls before\nhandling shoes or a hair covering. (This is particularly important where the clothing is to be\nreused; for example, if someone is temporarily leaving the area for lunch or a break.)\nThe footwear worn in these areas must be dedicated to the factory (i. e. factory-issued and\nnot worn outside the factory) and captive to the area (i. e. worn only in the high-risk area).\nThe changing area must be laid out with an effective system to differentiate areas for\nwearing high-risk footwear (e. g. by the use of a barrier or bench system).\nBy exception, boot-wash facilities may be used instead of changing into captive footwear\ndedicated to the area; these must be located at the entrance to an area. Boot-wash facilities\nmust be effectively controlled, managed and validated to prevent the introduction of\npathogens. The site must have undertaken a risk assessment to identify the suitability of the\nboot-wash facilities, and have established controls to manage the effective sanitation of\nfootwear. The controls must have been validated by microbiological swabbing of footwear,\nfloors and drains in the high-risk or high-care area to demonstrate the absence of pathogens\n(e. g. Listeria species).\nFor controls to be effective, they should include the following criteria:\n• The footwear must be company-issued and of a design which is easily cleaned (i. e. smooth\nupper surfaces, and cleats on soles sufficiently spaced so as not to trap dirt which may not\nbe easily removed by boot-wash equipment).\n• The potential for cross-contamination of boots prior to boot-washing must be considered.\n• Permitted areas where footwear may be worn prior to entry to an area must be clearly\ndefined. For example, the same footwear must not be worn outside the facility or in low-\nrisk processing areas prior to entering the area.\n• The boot-wash equipment must be suitably designed, well maintained and demonstrably\neffective in cleaning and sanitising the footwear.\n• The minimum cleaning time and concentrations of detergent and sanitiser must be\ndetermined, monitored, documented and controlled to ensure effective cleaning of\nfootwear.\n• A schedule for the cleaning of the boot-wash facility and equipment should be in place\nto ensure that the boot-wash does not become a source or vector of microbiological\ncontamination.\n• Records of the detergent/sanitiser checks and of the effectiveness of the boot-wash\nfacilities are to be kept.\nEnvironmental monitoring programmes must include specific reference to high-risk and\nhigh-care areas (e. g. footwear, floors and drains) to demonstrate the effectiveness\nof the footwear control.\nAll visitors and contractors entering the area will need dedicated footwear; shoe covers\nare not satisfactory for high-risk or high-care areas, as they rarely cover the whole shoe\nand often tear or fragment during use, resulting in a lack of protection and the potential to\nbecome foreign-body risks.\nThe objective of the use of dedicated clothing is to prevent the potential contamination\nof products. If members of the cleaning team (or indeed anyone else, such as engineers\nor visitors) enter an area while production is in progress or open products are present,\nthey must follow the same clothing rules as production staff. If cleaning occurs outside\nproduction time, the absolute rules on protective clothing may be adapted but must ensure\nthat the production area is left in a condition, after cleaning, such that no microbiological\nrisks have been introduced by the cleaners or the equipment used. The same principles\napply to engineers undertaking maintenance work (which should be followed by cleaning\nto restore the microbiological security of the area). Wherever practical, auditors will be\nexpected to observe the cleaning in high-risk areas to ensure that the practices used are\neffective and that controls are in place to prevent this activity introducing new risks.\nFurther details are available in the BRCGS guideline on Understanding High Risk, High Care\nand Ambient High Care, available on BRCGS Participate.\n8. 5 Housekeeping and hygiene in high-risk and high-care zones\nThe requirements in this section are in addition to those in section 4. 11. Sites are therefore recommended to review\nboth of these sections together, rather than separately."},{"id":"8.5.1","requirement":"Environmental cleaning procedures in high-care/high-risk areas shall consider the different microbiological risks associated with each production risk zone.","interpretation":"In addition to clause 4. 11. 2, the site must consider the different microbiological risks\nassociated with each high-risk and high-care area.\nDocumented cleaning procedures must be in place to ensure consistent and effective\ncleaning. These procedures should be specific to the area being cleaned, i. e. for the high-risk\nor high-care area, as the risks may be different.\nCleaning procedures for these areas need to include information on the:\n• staff responsible\n• equipment, building and plant to be cleaned\n• frequency of cleaning\n• methods to be used\n• materials to be used (e. g. required chemicals and concentrations – good practice is to\nfollow the cleaning chemical manufacturer’s instructions relating to concentration,\ntemperature and contact time)\n• equipment to be used, such as hoses or brushes\n• instructions on the correct and safe dismantling of equipment where this is required for\ncleaning purposes\n• records to be kept\n• responsibility for verification of cleaning\n• methods of verification (e. g. visual inspection, ATP monitoring, microbiological swabs or\nallergen swabs)\n• procedures to prevent contamination; for example, if the cleaning team moves from one\nproduction risk zone to another during the cleaning operations, good practice is to move\nfrom the higher-risk area to the lower-risk area.\nWhere equipment requires different levels of cleaning (e. g. between products, or between\ndaily and weekly cleans), each requirement should be clearly detailed.\nIt may be useful to include photographs in the instructions. The procedures need to be\nreviewed and updated when changes occur to the areas to be cleaned."},{"id":"8.5.2","requirement":"Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk/high-care production risk zones.","interpretation":"At a minimum, limits of acceptable and unacceptable cleaning performance must be defined\nfor environmental cleaning (i. e. the factory environment) in high-risk and high-care areas.\nThe limits need to be based on the risk, and this should be used for assessing whether the\ncleaning undertaken is of an acceptable standard. Acceptable limits may be based on visual\ninspection, ATP monitoring or specific analysis such as microbiological testing.\nWhere the cleaning procedure forms part of a defined prerequisite (clause 2. 2.1), designed\nto manage a specific hazard, the procedure must be validated to confirm that the specified\ncleaning method, chemicals and concentrations are capable of consistently achieving the\nlevel of performance required. Records of validation must be maintained."},{"id":"8.5.3","requirement":"Equipment used for cleaning in high-care and high-risk areas shall be visually distinctive, dedicated, hygienically designed and stored hygienically.","interpretation":"Equipment used for cleaning high-risk or high-care areas must be dedicated for use in\nthat area, and therefore retained in the area (i. e. it should not be removed from the area for\ncleaning or any other purpose). It should also be visually distinct (e. g. colour-coded) from\ncleaning equipment used in other areas.\nWhere it is not possible to effectively clean equipment in the high-risk or high-care area, a\nsuitable transfer control should be in operation (e. g. heating or disinfection prior to transfer\nback into the high-risk or high-care area).\nThe cleaning equipment used in high-risk and high-care areas should also be:\n• hygienically designed and fit for purpose; for example, high-pressure hoses are not\nnormally used in high-risk areas because of the potential to create aerosols and move\ndebris\n• cleaned and stored to prevent contamination; for example, many items of equipment\nshould be stored off of the floors (the obvious exception being equipment designed for\ncleaning the floors), and in designated storage areas."},{"id":"8.5.4","requirement":"Where the site uses CIP equipment, either this shall be for a specific area only or the system shall be designed and controlled to prevent contamination (e.g. no recycling of rinse solutions from low-risk to high-risk).","interpretation":"It is important that cleaning equipment cannot be a source of product contamination.\nThis includes the use of CIP systems. Therefore, in addition to the requirements for CIP\nidentified in section 4. 11. 7, the site must ensure that specific risks to the high-risk and high-\ncare areas are managed appropriately. As a minimum, the CIP system for high-risk or high-\ncare areas must be either:\n• a dedicated system, with separate CIP from the systems used in other parts of the facility,\nor\n• controlled so that contamination cannot occur, including controlled direction of flow from\nhigher-risk to lower-risk areas, and not reusing or recycling cleaning chemicals, cleaning\nsolutions or rinse solutions from one area to another.\n8. 6 Waste and waste disposal in high-risk, high-care zones\nThe requirements in this section are in addition to those in section 4. 12. Sites are therefore recommended to review\nboth of these sections together, rather than separately."},{"id":"8.6.1","requirement":"Waste disposal systems shall ensure that the risk of contamination of products is minimised through the control of potential cross-contamination. Risk assessment shall consider the movement and flow of waste and waste containers.","interpretation":"It is important that waste disposal systems are not a source of contamination in high-risk or\nhigh-care areas. Therefore risk assessment must consider the movement and flow of waste\nand waste containers. For example, bins must be dedicated to either high-risk or low-risk\nareas and must not move between the two. Waste from high-risk and high-care areas should\nbe transferred to other containers at the transfer point.\nThe risk assessment for waste in high-risk and high-care areas may be included in the\nprevious documented risk assessment on waste disposal (see clause 4. 12. 3) or as a separate\ndocument.\n8. 7 Protective clothing in high-risk and high-care zones\nThe requirements in this section are in addition to those in section 7. 4. Sites are therefore recommended to review\nboth of these sections together, rather than separately."},{"id":"8.7.1","requirement":"Laundering of protective clothing for high-risk and high-care areas shall be done by an approved contracted or in-house laundry using defined criteria. This includes commercial sterilisation of protective clothing following washing and drying.","interpretation":"Protective clothing may be cleaned by contracting the services of a specialised laundry, or\nby laundering in-house.\nExternal contracted services must be incorporated within the company’s purchasing supplier\napproval programme (clause 3. 5.3. 1) and have systems of approval and continual assessment\nto ensure that the process is under control.\nIn-house laundering carried out on the company premises must be controlled. This is likely\nto be done via HACCP-style principles, controls and validation data, such as monitoring\nof the temperature and detergent, specifying items not to be washed together, overseeing\ndrying processes, and visual inspection. The laundry will also be included in the programme\nof internal audits (clause 3. 4.1).\nThe aim of the clause is to ensure management of the laundry process for high-risk and\nhigh-care protective clothing, including segregation of clean and dirty protective clothing\nand of clean clothing used in different risk production zones. Therefore laundries (both in-\nhouse and contracted) must ensure that:\n• dirty and clean clothing is adequately segregated to ensure that recently laundered items\nare not re-contaminated\n• high-risk, high-care and low-risk clothing is adequately segregated throughout the laundry\nprocess\n• the protective clothing is effectively cleaned (e. g. by the completion of microbiological\nvalidation and verification tests)\n• clothing is commercially sterile following the washing and drying process. This means that\nany vegetative forms of micro-organisms associated with food poisoning and/or spoilage\nmust have been removed. To achieve this, a garment should be laundered at a temperature\nno lower than 65°C for a minimum of 10 minutes, or laundered at a temperature no lower\nthan 71°C for a minimum of 3 minutes, or in accordance with local regulatory requirements\n• cleaned clothes are protected from contamination until delivered to the appropriate area\nof the site (e. g. specific storage for clean protective clothing in the high-risk changing\nfacility).\nHome laundering is not considered suitable for protective clothing used in high-risk or high-\ncare areas."},{"id":"8.7.2","requirement":"Where protective clothing for high-care or high-risk areas is cleaned by a contracted or in-house laundry, the laundry shall be audited either directly or by a third party.","interpretation":"The company will need to assess and monitor the laundry (e. g. through visual inspection,\nregular audits and a complaints procedure) to ensure that the processes in place for the\ncleaning of high-risk and high-care clothing are maintained and kept consistently under\ncontrol.\nThe audits of the laundry can be completed either directly (i. e. by the site) or by a suitable\nthird party. The frequency of the audits should be based on risk."},{"id":"8.7.3","requirement":"Protective clothing for use in high-risk and high-care areas shall be changed at an appropriate frequency based on risk, and at a minimum daily.","interpretation":"Protective clothing needs to be changed at an appropriate frequency to ensure that clothing\ncannot become a source of product contamination.\nProtective clothing worn in high-risk or high-care areas must be changed at least daily and\nhairnets changed daily or whenever removed (e. g. when leaving the area).\nWhere risk assessment determines that more frequent changing is appropriate, the site\nmust ensure this occurs. The auditor will expect to see the risk assessment, documented\nprotective clothing procedures, and application of the procedures in practice.\nSpare protective clothing should be available on demand should currently used items\nbecome soiled.\n9 Requirements for traded products\nTraded products are defined as food products that would normally fall within the scope of the Standard and are\nstored at the facilities of the site being audited, but that are not manufactured, processed, reworked, packed or\nlabelled at that site.\nThe site’s management of these products is covered by the requirements in this section.\nAll the relevant requirements from sections 1 to 8 must also be fulfilled in addition to the requirements outlined in\nthis section.\nWhere a site wishes to be audited against section 9 of the Standard, all of the food products and food raw materials\ntraded must be included in the audit scope. It is not permitted to include some traded food products or food raw\nmaterials and exclude others.\nNon-conformities against clauses within section 9 of the Standard will be recorded on the audit report and included\nin the calculation of the site’s grade.\nWhere a site has traded food products or food raw materials on site but wishes them to be excluded from the scope\nof the audit, this will be recorded as an exclusion from scope on the audit report.\nTraded products include food final products, food raw materials and food ingredients that are:\n• purchased and sold (but not manufactured, processed, reworked, packed or labelled on site)\n• stored for another site, e. g. another site in the same company (but are not manufactured, processed, reworked,\npacked or labelled on site).\nTraded products do not include:\n• non-food products, non-food ingredients or non-food raw materials\n• any material that is manufactured, processed, reworked, packed or labelled on site (for example, where a product is\nsubject to an outsourced process, but subsequently returns to the site for further processing, packing or labelling,\nit is not considered a traded product).\nThe auditor will require some additional time to complete the audit of traded products. Full information on audit\nduration, including the additional time required for auditing traded products, can be found in the audit duration\ncalculator.\n9. 1 The food safety plan – HACCP\nThe site shall operate a HACCP or food safety plan for the processes for which it is responsible.\nIt is important that traded products are managed correctly to ensure that:\n• product safety, legality and traceability are maintained\n• the traded products do not represent a food safety risk to the products manufactured, processed, reworked,\npacked or labelled on site.\nThe first step in the management of the traded products is therefore to complete a HACCP or food safety plan\nwhich specifically includes these products."}],"statement_of_intent":null},{"section":9,"title":"Requirements for traded products","clauses":[{"id":"9.1.1","requirement":"The company shall either have a HACCP or food safety plan specifically for the traded products handled on site, or incorporate the traded products into its existing HACCP or food safety plans.","interpretation":"hazards associated with the traded products. The site may either:\n• complete a separate HACCP or food safety plan solely relating to the traded products.\nA separate plan is most useful in situations where the traded products are considerably\ndifferent from the products manufactured, processed or packed on site, or have\nconsiderably different hazards associated with them; or\n• include the traded products within the existing HACCP or food safety plan completed in\naccordance with section 2 of the Standard. A combined food safety plan may be useful\nwhere the traded products are similar to those manufactured, processed or packed on site,\nand therefore have similar hazards.\nThe scope must include all the products and processes for which the site is responsible. As a\nminimum, this will include:\n• receipt of goods\n• storage\n• dispatch.\n9. 2 Approval and performance monitoring of manufacturers/packers of traded food\nproducts\nThe company shall operate procedures for approval of the last manufacturer or packer of food products which\nare traded to ensure that traded food products are safe, legal and manufactured in accordance with any defined\nproduct specifications.\nAll traded food products brought onto the site must be sourced from approved suppliers who are regularly\nmonitored for their performance. The risk assessment process should focus more on those products and suppliers\nthat present a greater risk (in terms of safety, authenticity, legality and quality)."},{"id":"9.2.1","requirement":"The company shall have a documented supplier approval procedure which identifies the process for initial and ongoing approval of suppliers and the manufacturer/processor of each product traded. • nature of the product and associated risks. • customer-specific requirements. • legislative requirements. • source or country of origin. • potential for adulteration or fraud. • potential risks in the supply chain. • brand identity","interpretation":"For easier management, sites could choose to integrate the approval process for their traded\nproducts suppliers with that for their raw materials suppliers, or organise the traded products\nsuppliers as a separate work stream.\nAll suppliers of traded products must be evaluated on the basis of a documented risk\nassessment for their ability to meet the specifications of the products they are supplying\nto the certificated site; in particular the requirements for safety, quality and legality. For\nexample, the assessment should consider:\n• known hazards associated with the product provided (e. g. microbiological, chemical or\nforeign-body risks). Access to reference information and an awareness of emerging food\nissues are essential to ensure all known risks are assessed (see clause 1. 1.8)\n• customer or legislative requirements (e. g. suppliers may be specified by customers, but this\ndoes not negate the need for risk assessment). Legislation in the country of expected sale\nshould be considered\n• geographic origins (products from particular countries may carry a greater risk because of\nenvironmental conditions, more relaxed local legal requirements or a less developed food\nsafety culture)\n• the potential for fraudulent activity or food defence issues in the supply chain (e. g.\nundeclared additions, dilution or substitution of the raw material or a component of it).\nAdditional focus must be placed on products where claims are being made (e. g. organic, or\nsuitable for individuals with food allergies). Suppliers and their control systems must be\nassessed robustly to ensure compliance with the requirements.\nThe outcome of this activity must also be considered when assessing the requirements for\nsupplier approval and monitoring procedures (clauses 9. 2.2 and 9. 2.4)."},{"id":"9.2.2","requirement":"The company shall have a procedure for the initial and ongoing approval of manufacturers of products. This approval procedure shall be based on risk and include either a valid certification to a BRCGS/GFSI standard, supplier audits, or a completed supplier questionnaire (for low risk only).","interpretation":"The company must document its procedure for supplier approval and monitoring. This needs\nto include the methods of approval, frequency of monitoring, staff responsibilities and how\nthe process will be managed.\nApproval will be dependent on the product and the risks associated with it (the output of\nclauses 9. 2.1 and 9. 1.1) and will include one or more of the following activities:\n• certification to the relevant BRCGS Standard (such as food safety, packaging, storage and\ndistribution, or agents and brokers) or a GFSI-benchmarked scheme. The site must confirm\nthe validity of the certification. This will include:\n• confirmation of the certification status (this could be confirmed on an independent\ndatabase; for BRCGS Standards, it can be confirmed in the BRCGS Directory).\nPhotocopies of certificates are not recommended and on their own are not considered\nsuitable validation of certification status. During the BRCGS audit, the site may be asked\nto demonstrate its validation process\n• confirmation that the certification remains up to date (e. g. by receiving confirmation of\nsuccessful completion of the recertification process or by recording certificate expiry\ndates and completing checks for ongoing certification)\n• confirmation that the products are within the scope of the certification.\n• a successful site audit which at a minimum covers product safety, traceability, HACCP\nand good manufacturing processes. This audit must be completed by an appropriately\nexperienced and competent auditor (i. e. someone who has completed training in auditing\ntechniques, has experience of auditing, and has knowledge of the product, ingredient or\nprocesses being audited). Non-conformities should be addressed (e. g. in an agreed action\nwith timescales) unless they are critical to product safety or legality, in which case supply\nshould not be permitted until non-conformities have been satisfactorily addressed. If the\nsupplier is audited to a standard that is not GFSI-benchmarked, this may be acceptable\nproviding that:\n• the scope of the audit meets the requirements of the Standard\n• the site has a copy of the full audit report (not just a certificate)\n• the site can demonstrate the competence of the auditor.\nWhere the risk assessment (completed as part of this clause) indicates that a supplier is low\nrisk (because of the history of trading with the site, the nature of the products traded etc.),\nthe completion of a supplier questionnaire with a focus on food safety and quality may\nbe sufficient. If a supplier questionnaire is the only mechanism used to assess a supplier\n(i. e. there are no additional activities such as supplier audits), then it is important that the\nquestionnaire (and the replies from the supplier) contains all the relevant information to\nallow the site to confidently decide on approval.\nThe auditor will expect to see, and will challenge, any risk assessments that determine that\nsuppliers have been deemed to be low risk."},{"id":"9.2.3","requirement":"Records shall be maintained of the manufacturer’s/packer’s approval process, including audit reports or verified certificates.","interpretation":"The site is required to maintain records of the approval methods along with the evidence\nused to approve that supplier.\nApproval and associated risk assessments must be up to date and the site should therefore\nreview the supplier assessment whenever there is an issue at the site manufacturing the\ntraded food product."},{"id":"9.2.4","requirement":"There shall be a process for the ongoing review of manufacturers/packers, based on risk and using defined performance criteria.","interpretation":"As much as it is important to know how and why suppliers are approved, it is also vital\nto ensure that ongoing approval is justified. The site is free to determine how it confers\ncontinuing approval on its suppliers, but it must ensure that the supplier’s performance is\nmatching its own food safety objectives.\nThe defined performance criteria can be determined by the site. These may include:\n• punctuality of deliveries against planned delivery times\n• incidences of contamination\n• quality of material supplied.\nFrequency of ongoing approval is also left for the site to determine; however, it must reissue\nthe questionnaires (where used) at least once every 3 years. The site should be able to\ndemonstrate to the auditor that the monitoring it uses is appropriate, justified and risk-based.\nExamples of different types of monitoring will be required.\nAll records of the review must be maintained.\n9. 3 Specifications\nSpecifications or information to meet legal requirements and assist customers in the safe usage of the product\nshall be maintained and available to customers.\nA finished product specification must exist for all traded food products to ensure that legislation requirements and\ncustomer expectations are met.\nConsideration must be given to the legislative requirements in the country where the product will be sold or used."},{"id":"9.3.1","requirement":"Specifications shall be available for all products.","interpretation":"Specifications for all products must be provided and adequately detailed. They must include\nthe defined data for all parameters critical to the safety, legality and quality of the product.\nThe specifications may be in the format provided by the supplier or in the company’s own\nformat, as long as the information controlling the product’s safety, quality and legality are\nclearly defined."},{"id":"9.3.2","requirement":"The company shall seek formal agreement of the specifications with relevant parties.","interpretation":"The site must have a formal specification approval process for its customers and suppliers.\nFor example, customer-branded finished product specifications must be formally agreed\nand, wherever possible, signed by both parties. However, where signature or approval is\nnot formally available, proof that specifications have been issued (such as an email request\nfor formal acknowledgement, or specifications uploaded onto a customer IT specification\nsystem) is required. In this situation the site must be able to demonstrate it is following a\nformal process agreed with its customer."},{"id":"9.3.3","requirement":"Companies shall operate demonstrable processes to ensure that any customer-specified requirements are met.","interpretation":"Many customers have specific requirements relating to product safety, authenticity,\nquality and legality and the site needs to ensure that it is aware of these requirements and\nunderstands them (e. g. by retaining copies of relevant customer’s policy documents or\nservice-level agreements).\nThe site must also have a mechanism for ensuring these requirements are met. For example,\nby communicating with the relevant suppliers of products, by incorporating the information\nin specifications, or by recording minutes of review meetings in which the requirements are\nagreed with the supplier.\nOccasionally the site may arrange for additional work to be completed on the product\nbefore it is sent to the customer. Good practice is to ensure that any changes to the\nrequirements are communicated and agreed in a timely manner."},{"id":"9.3.4","requirement":"Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years.","interpretation":"Specifications must be reviewed whenever changes occur to the product, process or\nformulation.\nWhere no known changes have occurred, the specifications should be reviewed at least\nevery 3 years, or more frequently if required, to ensure they remain completely up to date\nand accurate. Evidence that a review has been completed needs to be available. This could,\nfor example, be achieved by the addition of a signature and date to the specification, or by\nusing a matrix showing specifications and the latest review date and reviewer.\nThe control of the amendment and approval of specifications should be documented in a\nprocedure. The procedure should also detail who can approve the amendments.\nSome sites, companies or customers use cloud-based services which are able to notify\nthe user when there has been a change to the data. In this case the site should have a\nmechanism to review the specification/change to understand whether there is any impact on\nthe product.\n9. 4 Product inspection and laboratory testing\nThe site shall operate processes to ensure that the products received comply with buying specifications and that\nthe supplied product is in accordance with any customer specification.\nThe company needs to identify and schedule critical inspections and analyses for its traded food products. These\nmay include:\n• identification of known product safety risks associated with the product type\n• assessment of legal requirements, particularly those associated with the country of intended sale (where known)\n• assurance of product authenticity (e. g. where a genuine risk of adulteration, substitution or fraud has been\nidentified during a vulnerability assessment; see clause 5. 4.3)\n• inspection of quality attributes (e. g. where these form part of a specification agreed with the customer).\nThe frequency and types of inspections and analyses are not prescribed by the Standard, but should be risk-based,\nspecific to the type of products."},{"id":"9.4.1","requirement":"The site shall have a product sampling or assurance programme to verify that the products are in accordance with buying specifications and meet legal and safety requirements.","interpretation":"The company needs to have a documented schedule of product sampling or assurance tests\nwhich are carried out on the products.\nThe objective of product tests is to ensure that products are manufactured to specification\nand in compliance with safety and legislative requirements. The frequency and type of\nproduct tests should be based on risk and on any particular customer requirements. They\nmay, for example, include:\n• quality tests (e. g. appearance, colour or organoleptic qualities)\n• safety tests (e. g. chemical or microbiological) or tests to confirm legality (e. g. country of\norigin or species)\n• customer-specific requirements based on the specification or the customer’s contract with\nthe company.\nThe site should be able to explain and justify the basis for the frequency of tests with\nreference to historical or scientific information as appropriate.\nGood practice is for the test method and specifications to be documented. Where the\nresults of a test are not quantitative, colour standards or reference samples must be used to\nprovide a reference point for the test results (i. e. to define pass/fail criteria).\nWhere tests are completed on site, the location of the testing should be considered. For\nexample, laboratory facilities will need appropriate siting and controls, and organoleptic\ntests should be completed in a designated area rather than on the production line (see\nclause 5. 6.5)."},{"id":"9.4.2","requirement":"Where verification of conformity is provided by the supplier, the level of confidence in the information provided shall be supported by commissioning periodic independent product analysis.","interpretation":"The company must be able to demonstrate that each product meets legal requirements for\nits use.\nProducts are often traded with supporting evidence provided by the supplier (e. g. in the\nform of a certificate of analysis or certificate of conformity relating to the specific batch or\nlot of product supplied). Where these are used, they must be supported by procedures to\nsubstantiate the reliability of the information using independent product analysis.\nThe frequency of this periodic assessment should be based on risk assessment that\nconsiders the likelihood of an error occurring and the potential consequences if an error\noccurred."},{"id":"9.4.3","requirement":"Where claims are made about the products being handled, supporting information shall be available from the supplier or independently to verify the claim.","interpretation":"The types of claim covered by this clause relate to the provenance of products that\ndifferentiates it from the norm. Such a claim may be made either on the product label for\nthe consumer or in business-to-business communication. The types of claim include:\n• varietal claims (e. g. basmati rice, Aberdeen Angus beef, Bramley apples and cod fish cakes)\n• origin claims (e. g. Madagascan vanilla and Florida grapefruit)\n• assurance claims (e. g. GLOBALG. A.P. , Red Tractor, Marine Stewardship, dolphin-friendly\ntuna and sustainable palm oil)\n• identity-preserved claims (e. g. GMO (genetically modified organism) free).\nIt is the responsibility of the site to obtain sufficient supporting information to ensure that\nthe product claims are genuine and proven.\nFor many assurance schemes, such as GLOBALG. A.P. , it is possible to check the assurance\nstatus and the scope of products of the supplier on a database. Reliance solely on a\ndeclaration from a supplier will not be sufficient. Where claims relate to variety or species\n(e. g. varieties of fruit), examination of visual characteristics may suffice. However, for claims\nwhere visual analysis is not possible (e. g. block frozen fish), certificates of analysis and\nperiodic sample analysis will be required."},{"id":"9.4.4","requirement":"Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation (ISO/IEC 17025).","interpretation":"This clause applies to tests which are critical to product safety or legality. Results from such\ntests must be credible and may be called upon in a court of law.\nThe company needs to identify which tests are critical to product safety or legality, such as\ncompliance with label claims/declarations (e. g. nutritional claims, alcohol content) and tests\nfor contamination (e. g. by pesticides, aflatoxins).\nNote that while the laboratory itself may have accreditation, the actual test methods must\nalso be accredited. Any method of analysis that is not accredited needs justification as to\nwhy it was used (e. g. it may be a method for which no accreditation is yet available). Where\ncritical tests are carried out by non-accredited laboratories (either contracted or on-site\nlaboratories), there must be suitable documentary assurances that the laboratory is working\nto the requirements and principles of ISO/IEC 17025. This must include confirmation of the\nlaboratory’s procedures to meet the following general principles:\n• staff competency and documented training\n• documented test methodology based on accepted standards\n• equipment that is fit for purpose and appropriately calibrated\n• a documented quality assurance programme, including paired testing, ring testing etc.\n• completion of internal audits of the laboratory’s operation."},{"id":"9.4.5","requirement":"Test and inspection results shall be retained and reviewed to identify trends.","interpretation":"Systems of recording and review must be formalised and must include evidence of actions\ntaken on identified trends, or where unsatisfactory results have been recorded. The use of\ngraphs or charts of test results provides a good method of identifying trends and anomalous\nresults.\nIt is important that the employees completing the review understand the results and their\nsignificance such that appropriate actions can be taken; for example, if a result is outside\nspecification, or exceeds a legal or safety limit.\n9. 5 Product legality\nThe company shall have processes in place to ensure that the food products traded comply with the legal\nrequirements in the country of sale where known.\nThe company needs to maintain awareness of, and ensure compliance with, relevant legal requirements for its\nproducts in the countries where the products are sold. These may be associated with composition, labelling or how\nthe products are sold."},{"id":"9.5.1","requirement":"The company shall have documented processes to verify the legality of products which are traded. • labelling information. • compliance with relevant legal compositional requirements. • compliance with quantity or volume requirements","interpretation":"Products traded must meet all the legal requirements for the intended country of use. The\nsite must therefore have processes to ensure it remains up to date with requirements such\nas labelling in that country and that these requirements are met and fulfilled.\nAt a minimum the Standard requires labelling, composition, and quantity or volume\nrequirements as applicable, depending on the product to be considered.\nWhere labelling is not controlled by the company but is the responsibility of the customer,\nthis shall be clearly stated in contracts. Good practice is to ensure that all the relevant\ninformation is transferred to the customer and that any changes are communicated in a\ntimely manner.\n9. 6 Traceability\nThe company shall be able to trace all product lots back to the last manufacturer and forward to the customer of\nthe company.\nIn keeping with the traceability requirements for manufactured and processed products, sites that trade food\nproducts are required to maintain traceability, allowing food businesses and authorities to withdraw or recall\nproducts that have been identified as unsafe. The system must ensure that products supplied to customers are\nadequately labelled or identified to facilitate traceability. Traceability details need to be retained in a format that\nallows access in a timely manner."},{"id":"9.6.1","requirement":"The site’s traceability procedure shall include details of the system used for the traceability of traded products.","interpretation":"The site’s traceability procedure must include details of the system used for the traceability\nof traded products, to ensure legal requirements are maintained and that the site can\nidentify implicated batches of traded product in the event of a product recall or withdrawal.\nProducts may be identified by physical labelling or through the use of computerised bar-\ncoding systems. The level of traceability must be able to identify the supplier of the product\nand to whom it is supplied (i. e. one step forwards and one step back). This will enable the\nproduct to be identified if a particular batch needs to be recalled.\nConsider how the traceability system operates in practice (with the effective physical\nidentification of products). For example, if batches or lots of product are broken down into\nsmaller consignments for individual customers, is all of the necessary information available\nto the customer (i. e. was there any additional information on the original outer packaging\nthat the customer would need to ensure traceability?), and can the site confidently identify\nall of these individual customers?\nStrict controls on identification, traceability and segregation are also required to preserve\nthe integrity of any claims made, such as organic status. Where logos are used that\nmake specific claims about production systems (e. g. farm assurance), full traceability and\nvalidations must be demonstrated (see also section 5. 4)."},{"id":"9.6.2","requirement":"The company shall test the traceability system at least annually to ensure that traceability can be determined back to the last manufacturer and forward to the recipient of the product.","interpretation":"The site’s traceability system for traded products must be tested at least annually.\nTraceability testing may be completed as part of a real product recall or withdrawal\nscenario if one has occurred, since the objective is to test the system and identify areas for\nimprovement, rather than supply records of a ‘test’ for its own sake.\nThe system must provide traceability ‘forwards’ and ‘backwards’; therefore it should be\ntested in both directions. For example, a product could be selected and traced forwards to\nshow to whom it was dispatched.\nFurther information on the content of the BRCGS audit, including the vertical audit, can be\nobtained in the BRCGS guide to auditing techniques, available from BRCGS Participate."},{"id":"9.6.3","requirement":"The traceability test shall include the reconciliation of quantities of product received by the company for the chosen batch or product lot. Traceability should be achievable within 4 hours.","interpretation":"The test of traceability should be timed, and full traceability would be expected to be\nachieved within 4 hours, unless information is required from external parties, such as\nsuppliers. This is to reflect the need for rapid traceability in the event of a recall. Where\ntraceability takes longer than 4 hours, the site should review the areas where the retrieval of\ninformation is slow, in order to identify improvements.\nThe tests must also include a reconciliation of quantities (sometimes referred to as a\nquantity check or mass balance exercise). The objective is to be able to account for the\nusage of a full batch of product. This helps to ensure that the traceability systems are\ncapable of operating effectively should a product recall be required.\nThe reconciliation exercise is usually undertaken as follows:\n• Select a batch code of a particular specific product.\n• Identify the quantity of product received under that batch code.\n• Identify the customers purchasing that product and the amounts each received of the\nspecific batch.\n• Calculate the quantity of any unused part of the batch in the warehouse.\n• Reconcile the quantity received against the amounts sold plus any residual unused stock.\n1 Glossary \n2 Sources of further information \nAppendix \nGlossary\nAccreditation The procedure by which an authoritative body gives formal recognition of the\ncompetence of a certification body to provide certification services against a specified\nstandard.\nAdulterant An undeclared material added into a food item or raw material for economic gain.\nAdulteration The addition of an undeclared material into a food item or raw material for economic\ngain.\nAgent A company that facilitates trade between a site or company and their raw material or\npackaging suppliers or their customers through the provision of services, but does not at\nany point own or take title to the goods.\nAllergen A known component of food which causes physiological reactions due to an\nimmunological response (e. g. nuts and others identified in legislation relevant to the\ncountry of production or sale).\nAllergen cross-contact Allergen cross-contact occurs when an allergenic food, or ingredient, is unintentionally\nincorporated into another food that is not intended to contain that allergenic substance.\nAmbient high care An ambient area designed to a high standard where practices relating to personnel,\ningredients, equipment, packaging and environment aim to minimise potential product\ncontamination by pathogenic micro-organisms.\nAnimal primary\nconversion\nSites that complete the slaughter and/or evisceration of animals (including red meat,\npoultry and game) or the slaughter and/or gutting of fish. (Applicable sites will therefore\nfall within BRCGS product categories 1, 2 and 4.)\nAnnounced audit An audit where the company agrees the scheduled audit day in advance with the\ncertification body.\nAnnual/annually Within 12 months since the action was last conducted.\nAssured status Products produced in accordance with a recognised product certification scheme, the\nstatus of which needs to be preserved through the certified production facility (e. g.\nGLOBALG. A.P.).\nATP bioluminescence\ntechniques\nA rapid test for cleanliness of surfaces based on ATP (adenosine triphosphate) – a\nsubstance used in energy transfer in cells and therefore present in biological material.\nAudit A systematic examination to measure compliance of practices with a predetermined\nsystem, and whether the system is implemented effectively and is suitable to achieve\nobjectives, carried out by certified bodies.\nAuditor A person possessing the appropriate competence and skills to carry out an audit.\nAuthenticity/authentic\nproduct\nFood authenticity is ensuring that food or raw materials purchased and offered for sale,\nare of the nature, substance and quality expected.\nBatch The quantity of material prepared or required for one production operation.\nBlended audit An audit that is completed in two parts:\n• a remote audit of documents and records using ICT\n• an on-site audit concentrating on production, storage, good manufacturing practices\nand other on-site activities.\nBrand owner The owner of a brand logo or name who places the said logo or name onto retail\nproducts.\nBranded product Products bearing the logo, copyright or address of a company that is not a retailer.\nBroker A company which purchases or ‘takes title to’ products for resale to businesses (e. g.\nmanufacturers, retailers or food service companies) but not to the ultimate consumer.\nBusiness continuity A framework that enables an organisation to plan and respond to incidents of business\ninterruption in order to continue business operations at an acceptable predetermined\nlevel.\nCalendar days Calendar days are consecutive days, inclusive of Saturdays and Sundays.\nCalibration A set of operations that establish, under specified conditions, the relationship between\nvalues of quantities indicated by a measuring instrument or measuring system, or values\nrepresented by a material measure or reference material, and the corresponding values\nrealised by standards.\nCertificate suspension Revocation of certification for a given period, pending remedial action on the part of the\ncompany.\nCertificate withdrawal Where certification is revoked. Certification may only be regained following successful\ncompletion of the full audit process.\nCertification The procedure by which an accredited certification body, based on an audit and\nassessment of a company’s competence, provides written assurance that a company\nconforms to a standard’s requirements.\nCertification body Provider of certification services, accredited to do so by an authoritative body and\nregistered with BRCGS.\nCertification extension Where a site is operational, but an on-site audit has been prevented by Covid-\nrestrictions, a site may apply to its certification body for the validity of the current\ncertificate to be extended by a maximum of 6 months.\nA certificate extension can only be granted due to Covid-19 restrictions.\nFull details can be found in BRCGS072, Certification Extension for Audits Impacted by\nCovid-19, available on the BRCGS website.\nCheckweigher A checkweigher is a piece of automated equipment for checking that the weight of\nproducts is correct and within the relevant limits (e. g. meets legislative and customer\nlimits).\nClause A specific requirement or statement of intent that a site must comply with in order to\nachieve certification.\nCleaning Cleaning is the process of achieving and maintaining an area to a standard deemed\nvisually free from debris that can include dirt, food, faeces, blood, saliva and other bodily\nsecretions. In other words, it is the removal of soil, food residues, dirt, grease and other\nobjectionable matter.\nCleaning in place (CIP) The process of cleaning and sanitising food-processing equipment in its assembled\nposition without the need for dismantling and cleaning the individual parts.\nCodex Alimentarius\nCommission\nA body responsible for establishing internationally recognised standards, codes of\npractice and guidelines, of which HACCP (hazard analysis and critical control points) is\none standard.\nCompany The entity with legal ownership of the site which is being audited against a Global\nStandard.\nCompetence Demonstrable ability to apply skill, knowledge and understanding of a task or subject to\nachieve intended results.\nCompliance Meeting the regulatory or customer requirements concerning product safety, legality\nand quality.\nConsultant A company, organisation or individual that is subcontracted by the site to provide\ntechnical services relating to the product safety and quality management systems (for\nexample, the development, implementation or maintenance of the product safety\nmanagement system; the development or implementation of the HACCP plan; and the\nproduction of manuals or procedures).\nConsumer The end-user of the finished product, commodity or service.\nContamination Introduction or occurrence of an unwanted organism, taint or substance to packaging,\nfood, raw material or the food environment. Contamination includes physical, chemical,\nradiological, biological and allergen contamination.\nContract packer A company that packages the final product into consumer packaging.\nContractor or supplier A person or organisation providing services or materials.\nControl To manage the conditions of an operation to maintain compliance with established\ncriteria, and/or the state wherein correct procedures are being followed and criteria are\nbeing met.\nControl measure Any action or activity that can be used to prevent or eliminate a product safety hazard or\nreduce it to an acceptable level.\nControlled document A document which is identifiable and for which revisions and removal from use can\nbe tracked. The document is issued to specified individuals and their receipt of the\ndocument is recorded.\nCook ‘Cook’ is a thermal process which is designed to achieve typically a 6 log reduction in\nListeria monocytogenes, equivalent to 70ºC for 2 minutes. Alternative cooking processes\nmay be accepted or required where these meet recognised national guidelines and are\nvalidated by scientific data.\nNote that other processes achieving a 6 log reduction (e. g. irradiation, high-pressure\nprocesses) should be considered in the same way as conventional ‘cook’ processes when\nassessing product safety requirements.\nCorrective action\n(correction)\nAction to eliminate a detected non-conformity or non-conforming product.\nCritical control point\n(CCP)\nA step at which control can be applied and is essential to prevent or eliminate a food or\nproduct safety hazard or reduce it to an acceptable level.\nCross-contamination\n(cross-contact)\nThe transfer of any material from one surface or food to another.\nThe terms ‘cross-contact’ and ‘cross-contamination’ are used interchangeably in\nguidance about allergen management. See allergen cross-contact.\nCross-docking Material is unloaded at distribution premises, and handled, but not formally put away\ninto storage. This may be a staging area where inbound materials are sorted, consolidated\nand temporarily stored until the outbound shipment is complete and ready to ship.\nCustomer A business or person to whom a service or product has been provided, either as a\nfinished product or as a component part of the finished product.\nCustomer focus A structured approach to determining and addressing the needs of an organisation\nto which the company supplies products and which may be measured by the use of\nperformance indicators.\nDespatch/dispatch The point at which the product leaves the factory site or is no longer the responsibility\nof the company.\nDisinfection Disinfection is the process or act of destroying pathogenic micro-organisms; it removes\nmost organisms present on surfaces.\nDistribution The transportation of goods within any container (goods on the move) by road, rail, air or\nship.\nEnclosed product area An area of the factory where all products are fully enclosed and therefore not\nvulnerable to environmental contamination.\nEnd-consumer The ultimate consumer of a foodstuff, who will not use the food as part of any food\nbusiness operation or activity.\nFlow diagram A systematic representation of the sequence of steps or operations used in the\nproduction or manufacture of a particular food item.\nFood defence Procedures adopted to ensure the safety of raw materials and products from malicious\ncontamination or theft.\nFood fraud Fraudulent and intentional substitution, dilution or addition to a product or raw material,\nor misrepresentation of the product or material, for the purpose of financial gain, by\nincreasing the apparent value of the product or reducing the cost of its production.\nFood handler Anyone who handles or prepares food, whether open (unwrapped) or packaged.\nFood integrity Products that are of the nature, substance and quality expected (e. g. not substituted,\ndiluted, adulterated or misrepresented).\nFood raw materials Food ingredients, additives and processing aids used in the manufacture of a product.\nFood safety Assurance that food will not cause harm to the consumer when it is prepared and/or\neaten according to its intended use.\nFood safety and quality\nculture\nThe attitudes, values and/or beliefs which are prevalent at the site, relating to the\nimportance of product safety and the confidence in the product safety systems,\nprocesses and procedures used by the site.\nFood safety plan Often referred to as a HACCP plan. The food safety plan is a set of documents prepared\nin accordance with the Codex Alimentarius HACCP principles to ensure the control of\nfood-borne hazards.\nThe specific terminology used in the Standard, such as ‘prerequisites’ and ‘critical\ncontrol points’ (CCPs), is intended to reflect the global terminology used to describe\nexpectations. Sites are not required to use the specific terminology in the Standard;\nalternatives are acceptable providing it is evident that all the requirements have been\nfully met.\nFood security Procedures adopted to ensure the availability of raw materials and products.\nFundamental\nrequirement\nA requirement of the Standard that relates to a system which must be well established,\ncontinuously maintained and monitored by the company as absence or poor adherence\nto the system will have serious repercussions on the integrity or safety of the product\nsupplied.\nGenetically modified\norganism (GMO)\nAn organism whose genetic material has been altered by the techniques of genetic\nmodification so that its DNA contains genes not normally found there.\nGlobal Food Safety\nInitiative (GFSI)\nManaged by the Consumer Goods Forum, a project to harmonise and benchmark\ninternational food safety standards (www. mygfsi. com).\nGood hygiene practice The combination of process, personnel and/or service control procedures intended to\nensure that products and/or services consistently achieve appropriate levels of hygiene.\nGood manufacturing\npractice (GMP)\nImplemented procedures and practices undertaken using best-practice principles.\nHazard An agent of any type with the potential to cause harm (usually biological, chemical,\nphysical or radiological).\nHazard Analysis and\nCritical Control Point\n(HACCP)\nA system that identifies, evaluates and controls hazards which are significant for food\nsafety.\nHigh-care area A zone (or area) designed to a high standard where practices relating to personnel,\ningredients, equipment, packaging and environment aim to minimise product\ncontamination by pathogenic micro-organisms.\nHigh-care product A product that requires chilling or freezing during storage, is vulnerable to the growth of\npathogens, has received a process to reduce the microbiological contamination to safe\nlevels (typically 1–2 log reduction) and is ready to eat or heat.\nHigh-risk area A physically segregated zone (or area), designed to a high standard of hygiene, where\npractices relating to personnel, ingredients, equipment, packaging and environment aim\nto prevent product contamination by pathogenic micro-organisms.\nHigh-risk product A chilled or frozen ready-to-eat/ready-to-heat product or food where there is a high risk\nof growth of pathogenic micro-organisms.\nIdentity preserved A product which has a defined origin or purity characteristic which needs to be retained\nthroughout the food chain (e. g. through traceability and protection from contamination).\nImporter A company facilitating the movement of products across an international border.\nUsually the first recipient of the products in that country.\nIncident An event that has occurred that may result in the production or supply of unsafe,\nfraudulent, illegal or non-conforming products.\nInitial audit The audit for certification to a BRCGS standard at a company or site that is not in\npossession of a valid certificate. This may be the first audit at a site or a subsequent audit\nof a site whose certification has lapsed.\nInspection Targeted verification (often a visual check against a ‘tick list’ for fabrication, environment\nand equipment) to ensure operation to safe expected levels.\nIntegrity See food integrity.\nInternal audit General process of audit, for all the activity of the company. Conducted by or on behalf\nof the company for internal purposes.\nJob description A list of the responsibilities for a given position at a company.\nKey staff Those staff whose activities affect the safety, legality, authenticity and quality of the\nfinished product.\nLabel Any tag, mark, picture or other descriptive matter, whether it is written, printed or\notherwise marked, on or attached to the packaging of the product.\nWhere a product is unlabelled, specifications or information to meet legal requirements\nand to assist customers in the safe usage of the product shall be maintained, and are\nincluded in the definition of a label.\nLabelling Any words, picture or symbol relating to the food and placed on any packaging or label\naccompanying the product.\nLegality In compliance with the law in the place of production and in the countries where the\nproduct(s) is/are intended to be sold.\nLot See batch.\nLow-risk area An area where the processing or handling of foods presents minimum risk of product\ncontamination or growth of micro-organisms, or where the subsequent processing or\npreparation of the product by the consumer will ensure product safety.\nMalicious contamination Deliberate contamination of a product or raw material with the intention to cause harm\nto the consumer or damage to the company or brand owner.\nManufacturer A company that produces product from raw materials and/or components and packs the\nproduct or supplies product in bulk. A packer that packs product into retail units from\nbulk-supplied material can also be classed as a manufacturer.\nMay Indicates a requirement or text which provides guidance but is not mandatory for\ncompliance with the Standard.\nMeasurement\nuncertainty (sometimes\nreferred to as uncertainty\nof measurement)\nA parameter that is associated with the result of a quantitative measurement. It\ncharacterises the range of values that could reasonably be expected for the attribute\nbeing measured (e. g. the micro-organism, allergen or chemical). It is sometimes referred\nto as the margin of doubt for the result.\nMeasurement uncertainty is important when making conformity decisions (i. e. assessing\nwhether a test result is within legal, safe or acceptable limits) as the uncertainty or range\nof probable values may cross the limit.\nA full explanation of measurement uncertainty is given in the Global Standard Food\nSafety for clause 5. 6.2.\nMitigation strategies Controls to remove, or reduce to an acceptable level, an identified risk, vulnerability or\nthreat. It is often used in food defence where controls are needed to prevent potential\nthreats from occurring.\nMonitoring A planned sequence of observations or measurements of defined control parameters to\nassess whether predefined limits are being met.\nNon-conformity The non-fulfilment of a specified product safety, legal or quality requirement or a\nspecified system requirement.\nOnline verification\nequipment\nAutomated equipment (e. g. bar code scanners) that are used to check the accuracy or\nquality of product labels and printing.\nOpen product area An area in which product is open to the environment (i. e. not fully enclosed in packaging\nor within equipment/pipes).\nOuter packaging Packaging which is visible when the product is released from the site. For example, a\ncardboard box could be considered outer packaging even if wrapped in clear film.\nOutsourced processing\n(subcontracted\nprocessing)\nOutsourced processing (also referred to as subcontracted processing) is when\nintermediate production, processing, storage or a step in the manufacture of a product is\ncompleted at another company or site.\nOutsourced processing is an intermediate step; therefore during outsourced processing,\nthe product or partly processed product leaves the site being audited for the completion\nof the outsourced processing before returning to the site. The audited site may or may\nnot complete the additional packing or processing steps of the product.\nWhere raw materials receive additional storage or processing prior to their arrival on\nsite, this is not considered to be outsourced processing, but should be managed by the\nsite using supplier approval mechanisms, raw material risk assessments and raw material\nspecifications.\nWhen a product leaves the site and does not return, this is not outsourced processing;\nthe activities completed off site are outside the scope of the audit.\nOwnership (change of\ncompany ownership)\nA change of ownership occurs when the title is transferred from one individual or entity\nto another and results in a change of control of the organisation.\nPerformance indicators Summaries of quantified data that provide information on the level of compliance\nagainst agreed targets (e. g. customer complaints, product incidents, laboratory data).\nPlant-based product A product that does not intentionally contain materials of animal origin, and has not\nintentionally used ingredients (including additives, carriers, flavourings and enzymes),\nprocessing aids or any other substances that are of animal origin, at any stage during\nproduction and processing.\nPosition statement Where clarification of the interpretation of a requirement of a BRCGS Standard or\nits protocol is necessary, this will be published on the BRCGS website as a position\nstatement. Such statements are binding on the way that the audit and certification\nprocess are carried out and are considered to be an extension of the Standard. They are\napplicable from the date specified for implementation (or the date of publication on the\nBRCGS website, where no date is specified).\nPositive release Ensuring a product or material is of an acceptable standard prior to release for use.\nPotable water Water that is safe to drink, free from pollutants and harmful organisms, and conforms to\nlocal legal requirements.\nPremises A physical building or place owned by the company and audited as part of a site.\nPre-packaged products Products in their final packaging that is designed for sale to the consumer.\nPrepared primary\nproduct\nA food product which has undergone a washing, trimming, size-grading or quality-\ngrading process and is pre-packed.\nPrerequisite The basic environmental and operational conditions in a food business that are\nnecessary for the production of safe food. These control generic hazards covering good\nmanufacturing and hygiene practices, and form a foundation for the food safety or\nHACCP plan. Prerequisites shall be considered as part of that plan.\nPreventive action Action to eliminate the fundamental underlying cause (root cause) of a detected non-\nconformity and prevent recurrence.\nPrimary packaging The packaging that constitutes the unit of sale to the consumer or customer (e. g. bottle,\nclosure, label and tamper-evident seal of a retail pack or a raw material bulk container).\nWhen identifying primary packaging, due consideration must be given to the processes\nthat minimise or eliminate any risk which may result in contamination of a food product;\nfor example:\n• using suitable food contact materials\n• consideration of anything that is applied onto the surface of a permeable food contact\nmaterial (e. g. potential for migration of ink components through cardboard is a well-\ndocumented risk that has affected a range of packaging).\nAs a general rule, the Standard would not expect transit materials to be classified as\nprimary packaging (e. g. pallets, pallet wrap, shrink wrap, pallet sheets, labels or cable ties\napplied on the outside of the pallet wrap, recyclable and re-usable travel containers, and\nplastic crates used to hold glass bottles).\nProcedure Agreed method of carrying out an activity or process which is implemented and\ndocumented in the form of detailed instructions or process description (e. g. a flowchart).\nProcessed food A food product which has undergone any of the following processes: aseptic filling,\nbaking, battering, blending, bottling, breading, brewing, canning, coating, cooking, curing,\ncutting, dicing, distillation, drying, extrusion, fermentation, freeze drying, freezing, frying,\nhot filling, irradiation, microfiltration, microwaving, milling, mixing, being packed in\nmodified atmosphere, being packed in vacuum packing, packing, pasteurisation, pickling,\nroasting, slicing, smoking, steaming or sterilisation.\nProcessing aid Any substance not consumed as a food by itself, intentionally used in the processing of\nraw materials, foods or their ingredients to fulfil a certain technological purpose during\ntreatment or processing, and which may result in the unintentional but technically\nunavoidable presence of the residues of the substance or its derivatives in the final\nproduct – provided that these residues do not present any health risk and do not have\nany technological effect on the finished product.\nProduct recall Any measures aimed at achieving the removal of an unfit (e. g. unsafe) product from\ncustomers and final consumers.\nProduct security For the purposes of the Global Standard Food Safety, product security refers to\nmeasures to prevent theft or malicious damage to products.\nProduct withdrawal Any measures aimed at achieving the removal of out-of-specification or unfit (e. g.\nunsafe) products from customers, but not from final consumers.\nA withdrawal is normally used to remove product where there is no risk to consumers;\nfor example, where the product has not reached the point of sale to consumers.\nProduction risk zones Zones or areas within the processing and storage facilities that require specified levels\nof hygiene and segregation to reduce the potential for product contamination with\npathogenic micro-organisms. The Standard recognises five production risk zones:\n• high risk\n• high care\n• ambient high care\n• low risk\n• enclosed product areas.\nSites will also have a range of non-product areas which are separate from the processing\nand storage areas. Full details of the risk zones appropriate to the Standard are located in\nAppendix 2 of the Standard.\nProtective clothing Clothing and protective equipment (for example, overalls, hairnets, hats and beard\nsnoods) designed to protect the product from potential contamination by the wearer.\nProvenance The origin or the source of food or raw materials.\nQuality Meeting the customer’s specification and expectation.\nQuantity check/mass\nbalance\nA reconciliation of the amount of incoming raw material against the amount used in the\nresulting finished products, which also takes into account process waste and rework.\nQuantity control A check on the amount of product in the pack. May be related to weight, volume,\nnumber of pieces, size etc.\nQuarantine The status given to any material or product set aside while awaiting confirmation of its\nsuitability for its intended use or sale.\nRaw material Any base material or semi-finished material used by the organisation for the\nmanufacture of a product. Raw materials include food ingredients, packaging materials,\nadditives, processing aids etc.\nReady-to-cook food Food designed by the manufacturer to require cooking or other processing to effectively\neliminate, or reduce to an acceptable level, micro-organisms of concern.\nReady-to-eat food Food intended by the manufacturer for direct human consumption without the need for\na full cook.\nReady-to-heat food Food designed by the manufacturer to be suitable for direct human consumption\nwithout the need for cooking. The heating of the product is intended to make the\nproduct more palatable.\nRecognised laboratory\naccreditation\nLaboratory accreditation schemes that have gained national and international\nacceptance, have been awarded by a competent body, and are recognised by government\nbodies or users of the Standard (e. g. ISO/IEC 17025 or equivalents).\nReference sample Agreed product or components for referral by the manufacturer for production.\nRequirement Those statements comprising a clause with which compliance will allow sites to be\ncertificated.\nRetail brand A trademark, logo, copyright or address of a retailer.\nRetailer A business selling products to the public by retail.\nRetailer-branded\nproducts\nProducts bearing a retailer’s logo, copyright, address or ingredients used to manufacture\nwithin a retailer’s premises. These are products that are legally regarded as the\nresponsibility of the retailer.\nRetained production\nsample\nRepresentative product or components taken from a production run and securely held\nfor future reference.\nRisk The likelihood of occurrence of harm from a hazard.\nRisk analysis A process consisting of three components: risk assessment, risk management and risk\ncommunication.\nRisk assessment The identification, evaluation and estimation of the levels of risk involved in a process to\ndetermine an appropriate control process.\nRoot cause(s) The underlying cause(s) of a problem, which, if adequately addressed, will prevent a\nrecurrence of that problem.\nSampling plan A documented plan defining the number of samples to be selected, the acceptance or\nrejection criteria and the statistical confidence of the result.\nSanitisation Sanitisation means to adequately treat cleaned surfaces by a process that is effective in\ndestroying the vegetative cells of pathogens, and in substantially reducing the numbers\nof other undesirable micro-organisms, but without adversely affecting the product or its\nsafety for the consumer.\nSatellite depot A warehouse/distribution site receiving products only from another site within the same\ncompany.\nSchedule A tabulated statement giving details of actions and/or timings.\nSeasonal production site A site that is opened for a short duration (typically 12 weeks or less) during a 12-month\ncycle; for example, to specifically harvest and process a product.\nDetails of the additional considerations for the management of the audit and\ncertification process for seasonal production sites are given in II, section 2. 7.8.\nSecondary packaging Packaging that is used to collate and transport sales units to the retail environment or\ncustomer (e. g. corrugated case).\nSenior management Person or group of people who direct and control an organisation at the highest level.\nNote that top (senior) management has the power to delegate authority and provide\nresources within the organisation.\nShall Signifies a requirement to comply with the contents of the clause.\nShould Signifies that compliance with the contents of the clause or requirement is expected or\ndesired.\nSite A unit of a company; the entity which is audited and which is the subject of the audit\nreport and certificate.\nSpecification An explicit or detailed description of a material, product or service.\nSpecifier A company or person requesting the product or service.\nStandard, the The Global Standard Food Safety (Issue 9).\nSupplier The person, firm, company or other entity to which a site’s purchase order to supply is\naddressed.\nSuspension Where certification is revoked for a given period, pending remedial action on the part of\nthe company.\nThreat assessment A risk assessment designed to examine site processes for potential product security and\nfood defence issues.\nTraceability Ability to trace and follow raw materials, components and products, through all stages of\nreceipt, production, processing and distribution both forwards and backwards.\nTraded goods/products Traded products are defined as food products that would normally fall within the\nscope of the Standard and are stored at the site’s facilities, but are not manufactured,\nprocessed, reworked, packed or labelled at the site being audited.\nTrend An identified pattern of results.\nUnannounced audit An audit undertaken on a date unknown to the company in advance.\nUncertainty See measurement uncertainty.\nUser The person or organisation who requests information from the company regarding\ncertification.\nUtilities Commodities or services, such as electricity or water, that are provided by a public body.\nValidation Obtaining evidence through the provision of objective evidence that a control or\nmeasure, if properly implemented, is capable of delivering the specified outcome.\nVehicle Any device used for the conveyance of product that is capable of being moved upon\nhighways, waterways or airways. Vehicles can be motorised (e. g. a lorry) or non-motorised\n(e. g. container or rail truck).\nVerification The application of methods, procedures, tests and other evaluations, in addition to\nmonitoring, to determine whether a control or measure is or has been operating as\nintended.\nVulnerability assessment A risk assessment designed to examine processes and supply chains for potential food\nfraud.\nWhere appropriate In relation to a requirement of the Standard, the company will assess the need for\nthe requirement and, where applicable, put in place systems, processes, procedures\nor equipment to meet the requirement. The company shall be mindful of legal\nrequirements, best-practice standards, good manufacturing practice and industry\nguidance, and any other information relating to the manufacture of safe and legal\nproduct.\nWork in progress/work in\nprocess\nPartially manufactured products, intermediates or materials waiting for completion of\nthe manufacturing process.\nWorking day A day on which work is usually or routinely done at the site.\nWorkwear See protective clothing.\nAppendix \nSources of further information\nBRCGS Standards\nA series of globally recognised certification standards for manufacturers, storage and distribution, agents and brokers,\nand retail companies. Available from the BRCGS website.\nBRCGS guidelines\nBRCGS publishes a series of best-practice guidelines on topics including complaint-handling, pest control, internal\nauditing, product recall, traceability and foreign-body detection. These may be purchased from the BRCGS Store or\nviewed online at BRCGS Participate.\nBRCGS Performance Enhancement\nBRCGS Performance Enhancement provides businesses and individuals with BRCGS training and personal\ndevelopment programmes.\nCodex Alimentarius\nThe Codex Alimentarius Commission was created in 1963 by the FAO and WHO to develop food standards,\nguidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme.\nThe downloadable materials include:\n• General Principles of Food Hygiene (CXC 1-1969 as revised), which contains detailed information on HACCP steps\nand principles\n• Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008).\nCodex standards, guidelines and codes of practice can be downloaded from the ‘Codex Texts’ page on the FAO\nwebsite.\nFood and Drug Administration (FDA)\nThe Bad Bug Book provides examples of microbiological sources.\nRASFF\nThe Rapid Alert System for Food and Feed (RASFF), established in 1979, enables the rapid exchange of information\nwhenever a risk to food or feed safety is identified. Members comprise 27 member states, the European Commission,\nthe European Food Safety Authority, Iceland, Liechtenstein, Norway and Switzerland. The 2020 Annual Report is\navailable for download from the Europa website.\nNote: Links and references are made to websites which are intended to help the user with further information.\nBRCGS cannot, however, be responsible for the content or existence of any external website. Also note\nthat legislation and standards change frequently, and a user should confirm for themselves that any references are\ncurrent and still applicable.\nBRCGS\nFloor \n7 Harp Lane\nLondon EC3R 6DP\nT: +44 (0)20 3931 \nE: enquiries@\nTo learn more about the BRCGS certification programme please visit\nTo learn more about the BRCGS online publication service for\ncertificated sites, please visit brcgsparticipate. com\nTo purchase printed copies or PDFs from the full range of BRCGS\npublications please visit /store\nFood\nSafety"}],"statement_of_intent":"The site shall operate a HACCP or food safety plan for the processes for which it is responsible."}];