Guide to Auditing Techniques for the BRC Global Standard for Food Safety Issue 6

Guide to Auditing Techniques for the BRC Global Standard for Food Safety Issue 6
Contents
1.0 Introduction 2.0 Audit Duration 3.0 Auditor/Certification Body Preparation for the Audit 4.0 Composition of the Audit 4.1 Audit Schedule 4.2 The Opening Meeting 4.3 Documentation & GMP 4.4 Questioning Style 4.5 Interviewing Site Staff 4.6 Product Changeovers 4.7 Line Start Up 4.8 Equipment Hygiene Audits 4.9 Traceability and the Vertical Audit 4.10 Mass Balance Audit 4.11 The Closing Meeting 5.0 Non-Conformities 6.0 Auditor Notes Appendices Appendix 1 Example of Documentation Examined During a Vertical Audit Appendix 2 Example Checklist for the Vertical Audit 16 18 2 2 3 4 4 5 6 7 8 8 9 9 10 12 14 14 15

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1. Introduction
A key feature of Issue 6 of the BRC Global Standard for Food Safety is the format and content of the audit that assesses compliance with the requirements of the Standard. The audit is designed to be a complete assessment of the sites compliance and is challenging and fair, and consistent across all manufacturing sites. Audits against the BRC Food Standard shall include specific elements and auditing techniques to fully assess the companys food safety systems. These include: Production staff interviews Product changeover assessment Line start check review In depth hygiene checks of equipment Traceability exercise Vertical audit

3.0 Auditor/Certification Body preparation for the audit

In advance of the audit, the site is requested to supply the Certification Body with background information that enables the Certification Body to assign an appropriate auditor. This allows the auditor to be fully prepared, which maximises the efficiency of the audit. The information requested by the Certification Body typically includes: Basic information relating to the site (e.g. size and staff numbers) A summary of the critical control points (CCPs) The HACCP process flow diagram A simple site plan The management organisational chart The list of products or product groups produced at the site and if the company requested any products to be excluded, the justification for this Typical shift patterns Production schedules, to allow audits to cover relevant processes, for example night-time manufacture or where production processes are not completed every day (e.g. seasonal production) Where the site uses a different Certification Body to the previous audit then the site shall provide a copy of the previous audit report In addition to this information the auditor will also consider: Any issues or working practices highlighted by the previous audit report Any recalls that may be indicative of a non-conformity against a requirement of the Standard along with the corrective actions implemented to address these (manufacturing sites are required to notify their Certification Body within three days of a product recall and this information will therefore be easily available to the auditor) Publicly available information regarding site performance Current industry issues, known hazards or specialist activities/technologies that will form part of the audit and this may include reviews of Codex requirements or legislation in the country of production This information is required to enable the auditor to confirm the scope of the audit and plan effectively. In the event that significant information is not available in advance of the audit, this is likely to increase the audit duration, as the auditor will need to obtain and review the information whilst onsite.

This document highlights and explains some of the auditing techniques which shall be incorporated in the audit and aids awareness of the expectations in terms of content and structure.

2.0 Audit duration

Full details explaining the calculation of the length of the audit are available in the BRC Audit Duration Calculator (F038) which is available on the BRC website. It is important to note this duration refers to the time spent onsite but does not include any preparation in advance of the actual audit (refer to section 3) or post-audit activity such as report writing or the review of corrective actions. The duration of the audit is primarily based on: Number of employees (expressed as full-time equivalent employees per main shift including seasonal workers and based on the maximum number expected in a shift) Size of the manufacturing facility (in square metres) including storage facilities on site The number of HACCP studies included within scope (for the purpose of the audit duration calculation, a HACCP study corresponds to a family of products with similar hazards and similar production technology) The audit calculator allows a 30% variation in the duration of the audit based on previous experience of the site. For example, if the site has a very simple production process then less time might be required. Conversely, if the site has a complex production process, a large number of product lines or poor preparation by the site (e.g. failing to ensure that key documents are easily available) the time required may increase. Any variation must be explained in the audit report.

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4.0 Composition of the audit

A complete and comprehensive onsite audit is composed of a number of different activities:

Whilst the precise order of activities during the audit are likely to be site dependant a majority of audits will follow a similar format consisting of: The opening meeting Review of HACCP documentation (where a site has multiple HACCP plans each will be reviewed) First production area audit it is normal for the auditor to enter production as early in the audit as possible as this provides a clear understanding of the production processes and allows the auditor to gather information that will form the focus of future parts of the audit (refer to section 4.2 below) Review of documentation associated with the first production visit The audit is expected to include multiple visits to production areas rather than allocating one day to production and the second to documentation. Production visits could, for example include: HACCP process flow from goods in through storage, production and packing to dispatch Where a site has multiple production lines, each will be included in the audit Product changeover and line start up (refer to 4.6 & 4.7 for full details on these aspects of the audit) CCP monitoring Site security Pest control assessment Staff interviews

Further details can be found in section 4.3. The proposed schedule will be sent to the site in advance of the audit along with details of expected start/finish times and of all the attendees and their roles (e.g. witness assessors).

4.2 The opening meeting

The audit will commence with an opening meeting of sufficient duration to: Each of these topics is discussed below. Confirm the scope of the audit Confirm the agenda for the audit including production scheduling, arrangements for breaks and meals Explain the audit evaluation process Explain the roles of personnel (both key onsite personnel and those attending the audit (e.g. the auditor(s) and any witness assessors) Establish that the audit is a sampling process Explain the consequences of the potential audit outcomes Confirm confidentiality Answer any questions from the site

4.1 Audit schedule

A structured audit schedule will optimise the use of time during the audit and focus attention on the auditing activities. This schedule needs to contain information to enable an efficient audit process. However, it will need to be sufficiently flexible to account for the onsite activities that can only take place at prescribed times. For example, a product changeover can only occur at the end of one production and prior to the next product starting. The auditor will manage this so the changeover can be witnessed without causing the site undue delays. Similarly, if the auditor identifies evidence that is indicative of a non-conformity, more time may be required to review additional information or documents to verify the exact details of the non-conformity. The audit schedule will list the items to be covered during the audit but would not be expected to include times (other than for the opening meeting). The auditor will therefore discuss the expected scheduling with the site during the opening meeting, so the site can confirm to the auditor when activities are due to take place.

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4.3 Documentation and GMP

Production processes represent the key activities on site. So auditing these areas, therefore, forms a significant proportion of the audit. The expectation is that 50% of the audit will focus on GMP (Good Manufacturing Practice) within the production areas, and auditors will record the time spent for inclusion in the audit report. As an aid to this process, the requirements within the Standard have been colour coded. This shows what would usually be audited as part of the assessment of the production areas and facilities or what would form part of such an audit trail initiated in the factory:

A key element of this process is to cross-check the procedures with actual practice i.e. documents that are viewed can be verified in production. For example: HACCP process flow diagrams viewed as documentation should match the actual activity witnessed by the auditor in the production areas CCPs and critical limits listed in the HACCP documentation will be compared with records and procedures in production Documented metal detector procedures can be compared to the actual test procedure and records on the production line Risk assessments or controls for cross-contamination risks Products on hold according to documentation matched to product in store

4.4 Questioning style

The preferred style of audit questioning can be shown as a question funnel: Production areas include factory production, storage, dispatch, engineering, onsite laboratory facilities, and external areas such as site security. The emphasis of the audit should be on auditing systems in the production areas rather than reading through multiple documents or records in an office. For example, goods receipt could be audited by reading a copy of the policy, but it is preferable to ask a member of staff in the area about the process and how the activities are completed, and look for additional evidence during the audit (e.g. whilst in the receipt and storage areas). BRC audits are process audits and not checklist or tick box exercises. So the auditor will seek to understand the activity in production, challenge the site to demonstrate the reasoning for the activity and verify that the operations, procedures and controls are appropriate and consistently implemented. In this approach, during the GMP audit, information is gathered to test documentation later in the audit and vice versa. For example, information collected during the factory tour that could be used to verify documentation includes: Operator names rather than reviewing a random selection of training records, it is logical for the auditor to view the records of staff that were witnessed completing specific activities or interviewed regarding these activities. The auditor will then know which items of training should have been completed and that the records are relevant to active staff members Raw materials, packaging and finished products in storage and transit areas which can be compared with the agreed audit scope Equipment references to check calibration or cleaning records Raw material, supplier and batch code information for goods receipt and supplier approval documentation checks. The identification of glass or hard plastic items that can be checked on the glass register

The role of the auditor is to effectively establish how the site is: Meeting the objectives outlined in the Statement of Intent (at the top of each section of the Standard) Implementing the requirements of the Standard appropriately and consistently BRC auditors are experienced and knowledgeable in the food categories they audit and are able to ask specific questions relevant to the food type and the processes in operation. The audit is not just about asking if a set process has been followed but about assessing if the process is appropriate, effective and consistently achieved, using a series of probing questions. For example, the audit is not just asking, has the site got a HACCP plan?, but how does the site know the plan is correct?, how have they ensured all the hazards have been considered? and how do they know all the critical limits are set to the correct level?. This is followed by tests to check that the plan is implemented and records available.

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4.5 Interviewing site staff

During the audit the auditor will observe a number of activities and discuss these with the staff involved (during an interview). There are obviously some soft skills involved when interviewing staff especially those who may be unfamiliar with audits. For example, ensuring the interviewee understands the aim of the audit and is put at ease, so the auditor obtains information in a clear, concise format. The key aim of the interview is to ensure that the person understands the procedures they undertake and operates them correctly. It is therefore important to: Ask the right person the right questions Ask specific questions For example, within the goods-in area an approach is to ask the goods-in personnel to explain what they do, before asking more detailed questions to understand how this relates to procedures. E.g. what is recorded, what happens if The interviewing process also allows the auditor to: Understand the effectiveness of staff training do the staff understand their role, the procedures and the importance of the activity? Gain an insight into the company culture. The presence of knowledgeable, properly trained staff is often indicative of a management commitment to the Standard and to product safety

The product changeover is an opportunity to assess: The documented checks used by the site for example, check sheets, records or procedures used as part of the changeover process Lines have been suitably cleaned, including the removal of old packaging. Lines are ready for new production, for example, CCPs and quality parameters are correctly set for the new product e.g. metal detection checks are satisfactorily completed, cookers are set to the correct programme and the correct packaging is on the line The auditor should shadow staff responsible for line changeover or sign off to assess what they consider to be satisfactory.

4.7 Line start up

Similarly to product changeover (section 4.5) the audit shall, wherever possible, include assessment of the line start up. Good practice is for the auditor to audit alongside the individual responsible for the line sign off. This will enable the auditor to understand: What is being checked The acceptance criteria Staff understanding of the relevance of the checks and criteria Inspection of line start up may require slightly earlier start times than normal, which again emphasises the need for good planning and scheduling.

4.6 Product changeovers

Clause 6.1.6 of the Standard requires sites to manage product changeovers to ensure they are completed to an appropriate level of quality and control. If completed incorrectly, this represents a weakness at a key point in the production process, which could result in the production of non-conforming products such as: Incorrect product being packed Incorrect labels being used (a major cause of product withdrawals and recalls in several parts of the world) Insufficient cleaning between products and therefore the potential for microbiological or allergen crosscontamination or quality issues related to product contaminated or tainted with previous products The audit schedule shall include at least one product changeover. (In exceptional circumstances, such as no scheduled product changeovers during the course of the audit, this may not be possible and any exception or omission should be explained in the audit report.) Good practice is to discuss this during the opening meeting to establish when changeovers will take place.

4.8 Equipment hygiene audits

Clause 4.11.2 requires the site to define the limits of acceptable and unacceptable cleaning performance and introduce validated cleaning procedures to meet the required limits. During the course of the audit, equipment shall be opened and inspected to assess whether cleaning has been completed appropriately and in accordance with the sites policies, as well as to assess and challenge the post sanitation checks. It is important to note that the BRC are not expecting production lines to be stopped or production delayed to allow this audit. There are often production lines or equipment that are not operating during the audit or at least not operating throughout the whole audit, which can be viewed by the auditor. Some consideration is needed regarding the timing of this activity as it will probably require suitably qualified staff, such as the engineering team, to open the equipment and ensure that it safe for inspection.

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4.9 Traceability and the vertical audit

The BRC auditor shall undertake both a traceability audit and vertical audit as part of the audit process. There are two distinct aims of the traceability and vertical audit: Traceability is defined as the ability of the site to trace and follow specified batches or lots of food, raw materials (including packaging), from the immediate supplier through all stages, receipt, production, processing and distribution to the next recipient The principle of a vertical audit is that all the activities (inputs, processes and operations) that contributed to the final product are audited for conformity with the sites procedures and the BRC Standard. Therefore, during the vertical audit, all the records associated with the production run of the specified product can be examined, including CCP records, goods-in records, storage procedures, production and dispatch records, etc. As well as being a legislative requirement, traceability is a risk management tool, allowing food businesses and authorities to withdraw or recall products that have been identified as unsafe. A traceability system, therefore, needs to be established at all stages of production, processing and distribution, to identify where the raw materials have been supplied from and to which customers the finished product has been supplied. Traceability details need to be retained in a format that allows access in a timely manner (normally within 4 hours). The Standard expects (requirement 3.9.1) full traceability one up, one down and through the production process. Identification may be achieved by physical labelling of materials/products, by recording systems identifying the allocation of materials to production or mixing areas, or through the use of computerised systems (e.g. bar codes). The level of traceability (beyond the legal requirements) will normally be decided between the company and its customers, but the system used must ensure that all stages of production, processing and distribution can be established. The limitations of any system must be recognised. Bulk deliveries of products such as sugar may be delivered with clear batch identification; however, if they are emptied into a single storage tank that is mixed with earlier deliveries, the reduction in accurate traceability is obvious. If a particular delivery is subsequently identified as being contaminated, this would require disposal of the entire material in the storage tank, and several lot codes of finished product, as the company would not be able to identify the specific batch of finished product that contained the contaminated material. The traceability system needs to include: All the raw materials Primary packaging (i.e. in direct contact with food) Other relevant packaging materials (e.g. printed outer packaging) Processing aids (i.e. substances that are not required to be declared on the product label as an ingredient e.g. clarification agents used in the manufacture of alcoholic beverages) Intermediate or semi-processed products Rework and part-used materials Finished products Any material or product on hold pending investigation

The traceability system shall operate both forwards and backwards and the site should therefore test the system in both directions, i.e. a batch of raw material shall be selected and traced forward to show which finished products contained it, and a finished product shall be selected and traced back to show the raw material batch codes used to produce it. During the BRC audit, the auditor shall select the product, date and/or batch code for the traceability assessment. As a guide the auditor will select a product that was manufactured between one and five months before the audit date. Older products are not selected as systems may have changed during the intervening period. Very recently manufactured products should not be chosen to ensure the traceability archive system operates correctly (information relating to recently produced products may still be available on the production line). It is important that the product selection process is controlled by the auditor. The selection may be based on purchased product or by selection of a production date and selection of a suitable product from the production schedule for that day. The traceability test during the BRC audit will usually be in one direction tracing from the final product back to raw materials (unless there are specific concerns requiring further investigation in both directions). At all stages of the process it should be remembered that there are two distinct aims of the traceability and vertical audit: Verification of the sites traceability systems Verification that the specific batch of product has been manufactured using the correct production controls and that the appropriate records exist to demonstrate this Therefore, the vertical audit part of the exercise aims to provide the auditor with a picture of the sites entire activity on a given day or for a specified production batch. Appendix 1 shows an example of the traceability and vertical audit. In the diagram the left hand column shows the basic process flow for a site producing a cream filled cake. During the traceability and vertical audit, the auditor will assess the sites ability to trace a specific batch of product throughout this manufacturing process. In addition, the vertical audit will examine the records and procedures that demonstrate that the product was manufactured correctly and in accordance with the sites policies and procedures. For example, the goods receipt information for the specific batches of raw materials used, raw material specifications, line sign off records or the metal detector checks. The right hand column in Appendix 1 highlights some of the typical documents that the auditor will review. It is recommended that the documents are viewed in the area where a majority of them are stored, to allow easy and timely access to other records. For example, if the auditor has a concern regarding a record on the specified day of production then they may wish to view additional records for the same activity to establish whether a nonconformity exists.

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4.10 Mass balance audit

A quantity check or mass balance is defined as a reconciliation of the amount of incoming raw material against the amount used in the resulting finished products, taking into account process waste and rework. The Standard states that a quantity check or mass balance should be undertaken in any traceability test to account for the materials used. A mass balance audit is most commonly undertaken using the following process:

For example in a site packaging apples: 20,000 kg of apples were purchased. These were packed over the following three days into unit packs of either four apples in a tray or 10 per bag. The average weight of an apple is known to be 150 g (i.e. 0.15 kg). Production records show that the following quantities were packed: Day 1 10,000 x four-pack & 2,000 x bags Day 2 7,000 x four-pack & 300 x bags Day 3 10,000 x four-pack & 4,400 x bags Waste = 100 kg Waste = 330 kg Waste = 400 kg

However, the batch was finished partway through day 3 and another batch of apples was used to complete the order. So on day 3, only the four-packs were filled with the specific batch we are investigating.

Calculations:

Therefore, the approximate total used was 20,480 kg, compared with an original batch size of 20,000 kg. Some sites (for example those in the produce industry) sometimes employ a more sophisticated mass balance system that considers a period of time rather than a single batch. For example, how many organic apples were purchased in March 2013 compared to how many were incorporated into finished products in the same period. This style of mass balance auditing is compatible with the requirements of the BRC Standard. It is unlikely that the mass balance check will account for all materials with 100% accuracy. However, packed final product should never exceed the quantities of the raw material batches. The company shall justify any discrepancies and understand the nature of the variance. This may be inherent in the product characteristics, for example, the dehydration of fresh ingredients or portion variances.

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The frequency of mass balance testing by the company is dependent on whether there is a product claim relating to provenance, assured or identity preserved status:

6 Auditor notes
Throughout the audit process, the auditor will take notes to record evidence of conformity and any non-conformity. The level of objective evidence contained in these notes should be appropriate, legible and comprehensive so they can be used to review the audit and for confirming the certification decision. Certification Bodies must have a process to ensure that the auditor notes are collated and filed, either hard copy or electronically, so they can be easily retrieved. For example, in the event of a head office audit or customer complaint.

Where the site has a product(s) with a specified origin, provenance or identity preserved claim a mass balance exercise will be conducted during the BRC audit. Where a site manufactures a variety of products with applicable claims the most challenging will generally be selected for the audit.

4.11 The closing meeting

The audit will conclude with a closing meeting of sufficient duration to: Thank the relevant parties Reconfirm the scope of the audit and briefly summarise the activities that have been completed during the audit Review positive findings and improvements compared with the previous audit Repeat the information on any non-conformities identified during the audit and discuss in sufficient detail to ensure the site understands the nature of the non-conformity and is aware of the expectation for corrective action and root cause analysis Highlight the availability of BRC guidelines (e.g. on Root Cause Analysis) and Certification Body documentation available for the site to use Confirm the next steps of the audit process: the expected timings for the site to respond to non-conformities, the production of the audit report, certification decision and entries on to the Directory Encourage the site to provide feedback via the BRC site survey

5 Non-conformities
During the course of the audit, the auditor may identify non-conformities or areas for further investigation. Any such non-conformities must be identified at the time to the site representative accompanying the auditor. This ensures that the potential non-conformity has not resulted from a misunderstanding and helps to avoid conflict at the closing meeting.

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Appendix 1 Example of documentation examined during a vertical audit

In the diagram opposite the left hand column shows a basic process flow for a site producing cream cakes. During the traceability and vertical audit section of the audit, the auditor will assess the sites ability to trace a specific batch of product throughout the manufacturing process. In addition to this, the vertical audit will examine the records and procedures that demonstrate the specific batch of product was manufactured correctly and in accordance with the sites policies and procedures. For example, the goods receipt information for the specific batches of raw materials used, raw material specifications, line sign off record or the metal detector check record. The right hand column in the diagram highlights some of the typical documents that are reviewed:

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Appendix 2 Example checklist for the vertical audit

It is good practice for the auditor to provide the site with a checklist of documents that will be required during the vertical audit; the aim being to minimise potential delays where the site was unaware that specific documents would be required. (The example below is not an exhaustive list as the exact document list will depend on the processes operated by the site.)

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