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Guide To Auditing Techniques
Guide To Auditing Techniques
Guide To Auditing Techniques
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
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.
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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).
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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
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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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.
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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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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.
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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