Title Page
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Site conducted
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Conducted on
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Auditor Name
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Auditor Signature
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Department Manager / Auditee
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QMS Section Number
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Have all previous non conformances been closed out
Scope
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BRC 5.3 Management of Allergens
M&S 1.8 Management of Allergens, Management of Allergens Guidance and Specific Allergen Operation Standard
BRC - The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination of products and meets legal requirements for labelling in the country of sale.
M&S - Factories have a full understanding of the risks and mitigations required from raw materials, through the factory and to finished product with relation to allergen management including the potential for "mix up" or cross contamination.
To ensure practical application of all procedures, in line with the appropriate BRC and retailer requirements, that all of the records being used in Production are of the correct version number and that relevant staff are appropriately trained. To ensure that the non-conformances raised at the last audit are closed out.
5.3 Allergens
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Do we have a list in place of the legal allergens in the country where products are sold?
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Who is responsible for checking this list and ensuring raw materials used are legal for allergen limits.
5.3.1 Allergen Risk Assessment
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Has a risk assessment of raw materials been carried out?
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Does the risk assessment include a review of raw material specifications?
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Where SAQs are used, do they look for allergen information? To include the allergen status of the raw material, its ingredients and the factory in which it is produced?
5.3.2 Allergen-Containing Materials
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Is there list of allergen containing raw material used and handled at the site?
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Does the list consider raw materials, processing aids, intermediate and finished products and NPD?
5.3.3 Risk Assessment
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Is a documented risk assessment in place to consider routes of contamination?
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Does the risk assessment consider the physical state of the allergenic material (i.e. powder, liquid, particulate)?
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Does the risk assessment consider the identification of potential points of cross-contamination (cross-contact) through the process flow
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Does the risk assessment consider an assessment of the risk of allergen cross-contamination (cross-contact) at each process step?
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Does the risk assessment consider the identification of suitable controls to reduce or eliminate the risk of cross-contamination (cross-contact).
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Are all areas and new pieces of equipment on this list?
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Are Allergen Policies and Procedures in place to cover the handling of raw materials, intermediate and finished products to ensure cross-contamination is avoided? Detail Policy and Procedure references, version numbers and issue dates.
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Are all policies and Procedures used to control allergens detailed within the risk assessment (e.g. cleaning, training, intake etc.)
5.3.4 Allergen Procedure
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Are suitable systems in place AND does the Allergen Procedure detail measures to avoid cross contamination between allergen containing and non-allergen containing materials? To include the following control measures where appropriate: the physical or time segregation while allergen-containing materials are being stored, processed or packed, the use of separate or additional protective overclothing when handling allergenic materials the use of identified, dedicated equipment and utensils for processing, the scheduling of production to reduce changes between products containing an allergen and products not containing the allergen, systems to restrict the movement of airborne dust containing allergenic material, waste handling and spillage controls, restrictions on food brought onto site by staff, visitors and contractors and for catering purposes.
5.3.5 Rework/Reblend
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Are systems in place to ensure that allergens are controlled during rework/reblend operations, to include: the storage of items for reblending and that allergen containing materials are not reblended into raw materials that do not contain allergens. Briefly detail the controls in place
5.3.6 Warning Labels
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Where allergen controls cannot be used, are warning labels used?
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Is a risk assessment in place to show that allergens in raw materials are all fully controlled and that warning labels are not required?
5.3.7 Suitability Claims
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Is a list held of all free-from/or suitability claims?
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Are claims validated? Look at each claim made and check it has been validated.
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Are controls in place for products made where there is a claim?
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Are claims routinely verified and is this documented, if so how validated and where documented?
5.3.8 Allergen Cleaning
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Has allergen cleaning been validated, detail the date of the last validation
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Allergen cleaning should be either identified by colour/type, single use, or effectively cleaned. State which
Quality Manual
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Is the information recorded in the quality manual correct for all clauses of this audit?
M&S Management of allergens
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1.8.1 The supplier has conducted an effective allergen risk assessment which covers all raw materials and supplying sites, including packaging, all the allergens handled on the site across all products (not just those for M&S) and potential cross contamination risks within each manufacturing/ process area.
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1.8.2 The risk assessment is documented and auditable and is carried out as per the process steps listed below.<br>• Step 1 – Listing all allergens on site<br>• Step 2 – Detailed assessment of each M&S product<br>• Step 3 – Allergen improvement plan<br>• Step 4 – Use of alibi labelling decision tree (see Allergen Guidance for detail)<br>• Step 5– Overall factory grading
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1.8.3 The risk assessment is used to determine and implement appropriate mitigations designed to prevent cross contamination or product mix up.
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1.8.4 If allergen cross contamination cannot be mitigated to an acceptable level, then an alibi label disclaimer statement for finished product packaging is agreed with the M&S lead Technologist. In principle, cross contamination is still minimised or avoided where possible despite alibi labelling.
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1.8.5 The allergen risk assessment is reviewed following any changes to product or raw material or as a minimum annually. There must be regular engagement with M&S on the status and changes to the allergen management plan.
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1.8.6 The allergen status of all raw material suppliers is known and documented in each approved raw material specification.
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1.8.7 As a minimum there is an annual review of the raw material supplier allergen status and a mechanism in place to trigger a review if the supplier makes a change or there a complaint involving their raw material.
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1.8.8 If the supplier manufacturers products or raw materials under the following criteria they meet the additional Requirements of the Specific Allergen Operation Manufacturing Standard<br>• No Nut and Sesame Handling<br>• Made without Wheat / Gluten Free Manufacturing<br>• Made without Dairy Manufacturing
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1.8.9 Finished products or raw materials that carry the vegan claim on pack are alibi labelled for risk of dairy and egg cross contamination unless the supplier can demonstrate the meeting the Made without Dairy Requirements and in agreement with their M&S Lead Technologist.
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1.8.10 Prior to any changes in allergen status, the retail packaging must be changed as per M&S labelling guidelines to ensure the customer is clearly informed
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1.8.11 Finished products that are sleeved have the allergens additionally labelled on the top film. Products containing sachets/ pots have the allergens also declared them.
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1.8.12 The packaging verification decision tree, in Appendix 2 of the Allergens Guidance, is completed to determine the method of packaging verification for each packing line used for M&S products.
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1.8.13 Where manual packaging verification is required, appropriate documented systems are in place which ensure the correct version of the correct packaging is applied to M&S products. Procedures must be in place for reacting effectively to any instances of non-conforming product.
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1.8.14 Where automated packaging verification is required, the system uses 2D barcode or a unique mark to identify the correct version of packaging with a broken, auditable record of events for each run. There is regularly tested and robust fail-safe testing in place.
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1.8.15 If the automated packaging verification system becomes disabled, there is a contingency plan to rely on their manual verification systems. If the automatic system isn’t in place for an extended period of time then M&S is informed regarding a corrective action plan.
M&S Management of Allergens Guidance
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Refer to the relevant guidance document and highlight any non-compliance and compliance by recording it directly on the document (also state the version number used)
M&S Specific Allergen Operation Standard
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Refer to the relevant guidance document and highlight any non-compliance and compliance by recording it directly on the document (also state the version number used)
