INTERNAL AUDIT CHECKLIST - ALLERGEN CONTROL (AU-001-AD)

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Allergen Control - Risk Assessment CFMSR V2 32.1, 32.2, 32.6; BRC 5.3.1 5.3.2, 5.3.3, QA-008 Allergen Management, WSEP Code of Practice – 2.1, 2.2, 2.3, 2.5, 6.1, 7.1-7.3; SP-003 Approved Supplier Program;

• All sites must conduct allergen risk assessments, and, have a documented allergen control procedure / policy, which includes details of all raw materials, processing aids, product contact gases, processes, and allergens used on site,<br>including any transport used. The assessment shall also record details of physical form e.g. liquid or powder.<br>Where allergens are used or stored, the risk assessment must establish the potential for cross contamination. The risk assessment must include all processes and areas of the site, including product transfers, tools, cleaning chemicals and lubricants used by maintenance.<br>Documented procedures must be in place to ensure the effective management of allergenic materials, to prevent cross contamination of non‐allergen containing products;<br>• Physical or time segregation while allergen containing materials are being stored, processed or packed.<br>• The use of separate or additional protective overclothing when handling allergens.<br>• The use of identified, dedicated equipment and utensils for processing. <br>• Scheduling of allergenic products at the end of the day, or on a dedicated day of the week.<br>• Waste handling and spillage controls.<br>• Restrictions on food brought onto site by staff, visitors and contractors.<br>

  Further information is also available from The Allergen Bureau, including the VITAL® calculator (Voluntary Incidental Trace Allergen Labelling).

• For Woolworths suppliers – a mandatory risk assessment using guidance from the WSEP COP Management of Food Allergens V3, page 6-8 must be compiled.<br>The site must maintain a register of all allergens identified at the site, based on the risk assessment, including raw materials, products, chemicals and processing aids.<br>The risk assessment, conducted by a multi disciplinary team, will be formally reviewed and approved (through documented sign off), by the relevant Woolworths Quality Specialist. <br>Where there are no allergens or only 1 allergen that is in every Woolworths product then only Step 1 of the Risk Assessment needs to be completed and signed off with the relevant Woolworths Quality Specialist. <br>Risk assessment are to be reviewed if new allergens, new products, new processes (or any other changes that may affect the allergen risk assessment) are introduced that could affect the sites’ allergen status. <br>Otherwise, risk assessment and improvement plans are reviewed, as a minimum, annually.

  Refer to the WSEP Code of Practice filed in Quality Assurance National\Standards\Woolworths\Codes of Practice Audit Templates\ Supplier Excellence CoP – MGT of Food Allergens V3 for steps in process.

• Following completion of the Risk Assessment, any issues identified for improvement should be included within an Allergen Improvement Plan, which should be documented and agreed with the relevant Woolworths Quality Specialist.<br>Each Woolworths finished product must be assessed against each allergen handled on site which is not an intentional ingredient.<br>If the assessment indicates that allergen risks cannot be effectively controlled, advisory labelling must be applied to products which are at risk of allergen contamination. <br><br>

  This should first be discussed with Irena Gorsky - National Technical

• The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination by allergens. <br>All suppliers must undergo an evaluation prior to supplying product to Parmalat. Suppliers which meet the defined requirements as set out by Parmalat will achieve approved supplier status.<br>A Risk Assessment is needed for all new Raw Materials. Allergen containing raw materials are rated as high risk.<br>Updated PIF forms are to be maintained for all raw materials, and suppliers identified as using allergenic materials.<br>Transport of raw material must not pose a risk of cross contamination.

  Raw Material Risk Assessments filed in QA National\Approved Suppliers\Raw Materials\Risk Assessments. Raw Material specs and PIFs are available on the Parmalat W: drive (Approved Supplier Spreadsheet). product PIF forms are available from R&D.

• Product specifications must detail all recognised allergens handled on site, including raw materials, ingredients, processing aids, and chemicals. <br>The specification must provide detail of the risk of cross contamination.<br>Verification of the presence of allergens is documented in the Product Information Form ( PIF) for raw materials as well as finished products.<br>Where a claim is made regarding the suitability of a food for allergy sensitivity sufferers, the production process must be validated and the effectiveness of the process is regularly verified to ensure the claim is met.

  Yes

  No

  N/A

• Based on risk assessment, personnel manufacturing allergenic product must be clearly identifiable e.g. through wearing disposable protective clothing / using colour coded equipment. (CFMSR V2 32.20 Personnel - Medium areas)<br>Personnel moving between the production of allergen and non‐allergen containing products and products containing different allergens must change all protective clothing, hairnets, beard snoods, etc. and wash and sanitise their hands prior to moving to the new area. (CFMSR V2 32.13 Protective Clothing Changing - Medium areas). <br>If dedicated lines (for allergens) are not in place, scheduling must take into consideration the allergen content of the different products produced on the line - CFMSR V2 32.15 Segregation (Medium areas)<br>

  Yes

  No

  N/A

Allergen Control - Storage CFMSR V2 32.8 Storage ; QA-008 5.1.1; CFMSR V2 32.8.1 Nut Storage - Lemnos Only. CFMSR V2 32.9 Identification.

• Segregation of allergens must be based on risk assessment, i.e. product in unopened / fully sealed packaging poses less risk than materials that have been opened and re‐sealed.<br>When storing allergenic materials on vertical racking consideration must be given to what is stored vertically above each pallet (e.g. soy over soy, or wheat over wheat and not wheat over soy, etc)<br>Allergenic material must not be stored directly above non-allergens.<br>Where nuts are available onsite and could be a potential allergen to other products that do not contain nuts, the nuts must be secured in locked storage, separate to other products.<br>Based on risk assessment raw materials, work in progress, processing aids, rework, lubricants, chemicals, and finished product containing allergens must be clearly identified during storage and production.<br>

  Yes

  No

  N/A

Allergen Control - Rework CFMSR V2 32.9 Rework; QA-008 5.2.1, BRC 5.3.5 Rework

• Rework that contains allergenic ingredients must be reworked only into products that contain that allergen.<br>Rework shall be treated as an ‘ingredient’ into the new batch, and batch details of the rework product are recorded with the new batch records alongside all other ingredients<br>

  Yes

  No

  N/A

Allergen Control - Cleaning CFMSR V2 32.10, 32.12 Equipment Cleaning; QA-008 6.2.1 - 6.2.3 Validation of Cleaning; BRC 5.3.8; CFMSR V2 32.18 Spillage; BRC 5.3.4; CFMSR V2 32.23 Equipment

• Cleaning between the production of allergen and non‐allergen containing products and products containing different allergens must be thorough.<br>All cleaning processes post manufacture of products containing allergens must be validated. <br>A cleaning validation study must be available and reviewed annually or after any change in the equipment or procedures.<br>Validation must be repeated by testing 6 consecutive production runs to ensure that the cleaning process is effective.<br>Validation is to include, but is not restricted to the areas listed in QA-008-01.<br>Ongoing validation of allergen cleaning procedures is done by using protein swabs for the target allergen.<br>Consideration should also be given to cleaning of the environment.<br>Equipment and utensils used for handling allergenic ingredients must be identifiable and specific for allergen use - single use, effectively cleaned after use, or dedicated to specific ingredients.<br>Cleaning procedures are required for knife blades, scissors, and needles which have been in contact with allergens and other product types (e.g. from one species and / or allergen type to another).<br>Keys used in production (e.g. for accessing lockers, locked rejection boxes, etc.) shall be controlled so they do not pose a hazard.<br>

  Where tests are readily available, the cleaning procedures shall be validated with surface allergen testing kits.

• Any spillage of allergenic material that occurs during production, storage, or distribution must be contained and cleaned up immediately to ensure no risk of cross contamination.

  Yes

  No

  N/A

Allergen Training CFMSR V2 32.19, 32.19.1, 32.22 Allergen Training CFMSR V2 32.20.1 Visitors

• All personnel must receive allergen training as part of the site induction and annual refresher training whether allergens are produced at the site or not.<br>Personnel must be aware of the risks regarding cross contamination and the hazards associated with bringing allergenic material to the site (such as meals, snacks, and vending machine items).<br>Personnel working with allergenic materials shall receive job specific allergen training (e.g. Receiving, dispatch, maintenance, production, purchasing, QA, etc.).<br>For example, job specific training for maintenance personnel may include tool cleaning and changing protective clothing to prevent cross contamination when moving from one area to the next, and the skills to risk assess lubricants for allergen status. <br>Where allergen test kits are used to verify product changeovers and cleaning, training (and refresher training) shall be provided in their correct use.<br>Visitors to the site must be briefed on the site allergen controls that they may impact (e.g. maintenance contractors, materials and samples brought in by suppliers, etc.).<br>

  Yes

  No

  N/A

Allergen Labelling BRC 5.3.6; 5.3.7; CFMSR V2 32.21; 32.21.1 Allergen Labelling

• If cross contamination from an allergen cannot be prevented, a warning should be included on the label.<br>The presence of allergens must be declared in accordance with FSANZ Standard 1.2.3 – Mandatory warning and advisory statements and declarations of the Food Standards Code and the Coles Supermarkets Coles Brand Labelling<br>Guideline.<br>Verification of finished product labels shall be conducted against the product specification, formulation, and all raw materials to ensure that label and ingredient declarations are correct. (Label Review).<br>Verification shall be conducted at minimum annually or whenever changes to specification, formulation or raw materials occur.<br>

  Yes

  No

  N/A