Production risk analysis

Suggestions for implementing good practices, based on the frequent causes of allergen risk management failures:

• Critical element: production. Risks are assessed and risks are managed accordingly, to control the introduction of new allergens into the factory, considering different approaches, for specific hot spots (particles) and for homogeneous sources of allergens.

Where possible, there is separation between preparation areas and production areas. Appropriate critical control points are validated on a regular basis. Example every two years. Finished product is placed on hold, until critical control point verification or validation is completed.

Scheduling:

• The production matrix is documented, to ensure proper production order (sequencing), to minimize migration opportunities.

• An appropriate change management process is in place for the production matrix.

If equipment is shared, an effective and validated dry cleaning-cleaning system is in place (including bags, tanks, containers, reprocessing handling equipment, cleaning equipment, etc.), which takes into account the following aspects:

• There are written procedures for effective cleaning standards that must be fully complied with.

• Individuals responsible for each cleaning activity and task are identified.

• Post-cleaning and pre-operations inspections are documented and signed.

• Inspections are completed by a person other than the person responsible for cleaning (independent inspection).

• Cleaning equipment and utensils are not a source of contamination.

• The cleaning system does not contaminate adjacent lines. Example compressed air is not used.

• Procedures are effective in removing debris from cleaning equipment.

• Cleaning tools and utensils are effective and controlled (they are cleaned or are of specific use).

• There is sufficient cleaning equipment and sufficient time for cleaning.

Semi-finished product:

• Each unit (pallet, drum, bag, etc.) Is identified with product description, declared allergen and production date or other lot identification for full traceability.

• Reprocessed products are handled only as contained (reprocessed product matrix).

• Reprocessed products will only be returned to the line if scheduled.

• All processes are included in the allergen cleaning-dry cl