module 2 guidance documents states:
2.3.2 Implementation Guidance
What does it mean?
This element links with 2.4.5 Incoming Goods and Services. Before an approved supplier program can be implemented, specifications must be in place for all materials that could impact product safety and quality. This relates to raw materials, ingredients, packaging materials, processing aids, additives and chemicals used within their facility including cleaning compounds. The supplier is required to keep Material Safety Data Sheets (MSDS) and labels for all chemicals that are in use on-site.
What do I have to do?
Specifications must fully describe the materials provided. Safety-related information in raw material and ingredient specifications may include threshold levels for microbiological pathogens, factors affecting microbiological growth such as pH and water activity, threshold levels for potential chemical or physical contaminants and the presence or absence of known allergens. The extent to which these factors need to be included in the specifications will depend on the use of the material and the food safety risk to the finished product.
Quality related detail included in material specifications could include information such as color, grade, nutritional data, size, weight, type of packaging, etc. Quality requirements may be determined by customers.
A register of all raw material and packaging specifications (including finished product labels) must be kept, including a version number and date so that there is proof that specifications are updated as needed. The supplier must ensure that all relevant departments and employees have the most current information.
All raw and packaging materials must be validated to ensure hazards and risks to finished product safety and quality are identified and controlled. Raw and packaging materials should be included in the HACCP
Food Safety Plan (refer 2.4.3) and Food Quality Plan (refer 2.4.4) to ensure that controls are in place to eliminate hazards or reduce them to an acceptable level.
Validation is testing over and above daily monitoring to ensure that established food safety and quality limits are effective, i.e., they achieve the desired results, so that the supplier can have confidence that the product and process are safe. Validation methods will vary depending on the risk to finished product safety. Validation for low risk materials may include certificates of analysis or certificates of conformance, provided by a trusted vendor. For high risk materials, testing and analysis is required for validation, and must be carried out annually (refer 2.5.2). For food-contact packaging material, this may include testing or assurances for potential chemical migration to the food product.
Specifications must also meet the standards set by regulation in the country of origin and the country (ies) of intended destination. This includes maximum residue levels, allergen declarations, and in particular, in-country labelling requirements (refer also 2.4.1).
All current specifications for materials that could impact food safety and quality must be included on a register (list).