Last time we looked at the requirements for HACCP within Issue 6 of the BRC Global Standard for Food Safety. In these notes we begin to look at the Quality Management System requirements. Many aspects that we found in Issue 5 are retained for Issue 6. The notable exception to this is the removal of old clause 3.4 – Customer Focus from this new Issue and inclusion of control of non conforming products (3.8) which was formerly in section 4 of Issue 5.
The internal audit (3.4) requirements have been extended to include process/environment inspections, often carried out as part of a “hygiene audit” check, and require that this check is carried out at a minimum frequency of monthly. This is both an example of the greater GMP focus of Issue 6 and of the appearance of some mandatory procedural frequencies. This is a sensible move forward in ensuring that fabrication, equipment or housekeeping issues can be dealt with in a timely fashion – something that would not really be possible with less frequent inspection frequencies.
Greater emphasis has been placed on Supplier and Raw Material approval and performance monitoring (3.5). This now requires a documented risk assessment of raw materials (126.96.36.199) as the basis for establishing raw material supplier approval and sampling regimes. You will need to consider each raw material or raw material group, the credible hazards that could arise from them and the level of control you can or cannot exercise in eliminating these hazards. Take into account all hazard types – microbial, chemical, physical and allergenic. Think about what control you can exercise e.g. audit of supplier, actual analysis of raw materials, physical inspection, but also what controls you cannot exercise (for instance it is difficult to be sure whether something may have been contaminated by allergens using visual inspection alone). Your approval, testing and inspection criteria should be clearly based on this. Within section 3.5 requirements for suppliers of raw materials (3.5.2) have been separated from the management of suppliers of services (3.5.3) such as analytical services, equipment providers, laundry, agency staff providers, contracted cleaners etc. Since indirect hazards may be an issue from such providers it is important to take them into account. A new section has been included to cover the management of outsourced processing (3.5.4). This covers intermediate parts of a process which may be undertaken at another site e.g. Agglomeration of powders or maturation of cheese and ensures transparency to customers.
Requirements for corrective actions (3.7) and complaint handling (3.10) both now include requirements to ensure the root cause of the Issue is addressed. This has been addressed in previous posts but as a reminder it is a requirement to analyse what may have been behind a non conformance. For instance an overloaded chemical store room can often be the root cause of inappropriate storage of chemicals elsewhere!
The only change to the requirements for Traceability (3.9) is the inclusion of guidelines for the time, 4 hours, to retrieve records. This has been introduced to ensure information can be produced quickly in case of a recall. In practice however auditors will use the traceability exercise to undertake a review of processing records associated with the products chosen for the trace exercise.
Product recall now includes the requirement (3.11.4) to notify the Certification Body within 3 days where a recall is undertaken. This ensures that any incident can be reviewed and customers can have full confidence in certificates Issued.