BRCGS Consumer Products Issue 4 Traceability, CAPA, Complaints and Recall (Section 3 Part 2)

By Robert Low, Director, Lead Auditor & BRCGS Approved Trainer

The second half of Section 3 is where Issue 4 tests whether your system can handle things going wrong: specifications and technical files, corrective and preventive action, control of non-conforming materials, traceability, complaint handling, and the management of incidents, withdrawals and recalls. Auditors love this territory because it cannot be staged. Either the trace works or it does not.

Specifications and Non-Conforming Product

Specifications must exist, be adequate, current and formally agreed for materials and finished products, with technical files supporting safety and legality. The chronic finding is the unagreed specification, sent to the customer years ago, never signed, quietly diverged from since. On non-conforming product, the requirements are identification, segregation and authorised disposition, and the audit test is physical: the auditor finds the quarantine area and checks whether what is in it matches the log, and whether anything non-conforming is sitting outside it.

Traceability

The system must trace forwards from raw materials to customers and backwards from finished product to suppliers, including rework, and be tested at a defined frequency. I will not repeat my full traceability test guide here beyond its core: two directions, mass balance, timed, documented chain. Sites that only ever test the easy direction on the tidy line get found out during audits, live, with an audience.

CAPA and Complaints

Corrective and preventive action must investigate, address root cause and prevent recurrence, and complaint handling must record, investigate and trend. These two clauses reward the discipline I bang on about constantly: root cause that goes past operator error, prevention anchored to the cause, and verification afterwards, the CAPAVA approach. Complaint trending is the freebie sites waste: the data is sitting there, and a downward trend you can show the auditor is the cheapest good impression available.

Incidents, Withdrawal and Recall

The incident management procedure must define incident types, responsibilities, communication routes and recovery, and the recall element must be tested at least annually. A trace is not a recall test, as my mock recall article argues: test the decision-making and the phone tree, against the clock.

What Changes Under Issue 5

Issue 5, as per the public draft, sharpens this half considerably: incident management gains a 3 working day certification body notification, traceability targets tighten, and both traceability and CAPA carry Fundamental status. Full detail in the Issue 5 breakdown. Back to the series hub, or on to Section 4.