Handling failures, unsafe product, withdrawals and recalls
Plain-language summary
Deal properly with nonconformities and potentially unsafe product - contain it, correct it, fix the cause, and withdraw or recall when needed.
What the clause is really asking
When a control fails, the priority is preventing unsafe product reaching consumers. This clause covers corrections, corrective actions, the handling and disposition of potentially unsafe product (hold, release only on evidence of safety, divert or destroy), and the withdrawal and recall process. It is the safety net for everything the rest of the system is meant to prevent.
What auditors look for
Auditors examine real nonconformities: was product properly held, was the root cause found and fixed, was the disposition decision evidence-based. They scrutinise the recall procedure and look for a recent recall test - timed, reconciled, with roles and external communication exercised.
Typical evidence
Nonconformity and corrective-action records; product hold/release and disposition decisions; root-cause analyses; withdrawal/recall procedure and mock-recall results
How to comply — recommendations
Make sure any potentially unsafe product is held and only released on objective evidence it is safe, never on assumption. Drive genuine root-cause analysis so the same failure does not recur. Keep a tested recall procedure - run a timed mock recall at least annually, reconcile the quantities, and exercise the communication chain to customers and authorities.
Common nonconformities
Potentially unsafe product released without evidence of safety; corrective action treats symptoms not root cause; recall procedure never tested; mock recall not reconciled
Related clauses
ISO 22000 8.3 (traceability), 7.4, 10.1; Codex HACCP
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