Closing meeting: disputed major, weak corrective action, pressure to certify
It is the closing meeting of a stage 2 audit. Findings are: one major - undeclared milk protein in a sauce labelled dairy-free, caused by adding cream-based rework to a batch without re-evaluating the allergen statement; and four minors - three missing calibration stickers, internal audit overdue by six weeks, one missing PRP training record, and an out-of-date cleaning schedule. The technical manager disputes the major: the affected batch was quarantined and never shipped, so 'no harm done', and the FSMS caught it, so it should be a minor. For the major the client proposes to retrain two operators and add a signature box to the rework form within ten days, with no root cause analysis. The client also disputes the internal audit finding because the audit was performed, just not documented in the approved template. The certification decision is due in three weeks and the client's largest customer is pressing for the certificate.
1. Justify the grading of the major and respond to the 'no harm done' argument.
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Grade on the nature of the failure and its implications, not on the outcome of one batch. Allergen control here failed at three points: rework was introduced without a hazard re-evaluation, the labelling decision was not linked to the change, and the detection came from a downstream check rather than from control. That is not a documentation slip; it is a breakdown in the control of a hazard that can kill. The fact that quarantine worked shows the correction worked, not that the system worked.
A nonconformity is major where it affects the FSMS's ability to achieve its intended results, where a legal or regulatory requirement is breached (allergen declaration is a legal requirement in most markets), or where there is a food safety risk. It is minor where it is an isolated lapse not indicative of a system failure. Ask: would the same failure recur on another line, another rework batch, next month? If yes, major.
The same logic applies to the disputed minor. An internal audit that exists only in an unofficial template cannot be verified and cannot feed management review; the requirement is to maintain documented information as evidence of the audit programme's implementation. The finding stands. Hear the client's evidence - if they can produce a complete, contemporaneous record in the approved format within the audit, reconsider; if not, record the disagreement and the reason in the report. Findings are the auditor's judgement based on evidence; the client's comment is recorded, not voted on.
2. Evaluate the client's proposed corrective action for the major nonconformity. What would you accept, and what follow-up do you arrange?
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The proposal contains a correction (retraining, new signature box) but no corrective action, because no root cause has been established. Ask the questions root cause analysis should have answered: how was cream-based rework introduced into a dairy-free product - formulation control, rework approval, label generation, or change management (6.3)? Why did the allergen risk assessment not cover rework? Why did the label check not ask the question? Until the cause is known, training two operators addresses the symptom and leaves the system intact.
Acceptable evidence would include: a documented root cause analysis covering the rework approval flow, label/allergen sign-off and change management; the resulting changes (e.g. rework restricted by allergen profile, label release blocked until allergen statement re-verified, hazard analysis updated per 8.5.1.2); the correction for the affected batch (relabelled or destroyed, with records); communication to relevant staff; and verification of effectiveness - for example, an internal audit or a check of several subsequent rework batches and their labels, with results reviewed by management.
Follow-up: majors must be closed before certification. Set a defined deadline in line with the certification body's procedure (commonly up to six months), state whether verification is by document review or on-site, and state the evidence required. If the site's history suggests the change will not hold, verify on site. Confirm the arrangement in the closing meeting and in writing.
3. What do you recommend to the certification decision-maker, and what must the report contain given the dispute and the commercial pressure?
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Recommendation: certification cannot be granted until the major is closed and its corrective action verified; the minors require an acceptable plan with a defined completion date. State this plainly, and state the reason: an open major means the FSMS's ability to meet requirements is not demonstrated. Commercial pressure from the client's customer is irrelevant to the recommendation and should not be mentioned in it - but the decision-maker does need to know the timeline the client faces, because it explains why the client may push for shortcuts.
The report must contain: the scope and any limitations on sampling; each nonconformity with the clause, the objective evidence and the requirement not met; the grading and its rationale; the client's response to each finding, including the disagreements and why they were not accepted; what was accepted instead; the follow-up plan and deadlines; and a clear statement that the certification decision rests with the decision-maker, not the audit team. Also record any interference with the audit, such as requests to downgrade findings.
Guard against two failure modes: softening the major to meet the customer deadline, and refusing to listen to the client's evidence. An auditor who reopens a grading on genuine new evidence is doing the job properly; one who changes it because of a commercial deadline is not.