A contested finding, a group-wide distribution list and a closed CAPA
You have led a two-day internal audit of the mixing department at a coatings plant. Your draft report contains this finding: 'Document control is inadequate in production.' The evidence: 3 of the 15 work instructions checked at line 2 were at revision 3 while the master list showed revision 4; two operators said revision 4 was never distributed; the change altered the solvent ratio. The production manager accepts the facts but argues the change was editorial, that no nonconforming product resulted, and that the finding must be recorded as an opportunity for improvement rather than a major nonconformity - otherwise, he says, he will take it to the CEO. He also objects that the distribution list includes all site managers in the group and asks you to remove the operators' names and the line number. Separately, you notice that a similar finding from the 2024 audit was closed in the CAPA system with the comment 'instructions redistributed', with no evidence attached and no verification date.
1. Rewrite the finding in proper audit-finding form and justify the classification.
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A well-formed finding has three parts.
Requirement (criteria): internal procedure DOC-04 §5.2 - controlled documents must be available at the current revision and superseded copies withdrawn; ISO 9001:2015 7.5.2, 7.5.3 and 8.5.1 (current documents used where they affect conformity).
Evidence: on 14 May, 3 of 15 work instructions at line 2 (WI-201, WI-207, WI-214) were at revision 3 while master list ML-02 showed revision 4; operators on both shifts stated revision 4 was never issued; the change altered the solvent ratio; the distribution log contains no entry for revision 4.
Conclusion: 'The current revision of three work instructions affecting the solvent ratio was not in use at line 2, and distribution of revision 4 cannot be evidenced. DOC-04 §5.2 and ISO 9001 7.5.3 are not fulfilled.'
Classification: apply the programme's own definitions rather than instinct. If a major is defined as a systemic failure or the recurrence of a previous nonconformity, both tests are met - 3 of 15 across two shifts, and the same issue as 2024. The manager's point that no nonconforming product resulted speaks to consequence and urgency, not to whether a requirement was met.
2. How do you handle the disagreement and the request to change the distribution list and remove names?
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The auditee does not grade the finding. The audit team leader, with the audit client, decides content and conclusions.
- At the closing meeting, walk through the evidence item by item - which instructions, which revisions, the missing distribution entry - and let the manager respond. Disagreements often shrink once the evidence is on the table.
- If he still disagrees, offer to record his position in a response section of the report or in the CAPA record. That is fair and common. Do not trade the classification for peace.
- If he escalates, the audit client decides; the file should show that the finding was not withdrawn under pressure.
Distribution: agreed with the audit client (ISO 19011:2018 8.3) and kept to need-to-know. A group-wide list of site managers may not need the full operational detail; propose the full report to the auditee, the client and process owners, with a summary to the wider group - but the client decides.
Names: nothing requires naming individuals to keep the finding traceable. Identify role and line, redact operator names, and keep 'line 2', which is needed to locate the evidence again. Record the request and the decision.
3. Design the follow-up for this finding and for the 2024 CAPA that was closed without evidence.
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This finding. Raise a corrective action request requiring root cause analysis (why was revision 4 not distributed - is there a change control step, a distribution list, confirmation of receipt?), a named owner, and dates proportionate to risk: 30 days for correction and containment, 90 days for root cause and systemic fix.
Verification of effectiveness. 'Instructions redistributed' verifies implementation, not effectiveness. Define effectiveness evidence in advance: all line 2 work instructions at the current revision on a spot check across both shifts at 60 days; distribution log entries for the last three document changes; operators able to say where the current revision is kept; no recurrence at the next audit. Verification should be performed by an auditor not involved in raising the finding where practicable, and recorded as effective, partially effective (reopen) or not effective.
The 2024 CAPA. Closure with no evidence and no verification date is itself a nonconformity in the corrective action process (ISO 9001 10.2 and the internal CAPA procedure), not merely an untidy record. Raise it as a separate finding, reopen the item, and add CAPA closure discipline to the risk inputs for the next programme and to management review. Otherwise the same finding will be closed again, unevidenced, in two years' time.