Closing a Major Without the Evidence
You audited a logistics provider and raised a major nonconformity: temperature-controlled shipments had no documented evidence that data loggers were downloaded and reviewed. The provider submits a corrective action: they have written a new work instruction requiring logger download within 24 hours, retrained 6 staff, and attached a screenshot of one completed logger review as 'evidence of effectiveness.' They ask you to close the finding. The original finding covered 3 months of shipments (approximately 900 consignments). The screenshot is from a single consignment, dated after the corrective action, and shows a review but no evidence the reviewer acted on an out-of-range reading. You have not verified anything on site.
1. Should you close the finding? Justify against corrective-action closure criteria.
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No. Closure requires evidence that the corrective action was implemented and is effective, and this submission fails both tests.
- Implementation: A new work instruction and retraining are actions taken, not proof they are followed. There is no evidence of adoption across the operation.
- Effectiveness: One consignment out of ~900 over the affected period is not a sample - it cannot show the process now works. It is also dated after the fix, so it says nothing about whether the original gap was ever corrected for the 900 affected consignments.
- The screenshot itself is weak: it shows a review happened but not that out-of-range readings were actioned. The original finding was about review and response; a review with no disposition doesn't demonstrate the control.
- No verification: Nothing was checked on site or by record sampling beyond the one example.
A defensible closure needs: evidence of review across a representative sample of consignments post-implementation (spanning the period and shifts), evidence that out-of-range readings were escalated and dispositioned, and some verification activity (on-site or documented record sampling) by the auditor. I would return it as 'not effective - additional evidence required,' specifying exactly what sample and what evidence would support closure.
2. The provider pushes back, saying the fix is 'obviously working' and closure is bureaucratic. How do you respond and what do you require?
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Reframe around their risk, not the paperwork. A temperature excursion on a cold-chain consignment is a product-integrity event; the control exists to catch it. 'Obviously working' is exactly the claim an auditor cannot accept without evidence, because if a logger review misses an excursion, the consequence lands on them and their customers.
What I require, stated concretely so it's actionable:
- A sample of logger reviews across the post-implementation period - enough consignments to cover different routes/shifts, with record IDs.
- At least one example where an out-of-range reading was identified and the disposition recorded, to show the response step works.
- Evidence of how the 900 historical consignments were addressed (retrospective review or documented risk acceptance).
- A verification step by the auditor - either on-site sampling or review of submitted records - before closure.
I would set a target date and agree the sample size up front so closure isn't a moving target. Firm on evidence, flexible on logistics. If they genuinely can't produce it, that itself is information about whether the fix is embedded.