Closing a Corrective Action on Paper Only
A prior audit issued a major nonconformity: incoming inspection was not performed on a critical raw material. The auditee's corrective-action response proposes: revise the receiving procedure to require inspection, retrain two inspectors, and add a checklist. They submit a revised procedure (revision B), training records for two inspectors dated the same day, and a blank checklist template. They request closure. You are the auditor assigned to verify effectiveness. You have 30 minutes and no ability to observe receiving today because no shipments are due. The next shipment arrives in 9 days, after the closure deadline set by the customer.
1. Can you close this corrective action now? Justify your answer and state what you would do.
Read the worked answer
No - this cannot be closed as effective.
What the evidence supports:
- The correction/containment and planned action are documented: procedure revised, training done, checklist created.
- That is evidence of implementation intent, not of effectiveness.
What is missing:
- No evidence the inspection actually occurs. The checklist is blank; no shipment has been received since the change. Effectiveness requires evidence the control works in practice.
- Training records dated the same day as the procedure revision suggest a paper exercise; there is no verification of understanding or application.
- No root-cause analysis is shown for why inspection was skipped - if the cause was workload or a missing form, a new checklist may not address it.
What to do:
- Do not close. Mark the action as implemented, effectiveness pending verification.
- Schedule verification at the next shipment (9 days out), with a defined method: observe receiving, sample completed checklists, confirm nonconforming material handling.
- Communicate the deadline conflict to the audit program manager and customer: the closure date cannot be met without evidence; propose an interim status (containment verified, effectiveness verification scheduled) rather than a false closure.
- If the customer requires closure by a date, escalate - do not sign off to meet a calendar.
2. The auditee argues the procedure revision and training are 'enough' and that requiring observation is unreasonable. How do you justify the verification approach?
Read the worked answer
Justification:
- Corrective action has stages: correction → root cause → action → implementation → effectiveness. Procedure revision and training reach implementation. Effectiveness asks: did the nonconformity stop recurring, and is the control working?
- A blank checklist proves a form exists, not that anyone uses it. A same-day training record proves attendance, not competence. The original failure was that inspection did not happen - the only proof it now happens is observed or recorded inspection on actual material.
- Risk-based reasoning: this was a major nonconformity on a critical raw material. The consequence of a false closure is undetected nonconforming material reaching product. The cost of waiting 9 days is trivial by comparison.
Answering 'unreasonable':
- The requirement is not extra bureaucracy; it is the definition of closure. Closing on implementation alone would repeat the original error in a new form.
- Offer a pragmatic path: verify at the next shipment, define objective acceptance (e.g., 3 consecutive shipments with completed, accurate checklists and observed inspection), and close when met. This is reasonable, bounded, and evidence-based.
- Document the auditee's objection and your rationale in the record so the decision is transparent.