NCR, corrective action, and preventive action
Three terms that show up constantly on the CQE exam and in real quality systems—and are routinely confused.
| Term | Trigger | Goal |
|---|---|---|
| Nonconformance report (NCR) | A defect or out-of-spec condition already exists | Document and disposition the specific affected item (use as-is, rework, scrap, return) |
| Corrective action (CA) | A nonconformance has occurred | Find and eliminate the root cause so the same problem does not recur |
| Preventive action (PA) | A potential problem has been identified—nothing has happened yet | Remove the cause before a nonconformance occurs |
The NCR handles the symptom. Corrective action handles the disease. Preventive action is a vaccine.
Under ISO 9001:2015 (and most later standards), the standalone “preventive action” clause was absorbed into risk-based thinking. PA is now woven through planning and risk management rather than triggered by a form. The CQE exam still tests the classic three-way distinction.
Worked example
A batch of capsules is found to contain 5% broken units at final inspection. Walk through the three responses:
- NCR: Tag the batch, hold it from shipping, decide disposition (100% sort, rework, or reject lot). Document quantity and description of defect.
- Corrective action: Conduct a root-cause analysis (5 Whys, fishbone). Find that the filling-machine agitator speed was set too high after a maintenance reset. Update the maintenance SOP to include agitator speed verification. Verify the fix with a trial batch. Close the CA when zero breakage is confirmed over three subsequent runs.
- Preventive action (proactive, separate event): A risk review of a second filling machine—which has not produced breakage—shows it uses the same maintenance reset. Add the same agitator check to its SOP before a problem ever occurs.
Practice problem
An audit finds that three purchase orders in the last quarter were issued without required supplier-qualification records. The corrective action team fixes those three POs. Has corrective action been completed?
Show answer
No. Fixing the three specific POs is immediate containment (like an NCR disposition). Corrective action is complete only when the root cause is identified (e.g., the approval workflow does not check for qualification records) and eliminated (e.g., a system block added so POs cannot be issued without the record). Verify with a follow-up audit after the fix.
Common exam traps
- Containment is not corrective action. Sorting, quarantining, or re-inspecting a bad lot fixes the symptom. Root-cause elimination is corrective action.
- Corrective action requires verification. The action is not complete until you have evidence the root cause is gone and the problem has not recurred.
- Preventive action is triggered by potential risk, not an existing problem. If a defect already happened, it is corrective action territory.
- CAPA stands for Corrective And Preventive Action. Some quality systems use one form for both, but they remain conceptually distinct.
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