Glossary · Quality & audit
CAPA (corrective and preventive action) meaning
CAPA stands for corrective and preventive action: finding why a quality problem happened and stopping it from recurring. See the steps and a worked example.
What is the full form of CAPA?
CAPA stands for corrective and preventive action. The term is used across pharma, medical devices, food, automotive and contract manufacturing in India, and it appears in customer audits, supplier quality agreements and the pharmaceutical quality system model set out in the ICH Q10 guideline. A CAPA is usually raised after a customer complaint, an audit finding, a deviation, a failed inspection or a temperature excursion.
What is the difference between correction, corrective action and preventive action?
| Step | Question it answers | Example |
|---|---|---|
| Correction | How do we fix the bad product now? | Rework or quarantine the affected pieces |
| Corrective action | Why did it happen, and how do we stop it recurring here? | Replace the worn tool that caused it |
| Preventive action | Where else could the same cause strike? | Add a tool-wear check at every unit using that tool |
Many CAPA files stop at correction. Fixing the batch is necessary, but it is not a CAPA.
What are the steps of a CAPA?
- Record the problem with evidence: what, where, how many, when found.
- Contain affected product so it does not move further.
- Find the root cause using methods such as 5 whys or a fishbone diagram, tested against the evidence.
- Act on the cause, with an owner and a target date.
- Check effectiveness after enough time has passed to show whether the problem came back.
- Close only when the effectiveness check passes.
What does a CAPA look like? A worked example
Illustrative only. QA finds 12 of 240 pieces from one partner unit are 7 mm over the height tolerance. Correction: the 12 pieces are held and reworked. Root cause: the cutting template at that unit has worn at one edge. Corrective action: replace the template and add a template check at each shift start. Preventive action: the same template design is used at two other units, so their templates are checked too. Effectiveness check: the next several lots from all three units show no height failures, and the CAPA is closed.
Why do CAPAs fail?
- Root cause written as "operator error": it rarely is the root cause; ask why the process allowed the error.
- No evidence: without photos, measurements and names, the investigation becomes opinion. Our playbook on closing quality disputes with evidence covers what to keep.
- Closing on action, not result: a CAPA closed the day the action is taken has not been verified.
Evidence is easier when it already exists per piece. In quality inspection software for OEM partners such as Autowhat's AutoQC, failed pieces go back with a reason and the system keeps one page of evidence per barcode, with photos, measurements, photographer, reviewer and dispatch truck, which gives a CAPA investigation facts to start from.
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Where this shows up in our work. AutoQC: One barcode per piece, four measured photos against the spec, QA pass from anywhere. Book a 30-minute working session with an engineer.
Questions
What is the full form of CAPA?
CAPA stands for corrective and preventive action. It is the process of finding the root cause of a quality problem, fixing that cause, and stopping the same problem from happening again or elsewhere.
What is the difference between corrective and preventive action?
Corrective action deals with a problem that has already happened, removing its cause so it does not recur. Preventive action deals with a problem that has not happened yet, removing a potential cause in advance.
When should a CAPA be raised?
Raise a CAPA for significant or repeated problems such as customer complaints, audit findings, failed inspections, deviations and excursions. Your quality system should define the trigger criteria so minor one-off issues are not swamping it.