REAV

Glossary

CAPA

Corrective and Preventive Action

The formal handling of a problem: contain it, find why it happened, fix the cause, and verify the fix worked.

A corrective action is not the repair of the faulty item. Replacing a bad screen is correction; finding out why that batch of screens failed incoming inspection and changing what happens at goods-in is corrective action. ISO 9001 puts the requirement in clause 10.2, and it asks for the cause to be addressed, not the symptom.

The term pairs corrective with preventive, but the pairing is now partly historical. ISO 9001:2015 removed preventive action as a separate requirement and folded that intent into risk-based thinking in clause 6.1. Regulated sectors such as medical devices and pharmaceuticals kept the full CAPA vocabulary, which is why it still circulates widely.

A CAPA record is judged on four things: whether the problem statement is specific, whether the cause analysis goes past the first plausible answer, whether the action changes something structural, and whether effectiveness was verified afterwards. An action closed without verification is an open problem with a closed ticket.

In refurbishment the same few causes recur - a procedure that no longer matches the model, a part reference that is wrong, a test step that is easy to skip - so the value of a CAPA register is less about any single record and more about seeing which cause keeps coming back.

An improvement register that keeps the causes visible

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