Explanation
CAPA is the route from problem to lasting solution. You record a non-conformity, incident or complaint, repair the immediate damage, investigate the cause, choose corrective and preventive actions, carry them out and check that they work. Only then do you close the file.
Corrective means: removing the cause of something that happened, so it does not come back. Preventive means: preventing a potential problem that has not happened yet. Both need an owner, a deadline and a check. Without those three, a CAPA remains a list of good intentions.
The term is common in, among others, pharma and medical devices, but is widely used. How ISO standards name it exactly differs, the core is the same everywhere. Use a full CAPA file for what is structural: a one-off small error does not always call for a full process.
Example from practice
The same error has occurred three times in a row in order processing. The CAPA records the cause (an unclear work instruction), changes that instruction, instructs the team and checks after two months whether the error has disappeared.
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