Quality & safety

CAPA (Corrective and Preventive Action)

The discipline of turning a finding into a fix that sticks. A correction repairs the instance; a corrective action eliminates the root cause; a preventive action stops it happening elsewhere. Closing a CAPA with a correction is the classic counterfeit.

The device failed, so you replace the device — that is a correction, and it is necessary and insufficient. The corrective action asks why devices like this fail here: the procurement specification, a maintenance gap, the environment. The preventive action takes that answer to the six identical devices at the sister site.

And the step everybody skips is the last one: effectiveness verification. A scheduled check, after enough time has passed for the answer to mean something, that the problem actually stopped. An action closed at "done" is not a control; it is an assertion.

See also