CAPA (corrective and preventive action)

CAPA is the quality-system process for removing the cause of a nonconformity, or of a potential nonconformity, and for checking that the action worked.

A correction puts the immediate problem right: you relabel a box, you scrap a part, you edit a record. Corrective action asks why the problem happened and changes the process so it is less likely to happen again. Preventive action does the same for a problem that has not occurred yet but that your data says is plausible. ISO 13485:2016 puts corrective action in clause 8.5.2 and preventive action in clause 8.5.3. Both require you to review effectiveness.

Auditors look for a closed loop. The source (audit, complaint, supplier, trend) is identified. The cause is investigated with a method, not a guess. The action has an owner. Someone later checks effectiveness against a criterion chosen in advance. A CAPA closed on the day the training was emailed, with no later check, is a common finding.

In HAVGATE the CAPA record can start from an audit finding and can point at a document change and a training assignment. 5 Whys and Fishbone are the investigation tools on the CAPA page. The software does not decide that every nonconformance needs a CAPA. Your procedure should say how you evaluate the need for action.