CAPA

CAPA (Corrective and Preventive Action) is a regulated quality process for investigating non-conformances, correcting them, and putting preventive measures in place so they do not recur — mandatory under ISO 9001, IATF 16949, ISO 13485, FDA 21 CFR Part 820, and GMP.

In depth

A CAPA system turns a single defect into a structured root-cause investigation, a corrective action that fixes it, and a preventive action that changes the process so it cannot happen again. Each step is evidenced, reviewed, and closed out under audit. Azumuta's CAPA module links each case to the originating non-conformance, the revised work instructions, updated audit checklists, and retraining events in the skill matrix so the whole loop is traceable in one place.

See also

• 8D report
• Non-conformance

Azumuta resources

• Corrective and preventive action solution