What is CAPA?
First off, it is important to understand what corrective and preventative actions are, as well as to understand what a correction is. Here are a few definitions to help distinguish between the three terms:
- A correction is any action to eliminate a detected nonconformity.
- A corrective action is any action to eliminate the cause of a detected non-conformity or other undesirable situation.
- A preventative action is any action to eliminate the cause of a potential non-conformity or other undesirable situation.
A great way to think of it is that corrective actions prevent recurrence, while preventative actions prevent occurrence.
CAPA = An Essential Part of Any Quality System
Per 21 CFR Part 820.100(a), companies must establish and maintain procedures for implementing corrective and preventative actions. Compliant ISO 13485 quality systems also require CAPA procedures to be in place.