Corrective and preventive action also called CAPA are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards.

Systematic Investigation

It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Single System

The FDA considers the CAPA system a ‘single’ system.

The process requires the following:

1. Analysis – a thorough analysis of the issue
2. Investigation – a determination of the root cause(s)
3. Actions to correct and prevent – fix the problems and ensure they don’t happen again
4. Verification or validation of effectiveness of the actions – did the changes have their desired effect (more than once) and did they have any adverse effects?
5. Procedural changes – the means to institutionalize the changes
6. Communicating the changes to those directly involved – making sure everyone is aware of the changes, understands the changes, and implements the changes
7. Review at the management level – make management aware of and ensure they are on board with all the activities
8. Document everything – provide that “audit trail” of everything done