Corrective Action Preventive Action (CAPA)

CAPA focuses on the systematic investigation of non-conformances (failures and/or deviations) to prevent their recurrence or their potential occurrence.

Corrective Action aims to correct any event of non-conformance that has already occurred and to prevent its re-occurance.
Preventive Action is a proactive measure taken to identify and eliminate potential causes of potential non-conformances.

The FDA requires that all manufacturers find their problems, fix them and prevent their recurrence. The procedure for implementing CAPA includes requirements for:
1. Analyses of all sources of quality data to identify existing and potential causes of non-conformance.
2. Investigation of the causes of non-conformance.
3. Development of corrective actions to correct or prevent the occurrence of non-conformance.
4. Verification and validation to ensure effectiveness of corrective and preventive actions. The effect of these actions should not adversely affect the finished device.
5. Implementation of the changes in the methods or procedures needed to correct and prevent the quality problem identified. These changes are also recorded.
6. Dissemination of the CAPA information to the quality team.
7. Submission of relevant information on quality problem identification and the corrective and preventive action for management review.
8. Documentation of all activities required for the CAPA procedure.

The inputs for the CAPA procedure can be obtained from audits, customer complaints, process improvement projects, nonconformance reports, waste/rejection rates, FMEA, etc. The controls in CAPA to handle these inputs are:
* Design control
* Process control
* Facilities control
* Documentation and change control
* Materials control
All closed CAPA procedures should be audited to verify effectiveness.