Corrective and preventive action (CAPA, also called corrective action / preventive action) is a concept within good manufacturing practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions to be undertaken. CAPA is part of the overall quality management system (QMS).
CAPA concepts include:
- Clearly identified sources of data which identify problems that will be investigated.
- Root cause analysis to identify the cause of a discrepancy or deviation and suggest corrective actions to potentially prevent recurrence of a similar problem, or preventive action to ensure that discrepancies do not occur.
- Remedial corrections of a problem which is identified.