Glossary Term
CAPA (Corrective & Preventative Action)
Definition
Corrective and Preventive Action (CAPA) is a systematic process used in quality management systems (QMS) to identify, analyze, and address issues that could affect product quality, safety, or regulatory compliance. CAPA ensures corrective measures are implemented to resolve current issues and preventive actions are taken to avoid recurrence or occurrence of similar problems in the future.
Relevance to the MedTech Industry
CAPA is a cornerstone of quality management in the MedTech industry, ensuring continuous improvement, regulatory compliance, and the safety and efficacy of medical devices. It is essential for addressing product defects, non-conformities, or process deviations while maintaining public trust and adherence to standards like FDA QSR (21 CFR Part 820) or ISO 13485.
Additional Information & Related Terms
Non-Conformance (NC) Issues identified during CAPA processes often start as non-conformance reports.
Risk Management File (ISO 14971) CAPA integrates with risk management to address and mitigate identified risks.
Quality Management System (QMS) CAPA is a core element of QMS frameworks like ISO 13485.
Post-Market Surveillance CAPA helps resolve issues identified during post-market monitoring.