Corrective and Preventive Action (CAPA) is a cornerstone of quality management systems in regulated manufacturing. When a quality issue occurs — whether caught internally or reported from the field — the CAPA process provides a structured framework for investigation, resolution, and prevention.
A CAPA typically follows these phases: identification of the problem, containment of affected product, root cause investigation (often using tools like 5-Why or fishbone diagrams), implementation of corrective actions, verification that the fix works, and effectiveness monitoring over time to confirm the problem does not recur.
In FDA-regulated environments like medical device manufacturing, the CAPA system is one of the most scrutinized areas during audits. Regulators look for evidence that CAPAs are timely, thorough, and effective — not just documented. A well-structured CAPA system connected to production data accelerates root cause analysis and provides the traceability auditors require.