CAPAManagement

CAPA management is a systematic component of quality management that governs how organizations investigate and address nonconformities to prevent their recurrence and to prevent potential problems. CAPA stands for corrective action and preventive action. Corrective actions address the root causes of detected problems, while preventive actions aim to remove or mitigate root causes before problems arise.

Typically triggered by a deviation, complaint, audit finding, or process failure, the CAPA process begins with containment and documentation, followed by root cause analysis using methods such as 5 Whys, Ishikawa diagrams, or fault tree analysis. Based on the analysis, a CAPA plan is developed that includes corrective actions to fix the current issue and preventive actions to avert recurrence. Actions may involve design or process changes, supplier notifications, training, or additional controls.

Upon implementation, effectiveness verification is performed to confirm that the actions resolve the issue and reduce risk. Once effectiveness is demonstrated, the CAPA is closed and the results are recorded. Periodic reviews assess whether similar issues could occur elsewhere and whether the CAPA program remains fit for purpose.

CAPA management is a core requirement in many quality systems, including ISO 9001 and ISO 13485, and in regulated industries such as medical devices under FDA 21 CFR Part 820. Organizations typically assign a CAPA owner and a cross-functional team, with senior management oversight and trend analysis to drive continual improvement.

Key performance indicators include CAPA cycle time, rate of completed actions, demonstrated effectiveness, and recurrence rates. Effective CAPA programs reduce risk, improve product quality, and support compliance with regulatory and customer requirements.