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
Upon implementation, effectiveness verification is performed to confirm that the actions resolve the issue and reduce
CAPA management is a core requirement in many quality systems, including ISO 9001 and ISO 13485, and
Key performance indicators include CAPA cycle time, rate of completed actions, demonstrated effectiveness, and recurrence rates.