ISO 9001 Corrective and Preventive Action (CAPA)

Corrective and preventive action (CAPA) is a critical component of ISO 9001 quality management system standard. It refers to the systematic process of identifying, investigating, and eliminating the root cause of non-conformities, defects, or problems in products or services, and implementing measures to prevent their recurrence in the future.

Corrective action (CA) is taken to address non-conformities and correct the problem that has already occurred. The objective of CA is to prevent the recurrence of the non-conformity by eliminating its root cause. The process includes identifying the problem, analyzing the root cause, taking corrective actions, and verifying the effectiveness of the actions.

Preventive action (PA), on the other hand, is taken to prevent potential non-conformities or problems from occurring in the first place. The process involves identifying potential problems, analyzing the root cause, and taking preventive actions to eliminate or reduce the likelihood of occurrence.

ISO 9001 requires organizations to establish and maintain a documented CAPA process to continually improve the effectiveness of their quality management system. This process must include the identification of non-conformities, the evaluation of their significance, and the determination of appropriate corrective or preventive actions. It also requires that the effectiveness of these actions be monitored and reviewed to ensure continual improvement.

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