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Corrective and Preventive Action (CAPA)

The CAPA process is an important component of a quality management system defined by the guidelines of ISO 13485 and 21 CFR 820. CAPA processes are designed to identify medical device quality defects at their origin and develop ways to correct them. A common CAPA process goes through the following phases: Analysis, Investigation, Identification, Verification, Implementation, Assurance, and Submission. Corrective and preventive actions require a large documentary effort consisting of a multi-step process. The data analyzed from this process provides a sound basis for the continuous optimization of quality. The distinction between corrective and preventive actions is decisive:

  • Corrective actions deal with pre-existing product problems, non-conformances and the targeted elimination of root causes. They are used to prevent the problems from recurring.
  • Preventive measures include measures to analyze potential product problems and non-conformities that have not yet occurred and their elimination. This requires an extensive investigation of possible sources of defects, the development of procedures to prevent future events, the subsequent implementation and control of the efficiency and effectiveness of the procedures.
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