How to effectively use CAPA to improve Quality Management Systems?

CAPA stands for Corrective Action and Preventive Action. It is usually a set of actions that an organization requires in manufacturing, documentation, procedures, or systems to correct and eliminate recurring non-conformities. Non-conformity is determined after a systematic evaluation and analysis of the root cause of the non-compliance.

Corrective actions include identifying, documenting, and removing the root cause of the nonconformity or problem to prevent the problem from recurring.

Preventive measures are taken to prevent the occurrence of such non-compliances, generally as a result of a risk analysis.

The best way to start with the CAPA system is to go through the following articles:

• ISO 13485 continual improvement: Seven-step process for corrective and preventive actions https://advisera.com/13485academy/knowledgebase/iso-13485-continual-improvement-seven-step-process-for-corrective-and-preventive-actions/
• >What are the consequences of non-compliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/
• Complete guide to corrective action vs. preventive action https://advisera.com/9001academy/blog/2020/06/22/complete-guide-to-corrective-action-vs-preventive-action/
• Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/

After you will study these articles, if you will have any other questions, do not hesitate to contact us.