Corrective and Preventive Actions (CAPA)

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A Corrective and Preventive Actions (CAPA) is a continuous improvement program to improve product requirement conformance.



References

2019

2017

  • "Corrective and Preventive Actions (CAPA)]." FDA Publication.
    • QUOTE: ... The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem. ...
    • Corrective action taken to address an existing product or quality problem should include action to:

      Correct the existing product nonconformity or quality problems and; Prevent the recurrence of the problem.

2021

  • https://www.compliancequest.com/capa-corrective-and-preventive-action/
    • QUOTE: CAPA or Corrective And Preventive Action is a methodological strategy for mitigating risks and improving processes, identifying the sources of actual or potential issues and their root causes, planning solutions for those problems, and documenting the solution so that similar issues don’t occur in the future. CAPA is a way to improve the company’s processes by taking a series of actions that eliminate the recurring events and causes of non-conformities. The major intent of a CAPA system is to focus on the root causes of particular problems and risks so that there won’t be a need for either corrective action or preventive action in the future.

2001