Corrective and Preventive Actions (CAPA)

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

• Context:
  • It can involve the information collection, information analysis, and product and quality problem identify and investigate , and take appropriate and effective corrective and/or preventive action to prevent their recurrence.
  • …
• See: CAPA Program, CAPA SOP, 21 CFR, 21 CFR 820.100, FDA Quality System Regulation (QSR), FDA Quality System Inspection Technique (QSIT), ISO 9001, Requirement Nonconformance.

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References

2019

• https://www.greenlight.guru/blog/fda-qsit-inspection
  • QUOTE: ... QSR subsystems: A QSIT inspection focuses on 4 major subsystems of the Quality System that establish the basis for what FDA inspectors will review:
    • (1) Management Controls, (2) CAPA, (3) Design Controls and (4) Production and Process Controls. ...
  • The Quality System Inspection Technique, also known as the QSIT method, is a “top-down” approach to an inspection, which means that inspectors will generally begin by asking to see your procedures first, then drilling down further into your quality records. Your records are your proof. They should demonstrate that you are following your written procedures, supported by all ongoing activities. You can expect the inspector to ask for any/all of the following:
    1. To see your procedures.
    2. To interview key personnel within your organization.
    3. To learn more about your processes.
    4. To review the records that back up your processes.

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

• (Schnoll, 2001) ⇒ Les Schnoll. (2001). “Corrective and Preventive Action in Medical Device Manufacturing.” Quality Progress, 34(11).
  • QUOTE: ... One crucial element that was strengthened was the need for a system (or subsystem) to monitor the effectiveness of actions implemented to resolve past or potential nonconforming conditions. This subsystem, known as corrective and preventive action (CAPA), has become of ever-increasing importance and value. The requirements for this subsystem are identified in 21 CFR 820.100. Within its documented quality (and regulatory compliance) system, a medical device manufacturer should have a high-level procedure that describes its CAPA program. The basic sections of this procedure are described in this article. ...

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