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What is Corrective action and preventive action
4 Mar 2024

What is Corrective action and preventive action (CAPA)?

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Corrective Action and Preventive Action (CAPA) management is the focal point of an effective quality management system. FDA, ISO, EMEA, and other regulatory bodies expect robust systems for management of CAPAs using a systematic approach.

Corrective Action and Preventive Action (CAPA)¬†are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.

CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring such as would be identified by SPC.

Preventive actions are implemented in response to the identification of potential sources of non-conformity.

To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS).

Clearly identified sources of data which identify problems that will be investigated.

Corrective Action and Preventive Action (CAPA) is a systematic approach used by organizations to identify, investigate, and resolve issues or problems that arise in processes, products, or systems. The goal of CAPA is to address the root causes of problems to prevent their recurrence and improve overall quality.

Here’s a breakdown of the two components:

Corrective Action (CA):

  • Corrective actions are taken in response to non-conformances or deviations from requirements, standards, or expectations.
  • The focus is on addressing existing problems, such as customer complaints, product defects, process failures, or audit findings.
  • The steps involved in corrective action typically include identifying the problem, investigating its root causes, implementing corrective measures to fix the immediate issue, and verifying the effectiveness of the actions taken.

Preventive Action (PA):

  • Preventive actions are proactive measures taken to prevent the occurrence of potential problems or non-conformities before they happen.
  • The aim is to identify and eliminate the root causes of potential issues before they lead to problems.
    Preventive actions may involve risk assessment, process improvements, training, updating procedures, or implementing new technologies or controls to mitigate risks.
  • CAPA is often implemented as part of a larger quality management system (QMS) in organizations, such as those complying with ISO 9001 standards.
  • It emphasizes continual improvement and the pursuit of excellence by systematically addressing issues and preventing their recurrence.

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