Mastering the CAPA Process: A Clear, Step-by-Step Guide

Corrective and Preventive Action (CAPA) is a systematic enhancement of an organization’s processes designed to identify, eliminate, and prevent the root causes of non-conformities or other undesirable events.

The CAPA framework integrates multiple input streams—ranging from audit findings to post-market surveillance—so disciplined triage is essential. Apply rigorous scrutiny to distinguish isolated defects from systemic failures; reserve CAPA for issues that pose measurable quality, safety, or regulatory risk. Not every deviation warrants a CAPA.

When a systemic issue is confirmed, execute the following CAPA sequence:
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Further reading:

• WHO guidance on corrective and preventive action
• Clinical trial quality management and CAPA effectiveness
• FDA CAPA requirements for medical devices
• Quality improvement frameworks in health care
• Mayo Clinic quality improvement and patient safety