Corrective Action

Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization's processes taken to eliminate causes of or other undesirable situations. It is usually a set of actions which are required to be taken and implemented in an organization at levels of manufacturing, documentation, procedures or systems in order to rectify and eliminate the recurrence of nonperformance. Nonperformance is identified after systematic evaluation and analysis of the root cause of the nonperformance. Non-conformance may be a market complaint or customer complaint or a failure of a machinery or a quality management system, or misinterpretation of written instructions to carryout a work. The corrective and preventive action is designed by a team including quality assurance personnel and the personnel involved in the actual observation point of nonconfirmance, and is required to be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation in future.

In certain markets and industries, CAPA may be required as part of the quality management system, such as the Medical Devices and Pharmaceutical industries in the United States. In this case, failure to adhere to proper CAPA handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, a medicine or medical device can be termed as adulterated or substandard if the company has failed to investigate, record and analyse the root-cause of a non-conformance, and failed to design and implement an effective CAPA.

CAPA is used to bring about improvements to an organization's processes, and is often undertaken to eliminate causes of or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), Hazard Analysis and Critical Control Points/Hazard Analysis and Risk-based Preventive Controls (HACCP/HARPC) and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

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