Definition: Corrective Action Plan
Corrective Action Plan
A list of actions and an associated timetable for implementation to remedy a specific problem.
- 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 non-conformities or other undesirable situations. It is usually a set of actions which are required to be taken and implemented in an organisation 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-confirmation in future.In the Medical Devices and Pharmaceutical industries CAPA is required to be a part of quality management system. Failure to abide to proper CAPA handling is considered as violation of 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 root cause of a non-conformance and failed to design and implement a effective CAPA.CAPA is required to bring about 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), 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).Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring such as would be identified by statistical process control (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).
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