language-icon Old Web
English
Sign In

Corrective and preventive action

Corrective and preventive action (CAPA, also called corrective action/preventive action or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions that laws or regulations require an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring nonperformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. 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 carry out a work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of nonconformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. Corrective and preventive action (CAPA, also called corrective action/preventive action or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions that laws or regulations require an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring nonperformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. 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 carry out a work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of nonconformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. 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 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, as well as 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). A common misconception is that the purpose of a preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy. Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk avoidance). Corrective and preventive actions both include stages for investigation, action, review, and further action if required. It can be seen that both fit into the PDCA (plan-do-check-act) philosophy as determined by the Deming-Shewhart cycle.

[ "Quality audit", "Quality management system" ]
Parent Topic
Child Topic
    No Parent Topic