Corrective and preventive action (CAPA or simply corrective action) consists of improving an organization’s processes to eliminate the causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to correct production, documentation, procedures or systems and eliminate recurring nonconformities. Non-compliance is identified after systematic assessment and root cause analysis of non-compliance. Nonconformities may be market complaints or customer complaints or failure of equipment or quality management systems, or misinterpretation of written instructions for carrying out work. Corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved at the actual observation point of non-conformance. It must be systematically applied and monitored for its ability to eliminate further recurrences of such non-conformations. The Eight Discipline Problem Solving Approach, or 8D Framework, can be used as an effective method of forming a CAPA.
Corrective Actions: Actions taken to eliminate the causes of nonconformities or other undesirable situations, so as to prevent recurrence.
Preventive measures: Actions taken to prevent the occurrence of such non-conformities, usually as a result of a risk analysis.
In certain markets and industries, CAPA may be required as part of quality management systems, such as in the US medical device and pharmaceutical industries. In this case, failure to comply with proper CAPA handling is considered a violation of US federal regulations on good manufacturing practices. Consequently, a drug or medical device may be labeled as adulterated or substandard if the company fails to investigate, record and analyze the root cause of a discrepancy and fails to design and implement an effective CAPA.
CAPA is used to improve an organization’s processes and is often adopted to eliminate causes of non-conformance 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 Control (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 effort to prevent recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective actions are implemented in response to customer complaints, unacceptable levels of product nonconformity, problems identified during internal audits as well as adverse or unstable trends in product and process monitoring such as those identified by Statistical Process Control (SPC). Preventive measures are implemented in response to identifying potential sources of nonconformance.
To ensure that corrective and preventive actions are effective, systematic investigation of root causes of failure is important. CAPA is part of the overall Quality Management System (QMS).