Corrective Action and Preventive Action (CAPA) management is the focal point of an effective quality management system. FDA, ISO, EMEA, and other regulatory bodies expect robust systems for management of CAPAs using a systematic approach.
Corrective Action and Preventive Action (CAPA) are 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). It focuses on the systematic investigation of the root causes of non-conformities 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, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring such as would be identified by 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).
Clearly identified sources of data which identify problems that will be investigated.
Root cause analysis to identify the cause of a discrepancy or deviation and suggest corrective actions of a problem which is identified.
A common misconception is that the purpose of 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.
Implementation of corrective and preventive actions is the path towards improvement and effectiveness of Quality Management Systems. Corrective actions is nothing but the action/s based on the problem identification. The problem or a non-conformance can be identified.