Corrective and Preventive Action (CAPA) - The Most Important Process of the Quality Management System

OVERVIEW Corrective and preventive action (CAPA) is aprocess of the quality management system which, like other processes, has suppliers (other processes of the QMS), inputs such as corrective action requests and audit findings, a series of clearly defined activities, outputs, and customers. Its deliverables (outputs) include identification of a problem's root causes, corrective or preventive actions to suppress or disable the root causes, and organizational knowledge (ISO 9001:2015 clause 7.1.6) that allows deployment of the lessons learned to related activities. WHY SHOULD YOU ATTEND Corrective and preventive action (CAPA) is likely to be the most important process of any quality management system (QMS) because so many other activities depend on it. These include not just the traditional processes for handling poor quality, customer complaints, and audit findings but also outputs of the management review meeting and stakeholder-identified risks and opportunit...