Summary
This document is a guide on the Corrective and Preventive Action (CAPA) process, which is crucial for quality and process improvement within a quality system. It details the definitions of corrective and preventive actions, explaining that corrective actions are reactive measures taken to address existing nonconformities, while preventive actions are proactive steps aimed at preventing potential issues. The guide outlines the purpose of the CAPA system, emphasizing its necessity for compliance with ISO standards such as ISO 9001:2008 and ISO 17025, as well as FDA Quality System regulations. It describes the implementation steps required for an effective CAPA system, including defining processes, roles, and responsibilities, and measuring the effectiveness of the CAPA process through various metrics. The objective is to create a robust system that addresses issues and minimizes risks associated with process and product failures.
