Summary
This document is a CAPA audit checklist for ACME Company, which evaluates the effectiveness of the Corrective and Preventive Action (CAPA) system. The checklist identifies areas of improvement, including role clarity in closures, timely execution of actions despite resource constraints, and the need for more frequent updates to stakeholders. The document outlines the responses to various questions regarding the CAPA process, such as the clarity of documented policies, the definition of responsibilities, and the structured process for issue identification and analysis. It also addresses the development of CAPA plans, implementation processes, effectiveness evaluation, documentation, and regulatory compliance. The findings indicate that while many aspects of the CAPA process are well-defined, there are specific areas requiring attention, such as the assignment of closure responsibilities and the frequency of progress reporting. Action plans have been proposed to address these findings, ensuring continuous improvement in the CAPA system.
