Robust corrective and preventive action(CAPA)

摘要

Corrective and preventive action (CAPA) procedure in most organizations is merely used to log problems. These organizations do not implement a robust CAPA process, and as a result they are still struggling today with CAPA. Many firms have been using root cause analysis and corrective action program. A case study on a company which has long recognized that using a good root cause, corrective and preventive action program is crucial to satisfy its customers, has been conducted. This is to help managers to make decisions effectively. Initially CAPA was not properly implemented and not cost-effective for the company. For example, it could not meet the operational management's needs timely, efficiently and effectively. Therefore, the authors had conducted a secondary research and adopted a universal process & quality standards from CMMI Level 5 & ISO 20000 on the top levels of the CAPA procedure in order to improve the CAPA issues.