强有力的纠正和预防措施(CAPA)

A. Hatami Hardoroudi, Ali Farhang Dareshuri, Haslina Md.Sarkan, M. Nourizadeh
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引用次数: 3

摘要

纠正和预防措施(CAPA)程序在大多数组织中仅仅用于记录问题。这些组织没有实现一个健壮的CAPA过程,因此他们今天仍然在与CAPA斗争。许多公司一直在使用根本原因分析和纠正措施计划。对一家公司进行了案例研究,该公司长期认识到使用良好的根本原因,纠正和预防措施计划对满足客户至关重要。这是为了帮助管理者有效地做出决策。最初,CAPA没有得到适当的实施,对公司来说也没有成本效益。例如,它不能及时、高效、有效地满足运营管理的需求。为此,笔者进行了二次研究,在CAPA程序的顶层采用了CMMI Level 5和ISO 20000的通用过程和质量标准,以改进CAPA问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Robust corrective and preventive action(CAPA)
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.
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