摘要
质量风险管理(QRM)是对产品整个生产周期内的质量风险进行评估、控制、沟通和回顾评审的系统化过程。通过QRM的方法和工具,识别影响产品质量的关键控制点和工序中的高风险环节,可以有效保障产品质量。目前,QRM已被制药行业广泛用于药品生产质量管理规范(GMP)的实施过程中,但是其在采供血机构中应用较少。笔者拟通过对QRM理论的介绍,并且结合QRM在烟台市中心血站的应用实践,对采供血机构实施QRM的前景进行初步探讨,以期为采供血机构中质量管理体系(QMS)的有效运行提供新的思路。
Quality risk management(QRM)is a systematic process of evaluating,controlling,communicating and reviewing the quality risk throughout the entire production cycle of products.By means and tools of QRM methods,identifying the key control points affecting products quality and the high-risk links in the process,products quatily can be effectively guarantee.At present,QRM has been widely used by pharmaceutical manufacturers in the implementation of good manufacturing practice(GMP),but rarely used in blood collection and supply institutions.Based on the study of QRM theory and the application practices in Yantai Central Blood Station,this article investigates the application prospects of implementing QRM in blood collection and supply institutions,with a view to providing a new idea for the effective operation of quality management system(QMS)in blood collection and supply institutions.
作者
宋哲
李星
郭楠
杨建
Song Zhe;Li Xing;Guo Nan;Yang Jian(Yantai Central Blood Station,Yantai 264003,Shandong Province,China)
出处
《国际输血及血液学杂志》
CAS
2020年第3期272-276,共5页
International Journal of Blood Transfusion and Hematology
关键词
质量风险管理
质量管理体系
采供血机构
血液安全
Quality risk management
Quality management system
Blood collection and supply institutions
Blood safety
