基于危害分析与关键控制点法的采供血过程质量风险管理模型构建  

Construction of quality risk management model for blood collection and supply process based on hazard analysis and critical control points method

作　　者：宋哲 郭楠 李星 仪明刚 杨建 Song Zhe;Guo Nan;Li Xing;Yi Minggang;Yang Jian(Yantai Central Blood Station,Yantai 264003,Shandong Province,China)

机构地区：[1]烟台市中心血站,烟台264003

出　　处：《国际输血及血液学杂志》2023年第6期547-552,F0003,共7页International Journal of Blood Transfusion and Hematology

基　　金：山东省卫生健康委员会卫生健康政策研究课题项目(WZY202317)。

摘　　要：质量风险管理(QRM)是对产品整个生命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,其有效实施必须借助科学的风险管理工具。危害分析与关键控制点法(HACCP)作为最常用的专用QRM工具之一,已被广泛应用于食品、药品、化学品生产等行业中。但是由于目前国家、行业规范和标准尚未对采供血机构提出实施QRM的要求,该法尚未广泛应用于我国采供血机构的QRM中。笔者拟介绍HACCP原则和HACCP在我国采供血机构QRM中的研究现状,并结合HACCP在烟台市中心血站的应用实践,对HACCP在采供血机构QRM中应用进行探讨,旨在为采供血机构开展基于HACCP的QRM提供参考。Quality risk management(QRM)is a systematic process of evaluating,controlling,communicating,and reviewing quality risks throughout the entire product lifecycle.Its effective implementation must rely on scientific risk management tools.The hazard analysis and critical control points method(HACCP),as one of the most commonly used specialized QRM tools,has been widely applied in industries such as food,medicine,and chemicals.However,since the current national and industry norms and standards have not yet put forward QRM requirements for blood collection and supply institutions,the HACCP has not yet been widely used in the QRM of domestic blood collection and supply institutions.This article intends to introduce the HACCP principles and research status of HACCP in QRM of blood collection and supply institutions in China,and combined with the application practice of HACCP in Yantai Central Blood Station,discuss the application of HACCP QRM of in blood collection and supply institutions,aiming to provide a reference for carrying out QRM based on HACCP.

关 键 词：血液安全 危害分析与关键控制点 血站 质量管理体系 质量风险管理 

分 类 号：R197.6[医药卫生—卫生事业管理]