失效模式与效应分析法用于麻醉药品和精神药品检验样品管理效果分析  

Application Effect of FMEA Method in Sample Management of Narcotic Drugs and Psychotropic Substances Test

作　　者：詹宇杰 任春美 杨娅岚 ZHAN Yujie;REN Chunmei;YANG Yalan(Chongqing Institute for Food and Drug Control·NMPA Key Laboratory for Quality Monitoring of Narcotic Drugs and Psychotropic Substances,Chongqing,China 401121)

机构地区：[1]重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国药业》2024年第9期1-3,共3页China Pharmaceuticals

基　　金：国家药品监督管理局麻醉精神药品质量监测重点实验室开放课题项目[NPKF-2021-03];重庆市科研机构绩效激励引导专项项目[cstc2022jxjl120003]。

摘　　要：目的提升麻醉药品和精神药品(简称麻精药品)检验的风险管理能力。方法采用失效模式与效应分析(FMEA)法分析药品检验中的麻精药品子系统,建立麻精药品子系统的失效模式,分别对其严重度(SEV)、发生频度(OCC)、不易探测度(DET)进行评估,对风险优先数(RPN)高的失效模式进行控制和再评估。结果明确了麻精药品子系统的主要功能,建立了12个失效模式。其中,7个高风险失效模式和5个中风险失效模式均得到了有效控制,RPN降至3~5,达到可接受程度。结论FMEA法能有效提升麻精药品检验的风险管理能力,促进管理体系持续改进。Objective To improve the risk management level in the inspection of anesthetic drugs and psychotropic substances.Methods Failure mode and effect analysis(FMEA)method was used to analyze the anesthetic drugs and psychotropic substances subsystem in the drug inspection,the failure mode of the anesthetic drugs and psychotropic substance subsystem was established,its severity(SEV),occurrence(OCC),and detection(DET)were evaluated,and the failure mode with high-risk priority number(RPN)was controlled and re-evaluated.Results Twelve failure modes were established.Among them,seven high-risk failure modes and five medium-risk failure modes were effectively controlled,and the RPN decreased to 3-5,reaching an acceptable level.Conclusion The application of FMEA method can effectively improve the risk management level of the inspection of anesthetic drugs and psychotropic substances,and promote continuous improvement of the management system.

关 键 词：失效模式和效应分析法 麻醉药品 精神药品 药品检验 风险管理 

分 类 号：R954[医药卫生—药学] R971