目的 探讨失效模式与效应分析(FMEA)在药品检验机构仪器设备风险管理中的应用与控制。方法 组建25人团队小组,分析管理评审和外部评审中涉及仪器设备的因素,经头脑风暴法和专家咨询法,评估出34项风险隐患较大的因子。结果 风险优先数(RPN)值排名前5的风险因素分别为:设备未进行期间核查、技术人员经验不足、检验部门与设备管理部门之间的沟通风险、日常使用与维护不到位随意性较大、设备管理意识不高。结论 应用FMEA可识别和处理仪器设备管理过程中的失效模式,及时发现设备管理中存在的高风险项目,更好进行实验室质量控制。
Abstract
OBJECTIVE To investigate the application and control of failure mode and effect analysis (FMEA) in the risk management of food and drug inspection institutions. METHODS A 25-people team was set up and the factors related to equipments in the management review report and external review were analyzed through brainstorming and expert consultation. Thirty-four large risk factors were idendified. RESULTS The top five risk factors in respect to risk priority number(RPN) value were as follows equipment not undergoing period verification,lack of experience, communication risk between inspection department and equipment management department, daily use and maintenance not meeting the requirements,inadequate consciousness of equipment management. CONCLUSION The application of FMEA can identify and deal with the failure mode in the process of equipment management and timely detect high risk projects in the equipment management to achieve better control of quality of laboratories.
关键词
失效模式与效应分析 /
风险因子 /
设备管理 /
风险管理
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Key words
FMEA /
risk factor /
equipment management /
risk management
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中图分类号：
R917
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参考文献
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脚注
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基金
广西重大专项计划资助(桂科重1598005-10);广西青年科学基金资助项目(2017JJB10271)
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