基于FMECA的国家药品抽检检验流程风险因素分析及对策研究  

FEMCA Approach to Evaluate Risk Factors on Analytical Procedures of National Drug Sampling and Testing Activites with Mitigation Strategies Research

作　　者：郗昊 李睿 于健东[1] 朱炯[1] 王翀[1] 胡增峣 Xi Hao;Li Rui;Yu Jiandong;Zhu Jiong;Wang Chong;Hu Zengyao(National Institute of Food and Drug Control,Technology Supervision Center,Beijing 102629,China;Jiangsu Institute for Food and Drug Supervision and Inspection,Nanjing 210009,China;National Medical Products Administration,Beijing 100037,China)

机构地区：[1]中国食品药品检定研究院技术监督中心,北京102629 [2]江苏省食品药品监督检验研究院,南京210009 [3]国家药品监督管理局,北京100037

出　　处：《中国药事》2023年第1期1-17,共17页Chinese Pharmaceutical Affairs

摘　　要：目的:分析国家药品抽检检验流程主要风险因素,为优化检验过程管理提供参考。方法:基于失效模式影响及危害性分析法(FMECA)风险评估模型研究思路,对2011-2020年征集的检验流程潜在风险因子进行归类研判,结合法规要求与日常管理经验总结失效模式74个。综合风险严重程度(S)、发生度(O)和漏辨度(D)评价失效模式、计算平均风险优先数(RPN),针对高风险失效模式制定潜在应对策略。结果:经风险排序分级,发现高风险失效模式28项(RPN≥30),涉及全部7类管理工作,其中试剂管理(A)、人员管理(H)、检验报告书签发管理(C)中的高风险失效模式个数与占比相对较高,人员数量无法完全满足工作量要求(H3)被认为综合风险最大(RPN=65.9)。结论:FMECA可用于国家药品抽检检验流程风险因素的分析与评价,对完善检验流程管理和提高风险处置能力有一定的参考和促进作用。Objective: To provide reference for optimizing testing process management, main risk factors of national drug sampling inspection process were analyzed. Methods: The potential risk factors of the inspection process collected from 2011 to 2020 were classifi ed and evaluated, and 74 failure modes weresummarized based on regulatory requirements and daily management experience, risk severity(S), occurrence(O) and leakage discrimination(D) were integrated to evaluate failure modes, calculate average Risk Priority Number(RPN),potential mitigation strategies to high-risk failure modes were made. Results: By risk rank-order, 28 high-risk failure modes were found with RPN≥30, which were related with all 7 types of management work. The highrisk failure mode in management of reagent(A), people management(H), inspection report issuance management(C) were relatively high in quantity and proportion. Moreover, the numbers of qualifi ed laboratory technicians could not meet the workload requirements(H3) were considered with the highest combined risk(RPN=65.9).Conclusion: FMECA may be an optimism approach in the analysis and evaluation of risk factors in the testing process of National Sampling and Testing Activites, and may had a certain reference and promotion role in improving the capacity of inspection process management and risk disposal.

关 键 词：失效模式影响及危害性分析法 风险因素 排序分级 检验流程管理 应对策略 

分 类 号：R955[医药卫生—药学]