药检机构质量体系运行方面的风险管理研究

Research on Risk Management in the Operation of Quality System of Drug Testing Institutions

目的:基于新版《中华人民共和国药品管理法》,探讨药检机构在质量体系运行方面的风险管理,为进一步加强药检机构风险控制提供参考。方法:利用失效模式影响分析(FMEA)、过失树状分析(FTA)等风险评估工具,结合药检机构业务特点和管理现状,识别评估药检机构质量管理风险,并提出针对性建议。结果与结论:通过FMEA模型,识别出4个高风险、11个中风险以及6个低风险。结合FTA与风险过滤分析,高风险因素主要与机构权威性、检测报告和人员管理相关。基于新法更严、更高的监管要求,药检机构应进一步完善机构管理体系,加强数据真实性以及报告书发放管理,持续加强人员培训及管理,才能保障药检机构的权威性和先进性,保护人民用药安全。

Objective: Based on the latest version of the Drug Administration Law of the People’s Republic of China, the risk management of drug testing institutions in the operation of the quality system was discussed to provide references for further strengthening the risk control of drug testing institutions. Methods: Combined with the current business characteristics and management status of drug testing institutions, FMEA, FTA and other riskassessment tools were used to identify and evaluate the quality management risks of drug testing institutions, and targeted suggestions were put forward. Result and Conclusion: Through the FMEA model, 4 high risk points,11 medium risk points, and 6 low risk points were identified. Combined with FTA analysis and risk filtering analysis, high-risk factors are mainly related to institutional authority, test reports and personnel management.According to the stricter regulatory requirements of the new law, drug testing institutions should further improve the institutional management system, strengthen the data authenticity and report issuance management, and continuously strengthen personnel training and management, so as to ensure the authority and advancement of drug testing institutions and protect the safety of people’s medication.