基于FMEA方法对药品检验过程的风险分析

目的：应用FMEA法对药品检验过程的风险进行分析。方法：通过组建分析团队、分解流程、建立评分标准、识别分析失效模式并分析评估各失效模式的严重程度，估计发生度，确定检测度，计算风险优先数等步骤，量化分析药品检验中100多个风险点。结果：通过分析，发现某药品检验机构RPN大于150的共有9个失效模式，针对不同的失效模式提出不同的预防或纠正措施。结论：FMEA法可用于药品检验过程风险分析和管理，能够有效提高药品检验中的风险管理能力。

Application of FMEA Method in the Risk Analysis of Drug Inspection Process

Objective: The risk of drug inspection process was analyzed by FMEA method. Methods: By using the following steps, such as establishing analysis team, decomposing process, establishing scoring criteria, identifying and analyzing failure modes, analyzing and evaluating the severity of each failure mode, estimating the occurrence degree, determining the detection degree, and calculating the number of risk priority number, more than 100 risk points in drug inspection process were analyzed quantitatively. Results: Through the analysis process, it was found that there were 9 failure modes with RPN score greater than 150 in a drug inspection agency, and that different preventive or corrective measures were proposed for different failure modes. Conclusion: FMEA could be used for risk analysis and management in drug inspection process, and could effectively improve the risk management ability in drug inspection.