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
Key words
failure mode and effect analysis/narcotic drugs/psychotropic substances/drug inseption/risk management
维普
万方数据