失效模式和影响分析在医院制剂复方硼砂溶液偏差事件中的应用

Application of FMEA on deviation event of hospital preparation compound borax solution

目的探讨风险管理技术——失效模式和影响分析(FMEA)方法在分析和干预医院制剂配制过程中发生的偏差事件的可行性。方法运用FMEA系统地分析导致医院制剂复方硼砂溶液中微生物限度超标偏差事件的可能因素,并对此拟出对策依据。结果通过FMEA方法采取相应风险降低措施,复方硼砂溶液配制过程中发生的偏差得到有效控制。结论 FMEA方法适用于分析和干预制剂配制过程中发生的偏差事件。

Objective To discuss the feasibility of quality risk management technology-failure mode effect analysis(FMEA) method in the analysis and intervention of deviation event during hospital preparation process.Methods The possible reasons of microbial limit overproof event in hospital preparation compound borax solution were systematically analyzed by using FMEA method to give corresponding countermeasures.Results Corresponding risk reduction measures were adopted by using FMEA method,and the deviation in compound borax solution preparation process was effectively controlled.Conclusions The FMEA method applies to the analysis and intervention of deviation event during hospital preparation process.