失效模式与效应分析在耗材管理中的应用探讨

Application of Failure Mode and Effect Analysis in Consumables Management

目的以耗材管理流程为重点,运用失效模式与效应分析(Failure Mode and Effect Analysis,FMEA)方法开展风险评估,持续改善耗材管理的运行机制。方法成立FMEA质量改善小组,梳理耗材管理流程中各子流程的关键环节,运用FMEA评估其高风险因素,制定集束化的改善方案。比较此流程改善前后风险系数(Risk Priority Number,RPN)值、耗材管理相关指标的合格率、临床满意度。结果应用FMEA管理后,调研评估、临床科室对耗材引入填报、通知遗漏等失效模式的RPN值显著下降,差异有统计学意义(P<0.001)。管理后耗材准入符合规定率、质量管理指标信息记录完整率、库存耗材质量合格率、条码粘贴规范率、收费准确率、按时回访并记录率、耗材可追溯率、患者满意度等指标的合格率分别为99.0%、95.9%、98.0%、95.4%、96.4%、96.9%、99.5%和98.0%,高于管理前的91.1%、82.1%、93.4%、87.3%、84.9%、88.2%、87.7%和92.0%,差异有统计学意义(P<0.05)。结论FMEA作为风险管理的前瞻性工具,能及时帮助耗材管理者对其识别出的风险问题做出提前干预与控制,减少其业务流程管理的漏洞,防范风险。

Objective To carry out risk assessment and continuously improve the operation mechanism of consumables management by using the failure mode and effect analysis(FMEA)method and focusing on the consumables management process.Methods FMEA quality improvement team was established to sort out the key links of each sub process in the consumables management process,and to evaluate high-risk factors and formulate a cluster improvement plan.The risk priority number(RPN)value,qualification rate of consumables management related indicators,and clinical satisfaction before and after the improvement of this process were compared.Results After the application of FMEA to consumables management,the RPN value of failure modes such as introduction and notification of consumables was significantly decreased(P<0.001).After management,the qualified rates of consumables access compliance rate,quality management index information record integrity rate,inventory consumables quality qualification rate,bar code pasting specification rate,charging accuracy rate,on-time return visit and recording rate,consumables traceability rate and patient satisfaction were 99.0%,95.9%,98.0%,95.4%,96.4%,96.9%,99.5%,and 98.0%respectively,higher than 91.1%,82.1%,93.4%,87.3%,84.9%,88.2%,87.7%,92.0%before management(P<0.05).Conclusion As a forward-looking tool for risk management,FMEA method can timely help consumables managers intervene and control the identified risk in advance,reduce the loopholes in their business process management.