基于FMEA的质量风险管理模式在医疗机构外用溶液剂共线生产中的实践  

Practice of Quality Risk Management Mode Based on FMEA in Collinear Production of External Solution Preparations

作　　者：张春歌 倪瑶 柴煜莹 陆振强[1] 韩强[1] 吴憩[1] ZHANG Chunge;NI Yao;CHAI Yuying;LU Zhenqiang;HAN Qiang;WU Qi(The First Affiliated Hospital of Soochow University,Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院,江苏苏州215000

出　　处：《中国药学杂志》2024年第13期1267-1272,共6页Chinese Pharmaceutical Journal

基　　金：苏州市科技局医疗卫生科技创新项目资助(SKJY2021057);江苏省药学会正大天晴医院药学科研基金项目资助(Q202201)。

摘　　要：目的建立基于失效模式与效应分析(failure mode and effect analysis,FMEA)的质量风险管理模式,探讨其在外用溶液剂共线生产中的实施效果。方法对外用溶液剂共线生产的各个环节进行FMEA,根据优先风险数值(risk priority number,RPN)识别出中、高风险的失效模式,整理分析其失效原因,制定并实施改进措施。评估实施控制措施前后的风险等级、清洁验证持续确认效果、比较应用质量风险管理模式前后的设备故障发生率、首次清场合格率、质控达标率及偏差处理频率,评价改进效果。结果外用溶液剂共线生产各环节共识别出21项失效模式,其中高风险4项,中风险11项,低风险6项。通过持续改进污染和交叉污染控制措施,持续开展共线生产风险控制措施的监督和研究、持续进行设备清洁效果确认等措施,中、高风险失效模式均降级为低风险。各项清洁验证指标均控制在限度范围之内。并且,实施共线生产质量风险管理模式后,设备故障发生率及偏差处理频率明显降低,首次清场合格率和质控达标率显著上升,且差异均具有统计学意义(P<0.05)。结论将质量风险管理模式应用于外用溶液剂共线生产的全过程,能显著降低混淆、污染与交叉污染发生的风险,确保外用溶液剂的质量,提高质量管理体系的运行水平。OBJECTIVE To establish the quality risk management mode based on failure mode and effect analysis(FMEA),and explore the application effect in the collinear production of external solution preparations.METHODS FMEA was performed on each link during the whole process of collinear production of external solution preparations.The high and medium risk failure modes were identified according to risk priority number(RPN),and failure causes were analyzed for formulating and implementing improvement measures.The risk level and the continuous verification effect of cleaning verification were evaluated before and after the implementation of control measures,the incidence of equipment failure,the qualified rate of first clearance,the rate of quality control compliance and the frequency of deviation treatment before and after the application of quality risk management mode were compared,and the improvement effect was examined.RESULTS A total of 21 failure modes were identified in the whole process of collinear production,of which 4 were high-risk,11 were medium-risk and 6 were low-risk.The 15 items of medium and high risk failure modes were downgraded to low risk,and all cleaning verification indicators are controlled within the limits by continuous improvement of pollution and cross-contamination control measures,continuous supervision and research of collinear production risk control measures,continuous confirmation of equipment cleaning effect and other measures.Moreover,after the implementation of quality risk management mode,the incidence of equipment failure and the frequency of deviation treatment were reduced markedly,and the qualified rate of the first clearance and the quality control compliance rate were significantly increased,and the differences were statistically significant(P<0.05).CONCLUSION Applying the quality risk management model in the whole process of collinear preparation production can effectively reduce the risk of confusion,contamination and cross contamination,ensure the quality of collinear prepara

关 键 词：共线生产 质量风险管理 失效模式 效应分析 混淆 交叉污染 

分 类 号：R95[医药卫生—药学]