【作者】 黄竞； 马瑞生； 张妍； 杨毅恒；

【Author】 Huangjing;Zhangyan;Ma Ruisheng;Yang Yiheng;Department of Pharmacy,Peking University Third Hospital;

【机构】 北京大学第三医院药剂科；

【摘要】 目的:分析和确定我院制剂RYJH软膏粒度检验不合格的根本原因,制定改进措施,促进医院制剂质量的持续改进。方法:利用根本原因分析法(RCA)对事故进行回顾性追踪与分析;通过组建事件RCA工作小组,进行主、客观的资料收集;运用鱼骨图辨识事件发生的近端原因和根本原因。基于根本原因,工作小组从人员、设备、物料、方法 4个方面提出改进措施并在相应环节实施。同时排查了体系中的同类和类似的疏漏与风险。结果:通过RCA发现,从业人员的质量意识不强,缺乏对制剂检验指标适用性核查的意识,制剂原料和制剂成品粒度项检验标准前后不衔接,是本批次制剂粒度项不合格的根本原因。结论:通过对制剂检验不合格的典型案例进行RCA分析,实现了医院制剂质量持续改进。更多还原

【Abstract】 Objective To identify the root causes of the particle size disqualification of hospital preparation RYJH ointment, and develop measures to improve the preparation quality. Method Root Cause Analysis(RCA) was adopted to retrospective track and analysis the event. RCA group was organized to collect subjective and objective data; fish bone diagram tool was used to determine the proximal and root causes. Based on these root causes, 4 levels of improvement measures, including staff, equipments, raw materials and testing standards, were developed and carried out. Improvement measures were developed based on the causes.We also screened the similar risks in our system to avoid the recurrence of events. Results We found that the root causes of the event included the weak quality consciousness of the hospital employees, lacking of awareness to the test item verfication, and the particle size testing standards discrepancies between raw materials and preaparation. Conclusion Based on RCA method to analyze typical cases, we achieved continuous quality improvement of hospital preparations.更多还原