医院制剂如意金黄软膏粒度检查不合格的根本原因分析

Root Cause Analysis of the Unqualified Particle Size of Hospital Preparation RYJH Ointment

目的:分析和确定北京大学第三医院制剂如意金黄软膏(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。

Objective： To analyze and determine the root cause of the unqualified particle size of hospital preparation RYJH ointment and to develop measures to promote the quality of the hospital preparation. Methods：Root cause analysis（RCA） was adopted to carry out retrospective tracking and analysis of the event. RCA group was organized to collect subjective and objective data using fish bone diagram tool to determine the proximal and root causes. Based on these root causes, the group suggested 4 levels of improvement measures, including staff, equipments, raw materials and testing standards, and carried out improvement measures based on the causes.The group also screened the similar omissions and risks in the system to avoid the recurrence of events. Results： The root causes of the event were as follows： the weak quality consciousness of the hospital employees, the lack of awareness of verifying applicability of the test indicators, and the discrepancy in particle size testing standards between raw materials and finished preaparation. Conclusion： Continuous improvement of quality of hospital preparations was achieved through RCA of typical cases.