失效模式与效应分析在消毒供应中心包装工作中的应用

Application of failure mode and effect analysis in packaging work in central sterile supply department

目的通过失效模式与效应分析探讨包装工作中行之有效的管理方法,以减少包装质量缺陷的发生。方法选择2011年7月-2011年12月发生的包装质量缺陷为对照组(5316包),2012年1月-2012年6月发生的包装质量缺陷为改进组(6384包),分析包装流程中的失效模式和可能的原因,针对每一项失效模式制定预防措施与改进方法。结果实施FMEA管理后事先风险指数(risk priority number RPN)有明显的下降,RPN值管理前1436分,管理后401分,下降了72.0%,包装质量提高,临床科室对消毒供应中心满意度提高。结论失效模式与效应分析作为一种风险管理工具,能前瞻性地分析和发现包装工作中影响包装质量的各个环节,有效地防止包装缺陷,提高包装质量。

OBJECTIVE To discuss the effective management methods of the packaging work through failure mode and effect analysis so as to reduce the defects of packaging quality. METHODS The packaging quality defects （n= 5316） that occurred from Jul 2011 to Dec 2011 were chosen as the control group, while the packaging quality defects （n=6384） that occurred from Jan 2012 to Jun 2012 were set as the improvement group, then the causes of the detects and the failure modes during the packaging process were analyzed, and the prevention and improvement measures were formulated according to each of the failure modes. RESULTS The risk priority index （RPI） was significantly decreased after the implementation of FMEA; the original RPN was 1436 points, and the later RPN was 401 points, with an decrease by 72M. The packaging quality has been improved, and the satisfaction with the packaging quality of the central sterile supply department has also been raised. CONCLUSION As a risk management tool, the failure mode and effect analysis can prospectively analyze and find out the links that may affect the packaging quality, effectively avoid the packaging defects, and improve the packaging quality.