戴明环循环法在Ⅰ期临床药动学实验室质量管理中的应用  

Application of PDCA Method in Improving Quality System of Phase Ⅰ Labs

作　　者：张现化[1] 黄竞[1] 杨丽[1] 熊歆[1] 刘洋[1] 杨毅恒[1] 

机构地区：[1]北京大学第三医院药剂科,北京100191

出　　处：《中国药学杂志》2016年第4期326-328,共3页Chinese Pharmaceutical Journal

摘　　要：目的本研究结合戴明环(PDCA)法,阐述Ⅰ期实验室质量管理体系持续改进的基本流程。方法结合Ⅰ期实验室的具体情况,分别从体系运行层面以及项目开展层面研究戴明环工具的具体运用。结果戴明环法作为一种管理工具,与ISO17025质量管理体系目标一致,都可以促使Ⅰ期实验室质量管理体系不断完善。结论戴明环循环法在实现Ⅰ期实验室质量目标的过程中,有非常重要的意义,可保障Ⅰ期实验室检测结果的准确、可靠。OBJECTIVE To describe the continuous improvement process of the quality system of phase Ⅰ labs by using（ plan-docheck-action） PDCA method. METHODS Considering the particular characteristics of phase I labs, PDCA cycle was applied to the quality management system as well as the research programs. RESULTS As a quality management tool, PDCA method holds the same goal as ISO 17025 system, that is, to improve the management system of phase Ⅰ labs. CONCLUSION PDCA method is very useful in helping phase Ⅰ labs achieve the quality goals, which, as a result, can ensure the accuracy and reliability of the research resuits.

关 键 词：Ⅰ期实验室 戴明环循环 质量管理 

分 类 号：R933[医药卫生—生药学]