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

张现化, 黄竞, 杨丽, 熊歆, 刘洋, 杨毅恒

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (4) : 326-328.

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中国药学杂志 ›› 2016, Vol. 51 ›› Issue (4) : 326-328. DOI: 10.11669/cpj.2016.04.016
论 著

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

  • 张现化, 黄竞, 杨丽, 熊歆, 刘洋, 杨毅恒*
作者信息 +

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

  • ZHANG Xian-hua, HUANG Jing, YANG Li, XIONG Xin, LIU Yang, YANG Yi-heng*
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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ISO 17025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。

Abstract

OBJECTIVE To describe the continuous improvement process of the quality system of phase I labs by using(plan-do-check-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 results.

关键词

Ⅰ期实验室 / 戴明环循环 / 质量管理

Key words

phase I lab / PDCA cycle / quality management

引用本文

导出引用
张现化, 黄竞, 杨丽, 熊歆, 刘洋, 杨毅恒. 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[J]. 中国药学杂志, 2016, 51(4): 326-328 https://doi.org/10.11669/cpj.2016.04.016
ZHANG Xian-hua, HUANG Jing, YANG Li, XIONG Xin, LIU Yang, YANG Yi-heng. Application of PDCA Method in Improving Quality System of Phase Ⅰ Labs[J]. Chinese Pharmaceutical Journal, 2016, 51(4): 326-328 https://doi.org/10.11669/cpj.2016.04.016
中图分类号: R933   

参考文献

[1] ZHANG L,CHE H,ZHANG X L Establishment and running of the quality management system in hospital pharmaceutical laboratory[J]. Chin Pharm J (中国药学杂志),2011,46(19):1532-1534,
[2] LU C Application of PDCA measurement and testing laboratory management [J]. Market WeeklyTheoretical Research (市场周刊?理论研究),2006,5:87-88V
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