食品药品检验系统质量管理岗位分级模式调研与分析  

Investigation and Analysis of Hierarchical Position Mode for Quality Management in Food and Drug Inspection System

作　　者：丁文静[1] 顾颂青[1] 陆明[1] 沈漪[1] 陈祝康[1] 钱维清[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药事》2015年第1期32-35,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:在食品药品检验机构科室内部设立质量管理员,利用质量管理员的在线监督,保证检验科室全部要素始终处于正确、有效的状态,弥补所级质管部门在持续覆盖全面质量管理和监督工作内容方面的局限性,促进实验室质量管理体系的有效运行。方法:通过设计调查表及调查结果的统计,充分了解检验一线对质量管理员的岗位职责需求。结果与结论:明确科室质量管理员的岗位职责、工作重点、检查频次及人员条件,是质量管理岗位分级模式运行方案的基础。质量管理分级模式的试运行,是一次由内而外的质量改变,不仅将检验一线希望重点关注和提升检验质量的想法付诸行动,而且已初显成效。Objective： To set up the position of quality controller in departments in the food and drug inspection institutes, and take advantage of the frontline inspection of quality controller so as to keep all the elements in the inspection institute in a correct and effective status, compensate the limits in the sustained cover of comprehensive quality management and supervision work of quality management departments in institutes, and promote the effective operation of quality management system in laboratory. Methods： The demand for positions of quality controller in frontline was thoroughly investigated by survey and statistical analysis of survey results. Results and Conclusion： Clarification of responsibilities of quality controller, working focus, inspection frequency and personnel conditions are the foundation of the operation plan for the hierarchical position mode for quality management. The pilot operation of the hierarchical position mode for quality management is a quality transformation from inside. The realization of the thoughts of attention on focus areas and improvement of inspection quality into practical actions has achieved preliminary accomplishment.

关 键 词：食品药品 检验系统 岗位分级 质量管理 

分 类 号：R927.1[医药卫生—药学] R95