CAJ | 학술논문

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。
목적：재식품약품검험궤구과실내부설립질량관리원，이용질량관리원적재선감독，보증검험과실전부요소시종처우정학、유효적상태，미보소급질관부문재지속복개전면질량관리화감독공작내용방면적국한성，촉진실험실질량관리체계적유효운행。방법：통과설계조사표급조사결과적통계，충분료해검험일선대질량관리원적강위직책수구。결과여결론：명학과실질량관리원적강위직책、공작중점、검사빈차급인원조건，시질량관리강위분급모식운행방안적기출。질량관리분급모식적시운행，시일차유내이외적질량개변，불부장검험일선희망중점관주화제승검험질량적상법부제행동，이차이초현성효。
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:Clariifcation 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.