人员重复性比对试验的几点探讨  

Some Suggestions about the Technician Repeatability Test

作　　者：宁锐剑[1] 王培连[1] 李丹荣[1] 

机构地区：[1]广东省医疗器械质量监督检验所,广州510663

出　　处：《中国医疗器械信息》2013年第6期45-49,共5页China Medical Device Information

摘　　要：目的:通过内部比对试验的方法,特别是人员重复性比对试验,对检测人员的技术水平进行评价,满足实验室质量控制的需要。方法:组织人员重复性比对试验,共45人参加了"输入功率测定"的试验项目。运用稳健统计技术结合一般统计方法对结果数据进行了分析,并用综合、分类比较的方法得出综合评价意见。结果:数据准确性方面3人数据离群,80%以上人员可熟练操作相关的检测设备,检测结果在可控范围内。在原始记录的规范及良好操作习惯的养成方面,还有提高的空间。本次试验结果受检测人员学历、稳压电源的影响较小,检测人员临场发挥水平这个因素影响较大。结论:在人员重复性比对试验中应强调综合素质评价的必要性,充分发挥其在内部质量控制中的重要作用。利用好这个技术评价手段,补充外部能力验证或实验室间比对试验的不足,提高技术能力水平,保证实验室质量。Background： Internal profciency test, special y the technician repeatability test, could give technical level assessment for the testing engineers. It also can fulfl the laboratory quality control’s requirement. Method： There were 45 testing engineers participated the technician repeatability test of input power measurement. The Robust and general statistical method were comprehensively used to analyze the test results. The multiple evaluation suggestions were given by comprehensive classifed comparison analysis method. Result： There were 3 results out of the acceptable level. More than 80% engineers were familiar with the operation of the relevant equipments. This result was in the control able range. However, there was space for the good behavior improvement in recording original data and test operation. The less infuence factors included academic background and regulated power supply. The presence-performance played a important role in this test. Conclusions： The comprehensive technician evaluation is necessary in technician repeatability test analysis and important in internal quality control. Using this technical evaluation approach, the technician repeatability test, could complement the lack of external profciency test. It also has positive infuence on improve technical capacity and develop laboratory quality.

关 键 词：能力验证 比对试验 质量控制 实验室管理 医疗器械检测 人才素质 检测技术 内部质量保证 

分 类 号：R197.39[医药卫生—卫生事业管理]