实验室内部技术人员检测能力的科学评估方法  

Scientific Evaluation Method of the Internal Technical Personnel Proficiency of the Laboratory

作　　者：李娜[1,2] 郑学学[1] 谭德讲[2] 王翠杰[1] 李向群 杜颖 LI Na;ZHENG Xuexue;TAN Dejiang;WANG Cuijie;LI Xiangqun;DU Ying(Beijing Minhai Biotechnology Co.,Ltd.,Beijing 102609,China;NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drug,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]北京民海生物科技有限公司,北京102609 [2]国家药品监督管理局化学药品质量研究与评价重点实验室,中国食品药品检定研究院,北京102629

出　　处：《实验室研究与探索》2023年第8期258-264,共7页Research and Exploration In Laboratory

摘　　要：利用实验室能力验证中测量审核和能力比对两种方式,并结合稳健统计分析方法,建立一套科学有效的人员能力评定统计评价模式,同时以实例演示人员能力的评定过程。研究表明,当已知人员评定标准(参考值)时,则以评定标准为准则进行人员能力比对;当未知评定标准时,需要评定员根据已有数据结合统计分析制定出指定值。因指定值可能与真实结果之间有较大偏倚,从而导致人员能力被误判,有评定标准(参考值)的比无评定标准的更为可靠。该模式可用于实验室内部技术人员检测能力的科学评价,进而提升实验室的质量管理水平。This paper uses two methods of measurement audit and proficiency comparison in laboratory proficiency testing,and combines with robust statistical analysis methods,to establish a set of scientific and effective statistical evaluation patterns for personnel proficiency assessment.At the same time,the calculation process of personnel proficiency assessment is demonstrated with examples.Case studies show that when the evaluation specification(reference value)is known,the personnel proficiency comparison is carried out according to the evaluation specification.When the evaluation specification is unknown,the assessor needs to work out the assigned value according to the existing data combined with statistical analysis.Assessment results of personnel with evaluation specification(reference values)are more reliable than those without evaluation specification,because there may be a large bias between the assigned values and the reference results,resulting in misjudgment of personnel proficiency in subsequent judgment.This pattern can provide a scientific evaluation of the testing proficiency of laboratory technicians,so as to improve the quality management level of the laboratory.

关 键 词：人员能力评定 能力验证 稳健统计方法 能力统计量 指定值 

分 类 号：TM132[电气工程—电工理论与新技术]