食品药品检测机构仪器设备期间核查管理探讨.PDFVIP

中国药事 2018年3月 第32卷 第3期 335 食品药品检测机构仪器设备期间核查管理探讨 ﹡ ﹡ 王冠杰，毛歆，项新华，田子新，田利 ，张河战 （中国食品药品检定研究院，北京 100050） 摘要 目的： 方法： 总结食品药品检测机构期间核查存在的问题，提出仪器设备期间核查的管理方法。 统计4种常用设备2011-2015年的期间核查数据，对非正常使用情况进行分析，提出从核查方法、核查组 织和核查结果等方面对期间核查进行管理。结果：2011-2015年，仪器设备的正常使用率为89.1% ，根据 设备使用年限及时调整了期间核查周期。结论：期间核查是保证仪器设备状态正常的重要手段。 关键词： 仪器设备；期间核查 R955 A 1002-7777(2018)03-0335-04 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.03.007 Discussion on Intermediate Check of Instruments and Equipments in Food and Drug Testing Organizations ﹡ ﹡ Wang Guanjie, Mao Xin, Xiang Xinhua, Tian Zixin, Tian Li , Zhang Hezhan (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To summarize the intermediate check related problems of instruments and equipment in food and drug testing facilities and to propose a management method of intermediate check of instruments and equipment. Methods: The intermediate check data of four types of common equipment from 2011 to 2015 were analyzed. It was suggested that intermediate check should be managed for the check methods, check organizations and check results based on the analysis of abnormal data. Results: The pass rate of the four types of common equipment from 2011 to 2015 was 89.1%. Intermediate check cycle was adjusted according to the service life of equipment. Conclusion: Intermediate check is an important method to ensure the normal state of instruments and equipment. Keywords: instruments and equipment; intermediate check 1 期间核查的定义及意义 直接关系到科研成果和检测结果的公正性、科学性 仪器设备是食品药品检测中不可或缺的物质 和有效性[1] 。所以，仪器设备必须定期检定/校准， 手段和保