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基于检验过程管理的食品药品检测实验室风险评估和控制 被引量:27

Risk assessment and control of food and drug testing laboratory based on inspection process management
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摘要 食品药品检测在食品药品安全监管方面发挥着重要的技术支撑作用,但在食品检验检测过程中存在着许多影响检验的结果的风险。因此,需要对检测各环节的风险进行识别、分析和评估,建立实验室的质量风险管理体系,控制可能存在的重大风险,以保证食品药品检测实验室的检验质量。本研究以检验过程为主线,围绕整个检验周期,针对食品药品检验的过程,应用检验过程中工作危害的分析方法.逐一识别评估可能发生的风险,并对风险进行定性、量化分析评估和控制,以期达到对食品药品检验检测实验室风险的控制和管理。 Food and drug testing plays an important role in the supervision of food and drug safety, but in the process of food and drug testing, there are many risks that affect the results. Therefore, it is necessary to identify, analyze and evaluate the risks in each process of testing, establish the quality risk management system of laboratory, run risk management through the whole process of testing, and control the possible major risks, to ensure the inspection quality of food and drug testing laboratory. Taking the inspection process as the main line, focusing on the whole inspection cycle, aiming at the process of food and drug inspection, this study applied the analysis method of work hazards in the inspection process to identify and evaluate the possible risks one by one, and carried out qualitative and quantitative analysis, evaluation and control of the risks, so as to achieve the control and management of the risks in the food and drug inspection and testing laboratory.
作者 徐雪梅 续艳丽 周斌 白雯静 王冠杰 XU Xue-Mei;XU Yan-Li;ZHOU Bin;BAI Wen-Jing;WANG Guan-Jie(Lanzhou Institute for Food and Drug Control,Lanzhou 730050,China;National Institutes for Food and Drug Control,Beijing 100050,China)
出处 《食品安全质量检测学报》 CAS 2020年第21期8079-8085,共7页 Journal of Food Safety and Quality
基金 甘肃省药品监督管理局2020年度药品科研项目(2020GSMPA033)。
关键词 食品药品检测实验室 检验过程 过程分析 风险评估 控制 food and drug testing laboratory inspection process process analysis risk assessment control
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