食品药品检测实验室的风险管理探讨

Discussion on Risk Management of Food and Drug Analytical Laboratories

目的:探讨食品药品检测实验室(简称"实验室")的风险管理。方法:介绍实验室风险的概念,分析实验室风险的类别,提出进行实验室风险管理的方法。结果:实验室的风险主要可分为法律风险、资质风险、技术风险、管理风险、经济风险和来自客户的风险等。应通过风险识别、分析和评估风险的级别、特性及可接受程度,制订出回避风险、减少风险、转移风险和接受风险等不同的处置措施,并采取风险效用评估及信息传播和利用等手段,确保风险处置措施的有效实施。结论:风险管理应贯穿于实验室检测工作的各个环节,必须加强风险管理,实验室才能在当今复杂的食品药品安全监管环境中又好又快地发展。

OBJECTIVE： To discuss the risk management of food and drug analytical laboratories. METHODS： Through the analysis of laboratory risk categories, the methods about risk management of the laboratory were put forward. RESULTS： The risk of laboratory can be divided into the legal, qualification, technical, management, economical and client risks. Through analyzing and evaluating the risk level, characteristics and acceptability, different measures were developed for risk avoidance, risk reduc- tion, risk transformation and risk acceptance. The risk utility evaluation, information dissemination and use, and other means were adopted to ensure the effective implementation of risk management measures. CONCLUSIONS： Risk management exists throughout each link of laboratory detection. The laboratory must strengthen risk management, in order to maintain good and rapid development under present complex food and drug safety supervision environment.