药品质量安全问题备受关注，而药品质量安全是否能得到保障，除了取决于该药品的研制技术水平，更重要的还是取决于药品冷链物流的水平。区别于其他普通的冷链物品，冷链药品对于时间、温度的要求极高，储运时间的长短以及储运过程中温度过高过低都会影响到药品的质量，因此冷链药品在物流方面的风险性极大，特别是在冷链药品的运输和配送等方面，风险性极高。以A公司为研究对象，采用危害分析与关键控制点系统(HACCP)和失效模式与影响分析(FMEA)这2种风险管理工具，构建相应的风险管理模型，通过该模型对A公司药品冷链物流配送进行定性的风险因素识别，找出关键风险点；然后对识别出的关键风险点进行定量评估；最终，根据评估结果所得出的风险大小等级，提出相应的、科学合理的风险控制措施。

The quality and safety of drugs are of great concern, and whether the quality and safety of drugs can be guaranteed depends not only on the level of the development technology of the drugs, but more importantly, on the level of cold chain logistics of drugs.Unlike other common cold chain items, cold chain drugs have extremely high requirements on time and temperature.The length of storage and transportation time as well as excessively high or low temperature during storage and transportation may affect the quality of drugs, so the risk of cold chain logistics of drugs, especially in transportation and distribution, is extremely high.The article takes Company A as the research object, and applies two risk management tools, namely Hazard Analysis and Critical Control Point(HACCP) Failure Mode and Effects Analysis(FMEA),to build a corresponding risk management model.Firstly, the model is used to qualitatively identify the risk factors and find out the key risk points in the cold chain logistics of Company A;secondly, the identified key risk points are assessed quantitatively.Based on the risk level derived from the assessment results, corresponding scientific and reasonable risk control measures are proposed.