基于故障模式、影响与危害性分析的食品药品监管风险预警系统构建  

Construct risk warning system of food and drug regulation based on Fault Modes Effect and Criticality Analysis

作　　者：董作军[1] 邱琼[2] 钟元华 徐超[3] 孙国君[1] 

机构地区：[1]浙江工业大学,浙江杭州310014 [2]国家食品药品监督管理总局,北京100053 [3]浙江省食品药品监督管理局,浙江杭州310012

出　　处：《中国新药与临床杂志》2016年第10期713-717,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：浙江省食品药品安全"三网六体系"建设研究课题[浙食药监办(2014)24号]

摘　　要：梳理目前食品药品风险预警工作的现状与不足,探索以故障模式、影响与危害性分析(FMECA)风险评价工具为核心构建风险信息交流与评估系统。该系统涵盖风险信息采集、风险交流、信息处理、反馈预警等基本功能,使风险信息得以高效传递、标准化处理和科学评价。This paper clarified the current situation and problems of food and drug risk warning work, and explored the risk communication and assessment system with the tool of Fault Modes Effect and Criticality Analysis （FMECA）. The system includes basic function of information collection, risk communication, information processing and warning feedback, which can make efficient delivery, standard process and scientific assessment of risk information become possible.

关 键 词：食品 药用制剂 信息交流 危险性评估 风险预警 

分 类 号：R951[医药卫生—药学]