FDA+产品质量的风险评估原则(翻译).ppt

* 风险管评估先于风险管理 Risk assessment is not a single process, but “a systematic approach to organizing and analysing scientific knowledge and information” to support a risk decision. NRC (1994) Various paradigms exist for the execution of a risk assessment in public health; however, all paradigms have in common fundamental scientific principles. * 风险评估需要问以下问题: 什么会出错? 出错的可能性是什么? 后果是什么? * 风险管理需要问以下问题: 可以做什么? 那些方法是可用的? 就风险、利益和成本而言什么是风险的交易物? 目前的对将来的管理决定的影响是什么? * Roles/Tasks (--short list) Pose the risk question. Charge the Risk Assessors with the Risk Assessment Task. Convene stake holders. Analyze decision options. Make/recommend the decision. Identify data and gather information on the nature, extent, magnitude and uncertainty of the risk. Write the Risk Assessment. Recommends changes to RM questions. Risk Managers Risk Assessors * 风险评估 Regulatory Policy Risk Assessment: (e.g., Biotechnology RA to determine the need for risk management regulation.) Applied Risk Assessment: To determine compliance with a regulation or policy. Safety Assessments: Highly defined risk calculations. Usually under a “bright line” safety policy. * Safety vs. Risk Risk Limit e.g., Limit exceeded “10 times in 100” Safety Limit “Unsafe” “Safe” e.g., Declared “unsafe” Estimates of risk * 民主的风险分析 风险评估为风险分析提供事实. 风险 风险 风险 风险 风险 风险 风险 风险评估 风险 风险 风险 风险 风险 风险 风险 Worst ? * Risk Analysis in a Democracy The risk management decisions about which risks to manage are value-laden decisions. Risk Management Risk Risk Risk Risk Risk Risk Risk Risk Risk Risk Risk Risk Risk Risk Values Costs Worst ? Risk Management Rank ? * Translating Risk Analytic Paradigms Risk Analysis Risk Assessment Release Assessment Exposure Assessment Consequence Assessment Risk Estimation Risk Management Risk Communication Hazard Identification What can go wrong? What are the consequences? What is the likelihood that it would go wrong? What can be done? What are the trade-offs in terms of costs, benefits and ris