风险管理及案例分析 -九新徐影.ppt

Example of what might go wrong * Example of a risk assessment * Performing risk Evaluation * Example of risk evaluation * Risk Control * Example of Risk Control * Mention Q9/EU’s planed events(inspection, audit, product review etc) and unplanned event (recall) that lead to risk review. * * Just based on EU and FDA text, we immediately see some areas where we can use a RM approach to determine amount of activity required. * * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * 高级管理层需要做什么？ 确保组织了解ICH Q9及其能提供的机会 适当的教育和培训 鼓励开放的，有风险意识的文化 在组织内建立支持“QRM领导” * * 鼓励质量风险管理与目前的质量系统整合 不要建立一个单独的部门 协调实施及资源配制 按优先顺序，从小处开始，边做边学 What does Senior Management need to do?高级管理层需要做什么？ Setting up a practical program制定可操作的规程 找出必须重视的问题 选出有专业知识的人员 起草SOP，表格和报告模板 按照步骤 （风险识别，风险分析。。。） 如果有帮助，可使用风险管理工具 记住目的 – 更好的决策可助于更好的保护患者利益 * * Ask them what do they want to achieve by the end of the day? Pick on a few different people. Take note of what they say and if you can refer to it as you go through the training. * * Quality Risk management is quite new but the practice of Risk management has been around for a long time. For example in Insurance. Without a knowledge of risk, insurers would not be able to make money! * This is the major area where Risk Management is applied and almost all references you will find to techniques and tools refer to managing safety. However with appropriate adjustment, some of these tools can be used for quality risk management. The cas