Finally…ALWAYS BE SYSTEMATIC 最后，保持系统化
Look at symptoms 查看症状
Get good quality data
得到好的数据
分析和理解
Analyze and understand Consult others 咨询他人
Problem statement 陈述问题 Investigate and risk assess 调查和评定风险 DECISION! 做决策！
Questions to ask 要提问的问题
OPEN: To gather information 开始：收集信息
PROBING: To focus on specific issues 调查：集中在具体问题上 CLOSED(yes or no): To obtain agreement 结束（是/否）：得出一致结论 SUMMARY: To confirm understanding 总结：确认理解 HYPOTHETICAL: To generate ideas 假想：产生主意
Single or multiple batches? 单个还是多批 One or more plants? 单个还是多个工厂 Direct patient risk? 直接的患者危险 Regulatory or “compliance” risk? 监管还是法规风险 Risk to supply chain? 对供应链有风险吗
Risk Analysis 风险分析
After every Risk Analysis 在每个风险分析之后
Take “time out”
暂停
问自己“这样觉得对吗？”
Ask yourself “DOES THIS FEEL RIGHT” Professionally 从专业上 Morally 从道德上 Ethically 从伦理上 Beware of the “Management Hat”
A Simple Fact…一个简单的事实
YOU CAN’T MAKE THE RIGHT DECISION WITH A HIGH LEVEL OF UNCERTAINTY! 你不可能在高级别的不确定性下做出正确的决定！
Ask the RIGHT Questions… 问正确的问题 ACTIVELY LISTEN 积极地聆听
Structured Decision Making：Buzz Group 结构化决策：小组讨论
Review and reflect on what has been discussed 回顾和深思什么是被讨论的 Brainstorm all of the essential elements of a good decision making process 头脑风暴：一个好的决策过程包含哪些必要元素
BUT AVOID “PARALYSIS BY ANALYSIS”
Always Be DATA DRIVEN 常以数据 为驱动
Base decisions on facts, not assumptions 做决策时基于事实而非设想 Data must be 数据必须 Accurate 精准 Reliable 可靠 Unbiased 公正 Well presented 很好地被展示
Root Cause
Establish your Level of “Uncertainty” 建立你自己的“不确定 ”级别
Accept that you will never FULLY understand the problem 请接受：你永远不会完全理解问题 There will always be some uncertainty 总会有一些不确定 The smaller the level of uncertainty the better the decision 不确定的级别越小，做出的决定越好 The investigation must reduce uncertainty to an “acceptable” level 调查和研究必须可以把不确定降低到“可接受的”的水平
Individually(post its) 个人（即时贴） In your groups 小组
Design a process flow for structured decision making 设计一个结构化决策的流程
Risk Based Decision Making 基于 风险的决策
A structured approach 一个结构化的方法/途径 Understand the situation first 首先了解情况 Hold on to the BIG PICTURE 坚持大局为重
Questioning Skills: 提问的技巧
Ask the RIGHT people 向正确的人提问 Ask a broad audience 问广大听众
操作员和专家 OPERATORS and SUBJECT EXPERTS Generalist 多面手
Explore differences of opinion…don’t ignore 要忽视 KEEP AN OPEN MIND And listen 然后倾听
谨防扣上“管理帽子”

Risk Evaluation 风险评估
Comparison of risk vs. criteria 对照风险和标准 Assign PROBABILITY and SERVERITY 分配机率和严重性
May be quantitative or qualitative
可能定量的或定性的
Keep the BIG PICTURE
The 5Ws and the HOW 5W和如何
保持大局
Avoid getting sucked into detail early on 避免过早陷入以下细节
Magnitude of the problem or situation 考量问题和情况
Risk Reduction 风险降低
Mitigating SEVERITY 减轻严重性 Reducing PROBABILITY 降低发生的机率
Increasing DETECTABILITY(CARE!)
…and then RISK ACCEPTANCE
提高检测能力(小心!)
然后
风险接受
Understand the “Problem” 理解“ 问题”
Obtain “HARD” data and information 得到确实的数据和信息 THE WHO 谁 THE WHAT THE WHY THE HOW THE WHEN 什么 为什么 如何 什么时候 避免出现“分析麻痹”
One Last Word…最后一些话
The process may appear “linear” but decision making isn’t 流程看起来可能是“直线型的”但是做决策并不是 Decision making is a “recursive "process 做决策是一个“循环的”过程 You move up and down the decision making process 做决策的过程需要反复上上下下
Risk Control 风险控制
Is the risk unacceptable? 风险是不能被接受的吗？ What can be done to… 可以做些什么来．．． Reduce risk? 降低风险 Eliminate risk? 消除风险 Must be PROPORTIONATE! 必须成一定的比例 Risks 风险 Benefits 益处 Resources 资源
Risk Based Decision Making: Practical Application of Risk Assessment 建立在决策上的风险：风险评定 的实际应用
Structured Decision Making 结构化 决策
Helps to overcome these” in built” weaknesses 帮助克服这些“建立改变”的弱点 Design a SIMPLE process 设计一个简单的流程 Use it… until it becomes habit 使用这个流程，直到成为习惯 Refine and improve but KEEP IT SIMPLE! 精炼和改进但是保持简单化！ Learn from your mistakes 从你的错误中学习
Make the Decision but Remember…做决策但请记得
The “ripple” affect. Be prepared for resistance and disagreement “脉动”影响。做好接受阻力和不同意见的准备。 Think long and hard about communication 沟通是长期而艰苦的 FACE to FACE is the only way. Don’t be a coward 面对面交谈是唯一的方法。不要胆怯。 Top down vs. bottom up 自上而下 vs. 自下而上 Involve stakeholders in the decision… break them in slowly 让利益相关人参与到决策中来…慢慢地训练他们 Document everything. Remember your “little black book” 把所有记录都文档化。记住你有一本“私人笔记本”
Risk Analysis 风险分析
What are the possible consequences(SERVERITY) of harm to the PATIENT and the BUSINESS? 对病人和业务会带来何种结果（严重性）的危害？ What is the PROBABILITY of OCCURRENCE? 事件发生的机率是多少？ What is the LIKELIHOOD of DETECTION? 发现的可能性是多少？