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概念 - 范围 Concept - Scope

风险分析方法 Risk analysis approach 拜耳医药保健有限公司北京工厂 BHC Product Supply Beijing Site 2012 年 3 月 March, 2012. 概念 - 范围 Concept - Scope. 风险分析是为了找出 The scope of the risk analysis is to find out 任何种类的活动（非活动）可能的错误。 what could be wrong with any kind of activity (and inactivity….),

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概念 - 范围 Concept - Scope

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  1. 风险分析方法Risk analysis approach拜耳医药保健有限公司北京工厂BHC Product Supply Beijing Site2012年3月March, 2012

  2. 概念-范围Concept - Scope 风险分析是为了找出 The scope of the risk analysis is to find out 任何种类的活动（非活动）可能的错误。 what could be wrong with any kind of activity (and inactivity….), 我们能承受的来自被分析的活动的（最大的）损失what is the (maximum) damage we can suffer from the activity under analysis 如何改进现状 What we can do to improve the situation

  3. 这是否安全？Is it safe?

  4. 哪一个更安全？Which is safer?

  5. 安全还是危险？Safe or dangerous?

  6. 多安全才是安全？How much is safety? 为了确保设备更安全我们应该增加其它设施，在危险时进行控制和预先警示。 To make an equipment safer we should add-on other equipment to control and warn in advance in case of danger. 控制措施越多，设备越安全。 The more the controls, the safer the equipment. 当然，由于控制设施重量太大，飞机也许永远不能起飞…..也许情况会更糟糕…. Well, a plane would never take off due to the weight of the control instruments…..may be it would be even worse…. 这意味着当我们执行我们的活动时，我们已经接受“已知的”风险。 It means we have accept a “known” risk while performing our activity.

  7. 统计学的与确定性的Statistic vs. Deterministic • 通常，我们可以使用确定的方法来评估活动或工艺中可能会有哪些错误。Usually we can use deterministic approach to evaluate what can be wrong with an activity or a process or…. • 有时这些过程: • Sometimes the processes are: • 用确定性的方法来处理太复杂 • Too complicated to be treated with deterministic methods • 使用确定性的方法费用太高 • The deterministic method is too expensive to be used • 确定性的方法需要太长时间 • The deterministic method requires too long time • 所以我们需要分解问题，引入另外的方法：概率性的/统计学方法 • So we have to break down the problem and introduce an additional approach: probabilistic/statistical。

  8. F F dl 统计学的与确定性的Statistic vs. Deterministic dl 对于自行车的分析，全面的确定性方法是有用的，因为我们能够设想仅能分解为很少的模块…… A full deterministic approach can be useful for the bicycle as we can guess just a few modes to break down….. 一架飞机或者一座核电站有许多不同的可能有缺陷的模块 An airplane or a nuclear power station has MANY different MODES to be defective

  9. 什么是风险？What is Risk? 风险=可能性x 结果的影响 Risk = Probability x Effect • 可能性是统计学的部分 • Probability is the STATISTICAL part • 结果的影响是确定性的部分 • Effect is the DETERMINISTIC part • 例如： • For example: • 某人假如碰巧踩到香蕉皮滑倒，风险是什么？ • What is the risk a person runs into in case she/he slips a banana peel • 2) 对于地球上一个人来说，一旦宇宙另外的星系发生核爆炸，风险是什么？ • What is the risk for a person in our planet in case of a nuclear explosion in another galaxy of the universe

  10. 可能性Probability • 根据不同的模型计算（预先危险性分析，故障模型和失效影响分析，故障树分析……） • Calculated according to different methods (HAZOP, FMEA, Fault Tree Analysis…) • 建议从做简单的开始（通常是FMEA），然后如果需要，使用最精确的方法（故障树分析）。 • It is suggested to start from the easiest (usually FMEA) then, if needed, use the most precise (Fault Tree Analysis) • 最精确的方法也是成本最高的方法（需要时间和费用）。所以建议仅使用该方法用于评估非常复杂和危险的工艺。 • The most precise is also the most expensive (time and experts needed) so its use suggested only to evaluate the probability of very complicated and dangerous processes.

  11. 后果的影响Effect • 首先，影响可以根据普遍的经验预测，例如人员摔倒；着火；粉尘爆炸，在没有精确计算下。 • The effects can, at first, be predicted according to the common experience, i.e. people falling down; fire; dust explosion, without calculating “how much” • 可以根据数学模型评估，例如对于最复杂和最危险的工艺，火焰热辐射，爆炸超压。目的是计算影响有多大。 • Evaluated according to mathematical modeling, i.e. flame heat radiation, explosion overpressure, for the most dangerous and complicated processes. The scope is to evaluate how big can be the effect. • 建议评估“多米诺模型”，例如经过检查后的影响可能只是导致很小的火灾。但是如果它发生在大的储罐旁边，就可能会演变成很大的火灾。 • It is suggested to evaluate “domino effects”, i.e. the effect under examination may led to a small fire. But if it happens beside a big tank, the effect can evolve to a very big one.

  12. 故障模型和失效影响分析FMEA 故障Failure 模型Mode 影响Effect 分析Analysis 影响 工艺参数 变量 原因 进料feed L101 V101 P101

  13. 顶事件Top event or Ev 2.1 or Ev 1.2 Ev 1.3 Ev 1.1 and and Ev 2 Ev 1 Ev 3 Ev 4 Ev 5 Ev 2 故障树分析Fault Tree Analysis 顶事件是最终的影响 Top event is the final EFFECT P=Pev1xPev2 + Pev2xPev3xPev4 + Pev5

  14. 可能性和严重程度可以凭经验估计Probability and Severity can be evaluated empirically 在考虑“有多少控制措施”的基础上，可能性可以凭经验估计。例如， Probability can be estimated empirically based on “how many controls” we perform on the event. I.e. 控制措施1-我们有SOP，人员经过培训 Control 1 – we have an SOP and the personnel is trained - 高的HIGH - 控制措施2-除了“控制措施1”，还有设施显示相关参数 Control 2 – in addition to “Control 1” there is an instrument to indicate relevant parameters - 中等的MEDIUM - 控制措施3-除了“控制措施2”，一旦参数超出控制范围达到报警水平，就会有报警 Control 3 – In addition to “Control 2” there is an alarm in case the parameters under control reach an alert level. - 低的LOW -

  15. 谢谢！ Thank you!

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