Events and Consequences 事件与后果
在上一章中，我们使用了一个简单而结构化的分析方法，对各个事件进行了定性的风险等级分配。为了正确评估风险，必须理解事件的含义。
ISO 31000:2018 defines an event as:
Occurrence or change of a particular set of circumstances.
ISO 31000:2018 将事件定义为：
特定情况的发生或变化。
An event may have several causes and may or may not have consequences. It may be previously seen or experienced or may be just plain theoretical.
一个事件可能有多种原因，并且可能有或没有后果。它可能是以前见过或经历过的，或者只是纯粹的理论。
ISO 31000:2018 defines consequence as follows:
Outcome of an event affecting objectives.
ISO 31000:2018 将后果定义为：
影响目标的事件的结果。
When we evaluated the list of possible events in the previous chapter, the severity was assigned based on the consequence. Table 8.1 clarifies this in regard to the previous example.
在上一章中，由医疗质量检测技术及测试仪器展知悉，当我们评估可能发生的事件清单时，严重性是根据后果分配的。表8.1 对之前的示例进行了说明。
Consequence is simply the scale of severity we used earlier. It is, in fact, the measure of the impact. It is critical that risk professionals understand event and consequence. Mistakes here could lead to the analysis being overly redundant and, in the worst case, incorrect. The following are common mistakes in this regard:
后果就是我们之前使用的严重性等级。事实上，它是影响的衡量标准。理解事件和后果对风险专业人员而言至关重要。此处的错误可能导致分析过于冗余，或最糟糕的情况是分析错误。以下是此方面常见的错误：
– The idea that one event can have only one consequence 认为一个事件只能有一个后果
– The idea that consequences must be certain 认为后果必须是确定的
– Use of only the final consequence 仅使用最终后果
One event may lead to various different consequences, each with varying levels of probability. The consequence of the impact may be positive or negative. There arises a need to distinguish the level of impact so that the consequences can be compared and evaluated. This is usually done with the help of a ratings scale. In the previous example, the scale shown in Table 8.2 was used.
一个事件可能导致不同的后果，每个后果的概率各不相同。影响的后果可能是积极的，也可能是消极的。因此有必要区分影响的程度，以便比较和评估后果。通常使用评分等级来完成这一点。在前面的示例中，使用了表8.2中显示的等级。
In the earlier example, to keep it simple, we used only one consequence for most of the risky events. For slipping and falling, we used two consequences on purpose to demonstrate the various possibilities and probabilities of event outcomes. This event can be further expanded, as shown in Table 8.3. The need for detail must be assessed by the risk professional. In case you are conducting risk analysis for a complex system that has possibilities of multiple user or customer harms, you may want to explore the consequences in much greater detail.
在前面的示例中，为了简化处理，我们为大多数风险事件仅使用了一个后果。对于滑倒事件，我们故意使用了两个后果，以展示事件结果的各种可能性和概率。这个事件可以进一步扩展，如表8.3所示。风险专业人员必须评估细节的需求。如果你正在对一个可能对多个使用者或客户造成伤害的复杂系统进行风险分析，你可能需要更详细地探讨后果。
The activity of drawing out consequences and analyzing them is known as consequence analysis. A consequence analysis exercise can be done using the consequence polygon shown in Figure 8.1, which takes into account the following:
分析和推导后果的活动称为后果分析。后果分析可以通过图8.1中的后果多边形来完成，考虑以下方面：
– Nature of impact – chronic or acute 影响的性质 – 慢性或急性
– Type of impact – short or long term 影响的类型 – 短期或长期
– Magnitude – scope of the impact (local vs. global, immediate vs. trailing) 影响的范围（局部与全球，直接与后续）
– Effect on objective – positive or negative 对目标的影响 – 正面或负面
– Effect on stakeholder – user, manufacturer, or layman effects 对利益相关者的影响 – 用户、制造商或外行的影响
– Effect on control – change in modification/mitigation strategy 对控制的影响 – 修改/减轻策略的变化
One may choose not to include every section in the final risk analysis document, but it is important to have these points in mind during the consequence analysis activity.
在最终的风险分析文件中，可以选择不包含每个部分，但在进行后果分析时，牢记这些要点非常重要。
想要了解更多请前往医疗质量检测技术及测试仪器展
文章来源：瑞士WS卫森医药咨询
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