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The first common theme here (among these definitions) is the reference to chance or possibility. It follows that when the probability of an adverse event increases, the risk increases proportionally.
It is much riskier to walk on ice than concrete because the probability of slipping is higher on ice. Note that we have not yet even considered the level of consequence of slipping, which may result in a bruise, bleeding, broken bones, and so on.
在冰上行走比在混凝土上行走风险更大，因为在冰上滑倒的概率更高。在此我们还没有考虑滑倒的后果，可能导致擦伤、出血、骨折等。
Probability, like risk, is everywhere around us. For example, the probability of you driving to work in a snowstorm depends on the following:
概率就像风险一样无处不在。例如，在暴风雪中开车上班的概率取决于以下因素：
7. If the snowstorm turns into a whiteout blizzard 风雪是否会转变为白茫茫的暴风雪
Obviously, the probability of each event happening is different, and, even if the event occurs, it may still be likely that you will be able to reach work. On a qualitative scale, the probabilities range from very certain to extremely unlikely.
显然，每个事件发生的概率是不同的，即使事件发生仍然可能到达工作地点。概率的范围，在定性尺度上可以从非常确定到极不可能。
One might argue that a person could also die from the cold while driving and never reach work. The chance of “dying due to cold” is so low that it sounds preposterous. At the same time, if that does happen, it will be the event with the most severe outcome.
虽然一个人也可能因寒冷在驾驶时死亡而永远无法到达工作地点。“因寒冷而死”的概率极低而听起来很荒谬。但如果确实发生这种情况，那将是后果最严重的事件。
Such events are called black swan events. These are events of such low probability that they cannot be predicted with any amount of computational accuracy. These events are extremely impactful and usually far beyond the normal realm of practical expectations.
这种事件被称为“黑天鹅事件”。这些事件的概率如此之低，以至于无法通过任何计算精确预测。此类事件具有极大的影响，通常远超出正常实际预期的范围。
Included this here only to introduce the concept of a black swan. One could never hope to complete risk assessments practically if all imaginable black swan events were included.
这里提到这一点只是为了介绍“黑天鹅”的概念。如果将所有可想象的黑天鹅事件都包括在内，那么完成风险评估实际上是不可能的。
Now, let’s say our objective is to ensure that you get to work safely. I will do everything in my power to maximize your probability of getting to work. But I have limited resources and I need to prioritize the probabilities to ensure I use my resources in the best way possible.
现在，假设我们的目标是确保您安全到达工作地点。我会尽一切可能最大化您成功上班的概率。但我的资源有限，我需要优先考虑不同概率，以确保我以最佳方式利用资源。
So, using the key shown in Table 7.2, I assign a “probability” to each event listed earlier (see Table 7.3).
因此，使用表7.2中显示的关键点，我为先前列出的每个事件分配一个“概率”（见表7.3）。
Table 7.5 includes a column for the severity of each outcome as described earlier and reproduced here in the second column.
表7.5包括了一栏用于描述早先提到的每个结果的严重性，并在这里的第二栏中再次列出。
A simple definition of risk that lends itself to mathematical conversion is:
风险的一个简单定义，便于计算转换的是：
Risk is the combination of the probability of the occurrence of a consequence and the severity or impact of the consequence.
风险是发生后果的概率与后果的严重性或影响的结合。
Similarly, by focusing on the negative outcome of harm as the injury or damage to people, property, or environment, ISO Guide 63:2019 defines harm as:
同样的，通过关注伤害的负面结果，如对人员、财产或环境的伤害，ISO Guide 63:2019 将伤害定义为：
Combination of the probability of occurrence of harm and the severity of that harm.
伤害发生概率与伤害严重性的结合。
In this vein, let’s combine the probability and occurrence to find out the real risk of the harm of the events listed earlier. The easiest way to define this is through a key. Various ISO standards provide risk tables or risk matrices to accomplish this.
因此，让我们结合概率和发生情况，找出先前列出事件的实际伤害风险。定义这一点的最简单方法是通过一个关键点。各种ISO标准提供风险表或风险矩阵来实现这一点。
The key in Table 7.6 is adapted from ISO 14971:2007.
表7.6中的关键点改编自ISO 14971:2007。
In Table 7.7 we finish our sample risk assessment based on Table 7.6.
在表7.7中，我们基于表7.6完成了我们的示例风险评估。
Voila! We have now prioritized the items with the highest risk levels using a structured risk analysis such that targeted actions can be taken to reduce risk to an acceptable level.
The following are benefits of stakeholder communication in the risk identification process:
以下是利益相关者在风险识别过程中沟通的好处：
1. Drawing from different areas of expertise to assign accurate severity and occurrence values 从不同专业领域中获取信息，以分配准确的严重性和发生值
2. Using stakeholder expertise to cover all possible failures and consequences 利用利益相关者的专业知识涵盖所有可能的失败和后果
3. Ensuring all stakeholders are aligned on assigned risk levels 确保所有利益相关者对指定的风险级别保持一致
Involvement of stakeholders is not only important for risk identification but is also critical post–risk assessment when risk treatments and communication plans have to be developed.
利益相关者的参与不仅对于风险识别很重要，而且在风险评估后制定风险处理和沟通计划时也至关重要。
Another thing to consider is aggregate risk. In this case, the aggregate risk is the summation of risks that prevent the realization of the objective of reaching work on time.
另一个需要考虑的是总风险。在这种情况下，总风险是阻碍按时到达工作地点这一目标实现的风险总和。
One way to show this graphically is as a consequence–time series chart, as shown in Figure 7.1.
图形显示这一点的方法之一是后果-时间序列图，如图7.1所示。
It is important to consider the successive appearance of risks in time sequence or, in some cases, even the simultaneous occurrence of risks.
考虑风险按时间顺序的连续出现，或在某些情况下甚至是风险的同时发生，这一点很重要。
In this particular example, since the risks occur sequentially, a chart like Figure 7.1 shows their progression and level of acceptability or unacceptability as they stand without any treatment.
在这个具体例子中，由于风险是按顺序发生的，图7.1显示它们在不进行任何处理时的进展和可接受或不可接受的水平。
This shows the net position of the risks in terms of comparative acceptability. We know that the risk with the maximum footprint is the loss of control of the car on icy roads, which has the most severe impact, while the risk of a dead battery is also unacceptable but has a negligible impact on the objective.
这显示风险在相对可接受性方面的净位置。我们知道影响最大的风险是失控的汽车在冰雪路面上的失控，这具有最严重的影响，而电池耗尽的风险也是不可接受的，但对目标的影响可以忽略不计。
It also shows that we have three unacceptable levels of threats to our objective of reaching work. After attempts to reduce risks, this figure can be compared with the original levels to check the net loss of risk.
它还表明我们有三种对我们按时到达工作地点的目标构成不可接受威胁的风险水平。在试图降低风险后，可以将此图与原始水平进行比较，以检查风险的净损失。
1. ©ISO. This material is reproduced from ISO/IEC Guide 63:2019, with permission of the American National Standards Institute (ANSI) on behalf of the International Organization for Standardization. All rights reserved.
2. ©ISO. This material is reproduced from ISO 14971:2007, with permission of the American National Standards Institute (ANSI) on behalf of the International Organization for Standardization. All rights reserved.
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