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This chapter explores the concept of risk, focusing not only on its negative aspects but also on the opportunities that arise from uncertainty. By examining various definitions of risk, from ISO standards to practical applications, we highlight the importance of considering both the downside and the upside of risk. In particular, the chapter discusses how a balanced approach to risk management can enhance decision-making in both product development and broader organizational strategies. The concept of risk-benefit analysis is introduced, offering a framework for evaluating potential outcomes and their impact on objectives.
本章探讨风险的概念，不仅关注其负面方面，还强调了不确定性中可能出现的机遇（正面的风险）。通过审视不同的风险定义，从ISO标准到实际应用，本章突出考虑风险的负面与正面两方面的重要性。特别讨论平衡的风险管理方法如何在产品开发和更广泛的组织战略中促进决策。风险收益分析的概念可以引入为一种评估潜在结果及其对目标影响的框架。
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Looking at only the downside of risk is akin to considering a coin to have only one side. Table 11.1 reproduces the dictionary definitions of the term “risk.”
仅关注风险的负面，就如同认为硬币只有一面。表11.1展示了“风险”一词的字典定义。
There is certainly a negative connotation of the term “risk.” But let us dispel this falsehood early on. We saw a few definitions of risk in earlier chapters, some with broader scope than others. Let us contrast two standard definitions and discuss their implications. ISO 13485:2016 (Medical Devices - Quality Management Systems) defines risk as:
“风险”一词确实带有负面含义，但让我们尽早消除这种误解。在前几章中，我们看到了几个对风险的定义，其中一些范围较广。让我们对比两个标准定义并讨论其意义。ISO 13485:2016（医疗器械 - 质量管理体系）将风险定义为：
ISO 9000:2015 (Quality Management Systems - Fundamentals and Vocabulary), from which ISO 9001:2015 derives all terms and definitions, defines risk as:
ISO 9000:2015（质量管理体系 - 基础和术语）是ISO 9001:2015的术语和定义来源，它将风险定义为：
Note: An effect is a deviation from the expected - positive or negative.
注：影响是对预期的偏差 - 可能是正面的，也可能是负面的。
ISO 31000:2018 (Risk Management Guidelines) defines risk as:
ISO 31000:2018 (风险管理指南)定义风险为：
Note: An effect is a deviation from the expected. It can be positive, negative, or both, and can address, create or result in opportunities and threats.
注：影响是对预期的偏差。它可以是正面的、负面的，或两者兼有，并且可以涉及、创造或导致机遇和威胁。
As we can see from the three separate definitions, the scope of risk and risk management went from negative to positive. So which definition is right? The answer is, all of them.
从这三个独立的定义中，我们可以看到风险和风险管理的范围从负面延伸到了正面。那么哪个定义是正确的呢？答案是，所有的定义都正确。
The context of the organization as detailed in the upcoming Chapters 14 and 16 really defines the context of risk management. In the first definition, the negative aspect of risk is stressed since, in the context of medical devices, it makes sense to consider every possible failure of the device in detail from a safety and reliability standpoint. This one-tailed approach to risk arms the user with single-mindedness and specificity of scope (i.e., confined to failure and safety). But here too, one may argue that addition or deletion of design features may be opportunities that may well benefit from a risk and failure assessment. One can also argue that if one considers opportunities or upsides of risk right at the beginning, a more beneficial device can be manufactured.
正如之后的第14章和第16章所详细描述的，组织的背景真正决定了风险管理的背景。在第一个定义中，强调了风险的负面方面，因为在医疗设备的背景下，从安全性和可靠性角度考虑设备的每一个可能故障是有意义的。这种单边的风险方法赋予使用者专注和明确的范围（即仅限于失败和安全）。但也可以争辩，设计特性的增减可能是机遇，完全可以通过风险和失败评估来加以利用。也可以认为，如果一开始就考虑到风险的机遇或正面方面，可以制造出更有益的设备。
ISO 9001:2015 and ISO 31000:2018 are more universal standards that take the two-tailed approach to risk, which includes positive and negative aspects. The benefits of this approach are apparent in system-level, operational, strategic, and enterprise risk management. But when we get to the product, process, or service level, as the risks tend to become more and more specific, many practitioners find it difficult and at times redundant to incorporate the opportunity side.
ISO 9001:2015和ISO 31000:2018是更为通用的标准，采用双边风险方法，涵盖了正面和负面方面。这种方法在系统级、操作级、战略级和企业级的风险管理中展现了明显的优势。但当我们进入产品、过程或服务级别时，由于风险越来越具体，许多从业者发现很难在其中加入机会方面，有时甚至显得多余。
To simplify, let us define an event, which is full of uncertainty (i.e., full of risk), as follows:
为了简化，我们将具有不确定性的事件（即充满风险的事件）定义如下：
This risky event may be turning a screw in a spinal implant or choosing a new indication for a drug or adding a new navigation feature to a car. A potential failure mode is still a risk event but only with negative risk.
这个风险事件可能是转动脊柱植入物上的螺丝，选择药物的新适应症，或者为汽车增加新导航功能。一个潜在的失败模式仍然是一个风险事件，但只有负面风险。
Let us now look at an example that clarifies the concepts above related to risk, uncertainty, and positive and negative aspects. Let us consider a game where the correct guess on the outcome of a fair coin toss doubles your wager. We are aware that a fair coin toss has 50% probability of heads or tails. So here, the risky event is the coin toss, with a two-tailed risk.
现在让我们看一个例子，阐明上述关于风险、不确定性以及正面和负面方面的概念。我们来考虑一个游戏，在这个游戏中，正确猜测公平掷硬币的结果可以让你的赌注翻倍。我们知道公平的硬币投掷正反面概率各为50%。所以这里风险事件就是投掷硬币，具有双边风险。
If I flip a coin on a $5 wager and call heads, tails brings a 50% possibility of loss and financial injury to me, but heads brings a 50% possibility of profit for me. I could have chosen not to place the wager and not take a risk, but I decided that there was an opportunity for me to benefit by taking that risk. When such situations present themselves, how do you decide which path to take? Is the risk worth it?
如果在5美元的赌注上投掷硬币并猜正面，那么反面带来的50%的可能性是我会亏损并遭受经济损失，而正面则带来50%的可能性让我获得利润。我本可以选择不下注，避免冒险，但我决定通过承担这个风险来获取潜在的收益。当这种情况出现时，你会如何决定选择哪条路？这个风险值得吗？
A risk-benefit analysis can help drive a decision in such cases. Below is one that I performed on the fly for this simple two-outcome event by doing the following:
在这种情况下，风险收益分析可以帮助做出决策。下面是针对这个简单的两种结果事件快速进行的分析，方法如下：
Table 11.2 shows the tabulated risk-benefit analysis.
表11.2显示了整理出的风险收益分析。
Table 11.2, in fact, is known as expected monetary value analysis (commonly used in project management) and is often used to quantify aggregate risk by multiplying the likelihood of the outcome by the impact of the outcome. This multiplicative product gives an expected monetary value for each outcome, which can be added across all outcomes to give a final level of risk. The aggregate expected output here is $2.50, which does not mean I will earn $2.50 but if I play this game over and over again multiple times, I will probably end up with an average gain of $2.50.
事实上，表11.2被称为预期货币价值分析（在项目管理中常用），它通常用于通过将结果的可能性与结果的影响相乘来量化总风险。这个乘积给出了每种结果的期望货币价值，可以将所有结果加总，得出最终的风险水平。这里的总期望输出为2.50美元，这并不意味着我会赚到2.50美元，但如果我多次玩这个游戏，我可能最终会得到2.50美元的平均收益。
So, the question I need to answer in this simple risk-benefit analysis is: Am I fine with the expected monetary value of $2.50? or Am I fine with a 50% chance of losing $5 for a 50% chance to gain $10?
所以，我在这个简单的风险收益分析中需要回答的问题是：我接受2.50美元的期望货币价值吗？还是我接受50%的概率亏损5美元，换取50%概率获得10美元？
The key concept here is that risk is involved for all outcomes borne out of uncertainty. Some of these outcomes are beneficial and have a positive risk or an opportunity associated with them. Risk-benefit analysis is mentioned in detail in the upcoming Chapter 36.
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