质量风险管理Quality Risk Management⟴9. Risk Modification 风险修改

文摘 2024-09-18 12:00 上海

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以下分享美国质量学会出版的《质量风险管理基础：有效的基于风险思维的实用方法 Foundations of quality risk management: A practical approach to effective risk-based thinking》（第1版）中的第九章《Risk Modification 风险修改》的中英文对照。

之后我们将定期更新分享后续章节内容，并分享临床研发领域的风险管理案例分析。

快速回顾➡️

第一章请看：质量风险管理Quality Risk Management⟴1. 风险管理简介

第二章请看：质量风险管理Quality Risk Management⟴2. 质量和风险管理

第三章请看：质量风险管理Quality Risk Management⟴3. 风险是什么？

第四章请看：质量风险管理Quality Risk Management⟴4. 基于风险的思维

第五章请看：质量风险管理Quality Risk Management⟴5. 基于风险的决策

第六章请看：质量风险管理Quality Risk Management⟴6. ISO 9001与风险管理

第七章请看：质量风险管理Quality Risk Management⟴7. 基本风险识别与分析

第八章请看：质量风险管理Quality Risk Management⟴8. Events and Consequences 事件与后果

本篇摘要

In this chapter, we delve into the concept of risk modification, a crucial aspect of risk management that involves adjusting risk levels to achieve organizational goals. Risk modification encompasses various strategies such as risk treatment, risk mitigation, and risk control, all aimed at reducing adverse effects and enhancing positive outcomes. We will explore how to effectively approach risk modification by examining practical examples and methods to manage risks within different contexts. Understanding and applying these principles will help ensure that predetermined objectives are met with minimal issues and maximum efficiency.

在本章中，我们探讨风险修改的概念，这是风险管理中一个至关重要的方面，涉及调整风险水平以实现组织目标。风险修改包括多种策略，如风险处理、风险缓解和风险控制，所有这些都是为了减少不利影响并增强积极成果。我们通过举例探讨如何有效地进行风险修改，管理不同情境中的风险。理解和应用这些原则将有助于确保预定目标以最小的问题和最大效率实现。

Reference:

Moon, J. (2020). Risk modification. In J. Moon, (Ed)., Foundations of quality risk management: A practical approach to effective risk-based thinking. (1st Ed., pp. 36-39). American Society for Quality, Quality Press.

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To know is to know that you know nothing. That is the meaning of true knowledge.

知之为知之，不知为不知，是知也。

– Socrates

⟴

Risk Modification 风险修改

In the previous chapters, we learned the basic concepts of risk identification, analysis, and evaluation. These are informative assessments that set the stage for modification of the assessed risk for organizational benefit. Risk modification, depending on the nature of risk response, can be called risk treatment, risk mitigation, or risk control.

在前面的章节中，我们学习了风险识别、分析和评估的基本概念。这些信息性的评估为组织利益的风险修改奠定了基础。根据风险对应的性质，风险修改可以被称为风险处理、风险缓解或风险控制。

Modification of risk is expected to reduce the adverse effects and, where possible, increase the beneficial effects of an endeavor such that the predetermined objectives are met with the fewest issues along the way.

风险修改旨在减少不利影响，并在可能的情况下，增加事业的有利效果，从而以最少的问题实现预定目标。

In the previous example, we looked at the risk from driving in the snow. We identified certain unacceptable risks for reduction listed in Table 9.1.

之前章节中举例考虑在雪地中驾驶的风险。我们识别了需要减少的某些不可接受的风险，如表9.1所示。

The two obvious ways of reducing risks are to take actions to induce reduction in the probability and to take actions to induce reduction in the severity. In this example, it is much easier to effect a change in probability. The best way to approach risk modification is to modify the root cause of risk.Table 9.2 shows some modifications.

减少风险的两个明显方法是采取措施降低发生的概率和采取措施降低严重性。在这个例子中，改变概率更容易。最佳的风险修改方法是修改风险的根本原因。表9.2展示了一些修改措施。

The addition of mitigation, in this case, is an anticipation to reduce the probability that an event will happen. Thus, we must update this register with the new anticipated probabilities and recalculate risk to confirm their acceptability. This is done as shown in Table 9.3.

在这种情况下，缓解措施的加入是为了预期降低事件发生的概率。因此，我们必须用新的预期概率更新这个风险表，并重新计算风险以确认其可接受性。这如表9.3所示。

In this case, we have reduced all risks to an acceptable level individually. Let us now look at the aggregate risks using the consequence–time series chart in Figure 9.1.

在这种情况下，我们已经将所有风险单独降低到可接受的水平。现在让我们使用图9.1中的后果-时间序列图查看总体风险。

While we have reduced all unacceptable risks, we still need to be on the lookout for some high-severity risks as we embark on our objective to drive through the snow to reach our office. One cannot be carefree as a result of this exercise, as there are many subjective factors involved in this assessment. It is easier to predict an impact or consequence than the probability. Since no one can predict the future with 100% certainty, there is always some error involved in prediction regardless of the rigor of the methodology used.

虽然我们已减少所有不可接受的风险，但在我们继续实现目标，雪地驾驶到达办公室的过程中，我们仍需警惕一些高严重性的风险。由于涉及许多主观因素，这项评估不能掉以轻心。预测影响或后果要比预测概率容易。由于没有人能以100%确定性预测未来，无论使用何种方法，总会有一定的预测误差。

A monitoring and review phase is essential to continually assess the level of risk and to check whether the predicted profile is maintained. In this example, a driver will continually monitor the road and snow conditions. If the conditions worsen, one may decide to turn back. As objectives become more complex with the involvement of more processes and people, a need arises to structurally define the roles and responsibilities of the risk management process. There arises a need for understanding the stakeholders and planning the whole process to ensure it is inclusive, streamlined, and effective.

监测和审查阶段对于持续评估风险水平和检查预测的情况是否得到维持是至关重要的。在这个例子中，司机将持续监控道路和雪况。如果情况恶化，可以决定折返。随着目标变得更加复杂，涉及更多的过程和人员，需要结构性地定义风险管理过程中的角色和职责。需要了解利益相关者并规划整个过程，以确保其包容、简化和有效。

Risk modification should always be a balance between practicality and effectiveness. Outside the simple scenario we’ve been examining, this can translate into a lot of complex factors in an organizational context, including attitudes toward risk and the availability of the resources for modification. Therefore, a primary consideration before beginning organization-wide risk management activity should be to identify and engage stakeholders.

风险修改应始终在实用性和有效性之间保持平衡。除了我们一直在研究的简单情境外，在组织背景中，这可能涉及许多复杂因素，包括对风险的态度和修改资源的可用性。因此，在开始组织范围的风险管理活动之前，主要考虑因素应该是识别和接触利益相关者。

In this chapter, we focus on risk modification, which can be defined as:

在本章中，我们关注风险修改，可以定义为：

Risk Modification (treatment): The method of selection and implementation of options for addressing risk, which usually involves a measure that maintains and/or modifies risk.

风险修改(处理)：选择和实施应对风险的选择的方法，通常涉及保持和/或修改风险的措施。