发布时间 : 星期一 文章ICH-Q9质量风险管理更新完毕开始阅读ec10749077eeaeaad1f34693daef5ef7bb0d1261
Quality Risk Management/质量风险管理
Decision makers should 决策者应当：
? take responsibility for coordinating quality risk management across various functions and departments of their organization; and
负责在其组织内各职能部门间协调质量风险管理；以及，
? assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available.
确保明确，开展与评审了质量风险管理过程，并有适当的资源。 4.2 Initiating a Quality Risk Management Process 启动质量风险管理过程 Quality risk management should include systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following:
质量风险管理包括那些用于协调、促进和改善做出与风险相关的基于科学的决策系统过程。可能用于启动和策划一个质量风险管理过程的步骤可能包括以下几点：
? Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk;
明确问题和/或风险问题，包括辨识潜在风险相关假设；
? Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment;
收集与风险评估相关的潜在危险、伤害或影响人体健康的背景信息和资料和/或数据；
? Identify a leader and necessary resources; 辩识领导与必要的资源； ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process.
指定风险管理程序的时限、交付日期与决策水平。 4.3 Risk Assessment 风险评估
Risk assessment: consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards (as defined below). Quality risk assessments begin with a well-defined problem description or risk
question. When the risk in question is well defined, an appropriate risk management tool (see examples in section 5) and the types of information needed to address the risk question will be more readily identifiable. As an aid to clearly defining the risk(s) for risk assessment purposes, three fundamental questions are often helpful: 风险评估：其包括辨识危险因素与暴露在这些危险因素(定义于后)相关风险的分析和评估。质量风险评估开始于一个明确的问题或风险问题。当被讨论的风险被明确定义后，则将会很容易确定适当的风险管理工具(见第 5 节中的例子)翻译：徐禾丰 9
Quality Risk Management/质量风险管理
和需要用于风险问题说明的资料类型。在风险评估时，作为明确定义风险的辅助工具，通常如下这三个基本问题是非常有用的： 1. What might go wrong? 什么可能出错?
2. What is the likelihood (probability) it will go wrong? 会出错的可能性(概率)是什么? 3. What are the consequences (severity)? 结果(严重性)是什么?
Risk identification: is a systematic use of information to identify hazards referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Risk
identification addresses the “What might go wrong?” question, including identifying the possible consequences. This provides the basis for further steps in the quality risk management process.
风险辨识：其是指参照风险问题或问题描述，系统地运用信息来辨识危险因素。这些信息可能包括历史数据、理论分析、意见以及风险涉众的考虑。风险辨识关注“什么可能出错?”这个问题，包括辨识可能的结果。这为进一步的质量风险管理过程奠定了基础。
Risk analysis: is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.
风险分析：其是对风险所关联已经辨识了的危险因素进行估计。它是对发生事件可能性与及灾害严重性进行定量或定性过程。在一些风险管理工具中，探测伤害的能力(可检测性)同样是在估计风险中的因素。
Risk evaluation: compares the identified and analyzed risk against given risk criteria. Risk evaluations consider the strength of evidence for all three of the fundamental questions.
风险评价：其是比较已经辨识和分析的风险与给定的风险标准进行比较。风险评价考虑到了所有这三个基本问题的证据强度。
In doing an effective risk assessment, the robustness of the data set is important
because it determines the quality of the output. Revealing assumptions and reasonable sources of uncertainty will enhance confidence in this output and/or help identify its limitations. Uncertainty is due to combination of incomplete knowledge about a process and its expected or unexpected variability. Typical sources of uncertainty include gaps in knowledge gaps in pharmaceutical science and process understanding, sources of harm (e.g., failure modes of a process, sources of variability), and probability of detection of problems.
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Quality Risk Management/质量风险管理
在进行一个有效的风险评估时，数据集的完美性很重要，因为它决定了输出的质量。显示假设及合理资源不确定性将会加强输出的可靠性，并且/或有助于辨识其限度。不确定性是由于关于过程不完整的知识以及其期望的或非期望的变异性综合造成。典型的不确定来源包括制药科学知识差距、对过程理解差距、伤害来源(如一个过程的失效模式，变异行来源)以及发现问题概率。
The output of a risk assessment is either a quantitative estimate of risk or a qualitative description of a range of risk. When risk is expressed quantitatively, a numerical probability is used. Alternatively, risk can be expressed using qualitative descriptors, such as “high”, “medium”, or “low”, which should be defined in as much detail as possible. Sometimes a \In quantitative risk assessments, a risk estimate provides the likelihood of a specific consequence, given a set of risk-generating circumstances. Thus, quantitative risk estimation is useful for one particular consequence at a time. Alternatively, some risk management tools use a relative risk measure to combine multiple levels of severity and probability into an overall estimate of relative risk. The intermediate steps within a scoring process can sometimes employ quantitative risk estimation.
风险评估的输出既是一个对风险定量估计也是一个对风险范围的定性描述。当风险被定量地表达，则运用数值表达它的概率。另外，风险还可以运用如“高”、“中”或“低”等定性描述词来表达，对其应该尽可能详细地确定。一些时候，使用“风险记分”来进一步确定描述风险的排列。在定量风险评估中，对一个风险估计能提供一个特定结果的可能性，给出一系列产生风险状况。因此，定量风险评估对于在某个时间的特定后果非常有用。另外，一些风险管理工具采用了相对的风险度量将多种级别的严重性和概率合并到一个完整的相对风险估计中。在一个记分过程的中间步骤有时候可以使用定量风险评估。 4.4 Risk Control风险控制
Risk control: includes decision making to reduce and/or accept risks. The purpose of risk control is to reduce the risk to an acceptable level. The amount of effort used for risk control should be proportional to the significance of the risk. Decision makers might use different processes, including benefit-cost analysis, for understanding the optimal level of risk control.
风险控制：其包括做出的降低和/或接受风险的决定。风险控制的目的是降低风险到一个可接受的水平。用于风险控制所作工作量应该与风险的显著性相称。决策者可能会采用不同的过程，包括收益成本分析，来了解最佳的风险控制水平。
Risk control might focus on the following questions: 风险控制可能会集中在下列问题： ? Is the risk above an acceptable level? 是否风险超过了一个可接受的水平?
? What can be done to reduce or eliminate risks? 什么方法可以用来降低或消除风险?
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Quality Risk Management/质量风险管理
? What is the appropriate balance among benefits, risks and resources? 效益、风险和资源之间的恰当的平衡点是什么?
? Are new risks introduced as a result of the identified risks being controlled? 控制已经所辨识的风险是否引入新的风险?
Risk reduction: focuses on processes for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level (see Fig. 1). Risk reduction might include actions taken to mitigate the severity and probability of harm. Processes that improve the detectability of hazards and quality risks might also be used as part of a risk control strategy. The implementation of risk reduction measures can introduce new risks into the system or increase the significance of other existing risks. Hence, it might be appropriate to revisit the risk assessment to identify and evaluate any possible change in risk after implementing a risk reduction process.
风险降低：其是着眼于当风险超过了某个特定(可接受)水平(见图 1)后缓和或避免质量风险的过程。风险降低可能包括用于减缓伤害的严重性和概率所采取的行动。改善危险因素和质量风险可检测性的过程也可能作为一个风险控制策略中的一个部分。通过实施风险降低措施，新的风险可能被引入到系统中或者显著增加其它已经存在的风险。因此，在实施风险降低过程后，可能会适当地返回到风险评估中对风险中任何可能的改变进行辩识和评价。
Risk acceptance: is a decision to accept risk. Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. For some types of harms, even the best quality risk management
practices might not entirely eliminate risk. In these circumstances, it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level. This (specified) acceptable level will depend on many parameters and should be decided on a case-by-case basis. 接受风险：其是一个接受风险的决定。风险接受可以是一个接受剩余风险的正式决定或者是当剩余风险不具体时的被动接受。对于一些类型的伤害，甚至最好的质量风险实践也未必能全部消除风险。这些情况下，可以认为已应用了恰当的质量风险管理策略，并且质量风险已降低到一个特定(可接受)的水平。这个(特定)可接受的水平将会取决于许多参数，并且具体情况具体判断定。 4.5 Risk Communication风险沟通
Risk communication: is the sharing of information about risk and risk management between the decision makers and others. Parties can communicate at any stage of the risk management process (see Fig. 1: dashed arrows). The output/result of the quality risk management process should be appropriately communicated and documented (see Fig. 1: solid arrows). Communications might include those among interested parties; e.g., regulators and industry, industry and the patient, within a company, industry or regulatory authority, etc. The included information might relate to the existence, nature, form, probability, severity, acceptability, control, treatment,
detectability or other aspects of risks to quality. Communication need not be carried out for each and every risk acceptance. Between the industry and regulatory
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