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. Risk analysis is the estimation of the 风险分析：估计与已确认危险相联系的风risk associated with the identified 险，这是对危害发生的可能性和严重程度hazards. It is the qualitative or 进行定性和定量分析的过程。风险评价中quantitative process of linking the 同样也应用到某些管理工具检测危害的能likelihood of occurrence and severity 力（检测能力）。 of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk. Risk evaluation compares the 风险评估：将经过分析和鉴定的风险同给identified and analyzed risk against 定标准作比较，考虑三个基本问题的证据given risk criteria. Risk evaluations 力。风险评估中，数据的有效性决定了评consider the strength of evidence for 估结果的质量。揭示、设想、分析不确定all three of the fundamental questions. 性的来源将有助于增强对结果的信心、识In doing an effective risk assessment, 别结果的局限性。对过程了解不充分、过the robustness of the data set is 程中可预见及不可预见变动的发生，都将important because it determines the 导致不确定性的发生。知识结构的不完quality of the output. Revealing 整，有限的药学发展水平、不充分的过程assumptions and reasonable sources of 理解、危险来源（不成功的过程模式、变uncertainty will enhance confidence in 动的来源）及问题被发现的可能性都是不this output and/or help identify its 确定性的典型来源。评估结果可以是对风limitations. Uncertainty is due to 险的定量表示，也可以是对分险程度的定combination of incomplete knowledge 性描述。定量表示时可用数值表示可能about a process and its expected or 性，用高 、中 、低来给风险排序时，各unexpected variability. Typical 个词的适用范围都要详细规定，有时候还sources of uncertainty include gaps in 用到风险评分来进一步定义。定量评估能knowledge gaps in pharmaceutical 对给定的风险衍生环境中特定结果发生的science and process understanding, 可能性做出判断。因此，定量评估一次只sources of harm (e.g., failure modes of 能评判一个特定结果。于是一些管理工具a process, sources of variability), and 用到相对衡量尺度，将多重水平的严重性probability of detection of problems. 和可能性结合起来，以完成对相对风险的The output of a risk assessment is 整体评估。评分过程的中间步骤有时也用either a quantitative estimate of risk 到定量风险估计方法。 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 \score\is used to further define descriptors in risk ranking. In quantitative risk assessments, a risk estimate provides the likelihood of a a specific set of consequence, given 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. 4.4 Risk Control 4.4 风险控制 Risk control includes decision making 风险控制包括风险抑低和风险接受两方面to reduce and/or accept risks. The 的决策过程，进行控制的目的是将风险降purpose of risk control is to reduce the 低到可接受水平 ，投入努力量应与风险risk to an acceptable level. The amount 的严重程度相衬。决策者应用包括效益-of effort used for risk control should 耗费比分析在内的不同的程序去理解风险be proportional to the significance of 控制的最佳水平。 the risk. Decision makers might use 风险控制过程中以下问题会受到关注： different benefit-cost processes, including 风险水平是否高于可接受水平之上？ for 怎样做才能降低乃至消除风险？ analysis, understanding the optimal level of risk 如何寻求效益、风险和资源之间的合适平control. 衡？ Risk control might focus on the 对已确定风险进行控制时是否会引入新的following questions: 风险？ ? Is the risk above an acceptable level? ? What can be done to reduce or eliminate risks? ? What is the appropriate balance among benefits, risks and resources? ? Are new risks introduced as a result of the identified risks being controlled? Risk reduction focuses on processes 风险抑低：此过程着力于减轻或避免超过for mitigation or avoidance of quality 一定水平（可接受水平）的质量风险，包risk when it exceeds a specified 括为减轻危害严重性和发生可能性而采取(acceptable) level (see Fig. 1). Risk 的一系列措施，还包括一些致力于改善危reduction might include actions taken 险及质量风险可检测性的程序。风险抑低to mitigate the severity and 过程可能会给系统带入新的风险，其他业probability of harm. Processes that 已存在的风险的严重程度也可能增加。因improve the detectability of hazards 此，完成风险抑低程序后，有必要再重复and quality risks might also be used as 一下质量评估过程，来识别和评价风险系part of a risk control strategy. The 统的可能变化。 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.
企业质量风险管理中英文对照
