elements at a level of detail that is commensurate with the specific risk. Figure 1:典型质量风险管理过程简介
启动质量风险管理 风险风险鉴定 交流 风险分析 风险评估 不工合具 风险风险降低 风险接受 管理风险评估 风险风险质量管理的效果/结果 事件审核
Decision nodes are not shown in the 由于决策行为随时都可能发生，上图就没diagram above because decisions can 有显示决策点。这些决策有可能被反馈到occur at any point in the process. These 上一步以寻求更多信息，这些信息可用于decisions might be to return to the 调整风险模型；也可能用于管理过程的终previous step and seek further 止。注解：图中的“不可接受”项不仅指information, to adjust the risk models 违背了法令法规要求，也表示风险管理过or even to terminate the risk 程需要重头再来。 management process based upon information that supports such a decision. Note: “unacceptable” in the flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process. 4.1 Responsibilities 4.1. 职责分配 Quality risk management activities are 质量风险管理经常是但也不总是由交叉学usually, but not always, undertaken by 科团队执行。除了要有风险管理方面的经interdisciplinary teams. When teams 验人士，团队还应包括相关领域的专家are formed, they should include experts （ 例如：质量小组、事业发展、工程、from the appropriate areas (e.g., 管理，生产、行销、法律、统计和临床方quality unit, business development, 面等。决策者必须负责组织协调各部门之engineering, regulatory affairs, 间的关系，保障团队各项功能的有效发production operations, sales and 挥，确保整个管理过程得以合理展开、不marketing, legal, statistics and 断完善、反复审查，保障有足够的资源供clinical) in addition to individuals 团队使用。 who are knowledgeable about the quality risk management process. Decision makers should ? take responsibility for coordinating quality risk management across various functions and departments of their organization; and ? assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available. 4.2 Initiating a Quality Risk 4.2 质量风险管理的启动 Management Process Quality risk management should include 质量风险管理应包括这样一些系统程序，systematic processes designed to 这些设计好的程序用来协调，推动和改善coordinate, facilitate and improve 那些风险方面基于科学认识的决定。一项science-based decision making with 管理程序的发起和设计可能要经过如下步respect to risk. Possible steps used to 骤： initiate and plan a quality risk ?定义存在的难题和风险问题，包括识别management process might include the 潜在风险的相关假设； following: ?收集风险评估相关的关于潜在危险、危? Define the problem and/or risk 害或人体健康影响的背景信息和数据； question, including pertinent ?确定领导人和重要资源； assumptions identifying the potential ?详细说明决策的时间表，可交付性和适for risk; ? Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment; ? Identify a leader and necessary resources; ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process. 4.3 Risk Assessment 4.3 风险评估 当的标准。 Risk assessment consists of the 风险评估：此过程进行危险确认并对接触identification of hazards and the 这些危险所带来的风险进行分析评价。它analysis and evaluation of risks 以一个定义明确的难点描叙或风险问题开associated with exposure to those 始，当风险明确后，选择合适而有针对性hazards (as defined below). Quality 的管理工具和信息类型将会变得更容易。risk assessments begin with a 以下三个基本问题将有助于给出风险的清well-defined problem description or 晰定义。 risk question. When the risk in 1. 什么可能会出错？ question is well defined, an 2. 出错的可能性有多大？ 3. 出错的后果和严重性有哪些？ 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: 1. What might go wrong? 2. What is the likelihood (probability) it will go wrong? 3. What are the consequences (severity)? Risk identification is a systematic 风险鉴定：参照风险问题或难点描叙，系use of information to identify hazards 统利用已有信息去鉴定危险。这些信息包referring to the risk question or 括历史数据、理论分析、多方面观点和风problem description. Information can 险承担人的意见。风险鉴定时提出“什么include historical data, theoretical 会出错”这一问题，同时还确定可能答analysis, informed opinions, and the 案。这一过程为后续步骤奠定了基础。 concerns of stakeholders. Risk
企业质量风险管理中英文对照
