质量风险管理

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风险评估

风险评估包括风险识别、风险分析、风险评价三个部分

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risk assessment

Risk assessment includes three parts: risk identification, risk analysis, and risk evaluation

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风险识别

• 关注于将会出现的风险有那些，存在那些风险或潜在的风险、提出可能发生的风险
• 确定风险评估的问题/或风险提问，包括风险潜在性的有关假设
• 收集和组织信息，评估相关的潜在危害源，或对人类健康影响的背景资料与信息
  

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Risk identification

Focus on what risks will arise, what risks or potential risks exist, and propose possible risks

Identify issues for risk assessment/or risk questions, including assumptions about the potential for risk

Collect and organize information, evaluate relevant potential hazard sources, or background information and information on human health impacts

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风险分析

• 关注于风险发生的可能性有多大？风险发生的后果是什么
• 选择风险评估的工具
• 确定风险的因素，如发生的可能性危害的严重性，可测量性
• 界定风险因素的范围
  

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risk analysis

Focus on how likely the risk is to occur? What are the consequences of the risk

Select tools for risk assessment

Factors that determine the risk, such as the likelihood of occurrence, the severity of the hazard, and the measurability

Define the scope of risk factors

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风险评估

• 是指根据预先确定的风险评价方法与评价标准对已经确认风险进行评价，即确
• 定风险的严重程度
• 应用风险评估的工具进行风险评价，风险评价可以确定风险的严重性，将已识
• 别和分析的风险与预先确定的可接受标准比较
• 风险评价的结果可以是对风险的定量评估，也可以是对风险的定性描述
• 风险评估可以应用定性和定量的过程确定风险的严重性
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• risk assessment
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• It refers to the evaluation of identified risks based on pre-determined risk evaluation methods and standards
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• Determine the severity of the risk
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• Apply risk assessment tools for risk assessment, which can determine the severity of the risk
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• Comparison of risks analyzed with predetermined acceptable standards
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• The result of risk assessment can be a quantitative assessment of risks or a qualitative description of risks
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• Risk assessment can apply qualitative and quantitative processes to determine the severity of risks
  

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风险控制

• 风险控制包括制定降低和/或接受风险的决定。风险控制的目的是降低风险至可接受水平
• 包括风险降低和风险接受
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• Risk Management
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• Risk control includes making decisions to reduce and/or accept risks. The purpose of risk control is to reduce risks to an acceptable level
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• Including risk reduction and risk acceptance