质量风险管理

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风险降低

• 确定风险降低的方法，当风险超过可接受的水平时，风险降低将致力于减少或避免风险
• 包括采取行动来降低风险的严重性或风险发生的可能性；应用一些方法和程序提高鉴别风险的能力
• 需要注意的是，风险降低的一些方法可能对系统引人新的风险或显著提高其他已存在的风险，因此风险评估必须重复进行以确定和评估风险的可能的变化
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• Risk reduction
• Determine the method of risk reduction. When the risk exceeds an acceptable level, risk reduction will focus on reducing or avoiding the risk
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• Including taking actions to reduce the severity or likelihood of a risk occurring; Apply methods and procedures to improve the ability to identify risks
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• It should be noted that some methods of risk reduction may introduce new risks to the system or significantly increase other existing risks, so risk assessments must be repeated to identify and assess possible changes in risks
  

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风险接受

• 确定可接受的风险的最低限度。设计理想的QRM策略来降低风险至可接受的水平
• 即使是最好的质量管理措施，某些损害的风险也不会完全被消除。在这些情况下，可以认为已经采取了最佳的质量风险策略，质量风险已经降低至可接受水平
• 这个可接受水平由许多参数决定并应该具体情况分别对待
  

Risk acceptance

Determine the minimum acceptable risk. Design an ideal QRM strategy to reduce risk to an acceptable level

Even with the best quality management measures, the risk of certain damages will not be completely eliminated. Under these circumstances, it can be considered that the best quality risk strategy has been adopted and the quality risk has been reduced to an acceptable level

This acceptable level is determined by many parameters and should be treated separately on a case by case basis

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1、什么是FMEA？

• FMEA是一组使设计、制造/装配过程尽可能完善的系统化的活动
• FMEA是一种识别产品或过程中的潜在失效，以便在失效影响到顾客之前采取纠正措施的分析工具
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• 1. What is FMEA?
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• FMEA is a set of systematic activities that make the design, manufacturing, and assembly processes as complete as possible
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• FMEA is an analytical tool that identifies potential failures in a product or process in order to take corrective action before the failure affects customers
  

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2、FMEA包含两种评价

• 1.是用历史数据，针对相似产品、服务、数据、顾客抱怨、及其他可取得得的信息，加以定义失效
• 2.使用统计推论、数学模式、模拟分析、同步工程及可靠度等已确认以及定义失效
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• 2. The FMEA includes two evaluations
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• Using historical data to define failures for similar products, services, data, customer complaints, and other available information
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• Identified and defined failures using statistical inference, mathematical models, simulation analysis, synchronous engineering, and reliability
  

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3 、一个良好的FMEA具备

• 确认已知及潜在失效模式
• 确认每一失效模式的效应和原因
• 依据风险优先指数（风险的严重程度，发生频率、可探测程度）
• 进行纠正就预防措施
• 风险接收的标准
• 风险的追踪与回顾
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• 3. A good FMEA has
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• Identify known and potential failure modes
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• Identify the effects and causes of each failure mode
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• Based on the risk priority index (severity, frequency, and detectability of risks)
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• Take corrective and preventive measures
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• Criteria for risk acceptance
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• Tracking and reviewing risks
  

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5、FMEA 是基于风险发生严重性、可能性、可测性 （SOD）三个方面进行评估风险的水平

• 风险发生的严重性（S）
• 风险发生的可能性（O）
• 风险发生的可探测性（D）
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