质量风险管理工具介绍资料

1、Risk Management Tools 风险管理工具风险管理工具 Risk Management Tools 风险管理工具 Cause and Effect (Ishikawa) diagrams 因果图因果图（ Ishikawa） Failure Mode Effect Analysis (FMEA) 故障模式影响分析故障模式影响分析（ FMEA） Preliminary Hazard Analysis (PHA) 预先危险分析预先危险分析 Probabilistic Risk Analysis (PRA) 概率风险分析概率风险分析 2 Risk Management Tools 风险管理工具 The level of detail and quantification needed helps to determine the tool to use需要的详细程度和定量水平需要的详细程度和定量水平 帮助决定使用的工具帮助决定使用的工具: Methodology方法学方法学 e.g. formal or informal risk management process如，正式或非

2、正式的如，正式或非正式的 风险管理过程风险管理过程 System risks系统风险系统风险 e.g. risk ranking and filtering, FMEA如，风险排序和过滤、如，风险排序和过滤、 FMEA Process risks流程风险流程风险 e.g. FMEA, HACCP, process mapping, flow charts如，如， FMEA、HACCP、 流程地图、流程图流程地图、流程图 Product risks产品风险产品风险 e.g. flow charts, decision trees, tables, check sheets如，流程图、决策如，流程图、决策 树、表格、检查表树、表格、检查表 3 ISHIKAWA因果图 The purpose is to identify probable causes for a specific problem (effect). Then to determine the few key sources that contribute most significantly to the problem

3、being examined. These sources are then targeted for improvement. The diagram also illustrates the relationships among the wide variety of possible contributors to the effect.目的是鉴别一个具体问题目的是鉴别一个具体问题（结结 果果）的可能原因的可能原因。然后决定几个关键来源因素然后决定几个关键来源因素，其对被其对被 检查的问题有最显著的贡献检查的问题有最显著的贡献。然后设定这些来源因素以然后设定这些来源因素以 期改进期改进。图表同样解释了对结果起贡献的各种不同的来图表同样解释了对结果起贡献的各种不同的来 源因素之间的关系源因素之间的关系。 4 ISHIKAWA因果图 The creation of the diagram starts drawing a horizontal line, at the end of which the problem (effect) is represented. 图图 表开始为

4、画一个水平线表开始为画一个水平线，水平线的末端为代表的问题水平线的末端为代表的问题（ 结果结果）。 Problem 5 Then, 4 to 6 main influencing aspects are identified and represented as diagonal lines. In many applications, the main causes can be grouped under People; Methods; Machines; Materials; Measurements; Environment然后，然后， 鉴定出鉴定出4-6个主要影响因素，并画斜线。在许多应用场合，主要原因可以个主要影响因素，并画斜线。在许多应用场合，主要原因可以 按人、方法、设备、物料、度量、环境分类。按人、方法、设备、物料、度量、环境分类。 . Effect People Machines Methods Environment Materials ISHIKAWA因果图 Measurements 6 The last step consists in thinking a

5、bout the causes for the problem arising from each one of the main aspects, and drawing them in the diagram. The ultimate cause should be specific, measurable and controllable最后一步包最后一步包 含思考每一个主要因素的根源，并将其在图中画出。最终的根源应该具含思考每一个主要因素的根源，并将其在图中画出。最终的根源应该具 体、可度量和可控制。体、可度量和可控制。 Effect People Machines Methods Environment Materials ISHIKAWA因果图 Measurements 7 FMEA develops the simple Risk Ranking approach by adding another variable “detectability” to probability and severity. FMEA通过在概率和严通过在概率和严 重性的基础上增加重性的基础

6、上增加另一个变量另一个变量-“可探查性”开发了简单的风险排名方法。“可探查性”开发了简单的风险排名方法。 Detectability: what mechanisms are in place (if any) to detect a failure if it were to occur?可探查性：如果发生失败，什么机制（如果有的话）可以可探查性：如果发生失败，什么机制（如果有的话）可以 探查失败？探查失败？ The intent of FMEA is to assess causes of potential failure to determine priorities for actions that would reduce severity, reduce occurrence, and increase probability of detection. FMEA的目的是评估潜在失败的原因，的目的是评估潜在失败的原因， 以决定行动的优先顺序。采取的行动会减少严重性、减少发生率、并增以决定行动的优先顺序。采取的行动会减少严重性、减少发生率、并增 加侦查的可能性。加侦查的可能

7、性。 Failure Modes and Effect Analysis (FMEA)失效模式和效果分析 8 Create a scale for each variable (i.e. a scale for Severity; a scale for Probability; and a scale for ability to Detect) with definitions for each level.为每个变量制定标尺，定义各级程为每个变量制定标尺，定义各级程 度（如，严重性的标尺；概率的标尺；可侦查性的标尺）度（如，严重性的标尺；概率的标尺；可侦查性的标尺） e.g. For Risk Analysis of a process如，一个工艺的风险分析如，一个工艺的风险分析 Failure Modes and Effect Analysis (FMEA)失效模式和效果分析 9 Severity严重性严重性 Value 数值 Description说明 Criteria标准 1 Irrelevant不相关 No impact to product quality对产品质量不影

8、 响 4 Slight轻微 No impact to product quality对产品质量不影 响 9 Important重要 Noticeable impact to product quality, but can be recovered by reprocessing对产品质量有可 见的影响，但能通过返工而恢复质量。 16 Critical 紧要关键 Definite impact to product quality that may require rework对产品质量有确定的影响，需 要返工 25 Disastrous灾难性 Batch failure, not recoverable by rework整批 失败，不可以通过重新加工而恢复 10 Probability概率概率 Value 数值 Description说明 Criteria标准 1 An unlikely probability of occurrence不可能发生 Failure has never been but it is theoretically possible.失败从来未发生，但是理

9、论上可 能发生。 3 A remote probability of occurrence微弱可能性发生 Failure only seen once or twice只发生过一 两次失败 5 An occasional probability of occurrence偶尔可能发生 Failure potential has been noted. If procedures are followed the failure potential is minimal.已注意到有潜在失败。 如果遵循规程，失败潜在可能是最小。 7 A moderate probability of occurrence适度可能性发生 Failure potential has been noted. Additional in process control maybe required to avoid failure.已注意到有潜在失败。应需要额外 的流程控制以避免失败。 9 A high probability of occurrence 高度可能性发生 Failure potential has been noted. An active non-standard feed back control loop may be required.已注意到有潜在失败。应要 求活跃的非-标准反馈控制环路。 11 Detectability 可探查性可探查性 Value 数值 Description说明 Criteria标准 1 High degree of detectability高度可探查 性 A: Validated automatic detection system that is a direct measure of failure.已验证的自动探查系统，直接测定失 败/失效。 B: Two or more manual operated validated detection systems, direct or indirect.两个或更多个手动操作并已验 证的探查系统，直接或间接（测定失败） 3 Good detectability好的可 探查性 Single manually operated validat

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