质量风险管理工具介绍

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ISHIKAWA因果图
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， 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 按人、方法、设备、物料、度量、环境分类。
Criteria标准
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） Single manually operated validated detection system that is a direct measure of failure.单个手动操作并已验证的探查 系统，直接测定失败 Single manually operated validated detection system that is not a direct measure of failure.单个手动操作并已验证的 探查系统，不是直接测定失败 Non validated (manual or automated) detection.没有验证 过（手工或自动）可探查性 No ability to detect the failure.没有能力探查到失败
Measurements
Machines
Methods
Effect
People
Environment
Materials
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Failure Modes and Effect Analysis (FMEA)失效模式和效果分析
•FMEA develops the simple Risk Ranking approach by adding another variable – “detectability” to probability and severity. FMEA通过在概率和严 重性的基础上增加另一个变量--“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 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， 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。
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 being examined. These sources are then targeted for improvement. The diagram also illustrates the relationships among the wide variety of possible contributors to the Hale Waihona Puke Baiduffect.目的是鉴别一个具体问题（结 果）的可能原因。然后决定几个关键来源因素，其对被 检查的问题有最显著的贡献。然后设定这些来源因素以 期改进。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。
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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 帮助决定使用的工具:
Methodology方法学 e.g. formal or informal risk management process如，正式或非正式的 风险管理过程 System risks系统风险 e.g. risk ranking and filtering, FMEA如，风险排序和过滤、 FMEA Process risks流程风险 e.g. FMEA, HACCP, process mapping, flow charts如， FMEA、HACCP、 流程地图、流程图 Product risks产品风险 e.g. flow charts, decision trees, tables, check sheets如，流程图、决策 3 树、表格、检查表
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A moderate probability of occurrence适度可能性发生
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A high probability of occurrence 高度可能性发生
Detectability 可探查性
Value 数值
1
Description说明
High degree of detectability高度可探查 性
Risk Management Tools 风险管理工具
Risk Management Tools 风险管理工具
Cause and Effect (Ishikawa) diagrams 因果图（ Ishikawa） Failure Mode Effect Analysis (FMEA) 故障模式影响分析（ FMEA） Preliminary Hazard Analysis (PHA) 预先危险分析 Probabilistic Risk Analysis (PRA) 概率风险分析
•Describe the process in general unit operations and then section each unit operation into its component parts. Use a detailed flow chart of the process. Sectioning of the unit operation should be done in process increments of sufficient size to enable accurate risk assessment for each unit operation and in turn the entire manufacturing train.描述整个单元操作中的工艺流程， 并分解单元操作中的每一工序部分。使用工艺的详细流程图。单元操作 的分解应在足够的工艺范围内进行，以确保对每个单元操作并随之的整 个全生产流程进行准确的风险评估。
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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
Batch failure, not recoverable by rework整批 失败，不可以通过重新加工而恢复
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. Measurements
Machines
Methods
Effect
People
Environment
Materials
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ISHIKAWA因果图
The last step consists in thinking about 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 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。
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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 表开始为画一个水平线，水平线的末端为代表的问题（ 结果）。 Problem
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3
Good detectability好的可 探查性
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Likely to detect有可能探 查
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Fair detectability一般可 探查性 Low or no detectability很 低或无可探查性
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Failure Modes and Effect Analysis (FMEA)失效模式和效果分析
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Disastrous灾难性
Probability概率
Value 数值
1
Description说明
An unlikely probability of occurrence不可能发生 A remote probability of occurrence微弱可能性发生 An occasional probability of occurrence偶尔可能发生
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Severity严重性
Value 数值
1 4 9
Description说明
Irrelevant不相关 Slight轻微 Important重要
Criteria标准
No impact to product quality对产品质量不影 响 No impact to product quality对产品质量不影 响 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。
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Failure Modes and Effect Analysis (FMEA)失效模式和效果分析
•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 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
Criteria标准
Failure has never been but it is theoretically possible.失败从来未发生，但是理论上可 能发生。 Failure only seen once or twice只发生过一 两次失败 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。 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。 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 11 求活跃的非-标准反馈控制环路。