FMEA 培训Training (中英文版).ppt

FMEA WHAT ? 定义 What is a Failure Mode ? 什么是失效模式 Failure Effects 失效影响 Why use an FMEA?为什么要使用FMEA To evaluate the design validation plan (Product) and the current control plan (Process) for preventing failures from occurring. 为了评估产品/设计计划和当前控制计划(工序), 以期预防失效的发生. - Predict the impact corrective actions will have on specific failure modes 预测针对特定失效模式的整改行动的效果. - Establish a continuous improvement priority system. 建立基于持续改进的优化系统 Process Map Link to FMEA 工艺流程图与FMEA的联系 Definition of Terms 各要素定义 Process Step/Function: simple description of the process step or function being analysed. 工艺步骤/职能: 对工序做简单的描述或功能的分析 Failure Mode: the manner in which a specific Process Step could potentially fail to meet process requirements or intent. It is a description of malfunction at the process step under consideration. The Failure Mode can be associated with a failure in a previous operation or can be associated with a failure in a subsequent operation. 失效模式: 在该工序中引起无法满足设定要求的潜在原因, 并给予描述. 失效模式可能是与上道工序或下道工序的差错有联系. Failure Effect: impact on the customer. Generally external customer focus, but can also include downstream processes affected by the Failure Mode. The effect is described in terms of what the customer might notice or experience in the final product 失效影响: 对客户的影响. 通常是指外部客户, 但也可扩展至下道工序所受的影响. 该影响是指客户在产品的使用中会被告知或感受到的. Severity: a numeric rating given to a failure effect to describe the importance of the failure effect on the customer. Could also be concerned with potential safety or regulatory issues if failure occurs. (Scale usually 1-10, 1=not severe, 10=very severe) 严重度: 按失效模式影响的严重程度以量化的方式进行反映. 也可看作失效模式发生会产生潜在的安全性问题 Occurrence : frequency with which Failure Mode could occur. Usually refers to the frequency of a Failure Mode (Scale usually 1-10, 1=Not Likely, 10=Very Likely). 发生频次: 失效模式可能发生的频率 ( 标准1-10, 1 频率极低, 10 频率极高) C