FailureModeandEffectsAnalysis失效模式和影响分析.docVIP

Failure Mode and Effects Analysis 失效模式和影响分析 No. of issue: 版本号： 01 date of issue: 发行日期： 2012.4.12 PI-823-QMS-01 Monitoring and measurement of processes 过程的监视和测量 page: 页码： PAGE 2 of: 总页数 NUMPAGES 2 PI-823-QMS-01 01 avim solar production Co.,Ltd,Gaomi (China) . . Task / Objective目的 To define and establish basic requirements and a process to prepare, execute and follow-up Failure Mode and Effects Analyses. 为了规定建立基本的要求和程序以便于对失效模式及后果分析的准备、执行和跟踪。 Scope of Application范围 Avim solar production Co.,Ltd, Gaomi/China 埃孚光伏制造有限公司 高密/中国 Definitions术语和定义 FMEA 失效模式及后果分析 The Failure Mode and Effects Analysis (FMEA) is an analytical method of preventive quality assurance. It helps to identify and evaluate risks in time, and to initiate or propose suitable actions for risk minimization. The FMEA consists of 5 steps: Structural analysis, functional analysis, failure analysis, risk assessment and optimization. 失效模式及后果分析是预防性品质保障的一种分析方法，它可以帮助及时识别并评估风险，并启动或提议适当的行动把风险降低最低限度。失效模式及后果分析有五个步骤，即结构分析，功能分析，失效分析，风险评估及优化。 Product FMEA 产品的失效模式及后果分析 The Product FMEA analyses the design of products, product parts and their interfaces with regard to their quality over the whole product life cycle. 产品的FMEA是从产品寿命周期的角度来分析产品、产品部件、以及部件接合处的设计。 Process FMEA 过程的失效模式及后果分析 The Process FMEA analyses all planned and existing steps of process planning and process execution (manufacturing and assembling processes) until delivery to the customer. 过程FMEA对所有计划的和现行的过程设计和过程执行（生产和组装过程）步骤进行分析，直至发货给客户。 S Severity (of failure consequence) （失效后果的）严重度 O Occurrence probability (of failure cause) （失效原因的）频度 D Detection probability (of failure) （失效的）探测度 RPN Risk Priority Number 风险顺序数 BOM Bill of material 原材料清单 MOD Moderator 主持人 PDP Product development process 产品开发程序 Responsibilities职责 FMEA Organization FMEA的组织 FMEA Coordinator FMEA协调人 The FMEA coordinator is responsible for the FMEA procedure, FMEA training materials and general support. The QMS department i