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1、No. of issue:版本号: 01Failure Mode and Effects Analysis潜在失效模式及后果分析 date of issue:发行日期: 2012.4.12PI-823-QMS-01 Monitoring and measurement of processes过程的监视和测量 page:页码: 1 of:总页数 8Document文件Drawn by:编制Checked byTeam-leader/Manager:组长/经理审核Checked byDepartment Manager:部门经理审核Checked byDocument Manager:文件管理员
2、审核Approved by DGM:副总经理批准Approved by GM:总经理批准Name:姓名Tian Kai田凯Gao Peng高鹏 Jim.TimmermansTian Kai田凯Sun Rixu孙日旭Stephan Czerwonka陈泰房Date:日期 2012.4.10 2012.4.10 2012.4.10 2012.4.10 2012.4.11 2012.4.12Signature:签名Original signed原件签名Original signed原件签名Original signed原件签名Original signed原件签名Original signed原件签
3、名Original signed原件签名PI-823-QMS-01 01 avim solar production Co.,Ltd,Gaomi (China)1. 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。2. Scope of Application 范围- Avim
4、solar production Co.,Ltd, Gaomi/China埃孚光伏制造有限公司 高密/中国3. 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 minimizat
5、ion. 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 pro
6、ducts, 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 assemb
7、ling 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
8、BOM Bill of material原 材 料 清 单No. of issue:版本号: 01Failure Mode and Effects Analysis失效模式和影响分析 date of issue:发行日期: 2012.4.12PI-823-QMS-01 Monitoring and measurement of processes过程的监视和测量 page:页码: 2 of:总页数 8PI-823-QMS-01 01 avim solar production Co.,Ltd,Gaomi (China)MOD Moderator 主持人PDP Product developme
9、nt process产 品 开 发 程 序4. 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 is responsible for the coordination within Avim. 由 FMEA协调人负责FMEA程序,FMEA培训材料及总体
10、支持 。品保部负责埃孚内部的协调。- FMEA Moderator (MOD) FMEA主持人 The MOD ensures compliance with FMEA rules and applicable FMEA procedures. He/she is the local contact person for all questions in connection with the FMEA method and its implementation. 由FMEA主持人确保遵行FMEA规则及适用的FMEA程序。他或她是本地关于 FMEA方法及执行的一切问题的联系人。- Tasks
11、of the MOD: FMEA主持人的 任 务 Ensure a proper and complete preparation. 确 保 准 备 恰 当 而 全 面 Communicate basic knowledge about the method in case that team members do not possess it.在 团 队 成 员 不 了 解 方 法 时 , 和 团 队 成 员 沟 通 关 于 方 法 的 基 本 知 识 。 Moderate FMEA meetings. 主 持 FMEA会议。 Cancel FMEA meetings in case the
12、 premise are not given。在 前 提 条 件 不 具 备 情 况 下 取 消 FMEA会 议 。 Create and distribute FMEA reports. 创 建 并 发 布 FMEA报告。 The service of external FMEA moderators has to be approved project-specifically by QMS外 部 FMEA主持人服务具体由品保部批准。- FMEA Team FMEA团队 For efficient execution, interdisciplinary FMEA teams are fo
13、rmed, comprising normally of 4 to 8 participants. Further experts are called in as needed. It is helpful that the same team members stay through the entire project. 跨学科 FMEA团队一般由4 到8名成员组成,目的是为了有效的执行。如有需要,还可以另外请专家帮助,在整个项目期间,团队成员一直不变有益于项目的开展。 Each team member brings into the project, from their functi
14、onal area, the required specialist knowledge and all available information. Team members settle the problems occurring in their own speciality area, and consult with additional experts if necessary. Through their know-how and experience risks can be recognized and appropriate measures can be taken.
15、每一位团队成员根据各自的职能范围为项目提供所需专业知识和其他可能的信息。成员解决项目出现的各自专业知识范围内的问题,如有需要可咨询另外的专家。可借助于他们的专业技能和经验识别风险并采取妥当措施。 The participation in an FMEA meeting presupposes knowledge of the method. 参 加 FMEA的前提是了解其方法- Core FMEA Team: 核 心 的 失效模式及后果分析团队 MOD Moderator失效模式及后果分析主持人 QMS 品 保 部 ENG 技 术 部No. of issue:版本号: 01Failure Mo
16、de and Effects Analysis失效模式和影响分析 date of issue:发行日期: 2012.4.12PI-823-QMS-01 Monitoring and measurement of processes过程的监视和测量 page:页码: 3 of:总页数 8PI-823-QMS-01 01 avim solar production Co.,Ltd,Gaomi (China) MFG 生 产 部 TEF(optional) 设 备 部 ( 可 选 ) PUR(optional) 采 购 部 ( 可 选 ) External experts can complement the FMEA team. The ENG manager decides about their participation.