FailureModeandEffectsAnalysis失效模式和影响分析.doc

Failure Mode and Effects Analysis失效模式和影响分析No. of issue:版本号：01date of issue:发行日期：2012.4.12PI-823-QMS-01Monitoring and measurement of processes过程的监视和测量page:页码：8of:总页数81. 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 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 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。SSeverity (of failure consequence) （失效后果的）严重度OOccurrence probability (of failure cause) （失效原因的）频度DDetection probability (of failure) （失效的）探测度RPNRisk Priority Number风险顺序数BOMBill of material原材料清单MODModerator 主持人PDPProduct development process产品开发程序4. Responsibilities职责- FMEA Organization FMEA的组织- FMEA Coordinator FMEA协调人l 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培训材料及总体支持。品保部负责埃孚内部的协调。- FMEA Moderator (MOD) FMEA主持人l 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 of the MOD: FMEA主持人的任务l Ensure a proper and complete preparation. 确保准备恰当而全面l 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。l Moderate FMEA meetings. 主持FMEA会议。l Cancel FMEA meetings in case the premise are not given。在前提条件不具备情况下取消FMEA会议。l Create and distribute FMEA reports. 创建并发布FMEA报告。l 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l For efficient execution, interdisciplinary FMEA teams are formed, 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。l Each team member brings into the project, from their functional 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. 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。l 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l MOD Moderator失效模式及后果分析主持人l QMS 品保部l ENG 技术部l MFG生产部l TEF(optional)设备部（可选）l PUR(optional)采购部（可选）l External experts can complement the FMEA team. The ENG manager decides about their participation. 外来专家可以补充FMEA团队，由技术部经理决定他们的参与5. Description描述5.1 General 总论- FMEA has to be created or updated whenever one of the following points applies:当以下几种情况之下出现时，必须创建或更新FMEA：l New development of product or process 新的产品或过程开发l Changes in product or process 产品或过程有变化时l Changed application conditions for a product 产品的应用现状有变化时l Requirements changed by law or customer 法律规定或顾客对产品的要求发生变化- The Product FMEA is done at the engineering site and the Process FMEA is done at the manufacturing location. 产品的FMEA是在工程现场进行， 过程FMEA在生产制造场所进行。5.2 Integration of FMEA FMEA的整合5.2.1Integration of FMEA in the PDP（产品开发过程） 将FMEA的整合到产品开发过程中- For new product development projects the PDP defines when FMEA needs to be performed.对于新产品开发项目，由PDP决定何时启用FMEA。- ENG is responsible for product and process FMEA. 由技术部负责产品和过程FMEA5.2.2Updating of FMEA 失效模式及后果分析的更新- An already created FMEA has to be updated, e.g. due to changes in engineering design, manufacturing process, technical modifications, new applications for the product or any other changed boundary condition. 如出现工程设计和生产过程改变，技术性修改，产品新的应用，或其他边界条件的改变，已经创建的决定失效模式及后果分析必须更新。- It is the decision of the ENG manager to call for an additional FMEA meeting. 由技术部经理决定另外召开失效模式及后果分析会议5.3 Input for FMEA FMEA的输入5.3.1Input for Product FMEA 产品的FMEA的输入- The latest time to execute the initial version of the Product FMEA is after completion of the preliminary engineering design. 最初版本的产品FMEA最晚要在其初步工程设计完成时开始执行。- Required: 要求：l Preliminary engineering design (assembly drawing including position numbers) and preliminary BOM Functional analysis 初步工程设计（附带位置序号的安装图纸）和初步的BOM功能分析。l Product Concept / preliminary Project Management Plan.产品概念或初步的项目管理计划。l List of failures in the field of the predecessor product 在之前产品一栏列出故障清单。l Report concerning conformity with standards. This report has latest to be existent to the update of the Product FMEA before start of Process FMEA. 关于标准符合性的报告。在启动过程FMEA之前，这个最新的报告与产品FMEA的一起更新。- Recommended: 推荐l Exploded view 部件分解图l Overview subassemblies and possible assembly procedure 部件概况以及可能的装配程序。l Preliminary Test Plan or Test Plan from predecessor product 初步测试计划或前一期产品的测试计划l Functional prototype / already existing single parts 功能样板或现成的零件。l Similar product(s) including list of errors / weak points 类似产品（附带缺陷或瑕疵的清单）5.3.2Input for Process FMEA 过程FMEA的输入- Required: 要求：l Preliminary production layout and manufacturing plan 初步的设计布局和生产计划。l Assembly drawing including position numbers, individual part drawings (if available) and BOM 标注位置序号的安装图纸，单个的零件的图纸（如果可以）和物料清单。l (Demounted) prototype （卸除的）样品l Drawing of part/component (inhouse manufactured part/component) 零件或元件（自己生产的零件或元件）的图纸l List of failures / problems in manufacturing of the predecessor product 制造前期产品失效或问题的清单l Control Plan of predecessor product (if existent) 前期产品的控制计划(如果存在)l Updated Product FMEA 更新的产品FMEA5.4 Execution of an FMEA 一个FMEA的执行- Step-1: Structural analysis 第一步：结构分析l Listing and structuring of all elements involved. Creating a tree structure. 列出并组织所有相关元素，建立一个树状结构。- Step-2: Functional analysis 第二步：功能分析l Listing of all functions and characteristics of the elements. The total life cycle of the product has to be analyzed. 列出这些元素所有的功能和特性。分析产品整个生命周期。l Functions include internal and external requirements and expectations. They must be described with a noun and a verb. 功能包含内部和外部共同的要求和期望。用一个名词和一个动词来描述这些功能。l Characteristics are requirements that are specified with measurable variables as much as possible. 特性是由尽可能多的可测量变量规定的要求。l The more accurate the description of the functions and characteristics is, the more accurately the potential malfunctions can be derived. 对功能和特性的描述越准确，就越能准确地推导出可能存在的失效- Step-3: Failure analysis 第三步 失效分析l Analysis of potential malfunctions and functional deficits or potential process failures 分析可能存在的故障以及功能障碍或可能存在的过程失效- Step-4+ 5: Analysis of risks and optimization 第四步和第五步：风险分析和优化l Risk assessment for the current status, without additional measures。 不采取附加措施，对现状进行的风险评估。l Documentation of corrective measure(s) 对纠正措施进行记录l Risk assessment for the optimized status 对优化后状况进行风险评估- Documentation Job done marks: 工作完成标志：l A job done mark can be used by the MOD to sign in the FMEA file that an item was discussed in the FMEA meeting. 当一个项目在FMEA会议讨论之后，FMEA主持人可用工作完成标志FMEA文件中标注l The failure analysis, the analysis of risks and the optimization are done in the FMEA meeting by the interdisciplinary FMEA team. If the FMEA team identifies a risk, a discussion starts whether the risk is acceptable or not. 跨学科FMEA团队在FMEA会议上进行失效分析，风险分析，以及优化。一旦FMEA团队识别出一项风险，将对该风险能否接受进行讨论。a) Acceptable risk (always low RPN) 可接受风险（总是低风险顺序数）To document the result of the discussion of all acceptable risks the function can be marked by a job done mark. That means the FMEA team discussed the item in a sufficient way and identified no need for additional actions. The remaining risk is accepted. 为了记录讨论所有可接受风险的结果，可用工作完成标志来对该功能进行标注。也就是说FMEA团队已经对该项目进行充分讨论并认定不需要采取附加措施，当前的风险是可接受的b)Not acceptable risk 不可接受风险An open point will be created and measures to reduce the risk to an acceptable level will be defined. 将创建一个开放点并定义把风险降至可接受的程度的措施。NF No Failure: The conclusion of the discussion by the FMEA team in the FMEA meeting is that the remaining risk is low and accepted. Further actions are not necessary. 无失效：FMEA团队在FMEA 会议上讨论的结论为当前的风险很低，可以接受，没有必要采取附加措施。KP Known Predecessor: The conclusion of the discussion by the FMEA team in the FMEA meeting is that this technical solution is similar to the technical solution of a predecessor (engineering design or process design). It is proved in series production. Field (outside of avim) issues are not known. The conditions are not changed. The remaining risk is low and accepted. Further actions are not necessary. 已知的前期产品。FMEA团队在FMEA会议上讨论得出的结论是该技术方案与之前期产品(工程设计或过程设计)的技术方案类似，这在批量生产中得到了验证。未知的是外界（埃孚之外）问题。情况没有改变。当前的风险很低，可以接受。没有必要采取附加措施。- All potential weak points, discussed in the FMEA meeting, will be included in the FMEA documentation. 在FMEA会议中讨论的所有可能的弱点都将归入FMEA文档5.5 Risk Assessment风险评估- Potential failure modes are rated according to the severity of the failure consequence (S), the occurrence probability (O) and the detection probability (D). The evaluation tables (see appendix 1) based upon a 10-point rating scale are a binding skeleton to which local requirements may be added. 的失效模式是通过失效结果的严重度 (S), 频数(0)和探测度(D)进行分级的。分级表（见附件1）是1-10级，此等级标度是主要框架，可添加实际要求。- The Risk Priority Number (RPN) is the product of S, O and D. 风险顺序数是S,O和D等级的乘积。- For each open point a corrective measure has to be defined, which reduces the RPN. 对于失效的问题点，必须明确纠正措施，来降低RPN值。- The RPN is calculated twice for each potential failure mode. First for the current status without taking measures and then for the estimated situation after introducing the corrective actions(s). Thus, it becomes obvious whether or not the planned action(s) leads to the desired risk reduction. 在每个失效模式中，风险顺序数进行两次评定。首先对采取措施之前的现行状态进行计算，而后是纠正措施引入后的预计可达状态。计划的行动是否能实现预期的风险降低将显而易见。- If S is 9 or 10 and O1 and D1 for the improved situation after the FMEA team decides upon the corrective action(s), the potential failure mode is a project endangering open point. 在FMEA 工作组明确纠正措施之后，如果已改良状态的评分是S=9 或者 10，O1且 D1，则可称之为失效模式称之为项目中的危险点。- If S is 7 or 8 and O2 and D2 the FMEA team has to discuss whether the failure is a project endangering open point or not. 如果S=7或者8，O2 且 D2，则FMEA团队必须讨论此失效是否为项目危险点- Project endangering open points need to be added to the Risk Assessment Sheet and require a formal corrective action review in the weekly manager meeting. 项目危险点需要被添加在风险评估表中，并在周经理会上要求一个正式的纠正措施评审。- All corrective actions are reviewed by the FMEA team until completion. 所有的纠正措施都需要被FMEA团队评审，直到完成。5.6 Forms and Instructions表格和说明5.6.1Language语言 For local projects which only affect one site (including FMEA approval), the respective national language is allowed. For international and cross-language projects the language of the FMEA meeting and the FMEA report is English对于本土项目，仅对某个位置产生影响的（包括FMEA申请），可使用本国通用语言。 对于国际性的或跨语种的项目，FMEA会议及FMEA报告必须使用英语5.6.2FMEA Report报告5.6.2.1Number of the FMEA Report FMEA 报告的编号 For each product/product family or process which has to be analyzed by FMEA the local MOD has to assign a unique number. All FMEAs carried out for this product/product family or for this process have the same number. Changes and updates of FMEA files are identified with versions. 对于必须经过FMEA分析的每种产品/产品系列或者过程，本土的主持人必须给出一个独一无二的编号。所有有关于此产品、产品系列或者是过程FMEA的实施都必须使用同一编号。FMEA文件的修改和更新由不同的版本来识别。5.6.2.2Structure of the FMEA Report FMEA报告的构成 The FMEA report consists of following parts失效模式效果分析报告包含下列各部分: l Cover sheet 封面l Comments about the scope of analysis and carrying out 分析及实施范围的评价l Attendance sheet of FMEA meeting (signatures of the participants) FMEA会议的与会者（参会人员签字）l Picture or drawing and BOM照片、图纸及物料清单a) This form shows the subject matter as an assembly drawing, exploded view or picture of the CAD-model including a Bill of Materials with reference to the pictured representation. 这个表单显示了照片展示的参考信息如装配图纸、部件分解图或者是CAD模式的照片，包括物料清单l Project endangering open points 未解决的项目危险点a) This form serves for the overview of all project endangering potential failure modes.此表格是为了支持所有未解决的项目危险失效模式的概览l Open points 未解决的：a) Functions, failure modes, effects and causes, RPN as well as possible corrective measures with naming the responsible persons and a due date will be logged in this form. 功能，失效模式，后果及起因，RPN，最好也包括已经确定负责人及截止日期的纠正措施，记录在此表格中。l Master forms 主要表格a) FS-823-QMS-03“FMEA Cover sheet” and FS-823-QMS-04 “Failure Mode and Effects Analysis” FS-823-QMS-03潜在失效模式及后果