FMEA 失效模式影响分析 中英文版

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FMEA 失效模式影响分析 中英文版 五大质量手册
TABLE OF CONTENTS 目录 General Changes 总变更 General FMEA Guidelines FMEA的通用指南 Introduction 简介 FMEA过程 Purpose of Manual 于册目的 手册范围 Impact on Organization and Management 对组织和管理的影响. FMEA Explained FMEA说明 Follow-up and Continuous Improvement 6 跟进及持续改进 +· 第二章 Overview of FMEA Strategy Planning and Implementation 对FMEA的战略,策划和执行的概述 Introduction 简介 11 Basic st 基本结构 proach .8 方式 Identify the Team 定小组 10 Define the Scope 10 定义范围 10 Define the Customer 定义顾客 Identify Functions, Requirements, and Specifications 识别功能,要求和规定 Identify Potential Failure Modes...... 12 识别潜在失效模式 Identify Potential Effects…… 识别潜在后果 Identify Potential Causes……… 识别潜在起因 Identify Controls 识别控制 Identifying and Assessing Risk 识别和评估风险 Recommended Actions and Results…....…… 建议措施和结果… Management Responsibility………… 管理职赍 Chapter II 第三章 DFMEA Design Failure Mode and Effects Anal DEMEA设计失效模式及后果分析 简介 16 顾客定义 16 Team Approach 小组工作方式 Manufacturing, Assembly and Serviceability Consideration………… 制造,组装和可服务性考虑 17 Development of a Design FMEA 设计FMEA开发 Prerequisites…… 18 前提条件 Block(Boundary) Diagrams 方块图(界线)图 参数图 unctional required 功能要求 Other tools and Information Resourccs 其它工具和信息资源 Example DFMEA 设计FMEA范例… Header of the design FM上 A Form( fields A-H)… 设计FMEA表格表头(区域A body of the DFMEA Form(fields a-n) 设计FMEA表格主体(区域a-n) Maintaining DFMEAS……………… 设计FMEA维护 DFMEAS 设计FMEA利用 链接 111 --, Dcsign Verification Plan Report ( DVP&r) 设计验证策划和报告(DⅤP&R)…… PFMEA 过程FMEA 第四章 PFMEA Process Failure Mode and Effects Analysis 过程FMEA过程失效模式及后果分析. Introduction 68 简介 Customer Defined... 顾客定义 …69 Team approach 小组工作方式 69 Design Considerations……… 设计考底 Development of a Process FMEA 过程FMEA开发 Prerequisites 70 前提条件 Process Flow Diagram and linkage to PFMEA 过程流程图和过程FMEA链接 Other Tools and Information Sources..... 其它的工具和信息资源来源 研究信息… Example PFMEA Form……… 过程FMEA表格范例 Header of the Process FMEA Form(fields A-H) 75 过程FMEA表格表头(区城A-H) ody of the PFMEA Form( 过程FMEA表格主体(区域a-n) Maintaining PFMEAs… 过程FMEA维护 Leveraging PFMEAs…… l10 过程FMEA利用 链接 Linkages 111 To DFMEA 关于设计FMEA. 关于控制计划 附录 APPENDICES …,113 Appendix A: Sample Forms 附录A:表格范例… 114 DFMEA Forms 114 设计FMEA表格 过程FMEA表格…… Appendix B: System Level FMEA…… 附录B:系统层FMEA. 接口 互相影响 Relationships 133 关系 Multiple Levels of Design FMEAs 133 设计FMEA的多个层面…… Appendix C: Alternative Risk Assessments…… 135 附录C:可选的风险评估 RPN可选项 135 Alternative: SO(S X O) 可选项:SO(SxO) Alternative:SOD,SD….…… 136 可选项;SOD,SD 界:界!… 136 Appendix D: Alternative Analyses Techniques……… 137 附录D:可逅的分析技巧 Failure Mode, Effect and Criticality Analysis(FMECA) 失效模式,后果和危险程度分析( FMECA 137 Design review based on Failure Modes( DRBFM)…………… 依据失效模式的设计评审DRBM 137 ault Tree Analysis(FTA………………… 故障树分析(FTA References and Suggested Readings 1 参考资料和推荐阋读书籍, 守于着 索引 TABLES and FIGURES 表格和图 Figure II. 1a Block( Boundary)Diagram Examples Figurcs IIL 1b, c Block(Boundary) Diagram Examples 图ⅢIa方块(界线)小意图示例 Figure IlL. 2 Example of a Parameter(P)Diagram for a Generic Catalytic Converter. 图ⅢIb,c方块(界线)图示例 Table [IT. 1 Sample DFMEA Form with Minimal Information Elements Example Entries 图Ⅲ2一般催化转变的参数图范例 Table 1ll. 3 Example Potential Failure Modes 32 表格Ⅲ1包含必要信息要索和例证的 DFMEA表格样版 Table IL 4 Example Potential E1 35 表格Ⅲ3潜在失效模式范例 Table Cr I Suggested DFMEA Severity Evaluation Criteria 表格Ⅲ4潜在后果范例 Table Ill.5 Example Potential Causes ………42 表格Cr1建议 DFMEA严重度评价准则 Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria 表格I5潜在原因的范例 Table 1ll. 6 Examples of Prevention and Detection Design Controls 表格Cr2建议D}MEA频度评价准则 Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria 表格Ⅲ6预防和探测设讨控制的范例 Table III7 Examples of Causes, Controls and Recommended Actions 表格Cr3建议 DFMEA/PFMEA预防/探测评价准则 Figure II7 DFMEA Information Interrelationships Flow…………… 65 表格I7原因,控制和建议措施的范例…164 Figure IV 1 High Level to Detailed Process Maps 图Ⅲ7 DFMEA信息相互关系图 Figure Iv2 Example Process Flow Diagram……… 图IV1高层到详细过程图 Table IV I Sample PFMEA Form with Minimal Information Elements Example Entries 图Ⅳ2过程流程图范例 Table IV 2 Example of Process Step/Function/Requirements Columns on PFMEA Form including 表格IV1包含必要信息要素和例证的 DEMEA表格样版 Potential Failure Modes 表格ⅣV2在过程FMEA表格中包括潜在失效模式的过程步骤功能要求的范例 able Iv 3 Example of Effects 表格ⅣV3后果的范例 Table Crl Suggested PFMEA Severity Evaluation Criteria,……… 表格Cr1推荐的PMEA严重度评价准则 Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria 表格Cr2推荐的PMEA发生可能性评价准则 T able IV 4 Examples of Causes and Controls 表格ⅣV4原因及控制范例 Table Cr3 Suggested Process FMEA Detection Evaluation Criteria 表格Cr3建议过程PMEA探测评估准则 Table IV 5 Examples of Causes, Controls and Actions 表格Ⅳ.5原因,控制及措施范例. 110 Figure IV5 PFMEA Information Interrelationship Flow 111 图IV5 PFMEA信息相互关系图 DFMEA Form A…,, DFMEA表A FMEA Form B… DEMEA表B 116 DFMEA Form C DMEA表C 118 DF MEA Form D DFMEA表D A Form e DFMEA表E DFMEA Fom F DEMEA表F. PFMEA Form PFMEA表A PFMEA Form B PFMEA表B 123 PFMEA Form C… PFMEA表C PFMEA Form D.m..-. ““ P}MEA表D PFMEA Form E... 126 PFMEA Form F,....…… PFMEA表F PFMEA Form G PFMEA表G, 128 PFMEA表II 129 Figurc b 图B1相互联系和相可作用 Figure E.2lten, Functions, and Failure…… 图B项目,功能和失效 Figure B 3 DFMEA Effects Linkages 图B3DMEA后果链接 Table C 1 Contrast among RPN, SOD and sD 表格C1RN,SO和SD的对比 36 Examplc of DRBFM EL 138 图 D 1 DRBFM要素范例 Figurc D2 FTA Tree Structure 139 图D2FTA树形结构 Chapter i General FMEA guidelines 第章 FMEA的通用指南 FMEA的总体指南 Introduction 简介 This manual introduces the topic of Potcntial Failure Mode and ffects Analysis(FMEA)and gives general guidance in the 本于册介绍了潜在失效模式及后果分析(FMEA)的概 appl 念,给出了运用FMEA投术的通用指南。 FMEA Process MEA过程 FMEA is an analytical methodology used to ensure that potential HMEA是一种用以确保在产品和过程的开发过程中潜在 pr oblems have been considered and addressed througho product and process development process(APQP dvanced 问题被考虑并被阐明的分析方法(APQP一先期产品质 Product Quality Planning). Its most visible result is the 量策划〕。其最明显的结果就是跨职能小组的集体知识 documentation of the collective knowledge of cross-functional 的文件化 风险的评价是评估和分析的一部分。其重点是对设计 Part of the evaluation and analysis is the assessment of risk. The (产品或过程),功能和任何应用变更评审,以及潜在 important point is that a discussion is conducted regarding the design(product or process ), review of the functions and any 失效导致的风险进行讨论。 changes in application, and the resulting risk of potential failure 每个FMEA应确保关注产品或组装中的每个零部件。 MEA should ensure that attention is given to every 并对关键和安全性相关的零部件或者过程给予高度的重 in the produe related components or processes should be given a higher 适时性是成功实施FMEA最重要的因素之一,它是 个“事发前”的行为,而不是“后见之明”的行动。为 implementation of an FMEA program is timeliness. It is meant 达到最佳效益,FMEA必须在存在潜在失效模式的产品 to be a"before-the-event"action, not an"after-the-fact exercise 或过程被执行之前进行。事先花时间适当地完成 To achieve the greatest value, the FmEa must be done before the implementation of a product or process in which the failure FMEA分析,能够更容易、低成本地对产品过程进行 mode potential exists. Up-front time spent properly completing 修改,从而诚轻事后修改的危机。FMEA导致的活动 an Fmea, when product/process changes can be most easily 能够减少或消除因进行变更而带来更大损失的机会。 inexpensively implemented, will minimize late change crises Actions resulting from an FMEA can reduce or eliminate the 在理想的情况下,设计FMEA过程应该在设计和过程 hance of implementing a change that would create an even FMEA的早期阶段开始动,在工装或制造设备的开发 和采购之前。FMA涉及到设计和生产开发过程的每个 Ideally, the Design FMEA process should be initiated in the 阶段,同时可应用于问题的解决。 early stages of the design and the Process Fmea before tooling or manufacturing cquipment is developed and purchased. The FMEA也可应用于非生产的领域。例如,FMEA可以被 FMEA evolves throughout each stage of the design and 应用于管理过程中的风险分析,或是对安全系统的评 manufacturing development process and may also be used in 估。通常,FMEA应用于益处明显且潜在重要的产品设 dIving 计和制造过程中的潜在失效 fMeA can also be applied to non-manufacturing areas. For example, FMEA could be used to analyze risk in an Iministration process or the evaluation of a safety system. In general, FMEA is applied to potentiai failures in product design and manufacturing processes where the bencfits are clear and 2 General FMEA Guidelines 第 FMEA总仁指的 Chapter I of manual 手册的目的 Purpose This manual describes the basic principles and implementation of the FMEA process and how it is integrated within the product and process developent cycle. This includes the documentation 本手册描述了FMEA过程的基本原理和实施,以及 of this process and how the analyses can be applied for FMEA是如何在产品和过稈的开发周期中结合的。这包 ecessary improvement of a product or a process in its early and 括本过程的文件化,以及分析是如何在开发的早期和整 full development stage 个阶段中应用于产品或过程的适时的必要的改进 This manual also provides descriptions and examples of alternate and supporting methodologies for these analyses, their specific 本手册也提供对这些分析的备用的或支持的方法的描述 advantages and limitations, guidance of how the analysis is to be 和范例,他们特有优点和限制,以及如何分析以达到最 carried out for the maximum reliability improvement or 大的可靠性改进或潜在安全风险减轻的指南。本手册还 mitigation of potential safety risks. The manual provides guidance on how the risk can be represented, measured and 提供如何表述、测量,以及区分减轻失效后果的成本效 prioritized for cost effective mitigation of the failure effects 益的优先次序的指南。 As a tool in risk evaluation fmea is considered to be a method 作为一种风险评估工具,FMEA可以被看成是识别潜在 to identify severity of potential effects of failure and to provide 失效后果的严重度的一种方法,并为纾缓措施提供输入 an input to mitigating measures to reduce risk. In many 以减轻风险。在许多应用中,FMEA也包括对导致失效 applications, FMEA also includes an estimation of the probability of occurrence of the causes of failure and their 的原因及其导致的失效模式的发生机率的推断;这可以 resultant failure modes. This broadens the analysis by providing 通过提供失效模式可能性的测量以扩展分析。为了减少 a measure of the failure mode,s likelihood. To minimize risk the 风险,缄少失效发生的可能性以加强产品和过程的可靠 likelihood of failure occurrence is reduced which increas 性。FMEA是有助于改进可靠性的一种工具。 product or process reliability. FMEA is a tool that is instrumental in reliability improvement. 应用FMEA过程的时候会有三种基本的案例,每个案 three basic for which FMEa p IS 例都有不同的范围和重点 applied, each with a different scope or focus New designs, new 案例1:新设计、新技术或新过裎。该FMEA的 The scope of the Fmea is the complete 范围是完成设计、技术或过程。 案例2:修改现有的设计或过程。该FMEA的范 Case 2 Modifications to existing design or process 围应该在于修改设计或过程,有可能因 The scope of the MEA should focus on the 为某修改和市场上历史反映而有交互影 modification to design or process, possible interactions due to the modification and fieid 响。这可以包括法规要求的变更。 history. This can include changes in regulatory 案例3:在一个新的环境、地点、应用或使用信 息资料(包括工作循环,法规要求等) Case 3 Use of an existing design or process in a new 中使用一个现存的设计或过程 environment, location, application, o usag profile (including duty cycle, regulatory 该FMEA的范围是应重点关注新环境、 地点或应用方法在现有的设计或过程上 The scope of the FMea should focus on the 的影响。 mpact of the new environment, iocation, or application usage on the existing design or I 'The fmea present herein also is known as a Failure Modes Effects and Cntic nalysis(⊥MFCA) 1因为MFA包对风险的量化,所以在此也可称为是失效模式后果及关链分析( FMECA) General FMEA G 第章 HMFA的总体指南 hapter I Scope of Manual 手册的范围 The analytical methods presented in this manual are applicable 本于册中提到的分析方法适用于任何产品或过程。但 to any product or proccss. However, this manual will focus on 是,本于册会把重点放在汽车工业及其供应商的普遍应 those applications prevalent within the automotive industry and its suppliers Impact on Organization and Management 对组织和管理的影响 FMEA is an important activity within any company. Because the 在任何公司内FMEA都是一个重要的活动。因为 development of an FMEA is a multi-disciplined activity FMEA的开发是…个影响到整个产品实现过程的多方论 affecting the entire product realization process, its implementation needs to be well planned to be fully effective 证的活动,它的实施需要周详的计划以使其充分发挥效 This process can take considerable time and a commitment of the 力。这个过程需要一段相当长的时间,而且对所需要资 required resources is vital Important to FmEA development is a 源的诺是相当重要的。对于FMEA的开发来说,过 process owner and senior management commitment 程的所有人和最高管理部门的承诺是很重要的。 implementation approach will vary depending on the size and structure of the company concerned, although the principles will 尽管原则是相同的,实施的方法还是会随着相关公司的 规模和结构不同而不同: be the same The scope will cover FMEAs produced in house and by multi- 范围包括公司内部和由各阶供应商产生的FMEA ●当适用时,阐明设计和过程 FMEAS d process FMEAs, as applicable 通过将FMEA过程变成APQP过程的一个完整部分来 Accomplish this by having the FMEa process an integral part 完成。 of the apQP pro 工程技术评审的一部分。 Part of engineering technical reviews Part of the regular sign-off and approval of the product or 产品或过程设计定期的签核和批准的一部分, rocess FMEA是由多功能小组(或跨职能)小组开发的。小组 An FMEA is developed by a multi-functional (or cross- 的规模取决于设计的复杂程度以及公司的规模和组织 functional) team. The team size will depend both on the complexity of the design and the size and organization of the 小组的成员需要相关的专业知识,时间和管理者认可的 ompany Team members expertise 授权 tioned by manage 综合的培训项目的执行包括: should be implemented 管理的纵览 ◆ Management Overview 对使用者的培训 Training for user 供应商培训 建导者培训 最终,管理者对FMEA的开发和维护有责仼和所有 Ultimately, management has the responsibility and ownership for 权 of the FMEAs. Chapter I General FMEa gu FMEA总体指南 FMEA的解释 FMEA Explained FMEAs are an integral part of managing risk and supporting FMEA是支持风险管理和持续改进的一个重要部分。所 continual improvement. Consequently, FMEA becomes a key 以FMEA成为了产品和过程开发的个关键部分。先 part of Product and Process development. The Advanced Product 期产品质量策划(APQP)过程的定义在这个开发过程 Quality Planning(APQP)process identifies five general arcas of 中焦点的五个通用领城 focus in this development process 计划和定义项目 d Define program Product Design and Development 产品设计和开发 Process Design and Development 过程设计和开发 Product and Process validation 产品和过程的确认 Feedback Assessment and Corrective Action 反馈、评窜和纠正措施 The APQP Reference manual shows DFMEAs as an activity in the product design and Development section of the timing chart APQP参考手册将设计HMEA作为时间图的产品设计和 and PFMEAs in the Process Planning and Development section 开发部分的一个活动,过程FMEA作为过程策划和开 The development of either DFMEA or PFMEA is a process that 发部分的一个活动。无论是设计FMEA或是过程 helps to guide the teams in developing product and process FMEA的开发都是帮助在满足预期的开发产品和过程设 计中指导小组 The FMEA analysis should not be considered a single event, but FMEA分析不应被认为是一个单独的事件,而是一项完 development to valuated 成产品和过程开发的长期的任务,以确保对潜在的失效 and actions are taken to reduce their risk 进行了评估,并采取了措施减少风险。 One key aspect of continual improvement is the retention of knowledge from past learning which often is captured in FMEAs 持续改进的一个重要方面是对过去经常从FMEA中获 It is advisable for organizations to capitalize on prior analyses of 得的知识的保留。建议组织将对之前类似产品或过程的 similar product and process designs for use as the starting point 设计所做的分析作为下一个项目和(或)应用的起点 for the next program and/or application 当对一个项目(如失效模式,或原因)进行描述的时 The language used in FMEAs should be as specific as possible when describing an item(for example, failure mode, or cause 候,FMEA使用的语言应尽可能的明确,且不应扩展或 and not extend or extrapolate beyond the team's level of 推测,超出小组对可能产生的失效后果的认知程度。 understanding as to what the failure etfects may 明确的陈述,简明扼要的术语,对实际效应的关注,是 Clear statements, concise terminology and focus on the actual 识别和减轻风险问题的关键。 effects are key to the effective identification and mitigation of

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