TS16949认证五大工具应用之FMEA潜在失效模式及后果分析
Certification of TS16949 five tools of FMEA potential failure mode and effects analysis
何谓FMEA
What is FMEA
?   FMEA是一组系统化的活动，其目的是：
? FMEA is a set of systematic activity, its purpose is to:
?   发现、评价产品／过程中潜在的失效及其后果。
? discovery, evaluation of product / process potential failure and its consequences.
?   找到能够避免或减少这些潜在失效发生的措施。
? find can avoid or reduce these potential failure measures.
? 书面总结上述过程。
Written summary of the process?.
? 为确保客户满意，这是对设计过程的完善。
? to ensure customer satisfaction, which is on the process of design improvement.
FMEA发展历史
The history of FMEA development
?    虽然许多工程技术人员早已在他们的设计或制造过程中应用了FMEA这一分析方法。但首次正式应用FMEA技术则是在六十年代中期航天工业的一项革新。
? although many engineering and technical personnel already in their design or manufacturing process of the FMEA analysis method. But the first official FMEA application technology is in the mid sixty's aerospace industry a revolutionary.
FMEA的实施
The implementation of FMEA
?    由于不断追求产品质量是一个企业不可推卸的责任，所以应用FMEA技术来识别并消除潜在隐患有着举足轻重的作用。对车辆回收的研究结果表明，全面实施FMEA能够避免许多事件的发生。
? because of constant pursuit of product quality is an enterprise cannot the responsibility of shirk, so the application of FMEA technology to the identification and elimination of potential danger play a decisive role. On vehicle recovery results indicate that, the full implementation of FMEA can avoid many events.
?    虽然FMEA的准备工作中，每项职责都必须明确到个人，但是要完成FMEA还得依靠集体协作，必须综合每个人的智能。例如，需要有设计、制造、装配、售后服务、质量及可靠性等各方面的专业人才。
? although FMEA preparations, each job responsibility must be made clear to the people, but to complete the FMEA also have to rely on the collective cooperation, to everyone's intelligence. For example, need to have the design, manufacturing, assembly, after sale service, quality and reliability and other aspects of professionals.
?    及时性是成功实施FMEA的最重要因素之一，它是一个“事前的行为”，而不是“事后的行为”，为达到最佳效益，FMEA必须在设计或过程失效模式被无意纳入设计产品之前进行。
The successful implementation of FMEA? Timeliness is one of the most important factors, it is a" advance behavior", rather than" after the act", to achieve the best efficiency, FMEA must be in the design or process failure mode was not incorporated into the design of the product before.
?    事前花时间很好地进行综合的FMEA分析，能够容易、低成本地对产品或过程进行修改，从而减轻事后修改的危机。
Prior to spend time? Well integrated FMEA analysis, can be easily, low cost of the product or process changes, thus relieving afterwards modified crisis.
?    FMEA能够减少或消除因修改而带来更大损失的机会。
? FMEA can reduce or eliminate due to modify and bring greater chance of loss.
?    适当的应用FMEA是一个相互作用的过程，永无止境。
Appropriate application of? FMEA is an interactive process, world without end.
DFMEA（设计FMEA）
DFMEA ( FMEA )
简介
Brief introduction
?   设计潜在FMEA是由“设计主管工程师／小组”早期采用的一种分析技术，用来在最大范围内保证已充份的考虑到并指明各种潜在失效模式及与其相关的起因／机理。
Design of FMEA is a potential?" Design Engineer / team" early adopter of an analytical technique, used in the largest range that has been fully considered and indicates the potential failure modes and their associated cause / mechanism.
?    应评估最后的产品以及每个与之相关的系统、子系统和零部件。
? should evaluate the final product and each related systems, subsystems and components.
?    FMEA以其最严密的形式总结了设计一个零部件、子系统或系统时，一个工程师和设计组的设计思想(其中包括，根据以往的经验和教训对一些环节的分析)。
? FMEA in its most rigorous form, summarizes the design of a component, subsystem or system, an engineer and Design Group ( including the design idea, based on past experience and lessons in some aspects of the analysis ).
?    这种系统化的方法与一个工程师在任何设计过程中正常经历的思维过程是一致的，并使之规范化、文件化。
? this systematic approach and an engineer in any design process in normal experience thinking process is consistent, and the standardization, documentation.
?   在设计阶段使用FMEA时，能够用以下方法降低产品的失效风险
? in the design phase when using FMEA, can use the following methods to reduce product failure risk
?   有助于对设计要求的评估及对设计方案的相互权衡。
? to contribute to the design requirements of the assessment and design programmes to mutual balance.
? 有助于对制造和装配要求的最初设计。
? contribute to the manufacturing and assembly requirements of the original design.
? 提高在设计／开发过程中已考虑潜在失效模式及其对系统和车辆运行影响的(概率)可能性。
Improvement in the design / development process? Have considered the potential failure mode and effects of the system and the operation of the vehicle ( probability ) possibility.
?   对制定全面、有效的设计试验计划和开发项目，提供更多的信息。
To develop a comprehensive, effective? Design test plan and development projects, to provide more information.
?   根据潜在失效模式对“顾客”的影响，对其进行排序列表，进而建立一套改进设计和开发试验的优先控制系统。
? according to the potential failure mode to the" customer " influence, its ranking list, to establish a set of improve the design and development of test control system of priority.
? 为推荐和跟踪降低风险的措施提供一个公开的讨论形式。
? for referral and tracking measures of reducing risk to provide an open discussion forms.
?  为将来分析研究现场情况，评价设计的更改及开发更先进的设计，提供参考。
For the future? Analysis of site conditions, evaluation of design change and the development of more advanced design, provide a reference.
集体的努力
Collective efforts
?    在最初的设计潜在FMEA过程中，希望负责设计的工程师们能够直接地、主动地联系所有有关部门的代表。这些部门应包括(但不限于)：装配、制造、材料、 质量、服务和供方，以及负责下一总成的设计部门。
? in the initial design potential FMEA process, want to be in charge of design engineers can directly, and actively contact all representatives of relevant departments. These departments shall include ( but not limited to ): assembly, manufacturing, materials, quality, service and the supplier, and is responsible for all the design department.
?   FMEA可成为促进有关部门间充分交换意见的催化剂，从而提高整个集体的工作水平。
? FMEA can become the promotion of relevant authorities fully exchange views on catalyst, so as to improve the collective work level.
?   此外，任何(内部或外部的)供方设计项目应向有关负责设计的工程师进行咨询。
? in addition, any ( internal or external) the supplier's design project should be relevant to the design responsible engineer consulting.
?   设计FMEA是一份动态文件，应在一个设计概念最终形成之时或之前开始，而且，在产品开发各阶段中，当设计有变化或得到其它信息时，应及时，不断地修改，并最终在产品加工图样完成之前全部结束。
? FMEA design is a dynamic document, should be in a design concept ultimately form or before start, and, in the product development phase, when design changes or receive other information, should be timely, continuously modified, and finally the product processing design completed before all ends.
?   考虑制造／装配的要求是相互联系的，设计FMEA在体现设计意图的同时，还应保证制造或装配能够实现设计意图。制造或装配过程中可能发生的潜在失效模式和／或其原因／机理不需包含在设计FMEA当中，此时，它们的识别，影响及控制是由过程FMEA来解决。
Manufacturing / assembly? Consider requirements are interrelated, design FMEA embodied in the design intent while, also should ensure that the manufacturing or assembly can realize the design intent. Manufacturing or assembly process potential failure mode and / or the cause / mechanism does not need to be included in the design of FMEA, this time, their identification, the influence and the control process is driven by the FMEA to solve.
?   设计FMEA不是靠过程控制来克服设计中潜在的缺陷，但的确要考虑制造／装配过程中技术的／体力的限制，例如
? design FMEA does not rely on process control to overcome the potential defects of design, but to consider the manufacturing / assembly process technology / physical limitations, for example
?   必要的拔模(斜度)
? the necessary draft ( slope )
?   要求的表面处理
The surface treatment?
?   装配空间／工具可接近
Assembly space / tools accessible?
? 要求的钢材硬度
Requirements for hardness of steel?
?   过程能力／性能
Process capability / performance?
设计FMEA的开发
Design and development of FMEA
?   主管设计工程师拥有许多用于设计FMEA准备工作的文件。
Chief design engineer has many? Are used to design the FMEA preparation work file.
? 设计FMEA应从列出设计希望做什幺及不希望做什幺开始，如设计意图。顾客需求(正如由QFD之类活动所确定的一样)、车辆要求文件、已知产品的要求和制造／装配要求都应结合起来。
Design of FMEA from the list? Design hope that do and do not want to do anything, such as design intent. Customer needs ( such as the QFD activity as determined by the same), vehicle requirements document, known product requirements and manufacturing / assembly requirements should be combined.
?   期待特性的定义越明确，就越容易识别潜在的失效模式，采取纠正措施。
Definitions of characteristics? Look more clearly, the easier it will be to identify potential failure modes, corrective measures.
?   设计FMEA应从所要分析的系统、子系统或零部件的框图开始。附录A给出了一个框图的示例，这个框图也可指示出信息、能量、力、流体等的流程。其目的在于明确对于框图的(输入)，框图中完成的过程(功能)，以及来自框图的(输出)。
? FMEA should design the analysis system, subsystem or component diagram begins. Appendix A gives a block diagram of the sample, the chart also indicates information, energy, power, fluid flow. Its purpose is to clear the block diagram, the diagram ( input ) to complete the process of (functional), as well as from the diagram ( output ).
?   框图说明了分析中包括的各项目之间的主要关系，并建立了分析的逻辑顺序。
The analysis includes? Block diagram illustrating the project between the main relations, and the establishment of the analysis of the logical order.
? 用于FMEA的准备工作中这种框图的复制件应伴随FMEA过程。
? for FMEA in the preparation of this diagram copies should be accompanied by FMEA process.
目的
Purpose
?   生产品设计开发初期, 分析产品潜在失效模式与相关产生原因提出未来分析阶段注意事项, 建立有效的质量控制计划
Product design and development? Students early, analysis of product failure mode and related reasons put forward future analysis phase of the matters needing attention, the establishment of an effective quality control plan
定义
Definition
?   失效 :
The failure?:
?   在规定条件下(环境、操作、时间)不能完成既定功能。
? in specified conditions ( environment, operation, time ) can't finish function.
?   在规定条件下, 产品参数值不能维持在规定的上下限之间。
? under prescribed conditions, product values can not be maintained within the prescribed limits.
产品在工作范围内, 导致零组件的破裂、断裂、卡死等损坏现象。
Products in the scope of work, leading to components of the rupture, fracture, damage to the phenomenon of the dead.
?  为了便于将潜在的失效模式及其影响后果分析成文，已设计出专用表格。
? in order to simplify the potential failure mode and effects analysis written, has designed a special form.
?  下面介绍这种表格的具体应用，所述各项的序号都相应标在表上对应的栏目内，完成的设计FMEA表格的示例见附录B：
Following the presentation of this form? Specific applications, the number of the corresponding standard in the table corresponding to the column, the completion of the design form FMEA example see Appendix B:
• FMEA编号
FMEA number
?   填入FMEA文件编号, 以便查询。
? fill in the FMEA document number, so that the query.
?   系统、子系统或零部件的名称及编号
? system, subsystem or component name and number
• 设计责任
, design responsibility
?   填入整车厂（OEM）部门和小组, 如果知道，还应包括供方的名称。
? enter the OEM ( OEM ) groups and departments, if known, should also include the supplier name.
4）编制者
4) establishment
?   填入负责FMEA准备工作的工程师的姓名、电话和所在公司的名称。
Responsible for FMEA? In preparations for the engineer 's name, telephone and company name.
• 年型/车型
" Year type / model
?   填入将使用和/或正被分析的设计所影响的预期的年型及车型（如果已知的话）。
? in the use and / or being analyzed design impact on the expected years and models ( if known ).
• 关键日期
" Key date
?   填入FMEA初次预定完成的日期，该日期不应超过计划的生产设计发布的日期。
? fill FMEA first scheduled completion date, the date should not exceed the planned production design release date.
• FMEA日期
FMEA date
?   填入编制FMEA原始稿的日期及最新修订的日期。
In the original draft? Compilation FMEA date and latest revision date.
• 核心小组
" Core group
?   列出有权确定和/或执行任务的责任部门和个人姓名（建议所有参加人员的姓名、部门、电话、住址等都应记录在一张分发表上）。
? list have the authority to identify and / or execution of the responsible department and individual names ( recommended for all participants of the name, Department, telephone, address etc should be recorded in a branch publishing ).
• 项目/功能
" Project / function
?   填入被分析项目的名称和编号, 尽可能简洁地填入被分析项目的功能符号, 设计意图。包括这个系统作业相关的信息(如: 说明温度、压力、湿度范围)如果项目包含一个以上有不同潜在失效模式功能时, 则列出所有个别功能。
? fill in the analysis the project name and number, as succinct as possible to fill in by analysis of the functional symbols, design intent. This system includes operation related information ( such as: temperature, pressure, humidity range ) if item contains more than one have different potential failure mode function, list all the individual function.
• 潜在失效模式
" The potential failure mode
?   为零件、子系统或系统于符号设计意图过程中可能失效的种类, 也可能是较高阶子系统或系统之失效原因, 或较低阶零组件的失效效应。
? for parts, subsystem or system in symbol design intent process failure types, may also be higher order subsystem or system failure, or lower order component failure effect.
?   列出特别项目和功能的每一潜在失效模式。假设失效是将发生的但不是必须发生的, 潜在失效模式或尽可能发生于某些作业条件下(如: 热、冷、干燥、灰尘等)和某些使用条件下。
? list special projects and the function of each potential failure mode. If failure is will occur but not must occur, the potential failure mode or possibly occurs in some operating conditions ( such as: hot, cold, dry, dust etc.) and certain conditions of use.
?   一般的失效模式包含下列各项, 但不限于此: 裂纹、变形、松弛、泄漏、粘结、短路、生锈氧化、断裂。
? the general failure mode includes the following, but not limited to: crack, deformation, relaxation, leakage, short circuit, bonding, rust, oxidation of fracture.
• 潜在失效后果
, potential effects of failure
?   为被客户察觉在功能特性上失效模式的后果, 也就是: 失效模式一旦发生时, 对系统或装备以及操作使用人员所造成的影响。
Customers are aware of? For the function characteristics of effects of failure modes, namely: failure mode once it occurs, the system or equipment and operation personnel caused by the impact of.
?    一般在讨论失效后果时, 先检讨失效发生时对干部所产生的影响, 然后循产品的组合架构层次, 逐层分析一直到最高层级人员, 装备所可能造成的影响。
In the discussion? General consequences of failure, failure occurs when the first review of cadres by the impact, and then follows the product combination of architecture layers, layer by layer analysis up to the highest level of personnel, equipment that may be caused by impact.
?    常见的失效后果包括: 噪音、漏气、操作费力、电动窗不作用、煞车不灵、跳动、乱档、冷却不够、车辆性能退化, 产生臭气, 外观不良等。
The common failure? Consequences include: noise, leakage, laborious operation, electric windows, not faulty brakes, beating, random files, insufficient cooling, vehicle performance degradation, odor, poor appearance.
• 严重度 （S）
, severity ( S )
?   严重度是潜在失效模式发生时对下序零件、子系统、系统或顾客影响后果的严重程度（列于前一栏中）的评价指标。
? severity is the potential failure mode occurred on the sequence components, subsystems, systems or customer impact the severity of consequences ( in the top column ) evaluation index.
?   严重度仅适用于后果
Severity applies only to the consequences?
?   要减少失效的严重度级别数值，光能通过修改设计来实现，严重度的评估分为1到10级。
? to reduce failure severity level numerical, light energy by modifying the design to achieve, severity assessment is divided into 1 to 10 steps.
• 分级
" Classification
?   这个字段用来区分任何对零件、子系统或系统、将要求附加于制程管制的特殊产品特性(如关键的、主要的、次要的)。
Definition: this field is used to distinguish? Any parts, subsystem or system, will require additional to the process control of special product characteristics ( such as critical, major, minor ).
?   任何项目被认为是要求的特殊过程控制, 将被以适当的特征或符号列入设计FMEA的分级字段内, 并将于建议措施字段被提出。
? any items are considered requirements of special process control, will be appropriate to the character or symbol included in the design of FMEA classification field, and will be on the field was put forward suggestions and measures.
?   每一个于设计FMEA列出的项目, 将在过程FMEA的特殊过程管制中被列出。
? every to design FMEA list items, will be in the process of FMEA special process control is listed.
• 潜在失效的起因/机理
" Potential cause / mechanism of failure
• 潜在失
, potential loss