FMEA失效模式与效果分析(英文版)
失效模式及其影响分析讲座(英文版)
What is the influence of : use - time and environment on each component
Possibilities: fatigue,
(creep)
a. wear,
b. rust,
c. material
d. contamination, e. deformation under load
systems, parts & components
* Focus on the product itself, D-FMEA
Process
Production FMEA
* Focus on the manufacturing
w each process step
1
INTRODUCTION TO
FMEA
A reliability program ? Why necessary?
一 个 可 靠 性 的 计 划？
为 什 么 必 须？
Car 1: • Frequent Break downs • 频繁地破损 • Many minor components failures • 许多的小部件失效
FMEA approach
Traditional approach
Design Start
Development
Production Production Release
Time
TYPES of FMEA
TYPE
ALIASES
DESCRIPTION
Product
Design FMEA
review
FMEA
Failure Mode & Effect Analysis - Process
失效模式和效果分析
失效模式和效果分析(Failure Mode and Effect Analysis, FMEA)是一种用来确定潜在失效模式及其原因的分析方法。
具体来说，通过实行FMEA，可在产品设计或生产工艺真正实现之前发现产品的弱点，可在原形样机阶段或在大批量生产之前确定产品缺陷。
FMEA最早是由美国国家宇航局(NASA)形成的一套分析模式，FMEA是一种实用的解决问题的方法，可适用于许多工程领域，目前世界许多汽车生产商和电子制造服务商(EMS)都已经采用这种模式进行设计和生产过程的管理和监控。
FMEA简介FMEA有三种类型，分别是系统FMEA、设计FMEA和工艺FMEA，本文中主要讨论工艺FMEA。
实施FMEA管理的具体步骤见图1。
确定产品需要涉及的技术、能够出现的问题，包括下述各个方面：需要设计的新系统、产品和工艺；对现有设计和工艺的改进；在新的应用中或新的环境下，对以前的设计和工艺的保留使用；形成FMEA团队。
理想的FMEA团队应包括设计、生产、组装、质量控制、可靠性、服务、采购、测试以及供货方等所有有关方面的代表。
记录FMEA的序号、日期和更改内容，保持FMEA始终是一个根据实际情况变化的实时现场记录，需要强调的是，FMEA文件必须包括创建和更新的日期。
创建工艺流程图。
工艺流程图应按照事件的顺序和技术流程的要求而制定，实施FMEA需要工艺流程图，一般情况下工艺流程图不要轻易变动。
列出所有可能的失效模式、效果和原因、以及对于每一项操作的工艺控制手段：1．对于工艺流程中的每一项工艺，应确定可能发生的失效模式，如就表面贴装工艺(SMT)而言，涉及的问题可能包括，基于工程经验的焊球控制、焊膏控制、使用的阻焊剂(soldermask)类型、元器件的焊盘图形设计等。
2．对于每一种失效模式，应列出一种或多种可能的失效影响，例如，焊球可能要影响到产品长期的可靠性，因此在可能的影响方面应该注明。
3．对于每一种失效模式，应列出一种或多种可能的失效原因，例如，影响焊球的可能因素包括焊盘图形设计、焊膏湿度过大以及焊膏量控制等。
品质管理FMEAFMEA中英文
最新卓越管理方案您可自由编辑供参考1潜在失效模式及后果分析（FMEA）集体讨论什么情况下会导致一次培训失效品质管理FMEAFMEA中英文潜在失效模式及后果分析（PotentialFailureMode供参考andEffectsAnalysis）是一种系统化的可靠性定性分析方法。
通过对产品/过程各组成部分进行事前分析，发现、评价产品/过程中潜在的失效模式及起因2/机理，查明其发生的可能性及对系统的影响程度，以便采取措施进行预防。
失效（Failure）实体全部或部分失去了完成其功能的能力。
其中实体是指产品、过程或系统。
潜在有可能发生有可能不发生的事情。
供参考3PotentialFailureModeandEffectsAnalysis（FMEA）DiscussionWhatmayleadthetrainingfailed?DefinitionofFMEAPotentialFailureModeandEffectsAnalysis(FMEA)canbedescri bedasasystemizedandqualitativeanalysismethodforreliability. ThepurposeofFMEAistoRecognizeandanalyzethepotentialfailureo faproduct/process,evaluatitseffectsandprobabilitybeforethee vent,identifyactionswhichcouldeliminateorreducethechanceoft hepotentialfailureoccurring.供参考FailureItisamannerwhichthethingscouldfailtomeettheintentpartly orwholely.Thethingsmaytheproduct,processorsystem. PotentialThefailuremayhappenornot.FMEA的类型SFMEA——是针对产品开发、过程策划进行的FMEA。
潜在失效模式与效果分析
潜在失效模式与效果分析潜在失效模式与效果分析（Failure Modes and Effects Analysis，简称FMEA）是一种系统的、有序的、定量的方法，用于识别和评估产品或过程中的潜在失效模式以及这些失效模式可能导致的效果。
FMEA是一种常用的风险管理工具，广泛应用于制造业、医疗保健、航空航天、汽车工业等领域。
在本文中，我们将详细介绍FMEA的基本概念、步骤和应用，并阐述其在产品设计和过程改进中的重要性。
一、潜在失效模式与效果分析的基本概念潜在失效模式与效果分析是一种早期风险评估工具，其目的是通过系统地识别和评估潜在失效模式，以便预测和减少失效造成的负面影响。
具体来说，FMEA通过对潜在失效模式（Failure Modes）、失效原因（Causes）和失效后果（Effects）进行定量评估，可以帮助组织找出潜在问题并采取相应的措施来防止或减轻失效所带来的影响。
二、潜在失效模式与效果分析的步骤1.确定分析的范围和目标：在进行FMEA之前，需要明确分析的范围和目标，确定要分析的产品、过程或系统以及评估的关键项。
2.组建团队和制定计划：选择一个跨学科的团队，包括设计工程师、质量工程师、操作人员等，制定一个详细的计划来指导整个FMEA的过程。
3.识别失效模式：对于要分析的产品或过程，团队成员应该结合自己的专业知识和经验，识别可能的失效模式。
4.评估失效后果：对于每个失效模式，团队需要评估其可能的后果，包括对用户、环境、生产过程和设备的影响。
5.确定失效原因：对于每个失效模式，团队需要分析可能的失效原因，包括设计、材料、人员和设备等方面的问题。
6.评估失效的概率和严重程度：对于每个失效模式，团队需要评估其发生的概率和严重程度，以确定失效的风险级别。
7.制定纠正措施：根据对失效模式的分析和评估结果，团队制定相应的纠正措施，包括设计改进、工艺改进和人员培训等。
8.实施纠正措施和跟踪效果：团队需要实施纠正措施，并跟踪其效果，确保问题得到解决并进行效果验证。
fmea失效模式分析范文英文版
fmea失效模式分析范文英文版全文共3篇示例，供读者参考篇1Failure Mode and Effects Analysis (FMEA) is a systematic method used to identify potential failure modes, assess their impact and prioritize actions to mitigate risks in various industries including manufacturing, healthcare, and automotive. FMEA is a proactive approach that helps organizations to prevent failures and improve the quality of their products or services.The FMEA process consists of three main steps: identification of failure modes, assessment of their effects, and implementation of corrective actions. Each step involves thorough analysis and collaboration among team members to ensure a comprehensive understanding of potential risks.The first step in FMEA is to identify all possible failure modes that could occur in a process, product, or service. This involves brainstorming and gathering input from experts to create a comprehensive list of failure modes. Each failure mode is then evaluated based on its severity, occurrence, and detection.Severity refers to the impact of the failure on the system or end-user, occurrence refers to the likelihood of the failure happening, and detection refers to the ability to detect the failure before it reaches the end-user.Once all failure modes are identified and evaluated, the next step is to assess their effects using a risk priority number (RPN) calculation. The RPN is calculated by multiplying the severity, occurrence, and detection ratings of each failure mode. This helps prioritize the most critical failure modes that require immediate attention and corrective action.The final step in FMEA is to implement corrective actions to mitigate risks and improve the overall quality of the process, product, or service. This may involve redesigning processes, improving training, updating equipment, or implementing additional quality control measures. It is essential to monitor and review the effectiveness of these corrective actions to ensure that the identified failure modes are adequately addressed and risks are minimized.In conclusion, FMEA is a valuable tool for organizations to proactively identify and mitigate risks in their processes, products, or services. By systematically analyzing failure modes, assessing their impact, and implementing corrective actions,organizations can enhance quality, improve customer satisfaction, and prevent costly failures. FMEA should be an integral part of any organization's quality management system to ensure continuous improvement and long-term success.篇2Failure Mode and Effects Analysis (FMEA) is a widely used technique for identifying potential failure modes in a system, process, or product, and analyzing the potential effects of these failures. By identifying and prioritizing potential failure modes, FMEA helps organizations to proactively address risks and improve reliability and safety.FMEA is commonly used in industries such as manufacturing, healthcare, automotive, and aerospace to prevent failures that could result in safety hazards, customer dissatisfaction, or financial losses. The process of performing an FMEA involves several steps, including identifying potential failure modes, determining the severity and likelihood of each failure mode, and determining the overall risk associated with each failure mode.To illustrate the process of FMEA, let's consider an example of a manufacturing process for producing a medical device. Thefirst step in conducting an FMEA would be to identify potential failure modes associated with each step in the manufacturing process. This could include failures such as equipment malfunction, operator error, or material contamination.Once the potential failure modes have been identified, the next step would be to determine the severity of each failure mode. This involves evaluating the potential consequences of each failure, such as the impact on product quality, patient safety, or regulatory compliance. Failure modes that have severe consequences would be given a higher severity rating.After determining the severity of each failure mode, the next step in FMEA is to determine the likelihood of each failure mode occurring. This involves considering factors such as the frequency of the failure, the reliability of the equipment or process, and the skill level of the operators. Failure modes that are more likely to occur would be given a higher likelihood rating.Finally, the overall risk associated with each failure mode is determined by multiplying the severity and likelihood ratings. This risk assessment helps organizations to prioritize which failure modes to address first, based on the potential impact and likelihood of each failure.In the case of the manufacturing process for producing a medical device, an FMEA might identify equipment malfunction as a high-risk failure mode due to its potential to impact product quality and patient safety. As a result, the organization could implement preventive maintenance programs, operator training, and quality control measures to reduce the likelihood of equipment malfunctions and mitigate the associated risks.Overall, FMEA is a valuable tool for organizations seeking to improve reliability, safety, and quality by proactively addressing potential failure modes. By systematically analyzing and prioritizing risks, organizations can identify opportunities for improvement and enhance the overall effectiveness of their processes and products.篇3Failure Mode and Effects Analysis (FMEA) is a systematic method for analyzing potential failure modes within a system, process, design, or product in order to identify their causes and consequences. By conducting an FMEA, organizations can prioritize potential failure modes based on their risk levels and develop strategies to prevent, mitigate, or respond to these failures. This article will provide an overview of FMEA, its benefits, and a step-by-step guide on how to conduct an FMEA analysis.Benefits of FMEAThere are many benefits to conducting an FMEA analysis, including:1. Identifying potential failure modes: FMEA helps organizations proactively identify potential failure modes before they occur, allowing them to take preventive actions to avoid these failures.2. Prioritizing risks: By assessing the severity, likelihood, and detectability of each failure mode, FMEA helps organizations prioritize risks and focus their resources on addressing the most critical issues.3. Improving product quality: FMEA can help organizations identify weaknesses in their processes, designs, or products and make improvements to enhance their quality and reliability.4. Enhancing customer satisfaction: By reducing the likelihood of failures and improving product quality, FMEA can help organizations enhance customer satisfaction and loyalty.5. Compliance with regulatory requirements: Many industries require organizations to conduct FMEA as part of their quality management processes to comply with regulatory requirements and standards.Steps to Conduct an FMEA AnalysisThe following are the steps involved in conducting an FMEA analysis:1. Define the scope: The first step in conducting an FMEA analysis is to define the scope of the analysis, including the system, process, design, or product to be assessed.2. Identify the functions and failure modes: Identify the primary functions of the system, process, design, or product and the potential failure modes that could occur.3. Assess the severity of each failure mode: Evaluate the severity of each failure mode by considering its impact on safety, quality, customer satisfaction, and other important factors.4. Determine the likelihood of occurrence: Assess the likelihood of each failure mode occurring by considering factors such as historical data, experience, and expert judgment.5. Evaluate the detectability: Evaluate the detectability of each failure mode by considering how easily it can be detected before it affects the system, process, design, or product.6. Calculate the risk priority number (RPN): Calculate the RPN for each failure mode by multiplying the severity, likelihood, and detectability rankings together.7. Develop action plans: Develop action plans to address the high-risk failure modes identified during the analysis, including preventive and corrective actions.8. Implement the action plans: Implement the action plans to prevent, mitigate, or respond to the high-risk failure modes identified during the analysis.9. Monitor and review: Monitor the effectiveness of the action plans and review the FMEA analysis regularly to ensure that the organization is continuously improving its processes, designs, and products.ConclusionFMEA is a powerful tool for identifying potential failure modes, prioritizing risks, and improving product quality. By conducting an FMEA analysis, organizations can proactively identify and address issues before they occur, enhancing customer satisfaction and complying with regulatory requirements. By following the steps outlined in this article, organizations can conduct an effective FMEA analysis and develop strategies to prevent, mitigate, or respond to potential failures.。
fmea潜在失效模式分析中英文模版
FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工FMEA编号N准备人Prep主要参加人Core Team: QA部QA Dept./模具部Tooling. Dept.; /工程部Eng.Dept.FMEA日期D 潜在的失效模式及效应分析表POTENTIAL FAILURE MODE AND EFFECTS ANALYSI(PFMEA)项目名称 Item: 过程责任部门Process Responsibility: 车型年/车辆类关键日期Key Date:工ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：ALYSIS编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)：编号Number: 页码Page: 准备人Prepared By:日期Data(编制(orig):(修订REV)： ALYSIS21 of 22ALYSIS编号Number: 页码Page:准备人Prepared By:日期Data(编制(orig):(修订REV)：22 of 22。
FMEA失效模式及其影响分析中英文
Beginning and End
SYSTEM
START
After system functions are defined, before specific hardware is selected
E
When the project is turned over to design
6
Background
Developed in early 60’s by NASA to “failproof” Apollo missions.
Adopted in early 70’s by US Navy .
By late 80’s, automotive industry had implemented FMEA and began requiring suppliers do the same. Liability costs were the main driving force.
9
When is the FMEA Started?
AS EARLY AS POSSIBLE!
Guideline :
“Do the best you can with what you have”
10
When to Start ???
When new systems, products and processes are being designed
FMEA is a systematic approach used to examine potential failures and prevent their
occurrence. It enhances our ability to predict problems and provides a system of ranking, or
{品质管理FMEA}失效模式及其影响分析英文讲义
此处是大标题样稿字样十五字以内CZB698-00-0006| 23 九月 2020 | 2FMEA Course Schedule Day 29.00Real-life P-FMEA exercise -con’tReview10.30Tea-break 10.45D-FMEA12.00Lunch1.00Organization Aspect of FMEA3.00Tea-break 3.30Maturity GridDay 19.00IntroductionIntro to FMEA Process FMEA 10.30Tea-break10.45Process -FMEA (con’t) 12.00Lunch1.00Real-life P-FMEA exercise 3.30Tea-break3.45Real-life P-FMEA exercise -con’tCZB698-00-0006| 23 九月 2020 | 31 INTRODUCTIONTOFMEACZB698-00-0006| 23 九月 2020 | 4Car 2:•No Major Break downs • 非 主 要 的 破 损•Few failures • 很 少 的 失 效Car 1:•Frequent Break downs • 频 繁 地 破 损•Many minor components failures• 许 多 的 小 部 件 失效A reliability program ? Why necessary?一 个 可 靠 性 的 计 划？ 为 什 么 必 须？CZB698-00-0006| 23 九月2020 | 5Customer Satisfaction － 顾 客 满 意QUALITY ENGINEERING TOOLSTOOLS1 Design Review2 7 QC Tools3 New 7 QC Tools4 Statistical ProcessAPPLICATIONDesign Quality AssuranceData analysis/Problem-solving Business Process Mgt, QFP Holding the improvement Quality breakthroughsMeeting customer requirement Fool-proof Design & processesWhat is a FMEA?A structured, disciplined process to systematically andcomprehensively, identify and document potential problems and weaknesses in a design or process so that design changes can be made or other corrective actions taken to prevent actual occurrence of failure一个结构化和专业化的过程，它能系统和综合地找出并记录在设计和工艺过程中潜在的问题和缺点并由此作出设计改变或采取其它的改正措施以防止失效的实际发生CZB698-00-0006| 23 九月 2020 | 8Effect of FMEA on Process and Design changesDesign StartDevelopmentProduction ReleaseProductionTimeN o o f E n g i n e e r i n g C h a n g e sTraditional approachFMEA approachCZB698-00-0006| 23 九月 2020 | 9TYPES of FMEATYPEALIASESDESCRIPTIONProduct Design FMEA * Focus on the product itself, review FMEA D-FMEA systems, parts & componentsProcess Production FMEA * Focus on the manufacturing process, FMEAP-FMEA review each processstepCZB698-00-0006| 23 九月 2020 | 10 Objective of FMEAFailure Mode & Effect Analysis (FMEA) is used to improve •product reliability (considering usage, environment, lifetimeetc.)•quality of (purchased) parts (incl. ‘hidden’ functions of apart)•reproducibility of the product (reduction of fall off & repairs in assembly)•reproducibility of the production process (handling, transportetc.)Focus on technical problemsTypes of Risks •Market Riskshaving the right producton the right time •Technical Risks achieving the product spec quality, reproducibility•Project Risksproject organisation, team aspects, resourcesMarketRisksTechnicalRisksProjectRisksPlanningSpecificationKnow-how, capacityUse of FMEAA. Reliability Engineering- Reliability improvements.B. Producibility Analysis- Less repairs and scrap during manufacturing.- Improvement of the Zero- Hour Quality.C. Production Process Analysis- Less repairs and scrap.- Determination of process control points.- Process release.A andB during development phase.C during workpreparation phase.100 : 110 : 11 : 1PRODUCT DESIGNPROCESS DESIGNPRODUCTIONIMPROVE PRODUCTPAYBACKSLOW VISIBILITY/REWARDHIGH VISIBILITY/REWARDTIME500 : 1CONCEPT DESIGNQuality LeverReliability Investigation by MeansCZB698-00-0006| 23 九月 2020 | 14 of FMEAPremises:The normal functioning of the productQuestion:What is the influence of : use - time andenvironment on each componentPossibilities: a. wear, b. rust, c. material fatigue,d. contamination,e. deformation under load (creep)f. ageing,g.process failures.Producibility Analysis by Means ofCZB698-00-0006| 23 九月 2020 | 15 FMEAPremises:Measuring tool is: eg FOR/ppmActions:Actions as outcome of theProcess Quality Control (P.Q.C.) Analysis: Focused on failures which are made andnoticedduring the production process.2 PROCESS FMEAFMEA for the Production Process Subject for Analysis:- flow chart and scenario of theproduction process Focused on:- manipulations of the operator- wrong (deviations) material- process- equipment- transport- storageFailure mode RPN 2 = SO 2D 2Controls Cause 1RPN n = SO n D nControlsCause 1Development of a Process FMEA : An OverviewProcess step Purpose RPN 1 = SO 1D 1Controls Cause 1EffectsSeverity, SOccurrence, O n Detection, D nProcess FMEA Procedure5 Steps:•Establish the Process Flow•Analyze the Process•Establish purpose of each operation and the possible failure modes•Define the weak points of the Process•Establish actions and responsibilitiesStep 1 -EstablishCZB698-00-0006| 23 九月 2020 | 21 Process FlowTake into account the:•Specification for manufacturing•System Structure:-manufacturing strategy (manual/automaticetc)-technologies, processes & equipment-line & factory layout-suppliers, transport, material flow•System operation, control and maintenance •System environmental conditionsCZB698-00-0006| 23 九月 2020 | 22Process Flow Chart (eg)Mount part Handling process Glue partAdjustment process TestingMount subassy Handling process Mount part TestingStation1Station2Station3Station4CZB698-00-0006| 23 九月 2020 | 23Process Flow Chart (eg)EquipmentsLightpen carrierLightpen carrier Press-on toolLightpen carrierMounting fixtureElectric screwdriver Screw dispenser LDGU cutting/insertion machine Lightpen carrierSoldering equipment Grating adjustment machineGlue dispenser and curing unit Mount actuatr &install spring clip Mount & secure flexassembly Cut LDGU leads &mount LDGU into Lightpen housing Solder actuator and LDGU to flex assy Grating & glueing ofLDGU Mount rack & wirespringAssembly processFailure Mode and Effect Analysis ChartCZB698-00-0006| 23 九月 2020 | 24CZB698-00-0006| 23 九月 2020 | 25 Step 2 - Analysis of the Process Examination of:•How the purpose of the process/operation arerealised by the designers/engineers.•What are the working conditions* static* dynamicStep3 -Establish purpose of eachCZB698-00-0006| 23 九月 2020 | 26 operation and the possible failuremodes•What is the purpose of the process step ?•Which deviations are possible ? ( FAILURE MODE )•What is the effect of that deviation on the producibility? ( EFFECT )•What is the cause of that deviation ? ( CAUSE )CZB698-00-0006| 23 九月 2020 | 27MATERIALMANMACHINEMETHODMEASUREMENTENVIRONMENTPROCESSProduct Functions Product Functions Product FunctionsProcess Cause - Effect InvestigationPOTENTIAL CAUSEEFFECTPOTENTIAL FAILUREPOTENTIALCZB698-00-0006| 23 九月 2020 | 28 Potential Failure Modes*Failure means any one or more of the following …-failure to perform/deliverfunction-failure to meet designintent-failure to meet customerexpectations-something undesirable,e.g. a noisy projectorExamples :•corroded •cracked •deformed •oxidised •leaking •fractured •malformed •flattened •non-sticking •contaminatedFailure Mode and Effect Analysis ChartCZB698-00-0006| 23 九月 2020 | 29CZB698-00-0006| 23 九月 2020 | 30 Effects ( Process FMEA )Each failure mode may have undesirable side effectson some or all the following:1.End-user (product)2.Down-stream process (nextoperation)3.Local processAll 3 effects should be considered in any processFMEACZB698-00-0006| 23 九月 2020 | 31 Severity (Process-FMEA)~ Severity is the assessment of the seriousness of the effectRating Degree Effects on Effect on downEnd UserStream/Local process1Minor* not noticeable * noeffect2low* slightly noticeable * noimpact/limited effect3* limited impact on both4Moderate* cust dissatisfaction * mayrequire minor rework5 * reduced performance * mayreq. unscheduled rework6 * perform. Deterioration * maycause damage to equip.7High * high deg. of cust dissatisfaction * maycause serious disruption8 * loss of sub-system function, * may require majorreworkFailure Mode and Effect Analysis ChartCZB698-00-0006| 23 九月 2020 | 32Potential Cause(s) of Failure*How the failure mode could occur, described in terms of something correctable or controllable *list, using brainstorming or Fault Tree Analysis (FTA), every conceivable failurecause assignable to each failure mode*causes should be specific, e.g. “operator error” or “machine problem” are examples ofcauses which are not specific enough*causes may or may not be mutually exclusive -if eradicating a cause has a direct impact on the failure mode, then,Fault Tree exampleProblemCause A Cause B Cause C A1A2B1B2Occurrence (P-FMEA)Rating Degree Based on SPC Baseon failure rate1Remote CpK > 1.67< 1 ppm 2Very low CpK > 1.3350 ppm 3Low CpK > 1.00250ppm~ can be thought as the probability of occurrence of the failure modeFailure Mode and Effect Analysis ChartCZB698-00-0006| 23 九月 2020 | 36CZB698-00-0006| 23 九月 2020 | 37 Current controls*Current controls are descriptions of controls that:(a) prevent the failure mode from occurringor(b) detects the failure mode should it occur*Examples of process controls:- fixture fool-proofing- SPC- inspection either at the subject operation- testing or at the subsequent operations- gauge R & R- preventive maintenance- operator training- GMP (good manufacturing practice)- ISO 9000- SOP (standard operating procedures)- humidity / pressure / temp controls- finite element analysis- calibrationCZB698-00-0006| 23 九月 2020 | 38Detection (P-FMEA)Rating DegreeDescription1 Very High Process automatically detects failure2 Control will almost certainly detect failure3 High Control have good chance of detecting failure 4~ Assume the failure has occur, assess the probability that the controls will detect the failure mode before shipping outFailure Mode and Effect Analysis ChartCZB698-00-0006| 23 九月 2020 | 39CZB698-00-0006| 23 九月 2020 | 40 Step 4- Define the Weak Points•Define the severity of the failure ( = S )Effect Rating : 1 (10)•Define the probability of occurrence of the failure ( = O )Cause Rating : 1 (10)•Define the likelihood of detection of the failure ( = D )Time Effect Rating : 1 (10)•Risk Priority Number : (RPN)= > Severity x Occurrence x Detection=>RPN = S x O x D1 < RPN < 1000In themselves , absolute RPN numbers have no significance. They are only for ranking the failure causes, for corrective actionsRPN : Acceptance threshold•S = 5 (reduced performance + degradation)•O = 5 ( approximately 0.25%)• D = 5 (may detect prior to shipment)Generally, RPN 125 may be a good threshold to useie for RPN > 125 => corrective action is needed.But there are exceptions ;SxOxD RPN125SOD DescriptionAction?1011Failure unlikely to reach user 1101Frequent Minor, detectable failure 1110Minor defect reaches user infrequently 10101Serious and frequent failure11010Frequent minor defect reaches user 10110Serious defect reaches userStep 5 - Establish Actions andCZB698-00-0006| 23 九月 2020 | 43 Responsibilities1. What has to be improved :- change of design- life test- contact with supplier- control point build in, in production processetc.2. Who is responsible3. When is it finishedRPN acceptable?Corrective actionsDONew RPN 1Acceptable?EndYes NoNoYesRPN acceptable?Corrective actionsDONew RPN nAcceptable?EndYes NoNoYesChoice of Corrective ActionsUnlikely to be effectivePreferred choices*Increase inspection *Poka-yoke (fool-proofing)*Additional test*Process change*Additional check*design change*Re-train operators*Automation*Re-write SOP*ComputerisationCorrective Action PreferenceCZB698-00-0006| 23 九月 2020 | 47 HierarchyThe intent of any recommended corrective actionis to improve the RPN rating by reducingSeverity, Occurrence, Detection or all 3together.Emphasis should be on prevention, i.e. reducing Occurrence.Should prevention be impossible, the following Hierarchy of preference should be used:1. Prevention, or potential causeelimination2. Detection, as early in the product lifecycle as possible:FMEAis is not* structured* a show-piece* systematic* a number game* rigorous* a guessing game* comprehensive* a documentation exercise* scientific* a self-consolation exercise* a discipline..* preventive..* customer-focused..Real Life FMEA Exercise3 PRODUCT D-FMEA。
FMEA(中英文)
FMEA Failure Mode and EffectAnalysis (FMEA)失效模式及后果分析1FMEA Learning Objectives学习目标•Provide familiarization with FMEA principles and techniques.熟练运用FMEA原理与方法2Definition of FMEA FMEA的定义FMEA is a systematic design evaluation procedure whose purpose is to: FMEA是一个系统的设计评估程序，其用途是：1. recognize and evaluate the potential failure modes and causesassociated with the designing and manufacturing of a new product or a change to an existing product，识别与评估潜在失效模式与原因,与新产品的设计与制造或当前产品的变化联系起来，2. identify actions which could eliminate or reduce the chance of thepotential failure occurring，识别可消除或减少潜在失效事件产生的措施，3. document the process.将过程形成文件。
45FMEA is Function-driven FMEA 是功能性的FMEA begins with a definition of the FUNCTIONS an item is supposed toperform. The inputs must come from several sources to be effective:FMEA 是以其应该执行的项目功能的定义为开端。
FMEA潜在失效模式及后果分析英文版1
❖ It is helpful to have an “expert” on the product or process available to answer any questions the team might have.
Step #2 – Brainstorm Potential Failure Modes
❖ All team members should participate in brainstorming process.
Step #3 – List Potential Effects of Each Failure Mode
❖ After the failure modes are listed on the FMEA worksheet form, the FMEA team needs to review each failure mode and identify the potential effects of the failure should it occur.
❖ Method of generating and documenting ideas of potential failure modes. ❖ If product or process is complex, a series of brainstorming sessions, each
ProcessFMEA (失效模式分析)
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FMEA的輸出 的輸出
清單
潛在的失效模式清單 關鍵及重要特性清單 消除產品失效模式原因或減低其發生率的措施清單
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FMEA的使用環境 FMEA的使用環境
潛在失潛模式
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10. 潛在失潛模式
過程失效模式是零件被拒收的理由
零件特性不符工程規範 過程不能滿足其目的或功能
零件特性是零件的一種特點
如尺寸、大小、形狀、位置、安裝位置、組織、硬度、外 觀、塗復、反光性等。 例如工程圖紙上的尺寸，或是在工程技術要求的硬度。
何時更新FMEA？ ？ 何時更新
FMEA是一份动态文件 动态文件(Living Document) 动态文件 更新条件
凡对产品设计、应用、环境、材料或对产品的制造或装 配过程考虑有更改时 在设计或制造/装配过程中发生显著变化时
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潛在失效模式和效應分析 (FMEA)
系統/子系統/零部件項目名稱： 產品型號： 核心小組：
過程功能 ／要求
1
責任者： 生效日期： 編制人：
4 5 6
難 撿 度 風 險 優 先 數 RPN 建議措施
2 3
潛在失效 模式 潛在失 效效應 嚴 重 度 等 級 失效原因
7 文件編號： 7a 頁碼： FMEA制定日期： FMEA修訂日期：
過程失效模式及效應分析 Process Failure Mode Effect Analysis (PFMEA)
失效模式与效应分析(failure modes and effects analysis,FMEA)
失效模式与效应分析(failure modes and effects analysis, FMEA)又名：潜在失效模式与效应分析(potential failure modes and effects analysis)，失效模式、影响与危害性分析(failure modes，effects，and criticality analysis，FMECA)概述失效模式与效应分析( FMEA)是一步步地识别在设计、生产或装配过程以及最终产品和服务中所有可能失效的一种方法。
“失效模式”意思是可能产生某些失效的方式或模式。
失效是任何的错误或者缺陷，尤其是那些影响顾客的、潜在的或实际的。
“效应分析”指的是研究这些失效的后果或效应。
这些失效按照他们结果的严重性、发生的频率以及被检测到的容易度优先排序。
FMEA的目的是从有最高的、优先级的开始来采取行动消除或者减少失效。
FMEA通常把当前有关失效的知识以及所采取的行动文档化，用于持续的改进。
FMEA用于设计中预防失效的发生，之后又用于正在进行的过程操作中的控制。
理想地说，FMFA开始于产品的概念设计阶段，贯穿于产品或服务的整个生命期中。
FMEA在19世纪40年代最早被应用于美国的军队中，然后在航空和自动化行业得到进一步的发展应用。
一些行业已经把FMEA的标准正规化，下面是一个综述。
在采取F'MEA过程之前，需通过其他的参考资料和培训，从而学习更多关于组织和行业的标准和具体的方法。
适用场合·当一个产品或服务正在被设计或者重复设计时，在QFD之后或者在设计完成之后；·当以全新的方式应用现有的过程、产品或服务时；·在形成新的或改进过程的控制方法以前；·当对现有的过程、产品或服务计划改进的时候；·当分析现有的过程、产品或者服务失效原因时；·贯穿于过程、产品或者服务的生命期中定期进行检查。
实施步骤这只是一个大概的过程，具体的细节则随着组织或行业的标准而有所变化。
FMEA-过程失效模式及后果分析PFMEA61中英文2 精品
How do we do a PFMEA? A Summary
怎样进行PFMEA？提要
Calculate the risk priority number (RPN) to prioritize corrective actions 计算风险顺序数(RPN)以确定应优先采取的纠正措施
Plan corrective actions and assign owner 制订纠正措施并落实责任人
2. Develop a process flow diagram 绘制过程流程图
Use the Process Flow Diagram format 运用正规的过程流程图
是过程设计小组采用的一种分析方法，用于 识别由于制造或装配过程的失效而导致的潜 在产品失效模式，并确定所应采取的纠正措 施。
Process FMEA 过程FMEA
formal process 正式程序
customer focused 着眼于顾客
uses engineering judgment, and hard data where it is available 利用工程经验判断和可靠的数据
何谓PFMEA
何时作PFMEA
何人作PFMEA 如何作PFMEA 16步工作步骤
Process FMEA 过程FMEA
When do we do a PFMEA? 何时进行PFMEA？
While there is still time to bring about changes in the process and in the product! 当还有时间修改产品及工艺设计时！
Process FMEA 过程FMEA
PFMEA is focussed on the Product PFMEA 关注对产品的影响
FMEA潜在失效模式及后果分析英文版ppt74页6758
Noun
Indicates what the action relates to
light speed information
1.20
Describe Functions
Thought starters ...
❖ Satisfy user ❖ Attract user ❖ Guarantee durability ❖ Easy to repare ❖ Safety requirements
actionable level ❖ Represents all wants, both spoken
and unspoken.
1.19
Describe Function
Verb
Indicates action, occurrence, being
Generate Control Display
Design
❖ Assess effects on all customers
Proces
❖ Identifies potential manufacturing and assembly causes to focus controls on reducing occurrence or increasing detection.
1.21
Brainstorming
1.22
Functiontree
❖ Provides an organized approach to identify the essential features of a product
❖ Defines all spoken and unspoken requirements
Content of the course
FMEA (标准模板)中英文
FAILURE MODE & EFFECT ANALYSIS FORM (失效模式及后果分析)FMEA Type (FMEA类型) :Report No. & Date (报告编号&日期):LOGO Product Family/Process (产品家族/过程):Revision (版本号) :Prepared By (制作人):Sheet No. (页面) :ITEM NEWN0.编号Prevention预防行动RPN新RPN Description ofproductcharacteristic orprocess stepProduct deviationsfrom requirements orway process failsSxOxDDescription of recommendedactions with quantifiableresults (insert NR if notrequired)Name of personresponsible forcorrective actionsDescription of actual actiontaken after implementationS O D SxOxD产品特性或工艺描述产品与要求或工艺不相符建议行动及合格结果(如不需要写入NR)负责纠正措施的人姓名完善后实际行动的描述S O DAction Date行动日期Change No.更改编号目前预防失效措施及失效的预见性级数估计All potential failure causes per failuremode including occurrence of failureranking estimateCURRENT CONTROLSRPNFAILURE CAUSE失效原因ACTION DATE ANDCHANGE NUMBER行动时间及更改号RANKINGDetection侦测行动RECOMMENDED ACTIONS建议行动RESPONSIBILITY责任FAILURE MODE失效模式FAILURE EFFECT失效结果FUNCTION功能Classification失效影响包括严重性的描述Description of how customermight see the effects of thefailure including Severityranking estimate每一失效模式的全部失效原因ESTIMATES预计级数Effective finalization dateof agreed corrective action采取纠正行动的最终生效日期Current controls to prevent failures occurring or detection of failure includingDetectability ranking estimateACTION TAKEN采取的行动。
失效模式(FMEA)
Battery damage
Connections spec. wrong
Unable to detect battery Faults
13 of 33 15.
FMEA 格式逐项解说
14 of 33
1.
2.
3. 4. 5. 6.
7. 8.
9. 10. 11.
12.
13. 14.
15.
Severity Occurrence Detection RPN Severity Occurrence Detection RPN
影响 (Effect) 7. 鱼骨图分析造成此Failure mode
之可能原因 (Cause) 8. 根据相关产品之历史数据定义出
Severity /Occurrence Detection 之等级 9. 根据 S/O/D 的定义定出每个 Failure mode 之 S/O/D 值 10. 列出相似Model 目前实行之
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Proces
❖ Identifies potential manufacturing and assembly causes to focus controls on reducing occurrence or increasing detection.
Generating FMEA’s
Who initiates?
FMEA失效模式与效果分析（英文版）
Content of the course
❖ Introduction ❖ Product - FMEA
❖ Blockdiagram , functiontree ❖ Process - FMEA
❖ Process-flowdiagram (macro-level) , micro-level ❖ Facilitatorskills
❖ Identify potential failure modes ❖ Prioritize actions ❖ Document the process.
FMEA – Purpose
Failures
FMEA
CR
Time
(Productionstart)
FMEA – Purpose
FMEA’s are intended to ...
FMEA Sessions
FMEA on chosen FMEA on Architecture Architectures
FMEA on FMEA on EVT Model First Mechanical FMEA on Working Model Part Files
FMEA on L0 Schematics
❖ Evaluation of design relating to DFM DFA DFT
❖ Increases the possibility to detect possible failure modes.
Voordelen – Proces-FMEA’s
Design
❖ Assess effects on all customers
When to discard?
How documented?
When completed?
Who prepares?
Failure MFoMdeEAasnd
Effect Analysis
Who updates?
Who is FMEAcustomer?
Startingdate/ revisiondate?
FMEA – Introduction
Introduction
❖ Why FMEA’s? ❖ Definition, Purpose,
Types, Benefits ❖ Team Approach
Why FMEA’s?
❖ Appropriate recommended actions may not have been taken.
❖ Customer rejections
FMEA – Team Approach
Coreteam
Supportteam
Product-FMEA – Content
Product-FMEA Content
❖ Define FMEA-team ❖ Define scope ❖ Describe functions
• production
• quality
• purchase
• testdept.
• ...
Product-FMEA – Scope
Once coreteam is established ...
❖ Create Blockdiagram ❖ Identify the boundery for Analysis ❖ Confirm composition of support team.
❖ Savings in engineering time. ❖ Reduction of changes
immediately before productionstart (Commercial Release).
FMEA – Definition
Structured group of activities which...
Managing FMEA’s
FMEA’s are living documents and are updated ...
❖ Modification to a product or process is planned
❖ Component is to be used in new environment
❖ Rate severity of failure modes ❖ Identify actions to reduce occurence ❖ Test adequacy of controls
FMEA – Types
ProductFMEA
ProcessFMEA
Mechanical Electrical Optical Mechanical Electrical Optical
» Brainstorming » Function Trees
Product-FMEA – Team
Facilitator
DesignEnginieer
Production/ process-enginieer
Coreteam
Support team
Representitives from:
• development
Blockdiagram
Service
Assembly
Part
Screw Component/
Weld
Part
X
Assembly
Y
User
Other systems
Adhesive
Part Z
Example blockdiagram (Settop Wildfire)
(ftbo L0)
FMEA on L0 Board (ftbo L1)
FMEA on L1 Board (ftbo L2)
Benefits – Producபைடு நூலகம்-FMEA’s
Product Proces
❖ Assess failure mode effects on all customers.
❖ Aids in evaluating testspecifications