潛在失效模式及后果 四

潛在失效模式及后果分析第四版Potential

Failure

Mode

and

EffectsAnalysis4th

EditionAgendaIntroductions

簡(jiǎn)介Background

背景The

“New”

Stuff

“新增加”的內(nèi)容Development

using

the

“new”

stuff

使用新增加的內(nèi)容進(jìn)行FMEA開發(fā)Introduction

簡(jiǎn)介FMEA—Part

of

a

Family

of

OEM

DocumentsPublished

by

AIAGFMEA-AIAG發(fā)布的OEM文件中的一部分

Requirements

documents

要求的文件—1）ISO/TS16949

Automotive

SectorRequirements,ISO/TS16949汽車行業(yè)要求---ISO9001：2000

is

foundation,ISO9001是基礎(chǔ)--Standard

&

Customer

Specific

Requirementsinclude

the

implementation

of

an

FMEAprocess標(biāo)準(zhǔn)和顧客特殊要求，包括FMEA過程的實(shí)施2）PPAP:

Product

Part

Approval

ProcessPPAP:

生產(chǎn)件批準(zhǔn)：--PPAP

includes

requirements

for

FMEAimplementation

and

is

subject

tocompliance

audit.--PPAP包括FMEA實(shí)施的要求，以及屬于審核的一個(gè)項(xiàng)目。Reference

Documents

參考文件：--FMEA4th

ED

FMEA第四版--APQP2nd

ED

APQP第二版--SPC

2nd

ED SPC

第二版--MSA

3rd

ED

MSA

第三版Supported

by

被支持--Manuals

chartered

by

the

AIAG

QualitySteering

Committee.--符合AIAG

質(zhì)量策劃委員會(huì)的手冊(cè)The

FMEA

Reference

DocumentsFMEA

參考文件A

reference

document

is

guidance參考文件是指：--it

is

an

OEM

recommendation,

OEM的建議--it

is

not

prescriptive,

不是強(qiáng)制的--it

is

NOT

auditable,

unless:不是審核依據(jù)，除非The

organization

says

in

its

procedures

that

it

will

followtheManual

（versus

be

consistent

with

it）or組織宣稱他們的程序按照此手冊(cè)實(shí)施（等同采用）或A

customer

explicitly

requires

that

you

must

(currently

TS

andtheCustomer

Specific

Requirements

do

not

do

this—you

onlyhaveto

be

consistent

with

the

manual)顧客明確要求你必須使用（目前TS和顧客特殊要求不要求—你只能等同采用）The

FMEA

Reference

DocumentsFMEA

參考文件Usage

and

Application

of

FMEAs

is

includedinrequirements

or

compliance

documents

such

asISO/TS

16949

andPPAP使用和應(yīng)用FMEAs的要求被包含在16949標(biāo)準(zhǔn)或相關(guān)文件里面，如PPAP。ISO/TS16949

and

PPAP

describe

“what”

is

required

orthe

compliance

criteria

for

FMEAs

and

are

subjecttoaudit.ISO/TS16949和PPAP描述“什么”是被要求的，或FMEA的接收準(zhǔn)則，并且是作為審核的項(xiàng)目。FMEA

compliance

requirements

may

also

be

includedin

CSRFMEA的要求可能被包含在顧客特殊要求中。The

FMEA

Reference

DocumentsFMEA

參考文件The

FMEA

reference

document

containsinformation

and

guidance

for

completing

andusing

FMEAs--the

FMEA

document

describes

the

“how”;

theimplementation

tools

for

effectively

developingFMEAs--

it

is

also

a

resource

for

developing

proceduresand

training

inFMEAFMEA

參考文件包括完成和使用FMEA的信息和指南--

FMEA文件描述“怎么做”，有效開發(fā)FMEA的實(shí)施工

具--同樣它也是FMEA開發(fā)程序和培訓(xùn)的資源Background背景WhatisFMEA？FMEA是什么？FMEAstandsforfailuremodeandeffectsanalysis--FMEAisananalyticalmethodologyusedtoensurethatpotentialproblemshavebeenconsideredandaddressedthroughouttheproductandprocessdevelopmentprocess--keyishavingtherightpeoplehavinggooddiscussionaboutissuesandrisksintheproductandprocessdesign,andthemitigationofhighriskissues--thisbecomespartoftheorganization’sknowledgemanagementFMEA表示失效模式后后果分析--FMEA是一個(gè)分析工具，以確保潛在問題已經(jīng)被考慮，WhyaFourthFMEA？為什么發(fā)布FMEA第四版？

FMEAisaprocessnotadocument--previousversionfocusedprimarilyonthecompletionoftheFMEAformandtheknowledgecontainedtherein.FMEA是一個(gè)過程，而不是一個(gè)文件--早期的版本，主要關(guān)注到的是FMEA的表格完成和里面的概念。

Reinforcethatmanagement

is

an

integralpartofthisprocess

需要強(qiáng)調(diào)的是，管理是這個(gè)過程所必需的一部分。WhyaFourthFMEA？為什么發(fā)布FMEA第四版？

MinimizeorEliminatecolumn

shifting--placinginformationinthe

wrongcolumnsthushinderingthe

analysisandproduct/processimprovementefforts

減少或者消除欄目--將信息填入錯(cuò)誤的欄目，會(huì)阻礙分析和產(chǎn)品/過程改進(jìn)的效果WhyaFourthFMEA？為什么發(fā)布FMEA第四版？MinimizeorEliminatesolerelianceontheRPN

intheevaluation

ofriskprioritiesandimprovementactions--Practice

of

DeflatingoftheRPN

to

meetanarbitrarythreshold.減少或消除單一依靠RPN值，去評(píng)價(jià)風(fēng)險(xiǎn)縫隙的

優(yōu)先程度和改進(jìn)措施。--習(xí)慣于去刻意降低RPN值，以滿足某個(gè)主觀的指

標(biāo)。WhyaFourthFMEA？為什么發(fā)布FMEA第四版？Lack

of

understandingofthe

roleoftheFMEAprocessthroughout

theAPQP

phases--includingcontinualimprovementduringproduction;

i.e.,

lookingattheFMEAasastaticdocumentnecessary

onlyforPPAPapproval.缺乏對(duì)FMEA在APQP各階段中的角色的理解?！ㄔ谏a(chǎn)過程中的持續(xù)改進(jìn)。如，只將FMEA視為PPAP批準(zhǔn)所需的靜態(tài)文件。The“New”Stuff新內(nèi)容ImprovementsinFMEA4th第四版FMEA的改進(jìn)HighlyVisibleImprovements可見的改進(jìn)Changes

in

format格式變化--additional

example增加例子--bettergraphics更好的圖形Changes

to

S,O,and

Drankingtables.更改了S，O，D值的表格AlternativeForms可選的表格Reduced

Emphasis

on

RPN減少對(duì)RPN的強(qiáng)調(diào)--AlternativestoRPN

RPN的可選AlternativeMethods

to

AnalyzeDesign

Risk可選的方法去分析設(shè)計(jì)風(fēng)險(xiǎn)Ease

of

Readingand

Use更容易的閱讀和使用Changeinformat格式的變化--Similar

to

thatofthe

SPCandMSA

manuals與SPC和MSA手冊(cè)相似Anindexisalso

included

to

aidinnavigatingthemanual.增加抬頭，以便于索引。Additional

Examples增加案例Additional

examples

andverbiagehavebeenprovidedtoimprovetheutilityofthemanual

andtoprovide

aclosertieintotheFMEAprocess

as

it

develops.所提供增加的案例和內(nèi)容，以改進(jìn)手冊(cè)的效果，以及提供一個(gè)更接近的關(guān)系去開發(fā)FMEA過程。Changes

toRiskRanking

Tables風(fēng)險(xiǎn)等級(jí)表格的更改Improvements

totheSeverity,Occurrence,Detection

rankingtables

sothattheyare

moremeaningfulto

real

world

analysis

and

usage.對(duì)S，O，D值表格的改進(jìn)，可以讓他們更有意義義的去分析真實(shí)世界和使用。Alternative

Forms替換表格The

3rdedition

used

asingle“standard”form第三版FMEA使用單一

的“標(biāo)準(zhǔn)”表格--

although

itallowed

for

other

forms,no

examples

were

provided.盡管它允許用其他表格，但沒有提供例子。The

4thedition

identifies

alternativeexample

forms第四版提供了替換表格-- the

focus

on

the“standard

form”has

been

replacedwithseveraloptions

that

represent

the

currentapplication

ofFMEAinindustry.關(guān)注“標(biāo)準(zhǔn)格式”已經(jīng)被替換成代表當(dāng)前工業(yè)領(lǐng)域使用的

FMEA的多種選擇--

Manualidentifiestheminimum

informationthatshouldbecontainedon

any

form.手冊(cè)識(shí)別了最低內(nèi)容，這些內(nèi)容必須被

包括在任何使用的表格中。--

allowsfor

use

ofthe3rdeditionform允許使用第三版的表格。DFMEAFormExamples例子：類似產(chǎn)品的DFMEA及FMA項(xiàng)目/功

能要求潛在失效模式潛在失效影響S級(jí)別潛在失

效起因O現(xiàn)行設(shè)計(jì)控制—預(yù)防現(xiàn)行設(shè)計(jì)控制—探測(cè)DRPN項(xiàng)目/功

能要求潛在失效模式潛在失

效影響S級(jí)別潛在失效起因O現(xiàn)行設(shè)

計(jì)控制—預(yù)防現(xiàn)行設(shè)計(jì)控制—探測(cè)D

RPN項(xiàng)目/功

能要求潛在失效模式潛在失

效影響S級(jí)別潛在失效起因現(xiàn)行設(shè)計(jì)控制—預(yù)防O現(xiàn)行設(shè)計(jì)控制—探測(cè)DRPN項(xiàng)目/功

能要求潛在失效模式潛在失效影響S級(jí)別潛在失效起因現(xiàn)行設(shè)計(jì)控制—預(yù)防O現(xiàn)行設(shè)計(jì)控制—探測(cè)D

RPNDFMEAReduced

Emphasis

onRPN降低對(duì)RPN的強(qiáng)調(diào)Moremeaningfulmethods

for

evaluatingpotential

designrisk更有意義的方法去評(píng)價(jià)潛在設(shè)計(jì)風(fēng)險(xiǎn)Prioritiesshould

not

bebasedon

RPN

alone.并不能單獨(dú)依據(jù)RPN值的大小來決定采取措施的優(yōu)先權(quán)。Alternatives

toRPN可供選擇的RPNS

andS

*O

(Severity

times

Occurrence)嚴(yán)重度和嚴(yán)重毒乘以頻度SOD

(Severity-Occurrence-Detection)嚴(yán)重度乘以頻度乘以探測(cè)度Alternative

Methodsto

AnalyzeDesign

Risk多種方法來分析設(shè)計(jì)風(fēng)險(xiǎn)Alternative

Methodsare

introducedthatarecurrently

beingapplied

inindustry.介紹了多種應(yīng)用于當(dāng)前工業(yè)的方法FTA故障樹FMECA(Failure

Mode

Effects

andCriticalityAnalysis)失效模式后果和關(guān)鍵性分析DRBFM(Design

ReviewBaseon

FailureMode)基于失效模式的設(shè)計(jì)評(píng)審FMECAFMECAis

similar

toFMEA與FMEA相似The

Cin

FMECAindicatesthatthecriticality(orSeverity)of

the

variousfailureeffectsareconsideredandranked.FMECA中的C，指的是：若干個(gè)失效影響的關(guān)鍵度（或嚴(yán)重度）已經(jīng)被考慮和歸類。Today,FMEA

isoftenusedas

asynonym

forFMECA.今天，F(xiàn)MEA經(jīng)常等同于FMECA來使用。Improvements

inFMEA4th–改進(jìn)Not

so

easily

seen不能輕易看到：

1)Identification

ofthe

need

for,and

types

of,Management

Support.識(shí)別了管理層支持的所需和類型。2)Increased

emphasison

the

FMEA

process強(qiáng)調(diào)了

FMEA過程--Alignment

with

APQP.和APQP的密切關(guān)系--increased

emphasisof“Team”discussionanddevelopment強(qiáng)調(diào)了“小組

”討論和開發(fā)--

Increased

emphasis

on“prerequisites”,--Linkagebetween

DFMEAand

PFMEADFMEA和PFMEA的聯(lián)系ConsistentFMEAapproachin

Chapter3

and4(DesignandProcess)第三章和第四章一樣的

FMEA方法Reduced

Emphasis

onRPN減少了對(duì)RPN值得強(qiáng)調(diào)The

Need

and

Type

ofManagement

Support管理層支持的所需和類型Reinforcement

oftheneedformanagementsupport,interest,andreviewoftheFMEAprocessandresults.增強(qiáng)對(duì)管理者支持的所需，興趣和FMEA過程的評(píng)審和結(jié)果“ManagementownstheFMEAprocess.Managementhas

the

ultimate

responsibilityofselectingand

applying

resources

andensuringan

effective

risk

managementprocessincluding

timing”.管理層擁有FMEA過程。管理層層具有最終的職責(zé)，以選擇和提供資源，以及一個(gè)包括時(shí)機(jī)的有效的風(fēng)險(xiǎn)管理過程。Emphasison“Prerequisites”andTeamDiscussions強(qiáng)調(diào)前提和小組討論Tominimizeoreliminatecolumnshifting,itisrecommended.為了減少或消除列項(xiàng)，建議：UseseparatecolumnsItem/Step,Function,andRequirements.使用獨(dú)立的列項(xiàng)：項(xiàng)目/步驟，功能，要求。Base

FailureModesonRequirements,notbrain-storming.制定基于要求的失效模式，而不是頭腦風(fēng)暴。Linkage

BetweenDFMEAand

PFMEADFMEA和PFMEA的聯(lián)系Defineand

Strengthenthe

understandingofthelinkagebetweenDFMEAandPFMEAaswellasdefiningthelinkagestoothertools.確定和加強(qiáng)對(duì)DFMEA和PFMEA聯(lián)系的理解以及和其他工具的聯(lián)系。--MainLinkageishowthedesigncanimpactmanufacturingorassemblyandconversely.主要的聯(lián)系是設(shè)計(jì)如何能夠影響制造或裝配過程，反之亦然。--ProductdesignriskimpactedbymanufacturingofdesignthatmaybeidentifiedduringtheDFMEAresearchandanalysisprocess.產(chǎn)品設(shè)計(jì)風(fēng)險(xiǎn)被被在DFMEA調(diào)查和分析過程中識(shí)別的制造過程程設(shè)計(jì)所影響。--TheeffectofaProcessfailuremodecanbeaDesignfailuremode(andallitseffects)一個(gè)過程失效模式的影響，可能是一個(gè)設(shè)計(jì)失效模式（以以及所有它的影響）。--Also,connectionstoControlPlans,DVPR,etcLinkagesbetweenDesignandProcess設(shè)計(jì)和過程的聯(lián)系Designdevelopment設(shè)計(jì)開發(fā)--A“standard”radiusspecifiedbuthardtomanufacture.一個(gè)標(biāo)準(zhǔn)的半徑，但是難以加工--Stylingshapes,whichlookgoodbutarehardandexpensivetoshape.一個(gè)外形，看著很漂亮，但是難以以，和需要昂貴的加工。--

Sharpedges

whichcould

injure

the

operator尖銳的棱角可能會(huì)傷害到操作者--Characteristicsthatarecritical,

excessivevariationSystemDevelopment系統(tǒng)開發(fā)--A

childfailuremodecausesaparentfailuremodesandallitseffects.一個(gè)子失效模式，會(huì)導(dǎo)致一個(gè)母失效模式和它所有的影響。Process

Development過程開發(fā)--ProcessFailuremodecausesaDesignFailureModesandallitseffects.過程的失效模式，會(huì)導(dǎo)致設(shè)計(jì)失效模式以及它所有的影響。ConductaCaseStudy!聽了這么久，做個(gè)案例吧？！回形針SCENARIO案例YouworkforDilbertWireForming(DWF),afirmthathaslongprosperedbysupplyingtheautomotiveindustrywithformedwireproducts,suchasspringsandwireclips.Tobecomeeconomicallymorerobust,DWFwishestobroadenitsproductlinesothatitcouldmoveintonewmarkets.Agroupisformedconsistingofmarketresearch,production,sales,anddesignassociatestolookintowhatnewproductcouldbemadeutilizingthecompany’sexperienceinwireformingYouareamemberofthisgroup.你為DWF公司工作。該公司是一個(gè)在汽車行行業(yè)用成型鋼絲產(chǎn)品（比如彈簧和電線夾）有有著長(zhǎng)期成功供貨經(jīng)驗(yàn)的公司。為了公司的發(fā)展，公司希望在其他市場(chǎng)擴(kuò)大其產(chǎn)品線。一個(gè)由市場(chǎng)調(diào)研，生產(chǎn)，銷售和設(shè)計(jì)人員在

內(nèi)的小組已構(gòu)成，以尋求能基于公司在鋼絲產(chǎn)產(chǎn)品經(jīng)驗(yàn)的基礎(chǔ)上開發(fā)新的產(chǎn)品。你是小組的成員之一。Thegrouphasidentifiedwirepaperclipsasaviablenewproduct.--inrecentyearsthepriceofpaperclipshadrisenalmostthreetimesasfastasthepricewire--demandfortheproductwasup,and--thereappearstobelittlecustomerloyaltytoanyparticularbrand.Outlook--domesticmarketisestimatedtobe500millionpaperclipsperyear--ifthemanufacturingcostsare$0.0035perclip,DWFmightexpecttocapture10percentofthemarket--ifthecostis$0.0025perclipdomesticsalescanexpecttobe80millionpaperclipsandexportanother20millioneachyear.小組已經(jīng)識(shí)別出了回形針是一個(gè)可行的新產(chǎn)品：--在最近幾年中，回形針的價(jià)格漲了三次，比鋼絲的價(jià)格上漲次數(shù)還多--產(chǎn)品的需求在上漲，并且--顯示出，部分顧客對(duì)某一特定品牌的忠誠(chéng)度很高。展望--本地市場(chǎng)，每年估計(jì)有5億只需求；--如果制造成本是每只0.0035美元，那么公司期望能獲得10%的市場(chǎng)占有率--如果成本在0.0025美元，那么每年，本地市場(chǎng)預(yù)計(jì)可以銷售8000萬只，出口達(dá)到2000萬只。Sincethestandard-siz“eG“em”a”ccountsfor90percentofthemarket,itsov

eralldimensionsusedasthedesignstartingpoint.Tobecomecompetitive,yourgroupdecidedthatifthelegscouldbecutoffshorter,upto10%lesstotalwirewouldbeneededforeachpaperclipthus--reducingthecostofrawmaterials,whichrepresentsoverhalfthemanufacturingcost--reflectsavingsinshippingcostssinceitwouldbelighter.普通標(biāo)準(zhǔn)尺寸的回形針占了90%的市場(chǎng)占有率，所

所以設(shè)計(jì)的起始點(diǎn)放在產(chǎn)品的外輪廓尺寸上。為了具有競(jìng)爭(zhēng)力，小組決定：如果回形針的腳能切

切短一點(diǎn)，達(dá)到鋼絲原有用量的10%，那么，每一一個(gè)回形針可以：--降低材料成本，并能降低一半的制造成本；--因?yàn)闇p輕了重量，則同時(shí)降低了運(yùn)輸成本。Concern:Willthepaperclipstill“Clip”?關(guān)注：回形針還能發(fā)揮作用嗎？Howapaperclip

works回形針如何工作的Paperclipsaresmallobjects,usuallyconstructedfrom

metal

wire,thatservetoholdseveral

sheetsofpapertogetherasa

singleunit.回形針是個(gè)小物體，通常采用金屬鋼絲制造，用于夾緊一層紙張。Ineffect,apaperclipconsistsoftwometalsurfacesthatarepressedagainstoneanotherbytheelasticityofthemetalwirefromwhichthepaperclipisbuilt.實(shí)際上，一個(gè)回形針包括兩個(gè)互相貼合的金屬表面，通過金屬絲的彈性來夾緊紙張。Asyoudistortthepaperclipaway

fromits

equilibriumshape,byspreadingthe

twosurfacesapart,itexperiencesrestoringforces.當(dāng)你將回形針的兩個(gè)表面分開，使之變形，會(huì)有一個(gè)回彈力。Theseforcestendtoreturnthe

paper

cliptoits

equilibrium

shapeandpushthetwosurfacestogether.這種力量會(huì)導(dǎo)致回形針回復(fù)到一個(gè)平面，并將兩個(gè)表面合在一起。A

testengineerdeterminedthat

thischangewould

resultinonly2percentdecreaseinspringaction

gripping.一個(gè)測(cè)試工程師確定，這種更改只會(huì)降低彈力的

2%。BasicCustomerRequirementsfor

apaperclip對(duì)于回形形針，顧客的基本要求。BasicFunction:Holdspapers

securely基本功能：安全的夾緊紙張Maintainsintegrityof

thestackofpaper保持一堆紙張整齊Does

notcatch,mutilate,or

tearpapers不能卡住或撕破紙張Holdsa

thick

setofpapers夾緊一摞厚紙Iseasilyinserted.能輕松插入Safe

to

use使用安全Does

notgettangledwith

other

clips

in

thebox在盒子里，不能和其它回形針發(fā)生干涉islightweightand

requires

lesspostage輕量，并且需要較少的郵費(fèi)Ischeap便宜Isdurable—does

notrust耐用，不能生銹BlockDiagram簡(jiǎn)圖DFMEADevelop

aDFMEAtodetermine

whataretherisksinusingthis

designwith

thenewchanges開發(fā)一個(gè)DFMEA以確定這個(gè)新的更改所產(chǎn)生的設(shè)計(jì)風(fēng)險(xiǎn)。DFMEARequirement:Doesnotcatch,Mutilate,ortear

papers要求：不能卡住或撕破紙張Team

Exercise小組測(cè)試Develop

thebranchinthe

DFMEA

forthisrequirement

ofthebasicfunctionoftheitem:paperclip以以上要求，開發(fā)一個(gè)DFMEA。DFMEARequirement：Does

notcatch,Mutilate,

ortearpapers.不能卡住或撕破紙張F(tuán)ailure

Mode:

PaperClipcatches,mutilates,ortearspapersinnormaluse,oninsertion,oronextraction.在正常的插入或拔出過程中卡住或撕破