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FMEA Failure Mode Effects Analysis

Quality and Reliability


Quality is a relative term often based on customer perception or the degree to which a product meets customer expectations Manufacturers have long recognized that products can meet specifications and still fail to satisfy customer expectations due to ! Errors in design ! Flaws induced by the manufacturing process ! Environment ! "roduct misuse ! #ot understanding customer wants$needs

Quality% Reliability and Failure "revention


&raditionally 'uality activities have focused on detecting manufacturing and material defects that cause failures early in the life cycle &oday% activities focus on failures that occur beyond the infant mortality stage Emphasis on Failure Prevention

Failure Mode ( Effects Analysis )FMEA*


FMEA is a systematic method of identifying and preventing system% product and process problems before they occur FMEA is focused on preventing problems% enhancing safety% and increasing customer satisfaction +deally% FMEA,s are conducted in the product design or process development stages% although conducting an FMEA on existing products or processes may also yield benefits

FMEA$FME-A .istory
&he history of FMEA$FME-A goes bac/ to the early 0123s and 0143s5
! 6575 #avy 8ureau of Aeronautics% followed by the 8ureau of #aval 9eapons ! #ational Aeronautics and 7pace Administration )#A7A*

:epartment of :efense developed and revised the M+;<7&:<04=1A guidelines during the 01>3s5

FMEA$FME-A .istory (continued)


Ford Motor -ompany published instruction manuals in the 01?3s and the automotive industry collectively developed standards in the 0113s5 Engineers in a variety of industries have adopted and adapted the tool over the years5

"ublished @uidelines
A0>B1 from the SAE for the automotive
industry. A+A@ FMEA<B from the Automotive Industry Action Group for the automotive industry. AR"22?3 from the SAE for nonautomotive applications.

Cther @uidelines
Cther industry and company<specific guidelines exist5 For example ! E+A$AE"0B0 provides guidelines for the
electronics industry% from the AE:E-$E+A5

Introduction

! "<B3=<>=3 provides guidelines for #A7A,s


@7F- spacecraft and instruments5

! 7EMA&E-. 1=3=314BA<E#@ for the


semiconductor e'uipment industry5 ! EtcD

FMEA is a &ool
FMEA is a tool that allows you to ! "revent 7ystem% "roduct and "rocess problems before they occur ! reduce costs by identifying system% product and process improvements early in the development cycle ! -reate more robust processes ! "rioritize actions that decrease ris/ of failure ! Evaluate the system%design and processes from a new vantage point

A 7ystematic "rocess
FMEA provides a systematic process to ! +dentify and evaluate
potential failure modes potential causes of the failure mode

! +dentify and 'uantify the impact of potential failures ! +dentify and prioritize actions to reduce or eliminate the potential failure ! +mplement action plan based on assigned responsibilities and completion dates ! :ocument the associated activities

"urpose$8enefit
cost effective tool for maximizing and documenting the collective /nowledge% experience% and insights of the engineering and manufacturing community format for communication across the disciplines provides logical% se'uential steps for specifying product and process areas of concern

8enefits of FMEA
-ontributes to improved designs for products and processes5 ! .igher reliability ! 8etter 'uality ! +ncreased safety ! Enhanced customer satisfaction -ontributes to cost savings5 ! :ecreases development time and re<design costs ! :ecreases warranty costs ! :ecreases waste% non<value added operations -ontributes to continuous improvement

8enefits
-ost benefits associated with FMEA are usually expected to come from the ability to identify failure modes earlier in the process% when they are less expensive to address5 ! Erule of tenF +f the issue costs G033 when it is discovered in the field% thenD +t may cost G03 if discovered during the final testD 8ut it may cost G0 if discovered during an incoming inspection5 Even better it may cost G3503 if discovered during the design or process engineering phase5

FMEA as .istorical Record


-ommunicate the logic of the engineers and related design and process considerations Are indispensable resources for new engineers and future design and process decisions5

7ystem
-omponents 7ubsystems Main 7ystems

:esign
-omponents 7ubsystems Main 7ystems

"rocess
Manpower Machine Method Material Measurement Environment Focus Minimize failure effects on the "rocesses CbHectives$@oal Maximize &otal "rocess Quality% reliability% -ost and maintenance

Focus Minimize failure effects on the 7ystem CbHectives$@oal Maximize 7ystem Quality% reliability% -ost and maintenance

Focus Minimize failure effects on the :esign CbHectives$@oal Maximize :esign Quality% reliability% -ost and maintenance

Machines
&ools% 9or/ 7tations% "roduction ;ines% Cperator &raining% "rocesses% @auges

9hy do FMEA,sI
Examine the system for failures5 Ensure the specs are clear and assure the product wor/s correctly +7C re'uirement<Quality "lanning
! ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures, and the applicable documentation

9hat tools are available to meet our obHectiveI


8enchmar/ing customer warranty reports design chec/list or guidelines field complaints internal failure analysis internal test standards lessons learned returned material reports Expert /nowledge

9hat are possible outcomesI


Actual$potential failure modes customer and legal design re'uirements duty cycle re'uirements product functions /ey product characteristics "roduct Jerification and Jalidation

.ow to FmeaD&he "re<&eam Meeting


"rior to assembling the entire team% it may be useful to arrange a meeting between two or three /ey engineers &his could include persons responsible for design% 'uality% and testing5

.ow to FMEA55 )cont5*


&he purpose of this meeting is to ! :etermine scope ! @ather bac/ground reference material ! -reate update bloc/ diagrams ! +dentify team members ! "repare an agenda% schedule% milestones ! +dentify item functions% failure modes and their effects

Assumptions of :FMEA
All systems$components are manufactured and assembled as specified by design Failure could% but will not necessarily% occur

:esign FMEA Format


&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

@eneral
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

Every FMEA should have an assumptions document attached )electronically if possible* or the first line of the FMEA should detail the assumptions and ratings used for the FMEA5 "roduct$part names and numbers must be detailed in the FMEA header All team members must be listed in the FMEA header Revision date% as appropriate% must be documented in the FMEA header

Function<9hat is the part supposed to do in view of customer re'uirementsI


:escribe what the system or component is designed to do
! +nclude information regarding the environment in which the system operates define temperature% pressure% and humidity ranges

;ist all functions Remember to consider unintended functions


! position$locate% support$reinforce% seal in$out% lubricate% or retain% latch secure

Function
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E .JA- system must defog windows and heat or cool cabin to >3 degrees in all operating conditions )<L3 degrees to 033 degrees* < within B to 2 minutes or < As specified in functional spec MNNNNNNNO rev5 dateNNNNNNNNN

"otential Failure mode


:efinition the manner in which a system% subsystem% or component could potentially fail to meet design intent As/ yourself< F.ow could this design fail to meet each customer re'uirementIF Remember to consider
! ! ! ! ! ! absolute failure partial failure intermittent failure over function degraded function unintended function

Failure Mode
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E7 .JA- system does not heat vehicle or defog windows .JA- system ta/es more than 2 minutes to heat vehicle .JA- system does not heat cabin to >3 degrees in below zero temperatures .JA- system cools cabin to 23 degrees .JA- system activates rear window defogger

-onsider "otential failure modes under


Cperating -onditions
! hot and cold ! wet and dry ! dusty and dirty

6sage
! Above average life cycle ! .arsh environment ! below average life cycle

-onsider "otential failure modes under


+ncorrect service operations
! -an the wrong part be substituted inadvertentlyI ! -an the part be serviced wrongI E5g5 upside down% bac/wards% end to end ! -an the part be omittedI ! +s the part difficult to assembleI

:escribe or record in physical or technical terms% not as symptoms noticeable by the customer5

"otential Effect)s* of Failure


:efinition effects of the failure mode on the function as perceived by the customer As/ yourself< F9hat would be the result of this failureIF or E+f the failure occurs then what are the conse'uencesF :escribe the effects in terms of what the customer might experience or notice 7tate clearly if the function could impact safety or noncompliance to regulations +dentify all potential customers5 &he customer may be an internal customer% a distributor as well as an end user :escribe in terms of product performance

Effect)s* of Failure
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E -annot see out of front window Air conditioner ma/es cab too cold :oes not get warm enough &a/es too long to heat up

Examples of "otential Effects


#oise loss of fluid seizure of adHacent surfaces loss of function no$low output loss of system +ntermittent operations rough surface unpleasant odor poor appearance potential safety hazard -ustomer dissatisfied

7everity
:efinition assessment of the seriousness of the effect)s* of the potential failure mode on the next component% subsystem% or customer if it occurs 7everity applies to effects For failure modes with multiple effects% rate each effect and select the highest rating as severity for failure mode

7everity
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E -annot see out of front window ! severity 1 Air conditioner ma/es cab too cold ! severity 2 :oes not get warm enough ! severity 2 &a/es too long to heat up ! severity L

-lassification
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

-lassification should be used to define potential critical and significant characteristics -ritical characteristics )1 or 03 in severity with = or more in occurrence<suggested* must have associated recommended actions 7ignificant characteristics )L thru ? in severity with L or more in occurrence <suggested* should have associated recommended actions -lassification should have defined criteria for application EKAM";E -annot see out of front window ! severity 1 ! incorrect vent location ! occurrence = Air conditioner ma/es cab too cold ! severity 2 < +ncorrect routing of vent hoses )too close to heat source* ! occurrence 4

"otential -ause)s*$Mechanism)s* of failure


:efinition an indication of a design wea/ness% the conse'uence of which is the failure mode Every conceivable failure cause or mechanism should be listed Each cause or mechanism should be listed as concisely and completely as possible so efforts can be aimed at pertinent causes

-ause)s* of Failure
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E +ncorrect location of vents +ncorrect routing of vent hoses )too close to heat source* +nade'uate coolant capacity for application

"otential -ause
&olerance build up insufficient material insufficient lubrication capacity Jibration Foreign Material +nterference +ncorrect Material thic/ness specified exposed location temperature expansion inade'uate diameter +nade'uate maintenance instruction Cver<stressing Cver<load +mbalance +nade'uate tolerance

Mechanism
Pield Fatigue Material instability -reep 9ear -orrosion

Cccurrence
:efinition li/elihood that a specific cause$mechanism will occur 8e consistent when assigning occurrence Removing or controlling the cause$mechanism though a design change is only way to reduce the occurrence rating

Cccurrence
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E +ncorrect location of vents ! occurrence B +ncorrect routing of vent hoses )too close to heat source* ! occurrence 4 +nade'uate coolant capacity for application ! occurrence =

-urrent :esign -ontrols


:efinition activities which will assure the design ade'uacy for the failure cause$mechanism under consideration -onfidence -urrent :esign -ontrols will detect cause and subse'uent failure mode prior to production% and$or will prevent the cause from occurring
! +f there are more than one control% rate each and select the lowest for the detection rating

-ontrol must be allocated in the plan to be listed% otherwise it,s a recommended action B types of -ontrols ! 05 "revention from occurring or reduction of rate ! =5 :etect cause mechanism and lead to corrective actions ! B5 :etect the failure mode% leading to corrective actions

-urrent :esign -ontrols


&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

EKAM";E Engineering specifications )"* ! preventive control .istorical data )"* ! preventive control Functional testing ):* ! detective control @eneral vehicle durability ):* ! detective control

Examples of -ontrols
&ype 0 control
! 9arnings which alert product user to impending failure ! Fail$safe features ! :esign procedures$guidelines$ specifications

&ype = and B controls


! ! ! ! ! ! ! ! Road test :esign Review Environmental test fleet test lab test field test life cycle test load test

:etection
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

:etection values should correspond with A+A@% 7AE +f detection values are based upon internally defined criteria% a reference must be included in FMEA to rating table with explanation for use :etection is the value assigned to each of the detective controls :etection values of 0 must eliminate the potential for failures due to design deficiency EKAM";E Engineering specifications ! no detection value .istorical data ! no detection value Functional testing ! detection B @eneral vehicle durability ! detection 2

R"# )Ris/ "riority #umber*


&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

Ris/ "riority #umber is a multiplication of the severity% occurrence and detection ratings ;owest detection rating is used to determine R"# R"# threshold should not be used as the primary trigger definition of recommended actions EKAM";E -annot see out of front window ! severity 1% ! incorrect location ! =% Functional testing ! detection B% R"# < 2L

for

vent

Ris/ "riority #umber)R"#*


7everity x Cccurrence x :etection R"# is used to prioritize concerns$actions &he greater the value of the R"# the greater the concern R"# ranges from 0<0333 &he team must ma/e efforts to reduce higher R"#s through corrective action @eneral guideline is over 033 Q recommended action

R"# -onsiderations
Rating scale example
! 7everity Q 03 indicates that the effect is very serious and is EworseF than 7everity Q 05 ! Cccurrence Q 03 indicates that the li/elihood of occurrence is very high and is EworseF than Cccurrence Q 05 ! :etection Q 03 indicates that the failure is not li/ely to be detected before it reaches the end user and is EworseF than :etection Q 05
1 5 10

R"# -onsiderations (continued)


R"# ratings are relative to a particular analysis5
! An R"# in one analysis is comparable to other R"#s in the same analysis D ! D but an R"# may #C& be comparable to R"#s in another analysis5
1 5 10

R"# -onsiderations (continued)


8ecause similar R"#Rs can result in several different ways )and represent different types of ris/*% analysts often loo/ at the ratings in other ways% such as
! Cccurrence$7everity Matrix )7everity and Cccurrence*5 ! +ndividual ratings and various ran/ing tables5
1 5 10

Recommended Actions
:efinition tas/s recommended for the purpose of reducing any or all of the ran/ings Cnly design revision can bring about a reduction in the severity ran/ing Examples of Recommended actions
! "erform
:esigned experiments reliability testing finite element analysis

! Revise design ! Revise test plan ! Revise material specification

Recommended Actions
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

All critical or significant characteristics must have recommended actions associated with them Recommended actions should be focused on design% and directed toward mitigating the cause of failure% or eliminating failure mode +f recommended actions cannot mitigate or eliminate the potential for failure% recommended actions must force characteristics to be forwarded to process FMEA for process mitigation

the

Responsibility ( &arget -ompletion :ate


&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

All recommended actions must have a person assigned responsibility for completion of the action Responsibility should be a name% not a title "erson listed as responsible for an action must also be listed as a team member &here must be a completion date accompanying each recommended action

Action Results
&tem Potential %ailure "ode
%unction

Potential E$$ect(s o$ %ailure

S e v

C l a s s

Potential Cause(s ! "ec#anism(s O$ %ailure

O c c u r

Current Design Controls


Prevent Detect

D e t e c

Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N

6nless the failure mode has been eliminated% severity should not change Cccurrence may or may not be lowered based upon the results of actions :etection may or may not be lowered based upon the results of actions +f severity% occurrence or detection ratings are not improved% additional recommended actions must to be defined

Exercise :esign FMEA


"erform A :FMEA on a pressure coo/er

Pressure Coo er Safety Features


05 7afety valve relieves pressure before it reaches dangerous levels5 =5 &hermostat opens circuit through heating coil when the temperature rises above =23S -5 B5 "ressure gage is divided into green and red sections5 T:angerT is indicated when the pointer is in the red section5

Pressure Coo er F!EA


:efine 7cope 05 Resolution < &he analysis will be restricted to the four maHor subsystems )electrical system% safety valve% thermostat% and pressure gage*5 =5 Focus < 7afety

"ressure coo/er bloc/ diagram

"rocess FMEA
:efinition
! A documented analysis which begins with a teams thoughts concerning re'uirements that could go wrong and ending with defined actions which should be implemented to help prevent and$or detect problems and their causes5 ! A proactive tool to identify concerns with the sources of variation and then define and ta/e corrective action5

"FMEA as a toolD
&o access ris/ or the li/elihood of significant problem &rouble shoot problems @uide improvement aid in determining where to spend time and money -apture learning to retain and share /nowledge and experience

Customer Re'uirements Deign Speci$ications (e) Product C#aracteristics "ac#ine Process Capa*ilit)

Process %lo+ Diagram

Process %"EA

Process Control Plan

Operator ,o* &nstructions

Con$orming Product Reduced Variation Customer Satis$action

+nputs for "MEA


"rocess flow diagram Assembly instructions :esign FMEA -urrent engineering drawings and specifications :ata from similar processes
! ! ! ! 7crap Rewor/ :owntime 9arranty

"rocess Function Re'uirement


8rief description of the manufacturing process or operation &he "FMEA should follow the actual wor/ process or se'uence% same as the process flow diagram 8egin with a verb

&eam Members for a "FMEA


"rocess engineer Manufacturing supervisor Cperators Quality 7afety "roduct engineer -ustomers 7uppliers

"FMEA Assumptions
&he design is valid All incoming product is to design specifications Failures can but will not necessarily occur :esign failures are not covered in a "FMEA% they should have been part of the design FMEA

"otentional Failure Mode


.ow the process or product may fail to meet design or 'uality re'uirements Many process steps or operations will have multiple failure modes &hin/ about what has gone wrong from past experience and what could go wrong

-ommon Failure Modes


Assembly
! ! ! ! ! Missing parts :amaged Crientation -ontamination Cff location

Machining
! ! ! ! &oo narrow &oo deep Angle incorrect Finish not to specification ! Flash or not cleaned

&or'ue
! ;oose or over tor'ue ! Missing fastener ! -ross threaded

"otentional failure modes


7ealant
! Missing ! 9rong material applied ! +nsufficient or excessive material ! dry

:rilling holes
! ! ! ! ! ! Missing ;ocation :eep or shallow Cver$under size -oncentricity angle

"otential effects
&hin/ of what the customer will experience
! End customer ! #ext user<conse'uences due to failure mode

May have several effects but list them in same cell &he worst case impact should be documented and rated in severity of effect

"otential Effects
End user
! ! ! ! ! ! #oise ;ea/age Cdor "oor appearance Endangers safety ;oss of a primary function ! performance

#ext operation
! ! ! ! ! ! ! ! -annot assemble -annot tap or bore -annot connect -annot fasten :amages e'uipment :oes not fit :oes not match Endangers operator

7everity Ran/ing
.ow the effects of a potential failure mode may impact the customer Cnly applies to the effect and is assigned with regard to any other rating "otential effects of failure -annot assemble bolt)2* Endangers operator)03* Jibration )4* 7everity

03 &a/e the highest effect ran/ing

-lassification
6se this column to identify any re'uirement that may re'uire additional process control
! UV-U < /ey characteristic ! UFU ! fit or function ! U7U < safety ! Pour company may have a different symbol

"otential -auses
-ause indicates all the things that may be responsible for a failure mode5 -auses should items that can have action completed at the root cause level )controllable in the process* Every failure mode may have multiple causes which creates a new row on the FMEA Avoid using operator dependent statements i5e5 Eoperator errorF use the specific error such as Eoperator incorrectly located partF or Eoperator cross threaded partF

"otential -auses
E'uipment
! ! ! ! ! &ool wear +nade'uate pressure 9orn locator 8ro/en tool @auging out of calibration ! +nade'uate fluid levels

Cperator
! ! ! ! +mproper tor'ue 7elected wrong part +ncorrect tooling +ncorrect feed or speed rate ! Mishandling ! Assembled upside down ! Assembled bac/wards

Cccurrence Ran/ing
.ow fre'uent the cause is li/ely to occur 6se other data available
! "ast assembly processes ! 7"! 9arranty

Each cause should be ran/ed according to the guideline

-urrent "rocess -ontrols


All controls should be listed% but ran/ing should occur on detection controls only ;ist the controls chronologically
! :on not include controls that are outside of your plant

:ocument both types of process controls


! "reventative< before the part is made
"revent the cause% use error proofing at the source

! :etection< after the part is made


:etect the cause )mista/e proof* :etect the failure mode by inspection

"rocess -ontrols
"reventative
! ! ! ! ! ! ! ! 7"+nspection verification 9or/ instructions Maintenance Error proof by design Method sheets 7et up verification Cperator training

:etection
! ! ! ! ! Functional test Jisual inspection &ouch for 'uality @auging Final test

:etection
"robability the defect will be detected by process controls before next or subse'uent process% or before the part or component leaves the manufacturing or assembly location ;i/ely hood the defect will escape the manufacturing location Each control receives its own detection ran/ing% use the lowest rating for detection

Ris/ "riority #umber )R"#*


R"# provides a method for a prioritizing process concerns .igh R"#,s warrant corrective actions :espite of R"#% special consideration should be given when severity is high especially in regards to safety

R"# as a measure of ris/


An R"# is li/e a medical diagnostic% predicting the health of the patient At times a persons temperature% blood pressure% or an EV@ can indicate potential concerns which could have severe impacts or implications

Recommended actions

Control

&n$luence

Can-t control or in$luence at t#is time

Recommended Action
:efinition tas/s recommended for the purpose of reducing any or all of the ran/ings Examples of Recommended actions
! "erform
"rocess instructions )"* &raining )"* -an,t assemble at next station ):* Jisual +nspection ):* &or'ue Audit ):*

P"EA as a &n$o 0u* Customer Design re'uirements Process %lo+ Diagram Current or E.pected 'ualit) per$ormance

Process C#anges

&mplementation and veri$ication

Process %"EA document

Recommended Corrective actions i/e/ Error proo$ing Continuous &mprovement E$$orts And RPN reduction loop

Process Control Plan

Operator ,o* &nstructions

Communication o$ standard o$ +ork to operators

FMEA process flow

"rocess FMEA exercise


&as/ "roduce and mail sets of contribution re'uests for 8reast -ancer research Cutcome "rofessional loo/ing re'uests to support research for a cure% 23 sets of information% contribution re'uest% and return envelope

Re'uirements
#o inHury to operators or users Finished dimension fits into envelope All items present )info sheet% contribution form% and return envelope* WVEPX All pages in proper order )info sheet% contribution form% return envelope* WVEPX #o tattered edges #o dog eared sheets +tems put together in order )info sheet Yfolded to fit in legal envelopeZ% contribution sheet% return envelope* WVEPX @eneral overall neat and professional appearance "roper first class postage on envelopes 8reast cancer seal on every envelope sealing the envelope on the bac/ Mailing label% stamp and seal on placed s'uarely on envelope WVEPX Rubber band sets of =2

"rocess steps
Fold information sheet to fit in legal envelope -ollate so each group includes all components 7tuff envelopes Affix address% postage% and seal Rubber bands sets of =2 :eliver to post office for mail today by 2 pm

03 steps to conduct a FMEA


05 =5 B5 L5 25 45 >5 ?5 15 035 Review the design or process 8rainstorm potential failure modes ;ist potential failure effects Assign 7everity ratings Assign Cccurrence ratings Assign detection rating -alculate R"# :evelop an action plan to address high R"#,s &a/e action Reevaluate the R"# after the actions are completed

Reasons FMEA,s fail


05 =5 B5 L5 25 Cne person is assigned to complete the FMEA5 #ot customizing the rating scales with company specific data% so they are meaningful to your company &he design or process expert is not included in the FMEA or is allowed to dominate the FMEA team Members of the FMEA team are not trained in the use of FMEA% and become frustrated with the process FMEA team becomes bogged down with minute details of design or process% losing sight of the overall obHective

Reasons FMEA,s fail


45 Rushing through identifying the failure modes to move onto the next step of the FMEA >5 ;isting the same potential effect for every failure i5e5 customer dissatisfied5 ?5 7topping the FMEA process when the R"#,s are calculated and not continuing with the recommended actions5 15 #ot reevaluating the high R"#,s after the corrective actions have been completed5

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Sample

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