STM Quality Limited
TOTAL QUALITY MANAGEMENT
What do we do when it"s #nished!
Introduction
Failure Mode and Efect Analysis?
F.M..A. is a sim$le way o% $redi&tin' what mi'ht 'o wron'.
By usin' a stru&tured method( results 
&an )e *uanti#ed and hen&e &om$ared.
 
+denti#es &riti&al and si'ni#&ant  &hara&teristi&s
,el$s en'ineers $rioritise and %o&us on
 
tilise indi-iduals" /nowled'e and s/ills within a team en-ironment
 
Failure Mode and Efect Analysis
F.M..A.s &an )e done %or any desi'n( manu%a&turin' or in1ser-i&e a&ti-ity
F.M..A.s are modular and &an )e
&arried out %or sin'le $arts or lar'e assem)lies
 
!ene"ts # Desi$n F.M.E. A.
Aids in e-aluatin' re*uirements and alternati-es Aids in initial esi'n %or Manu%a&ture +n&reases $ro)a)ility o% dete&tin' %ailure 
modes and their e3e&ts Pro-ides additional in%ormation %or
testin' re*uirements ,el$s identi%y &riti&al and si'ni#&ant 
&hara&teristi&s ,el$s -alidate test methods
 
!ene"ts # Process F.M.E. A.
+denti#es $otential $ro&ess related %ailure modes whi&h will e3e&t internale4ternal &ustomers 5edu&es &osts o% re$airs due to %aulty
$ro&ess methodolo'y +n&reases e6&ien&y sta)lishes a $riority system %or
&onsiderin' &orre&ti-e a&tions +denti#es &on#rmed &riti&al and
si'ni#&ant &hara&teristi&s
 
F.M..A +denti#es 5is/s
$esi%n &esponsibility
 To /ee$ u$ with &om$etition
 To retain &urrent )usiness
,el$ o)tain new )usiness
 
FM..A.s are li-in' do&uments and are u$dated when9
Modi#&ation to a &om$onent( $ro&ess or system is $lanned:
om$onent is to )e used in new en-ironment:
ustomer &on&ern arises.
 Then identi%y )oundary %or analysis
<e4t( &reate a ;ow &hart %or one o$eration
Process Flow %hart
=$.>0 Pre$aration
=$.?0 Weld
=$.@0 assem)le
=$.C0 +ns$e&t D Pa&/StorePa&/
=$.20 Mould
!oundary For Analysis
Press EStart" )utton
=$.0 Trim
$esi%n &esponsibility
From Pro&ess ;ow9
nter a sim$le des&ri$tion o% the $ro&ess )ein' analysed i.e. Pla&e $art on trim ma&hine #4ture:
+ndi&ate the $ur$ose o% the $ro&ess )ein' analysed i.e. Fully seat $art in &orre&t orientation:
List se$arately other o$erations in-ol-ed with that $ro&ess:
Pro&ess %un&tion &ontains )oth $rodu&t and $ro&ess &hara&teristi&s.
Process)Function *e+uire,ents
What is the $ro&ess $ur$ose!
What is its %un&tion!
De"ne the Process Purpose
Process Purpose
=$.0 Trim
 
 
$esi%n &esponsibility
e#nition9
Potential %ailure mode is the manner in whi&h the $ro&ess &ould $otentially %ail to meet the $ro&ess re*uirements andor desi'n intent.
  +t is a des&ri$tion o% the non1 &on%orman&e at that s$e&i#& o$eration.
Failure Mode
<o %un&tion
Partial %un&tion
+ntermittent %un&tion
$esi%n &esponsibility
e#nition9
 The e3e&ts o% the %ailure mode on the &ustomer. The &ustomer &ould )e the ne4t o$eration( su)se*uent o$erations or the #nal &ustomer user.
Efects o' Failure Mode
ne4t user
downstream user
ultimate &ustomer
ma&hines e*ui$ment
Efects o' Failure Mode
'ncorrect to
$esi%n &esponsibility
e#nition9
An assessment o% the seriousness o% the e3e&t o% the $otential %ailure mode on the &ustomer.
eerity
 
 with
warnin'
H

<one <o 3e&t >
 
$esi%n &esponsibility
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Identi'y pecial %haracteristics
5+T+AL9 5e*uirements that a3e&t &om$lian&e with 'o-ernment re'ulations or sa%e -ehi&le $rodu&t %un&tion and re*uire s$e&ial &ontrols KS&ore H or >0
 
$esi%n &esponsibility
e#nition9
Potential &ause o% a %ailure is de#ned as how the %ailure &ould o&&ur in terms o% somethin' that &an )e &orre&ted or &ontrolled.
%ause
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=nly s$e&i#& errors or mal%un&tions Ke'. =$erator %ails to remo-e waste should )e listed.
Am)i'uous $hrases Ke.'. =$erator error( ma&hine mal%un&tion should not )e used.
%ause
$esi%n &esponsibility
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STM Quality Limited
,ow %re*uently the &ause is $roOe&ted to o&&ur. Based on9
8 ,istori&al manu%a&turin'assem)ly %ailure rates with similar $arts
8 Statisti&al data %rom similar $ro&ess
84istin' $ro&ess &ontrols
8ustomer &on&ern data
8 5eOe&ts( PPM( Warranty data
(ccurrence
 About 1 in 2
 About 1 in 80
 About 1 in 400
 About 1 in 2000 @
$esi%n &esponsibility
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STM Quality Limited
+n&reasin' ins$e&tion is only a tem$orary measure. Permanent orre&ti-e A&tion is re*uired.
m$hasis must )e $la&ed on $re-entin'  de%e&ts rather than dete&tin' them Ke.'. S.P..
%ontrols
Pre-ention ontrols
8 Pla&e a EP" )e%ore ea&h $re-ention &ontrol listed
ete&tion ontrols
8 Pla&e a E" )e%ore ea&h dete&tion &ontrol listed
%ontrols
Pre-ention9 KPre%erred o$tion
Pre-ent the &ause me&hanism o% %ailure or the %ailure mode o&&urrin'( or redu&e their rate o% o&&urren&e
Preention %ontrols
ete&tion9
ete&t the &ause me&hanism o% %ailure or the %ailure mode and lead to &orre&ti-e a&tions
Detection %ontrols
Audi)le or -isual warnin' de-i&es
+n Pro&ess Final ins$e&tion
S.P..
$esi%n &esponsibility
ete&tion is an assessment o% the $ro)a)ility that9
 The $ro&ess &ontrols listed will dete&t a $otential &ause me&hanism K$ro&ess wea/ness ( or
 The $ro&ess &ontrols listed will dete&t a su)se*uent %ailure mode.
Detection
Almost &ertain
>
Pro&ess &ontrol will not andor &annot dete&t a $otential &ause J or there is no $ro&ess &ontrol
 
 
o&&urren&e
ete&tion Add to or im$ro-e the &ontrol methods
han'e the desi'n ... or the $ro&ess i% o$erator sa%ety is in-ol-ed
han'e the desi'n or $ro&ess
+m$ro-e a)ility to dete&t a %ailure mode
 
 
$esi%n &esponsibility
We ha-e seen that the F.M..A. as/s three *uestions9
What mi'ht 'o wron'!
What &aused the $ro)lem!
Failure Mode and Efect Analysis
From the answers to the three *uestions we &an wor/ out a ris/ $riority num)er9
*is/ Priority 0um)er
,ow do we &al&ulate the 5.P.<.!
We sim$ly use the s&orin' &riteria easily remem)ered )y9
Se-erity o% the $ro)lem
 
a&h is 'i-en a -alue %rom > to >0
Let"s try this out %or S( = D
For 4am$le(
=&&urren&e > 2 ? @ C 7 N H >0
ete&tion > 2 ? @ C 7 N H >0
 
Failure Mode and Efect Analysis
,ow &an we use these -alues to 'i-e an o-erall ris/!
We multi$ly the three #'ures to'ether9
e.'. 7 4 @ 4 ? N@.
So the 5.P.<. is N@.
 
Failure Mode and Efect Analysis
From the 5.P.<. we &an now see the areas o% 'reatest &on&ern
i.e. Those %ailures with the hi'hest ris/ $riority num)ers
 
Failure Mode and Efect Analysis
We &an now %o&us our attention on the worst $ro)lems 8 those with the hi'hest 5.P.<.
With limited resour&es( this must )e a 'ood idea
We &an now eliminate or
redu&e the $otential %ailure
 
$esi%n &esponsibility
*eco,,ended Actions
 The intent o% any 5e&ommended A&tion is to redu&e ran/in's in the %ollowin' order9
Se-erity
$esi%n &esponsibility
*esponsi1ility
a&h a&tion must )e assi'ned to a s$e&i#& indi-idual and not a de$t. or'anisation
 
$esi%n &esponsibility
Actions aken
 
Actions aken
 
Ad-anta'es o% F.M..A.s
+m$ro-ed $arti&i$ation a&ross traditional )oundaries
 
More ad-anta'es o% F.M..A.s
ses e4tensi-e D unta$$ed  $ersonnel$ro&ess /nowled'e to  im$ro-e new D e4istin' wor/
Pro-ides a -ehi&le %or &ontinuous im$ro-ement
Su$$orts $rodu&t lia)ility
 There are draw)a&/s %or F.M..A.s9
Must )e ade*uate time D resour&es  %or F.M..A.s
Produ&t Lia)ility
 
Failure Mode and Efect Analysis
 
ee$ the meetin's short and the tem$o shar$
esi'n F.M..A. team 1 hairman( Produ&tion( Ser-i&e( Quality Personnel
Pro&ess F.M..A. team 1 R= ,==S