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Transcript of PPAP trg.ppt
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Good Morning
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• Understanding APQP (Advanced ProductQuality Planning)
• Production Part Approval Process (PPAP)
• Purpose
• Benefts
•Standards• When is PPAP required?
• PPAP subission levels
• !leents o" PPAP and its iportance
• #esign $ecords• Process %lo& #iagra
• #%'!A P%'!A
• ontrol Plan
• 'SA• *nitial Process apability Study
Learning Objectives
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Advanced Product Quality
Planning (APQP)
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Advanced Product Quality Planning
accompanies the development of a product
and is intended to ensure that all of the
customer's requirements are met. The
objective is to provide a quality product at
the right time.
Advanced Product Quality Planning
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Advanced Product Quality Planning
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Definition phaseDuring the definition phase, design or! is carried out on
products and processes and project planning ta!es place. The
quotation is then prepared on the basis of the results.
Prototype phase
During the prototype phase and or!ing from the product
design, the product function is developed and proven ith the
help of the Design "erification Plan #D"P$. A product design is
dran up and developed as far as the initial layout.
Advanced Product Quality Planning
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*amp(up phase
The ramp(up phase,
hich follos the start ofproduction,forms a
transition from the
development phase to the
stable production phase.
The ramp(up of volume
production is
accompanied by a project
team. All measures that
are required in order toachieve the productivity
and cost objectives are
introduced.
Advanced Product Quality Planning
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APQP 1 - Sourcing Decision
Formal commitment of the customer to work with the sulier !customer or"er#
$omination Letter etc%& so that investments can be effecte" on sche"ule%
APQP ' - (ustomer Secifications
)o avoi" misun"erstan"ings in (ustomer secifications inclu"e the "esign criteria an"
rogram re*uirements# e%g% "rawings# secifications !+$ote, if material orcoatinglating# etc% is not inclu"e" on the "rawing or in secifications# then there must
be a sign off between engineering# urchasing# an" sulier rior to issue of urchase
or"er& an" "esign re*uirements which are necessar. for the intro"uction of the
sulier/s APQP%
APQP 0 - (ontract eview
)o carr. out a commercial an" technical assessment of the "ocuments rovi"e" b. thecustomer to check that the. are comlete# u-to-"ate an" feasible%
APQP 2 - (raftsmanshi
)o "efine characteristics relating to aearance# te3ture# han"ling abilit.# noise an"
smell%
APQP +lements
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APQP 4 - Design-F56A
)o revent "efects "uring ro"uct "eveloment
APQP 7 - Design eview
)o revent misun"erstan"ings an" roblems8 to monitor the rogress of measures
an" to ensure that objectives are met
APQP 9 - Design :erification Plan D:P
)o rovi"e a clear illustration of the rogress that a subcontractor is making on aroject
APQP ; - Qualit. Planning for Subcontractor
)o rovi"e a clear illustration of the rogress that a subcontractor is making on a
roject
APQP < - Facilities# )ools
)o obtain caablerelease" oerating materials from initial samles onwar"s
APQP +lements
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APQP 1= - >nsection 5etho"s an" 6*uiment)o obtain caablerelease" insection e*uiment# which is suitable for the measuring task
re*uire" of it# from initial samling onwar"s8 lanning !monitoring of "ates& an" rovision
of all necessar. insection e*uiment8 accetance in accor"ance with the criteria of 5SA
!>SO
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APQP 14 - DrawingsSecifications !Design Freee&
)o rovi"e# on sche"ule !customersulier all "rawings an" secifications that
are nee"e" to observe the initial samle "atestart of ro"uction !SOP&%
APQP 17 - (onfirmation of 5anufacturing Feasibilit.
)o assess ro"uction feasibilit. !volume& relative to the inten"e" "esign
APQP 19 - Process Flow Diagram an" Pro"uction La.out
)o rovi"e a foun"ation for investment lanning# S.stem F56A Process Process
F56A# ro"uction lan# control lans an" visual ai"s
APQP 1; - LogisticsSul. (oncet
)o ensure "eliver. caabilit.
APQP 1< - Process Freee
)o ensure that there are no roblems at start of ro"uction
APQP '= - Process F56A
)o revent "efects "uring rocess "eveloment
APQP +lements
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APQP '1- 5easurement S.stems 6valuation an" >nsection 6*uiment (aabilit.
)o evaluate the suitabilit. !scatter& of insection e*uiment for the re*uire"
measurement task
APQP '' - Pre-ro"uction >nsection PlanPre-launch >nsection Plan
)o ensure that rocess an" ro"uct re*uirements are imlemente"
APQP '0 - Process >nstructions
)o ensure *ualit. an" *uantit.
APQP '0 - Packaging 5aterials an" Secifications
)o maintain the *ualit. achieve"
APQP '2 - Pro"uction )rial un
)o ensure that volume ro"uction starts without an. roblems an" that the re*ueste"
values are observe" !cost - rofitabilit.&
APQP '4 - Pro"uction (ontrol Plan
)o ensure that rocess an" ro"uct re*uirements are imlemente"
APQP +lements
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APQP '7 - Preliminar. Process (aabilit. Stu".
)o rovi"e statistical roof of caable rocesses
APQP '9 - )echnical )ests on Pro"uction Parts
)o confirm that the arts meet technical stan"ar"scustomer
re*uirements%
APQP '; - >nitial Samling >nsection
)o rovi"e roof of ro"uct an" rocess release%
APQP +lements
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APQP PROCESS FLOWPrepare for
APQP
Plan and Define Program Product Design
and Development
Product and
Process
"alidation
Process Design and
Development
eedbac!,
Assessment and
-orrective Action
• Organize the Team
• Define the Scope
• Establish Team-to-
Team Communication
• Provide Core Tools
Training
• Involve Customers
and Suppliers
• Implement
Simultaneous
Engineering
• Develop Control
Plan ormat
• Decide on Concern
!esolution
• Develop Product
"ualit# Timing Plan
• $oice of theCustomer
• %usiness
Plan&'ar(eting
Strateg#
• Product&Process
%enchmar( Data
• Product&Process
)ssumptions
• Product !eliabilit#
Studies
• Customer Inputs
• Design *oals
• !eliabilit# and
"ualit# *oals
• Preliminar# %ill of
'aterial
• Preliminar# Process
lo+ Chart
• Preliminar# ,istingof Special Product
and Process
Characteristics
• Product )ssurance
Plan
• 'anagement
Support
• Design ailure odeand +ffects Analysis
#D+A$
• Design for
'anufacturabilit# and
)ssembl#
• Design $erification
• Design !evie+s
• Prototype /uild 0
-ontrol Plan
• Engineering Dra+ings
Including 'ath Data.
• Engineering
Specifications
• 'aterial Specifications
• Dra+ing and
Specification Changes
• /e+ E0uipment1
Tooling and acilities!e0uirements
• Special Product and
Process Characteristics
• *ages&Testing
E0uipment
!e0uirements
• Team easibilit#
Commitment and
'anagement Support
• Pac(aging Standards
• Product&Process
"ualit# S#stem !evie+
• Process lo+ Chart
• loor Plan ,a#out
• Characteristics 'atri2
• Process ailure ode
and +ffects Analysis
#P+A$
• Pre(1aunch -ontrol
Plan
• Process Instructions
• easurement 2ystems
Analysis Plan
• Preliminary Process
-apability 2tudy Plan
• Pac(aging
Specifications• 'anagement Support
• Production Trial!un
• easurement
2ystems +valuation
• Preliminary
Process -apability
2tudy
• Production Part
Approval
• Production
$alidation Testing
• Pac(aging
Evaluation
• Production -ontrol
Plan
• "ualit# Planning
Sign-Off and
'anagement Support
• !educed $ariation
• Customer
Satisfaction
• Deliver# and Service
I / P 3 T
I / P 3 T
I / P 3 T
I / P 3 T
I / P 3 T
O 3 T P 3 T
O 3 T P 3 T
O 3 T P 3 T
O 3 T P 3 T
O 3 T P 3 T
'E)
)P"P
'S)
SPC
PP)P
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What is PPAP?
•Pro"uction Part Aroval Process
•Stan"ar" use" to formall. re"uce risksrior to ro"uct or service release#in a team oriente" manner using well
establishe" tools an" techni*ues
•>nitiall. "eveloe" b. A>AB !Auto >n"ustr.Action Brou& in 1
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The Purpose of PPAP
A) If all customer engineering design records and specificationrequirements are properly understood by the supplier(Customer and Supplier have a common understanding ofCustomer requirements)
B)The process has potential to produce parts consistently
meeting the requirements during an actual production run atthe quoted production rate (Is the process capable ofmeeting customer requirements during on going productionprocess)
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Applicability of PPAP• PPAP shall apply to Eternal and internal
suppliers sites of!"ul# $aterial
Production $aterial
Production Parts
Service Parts
%or "ul# material PPAP is not required unlessas#ed by the customer&
•A supplier of production parts ' service partsshall comply ith the PPAP requirements unlessthe same is formally aived by the Customer(documented evidences should be available)
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SomethingChanged
Application
A*A+ (Autootive*ndustry Action +roup)PPAP anual defnes&hen PPAP subission
is required – ,e& part
– orrection to discrepancyin previous subission
– #esign or process change
– hange in source o"subcontracted aterialsor services
– trans"er or
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Benefts o" PPAPsubission
• -elps to aintain design integrity• *dentifes issues early "or resolution
• $educes &arranty charges andprevents cost o" poor quality
• Assists &ith anaging supplierchanges
• Prevents use o" unapproved and
noncon"oring parts• *dentifes suppliers that need ore
developent
• *proves the overall quality o" theroduct custoer satis"action
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PPAP Process )equirements S*"$ISSI+, T+ C*ST+$E - .E/E.S +% E/I0E,CE
Submission .evels
The supplier shall submit the items and'or records specified bythe level as requested by the customer&
.evel 1 - 2arrant only (and for designated appearance items3 anAppearance Approval eport) submitted to the customer&
.evel 4 5 2arrant ith product samples and limited supportingdata submitted to the customer&
.evel 6 - 2arrant ith product samples and complete supporting
data submitted to the customer&
.evel 7 - 2arrant and other requirements as defined by thecustomer&
.evel 8 5 2arrant ith product samples and complete supportingdata available for revie at the supplier9s manufacturing location&
PPAP 1 l f 2 b i i d * t ti
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PPAP 1evels for 2ubmission and *etention
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#efnition o" $is. • -igh $is.
Parts associated &ith ultiple critical "eatures/ cople0design/ or high end technology that is not yetestablished in the general anu"acturing environent
Supplier1s quality syste and2or quality per"orance isnot to ustoer1s satis"action
• 'ediu $is.
Parts that have at least one critical "eature
• 3o& $is.
Parts that have no critical "eatures and can beanu"actured by any anu"acturer in the cooditycategory
Supplier1s quality syste and quality per"orance areacceptable• ,e& Parts,e& Parts
3evel 4 is required "or 3o& $is. Parts
3evel 5 is required "or 'ediu and -igh $is. Parts
• Part hangesPart hanges
3evel 5 is required "or Parts produced at a ne& or additional location
Supplier Quality !0cellence &ill defne the level required "or all other changes
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PPAP Status66667• Approved8he part eets all ustoer
requireents
Supplier is authori9ed to ship
production quantities o" the part• *nteri ApprovalPerits shipent o" part on a
liited tie or piece quantity basis• $e:ected8he part does not eet custoer
requireents/ based on theroduction lot "ro &hich it &as
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Official PPAP e*uirements
1% Design ecor"s'% Authorie" 6ngineering (hange Documents
0% (ustomer 6ngineering Aroval# if re*uire"
2% Design Failure 5o"es an" 6ffects Anal.sis !DF56A& applied in
special situations
4% Process Flow Diagram
7% Process Failure 5o"es an" 6ffects Anal.sis !PF56A&
9% (ontrol Plan;% 5easurement S.stems Anal.sis !5SA&
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;7 #esign $ecords
Design ecor"s an" @ubble" Part Prints Purose?
)o "ocument rovi"e a co. of the formal art rint%
All art rints must have clearl. "efine" ()QCs
)o rovi"e an. a""itional engineering recor"s for reference%
All submissions shoul" have one co. of the formal rint
@ubble rint that suorts the "imensional reort%
5ust have all notes an" secifications circle" an"
numbere"%
5ust be clear an" legible%
An. a""itional suorting information inclu"ing
eference rints
Sub-assembl. rints
(omonent rints with a "ifferent art number
Alicable secifications
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#esign $ecord < hec.3ist
5ust be a clean an" legible +@ubble, rint
5ust have correct Part $umber an" evision $o%
6ver. re*uirement must have a searate bubble
Dimensions$otes
()QCs are i"entifie"
eference" secifications
:erif. that no other rints nee" to be submitte"Sub-assemblies
(omonent level "etail
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47 !ngineering hange#ocuents
• 8he supplier shall provideauthori9ed change docuents"or those changes not yet
recorded in the design record/but incorporated in the product/part or tooling/ such as=
!,s (must be approved, not pending)
Specifcations %easibility studies < Advantages
Supplier change requests
Sub>assebly dra&ings
3i"e or reliability testing requireents
ustoer ng neer ng
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7 ustoer ng neer ngApprovals
Purose?
)o "emonstrate re-aroval b. (ustomer
to ro"uce a ro"uct
e*uire" onl. when customer "eman"s
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%'!A%ailure 'ode and !ects
AnalysisEhat we learnGEhat is itG
5otivation
F56A 5etho"s
63amle
F56A in-class e3ercise
at s
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at s%ailure 'ode !ect
Analysis#escription=• A procedure that e0aines each ite
in a syste/ considers ho& that itecan "ail and then deterines ho& that"ailure &ill aect the syste
A structured approach to3)dentifying the ays in hich a product or process can fail
+stimating ris! associated ith specific causes
Prioriti&ing the actions that should be ta!en to reduce ris!
+valuating design validation plan #product$ or current control plan #process$
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-istory o" %'!A
• %irst used in the ;@1s in theAerospace industry during the Apolloissions
• *n ;@CD/ the ,avy developed MIL-STD-
1629 regarding the use o" %'!A• *n the late ;@C1s/ the autootive
industry &as driven by liability coststo use %'!A
• 3ater/ the autootive industry sa&the advantages o" using this tool toreduce ris.s related to poor quality
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D7 #!S*+, %'!A(#%'!A)
• )he Design F56A is use" to anal.e ro"uctsbefore the. are release" to ro"uction%
• >t focuses on otential failure mo"es of ro"ucts
cause" b. "esign "eficiencies%
• Design F56As are normall. "one at three levels H s.stem# subs.stem# an" comonent levels
• )his t.e of F56A is use" to anal.e har"ware#functions or a combination
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7 P$E!SS %'!A (P%'!A)
• 8he Process %'!A is norally used toanaly9e anu"acturing and asseblyprocesses at the syste/ subsyste
or coponent levels7
• 8his type o" %'!A "ocuses onpotential "ailure odes o" the process
that are caused by anu"acturing orassebly process defciencies7
'ethod to onduct an
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'ethod to onduct an%'!A
– *denti"y all coponents or systes atgiven level o" the design hierarchy7
– 3ist the "unction o" each identifed
coponent or syste7 – *denti"y "ailure odes "or each
coponent2syste7 8ypically there&ill be several &ays in &hich a
coponent can "ail7 – #eterine the eect (both locally
and globally) on the syste7
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'ethod to onduct an%'!A
– lassi"y the "ailure by its eects onthe syste operation7
– #eterine the "ailure1s probability
o" occurrence7 – *denti"y ho& the "ailure ode can
be detected (ay point out &hatneeds to be inspected on a regularbasis)7
– *denti"y any copensatingprovisions or design changes to
itigate the "ailure eects7
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FMEA Form
Blank FMEA form
%'!A 8erinology
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%'!A 8erinology 'ethods
• Process Function e*uirements
– Simle Descrition of the rocess or oerations being anal.e"!eg% )urning# assembling# etc%#&
– Function comes from Functional Anal.sis# Functional
Decomosition
• Potential Failure 5o"e
– 5anner in which the "esign rocess coul" otentiall. fail to meetthe rocess or re*uirements
– Potential Failure 5o"e comes from things that have gone wrong in
the ast# concerns of "esigners# an" brainstorming% Possible
consi"erations are artial function# intermittent function# e3cess
function%
• Potential 6ffects of Failure
– )he effect of the failure mo"e on customer
– Potential 6ffects are conse*uences to the "esign# the user# an" the
environment% Safet. an" regulation noncomliance are critical
issues%
%'!A 8erinology
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%'!A 8erinology 'ethods
• Severit.
– Assessment of the seriousness of the effect of the otential failure
mo"e to the customer% Bive ranking between 1 1= as er the
gui"elines
• (lassification
– )o (lassif. an. secial characteristics such as critical# ke.# major#
significant# etc%#
• Potential (auses 5echanism of Failure
– Iow failure coul" occur H "escribe" in terms of how the failure
can be correcte" or can be controlle"%
– Potential (auses of failure shoul" be engineering relate" such as
incorrect material# corrosion# wear an" human relate" such asine3erience# misuse# etc%
• Occurrence
– Iow fre*uentl. the secific failure cause mechanism is rojecte"
to occur% Bive ranking between 1 1= as er the gui"elines
%'!A 8erinology
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%'!A 8erinology 'ethods• (urrent Process (ontrol
– (urrent rocess "esign control metho"s a"ote"
– (urrent Design (ontrols are things like insections# testing# oke
.oke# an" other "esign checks that are inten"e" to revent the
roblem%
• Detection
– Iow the e3isting control s.stem "etects the failure mo"e% Bive
ranking between 1 1= as er the gui"elines• *is! Priority 4umber #*P4$
– Assign values to 2everity, %ccurrence, and Detection using the tables.
– Determine the *is! Priority 4umber #2everity5 %ccurrence 5 Detection$
• Develop an action plan
• *ecommended Actions
– -orrective actions to be first arrived for highest ran!ed *P4• *esulting *P4
• ollo up
G id li f S it
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Guidelines for SeverityRanking
!ect $an. riteria
None 1 No eect
Very Sligt ! Negligi"le eect on #erformance$ Some usersmay notice$
Sligt % Sligt eect on &erformance$ Non vital faults 'ill"e noticed "y many users
Minor ( Minor eect on &erformance$ )ser is sligtlydissatis*ed$
Moderate + Reduced &erformance 'it gradual &erformancedegradation$ )ser dissatis*ed$
Severe , -egraded &erformance. "ut safe and usa"le$ )serdissatis*ed$
/ig Severity 0 Very &oor &erformance$ Very dissatis*ed user$
Very /igSeverity
2no&era"le "ut safe$
E3treme Severity 4 #ro"a"le failure 'it a5ardous eects$6om&liance 'it regulation is unlikely$
Ma3imumSeverit
17 )n&redicta"le failure 'it a5ardous eectsalmost certain$ Non8com liant 'it re ulations$
G id li f 9
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Guidelines for 9ccurrenceRanking
Eccurrence $an. riteria
E3tremely)nlikely
1 :ess tan 7$71 &er tousand
Remote :ikeliood ! ≈7$1 &er tousand rate of occurrence
Very :o'
:ikeliood
% ≈7$+ &er tousand rate of occurrence
:o' :ikeliood ( ≈1 &er tousand rate of occurrence
Moderately :o':ikeliood
+ ≈! &er tousand rate of occurrence
Medium:ikeliood
, ≈+ &er tousand rate of occurrence
Moderately /ig:ikeliood
0 ≈17 &er tousand rate of occurrence
Very /igSeverity
≈!7 &er tousand rate of occurrence
E3treme Severity 4 ≈+7 &er tousand rate of occurrence
Ma3imum 17 ≈177 &er tousand rate of occurrence
G id li f - t ti
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Guidelines for -etectionRanking
#etection $an
.
riteria
E3tremely :ikely 1 6an "e corrected &rior to &rototy&e; 6ontrols 'illalmost certainly detect
Very /ig:ikeliood
! 6an "e corrected &rior to design release;Very /ig&ro"a"ility of detection
/ig :ikeliood % :ikely to "e corrected;/ig &ro"a"ility of detectionModerately /ig:ikeliood
( -esign controls are moderately eective
Medium :ikeliood + -esign controls ave an even cance of 'orking
Moderately :o':ikeliood
, -esign controls may miss te &ro"lem
:o' :ikeliood 0 -esign controls are likely to miss te &ro"lem
Very :o':ikeliood
-esign controls ave a &oor cance of detection
Remote :ikeliood 4 )n&roven. unrelia"le design;&oor cance for detection
E3tremely )nlikely 17 No design tecni
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%ailure 'odes and!ects
• 8he relationship bet&een "ailure odesand eectsis not al&ays ; to ;7
Failure Mode 1
Failure Mode 2
Effect 1
Effect 2
Failure Mode 1
Failure Mode 2
Effect 1
Failure Mode 1
Effect 1
Effect 2
Process %'!A < hec.
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Process %'!A < hec.3ist
Feri"y there is a syste "orprioriti9ing ris. o" "ailure such as$P, nubers o" ;4G or above
'a.e sure that high $P,process concerns are carriedover into the control plan
'a.e sure that all critical "ailure
odes are addressed
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%'!A !H!$*S!
G P %l
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G7 Process %lo&#iagras
Ehat is >tG• A visual "iagram of the entire rocess from receiving
through shiing# inclu"ing outsi"e rocesses an"
services
)o hel eole +see, the real rocess% Process mas
can be use" to un"erstan" the following characteristics
of a rocess?• Set-b.-ste rocess linkage• Offline activities !measurement# insection#
han"ling&
• ework# scra
Objective or Purose
Wh t U %l h t
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When to Use a %lo&chart
• =o develo& understanding of o' a &rocess isdone$
• =o study a &rocess for im&rovement$
• =o communicate to oters o' a &rocess is done$
• >en "etter communication is needed "et'een&eo&le involved 'it te same &rocess$
• =o document a &rocess$
• >en &lanning a &ro?ect$
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Process %lo& #iagras
Ehen to Jse >t G• )o un"erstan" how a rocess is "one• Prior to comleting the PF56A
• J"ate" after ro"uction trial run%
• $ee" to in"icate secial characteristics generate" at
each ste%• (omlete" Along with (ontrol Plan !APQP Process&%
Process %lo #iagra
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Process %lo& #iagra!0aple
Process %lo& #iagras
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Process %lo& #iagras <hec. 3ist
Process Flow must identify each step in the process
Should include abnormal handling processes
Scrap
Rework
Process Flow must include all phases of the process
Receiving of raw material
Part manufacturing
Offline inspections and checks Assembly
Shipping
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6hat e learn7
6hat is it7
6hen to use7
6hy *equired7
%ver vie
+ample of -ontrol Plan
-ontrol Plan Process
-lass +ercise
8. -%4T*%1 P1A4
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ontrol plan types
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Ehat >s A (ontrol PlanG
>t is a management tool to i"entif. an" monitor the activit. re*uire"
to control the critical inuts or ke. oututs for a rocess so the
rocess will continuall. meet its ro"uct or service goals%
(ontrol lans are usuall. monitore" at least b. Qualit. Assurance#
"eartments using insection roce"ures an" sometimes using*ualit. function "elo.ment metho"s%
(ontrol charts are t.icall. use" in a control lan to monitor items%
Ehen >s >t Jse"G>t is use" in the control hase to i"entif. an" recor" controls#
targets# an" secification limits for Ke. Process >nut :ariables an"
Ke. Process Outut :ariables%
-%4T*%1 P1A4
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Iea"er information
6nter the Iea"er information as re*uire"
PartProcess $umber)his item number is usuall. reference" from the Process Flow (hart% >f
multile art numbers e3ist !assembl. list the in"ivi"ual art numbers
an" their rocesses accor"ingl.%
Process $ame Oeration Descrition
All stes in the manufacturing of a comonent are "escribe" in a rocess
flow "iagram% >"entif. the rocessoeration name from the flow "iagramthat best "escribes the activit. being a""resse"%
5achine# Device# ig# )ools for 5anufacturing
For each oeration that is "escribe"# name the rocessing e*uiment as
aroriate%
$umber
6nter a cross reference number from all alicable "ocuments such as#
but not limite" to# rocess flow "iagram# numbere" blue rint# F56As#
an" sketches !comuter generate" or otherwise if re*uire"%
-ontrol Plan Process
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Pro"uct
Pro"uct (haracteristics are the features or roerties of a art#
comonent or assembl. that are "escribe" on "rawings or other rimar.engineering information%
)he (ore )eam shoul" i"entif. the Secial Pro"uct (haracteristics that
are a comilation of imortant Pro"uct (haracteristics from all sources%
All Secial (haracteristics must be liste" on the (ontrol Plan% >n a""ition#
the manufacturer ma. list other Pro"uct (haracteristics for which
rocess controls are routinel. tracke" "uring normal oerations%
Process
Process (haracteristics are the rocess variable !inut variables& that
have a cause an" effect relationshi with the i"entifie" Pro"uct
(haracteristic%
A Process (haracteristic can onl. be measure" at the time it occurs%
)he (ore )eam shoul" i"entif. Process (haracteristics for which
variation must be controlle" to minimie ro"uct variation%
)here coul" be one or more Process (haracteristics liste" for each
Pro"uct (haracteristic% >n some rocesses one Process (haracteristic
ma. affect several Pro"uct (haracteristics%
-ontrol Plan Process
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Secial (haracteristic (lassification
Jse the aroriate classification to "esignate the t.e of secial
characteristic or this fiel" can be left blank for other un"esignate"characteristics% Please refer to the Danaher 5otion Qualit. 5anual to see
the "escritive terms an" s.mbols%
Pro"uct Process Secification )olerance
Secificationtolerance ma. be obtaine" from the engineering
"ocuments%
6valuation 5easurement )echni*ue
)his columns i"entifies the measurement s.stem being use"% )his coul"
inclu"e gages# fi3tures# tools# an"or test e*uiment re*uire" to measure
the artrocessmanufacturing e*uiment% An anal.sis of the
rero"ucibilit.# reeatabilit. an" accurac. of the measurement s.stem
shoul" be "one rior to rel.ing on a measurement s.stem an"
imrovements ma"e accor"ingl.
Samle SieFre*uenc.
Ehen samling is re*uire" list the correson"ing samle sie an"
fre*uenc.%
-ontrol Plan Process
-ontrol Plan Process
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(ontrol 5etho"
)his column contains a brief "escrition of how the oeration will be
controlle"# inclu"ing roce"ure numbers where alicable%
)he control metho" utilie" shoul" be base" on effective anal.sis of the
rocess%
)he control metho" is "etermine" b. the t.e of rocess that e3ists%
Oerations ma. be controlle" b.# but are not limite" to# StatisticalProcess (ontrol# insection# attribute "ata# mistake-roofing#
!automate"non-automate" an" samling lans%
)he (ontrol Plan "escritions shoul" reflect the lanning an" strateg.
being imlemente" in the manufacturing rocess%
>f elaborate control roce"ures are use"# the lan will t.icall. reference
the roce"ure "ocument b. a secific i"entification name an"or number%
)he metho" of control shoul" be continuall. evaluate" for effectiveness
of rocess control% For e3amle# significant changes in the rocess or
rocess caabilit. shoul" lea" to an evaluation of the control metho"%
-ontrol Plan Process
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eaction Plan
)he reaction lan secifies the corrective actions necessar. to avoi"ro"ucing nonconforming ro"ucts or oerating out of control%
)he actions shoul" normall. be the resonsibilit. of the eole closest to
the rocess# the oerator# job setter# or suervisor# an" be clearl.
"esignate" in the lan%
Provisions shoul" be ma"e for "ocumenting%
>n all cases# susect an" nonconforming ro"ucts must be clearl.
i"entifie" an" *uarantine"# an" "isosition ma"e b. the resonsible
erson "esignate" in the reaction lan%
)his column ma. also refer to a secific reaction lan number an"
i"entif. the erson resonsible for the reaction lan%
-ontrol Plan Process
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Au"it Plans
• Au"it lans shoul" be inclu"e" in the control lan as a searate line%• Au"iting is an imortant tool for control%
• Process au"iting shoul" be a ke. element of the *ualit. s.stem of a
business%
• Au"its generall. cover?
6ffectiveness of controls(ontrol lan !sa.& vs% what is actuall. "one
!"o&• Au"its shoul" be objective !"one b. internal or e3ternal thir" arties if
ossible&%
• Au"it fre*uencies shoul" be base" on balancing level of risk !F56A&
an" cost%
-ontrol Plan Process
- l Pl -h ! 1i
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Jse rocess flow "iagram an" PF56A to buil" the control lan8 kee
them aligne"
(ontrols must be use" to be effective% Kee it simle%
6nsure that the control lan is in the "ocument control s.stem of thebusiness
Boo" control lans a""ress?
All testing re*uirements - "imensional# material# an" erformanceAll ro"uct an" rocess characteristics at ever. ste throughout
the rocess
)he control metho" shoul" be base" on an effective anal.sis of therocess
Such as SP(# 6rror Proofing# >nsection# Samling Plan (ontrol lans shoul" reference other "ocumentation
Secifications# tooling# etc%
-ontrol Plan -hec! 1ist
- l Pl -l + i
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Prepare a control plan for the a drilling process on a rectangular bloc!
-ritical parameters
/ig 9ole diameter 0 :;.>;
2mall 9ole diameter 0 :>.>;
Distance beteen the holes 0 8> .:
-ontrol Plan -lass +ercise
J 'easureent Syste
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J7 'easureent SysteAnalysis ('SA)
An 5SA is a statistical tool use" to "etermine if a
measurement s.stem is caable of recise measurement%
Ehat is >tG
Objective or Purose
• )o "etermine how much error is in the measurement "ue to
the measurement rocess itself%• Quantifies the variabilit. a""e" b. the measurement
s.stem%• Alicable to attribute "ata an" variable "ata%
Ehen to Jse >t
• On the critical inuts an" oututs rior to collecting "ata
for anal.sis%• For an. new or mo"ifie" rocess in or"er to ensure the
*ualit. of the "ata%
'easureent Syste
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'easureent SysteAnalysis ('SA)
Measurement System Analysis isan analysis of the measurementprocess, not an analysis of thepeople!!
PORTANT! Who Shoul e "n#ol#e
E#eryone $ho measures an ma%esecisions aout these measurementsshoul e in#ol#e in the MSA&
– AttriuteAttriute 'ata E(amples)
Count, Pass*fail, yes*no, re*+reen*yello$,
time%eepin+ uc%ets
– arialeariale 'ata E(amples)
Physical measurement -len+th, $ith, area, ./
Physical conitions -temperature, pressure./
Physical properties -stren+th, loa, strain./
Continuous or non0enin+
Measurement System
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easu e e Sys eAnalysis @MSA
Error in Repeataility1he inaility to +et the same ans$erfrom repeate measurements mae ofthe same item uner asolutely ienticalconitions&
Possile Cause Lac% of stanar operatin+ proceures-SOP/, lac% of trainin+, measurin+system #arialilty&
Repeatability
E2uipment ariationE2uipment ariation
easureen ys e
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yAnalysis ('SA)
Error in Reprouciility1he inaility to +et the same ans$erfrom repeate measurements maeuner #arious conitions from ifferentinspectors&
Possile Cause Lac% of SOP, lac% of trainin+&
Reproducibility
Appraiser ariationAppraiser ariation
Varia"le MSA B Gauge RCR
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Varia"le MSA Gauge RCRStudy
• +auge $$ is the cobinedestiate o" easureentsyste $epeatability$epeatability and
$eproducibility$eproducibility• 8ypically/ a 5>person study isper"ored !ach person randoly easures ; ar.ed parts per
trial !ach person can per"or up to 5 trials
• 8here are 5 .ey indicators !F!F or !quipent Fariation
AFAF or Appraiser Fariation
ar a e B auge
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;7 Select ; ites that represent the "ull range o" long>terprocess variation7
47 *denti"y the appraisers7
57 *" appropriate/ calibrate the gage or veri"y that the lastcalibration date is valid7
D7 Epen the +auge $$ &or.sheet to record data7
G7 -ave each appraiser assess each part 5 ties (trials < frstin order/ second in reverse order/ third rando)7
7 *nput data into the +auge $$ &or.sheet7C7 !nter the nuber o" operators/ trials/ saples and
specifcation liits
J7 Analy9e data in the +auge $$ &or.sheet7
@7 Assess 'SA trust level7
;7 8a.e actions "or iproveent i" necessary7
gSte&s
Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step : Step 3;Step <
Tips and Lessons Learned'easureent Syste
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>mortant? An 5SA is an anal.sis of the rocess# not an anal.sis of the
eole% >f an 5SA fails# the rocess faile"%
A :ariable 5SA rovi"es more anal.sis caabilit. than an Attribute 5SA%
For this an" other reasons# alwa.s use variable "ata if ossible%
)he involvement of eole is the ke. to success%
>nvolve the eole that actuall. work the rocess
>nvolve the suervision
>nvolve the suliers an" customers of the rocess
An 5SA rimaril. a""resses recision with limite" accurac. information%
p 'easureent SysteAnalysis ('SA)
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'SA < hec. 3ist*" the gauge2inspection aects
quality/ then conduct a +auge $$
'a.e sure the study is recent >less than ; year
opare the control plan againstthe +auge $$s
*" you question that gauge/ then
−Question the technique and partsapling
−As. "or additional studies
@ #iension 8est
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@7 #iension 8est$esults
6vi"ence that "imensional verifications have been comlete"
an" results in"icate comliance with secifie" re*uirements%
Ehat is >tG
Objective or Purose
• )o show conformance to the customer art on "imensions
an" all other note" re*uirements%
Ehen to Jse >t
• For each uni*ue manufacturing rocess !e%g%# cells or
ro"uction lines an" all mol"s# atters# or "ies
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#iension 8est $esults
)hirt.-five critical "ata oints 4 non-critical "ata oints arere*uire" for art *ualification
(ritical an" non-critical "ata oints must be taken from thesame 04-iece samle
Five arts from a ro"uction run must be shie" to customer
for verification of form# fit# an" function )he same 4 arts will be use" to verif. both critical an" non-
critical "imensions
Sulier must clearl. i"entif. which of the 04 arts are beingshie"
Sulier shoul" make ever. effort to shi 4 arts that reresentboth the low an" high en"s of the secifications for non-critical
"imensions
(aabilit. must be greater than 1%79 for critical "imensions an"greater than 1%00 for non-critical "imensions
7 ecor s o'aterial2Per"orance 8est
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'aterial2Per"orance 8est$esults
'aterial 8est $esults'aterial 8est $esults 8he supplier shall per"or tests "or all parts and product
aterials &hen cemica!, p"sica!, or meta!!urgica! requireents are specifed by the design record orontrol Plan
%or products &ith ,$>developed aterial specifcations and2oran ,$>approved supplier list/ the supplier shall procureaterials and2or services "ro suppliers on that list
Per"orance 8est $esultsPer"orance 8est $esults 8he supplier shall per"or tests "or all parts or productaterials &hen per#ormance or #unctiona! requireentsare specifed by the design record or ontrol Plan
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'aterial 8est $esults
Material Results shall inclue) The name of the laboratory that conducted the test The type of test that was conducted The number, date, and specification to which the part was tested The actual test results
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Per"orance 8est $esults
Performance 1est Results shall inclue) The name of the laboratory that conducted the test The type of test that was conducted A description of the test The parameters tested The actual test results
i i l S d
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;;7 *nitial Process Study
Ehen to Jse >t G
1% )o establish baseline caabilit.%
'% )o vali"ate rocess imrovements%
Ehat is >tGA set of tools use" to un"erstan" rocess caabilit.%
• )o evaluate the erformance of .our rocess as comare" to
secification limits%
• )o "etermine if the ro"uction rocess is likel. to ro"uce ro"uct
that will meet customer re*uirements
eps or e er n ngP bilit
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p gProcess apability
Step 3 Step < Step 4 Step 5 Step 6 Step 7 Step 8
1$ -ecide on te &roduct or &rocesscaracteristic to "e assessed
!$ Validate te s&eci*cation limits
%$ Validate te measurement system
($ 6ollect data
+$ Assess data caracteristics
,$ Assess &rocess sta"ility
0$ 6alculate &rocess ca&a"ility
%ocus on Fariable #ata
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%ocus on Fariable #ata• 8he initial process study should be "ocused
on variab!evariab!e/ not attribute data
Assebly errors/ test "ailures/ andsur"ace de"ects are e0aples o" attributedata/ &hich is iportant to understand/but is not covered in this initial study
Unless approved by an authori9edustoer representative/ attribute dataattribute data
are not acceptab!e #or $$%$ submissionare not acceptab!e #or $$%$ submission
apability *ndices
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p y
Capability
IndexFormula hat it shows
p
Relates short term -$ithin su+roup/ stanar
e#iation to tolerance
Sometimes calle =Entitlement,> meanin+ it is the
est the current process can o, if centere
pk
Relates short term mean ? short term -$ithin
su+roup/ stanar e#iation to tolerance
Only tells you aout the nearest spec limit@ oesnt
tell anythin+ aout the other sie
PP Relates lon+ term -o#erall/ stanar e#iation totolerance
Ppk Relates mean ? lon+ term -o#erall/ stanar
e#iation to tolerance
Only tells you aout the nearest spec limit@ oesnt
tell anythin+ aout the other sie
3S, 4 ,S,.
56sshort-term
3S, 4 ,S,.
56slong-term
'in73S, 4 8.1 8 4 ,S,.9
:6sshort-term
:6slong-term
'in73S, 4 8.1 8 4 ,S,.9
(aabilit. >n"ices - (k
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.
• (( predicts capability predicts capability @ase" on short term within subgrou variation
Does not measure how well the rocess "istribution off the
centre of limits%
• (k >n"e3 of of ((k >n"e3 of of (
meameasures the variation of p valuesures the variation of p value
between ! and " and consider thebetween ! and " and consider the
variation closest to Specification limit#variation closest to Specification limit#
apability *ndices > Pp.
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p y p
Pk in"icatesPk in"icates past performance past performance
@ase" on long term total variation
Jnlike (k# Pk is not limite" to variation within subgrous
Ehen calculate" from the same "ata set# (k an" Pk canbe comare" to anal.e the sources of rocess variation
Pk shoul" be use" whenPk shoul" be use" when? – )he art are newl. "esigne"%
– )he sulier is new to (ustomer# but has alrea". beenmanufacturing a art
– )he sulier is e3isting# but has ro"uce" a number of
nonconforming arts
(omments On (# (k•(1 means the rocess variation e3cee"s
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secification# an" a significant number of "efects are
being ma"e%
•(M1 means that the rocess is just meetingsecifications% A minimum of %0N "efects will be ma"e
an" more if the rocess is not centere"%•(1 means that the rocess variation is less than
the secification# however# "efects might be ma"e if
the rocess is not centere" on the target value•( M (k when rocess is centere"•(k ( alwa.s this situation•(k 1%== rocess ro"ucing rejects•(k M = ⇒ rocess center is at one of sec% limit !Jor L&•(k =⇒ i%e% H ve value# average outsi"e of limits•(k 1to 0 ⇒ i%e rocess cabable but normal!Samling insection re*uire"&
>nitial Process Stu". H (heck List
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>nitial Process Stu". (heck List
6nsure that the results are accetable# an"that the rocess is stable an" caable of
ro"ucing a *ualit. art
PPAPs shoul" onl. be arove" if thecaabilit. is greater than 1%79 for critical
"imensions an" greater than 1%00 for non-
critical "imensions
;47 Qualifed 3aboratory# t ti
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#ocuentation• *nspection and testing "or PPAP shall
be per"ored by a qualifedlaboratory as defned by ustoerrequireents (e7g7/ an accreditedlaboratory)7
• 8he qualifed laboratory (internal ore0ternal to the supplier) shall have alaboratory scope and docuentation
sho&ing that the laboratory isqualifed "or the type o"easureents or tests conducted
When an e0ternal laboratory is used/ the supplier shallsubit the test results on the laboratory letterhead or the
noral laboratory report "orat
Qualified 1aboratory Documentation 0 -hec! 1ist
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)hir" art. labs that measure arts for erformance#
material or "imensional shoul" be accre"ite"%
>f an. testing is erforme" to measure or monitor
art *ualit. the. shoul" have?
Lab Scoe H internal labs
6vi"ence of (alibration- in rocess
Accre"itation? 5inimum thir" art. accre"itation
b.?
6ither >SO 19='4 or A'LA !A'LA-AmericanAssociation for Laborator. Accre"itation&
Lab Scoe? 5ake sure internal labs have a
+S.stem, "efining what can be measure"# metho"#
trainin etc%
Q y
A&&earance A&&roval
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Re&ort
Ehen to Jse >t• Prior to tooling for production
Ehat is >tG
• A report completed by the supplier containingappearance and color criteria
Typically only applies for parts ith color, grain, or surface appearance requirements
Objective or Purose
• $o demonstrate that the part has met the appearanc
re%uirements on the design record
;D7 Saple Production
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Actual samples that reflect the parts ocumente inthe PPAP&
What is "tB
Oecti#e or Purpose!Confirm cosmetic or functional part appro#al&
When to Dse "t
!Sample parts shoul e eli#ere W"1 the PPAPsumission
Parts
• The sample parts provided should be the same parts measured for the dimensional results
• Default quantity for all submissions is ? parts unless otherise requested
Saple Production Parts
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• Saple production parts 'US8be properly identifed – *nclude the "ollo&ing in"oration on the
part label=
• #ate parts &ere pac.ed• ustoer part nuber
• Quantity
• Serial nuber
• Supplier part nuber (optional)
• Part description
• ountry o" origin
• Approval ar.ings (!/ etc7) &here
:;. aster 2ample
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Purose? )he original intent was that a +5aster, art must be
maintaine" throughout a ro"ucts ro"uction life for all revision
levels% (oncet is goo" but "ifficult to maintain an" store arts%
)he automotive in"ustr. rela3e" this re*uirement in various
wa.s%
(ustomer "oes not re*uire 5aster Part maintenance e3cet
when?
A Level 4 PPAP is re*ueste"%
).icall. a high risk art
)he criticall. of the ro"uct warrante" on site review
)herefore 5aster Part maintenance is a useful tool
(ustomer re*uires 5aster Part maintenance as follows?
1 5aster art for ever. art number at the most recent
revision level%
5ust be maintaine" for the life of the ro"uct%
:;. aster 2ample
2ample Production Parts and
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2ample Parts should be received ith every PPAP submission and
eamined thoroughly,
*evieer needs to determine if any value added analysis can be
gained using the 2ample Parts3
@et additional dimensional data
eedbac! and questions from engineering
Perform additional testing
unctional analysis
it Analysis
2ample Parts must be properly tagged, if not reject
)f aster samples are requested ma!e sure the supplier has a
system for maintaining the parts
p
aster 2amples 0 -hec! 1ist
:. -hec!ing Aids
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Purose? )o rovi"e evi"ence that the checking ai"s use" to
verif. ro"uct e3ist an" have been roerl. vali"ate"%
)here are man. "ifferent t.es of checking ai"s%
(ertifie" (heck Fi3tures
Jn-certifie" check fi3tures
)emlates
(ustom Bauges >n-house "eveloe" test stan"s !e3? leak test&
(ustomer ma. re*uire the following for all checking ai"s%
(o. of a controlle" rint that "ocuments the "esign of the
checking ai" >f the ai" confirms form or fit# then there shoul" be a thir"
art. certification
6vi"ence that the checking ai" has been verifie"
successful%
63amle? Bage
-hec!ing Aids 0 -hec! 1ist
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eviewerCs (hecklist
>f a fi3ture is use" to check h.sical rint "imensions eitherin rocess or off line then it is a checking ai"%
(hecking ai"s must be "ocumente" through a rint an"
submitte" with PPAP%
(heck Fi3tures
)emlates
Assembl. fi3tures that confirm fit
(hecking ai"s must have evi"ence of?
(onformance to the rovi"e" rint
eeatabilit.B for ()Q features
6ncourage suliers that utilie critical checking ai"s to get
thir" art. certification
-hec!ing Aids -hec! 1ist
:8. -ustomer 2pecific *equirements
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Purose? Provi"e a lacehol"er for all customer secific
re*uirements that are not covere" in the first 17 elements of PPAP%
Jse" "ifferentl. b. ever. customer for all t.es of re*uirements
)here are 4 secific re*uirements "efine" for PPAP submissions%
)ooling >nformation Form Packaging Form
>nsection Plan
Secification Deviation Form
Sulier PPAP (hecklist
6ach customer ma. re*uest a""itional "ocuments on a case b.
case basis%
:8. -ustomer 2pecific *equirements
;J7 Parts Subission
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Warrant• Upon satis"actory copletion o" all
required easureents and tests/ enterall required in"oration on the &arrant7
• A separate PSW is required "or eachpart nuber7
• $esponsible supplier oLcial verifes – 'easureents and tests con"or to custoer
requireents
– $equired docuentation is available "or propersubission level7
– Signs &arrant and provided date/ title andtelephone nuber7
Part Subission Warrant
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Part Subission WarrantEhat is >tG• Document re*uire" for all newl. toole" or revise"
ro"ucts in which the sulier confirms that
insections an" tests on ro"uction arts show
conformance to (ustomer re*uirements
Jse" to ?• "ocument art aroval• rovi"e ke. information• "eclare that the arts meet secification
Objective or Purose
Ehen to Jse >t• Prior to shiing ro"uction arts
Part Subission Warrant
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hec. 3ist
5ust be comletel. fille" out
5ust be signe" b. the sulier
5ust match the PO
Submitte" at the correct revision level
Submitte" at the correct submission level
Points to $eeber
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Points to $eeber 677
• Sulier is resonsible for meeting all alicable secifications%
• Do not submit arts an" "ocumentation results if the. are
outsi"e secification%
• )ake corrective action to meet all "esign recor" re*uirements%
• (ontact customer if unable to meet all re*uirements
• (oml. with customer "eveloe" material secifications an"or
arove" source list%
• Suliers are re*uire" to comlete an" maintain coies of all
"ocumentation i"entifie" in +re*uirements for aroval,regar"less of submission level%
• ecor"s of PPAP are to be retaine" for the life of the art lus
one calen"ar .ear%
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*eferences
PPAP BT9 +dition Quality Planning and Analysis by C..Curan ran!..@ryna
.citehr.com
Production %perations anagement 0 Dr./.2.@oel
6i!ipedia
http://www.citehr.com/http://www.citehr.com/