PFMEA

Process Failure Mode and Effects

Analysis
James
James Davis,
Davis, General
General Dynamics
Dynamics
Purpose

The
The purpose
purpose of of this
this presentation
presentation is is to
to
share
share the
the benefits
benefits ofof aa detailed
detailed Process
Process
Flow
Flow Diagram,
Diagram, conducted
conducted during
during aa
Process
Process Failure
Failure Mode
Mode and
and Effects
Effects
Analysis,
Analysis, that
that will
will ensure
ensure product
product
quality
quality in
in the
the manufacturing/assembly
manufacturing/assembly
process.
process.

James Davis, GDLS Slide Number: 2

 Introduction
Introduction

James Davis, GDLS Slide Number: 3

Definition of FMEA

AAFMEA
FMEAisisanananalytical
analyticaltool
toolthat
thatuses
usesaa
disciplined
disciplinedtechnique
techniquetotoidentify
identifyand
andhelp
help
eliminate
eliminateproduct
productand
andprocess
processpotential
potentialfailure
failure
modes.
modes.
o By
ByID
IDofofpotential
potentialfailures
o
failures
o Assessing
Assessingthe
therisks
riskscaused
causedby
byfailure
failuremodes
modesand
o
and
Identify
Identifycorrective
correctiveactions
actions
o Prioritizing corrective actions
o Prioritizing corrective actions
o Carry out corrective actions
o Carry out corrective actions

James Davis, GDLS Slide Number: 4

Most COMMON Types of FMEA's

Design
Design(Potential)
(Potential)Failure
FailureModes
Modesand
andEffects
Effects
Analysis-DFMEA
Analysis-DFMEA
••Focus
Focusisison
onpotential
potentialdesign-
design-related
relatedfailures
failures
and
andtheir
theircauses.
causes.

Process
Process(Potential)
(Potential)Failures
FailuresModes
Modesand
and
Effects
EffectsAnalysis-PFMEA
Analysis-PFMEA
••Focuses
Focusesisison
onpotential
potentialprocess
processfailures
failuresand
and
their
theircauses.
causes.

James Davis, GDLS Slide Number: 5

 Value of FMEA's
Aids in improving designs for products and
Aids in improving designs for products and
process
process
Increased
Increasedsafety
safety
Enhances
EnhancesCustomer
CustomerSatisfaction
Satisfaction
o Better
BetterQuality
o
Quality
o Higher
HigherReliability
o
Reliability
Contributes to cost savings
Contributes to cost savings
Decreases
Decreaseswarranty
warrantycosts
costs
Decreases
Decreaseswaste,
waste,non-value
non-valueadded
addedoperations
operations

James Davis, GDLS Slide Number: 6

 PFMEA's
Focus is on potential process –related
Focus is on potential process –related
failures
failuresand
andtheir
theircauses.
causes.
Main
Maindrive
driveisistotounderstand
understandthe
theprocess
processthrough
throughthe
the
identification
identificationofofas asmany
manypotential
potentialfailures
failuresas
aspossible.
possible.
o e.g.
e.g.Incorrect
Incorrectmaterial
materialused
o
used
PFMEA typically assumes that the design
PFMEA typically assumes that the design
isissound.
sound.
Development of Recommended Actions is
Development of Recommended Actions is
targeted
targetedat
ateliminating
eliminatingthe
the Root
RootCause
Causeof
of
the
thepotential
potentialfailures.
failures.

James Davis, GDLS Slide Number: 7

 PFMEA

Three
Three Parts:
Parts:
Process
Process Flow
Flow Diagram
Diagram (PFD)
(PFD)
Process
Process Failure
Failure Mode
Mode and
and Effects
Effects
Analysis
Analysis (PFMEA)
(PFMEA)
Process
Process Control
Control Plan
Plan (PCP)
(PCP)

James Davis, GDLS Slide Number: 8

Information Flow
Customer Requirements:
SOR, Vehicle Tech Specs,
System Technical Specs
Product Definition:
Key Product Characteristics, DFMEA

Process Definition:
Process Flow Diagram (PFD),
Product and Process Characteristics
Failure Mode Analysis:
PFMEA

Control Strategy:
Control Plan,
Error proofing
Manufacturing:
Work Instructions & Process Monitoring

James Davis, GDLS Slide Number: 9

 DFMEA/PFMEA Information
Interrelationships

Boundary (Block) Process Flow

Diagram, P- Diagram, Diagram
Etc.

DFMEA PFMEA
Design FMEA Process FMEA

Process Control
Design Verification Plan
Plan & Report
(DVP&R)

James Davis, GDLS Slide Number: 10

Process Flow Diagrams
 The Process Flow Start
The Process Flow Start

Diagram
Diagramprovides
providesaa
logical
logical(visual)
(visual)
Process Step
Process Step

depiction
depictionofofthe
the
process
processthat
thatisisbeing
being Data Input
Data Input
analyzed.
analyzed.
Decision Point
Decision Point

Process Step Document

Process Step Document

End
End

James Davis, GDLS Slide Number: 11

Process Function / Requirement
 The SAE/AIAG PFMEA guidelines describe two
methods of defining process functions.
Either or both may be used.
 Process Functions may be described in terms of:
 The product features/characteristics that are
created
or
 The process actions that are performed
 Process functions should be identified in detail as
necessary to provide information for the PFMEA
to develop effective Process Controls

12
James Davis, GDLS Slide Number: 12
Process Function / Requirement
 Consider a simple operation to drill a hole in a
metal part
 The product characteristics & requirements are:

 Hole size: 4.00 mm +/- 0.13 Y

X
 Hole Location: 4.00

X = 28.0 mm +/- 0.2

Y = 15.0 mm +/- 0.2
 Perpendicular to surface, no burrs, etc.
 Theprocess operation must create these
product characteristics and meet the
requirements
13
James Davis, GDLS Slide Number: 13
Process Function / Requirement
 To drill the correct hole size in the specified
location, the process must:
 Position and hold the part
 Align the part fixturing
with the drill position
 Assure the correct drill
bit size is used
 Set and control drill speed
 Anticipate tool wear and
schedule preventive maintenance
 Ifthe Function/Requirement is defined in
the PFMEA as “Drill Hole” could any of
these be missed?
James Davis, GDLS Slide Number: 14
Process Flow Diagram (PFD)
 Process Flow Diagram is the foundation
Process Flow Diagram is the foundation
 The
Theprocess
processmust
mustbebedefined
definedstep
stepbybystep,
step,including
includinginterfaces
interfaces
 The
ThePFD
PFDprovides
providesthe
thestructure
structuretotodocument
documentwhatwhatproduct
product
characteristics
characteristicsand
andrequirements
requirements(OUTPUTS)
(OUTPUTS)are areaffected
affectedbybyaa
given
givenoperation
operationand
andhow
howthese
thesecharacteristics
characteristicsandandsources
sourcesofof
variation
variationare
arecontrolled
controlled(INPUTS)
(INPUTS)
 PFD
PFDisisaagraphical
graphicalrepresentation
representationofofevery
everypossible
possiblepath
pathaapart
part
can take through the anticipated manufacturing process
can take through the anticipated manufacturing process
 AAwell
welldefined
definedPFD
PFDestablishes
establishesthe
thefoundation
foundationforforthe
thePFMEA
PFMEA
 Helps in developing equipment specifications.
Helps in developing equipment specifications.
 How
Howwill
willthe
theprocess
processcontrol
controlnon-conforming
non-conformingmaterial?
material?
 How
Howand
andwhen
whenwill
willinspections
inspectionsbebeperformed,
performed,what
whatisisrequired?
required?
 How
Howand
andwhen
whenwill
willparts
partsbe
bere-introduced
re-introducedinto
intothe
theprocess?
process?

James Davis, GDLS Slide Number: 15

Process Flow Diagram (PFD)
 Hidden Factories:
Hidden Factories:
 Interfacing
InterfacingProcesses
Processes
Quality Audits Product/tooling Changeovers
Quality Audits Product/tooling Changeovers
Rework Processes Part Ident./Labeling
Rework Processes Part Ident./Labeling
Alternative Processes Teardown
Alternative Processes Teardown
Scrap Gauging Stations
Scrap Gauging Stations
Part Buffers Reject Handling
Part Buffers Reject Handling
Part Movement
Part Movement
 Interface
Interfaceprocess
processissues
issuesaffect
affectquality
qualityperformance
performance
o Rework
Reworkand
o andscrap
scrapparts
partsbypass
bypassprocess
processcontrols
controls
o Mixed parts in the manufacturing process at changeovers
o Mixed parts in the manufacturing process at changeovers

 Need for common systems

Need for common systems
 Part
Partofofthe
theoverall
overallQuality
QualityStrategy
Strategymust
mustinclude
include
o Common content, common format, common approach
o Common content, common format, common approach
 Quality
Qualitystrategy
strategymust
mustextend
extendtotosuppliers
suppliers
o Considered an extension of the Total Quality processes
o Considered an extension of the Total Quality processes

James Davis, GDLS Slide Number: 16

 SAE J1739 March 2009

James Davis, GDLS Slide Number: 17

 Micro Level PFD Example

James Davis, GDLS Slide Number: 18

 Process Characteristics

James Davis, GDLS Slide Number: 19

 PFD Feeds PFMEA
Identify the Function(s)
 Function is a description of what the
Function is a description of what the
Process
Process does
does to
to meet
meet the
the requirements
requirements
Related
Relatedto
toprocess
processspecification
specificationand
andproduct
product
characteristics
characteristics
Comes
Comesfrom
fromthethePFD
PFDoperation
operationdescription
descriptioncolumn
column
 Functions can be described as:
Functions can be described as:
Do
Dothis
thisoperation…
operation…
To
Tothis
thispart
partor
ormaterial…
material…
With
Withthis
thistooling
toolingor
orequipment…
equipment…

James Davis, GDLS Slide Number: 20

 PFD Feeds PFMEA

James Davis, GDLS Slide Number: 21

 Linkage to PFMEA

James Davis, GDLS Slide Number: 22

PFMEA Example continued..

James Davis, GDLS Slide Number: 23

 Sources and Types of Manufacturing Variation

Source of Variation Types of Variation Typical Process Controls

Operator Skill, Training, instructions, visual aids, feedback
Operator Ergonomic Factors layout, motion analysis, human factors

Component / Incoming raw material, purchased Supplier management, internal controls, error
Material parts, previous operations proofing

Equipment / Machine capability, adjustment, Equipment specifications, closed-loop

Machine wear over time machine controls, preventive maintenance

Temperature, humidity, dust, noise Climate control, air filtration, clean room,
Environment sound insulation

Industrial Engineering techniques,

Methods & Systems Sequence, procedure, layout Lean Flow analysis

Set Up Process specification, first / last piece check,

(for stable Initial set up or adjustment automated controls
processes)

Wear over time, breakage, Predictive maintenance, detection error-

Tool tool-to-tool differences proofing, tooling specifications

Repair, replacement, reassembly, Instructions, error-proofing, machine

Maintenance adjustment qualification, production trial run

Position tolerance, adjustment, Predictive maintenance, prevention and

Fixture / Pallet wear over time detection error-proofing

James Davis, GDLS Slide Number: 24

Process Control Plan
 PCP will be based on the previous
activities in PFD and PFMEA.
 Review the PFMEA information
developed & supplied and use to identify:
 Specific controls that may be needed due to the
information added
 Identify which controls are Product or Process
o Note any Special Characteristics
o Identify evaluation methods, frequency and Control
Methods
o Note Reaction Plans (particularly related to NC parts)

James Davis, GDLS Slide Number: 25

 Process Control Plan Example
Form 818-1 (Rev 12Apr02)

Prototype Pre-Launch Production CONTROL PLAN Control Plan No:

Part Number/Latest Change Level Key Contact/Phone Date (Orig.) Date (Rev.)

Customer Part Number Core Team Customer Engineering Approval/Date (If Req'd.)

Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)

Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)

Characteristics Methods

Part/ Machine, Special Sample

Process Name / Reaction
Process Operation Device, Jig, Char. Product / Process Evaluation
Description Plan
Number Tools for Mfg. No. Product Process Class. Specification / Measurement Size Frequency Control Method
Tolerance Technique

Weld beads Tube welds meet Pull test 1 pc. Per shift. Hydraulic pull test Quarantine
300 Initiate weld Robotic Arm per design pull test with using test instruction TI21-01 material
sequence / controller. specification. failure in parent fixture 20-1. since last
TIG welders. Process monitoring
material. form PMF-20-01 good pull
Perform TIG weld of test.
frame parts.
Good welds, yes Weld appearance Operator 100% Each Visual inspection OWI Remove part
no visible meets visual evaluation to piece. #20-01. and send to
defects. standard. Visual Std repair.
TB20-VS1
Weld voltage yes 24 Volts AC Machine 100% Each Closed-loop machine Scrap part &
+/- 2.0 volts Control weld control. Re-start
cycle. welder.
Weld voltage yes 24 Volts AC Visual Once Shift start Set-up OWI #20-02 & Scrap
+/- 2.0 volts each or Form PMF-20-02 current part.
change- Periodic Shut down.
over or maintenance per PM- Notify
maint. WI #20. maintenance
event. .
Inert gas yes 5 cubic feet / min. Visual twice Per shift. Operator cleans gas Notify
flow rate +/- 0.5 cfm cup twice per shift maintenance
PM-WI-20. Process .
monitoring form PMF-
20-01

Inert gas yes 5 cubic feet / min. Visual of Once Shift start Set-up OWI #20-02 &
Quarantine
flow rate +/- 0.5 cfm verification each or Form PMF-20-02. material
of Flow change- Equipment since last
Meter over or Calibration Procedure
good pull
maint. #368 test.
event Notify
James Davis, GDLS Slide Number:maintenance
26
.
 Process Control Plan Example
Characteristics Methods
Part/ Machine, Special
Process Name / Evaluation Reaction
Process Device, Jig, Char. Product / Process Sample
Operation Description Plan
Number Tools for Mfg. No. Product Process Class. Specification / Measurement Control Method
Tolerance Technique Size Frequency
.
Initiate weld sequence / Robotic Arm
Close and latch curtain TIG welders
300

Weld beads per Tube welds meet Pull test 1 pc. Per shift. Hydraulic pull test Quarantin
300. Initiate weld sequence / Robotic Arm design pull test with failure using test instruction TI41-01 e material
Perform TIG weld of TIG welders specification. in parent material. fixture 20-1. since last
frame parts. and controllers. Process monitoring
form PM-20-010 good pull
test.
Good welds, no yes Weld appearance Operator 100% Each Visual inspection OWI Remove
visible defects. meets visual evaluation to piece. #20-010. part and
standard. Visual Std send to
TB20-VS1. repair.
Initiate weld sequence / Weld voltage yes 24 Volts AC Machine 100% Each weld Closed-loop machine Scrap part
Confirm Weld voltage +/- 2.0 volts Control cycle. control. & Re-start
welder
Weld voltage yes 24 Volts AC Visual Once Shift start Set-up OWI #20-02 & Scrap
+/- 2.0 volts each or change- Form PM-20-02 current
over or Periodic maintenance part.
maint. per PM-WI #20. Shut down.
event Notify
Visual twice Per shift. Operator cleans gas maintenanc
Notify
Inert gas flow yes 5 cubic feet / min.
cup twice per shift e.
maintenan
Initiate weld sequence / rate +/- 0.5 cfm
Confirm Inert Gas flow PM-WI-2500. Process ce.
rate monitoring form PMF-
20-10
Inert gas flow yes 5 cubic feet / min. Visual Once Shift start Set-up OWI #20-02 & Quarantin
rate +/- 0.5 cfm verification of each or change- Form PM-00-02. e material
Flow Meter over or Equipment Calibration since last
maint. Procedure #368 good pull
event test.
Initiate weld sequence / Notify
Weld wire yes 300 mm / minute Machine 100% Each weld Closed-loop machine Scrap part &
maintenan
Confirm Wire feed rate feed rate +/- 10 mm / min. Control cycle. control. Re-start
ce.
welder
Weld wire yes 300 mm / minute Operator 100% Shift start Set-up OWI #20-020 & Scrap current
feed rate +/- 10 mm / min. setup check or change- Form PM-20-020 part.
and over or Predictive Shut down.
verification maint. maintenance Notify
event pinch roller replace @ maintenance.
180 days.

James Davis, GDLS Slide Number: 27

Case Studies – Supplier A
 Not ISO Certified, Primarily Defense business base
Not ISO Certified, Primarily Defense business base
 Sole Source - Unique Technology
Sole Source - Unique Technology
 No Process Flow
No Process Flow
 Operator
Operatorwork
workinstruction
instructionfor
for100
100piece
piececomponent
component
o 20
20process
processsteps
stepson
onaasingle
singlepiece
pieceofofpaper
paper(included
(includedmachining)
o
machining)
o Building
Buildingthe
thecomponent
componentrelied
reliedon
onTribal
TribalKnowledge
o
Knowledge
 Diagramming the Process Flow
Diagramming the Process Flow
 20
20steps
stepsturned
turnedinto
into951
951steps
stepstotoproduce
producethe
thecomponent
component
 22
22manufacturing
manufacturingrelated
relatedissues
issues(from
(fromDFMEA)
DFMEA)were
were
incorporated
incorporatedininthe
thePFD/PFMEA
PFD/PFMEA
 Supplier A used PFD - FMEA to
Supplier A used PFD - FMEA to
 Develop
Developwork
workinstructions
instructions
 Determine
Determinethe
therequirement
requirementtotodeveloped
developedtraining
trainingprograms
programsfor
for
assemblers
assemblers/ /machinists,
machinists,QC QCpersonnel
personnel
 Develop
Developsafety
safetyprogram
program/ /training
training
James Davis, GDLS Slide Number: 28
Case Studies – Supplier B
 ISO Certified, Primarily Defense business base
ISO Certified, Primarily Defense business base
 Sole Source - Unique Design
Sole Source - Unique Design
 “Fair” Documented Process Flow
“Fair” Documented Process Flow
 Relied
Reliedon
onaacombination
combinationofofoperator
operatorknowing
knowingwhat
whatshould
shouldbe
be
done
donenext
nextwith
withoperator
operatorwork
workinstructions.
instructions.
o
o However
Howeverititdid
didallow
allowfor
forrepeatable
repeatableassembly
assemblyofofcomponent
componentwith
with
skilled
skilledemployee
employee
 Diagramming the Process Flow
Diagramming the Process Flow
 270
270step
stepPFD
PFDbecame
became1,170
1,170steps
steps
o FMEA
FMEAanalysis
analysisdetermined:
determined:work
workinstructions
instructionsthat
thatneeded
o
needed
improvement
improvementand
andnew
newwork
workinstructions
instructionswere
wererequired
required
 Supplier B used PFD- FMEA to
Supplier B used PFD- FMEA to
 Update
Updatework
workinstructions
instructionstotoerror
errorproof
proofbuild
buildprocess
process

James Davis, GDLS Slide Number: 29

Case Studies – Supplier C
 ISO Certified, Defense/Civil business base
ISO Certified, Defense/Civil business base
 Well Documented Process Flow
Well Documented Process Flow
 Operator
Operatorwork
workinstructions
instructionsallowed
allowedfor
forrepeatable
repeatableassembly
assembly
 Error
ErrorProofing
Proofingallows
allowsfor
forassembly
assemblywith
with“average”
“average”
employees
employees
 Diagramming the Process Flow
Diagramming the Process Flow
 263
263step
stepPFD
PFDbecame
became268 268steps
steps
 32
32manufacturing
manufacturingrelated
relatedissues
issues(from
(fromDFMEA)
DFMEA)werewere
incorporated
incorporatedininthe
thePFD/PFMEA
PFD/PFMEA
o FMEA analysis determined: work instructions that needed
o FMEA analysis determined: work instructions that needed
improvement
improvementand
andnew
newwork
workinstructions
instructionswere
wererequired
required
 Supplier
SupplierCCused
usedPFD-
PFD-FMEA
FMEAto to
 Update
Updatework
workinstructions
instructions

James Davis, GDLS Slide Number: 30

Case Studies – Supplier D
 ISO
ISOCertified,
Certified,Aerospace
Aerospacebusiness
businessbase
base
 Very
VerySmall
SmallCompany
Company
 22Master
MasterAssemblers
Assemblers(1(1of
ofwhich
whichwas
wasthe
theAssembly
Assembly&&Test
TestManager)
Manager)
 Unique
UniqueTechnology
Technology
 “Fair”
“Fair”Documented
DocumentedProcess
ProcessFlow
Flow
 Relied
Reliedon
onaacombination
combinationofofoperator
operatorknowing
knowingwhat
whatshould
shouldbe
bedone
donenext
next
with broad operator work instructions.
with broad operator work instructions.
o
o However
Howeverititdid
didallow
allowfor
forrepeatable
repeatableassembly
assemblyofofcomponent
componentwith
withhighly
highly
skilled employee
skilled employee
 Diagramming
Diagrammingthe
theProcess
ProcessFlow
Flow
 55page
pagePFD
PFDbecame
became22
22pages
pages
 FMEA
FMEAanalysis
analysisdetermined:
determined:work
workinstructions
instructionsneeded
neededimprovement
improvementtoto
allow
allowfor
forproduction
productionofofmore
morethan
than11component
componentatataatime
time
 Supplier
SupplierDDused
usedPFD
PFD--FMEA
FMEAto
to
 Develop
Developwork
workinstructions
instructionswith
withboundary
boundaryphotos
photos
 Recall
Recallnon-compliant
non-compliantparts
parts
 Determine
Determinethe
therequirement
requirementtotodeveloped
developedtraining
trainingprograms
programsfor
for
assemblers, QC personnel
assemblers, QC personnel
 Develop
Developdetailed
detailedATP
ATP
James Davis, GDLS Slide Number: 31
Recapping
Process Flow Diagram
“What does the process do?

PFMEA
“What could go wrong?”
“Could we prevent or detect?”

Control Plan
“What needs to be controlled/monitored?”
“How do we react to problems?”

Operator Instructions & Monitoring

“What am I supposed to do?”
“How am I supposed to do it?”
“Where am I supposed to record it?”
32
James Davis, GDLS Slide Number: 32
 References
 AIAG FMEA Fourth Edition June 2008
AIAG FMEA Fourth Edition June 2008
 SAE J1739 March 2009
SAE J1739 March 2009

James Davis, GDLS Slide Number: 33

 Vocabulary

 AIAG FMEA Fourth Edition Published June 2008

AIAG FMEA Fourth Edition Published June 2008
 SAE FMEA J1739 Published March 2009
SAE FMEA J1739 Published March 2009
 PFD, Process Flow Diagram
PFD, Process Flow Diagram
 PFMEA, Process Failure Modes and Effects
PFMEA, Process Failure Modes and Effects
Analysis
Analysis
 PCP, Process Control Plan
PCP, Process Control Plan

James Davis, GDLS Slide Number: 34