PFMEA

Process Failure Mode and Effects

Analysis
James Davis, General Dynamics
Purpose

The purpose of this presentation is to

share the benefits of a detailed Process
Flow Diagram, conducted during a
Process Failure Mode and Effects
Analysis, that will ensure product
quality in the manufacturing/assembly
process.

James Davis, GDLS Slide Number: 2

 Introduction

James Davis, GDLS Slide Number: 3

Definition of FMEA

A FMEA is an analytical tool that uses a

disciplined technique to identify and help
eliminate product and process potential
failure modes.
o By ID of potential failures
o Assessing the risks caused by failure modes and
Identify corrective actions
o Prioritizing corrective actions
o Carry out corrective actions

James Davis, GDLS Slide Number: 4

Most COMMON Types of FMEA's

Design (Potential) Failure Modes and

Effects Analysis-DFMEA
• Focus is on potential design- related failures
and their causes.

Process (Potential) Failures Modes and

Effects Analysis-PFMEA
• Focuses is on potential process failures and
their causes.

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 Value of FMEA's
z Aids
in improving designs for products and
process
ƒ Increased safety
ƒ Enhances Customer Satisfaction
o Better Quality
o Higher Reliability
z Contributes to cost savings
ƒ Decreases warranty costs
ƒ Decreases waste, non-value added operations

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 PFMEA's
z Focus is on potential process –related
failures and their causes.
ƒMain drive is to understand the process through the
identification of as many potential failures as possible.
o e.g. Incorrect material used
z PFMEA typically assumes that the design
is sound.
z Development of Recommended Actions is
targeted at eliminating the Root Cause of
the potential failures.

James Davis, GDLS Slide Number: 7

 PFMEA

Three Parts:
zProcess Flow Diagram (PFD)
zProcess Failure Mode and Effects
Analysis (PFMEA)
zProcess Control Plan (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
z The Process Flow
Diagram provides a
logical (visual)
depiction of the
process that is being
analyzed.

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Process Function / Requirement
z The SAE/AIAG PFMEA guidelines describe two
methods of defining process functions.
Either or both may be used.
z Process Functions may be described in terms of:
ƒ The product features/characteristics that are
created
or
ƒ The process actions that are performed
z 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
z Consider a simple operation to drill a hole in a
metal part
z The product characteristics & requirements are:
ƒ Hole size: 4.00 mm +/- 0.13 Y
X
ƒ Hole Location: 4.00

X = 28.0 mm +/- 0.2

Y = 15.0 mm +/- 0.2
ƒ Perpendicular to surface, no burrs, etc.
z Theprocess operation must create these
product characteristics and meet the
requirements
13
James Davis, GDLS Slide Number: 13
Process Function / Requirement
z To drill the correct hole size in the
specified location, the process must:
ƒ Position and hold the part
ƒ Align the part fixturing
with the drill position
ƒ Assure the correct drill
bit size is used
ƒ Set and control drill speed
ƒ Anticipate tool wear and
schedule preventive maintenance
z Ifthe Function/Requirement is defined in
the PFMEA as “Drill Hole” could any of
these be missed?
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Process Flow Diagram (PFD)
z Process Flow Diagram is the foundation
ƒ The process must be defined step by step, including
interfaces
ƒ The PFD provides the structure to document what product
characteristics and requirements (OUTPUTS) are affected
by a given operation and how these characteristics and
sources of variation are controlled (INPUTS)
ƒ PFD is a graphical representation of every possible path a
part can take through the anticipated manufacturing
process
ƒ A well defined PFD establishes the foundation for the
PFMEA
z Helps in developing equipment specifications.
ƒ How will the process control non-conforming material?
ƒ How and when will inspections be performed, what is
required?
ƒ How and when will parts be re-introduced into the
process?
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Process Flow Diagram (PFD)
z Hidden Factories:
ƒ Interfacing Processes
Quality Audits Product/tooling Changeovers
Rework Processes Part Ident./Labeling
Alternative Processes Teardown
Scrap Gauging Stations
Part Buffers Reject Handling
Part Movement
ƒ Interface process issues affect quality performance
o Rework and scrap parts bypass process controls
o Mixed parts in the manufacturing process at changeovers
z Need for common systems
ƒ Part of the overall Quality Strategy must include
o Common content, common format, common approach
ƒ Quality strategy must extend to suppliers
o Considered an extension of the Total Quality processes

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 SAE J1739 March 2009

James Davis, GDLS Slide Number: 17

 Micro Level PFD Example

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 Process Characteristics

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 PFD Feeds PFMEA
Identify the Function(s)
z Function is a description of what the
Process does to meet the requirements
¾Related to process specification and product
characteristics
¾Comes from the PFD operation description column
z Functions can be described as:
¾ Do this operation…
¾ To this part or material…
¾ With this tooling or equipment…

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 PFD Feeds PFMEA

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 Linkage to PFMEA

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PFMEA Example continued..

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 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
z PCP will be based on the previous
activities in PFD and PFMEA.
z Review the PFMEA information
developed & supplied and use to identify:
ƒ Specific controls that may be needed due to the
information added
ƒ 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 Customer Engineering Approval/Date (If Req'd.)

Team
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
Process Name / Sample Reaction
Process Device, Jig, Char. Product / Process Evaluation
Operation Description Plan
Number Tools for Mfg. No. Product Process Class. Specification / Measurement Control Method
Tolerance Technique Size Frequency
Weld beads Tube welds meet Pull test 1 pc. Per shift. Hydraulic pull test Quarantine
300 Initiate weld sequence Robotic Arm per design pull test with using test instruction TI21-01 material
/ 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 weld Closed-loop machine Scrap part &
+/- 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 Form PMF-20-02 current part.
change- Periodic Shut down.
over or maintenance per PM- Notify
maint. WI #20. maintenance
event. .
Inert gas flow yes 5 cubic feet / min. Visual twice Per shift. Operator cleans gas Notify
rate +/- 0.5 cfm cup twice per shift maintenance
PM-WI-20. Process .
monitoring form PMF-
20-01

Inert gas flow yes 5 cubic feet / min. Visual of Once Shift start Set-up OWI #20-02 & Quarantine
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
maintenance
.
James Davis, GDLS Slide Number: 26
 Process Control Plan Example
Characteristics Methods
Part/ Machine, Special
Process Name / Product / Process Evaluation Sample Reaction
Process Device, Jig, Char.
Operation Description Class. Plan
Number Tools for Mfg. No. Product Process 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 Quarantine
300. Initiate weld sequence / Robotic Arm design pull test with failure using test instruction TI41-01 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 & Quarantine
rate +/- 0.5 cfm verification of each or change- Form PM-00-02. 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 &
Confirm Wire feed rate maintenan
Re-start
feed rate +/- 10 mm / min. Control cycle. control. 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
z Not ISO Certified, Primarily Defense business base
z Sole Source - Unique Technology
z No Process Flow
ƒ Operator work instruction for 100 piece component
o 20 process steps on a single piece of paper (included machining)
o Building the component relied on Tribal Knowledge
z Diagramming the Process Flow
ƒ 20 steps turned into 951 steps to produce the component
ƒ 22 manufacturing related issues (from DFMEA) were
incorporated in the PFD/PFMEA
z Supplier A used PFD - FMEA to
ƒ Develop work instructions
ƒ Determine the requirement to developed training programs
for assemblers / machinists, QC personnel
ƒ Develop safety program / training
James Davis, GDLS Slide Number: 28
Case Studies – Supplier B
z ISO Certified, Primarily Defense business base
z Sole Source - Unique Design
z “Fair” Documented Process Flow
ƒ Relied on a combination of operator knowing what should
be done next with operator work instructions.
o However it did allow for repeatable assembly of component with
skilled employee
z Diagramming the Process Flow
ƒ 270 step PFD became 1,170 steps
o FMEA analysis determined: work instructions that needed
improvement and new work instructions were required
z Supplier B used PFD- FMEA to
ƒ Update work instructions to error proof build process

James Davis, GDLS Slide Number: 29

Case Studies – Supplier C
z ISO Certified, Defense/Civil business base
z Well Documented Process Flow
ƒ Operator work instructions allowed for repeatable assembly
ƒ Error Proofing allows for assembly with “average”
employees
z Diagramming the Process Flow
ƒ 263 step PFD became 268 steps
ƒ 32 manufacturing related issues (from DFMEA) were
incorporated in the PFD/PFMEA
o FMEA analysis determined: work instructions that needed
improvement and new work instructions were required
z Supplier C used PFD- FMEA to
ƒ Update work instructions

James Davis, GDLS Slide Number: 30

Case Studies – Supplier D
z ISO Certified, Aerospace business base
z Very Small Company
ƒ 2 Master Assemblers (1 of which was the Assembly & Test
Manager)
z Unique Technology
z “Fair” Documented Process Flow
ƒ Relied on a combination of operator knowing what should be done next
with broad operator work instructions.
o However it did allow for repeatable assembly of component with highly
skilled employee
z Diagramming the Process Flow
ƒ 5 page PFD became 22 pages
ƒ FMEA analysis determined: work instructions needed improvement
to allow for production of more than 1 component at a time
z Supplier D used PFD - FMEA to
ƒ Develop work instructions with boundary photos
ƒ Recall non-compliant parts
ƒ Determine the requirement to developed training programs for
assemblers, QC personnel
ƒ Develop detailed 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
z AIAG FMEA Fourth Edition June 2008
z SAE J1739 March 2009

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

James Davis, GDLS Slide Number: 34