Supplier APQP Process Training (In-Depth)

Advanced Product Quality Planning (APQP) and
Production Part Approval Process (PPAP)
Supplier Overview Training

Document CQD-116; Rev 1; 1/15/15
© 2014 Eaton. All Rights Reserved.

What is APQP?
Advanced Product Quality • Advanced Product Quality Planning
Planning Cycle
method to assure that a product satisfies
the customer (both internal and external)
• The goal of APQP is to:
• Plan before acting
• Anticipate and prevent issues
• Validate before moving forward
• Facilitate communication
• Each Advanced Product Quality Plan is unique and is a living document
• Particular emphasis should be placed on identifying critical path activities

and ensuring those are fully resourced

2
APQP Background
• Automotive industry challenges:

• Innovation, more complex product
• Reduce NPD times
• Complicated Supply chain
• Increasing customer and quality requirements
• Solution:
• Ford, GM, Chrysler APQP Task Force jointly developed in the
late 80’s to standardize their respective supplier quality
systems.
• Continuous Improvement:
• Many industries outside the Automotive industry have
embraced the AIAG APQP process to achieve similar benefits
3
APQP – timing chart and phases - AIAG
The Advanced Product Quality Planning process consists of four phases and five major
activities and has some 20+ supporting tools (e.g. DFMEA, PFMEA, CTQ, Special
Characteristics, Control Plan, SPC) along with ongoing feedback assessment and corrective
action.

4
1. Plan and Define Program
INPUTS: OUTPUTS:
• Voice of the Customer • Design Goals
• Market Research • Reliability & Quality
• Historical Warranty goals
and Quality • CONC targets
Information • Preliminary Bill of
• Team Experience Materials
• Business Plan/Marketing • Preliminary Process
Strategy Flow Chart
• Product/Process • Preliminary list of
Benchmark Data Special Product and
Assure that • Product/Process Process
customer needs Assumptions Characteristics
and expectations • Product Reliability • Product Assurance
are clearly Studies Plan
understood. • Customer Inputs • Management Support
* The inputs and outputs applicable to the process may vary according to the
product process and customer needs and expectations.

5
2. Product Design and Development - 1
INPUTS: OUTPUTS:
• Design Goals • Design Failure Mode and Effects
• Reliability & Quality Analysis (DFMEA)
goals • Design For Manufacturability and
• Preliminary Bill of Assembly
Materials • Design Verification
• Preliminary Process • Design Reviews
Flow Chart • Prototype Build – Control plan
• Preliminary list of • Engineering Drawings (Including
Special Product and Math Data)
Process • Engineering Specifications
Develop design into Characteristics • Material Specifications
a near final form. • Product Assurance • Drawing and Specification
Prototype and Plan Changes
feasibility studies –
volumes, schedule,
manufacturing.
Cont. next slide

6
2. Product Design and Development - 2
INPUTS: OUTPUTS:
• Design Goals • New Equipment, Tooling and
• Reliability & Quality Facilities Requirements
goals • Special Product and Process
• Preliminary Bill of Characteristics
Materials • Gages/Testing Equipment
• Preliminary Process Requirements
Flow Chart • Team Feasibility
• Preliminary list of Commitment
Special Product and • Management Support
Process
Develop design into Characteristics
a near final form. • Product Assurance
Prototype and Plan
feasibility studies –
volumes, schedule,
manufacturing.

7
3. Process Design and Development
INPUTS: OUTPUTS:
• Design Failure Mode and Effects Analysis • Packaging Standards
(DFMEA)
• Design For Manufacturability and • Product/Process Quality
•
Assembly System Review
Design Verification
• Design Reviews • Process Flow Chart
• Prototype Build – Control Plan • Floor Plan Layout
• Engineering Drawings (Including Math
Data) • Characteristics Matrix
• Engineering Specifications • Process Failure Mode and
• Material Specifications
• Drawing and Specification Changes Effects Analysis (PFMEA)
• New Equipment, Tooling and Facilities • Pre-Launch Control Plan
Requirements
• Special Product and Process • Process Instructions
Develop a Characteristics • Measurement Systems
• Gages/Testing Equipment Requirements
manufacturing • Team Feasibility Commitment Analysis Plan
system and its • Management Support • Preliminary Process
related control Capability Study Plan
plans to achieve • Packaging Specifications
quality products. • Management Support

8
4. Product and Process Validation
INPUTS: OUTPUTS:
• Packaging Standards • Measurement Systems
• Product/Process Quality
Evaluation
System Review • Significant Production Run
• Process Flow Chart • Preliminary Process
• Floor Plan Layout
Capability Study
• Characteristics Matrix • Production Part Approval
• Process Failure Mode and • Production Validation
Effects Analysis (PFMEA) Testing
• Pre-Launch Control Plan • Packaging Evaluation
Validate manufacturing • Process Instructions
process through • Production Control Plan
production trial run.
• Measurement Systems • Quality Planning Sign-Off -
Validate that the control Analysis Plan formal
plan and process flow • Preliminary Process • Management Support
chart are effective and
that the product meets Capability Study Plan
customer expectation. • Packaging Specifications
• Management Support

9
Feedback, Assessment, Corrective actions
INPUTS: OUTPUTS:
• Production Trial Run • Reduced Variation
• Measurement Systems • Improved Customer
Evaluation Satisfaction
• Preliminary Process • Improved Delivery and
Capability Study Service
• Production Part Approval • Effective use of best
Evaluate outputs, • Production Validation practice, lessons learned
effectiveness of Testing • Maximum ROI
the product • Packaging Evaluation • Minimum Waste
quality planning • Production Control Plan • Minimum CONC
efforts. • Quality Planning Sign-Off
and Management
Support

10
Application to Different Mfg. Environments
• High Volume
• APQP plans and activities are organized by part number and are
very specific to the part
• Low Volume
• APQP plans may be specific to part families with activities focused
on the parent part
• More limited validation would be done on child parts
• Family part differences should be understood and higher risk
differences incorporated into APQP plans
• Engineer to Order (ETO)
• APQP plans may use a part family approach for standardized
elements
• Consider a manufacturing process focus for non-standard elements
• Create FMEAs and Control Plans for manufacturing processes rather than
parts
11
APQP Summary:
What we do: How we do it: What we get:
APQP
• Design Quality
• DFMEA / PFMEA / • Defect Free
DFM/A Launches
• Manufacturing Quality UP • Reduced Warranty
• Control Plans Claims
• Process Flows • Zero Spills
FRONT • Customer
• Measurement
System Analysis Satisfaction
• Capability Analysis DETAILED • Robust Products
• Process Validation • Greater Supplier
• Run at rate Control
• Supplier Qualification &
QUALITY • Reduced supplier
Quality Requirements cost
• Product Qualification PLANNING
• 1st Article
Inspection
• PPAP
• Tooling & Gauges
• Testing
Leadership
1 Engagement is Critical
12
APQP Benefits:
Manufacturing process functions that are clearly planned,
validated, documented and communicated that result in:
• Robust and reliable designs
• Reduced process variation
CONC
• Enhanced confidence in supplier’s
capabilities
• Better controlled process changes
$$ Total Cost of Quality

Redesign
• Defect free launches Re-qualifications
Escape Investigations
• Improved Customer satisfaction
• Improved Delivery and Service
• Maximum ROI
• Minimum Waste Prevention through APQP
Current state
• Minimum Cost of Non-
Time
conformance Development Production

13
Key Take Aways:
• APQP is cross-functional planning and execution to

produce product that fully meets the customer’s
expectations the first time
• AIAG APQP phases are Planning, Product Design,
Process Design, Validation, Production
• Phase approach ensures activities are completed in the
appropriate order
• Can be applied to different manufacturing environments
– High Volume, Low Volume, ETO
• It’s cross-functional –
Marketing/Design/Manufacturing/SCM/Quality
14
Production Part Approval Process (PPAP)

What is a First Article Inspection?
• A First Article Inspection (FAI) requires that all

dimensions for a part be checked and verified
prior to full production and receipt of part into
the customer facility.
• All dimensions, (except reference dimensions),
characteristics, and specifications, as noted on
the design record and process control plan,
are to be listed on the FAI Report with the
actual dimension results recorded.

16 16
What is PPAP?
• Production Part Approval Process

• Standard used to formally reduce risks prior to product
or service release, in a team oriented manner using
well established tools and techniques
• Initially developed by AIAG (Auto Industry Action
Group) in 1993 with input from the Big 3 - Ford,
Chrysler, and GM
• AIAG’s 4th edition effective June 1, 2006 is the most
recent version
• PPAP has now spread to many different industries
beyond automotive
17
Production Run
• PPAP data must be submitted from a

production run using:
• Production equipment and tooling
• Production employees
• Production rate
• Production process
All data shall reflect the actual production

process that will be used at start-up!

18
Purpose of PPAP
• Provide evidence that all customer

engineering design record and specification
requirements are properly understood by the
organization
• To demonstrate that the manufacturing
process has the potential to produce product
that consistently meets all requirements during
an actual production run at the quoted
production rate

19
What’s the Difference in PPAP vs. FAI?
• FAI gives confidence regarding the sample.

• In addition, PPAP gives confidence in future
product.

20 20
When is PPAP Required?
• New part
• Engineering change(s)
• Durable Tooling: transfer, replacement, refurbishment, or
additional
• Tooling inactive > one year
• Correction of discrepancy
• Change to optional construction or material
• Sub-supplier or material source change
• Change in part processing
• Parts produced at a new or additional location
PPAP is required with any significant
change to product or process!

21
Benefits of PPAP Submissions
• Helps to maintain design integrity

• Identifies issues early for resolution
• Reduces warranty charges and prevents cost of
poor quality
• Assists with managing supplier changes
• Prevents use of unapproved and nonconforming
parts
• Identifies suppliers that need more development
• Improves the overall quality of the product &
customer satisfaction
22
PPAP Submission Levels
Production Warrant and Appearance Approval

Level 1
Report (if applicable) submitted to Eaton
Production Warrant, product samples, and

Level 2
dimensional results submitted to Eaton
Production Warrant, product samples, and

Level 3
complete supporting data submitted to Eaton
Production Warrant and other requirements

Level 4
as defined by Eaton
Production Warrant, product samples and

complete supporting data (a review will be
Level 5
conducted at the supplier's manufacturing
location)

23
PPAP Submission Requirements
Requirement Level 1 Level 2 Level 3 Level 4 Level 5
1.Design Record R S S * R
2.Engineering Change Documents, if any R S S * R
3.Customer Engineering approval, if required R R S * R
4.Design FMEA R R S * R
5.Process Flow Diagrams RNote: For
R eachSlevel, full
* APQPRis
6.Process FMEA R R S * R
7.Control Plan Rrequired.
R The PPAP
S level
* simply
R
8.Measurement System Analysis studies Rindicates
R whichSelements* you R
9.Dimensional Results R S S * R
10.Material, Performance Test Results R
submit, S
and which
S
you retain
*
atR
11.Initial Process Studies Ryour site.
R S * R
12.Qualified Laboratory Documentation R S S * R
13.Appearance Approval Report (AAR), if applicable S S S * R
14.Sample Product R S S * R
15.Master Sample R R R * R
16.Checking Aids R R R * R
17.Records of Compliance With Customer Specific Requirements R R S * R
18.Part Submission Warrant S S S S R
19.Bulk Material Checklist S S S S R
Any customer specific requests
S = The organization shall submit fall
to the customer and retain a copy of records or documentation items at appropriate
under Element # 17
locations
R = The organization shall retain at appropriate locations and make available to the customer upon request
* = The organization shall retain at the appropriate location and submit to the customer upon request

24
PPAP Element 17: Eaton Requirements
• Depending on the specific Eaton business, Eaton may require:
• APQP Kickoff - team
• APQP Timeline Template
• Action Item Log
• Production Feasibility Agreement (PFA)
• Gage Plan
• Dimensional Correlation Matrix
• Pass Through Characteristics (PTC)
• Safe Launch Control Plan
• AS 9102 Forms (Aerospace Industry)
• Ramp Up & Down Plan
• Packaging Specification Data Sheet
• Submit Bar Code Label Packaging Approval
• PPAP Interim Recovery Worksheet
• Capacity R@R Worksheet
• Production Readiness Review (PRR)
25
PPAP Status
• Approved
• The part meets all Eaton requirements
• Supplier is authorized to ship production quantities of the part
• Interim Approval
• Permits shipment of part on a limited time or piece quantity
basis
• Rejected
• The part does not meet Eaton requirements, based on the
production lot from which it was taken and/or accompanying
documentation
Production quantities shall

not be shipped before Eaton
Approval
26
Eaton PPAP Process
• Eaton determines PPAP level based on component risk

• Submission requirements are increased for higher risk
components
• Eaton communicates requirements to supplier (RFQ,
APQP Kick-off Meeting, and/or PPAP request – PPAP
Workbook, etc.)
• Eaton provides a standard PPAP workbook with all
necessary tools
• Supplier can use their own templates and tools if they meet
the AIAG requirements
• Supplier conducts APQP per AIAG requirements (Use
PPAP workbook forms as necessary)
27
Adapting PPAP for High Mix/Low Volume
and Engineer to Order Manufacturing
• Group parts into part families

• Which parts use the same manufacturing process
flow?
• Which parts have 90%+ features in common?
• Design and validate processes based on part
families
• Look at individual processes – use planning
and prevention tools such as PFMEA, Control
Plan by process

28
PPAP Element #1: Design Record
• Includes:
• Component drawings
• Assembly drawings
• Bill of Materials
• Referenced engineering specifications
• Material specifications
• Performance or test specifications
• Ensures manufacturer has the complete design record at the
correct revision levels
• This requirement may be satisfied by attaching the “ballooned”
design record to the Production Feasibility Agreement (PFA) –
located in the PPAP Workbook
• Some Eaton businesses may use an alternate approach
29
PPAP Element #2:
Authorized Engineering Change Documents
• The supplier shall provide authorized change

documents for those changes not yet recorded
in the design record, but incorporated in the
product, part or tooling, such as:
• ECNs (must be approved, not pending)
• Specification changes
• Supplier change requests
• Sub-assembly drawings
• Life or reliability testing requirements

30
PPAP Element #3:
Customer Engineering Approval
• Written statement from Customer Engineering

approving the parts
• Example: supplier designed components in which
we require additional information for validation of
designs…for structural integrity
• The engineering design requires approval
• Other elements of the PPAP validate the
manufacturing process

31
PPAP Element #4: Design Failure Mode
and Effects Analysis (DFMEA)
• Provide potential cause and effect relationships for the basic design
of the product
• Helps to plan design needs for:
• Materials selection
• Tolerance stack-up
• Software
• Interfaces
• DVP&R (life cycle tests)
• Employs R.P.N rating system
• High R.P.N’s and Severity> 8 need recommended Corrective Actions (CA)
• PROLaunch element
• Initial DFMEA in Phase 2
• Complete DFMEA in Phase 3
• May be “Family” based

32
Difference between DFMEA and PFMEA
• DFMEA does not reference manufacturing

controls
• Design controls include:
• Tolerance stack-up analysis
• Simulation
• Finite Element Analysis
• Testing
• Recommended actions should be Design actions
• Re-design
• Testing
• Analysis
33
DFMEA Common Pitfalls
• One time document

• Must be continuously reviewed and updated
• What if the latest change or revision has a significant impact?
• Not submitted or reviewed with supplier
• The After Thought
• Completed after drawing and production release
• Doesn’t help to direct the design effort
• Does not consider all potential failure modes
• Critical and/or Special Characteristics not identified
• Only considers full assembly
• Not completed to correct level – component, sub assembly, assembly,
product
• Family based DFMEA not all inclusive
• Not reviewed for specific/ custom application/ designs
34
“Good” DFMEA Example
Potential S O Current D R
Potential Failure Potential Current Controls
Failure E C Controls E P
Effects Causes Detect
Mode(s) Class V C Prevent T N
Impeller stress analysis,
Impeller Low Flow at High
8 Impeller Fracture 2 thermal limits, vibration 6 96
Failure Speeds & High Flows
analysis
Reduced Overall Relief Valve Stuck Relief valve force margin,
Relief Valve
Efficiency due to 8 due to 3 relief valve clearances, 5 120
Open
Internal Leakage Contamination sharp edges
Reduced Overall Analyze housing vibration
Housing Housing Fracture
Efficiency due to 4 3 modes in conjunction with 6 72
Fracture due to Vibration
Internal Leakage vibration requirements
Action Target Actions N S N O N D N R

Actions Recommended e E e C e E e P
Owner Date Taken
w V w C w T w N
Perform Stack Up Analysis
Stackups
with Transient / Steady State Joe Smith 11-May-14 8 2 2 32
complete
Thermal Effects
Perform Cartridge Static Load Analysis

Jan Doe 11-Aug-14 8 2 2 32
& Deflection Analysis complete
Perform Thermal Stack Thermal

Analysis and Thermal Shock Joe Smith 12-Sep-14 analysis 4 3 3 36
Test complete

35
Progress Check: DFMEA
• In which APQP phase would you first create a DFMEA?
• APQP: Phase 2 – Product Design
• Which of the following activities should be done before the
DFMEA? After
• Create PFMEA
• Customer CTQs identified
After
• Suppliers Selected
After
• Gage Plan Created
• Which FMEA risks need recommended actions?
• Any over 100 RPN
• Higher risks - by RPN, Severity or Occurrence
• What is the impact of creating a PFMEA without a DFMEA?
• May not properly understand the severity of failure effects
36
PPAP Element #5: Process Flow
Diagram(s)
• Step by Step designation of the process flow

required to produce the referenced product
which meets all customer requirements
• Provide linkage to PFMEA and Control Plan
• Traditional block diagram
• May employ “Family” based diagrams
• Should cover all steps from Receiving to Shipping
(for additional details reference Advance Product Quality Planning and

Control Plan AIAG Manual)

37
Process Flow Diagrams
PROCESS / INSPECTION FLOWCHART
Product Program Issue Date ECL ECL

Supplier Name ORGANIZATION Part Name NAME
Supplier Location CITY STATE Part Number NUMBER
Legend:
Operation Transportation Inspection Delay Storage
STEP
Operation or Event Description of Evaluation

Operation or Event and Analysis Methods
The process flow diagram

utilizes these symbols to
clearly identify each step
in the process

38
Preparing the Process Map
• Team Effort:
• Engineers
• Operators
• Supervisors
• Maintenance
• Supply Chain
• Possible Inputs to Mapping:
• Engineering specifications
• Lead time requirements
• Target manufacturing costs
• Operator experience
• Observation
• Brainstorming
39
Process Flow Diagrams
• Reviewers Checklist
 Process Flow must include all phases of the process
• Receiving
• Storage/ material handling
• Manufacturing
• Offline inspections and checks
• Assembly
• Testing
• Shipping
 Should include abnormal handling processes
• Scrap
• Rework
• Extended Life Testing
 May also include Transportation
40
Process Map and APQP
• During which APQP phase would you first create a

process map?
 APQP: Phase 1 – Planning
• Why not wait until later in the process?
• A basic understanding of the process assists in cost estimating/
quoting
• Need to know process steps to understand what
equipment/tooling/gages may be required
• Why would volumes and lead-times be important to
know?
• Volumes and lead-times might influence the manufacturing
processes you select (i.e. automated processes for high
volume)
41
PPAP Element #6: Process FMEA (PFMEA)
• What is It? POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)
• A tool used to identify and prioritize risk Item:

Model Year(s)/Program(s) APPLICATION
Process Responsibility
Key Date
ORGANIZATION
areas and their mitigation plans. Core Team:

Process Step
Current Current
Classification
Occurrence
Detection
/ Function Potential Potential Potential
Severity
Process Process
RPN
• Objective or Purpose
Failure Effect(s) Causes(s)
Mode of Failure of Failure Controls Controls
Prevention Detection
Requirements
• Identifies potential failure modes, causes,

and effects. Inputs come from the process
flow diagram.
• Identifies key inputs which affect quality,
reliability and safety of a product or
process.
• When to Use It
• IMPORTANT!
New product launches
• After completion of the process flow diagram. The PFMEA should be completed
• Prior to tooling for production using a cross-functional team!
• When troubleshooting production issues
• When planning and closing preventive and
corrective actions
42
FMEA Origins
• Initially developed by the

US Military as Failure
Mode Effects and Criticality
Analysis (FMECA)
• Widely adopted by NASA Apollo 1 Failure
during the 1960s to
prevent errors on the
Apollo program
• Brought over to the
automotive industry by
Ford after issues with Pinto
fuel tanks Ford Pinto
43
PFMEA - Step 1
C Current Controls
L
S A O D
Potential Failure Potential Failure E S C E
Process Step Mode Failure Modes
Effects V Potential Causes S C Prevent Detect T
What isFor each Process Input,
How severe is the effect to the customer?

What is the process In what way(s) could the impact What causes the input What are the existing What are the existing
Classify any special product or process
How often does the cause of the failure

step or input being the step or input fail to on the output to go wrong? process controls to process controls to
determine the ways in
How well can you detect the cause of

evaluated? meet the specificed variables (customer prevent the cause of detect the cause of
which the input can What go
characteristics needing additional

requirements? requirements) could cause the failure or failure mode failure or failure mode
Consider: or wrong.
internal failure, in terms of from occurring or and lead to corrective
failure mode? See DET table.

mode occur? See OCC table.
(A) No Function requirements? something that can be reduce the rate of action(s)?
(B) corrected or controlled? occurrence? Should include an
Partial/Over/Degraded What are the effects Should include an SOP number.
Function of the failure on the SOP number.
(C) Intermittent function as perceived
See SEV table.

Function by internal and
(D) Unintended external customers?
controls.
Function.
Operator places wrong

Wrong and/or missing Customer unable to Work Instructions, Visual Inspection;
Assemble Hardware Kit 8 hardware and/or label 3 8
parts/labeling (B) install product Pack Positive Scale to weigh kits
with kit
Customer unable to
Assemble Hardware Kit Bad seal (B) install product, due 8 Bagger error 2 Work Instructions Visual Inspection 8
to missing hardware.
Using the completed

Process Flow Diagram,
enter the process step. TIP
• There should be at least one failure mode for each input.
44
Potential Failure Mode
• List all credible failure modes or ways the process/operation can fail in the
PFMEA document before addressing failure effects and failure causes
• In each instance, the assumption is made that the failure could occur, but
will not necessarily occur
• The failure mode:
• “… is the manner in which the process could potentially fail to meet the process
requirements and/or design intent.”
• Is a description of nonconformance
• Assumes incoming parts are correct
• Considers subsequent operations
• Typical failure modes could be, but are not limited to:
• Bent • Cracked • Tool worn
• Open circuited • Improper setup • Handling Damage
• Dirty • Burred
• Binding • Deformed

45
Example Failure Modes by Activity
Placement Bend Test Insert Remove / Unload Index Measure
Accept Non- Fails to Remove Non- Accept Non-

Missing Component X Orientation Conforming Part No Insertion Conforming Part X-Y Orientation Conforming Part
Reject Conforming Removes Conforming Reject Conforming
Wrong Component Z Orientation Part Partial Insertion Part No index Part
Multiple
Components Y Orientation No test Over Insertion Miscategorization No measure
X Location Radial Orientation No remove Inaccurate Gaging
Y Location Dirt Contamination Missed op
Z Location Damage Damage
Radial Orientation Flattened Contamination
Dirt Contamination Cracked
Damage Folded
Upside down Broken fold
Backwards Scratch
Dents
Chips
Deformed
No bend

46
Example Failure Modes by Activity (cont.)
Stake Dip Package Initialize Synchronize Setup Pump-Up

Fail to Clear Fail to Recognize
No Stake Missed Operation Incorrect Qty Registers Station Incorrect Setup Does not Pump-Up
Write Incorrect Value
to Register During
Under Stake Partial Dip Incorrect Label Clearing No Synchronize Incomplete Setup
Over Stake Incorrect Box No Setup
Mixed Parts
Damage
Feed-Out Wind Cut-Off Press Load Fill / Oil Torque

Damaged
Wrong Wire Too Few Coils No Cut-Off High force Wrong part Wrong fluid component
No Feed Too Many Coils Low force Mix part Too much fluid No torque
Feed Too Short Free Length Short Tooling alignment Dirty part Too little fluid Over torque
Feed Too Long Free Length Long Too Fast Speed Wrong lane
Too slow speed Wrong orientation
Short stroke Damage
Over stroke

47
Example Failure Modes by Activity (cont.)
Rotate Mark Grease Mold
Partial Rotation Incomplete Wrong Grease Density variation
Over Rotation Illegible no grease Dimension variation
No rotation Wrong Mark X-Y Orientation Sink
Rotate to wrong side Missing Mark Z Orientation Flowlines

Damaged
component Wrong location Damage Shorts
Contamination Too much Warp
Too little Molded contamination
Contamination Weldlines
Incorrect number of
greasing points color variation
brittleness
scratches
drag marks
gate stubs
burns
flash
mixed parts
part count incorrect
bubbles
sirface contamination
voids
splay
damaged part
wrong part

48
PFMEA - Step 2
Potential Failure Effects
For each Failure Mode,
determine what effect
the specific failure
could have on the
process output.
TIPS
• There should be at least one failure effect for each failure mode.
• Effects should be specific, clear, and leave no doubt to the uninformed reviewer.
49
Potential Effect(s) of Failure
• Effect of failure mode based on what customer

might notice/experience
• Includes subsequent process operations
• Typical effects may include, but are not limited to:
• No Function
• Partial/Over Function/Degraded over time
• Intermittent Function
• Unintended Function
• Erratic operation
50
PFMEA – Step 3
Class
Identify special product or
process characteristics

51
PFMEA - Step 4
Potential Causes
For each Failure Mode,
determine the possible
cause of the failure.
TIP
• There should be at least one potential cause for each failure mode.

52
Potential Cause(s) of Failure
• “…how the failure could occur.”

• Described in terms of something that can be corrected/controlled
• Requires determination of root cause
• Sources of process variation that cause the failure mode to occur
• Typical failure causes may include, but are not limited to:
• Improper torque – over, under
• Improper weld – current, time, pressure
• Inaccurate gauging
• Improper heat treat – time, temperature
• Inadequate gating/venting
• Part missing or installed incorrectly
• Thermocouple broken
• Typographical error

53
PFMEA - Step 5
Current Controls
For each potential
cause, list the current
method used for
preventing and/or
detecting failure.
TIPS
• This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan.
• If a procedure exists, enter the document number.
• If no current control exists, list as “none.” There may not be both preventive and detection controls.
54
PFMEA - Step 6
Assign Detection
Assign Severity (How easily can the
(How serious is the cause or failure
effect if it fails?) mode be detected?)
Assign
Occurrence
(How likely is
the cause to
occur?)

55
PFMEA - Definition of Terms
• Severity (of Effect) - severity of the effect on the

Customer and other stakeholders (Higher Value = Higher
Severity)
• Occurrence (of Cause) - frequency with which a given
Cause occurs and creates Failure Mode. (Higher Value =
Higher Probability of Occurrence)
• Detection (Capability of Current Controls) - ability of
current control scheme to detect the cause before creating
the failure mode and/or the failure mode before suffering
the effect (Higher Value = Lower Ability to Detect)
Caution: Notice the scale difference for Detection

56
Example: Severity Rating Definitions
Suggested PFMEA Severity Evaluation Criteria
Criteria: Criteria:
Rank Effect Severity of Effect on Product Effect Severity of Effect on Process
(Customer Effect) (Manufacturing / Assembly Effect)
Failure to Meet Potential failure mode affects safe Product operation and/or involves Failure to Meet May Endanger Operator (machine or assembly)
10
Safety and/or noncompliance with government regulation without warning Safety and/or without warning
Regulatory Potential failure mode affects safe Product operation and/or involves Regulatory May Endanger Operator (machine or assembly) with
9 Requirements Requirements
noncompliance with government regulation with warning warning
Loss of primary function (Product inoperable, does not affect safe 100% of product may have to be scrapped. Line
8 Loss or Major Disruption
Product operation) shutdown or stop ship.
Degradation of
A portion of the production run may have to be
Primary Degradation of primary function (Product operable, but at reduced Significant
7 scrapped. Deviation from primary process including
Function level of performance) Disruption
decrease line speed or added manpower.
Loss or Loss of secondary function (Product operable, but comfort / 100% of production run may have to be reworked off
6
Degradation of convenience functions inoperable) line and accepted
High Disruption
Secondary Degradation of secondary function (Product operable, but comfort / A portion of production run may have to be reworked
5 Function convenience functions at reduced level of performance) off line and accepted
Appearance or audible Noise, Product operable, item does not 100% of production run may have to be reworked in
4
conform and noticed by most customers (>75%) Moderate station before it is processed.
Appearance or audible Noise, Product operable, item does not Disruption A portion of production run may have to be reworked
3 Annoyance
conform and noticed by most customers (50%) in station before it is processed.
Appearance or audible Noise, Product operable, item does not
2 Minor Disruption Slight inconvenience to process operation or operator.
conform and noticed by most customers (<25%)
1 No Effect No discernible effect No Effect No discernible effect

57
Example: Occurrence Rating Definitions
Suggested PFMEA Occurrence Evaluation Criteria
Criteria:
Likelihood of
Rank Occurrence of Cause - DFMEA
Failure
(Incidents per Item / Products)
=> 100 per Thousand

10 Very High
=> 1 in 10
50 per Thousand
9
1 in 20
20 per Thousand
8
High 1 in 50
10 per Thousand
7
1 in 100
2 per Thousand
6
1 in 500
0.5 per Thousand
5 Moderate
1 in 2,000
0.1 per Thousand
4
1 in 10,000
0.01 per Thousand
3
1 in 100,000
Low
=< 0.001 per Thousand
2
1 in 1,000,000
1 Very Low Failure is eliminated through preventive control

58
Example: Detection Rating Definitions
Suggested PFMEA Prevention / Detection Evaluation Criteria
Likelihood Inspection Types Criteria:
Rank of Opportunity for Detection
A - Error B- C- Likelihood of Detection by Design Control
Detection Proofed Gauged Manual
Almost
10 No Detection Opportunity X No Current Process Control; Cannot Detect or is not Analyzed
Impossible
9 Very Remote Not Likely to Detect at any Stage X Failure Mode and/or Error (Cause) is not easily detected (eg random audits)
Controls will probably not detect. Failure Mode detection post processing by operator through visual tactile audible
8 Remote X
Problem detection post processing. means
Failure Mode detection in-station by operator through visual tactile audible means or
Controls have poor chance of detection
7 Very Low X X post processing through use of attribute gauging (go/no go, manual torque check /
Problem detection at source.
clicker wrench etc.)
Failure Mode detection post processing by operator through variable gauging or in-
Controls might detect.
6 Low X X station by operator through the use of attribute gauging (go/no go, manual torque
Problem detection post processing.
check / clicker wrench etc.)
Failure Mode or Error (Cause) detection in-station by operator through the use of
Controls might detect. variable gauging or by automated controls in-station that will detect discrepant part
5 Moderate X X
Problem detection at source. and notify operator (light buzzer etc.). Gauging performed on set-up and first piece
check (for set-up causes only)
Moderately Controls may detect. Failure Mode detection post processing by automated controls that will detect
4 X X
High Problem detection post processing. discrepant part and lock part to prevent further processing.
Controls have a good chance to detect. Failure Mode detection in-station by automated controls that will detect discrepant
3 High X
Problem detection at source. part and automatically lock part in station to prevent further processing.
Controls almost certain to detect. Error (Cause) detection in-station by automated controls that will detect error and
2 Very High X
Error detection and or problem prevention. prevent discrepant part from being made.
Error (Cause) prevention as a result of fixture design, machine design or part design.
Almost
1 Detection not applicable, error prevention. X discrepant parts cannot be made because item has been error proofed by
Certain
process/product design.

59
PFMEA - Step 7
C Current Controls
L
S A O D R
Potential Failure Potential Failure E S C E P
Process Step Mode Effects V S Potential Causes C Prevent Detect T N
Operator places wrong
Wrong and/or missing Customer unable to Work Instructions, Visual Inspection;
Assemble Hardware Kit 8 hardware and/or label 3 8 192
parts/labeling (B) install product Pack Positive Scale to weigh kits
with kit
Customer unable to
Assemble Hardware Kit Bad seal (B) install product, due 8 Bagger error 2 Work Instructions Visual Inspection 8 128
to missing hardware.
Calculate the Risk Priority Number

RPN = Severity x Occurrence x Detection
TIPS
• The RPN is used to prioritize the most critical risks
• Higher RPNs are flags to take effort to reduce the calculated risk
• Continually work to improve highest risk items - don’t set an RPN

threshold
• In addition to RPN, examine top Severity and Occurrence risks

60
PFMEA – Remediation Guidelines
• Severity – can only be improved by a design

change to the product or process
• Occurrence – can only be reduced by a change
which removes or controls a cause. Examples
are redundancy, substituting a more reliable
component or function or mistake-proofing.
• Detection – can be improved by deploying better
controls. Examples are mistake-proofing,
simplification and statistically sound monitoring.
In general, reducing the Occurrence
is preferable to improving the Detection
61
FMEA – Step 8
Current Controls
D R S O D R
E P Actions E C E P
Prevent Detect T N Recommended Responsible Actions Taken V C T N
Work Instructions, Visual Inspection; Implement scale to 7/11/11 - Scale implmented to

8 192 Kolumban 8 3 5 120
Pack Positive Scale to weigh kits weigh hardware kits weigh kits. SK.- Complete
2010 Capital Plan - New HM

Autobagger. Follow status on
HM 2010 VSM implementation
Repair/replace worn
Work Instructions Visual Inspection 8 128 Zindler plan. 8 1 8 64
bagger
7/11/11 - New Bagger
implemented 3Q 2010. APZ -
Complete
For the high risk items,

determine the
recommended actions.

62
FMEA – Steps 9 and 10
Current Controls
D R S O D R
E P Actions E C E P
Prevent Detect T N Recommended Responsible Actions Taken V C T N
Work Instructions, Visual Inspection; Implement scale to 7/11/11 - Scale implmented to

8 192 Kolumban 8 3 5 120
Pack Positive Scale to weigh kits weigh hardware kits weigh kits. SK.- Complete
2010 Capital Plan - New HM

Autobagger. Follow status on
HM 2010 VSM implementation
Repair/replace worn
Resp (responsibility)
Work Instructions Visual Inspection 8 128
bagger
Zindler plan. 8 1 8 64
Assign a specific person 7/11/11 - New Bagger
implemented 3Q 2010. APZ -
who will be responsible Complete
for recommended actions.
Actions Taken
As actions are identified
and completed, document SEV, OCC, DET, RPN
in the “Actions Taken” As actions are complete
column. reassess Severity,
Occurrence, and Detection
and recalculate RPN.

63
Summary Steps To Complete a FMEA
1. For each Process Input, determine the ways in which the Process
Step can go wrong (these are Failure Modes)
2. For each Failure Mode associated with the inputs, determine Effects
on the outputs
3. Mark special characteristics (product and process)
4. Identify potential Causes of each Failure Mode
5. List the Current Controls for each Cause
6. Assign Severity, Occurrence and Detection ratings after creating a
ratings key appropriate for your project
7. Calculate RPN
8. Determine Recommended Actions to reduce high risks
9. Take appropriate Actions and Document
10. Recalculate RPNs
11. Revisit steps 7 and 8 to continually reduce risks
64
Example: “Good” PFMEA
PROCESS OR RESPONSIBLE
PRODUCT Product Family XYZ TEAM LEADER: Jane Doe DATE (Orig) 3/1/2002 (REV) 3/1/2011
TEAM
MEMBERS: John Smith, Jane Doe, Sun Tzu, Szent Istvá n, John of Gaunt
C
S l Potential O Current PROCESS Current PROCESS D R S O D R
Process Potential Potential Actions
E a Causes(s) C Controls Controls E P Resp. Actions Taken E C E P
step/Input Failure Mode Failure Effects s Recommended
V s of Failure C - Prevention - - Detection - T N V C T N
Add message to
prompt the
operator that the BPB. October
New prompt and
Operator turns off grease is off. Add 2004 8 3 5 120
sensor
grease, grease not sensor to grease Completed
7 5 Visual inspection 8 280 valve to sense that
pumping, or barrel
Sleeve/bearing empty it is firing.
No grease in
wears out -
bearing sleeve Add new sensors
warranty claim PT. October 2010
to detect pumping New sensors added 8 3 4 96
Completed
of air
Add sensors to Modified equipment
Impropoer grease confirm correct PT. October 2010 and changed
7 2 Visual inspection 8 112 8 2 4 64
volume block used voume block is Completed program to look at
used sensors
Op 35.
Grease not Add new sensors
Test and PT. October 2010
7 pumping or barrel 2 Visual inspection 8 112 to detect pumping New sensors added 8 2 4 64
grease No grease in Premature Completed
empty of air
bearing bearing/sleeve
Add sensors to Modified equipment
(Product Z failure - warranty
Impropoer grease confirm correct PT. October 2010 and changed
only) claim 7 2 Visual inspection 8 112 8 2 4 64
volume block used voume block is Completed program to look at
used sensors
Customer will
Wrong bearing TP- 100% inspection of
not be able to 6 Wrong set-up 2 4 48 0
housing 12 housing in tester
install
Modify program to
PT. December
cosmetic issue prompt operator to Modified program 5 3 7 105
Damage to 2010 Completed
and potential Part mislocated in check orientation
mounting 5 3 100% visual check 8 120
effect on bolt tester fixture Change design of
holes PT. February Installed March
torque fixture and 5 2 7 70
2011 Completed 2011
locators

65
Process FMEA (PFMEA)
 Verify risks are prioritized and high risk items have
identified improvement actions
 Make sure that high risk process concerns are carried
over into the control plan
 Make sure that all critical failure modes are addressed
• Safety
• Form, fit, function
• Material concerns
• See PPAP Workbook for detailed PFMEA
checklist
66
Progress Check: PFMEA and APQP
• In which APQP phase would you first create a PFMEA?
• APQP: Phase 3 – Process Design
• Which of the following activities should be done before the
PFMEA?
After
• Purchase capital equipment
• Create the DFMEA
After
• Purchase End of Line Testers
After
• Make Tools/Molds
• Which FMEA risks need recommended actions?
• All
• Any over 100 RPN
• Higher risks - by RPN, Severity or Occurrence
• How would you utilize PFMEA in an ETO environment?
• By part families or by manufacturing processes
67
PPAP Element #7: Control Plan
• What is It?
• A document that describes how
to control the critical inputs
(FMEA) to continue to meet
customer expectations
• Objective? - Planning
• Needed gaging, testing, error
proofing
• Sampling and frequencies
• How to react when something
fails a test or inspection
• When to Use It Since processes are expected to be continuously
updated and improved, the control plan
• Implementing a new process is a living document!
• Implementing a process change
68
Control Plan
Tool Interaction
6 Sigma Project Project Idea Department/Group Project
High Level Process Map High Level Process Map Key S O D R E S O D R
Potential Potential Actions
Process Step Process Key E Potential
S Causes C Current O Controls E PD OR E Resp. Actions Taken E C SE OP D R
Failure Mode Failure Effects
Potential PotentialV Recommended Actions
Process StepInputProcess C C Current Controls
T NE CP O Actions TakenV C E T CN E P
Fill Out Master
Form
with Initial E Potential Causes Resp.
Information Failure Mode Failure Effects Recommended
Input V C T N C V C T N
Receive Checks Delay internal AR balance does Inadequate None Investigate mail room G. Lee Added another mail
Other Required Other Required
Signatures: Signatures:
6 Sigma Assigns Segment CEO Champion: Group Assigns Get DLN
Get WO Assigned
Project Number Champion
Process Owner
No
Prefer to work
this project
Process Owner
Project Owner
Project Number Assigned
Payment
Receive Checksmail Delay internal
not go AR
downbalance doesstaffin gInadequate
in mail None staffingInvestigate
and associated
mail room G. Leeclerk. Adjusted dock mail
Added another
7 7 10 490 processes 7 1 10 70
BB or GB Dept GB/BB/MBB
not go down room staffin g in mail schedule.

within your
Process Steps
Monitor Progress
area?
Payment mail staffing and associated clerk. Adjusted dock
Begin/Work
Project
through Power
Steering and Finance Approval
Yes Monitor Progress
through Bi-
Weekly Updates
Begin/Work
Project 7 room 7 10 490 processes schedule. 7 1 10 70
Monthly and Signature Finance Approval
Follow DMAIC or and Monthly Follow DMAIC or
Financial and Signature
Identify Wire Information not AR balance is Customer or bank Acct id entifies problem Poka-Yoke wire transer N. Peart Contacted banks and
DFSS process Do you Reviews DFSS process
Reviews
No have BB/GB to
Assist/Work the
Master Form Will

project?
Customer
Identify TransferWire supplieInformation
d past
notdueAR balance is did notCustomer
include or bankwhen tryin g itod entifies
Acct apply problem processPoka-Yoke wire transer N. Peart
established wire banks and
Contacted
Customer reference past due 10 name and/or did not include5 paymentwhen tryin g to apply5 250 transferestablished
procedure wire
(DI
Complete Project Generate Yes Complete Project
Transfer supplie d process

(Has to be fully Contract Master Form Will (Has to be fully
2112) transfer procedure10(DI 1 3 30

Documented Generate Documented)
Yes Is Hard
Contract
line reference accountname
info on
and/or payment
Savings > $???
line wire10transfer
account info on 5 5 250 2112) 10 1 3 30
Enter Remaining
Final Project 6 Sigma Final Project
wire transfer
Information on No
Review Project Review
Master Form
Does the
Yes
Department Enter Remaining
Identify Invoice Checks Incorrect Invoice shows Customer error Customer might catch Provide payment stub A. Lifeson Revised statement to
Project Involve
or Group Information on
Identify Invoice ChecksinvoiceIncorrect outstandin gc(AR Customer error it whenCustomer

reviewingmight the catch with statement for each stub A. Lifeson
in clu deRevised
paymentstatement
stub to
Only Your
Group? Project Master Form
Invoi e shows Provide payment
Finance Approval Finance Approval
supplieinvoice
d balanceoutstandi 5
does gon g (AR 5 next statement 10 250 invoice with each 5 1 5 25
in cluinvoice.
and Signature and Signature
No
it when reviewing the with statement for each de payment stub
Other Required
Signatures:
Champion: Dir T&E
Process Owner
Does the
Project Involve
>2 Groups in
Eng?
No
Other Required
Signatures:
Champion: Dir T&E
Process Owner
New/Revised Process supplie d down) balance does go 5
Identify Invoice Checks Invoice number Invoicedown) shows Customer error
5 next statement
Acct id entifies problem
10 250 invoice with each invoice.
Provide payment stub S. Hagar Revised statement to
5 1 5 25
Identify Invoice Checksnot supplied outstandin gc(AR Customer error10 when tryi n g itod entifies
apply problem with statement for each stub S. Hagar
in clu deRevised
paymentstatement
stub to
Steps
Project Owner Project Owner
Dept BB or MBB Yes Dept BB or MBB
Invoice number Invoi e shows5 Acct Provide payment
Complete all Complete all
balanceoutstandi
not supplied does gon g (AR paymentwhen tryin g to apply5 250 invoicewith statement for each with eachin cluinvoice.
5 1 5 25
de payment stub
Does the
Documentation
including a
(1) Page Close-
Close
Project
Yes Project Involve
>3 Depts.
No Close
Project
Documentation
including a
(1) Page Close-
down) balance does go 5 10 payment 5 250 invoice with each invoice. 5 1 5 25
outside Eng?
out Sheet out Sheet
down)
Process FMEA
Process Flowchart
d
ize s
it p
Pr io r St e
o ce Pr ss
ss sk ce
N St Ri ro
Pr ew ep P ed
o c /R s v
o ols
es e r
p tr
s v
St ise I on
m
ep d C
s
Control Plan
69
The Control Plan Form
CONTROL PLAN
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
NUMBER ECL
Part Name/Description Organization/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
NAME
Organization/Plant Organization Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
ORGANIZATION CODE
MACHINE, CHARACTERISTICS METHODS
PART/ PROCESS NAME/ SPECIAL
DEVICE REACTION
PROCESS OPERATION CHAR. PRODUCT/PROCESS EVALUATION/ SAMPLE
JIG, TOOLS CONTROL PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
TOLERANCE TECHNIQUE

70
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
TOLERANCE TECHNIQUE
Administrative Section
Identifies part number and description,
supplier, required approval signatures,
and dates.

71
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
3 Distinct Phases
1. Prototype – a description of the dimensional measurements and material
and performance tests that will occur during Prototype build.
2. Pre-Launch – a description of the dimensional measurements and material
and performance tests that will occur after Prototype and before full
Production.
3. Production – a comprehensive documentation of product/process
characteristics, process controls, tests, and measurement systems that will
occur during mass production

72
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
TOLERANCE TECHNIQUE
Each stage of production and testing. Can be:

• Each operation indicated by the process flow
• Each workstation
• Each machine
Include testing and audits
“Process Number” should cross reference with PFMEA
and Process Map
73
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
Product characteristics that are important. These can be

determined by referencing:
• ST Dimensions on the drawing
• Customer critical characteristics
• Process critical characteristics
There may be several for each operation
Can be dimensional, performance or visual criteria
74
Process parameters that are important. A process

parameter is a setting made within a process that effects
the variation within the operation. Examples include:
• Temperature (molding, heat treat, etc.)
• Pressure
• Fixture settings
• Speed
• Torque
75
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
Class refers to special characteristics –

product or process. Should align with
FMEA

76
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
This is a specification from the Design Record or a key

process parameter

77
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
How is the characteristic or parameter going to

measured? Examples include:
• Caliper
• Attribute gage
• Visual
• Fixture
• Test equipment

78
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
How many parts will be measured and how often.

Examples:
Final testing, visual criteria
• 100%
SPC, Audit,
• The sample size and frequency

79
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
How the characteristic or parameter will be controlled

(this is the record) Examples include:
• Xbar/R Chart • Mistake proofing
• NP Chart • 1st piece inspection
• Pre-control Chart • Lab report
• Checklist
• Log sheet

80
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
ORGANIZATION CODE
DEVICE REACTION
CONTROL
JIG, TOOLS PLAN
TOLERANCE TECHNIQUE
What happens when the characteristic or parameter is

found to be out of control. Must include:
• Segregation of nonconforming product
• Correction method
May include (as appropriate):
• Sorting
• Rework/Repair
• Customer notification

81
Control Plan – Example
A supplier manufactures a circuit board with electronic components soldered on the
board. Properly soldered connections are the major product characteristics. Two major
process characteristics for the wave solder machine are solder level and flux
concentration. An automated feeder controls the solder level by sensing the level of
solder and feeding in additional solder as the level is reduced. This characteristic is
measured 100% by checking electrically for continuity. The flux must be sampled and
tested for the concentration level.
CONTROL PLAN
Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)
002 T. Smith / 313-555-5555 11/29/2009 2/20/2010
54321231 / D Erin Hope, Alan Burt, Ken Light
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.)
Electronic Circuit Board
Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
ACR Control 439412
Characteristics Methods
Machine,
Part / Process Name Special Sample
Device, Product/Process Evaluation / Reaction
Process / Operation Char. Control
Jig, Tools, No. Product Process Specification/ Measurement Plan
Number Description Class Size Freq. Method
for MFG. Tolerance Technique
Automated
Wave Wave Sensor inspection
Soldering solder solder continuity (error Adjust and
2 Connections machine height 2.0 +/- .25 mc check 100% Continuous proofing) retest
Flux Test sampling
concen - lab Segregate
tration Standard #302B environment 1 pc 4 hours x-MR chart and retest

82
Control Plan: Reviewer’s Checklist
 Remember the Control Plan is a planning tool –

• Use it to decide what you should be doing
• The AIAG format will help make sure the plan makes sense and is complete
 Use process flow diagram and PFMEA to build the control plan; keep
them aligned
 Controls should be effective. Keep it simple.
 Ensure that the control plan is in your document control system
 Good control plans address:
• All testing requirements - dimensional, material, and performance
• All product and process characteristics at every step throughout the process
 The control method should be based on an effective analysis of the
process
 Control plans should reference other documentation
• Specifications, tooling, etc.

83
Control Plan and APQP
• In what APQP Phase would you first create a

control plan?
 Prototype CP in Phase 2: Product Design
 Pre-production CP in Phase 3: Process Design
 Production CP in Phase 4: Validation
• How does the reaction plan help with process
design?
 Identify rework needs, quarantine product location
needs, etc.

84
PPAP Element #8:
Measurement System Analysis (MSA)
What is It?
An MSA is a statistical tool used to
determine if a measurement system
is capable of precise measurement.
Objective or Purpose
• To determine how much error is in
the measurement due to the
When to Use It measurement process itself.
• On systems measuring critical inputs • Quantifies the variability added by
and outputs prior to collecting data the measurement system.
for analysis. • Applicable to attribute data and
• For any new or modified process in variable data.
order to ensure the quality of the
IMPORTANT!
data.
Who Should be Involved Measurement System Analysis is
an analysis of the measurement
Everyone that measures and makes
process, not an analysis of the
decisions about these measurements
should be involved in the MSA. people!!

85
Inspection – what do you really see?

86
Observed Variation
Resolutio
n
Precision
(Variability Repeatability
) Reproducibilit
y
Measurement
System
Variation
Linearit
y
Observed Accuracy Bia
Observed (Central
Variation
Variation s
Location)
Stabilit
y
Process
Variation Calibration helps address accuracy

87
Resolution
Error in Resolution
The inability to detect small
changes.
Possible Cause
Wrong measurement device
selected - divisions on scale
not fine enough to detect
changes.

88
Repeatability
Error in Repeatability
The inability to get the same
answer from repeated
measurements made of the
same item under absolutely
identical conditions.
Possible Cause
Lack of standard operating
procedures (SOP), lack of
training, measuring system
variablilty.
Equipment Variation

89
Reproducibility
Error in Reproducibility
The inability to get the same
answer from repeated
measurements made under
various conditions from
different inspectors.
Possible Cause
Lack of SOP, lack of training.
Appraiser Variation

90
Variable MSA – Gage R&R Study
• Gage R&R is the combined estimate of

measurement system Repeatability and
Reproducibility
• Typically, a 3-person study is performed
 Each person randomly measures 10 marked parts per trial
 Each person can perform up to 3 trials
• There are 3 key indicators

 % P/T or measurement variation compared to tolerance
 % R&R or measurement variation compared to process
variation
 Number of distinct categories (ndc) or measure of resolution

91
Variable MSA – AIAG GR&R VAR(Tol)
GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET
VARIABLE DATA RESULTS VARIABLE DATA RESULTS
Part Number Gage Name Appraiser A Part Number Gage Name Appraiser A
NUMBER NUMBER
Part Name Gage Number Appraiser B Part Name Gage Number Appraiser B
NAME NAME
Characteristic Specification Gage Type Appraiser C Characteristic Gage Type Appraiser C
Lower Upper
Characteristic Classification Trials Parts Appraisers Date Performed Characteristic Classification Trials Parts Appraisers Date Performed
APPRAISER/ PART AVERAGE Measurement Unit Analysis % Tolerance (Tol)
Included in PPAP Workbook

TRIAL # 1 2 3 4 5 6 7 8 9 10 Repeatability - Equipment Variation (EV)
1. A 1 EV = R x K1 Trials K1 % EV = 100 (EV/Tol)
2. 2 = 2 0.8862 =
3. 3 = 3 0.5908 =
4. AVE xa= Reproducibility - Appraiser Variation (AV)
5. R ra= AV = {(xDIFF x K 2)2 - (EV 2/nr)}1/2 % AV = 100 (AV/Tol)
6. B 1 = =
7. 2 = =
Automatically calculates x
8. 3 A p p ra i s e rs 2 3
9. AVE b= n = parts r = trials K2 0.7071 0.5231
%GRR, %PV, ndc

10. R r b= Repeatability & Reproducibility (GRR) % GRR = 100 (GRR/Tol)
11. C 1 GRR = {(EV 2 + AV 2)}1/2 Parts K3 =

12. 2 = 2 0.7071 =
13. 3 = 3 0.5231
14. AVE xc = Part Variation (PV) 4 0.4467
15. R rc = PV = RP x K 3 5 0.4030 % PV = 100 (PV/Tol)
16. PART X= = 6 0.3742 =

AVERAGE Rp= = 7 0.3534 =
17. (ra + rb + rc ) / (# OF APPRAISERS) = R= Tolerance (Tol) 8 0.3375
18. x DIFF = (Max x - Min x) = xDIFF = Tol = Upper - Lower / 6 9 0.3249 ndc = 1.41(PV/GRR)
19. * UCLR = R x D4 = UCLR = = ( Upper - Lower ) / 6 10 0.3146 =
= =
* D4 =3.27 for 2 trials and 2.58 for 3 trials. UCLR represents the limit of individual R's. Circle those that are
beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or
discard values and re-average and recompute R and the limiting value from the remaining observations. For information on the theory and constants used in the form see MSA Reference Manual , Fourth edition.
Notes:

92
Variable MSA – Gage R&R Steps
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9
1. Select 10 items that represent the full range of long-term process variation
2. Identify the appraisers – they should be operator who normally use the gage
3. If appropriate, calibrate the gage or verify that the last calibration date is valid
4. Open the GR&R VAR(Tol) worksheet in the AIAG Core Tools file to record data, or use
MiniTab
5. Have each appraiser assess each part 3 times preferably in random order (Minitab can
generate a random run order)
6. Input data into the GR&R VAR(Tol) worksheet or MiniTab
7. Enter the number of operators, trials, samples and specification limits
8. Analyze data and review GR&R and PV values
9. Take actions for improvement if necessary.

93
Measurements Systems Analysis MSA
Tips and Lessons Learned
 Important: An MSA is an analysis of the process, not an analysis of the

people. If an MSA fails, the process failed.
 A Variable MSA provides more analysis capability than an Attribute MSA.
For this and other reasons, always use variable data if possible.
 The involvement of people is the key to success.
 Involve the people that actually work the process
 Involve the supervision
 Involve the suppliers and customers of the process
 An MSA primarily addresses precision with limited accuracy information.

94
MSA: Reviewer’s Checklist
 If the gage/inspection measures a special characteristic

or other important feature, then conduct a Gage R&R
 Make sure the study is recent - less than 1 year
 Compare the control plan gages against the Gage R&Rs
 % R&R and %P/T should be less than 10%
 Values greater than 10% should be reviewed with Eaton
 Number of distinct categories should be >5
 If you question that gage, then
• Question the technique and part sampling
• Ask for additional studies

95
MSA Summary
• Measurement systems must be analyzed BEFORE

embarking on process improvement activities
• MSA helps understand how much observed variation is
from the measurement system
• MSA will tell you about the repeatability, reproducibility and
discrimination
• Sample selection is very important – sample during normal
production to capture total range of process variation
• MSA assessors should be operators that would normally
use the measurement system
• MSA should be done on a regular basis

96
PPAP Element #9: Dimensional Results
Production Part Approval / Dimensional Test Results Corporate SCM Form-XX (Rev. A, 2014)
Supplier 0 Part Number 0
Supplier / Vender Code Part Name
Inspection Facility Design Record Change Level 0
Engineering Change Document
Dimension / Specification / Test Qty. Supplier Measurement Not

Item Measurement Method OK
Specification Limits Date Tested Results (DATA) OK
What is It?
• To show conformance to the
Evidence that dimensional customer part print on dimensions
verifications have been completed and all other noted requirements
and results indicate compliance with
specified requirements When to Use It
• For each unique manufacturing
process (e.g., cells or production
lines and all molds, patterns, or
dies
97
Dimensional Results
• Reviewer’s Checklist
 All design record specifications (notes, referenced specifications, etc.)
shall be included in the Dimensional Results
• Material and performance specifications results can be reported on the
separate Material, Performance Test Results
 Results shall include samples from each tool cavity, manufacturing
line, etc.
 Data points should come from PPAP samples included with PPAP
submission
• The agreed upon # of parts from the production run must be shipped to the
customer for verification of form, fit, and function
• Supplier must clearly identify PPAP samples used for dimensional results
 Results that do not meet the design specification shall be addressed
prior to PPAP submission
• “Not OK” results typically require changes to the manufacturing process prior to
PPAP submission. In some cases the customer may agree to engineering
changes.
98
PPAP Element #10: Records of
Material/Performance Test Results
• Material Test Results

• The supplier shall perform tests for all parts and product
materials when chemical, physical, or metallurgical
requirements are specified by the design record or Control
Plan
• For products with Eaton-developed material specifications
and/or an Eaton-approved supplier list, the supplier shall
procure materials and/or services from suppliers on that list
• Performance Test Results
• The supplier shall perform tests for all parts or product
materials when performance or functional requirements
are specified by the design record or Control Plan
99
Material Results
Production Part Approval
Material Test Results
ORGANIZATION: PART NUMBER:
SUPPLIER / VENDOR CODE: PART NAME:
MATERIAL SUPPLIER: DESIGN RECORD CHANGE LEVEL:
*CUSTOMER SPECIFIED SUPPLIER / VENDOR CODE: ENGINEERING CHANGE DOCUMENTS:
*If s o urce ap p ro val is req 'd , includ e t he Sup p lier (So urce) & Cus t o mer as s ig ned co d e. NAME of LABORATORY:
SPECIFICATION / TEST QTY. NOT
MATERIAL SPEC. NO. / REV / DATE SUPPLIER TEST RESULTS (DATA) OK
LIMITS DATE TESTED OK
Material Results shall include:

 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

100
Performance Test Results
Performance Test Results shall include:

 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

101
PPAP Element #11: Initial Process Studies
• Capability studies are measures

of how well the process is
meeting the design
requirements.
• Is the process employed Stable
and Capable?
• MSA before Cpk
• MSA must be acceptable and
should represent tools/process
used for Initial Process Studies
• >1.67 Cpk for SCs, >1.33 for
other characteristics
• Cpk & Ppk minimums are higher
for initial release vs. ongoing

102
PPAP Element #11: Initial Process Study
Purposes of Initial Process Study
• To evaluate how well a process can produce product that
meets specifications
• To provide guidance about how to improve capability
• better process centering
• reduced variation
• Capability studies can be used to identify a problem or to

verify permanent corrective actions in the problem
solving process.

103
Process Capability:
The Two Voices

104
Examples of Non-Capable Processes
Product produced
Product produced Product produced
beyond both
above the below the
Upper and Lower
Upper Spec Limit. Lower Spec Limit.
Spec Limits.

105
Capability Studies
Process Data for Co2
15 A short-term capability study
14 UCL=14.18
covers a relative short period of
Individual Value
time during which extraneous

13
X=12.64
12
11 LCL=11.10 sources of variation have been

10
excluded. (Guideline: 30-50
9
0 50 100 150 data points.)
Observation Number
Process Data for Co2

15 A long-term capability study
14 UCL=14.18
covers a longer period of time in
Individual Value
13
12
X=12.64
which there is more chance for a
11 LCL=11.10
process shift. (Guideline: 100-200
10
9 data points.)
0 50 100 150
Observation Number

106
Steps for Determining Process Capability
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7
1. Decide on the product or process characteristic to

be assessed
2. Verify the specification limits
3. Validate the measurement system
4. Collect data per sample size/frequency in Control
Plan Let’s take a closer look
5. Assess data characteristics at data characteristics
and process capability
6. Assess process stability
7. Calculate process capability
107
Step 5: Data Characteristics
Step 5 Assess data characteristics
Histogram of Mfg Hours
Mean 14.87
20
Examine the shape of your data.

StDev 3.088
N 100
15
• Is it what you would expect?
Frequency
10
If not, investigate.
5
0
8 10 12 14 16 18 20 22
Mfg Hours
Bimodal Data
The shape of your data is Histogram of Mfg Hours

Mean 19.98 20
Histogram of Mfg Hours
Mean 20.19
important for determining 25 StDev 1.713 StDev 18.87

N 100 N 100
which type of Capability 20 15
Analysis applies. If the

Frequency
Frequency
15
10
data exhibits a non-normal 10
shape, consult your 5
statistics reference. 0
16 18 20
Mfg Hours
22 24
0
-15 0 15 30
Mfg Hours
45 60 75
Normal Data Skewed Data

108
Step 6: Process Stability
Assess process stability in order to understand
Step 6 how your process behaves over time. Control
charts are the recommended tool.
Control Chart Examples
Process is stable and in Process is not stable and

control therefore not in control
Capability is only valid
when the process being
studied is stable!

109
Difference between Cp & Cpk
 Cp – determines capability of producing to specification
 Cpk – same as Cp, but also measures how centered the process is
 It is important to look at both!
Cp > 1.67 Cp > 1.67

Cpk > 1.67 Cpk < 1.00
Capable, Capable,
Centered Not Centered
LSL USL LSL USL
Cp < 1.00 Cp < 1.00

Cpk < 1.00 Cpk < 0
Not Capable, Not Capable,

Centered Not Centered
LSL USL LSL USL

110
Acceptance Criteria
Acceptance criteria for critical vs. non-critical characteristics
Short-term Long-term Decision

Red (Bad) <1.33 <1.00
Yellow (Marginal)
1.33-1.67 1.00-1.33
Green (Good)
>1.67 >1.33
Cpk must be greater than or equal to

1.67 for critical processes
Cpk must be greater than or equal to

1.33 for non-critical processes

111
Initial Process Study: Reviewer’s Checklist
 Check to see if the data demonstrates a stable

process and exhibits a normal distribution
• Note: source data/ charts to understand stability may not
always be provided. If you have concerns, ask for the data.
 PPAPs should only be approved if the capability is
greater than 1.67 for critical dimensions and greater
than 1.33 for non-critical dimensions
 Capability template is in the PPAP Workbook

112
PPAP Element #12:
Qualified Laboratory Documentation
• Inspection and testing for PPAP shall be performed by a

qualified laboratory (e.g., an accredited laboratory).
• The qualified laboratory (internal or external to the
supplier) shall have a laboratory scope and documentation
showing that the laboratory is qualified for the type of
measurements or tests conducted
• When an external laboratory is used, the supplier shall submit
the test results on the laboratory letterhead or the normal
laboratory report format
• The name of the laboratory that performed the tests, the date(s)
of the tests, and the standards used to run the tests shall be
identified.
• Eaton to validate results to specifications.
113
PPAP Element #13:
Appearance Approval Report
APPEARANCE APPROVAL REPORT
PART DRAWING APPLICATION What is It?
• A report completed by the supplier
NUMBER NUMBER (VEHICLES)
PART BUYER E/C LEVEL DATE
NAME CODE
ORGANIZATION MANUFACTURING SUPPLIER / VENDOR containing appearance and color
NAME LOCATION CODE
REASON FOR PART SUBMISSION WARRANT SPECIAL SAMPLE RE-SUBMISSION OTHER criteria
SUBMISSION PRE TEXTURE FIRST PRODUCTION SHIPMENT ENGINEERING CHANGE
APPEARANCE EVALUATION
AUTHORIZED CUSTOMER
ORGANIZATION SOURCING AND TEXTURE INFORMATION PRE-TEXTURE REPRESENTATIVE
EVALUATION
CORRECT AND
SIGNATURE AND DATE
PROCEED
CORRECT AND • To demonstrate that the part has
PROCEED
APPROVED TO
ETCH/TOOL/EDM
met the appearance requirements
COLOR EVALUATION on the design record
METALLIC COLOR
COLOR TRISTIMULUS DATA MASTER MASTER MATERIAL MATERIAL HUE VALUE CHROMA GLOSS BRILLIANCE SHIPPING PART
SUFFIX DL* Da* Db* DE* CMC NUMBER DATE TYPE SOURCE RED YEL GRN BLU LIGHT DARK GRAY CLEAN HIGH LOW HIGH LOW SUFFIX DISPOSITION
When to Use It
• Prior to tooling for production
IMPORTANT!
Only applies for parts with color, grain,
or surface appearance requirements

114
PART DRAWING APPLICATION
NUMBER NUMBER (VEHICLES)
NAME CODE
ORGANIZATION MANUFACTURING SUPPLIER / VENDOR
NAME LOCATION CODE
REASON FOR PART SUBMISSION WARRANT SPECIAL SAMPLE RE-SUBMISSION OTHER
AUTHORIZED CUSTOMER
EVALUATION SIGNATURE AND DATE
CORRECT AND
PROCEED
CORRECT AND
PROCEED
APPROVED TO
ETCH/TOOL/EDM
COLOR EVALUATION
METALLIC COLOR
SUFFIX DL* Da* Db* DE* CMC NUMBER DATE TYPE
Administrative Section
SOURCE RED YEL GRN BLU LIGHT DARK GRAY CLEAN HIGH LOW HIGH LOW SUFFIX DISPOSITION
Identifies part number and description,

supplier, required approval signatures,
and dates.

115
PART DRAWING APPLICATION
NUMBER NUMBER NUMBER (VEHICLES) APPLICATION
NAME NAME CODE ECL
ORGANIZATION MANUFACTURING ADDRESS SUPPLIER / VENDOR
NAME ORGANIZATION LOCATION CITY STATE ZIP CODE CODE
REASON FOR PART SUBMISSION WARRANT SPECIAL SAMPLE RE-SUBMISSION OTHER
AUTHORIZED CUSTOMER
EVALUATION SIGNATURE AND DATE
CORRECT AND
PROCEED
CORRECT AND
PROCEED
APPROVED TO
ETCH/TOOL/EDM
COLOR EVALUATION
COLOR
COLOR TRISTIMULUS DATA MASTER MASTER HUE VALUE CHROMA GLOSS SHIPPING PART
Appearance Evaluation Details

Identifies supplier sourcing, texture
information and submission customer
signature.
COMMENTS 116
COLOR EVALUATION
METALLIC COLOR
COMMENTS
ORGANIZATION PHONE NO. DATE AUTHORIZED CUSTOMER DATE

SIGNATURE REPRESENTATIVE SIGNATURE
Color Evaluation Details

• Identifies supplier part color
dimensions, use of color
spectrometer or RAL charts to
determine finish information
• Requires supplier and customer to
sign
117
PPAP Element #14:
Sample Production Parts
What is It?
Actual samples that reflect the parts
documented in the PPAP.
• Confirm cosmetic or functional
part approval.
When to Use It
• Sample parts should be delivered
WITH the PPAP submission

118
• The sample parts provided should be the

same parts measured for the dimensional
results
• PPAP sample quantity is based on needs from
Eaton Engineering, Manufacturing and Quality

119
Sample production parts MUST be properly identified

Include the following information on the part label:
• Date parts were packed
• Eaton part number
• Quantity
• Serial number
• Supplier part number (optional)
• Part description
• Country of origin
• Indication of regulatory compliance where applicable (RoHS,
REACH, Conflict Minerals, etc.)
• Approval markings (UL, CE, etc.) where applicable
120
PPAP Element #15: Master Samples
PPAP Element #16: Checking Aids
• Master Sample (PPAP Element #15)

• The “perfect” or “golden” sample that subsequent parts can be compared
against
• Often the first good part off a new tool for injection molding or stamping
• Is sometimes used to verify testing equipment and measurement
systems
• Master samples are not normal for every product or manufacturing
process
• Checking aid (PPAP Element #16)
• Tools, gages, or test equipment, used to inspect production parts
• Examples include:
• Visual standards for color or appearance
• Shadow boards or templates used to verify general shape or presence of required
features
• Custom gages

121
PPAP Element #17: Eaton Requirements
• APQP Kickoff - team

• These items all have templates
APQP Timeline Template
in the PPAP Workbook – many
• Action Item Log of which are self-explanatory
• Production Feasibility Agreement (PFA)
• Gage Plan
• Dimensional Correlation Matrix Items in blue have
• Pass Through Characteristics (PTC) additional instructions
• Safe Launch Control Plan embedded in the PPAP
• Workbook
AS 9102 Forms (Aerospace Industry)
• Ramp Up & Down Plan
• Packaging Specification Data Sheet
• Submit Bar Code Label Packaging Approval Let’s take a closer look
• PPAP Interim Recovery Worksheet at the items in red…
• Capacity R@R Worksheet
• Production Readiness Review (PRR)
122
Production Feasibility Agreement (PFA)
Production Feasibility Agreement (PFA) Corporate SCM Form-XX (Rev. A, 2014)
Supplier Name: 0 Part Number: 0 Eaton Plant: Initial PFA:
Supplier Address: Part Name / Description Part Risk Level: Interim PFA:
• The PFA is designed

Eaton Purchasing Rep.: Part Family (if Applicable): Date Submitted: Final PFA:
Signature and Date: Revision Level: 0 Any Issue: PFA Version:
Note: Eaton recommends that this agreement be completed by the quoting supplier's production, quality or engineering staff. Add rows as required. Page: 1 of xx
Supplier Input Data Eaton Input Data
Special Confirm supplier (you) Measure and input at

Print Requirements Evaluation
Characteristics are capable of the completion of Eaton Engineering or Quality Representative Only!
(Including all Dimensions, Measurement
# / Critical To manufacture and meet PPAP run Supplier Comments
Notes and Specifications or Technique
Quality (CTQ) the require specification
as instructed by Eaton) (Gage used)
(Yes or No) (Yes / No) Eaton Agrees Specification
SPC PpK / CpK Comment
(Yes / No) Change Required
to ensure the
- Require to fill in all the Print requirements following by the Ballooned prints with numbering.
- For complicated or family parts, only listing the exceptional dimensions or requirements is acceptable. But Ballooned prints are necessary to be attached to show all the
Print requirements have been reviewed.
1
2
3
4
5
6
7
supplier clearly
8
9
10
11
12
13
14
15
16
17
understands and can

18
19
20
21
22
23
24
OTHER REQUIREMENTS: Please include any exceptions to print notes, referenced specifications, Gerber files, schematics, reference drawings , assembly drawings, plating, Eaton Agrees Specification
Comment
finishing, special processes and/or packaging requirements as may be specified on drawing, purchase order or in the supplier quality manual. Add rows as required. (Yes / No) Change Required
meet all Eaton

1
2
3
4
5
Eaton Agrees Specification
IMPORT SPECIFIC REQUIREMENTS: Add rows as required. Please refer to the Supplier Excellence Manual for further clarifications of governing requirements. Comment
Material COA Requirement Please identify material standard and where The test will Be
1 (Raw Material Composition done (3rd party lab / supplier plant lab / material supplier)
Test)
design requirements
Material Performance Test Please identify which test can be done and where (3rd party
2
lab / supplier plant lab / material supplier)
Product safety requirement For material part or Casting process part, please identify
whether the product's radiation conforms with all specific
3 national standards. List who completed the radiation testing
(supplier plant lab or 3rd party). For other material or
process part, fill "NA" in the item
4
5
• It also provides a
Team Feasibility Commitment Questions
Lessons Learned
# Consideration Yes / No Comments
Caliper 1 Is product adequately defined (application requirements, etc. to enable feasibility evaluation?
CMM 2 Can Engineering Performance Specifications be met as written?
3
Color Chip Can product be manufactured to tolerances specified on drawing?
4
Drop Gage Can product be manufactured with Cpk's that meet requirements?
5
Gage Blocks Is there adequate capacity to produce product?
6
Height Gage Does the design allow the use of efficient material handling techniques?
7
Micrometer Is statistical process control required on the product?
Is statistical process control presently used on similar products?
Optical 8Comparator
formal way to solicit

Overlay9 Where statistical process control is used on similar products:
9a
Pin Gage Are the processes in control and stable?
9b
Profilometer Are Cpk's greater than 1.33?
Supplier comments for Cost improvement (Ideals for recommendation, Ex. VA/VE, substitute material, tooling, process, etc.)
and track supplier

Spectrophotometer
By signing this document you (supplier) confirm that at the time of mass production you can achieve all print requirements unless otherwise noted "No" in column F above
Texture Plaques
Thread Gage Supplier Representative Signature and Date Eaton SDE/SQE Name & Signature Date Eaton Engineering Name & Signature Date
Visual x Sign Here X Sign Here X Sign Here
Type/Print name here Type/print name here Type/print name here
Type/Print Title Here
Suppliers: Type name on each page Eaton Purchasing Name & Signature Date
x Sign Here
Type/print name here
Comments from Eaton Design Engineering or Purchasing
design input
123
PFA (cont.)
rporate SCM Form-XX (Rev. A, 2014)
• Supplier first reviews each

specification on the print,
including notes, materials and
referenced specification
• Supplier attaches ballooned
drawing to the form
INSERT BALLONED DRAWING AS ILLUSTRATED

124
PFA (cont.)
Supplier Input Data
Evaluation
Special Confirm supplier (you) Measure and input at
Print Requirements Measurem
Characteristics are capable of the completion of
(Including all Dimensions, ent
# / Critical To manufacture and meet PPAP run Supplier Comments
Notes and Specifications or Technique
Quality (CTQ) the require specification
as instructed by Eaton) (Gage
(Yes or No) (Yes / No)
used) SPC PpK / CpK
- Require to fill in all the Print requirements following by the Ballooned prints with numbering.
- For complicated or family parts, only listing the exceptional dimensions or requirements is acceptable. But Ballooned prints are necessary to be attached to show
all the Print requirements have been reviewed.
1
2
3
4
5
6
7
8
9
10
11
12
• The supplier enters design specifications and

indicates capability to manufacture
• For complex parts with many dimensions and
features, the supplier may elect to focus on
special characteristics and problem
features/tolerances
125
PFA (cont.)
Eaton Input Data
Eaton Engineering or Quality Representative Only!
Eaton Agrees Specification

Comment
When requested, Eaton indicates a

design change to accommodate the
supplier, or indicates the design
must remain un-changed

126
PFA (cont.)
Team Feasibility Commitment Questions
# Consideration Yes / No Comments
1 Is product adequately defined (application requirements, etc. to enable feasibility evaluation?
2 Can Engineering Performance Specifications be met as written?
3 Can product be manufactured to tolerances specified on drawing?
4 Can product be manufactured with Cpk's that meet requirements?
5
6
Is there adequate capacity to produce product?
Does the design allow the use of efficient material handling techniques?
• Supplier answers general
7
8
Is statistical process control required on the product?
Is statistical process control presently used on similar products?
feasibility questions and signs
9
9a
Where statistical process control is used on similar products:
Are the processes in control and stable? • Supplier may also make cost
9b Are Cpk's greater than 1.33?
improvement recommendations
Supplier comments for Cost improvement (Ideals for recommendation, Ex. VA/VE, substitute material, tooling, process, etc.)
By signing this document you (supplier) confirm that at the time of mass production you can achieve all print requirements unless otherwise noted "No" in column F
Texture Plaques
Supplier Representative Signature and Date Eaton SDE/SQE Name & Signature Date
x Sign Here X Sign Here
Type/Print name here Type/print name here
Type/Print Title Here
Suppliers: Type name on each page Eaton Purchasing Name & Signature Date
x Sign Here
Type/print name here

127
Gage Plan
Gage Plan
Supplier Part Revision
Manufacturing Location Document Revision
Part Name Eaton Plant
Part Number or Specification
Supplier Eaton Quality Team
Characteristic Supplier’s Is measurement
Print Balloon Eaton User Plant Issues / Comments / Next Steps
(Dimension and Char. Type measurement method
No. Control Method
tolerance) method acceptable?
example 999.999 +/- 0.9999 Critical CMM CMM Yes Briefly describe planned actions.
• Identify all gages to be utilized for product

validation
• Include any clarification or additional set up
required for accurate validation

128
Gage Correlation Matrix
Dimensional Correlation Matrix
Supplier 0 Drawing Number: Supplier Representative:
Manufacturing Location Part Revision and Date 0 Phone number:
Part Name Document Revision Correlation Date:
Part Number or Specification 0 Eaton Plant
% of tolerance
Eaton Bonus Supplier
Print feature Sample Eaton Measuring (if value is > or = to 25% or -25%,
part/Assembly Upper Tolerance (+) Lower Tolerance (-) Total Tolerance Nominal target Tolerance Eaton reading Measuring Supplier reading Delta
name Number equipment type correlation improvement
number Y/N equipment type
is recommended)
Example Ball diameter 1 0.0025 0.0025 0.005 5.556 N Beta laser mic 5.5592 Non contact laser 5.5586 0.00063 13%
• This template is for Suppliers to populate

and compare their actual dimensions to
Eaton measured values
• Only required for specific features as
identified by Eaton

129
Production Readiness Review (PRR)
Supplier Production Readiness Review
Supplier 0 Review Date
Mfg. Location Commodity
Status Intended for Use Recovery Plan/Comments Responsible Person's
Element Readiness Criteria Due Date Comments
G/Y/R Prior to … (if status is Red or Yellow) Name
Was an APQP project established and have required PPAP activities been completed
PPAP /
1 in the APQP process? For those activates that remain open, are they planned to be
Production Run
g completed in line with the APQP timeline?
Supplier Eaton
Complete Reviewed
Did the supplier complete and did the plant / approving authority review the PPAP
2 Production Run
g package in details and there are no outstanding issues pending?
2.1 g Production Run a. Process Capability
Production Readiness Review (PRR) evaluates and verifies the readiness of a

supplier to move from development to initial production
Utilized as an assessment of risk identification/mitigation plan, not as a pass/fail

audit
Conducted prior to the manufacturing build with time to mitigate risks
Completed on-site by Eaton personnel and/or by supplier as a self-assessment
Validates APQP Process was followed & checks other important factors for
success

130
PPAP Element #18:
Part Submission Warrant (PSW)
Part Submission Warrant
Part Name Cust. Part Number
Show n on Draw ing Number Org. Part Number
Engineering Change Level
Additional Engineering Changes

Dated
Dated
What is It?
Safety and/or Government Regulation Purchase Order No. Weight (kg)
• Required document in which the

Yes No
Checking Aid Number Checking Aid Eng. Change Level Dated
ORGANIZATION MANUFACTURING INFORMATION CUSTOMER SUBMITTAL INFORMATION
Supplier Name & Supplier/Vendor Code
Street Address
Customer Name/Division
Buyer/Buyer Code
supplier confirms the design and
City
MATERIALS REPORTING
Region Postal Code Country Application validation of manufacturing
Has customer-required Substances of Concern information been reported?
Submitted by IMDS or other customer format:

Yes No
processes that will produce parts
Are polymeric parts identified w ith appropriate ISO marking codes?
REASON FOR SUBMISSION (Check at least one)

Yes No n/a
to specification at a specific rate
Initial submission Change to Optional Construction or Material
Engineering Change(s) Sub-Supplier or Material Source Change
Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part Processing
Correction of Discrepancy Parts produced at Additional Location
Tooling Inactive > than 1 year Other - please specify
REQUESTED SUBMISSION LEVEL (Check one)

Level 1 - Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to customer.
Level 2 - Warrant w ith product samples and limited supporting data submitted to customer.
• Used to :
•
Level 3 - Warrant w ith product samples and complete supporting data submitted to customer.
Level 4 - Warrant and other requirements as defined by customer.
Level 5 - Warrant w ith product samples and complete supporting data review ed at organization's manufacturing location. document part approval
SUBMISSION RESULTS
The results for dimensional measurements
These results meet all design record requirements:
Mold / Cavity / Production Process
material and functional tests
Yes NO
appearance criteria statistical process package
(If "NO" - Explanation Required) • provide key information
DECLARATION
I affirm that the samples represented by this w arrant are representative of our parts, w hich w ere made by a process that meets
all Production Part Approval Process Manual 4th Edition Requirements. I further affirm that these samples w ere produced at the
• declare that the parts meet
production rate of ____/____ hours. I also certify that documented evidence of such compliance is on file and available for your
specification
review . I have noted any deviation from this declaration below .
EXPLANATION/COMMENTS:
When to Use It
Is each Customer Tool properly tagged and numbered? Yes No n/a
Organization Authorized Signature Date
Print Name Phone No. Fax No.
• Prior to shipping production parts

Title E-mail
FOR CUSTOMER USE ONLY (IF APPLICABLE)
PPAP Warrant Disposition: Approved Rejected Other

Customer Signature Date
Print Name Customer Tracking Number (optional)

131
Show n on Draw ing Number Org. Part Number
Engineering Change Level Dated
Additional Engineering Changes Dated
Safety and/or Government Regulation Yes No Purchase Order No. Weight (kg)
Supplier Name & Supplier/Vendor Code Customer Name/Division
Street Address Buyer/Buyer Code
City Region Postal Code Country Application
Administrative section containing basic

part information, including Part Number
and Revision

132
Administrative section identifying
Show n on Draw ing Number supplier location and customer location
Org. Part Number
Engineering Change Level Dated
Additional Engineering Changes Dated
Safety and/or Government Regulation Yes No Purchase Order No. Weight (kg)
Supplier Name & Supplier/Vendor Code Customer Name/Division
Street Address Buyer/Buyer Code
City Region Postal Code Country Application

133
ADDRESS
CITY
City
Part Submission
STATE ZIP
Warrant (PSW)
APPLICATION
Region Postal Code Country Application
MATERIALS REPORTING
Has customer-required Substances of Concern information been reported? Yes No
Are polymeric parts identified w ith appropriate ISO marking codes? Yes No n/a


Here the supplier is required to identify how it
hasother
Level 4 - Warrant and reported Substances
requirements as defined by of Concern:
customer.
• ith IMDS,
Level 5 - Warrant w product samples
RoHS, andREACH,
complete supporting dataMinerals,
Conflict review ed at organization's manufacturing location.
SUBMISSION RESULTS etc.

The results for dimensional measurements material and functional tests appearance criteria statistical process package
These results meet all design record requirements: Yes NO (If "NO" - Explanation Required)
DECLARATION © 2014 Eaton. All Rights Reserved.

134
ADDRESS
CITY
City
Part Submission
STATE ZIP
Warrant (PSW)
APPLICATION
MATERIALS REPORTING
Has customer-required Substances of Concern information been reported? Yes No
Are polymeric parts identified w ith appropriate ISO marking codes? Yes No n/a


Level 5 - Warrant w ith product samples and complete supporting data review ed at organization's manufacturing location.
SUBMISSION RESULTS
The supplier indicates the reason for the PPAP
submission

135
ADDRESS
CITY
City
Part Submission
STATE ZIP
Warrant (PSW)
APPLICATION
MATERIALS REPORTING
• The
Has customer-required Substances supplier
of Concern indicates
information the PPAP
been reported? level
Yes and No
Submitted by IMDScertifies that the

or other customer validation results meet all
format:
design specifications.
• w ith
Are polymeric parts identified This certification
appropriate iscodes?
ISO marking by cavity, production
Yes No n/a
REASON FOR SUBMISSION (Check line,atetc.

least one)

SUBMISSION RESULTS

136

SUBMISSION RESULTS
DECLARATION
all Production Part Approval Process Manual 4th Edition Requirements. I further affirm that these samples w ere produced at the
Print Name Phone No. 555-555-5555 Fax No.

Title E-mail
PPAP Warrant Disposition: • The supplierRejected

Approved
declares that the PPAP
Other
Customer Signature
submission is based on production processesDate
run at a normal or planned production rate.
• The supplier states the production rate.
• The supplier indicates that any customer
owned tooling is properly identified
137

SUBMISSION RESULTS
These results meet all design record requirements:
• Yes NO (If "NO" - Explanation Required)
Prior to submitting the PPAP, the supplier
representative signs the warrant, indicating the
DECLARATION
part meets Eaton requirements
all Production Part Approval• Process
The customer then
Manual 4th Edition approvesI further
Requirements. or rejects the
affirm that these samples w ere produced at the
PPAP and signs to confirm the decision
• The customer approved PSW is a prerequisite
for production shipments
Print Name Phone No. 555-555-5555 Fax No.

Title E-mail
PPAP Warrant Disposition: Approved Rejected Other

Customer Signature Date

138
 Must be completely filled out
 Must be signed by the supplier
 P/N must match the PO
 Product family submissions allowed
 Submitted at the correct revision level
 Submitted at the correct submission level
 Specify the reason for submission
 Include IMDS, RoHS, etc. as required
 Clearly state the production rate used for validation
139
PPAP Progress Check – Final (True/False)
• Eaton considers FAI to be better than PPAP

T F
• FMEAs should have additional actions
identified T F
• The supplier should complete the Control
Plan prior to the production trial run T F
• The reaction plan part of Control Plan is
optional T F
• The supplier should state the production
rate used during the production trial run on
T F
the PSW

140
PPAP Summary
• PPAP checks that any process changes have

been properly designed and validated, and the
resulting process is capable of repeatedly
producing parts to specification
• The PPAP elements should be part of your Quality
Management System. PPAP shouldn’t require
much extra effort, because you’ve already done
the work internally to manage your changes.
• Reacting to later issues with the product or
process can be expensive and time-consuming!
141
142

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Advanced Product Quality Planning (APQP) and

Production Part Approval Process (PPAP)

Supplier Overview Training

© 2014 Eaton. All Rights Reserved.

• Each Advanced Product Quality Plan is unique and is a living document

• Particular emphasis should be placed on identifying critical path activities

© 2014 Eaton. All Rights Reserved.

• Automotive industry challenges:

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

Cont. next slide

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

$$ Total Cost of Quality

© 2014 Eaton. All Rights Reserved.

• APQP is cross-functional planning and execution to

© 2014 Eaton. All Rights Reserved.

• A First Article Inspection (FAI) requires that all

© 2014 Eaton. All Rights Reserved.

• Production Part Approval Process

• PPAP data must be submitted from a

All data shall reflect the actual production

© 2014 Eaton. All Rights Reserved.

• Provide evidence that all customer

© 2014 Eaton. All Rights Reserved.

• FAI gives confidence regarding the sample.

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

• Helps to maintain design integrity

Production Warrant and Appearance Approval

Production Warrant, product samples, and

Production Warrant, product samples, and

Production Warrant and other requirements

Production Warrant, product samples and

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

Production quantities shall

• Eaton determines PPAP level based on component risk

• Group parts into part families

© 2014 Eaton. All Rights Reserved.

• The supplier shall provide authorized change

© 2014 Eaton. All Rights Reserved.

• Written statement from Customer Engineering

© 2014 Eaton. All Rights Reserved.

© 2014 Eaton. All Rights Reserved.

• DFMEA does not reference manufacturing

• One time document

Action Target Actions N S N O N D N R

Perform Cartridge Static Load Analysis

Perform Thermal Stack Thermal

© 2014 Eaton. All Rights Reserved.

• Step by Step designation of the process flow

(for additional details reference Advance Product Quality Planning and

© 2014 Eaton. All Rights Reserved.

Product Program Issue Date ECL ECL

Operation or Event Description of Evaluation

The process flow diagram