Product 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.
2
 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
• PPAP has now spread to many different industries
beyond automotive
 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!
 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
 What’s the Difference in PPAP vs. FAI?

• FAI gives confidence regarding the sample.

• In addition, PPAP gives confidence in future
product.

6
 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!
 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
PPAP Submission Levels
Production Warrant and Appearance Approval
Level 1
Report (if applicable) submitted to OEM

Production Warrant, product samples, and

Level 2
dimensional results submitted to OEM

Production Warrant, product samples, and

Level 3
complete supporting data submitted to OEM

Production Warrant and other requirements

Level 4
as defined by OEM

Production Warrant, product samples and

complete supporting data (a review will be
Level 5
conducted at the supplier's manufacturing
location)
 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 R
required.
R
The PPAP
S
level
*
simply
R
8.Measurement System Analysis studies Rindicates
R whichSelements * you R
9.Dimensional Results Rsubmit,Sand which
S *
you retain atR
10.Material, Performance Test Results R S S * R
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

S = The organization shall submit to the customer and retain a copy of records or documentation items at appropriate
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

Any customer specific requests

fall under Element # 17
 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 R R S * R
6.Process FMEA R R S * R
7.Control Plan R R S * R
8.Measurement System Analysis studies R R S * R
9.Dimensional Results R S S * R
10.Material, Performance Test Results R S S * R
11.Initial Process Studies R 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

S = The organization shall submit to the customer and retain a copy of records or documentation items at appropriate
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

Any customer specific requests

fall under Element # 17
 PPAP Element 17: OEM
Requirements
• Depending on the specific Eaton business, Eaton may require:
– APQP Kickoff - team
– APQP Timeline Template
– Action Item Log
– Production Feasibility Agreement (PFA)
– Gauge 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)
 PPAP Status
• Approved
– The part meets all OEM 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 OEM requirements, based on
the production lot from which it was taken and/or
accompanying documentation

Production quantities shall

not be shipped before Eaton
Approval
 PPAP Process

• PPAP level based on component risk

– Submission requirements are increased for higher risk
components
• OEM communicates requirements to supplier (RFQ,
APQP Kick-off Meeting, and/or PPAP request – PPAP
Workbook, etc.)
• OEM 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)
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
 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
 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
 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
 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
 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
 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
 “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
 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?
– Create PFMEA After
– Customer CTQs identified
– Suppliers Selected After
– Gage Plan Created After
• 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
 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)
 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
 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
 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
 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)
 PPAP Element #6: Process FMEA
(PFMEA)
• What is It? POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS

– A tool used to identify and prioritize risk Item:

(PROCESS FMEA)

Process Responsibility ORGANIZATION

areas and their mitigation plans. Model Year(s)/Program(s)

Core Team:
APPLICATION Key Date

• Objective or Purpose Process Step

Classification

Occurrence
Current Current

Detection
/ Function

Severity
Potential Potential Potential

RPN
Process Process
Failure Effect(s) Causes(s)

– Identifies potential failure modes,

Mode of Failure of Failure Controls Controls
Prevention Detection
Requirements

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
– New product launches
• After completion of the process flow
diagram. IMPORTANT!
• Prior to tooling for production
The PFMEA should be completed
– When troubleshooting production issues
using a cross-functional team!
– When planning and closing preventive
and corrective actions
 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
 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
determine the ways in
on the output to go wrong? process controls to process controls to

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
or wrong.

failure mode? See DET table.

mode occur? See OCC table.
Consider: internal failure, in terms of from occurring or and lead to corrective
(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.

See SEV table.

(C) Intermittent function as perceived
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.
 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
 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 Reject Conforming
Wrong Component Z Orientation Part Partial Insertion Conforming 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
 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
Under Stake Partial Dip Incorrect Label During 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
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
 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.
 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
 PFMEA – Step 3

Class
Identify special product
or process characteristics
 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.
 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
 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.
 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?)
 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

 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

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

 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.
 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

 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
 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.
 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
Resp (responsibility)
Work Instructions Visual Inspection 8 128
Repair/replace worn
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.
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
 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 István, 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
 Process FMEA (PFMEA)

• Reviewers Checklist
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
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?
– Purchase capital equipment After
– Create the DFMEA
– Purchase End of Line Testers After
– Make Tools/Molds After
• 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
 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
 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
Potential Potential Actions
Process Step Process E Potential Causes C Current Controls E P O
Fill Out Master Failure Mode Failure Effects Recommended
Form
with Initial
Input V C T N C
Information

Other Required Other Required

6 Sigma Assigns
Signatures:
Segment CEO
Signatures:
Champion: Group Assigns Get DLN
Receive Checks Delay internal AR balance does Inadequate None Investigate mail room
Get WO Assigned
Project Number Champion Process Owner Project Number Assigned
Process Owner
BB or GB No
Prefer to work
this project
Project Owner
Dept GB/BB/MBB
Payment mail not go down staffing in mail staffing and associated
within your
7 room 7 10 490 processes

Process Steps
area?
Monitor Progress
Begin/Work Yes Monitor Progress Begin/Work
through Power
Project through Bi- Project
Steering and Finance Approval
Weekly Updates
Monthly and Signature Finance Approval
Follow DMAIC or and Monthly Follow DMAIC or
Financial and Signature
DFSS process Do you Reviews DFSS process
Reviews
No have BB/GB to
Assist/Work the
Identify Wire Information not AR balance is Customer or bank Acct identifies problem Poka-Yoke wire transer
Master Form Will
project?
Customer Transfer supplied past due did not include when trying to apply process
Complete Project Yes Complete Project
(Has to be fully
Documented
Generate
Contract Master Form Will (Has to be fully
Documented)
reference name and/or payment
Generate
Contract
line 10 account info on 5 5 250
Yes Is Hard
Savings > $???
wire transfer
Enter Remaining
Final Project 6 Sigma Final Project
Information on No
Review Project Review
Master Form

Does the
Project Involve Yes
Department Enter Remaining
Identify Invoice Checks Incorrect Invoice shows Customer error Customer might catch Provide payment stub
or Group Information on

Finance Approval
Only Your
Group? Project Master Form
Finance Approval
invoice outstanding (AR it when reviewing the with statement for each
and Signature and Signature
supplied balance does go 5 5 next statement 10 250 invoice

New/Revised Process
No

down)
Other Required Does the Other Required
Project Involve No
Signatures:
Champion: Dir T&E
Process Owner
>2 Groups in
Eng?
Signatures:
Champion: Dir T&E
Process Owner
Identify Invoice Checks Invoice number Invoice shows Customer error Acct identifies problem Provide payment stub

Steps
Project Owner
Dept BB or MBB Yes
Project Owner
Dept BB or MBB not supplied outstanding (AR when trying to apply with statement for each
balance does go 5 10 payment 5 250 invoice
Complete all Complete all
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)
outside Eng?
out Sheet out Sheet

Process FMEA
Process Flowchart

Control Plan
 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
CONTROL
JIG, TOOLS PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
TOLERANCE TECHNIQUE
 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
CONTROL
JIG, TOOLS PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
TOLERANCE TECHNIQUE

Administrative Section
Identifies part number and description,
supplier, required approval signatures,
and dates.
 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
CONTROL
JIG, TOOLS PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
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
 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
CONTROL
JIG, TOOLS PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
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
 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

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
The Control Plan Form

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
 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

Class refers to special characteristics –

product or process. Should align with
FMEA
 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

This is a specification from the Design Record or a key

process parameter
 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

How is the characteristic or parameter going to

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

How many parts will be measured and how often.

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

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
 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

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
 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
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)
002 T. Smith / 313-555-5555 11/29/2009 2/20/2010
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
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
 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.
 Control Plan

• When to 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.
 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!!
Inspection – what do you really see?
Measurement System Analysis (MSA)
Observed Variation
Resolution

Precision Repeatability
(Variability)
Reproducibility
Measurement
System
Variation
Linearity
Observed Accuracy
(Central Bias
Variation Location)
Stability

Process
Variation Calibration helps address accuracy
Measurement System Analysis (MSA)

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.
Measurement System Analysis (MSA)
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
 Measurement System Analysis (MSA)
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
 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
 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. A 1
1 2 3 4 5 6 7 8 9 10 Repeatability - Equipment Variation (EV)
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 r aiser s 2 3
9. AVE b= n = parts r = trials K2 0.7071 0.5231
10.

11. C
R

1
%GRR, %PV, ndc r b= Repeatability & Reproducibility (GRR)

GRR = {(EV2 + AV 2)}1/2 Parts K3

% GRR =

=
100 (GRR/Tol)

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 K3 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:
 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.

 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.
 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
 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
 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

Objective or Purpose
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
 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.
 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
 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 source approval is req'd, include the Supplier (Source) & Customer assigned code. 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
 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
 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
 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.
Process Capability:
The Two Voices

m
 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.
 Capability Studies
Process Data forCo2
15 A short-term capability study
14 UCL=14.18
covers a relative short period of
IndividualValue

13

12
X=12.64 time during which extraneous
11 LCL=11.10 sources of variation have been
10
excluded. (Guideline: 30-50 data
9
0 50 100 150 points.)
Observation Number

Process Data forCo2

15
A long-term capability study
14 UCL=14.18
covers a longer period of time in
IndividualValue

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
 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
6. Assess process stability and process capability

7. Calculate process capability

 Step 5: Data Characteristics
Step 5 Assess data characteristics
Histogram of Mfg Hours
Mean 14.87
20 StDev 3.088

Examine the shape of your data. 15

N 100

– Is it what you would expect?

Frequency
If not, investigate. 10

0
8 10 12 14 16 18 20 22
Mfg Hours

Bimodal Data
Histogram of Mfg Hours Histogram of Mfg Hours
The shape of your data is 25
Mean
StDev
19.98
1.713
20 Mean
StDev
20.19
18.87

important for determining

N 100 N 100

which type of Capability

20 15
Frequency

Frequency
Analysis applies. If the 15
10

data exhibits a non-normal 10

shape, consult your

5
5

statistics reference. 0
16 18 20 22 24
0
-15 0 15 30 45 60 75
Mfg Hours Mfg Hours

Normal Data Skewed Data

 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!
 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

 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
 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
 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.
 PPAP Element #13:
Appearance Approval Report
PART
APPEARANCE APPROVAL REPORT
DRAWING APPLICATION
What is It?
• A report completed by the supplier
NUMBER NUMBER (VEHICLES)
PART BUYER E/C LEVEL DATE

containing appearance and color

NAME CODE
ORGANIZATION MANUFACTURING SUPPLIER / VENDOR

criteria
NAME LOCATION CODE
REASON FOR PART SUBMISSION WARRANT SPECIAL SAMPLE RE-SUBMISSION OTHER
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 Objective or Purpose
PROCEED
CORRECT AND
PROCEED
• To demonstrate that the part has
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
 Appearance Approval Report
APPEARANCE APPROVAL REPORT
PART DRAWING APPLICATION
NUMBER NUMBER (VEHICLES)
PART BUYER E/C LEVEL DATE
NAME CODE
ORGANIZATION MANUFACTURING SUPPLIER / VENDOR
NAME LOCATION CODE
REASON FOR PART SUBMISSION WARRANT SPECIAL SAMPLE RE-SUBMISSION OTHER
SUBMISSION PRE TEXTURE FIRST PRODUCTION SHIPMENT ENGINEERING CHANGE
APPEARANCE EVALUATION
AUTHORIZED CUSTOMER
ORGANIZATION SOURCING AND TEXTURE INFORMATION PRE-TEXTURE REPRESENTATIVE
EVALUATION SIGNATURE AND DATE
CORRECT AND
PROCEED
CORRECT AND
PROCEED
APPROVED TO
ETCH/TOOL/EDM

COLOR EVALUATION
METALLIC COLOR
COLOR TRISTIMULUS DATA
SUFFIX DL* Da* Db* DE* CMC NUMBER DATE TYPE
Administrative Section
MASTER MASTER MATERIAL MATERIAL
SOURCE RED
HUE
YEL GRN BLU
VALUE CHROMA
LIGHT DARK GRAY CLEAN
GLOSS
HIGH LOW
BRILLIANCE SHIPPING
HIGH LOW SUFFIX
PART
DISPOSITION

Identifies part number and description,

supplier, required approval signatures, and
dates.
 Appearance Approval Report
APPEARANCE APPROVAL REPORT
PART DRAWING APPLICATION
NUMBER NUMBER NUMBER (VEHICLES) APPLICATION
PART BUYER E/C LEVEL DATE
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
SUBMISSION PRE TEXTURE FIRST PRODUCTION SHIPMENT ENGINEERING CHANGE
APPEARANCE EVALUATION
AUTHORIZED CUSTOMER
ORGANIZATION SOURCING AND TEXTURE INFORMATION PRE-TEXTURE REPRESENTATIVE
EVALUATION SIGNATURE AND DATE
CORRECT AND
PROCEED
CORRECT AND
PROCEED
APPROVED TO
ETCH/TOOL/EDM

COLOR EVALUATION
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

Appearance Evaluation Details

Identifies supplier sourcing, texture information
and submission customer signature.

COMMENTS
 Appearance Approval Report
COLOR EVALUATION
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

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
 PPAP Element #14:
Sample Production Parts
What is It?
Actual samples that reflect the parts
documented in the PPAP.

Objective or Purpose
• Confirm cosmetic or functional
part approval.

When to Use It
• Sample parts should be delivered
WITH the PPAP submission
 Sample Production Parts

• The sample parts provided should be the

same parts measured for the dimensional
results
• PPAP sample quantity is based on needs from
OEM, Manufacturing and Quality
 Sample Production Parts
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
 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
 PPAP Element #17: OEM
Requirements
• APQP Kickoff - team
• APQP Timeline Template These items all have templates
• Action Item Log in the PPAP Workbook – many
• Production Feasibility Agreement (PFA) of which are self-explanatory
• Gage Plan
• Dimensional Correlation Matrix
• Pass Through Characteristics (PTC) Items in blue have
• Safe Launch Control Plan additional instructions
• AS 9102 Forms (Aerospace Industry) embedded in the PPAP
• Ramp Up & Down Plan Workbook
• Packaging Specification Data Sheet
• Submit Bar Code Label Packaging Approval
• PPAP Interim Recovery Worksheet
• Capacity R@R Worksheet Let’s take a closer look
• Production Readiness Review (PRR) at the items in red…
 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:
Eaton Purchasing Rep.: Part Family (if Applicable): Date Submitted: Final PFA:

• The PFA is designed to

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

ensure the supplier

- 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

clearly understands and

6
7
8
9
10
11
12
13
14
15

can meet all Eaton

16
17
18
19
20
21
22
23
24

design requirements
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

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
(Yes / No) Change Required

• It also provides a formal

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)
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

way to solicit and track

4
5
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 Can product be manufactured with Cpk's that meet requirements?

supplier design input

Drop Gage
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
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.)

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
 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

 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
 PFA (cont.)
Eaton Input Data

Eaton Engineering or Quality Representative Only!

Eaton Agrees Specification

Comment
(Yes / No) Change Required

When requested, Eaton indicates a

design change to accommodate the
supplier, or indicates the design must
remain un-changed
 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 feasibility
7 Is statistical process control required on the product?
Is statistical process control presently used on similar products?
questions and signs
8
9 Where statistical process control is used on similar products:
9a 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
 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
 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%
Example Ball diameter 5 0.0025 0.0025 0.005 5.556 N Beta laser mic 5.5612 Non contact laser 5.5601 0.00113 23%
Example Ball diameter 2 0.0025 0.0025 0.005 5.556 N Beta laser mic 5.5595 Non contact laser 5.5581 0.00142 28%
Example Ball diameter 4 0.0025 0.0025 0.005 5.556 N Beta laser mic 5.5597 Non contact laser 5.5582 0.00151 30%

• 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
 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
 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?
Yes No

• Required document in which the

Safety and/or Government Regulation Purchase Order No. Weight (kg)

Checking Aid Number Checking Aid Eng. Change Level Dated

supplier confirms the design and

ORGANIZATION MANUFACTURING INFORMATION CUSTOMER SUBMITTAL INFORMATION

Supplier Name & Supplier/Vendor Code Customer Name/Division

Street Address Buyer/Buyer Code validation of manufacturing

City

MATERIALS REPORTING
Region Postal Code Country Application
processes that will produce parts
Has customer-required Substances of Concern information been reported?

Submitted by IMDS or other customer format:

Yes No
to specification at a specific rate
Are polymeric parts identified w ith appropriate ISO marking codes?

REASON FOR SUBMISSION (Check at least one)

Yes No n/a
Objective or Purpose
• Used to :
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

– document part approval

Tooling Inactive > than 1 year Other - please specify

REQUESTED SUBMISSION LEVEL (Check one)

– provide key information

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.
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.

SUBMISSION RESULTS
– declare that the parts meet
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) specification
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
production rate of ____/____ hours. I also certify that documented evidence of such compliance is on file and available for your
When to Use It
• Prior to shipping production parts
review . I have noted any deviation from this declaration below .

EXPLANATION/COMMENTS:

Is each Customer Tool properly tagged and numbered? Yes No n/a

Organization Authorized Signature Date

Print Name Phone No. Fax No.

Title E-mail

FOR CUSTOMER USE ONLY (IF APPLICABLE)

PPAP Warrant Disposition: Approved Rejected Other

Customer Signature Date

Print Name Customer Tracking Number (optional)

 Part Submission Warrant (PSW)
Part Submission Warrant
Part Name Cust. Part Number

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)

Checking Aid Number Checking Aid Eng. Change Level Dated

ORGANIZATION MANUFACTURING INFORMATION CUSTOMER SUBMITTAL INFORMATION

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
 Part Submission Warrant (PSW)
Part Submission Warrant
Part Name Cust. Part Number
Administrative section identifying supplier
Show n on Draw ing Number location and customer Org.location
Part Number

Engineering Change Level Dated

Additional Engineering Changes Dated

Safety and/or Government Regulation Yes No Purchase Order No. Weight (kg)

Checking Aid Number Checking Aid Eng. Change Level Dated

ORGANIZATION MANUFACTURING INFORMATION CUSTOMER SUBMITTAL INFORMATION

Supplier Name & Supplier/Vendor Code Customer Name/Division

Street Address Buyer/Buyer Code

City Region Postal Code Country Application

Supplier Name & Supplier/Vendor Code Customer Name/Division

ADDRESS

CITY Part Submission Warrant (PSW)

Street Address

STATE ZIP
Buyer/Buyer Code

APPLICATION
City Region Postal Code Country Application

MATERIALS REPORTING

Has customer-required Substances of Concern information been reported? Yes No

Submitted by IMDS or other customer format:

Are polymeric parts identified w ith appropriate ISO marking codes? Yes No n/a

REASON FOR SUBMISSION (Check at least one)

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.
Here
Level 3 - Warrant w the supplier
ith product iscomplete
samples and required to identify
supporting how ittohas
data submitted customer.
Level 4 - Warrant and other requirements
reported Substancesas defined by customer.
of Concern:
Level 5 - Warrant w ith product samples and complete supporting data review ed at organization's manufacturing location.
• IMDS, RoHS, REACH, Conflict Minerals, etc.
SUBMISSION RESULTS
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)
Mold / Cavity / Production Process

DECLARATION
Supplier Name & Supplier/Vendor Code Customer Name/Division

ADDRESS

CITY Part Submission Warrant (PSW)

Street Address

STATE ZIP
Buyer/Buyer Code

APPLICATION
City Region Postal Code Country Application

MATERIALS REPORTING

Has customer-required Substances of Concern information been reported? Yes No

Submitted by IMDS or other customer format:

Are polymeric parts identified w ith appropriate ISO marking codes? Yes No n/a

REASON FOR SUBMISSION (Check at least one)

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.
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.

SUBMISSION RESULTS The supplier indicates the reason for the PPAP
The results for dimensional measurements material and functional tests appearance criteria statistical process package
submission
These results meet all design record requirements: Yes NO (If "NO" - Explanation Required)
Mold / Cavity / Production Process

DECLARATION
Supplier Name & Supplier/Vendor Code Customer Name/Division

ADDRESS

CITY Part Submission Warrant (PSW)

Street Address

STATE ZIP
Buyer/Buyer Code

APPLICATION
City Region Postal Code Country Application

MATERIALS REPORTING

• Theof supplier
Has customer-required Substances indicates
Concern information the
been PPAP
reported? level and
Yes No

Submitted by IMDScertifies that the

or other customer validation results meet all
format:
design specifications.
• w ithThis
Are polymeric parts identified certification
appropriate is by
ISO marking cavity,
codes? productionYesline, No n/a

etc.at least one)

REASON FOR SUBMISSION (Check
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.
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.

SUBMISSION RESULTS
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)
Mold / Cavity / Production Process

DECLARATION
 Level 2 - Warrant w ith product samples and limited supporting data submitted to customer.
Level 3 - Warrant w ith product samples and complete supporting data submitted to customer.

Part Submission Warrant (PSW)

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.

SUBMISSION RESULTS
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)
Mold / Cavity / Production Process

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
production rate of ____/____ hours. I also certify that documented evidence of such compliance is on file and available for your
review . I have noted any deviation from this declaration below .

EXPLANATION/COMMENTS:

Is each Customer Tool properly tagged and numbered? Yes No n/a

Organization Authorized Signature Date

Print Name Phone No. 555-555-5555 Fax No.

Title E-mail

FOR CUSTOMER USE ONLY (IF APPLICABLE)

• The supplier declares that the PPAP submission is
PPAP Warrant Disposition: Approved Rejected Other
based on production processes run at a normal or
Customer Signature Date
planned production rate.
Print Name Customer Tracking Number (optional)
• The supplier states the production rate.
• The supplier indicates that any customer owned
tooling is properly identified
 Level 2 - Warrant w ith product samples and limited supporting data submitted to customer.
Level 3 - Warrant w ith product samples and complete supporting data submitted to customer.

Part Submission Warrant (PSW)

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.

SUBMISSION RESULTS
The results for dimensional measurements material and functional tests appearance criteria statistical process package
• record
These results meet all design to submittingYes
Priorrequirements: the NO the
PPAP, (If supplier
"NO" - Explanation Required)
Mold / Cavity / Production Process
representative signs the warrant, indicating the part
DECLARATION meets Eaton requirements
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
The customer thenRequirements.
Manual 4th Edition approves orI further
rejects the
affirm PPAP
that these samples w ere produced at the
production rate of ____/____ hours. I also certify that documented evidence of such compliance is on file and available for your
and signs to confirm the decision
review . I have noted any deviation from this declaration below .
• The customer approved PSW is a prerequisite for
EXPLANATION/COMMENTS:
production shipments
Is each Customer Tool properly tagged and numbered? Yes No n/a

Organization Authorized Signature Date

Print Name Phone No. 555-555-5555 Fax No.

Title E-mail

FOR CUSTOMER USE ONLY (IF APPLICABLE)

PPAP Warrant Disposition: Approved Rejected Other

Customer Signature Date

Print Name Customer Tracking Number (optional)

 Part Submission Warrant (PSW)

• Reviewers Checklist
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
 PPAP Progress Check – Final
(True/False)
• OEM 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 T F
on the PSW
 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!