Advanced Product Quality Planning (APQP) and

Production Part Approval Process (PPAP)

Supplier Overview Training
Document CQD-116; Rev 1; 1/15/15

2014 Eaton. All Rights Reserved.

What is APQP?
Advanced Product Quality
Planning Cycle

Advanced Product Quality Planning

method to assure that a product satisfies
the customer (both internal and external)
The goal of APQP is to:
Plan before acting
Anticipate and prevent issues
Validate before moving forward
Facilitate communication

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

Particular emphasis should be placed on identifying critical path activities
and ensuring those are fully resourced

2014 Eaton. All Rights Reserved.

APQP Background
Automotive industry challenges:

Innovation, more complex product

Reduce NPD times
Complicated Supply chain
Increasing customer and quality requirements

Solution:
Ford, GM, Chrysler APQP Task Force jointly developed in
the late 80s to standardize their respective supplier quality
systems.

Continuous Improvement:
Many industries outside the Automotive industry have
embraced the AIAG APQP process to achieve similar
benefits

2014 Eaton. All Rights Reserved.

APQP timing chart and phases - AIAG

The Advanced Product Quality Planning process consists of four phases and five major
activities and has some 20+ supporting tools (e.g. DFMEA, PFMEA, CTQ, Special
Characteristics, Control Plan, SPC) along with ongoing feedback assessment and corrective
action.

2014 Eaton. All Rights Reserved.

1. Plan and Define Program

OUTPUTS:

INPUTS:

Assure that
customer needs
and expectations
are clearly
understood.

Voice of the Customer

Market Research
Historical Warranty
and Quality
Information
Team Experience
Business Plan/Marketing
Strategy
Product/Process
Benchmark Data
Product/Process
Assumptions
Product Reliability
Studies
Customer Inputs

Design Goals
Reliability & Quality
goals
CONC targets
Preliminary Bill of
Materials
Preliminary Process
Flow Chart
Preliminary list of
Special Product and
Process
Characteristics
Product Assurance
Plan
Management Support

* The inputs and outputs applicable to the process may vary according to the
product process and customer needs and expectations.

2014 Eaton. All Rights Reserved.

2. Product Design and Development - 1

INPUTS:
Design Goals
Reliability & Quality
goals
Preliminary Bill of
Materials
Preliminary Process
Flow Chart
Preliminary list of
Special Product and
Process
Characteristics
Develop design into
Product Assurance
a near final form.
Plan
Prototype and
feasibility studies
volumes, schedule,
manufacturing.

OUTPUTS:
Design Failure Mode and Effects
Analysis (DFMEA)
Design For Manufacturability and
Assembly
Design Verification
Design Reviews
Prototype Build Control plan
Engineering Drawings (Including
Math Data)
Engineering Specifications
Material Specifications
Drawing and Specification
Changes

Cont. next slide

2014 Eaton. All Rights Reserved.

2. Product Design and Development - 2

INPUTS:
Design Goals
Reliability & Quality
goals
Preliminary Bill of
Materials
Preliminary Process
Flow Chart
Preliminary list of
Special Product and
Process
Characteristics
Develop design into
Product Assurance
a near final form.
Plan
Prototype and
feasibility studies
volumes, schedule,
manufacturing.

2014 Eaton. All Rights Reserved.

OUTPUTS:
New Equipment, Tooling and
Facilities Requirements
Special Product and Process
Characteristics
Gages/Testing Equipment
Requirements
Team Feasibility
Commitment
Management Support

3. Process Design and Development

INPUTS:

Develop a
manufacturing
system and its
related control
plans to achieve
quality products.

Design Failure Mode and Effects Analysis

(DFMEA)
Design For Manufacturability and
Assembly
Design Verification
Design Reviews
Prototype Build Control Plan
Engineering Drawings (Including Math
Data)
Engineering Specifications
Material Specifications
Drawing and Specification Changes
New Equipment, Tooling and Facilities
Requirements
Special Product and Process
Characteristics
Gages/Testing Equipment Requirements
Team Feasibility Commitment
Management Support

2014 Eaton. All Rights Reserved.

OUTPUTS:
Packaging Standards
Product/Process Quality
System Review
Process Flow Chart
Floor Plan Layout
Characteristics Matrix
Process Failure Mode and
Effects Analysis (PFMEA)
Pre-Launch Control Plan
Process Instructions
Measurement Systems
Analysis Plan
Preliminary Process
Capability Study Plan
Packaging Specifications
Management Support

4. Product and Process Validation

INPUTS:

Validate manufacturing
process through
production trial run.
Validate that the control
plan and process flow
chart are effective and
that the product meets
customer expectation.

Packaging Standards
Product/Process Quality
System Review
Process Flow Chart
Floor Plan Layout
Characteristics Matrix
Process Failure Mode and
Effects Analysis (PFMEA)
Pre-Launch Control Plan
Process Instructions
Measurement Systems
Analysis Plan
Preliminary Process
Capability Study Plan
Packaging Specifications
Management Support

2014 Eaton. All Rights Reserved.

OUTPUTS:
Measurement Systems
Evaluation
Significant Production Run
Preliminary Process
Capability Study
Production Part Approval
Production Validation
Testing
Packaging Evaluation
Production Control Plan
Quality Planning Sign-Off formal
Management Support

Feedback, Assessment, Corrective actions

INPUTS:

Evaluate outputs,
effectiveness of
the product
quality planning
efforts.

Production Trial Run

Measurement Systems
Evaluation
Preliminary Process
Capability Study
Production Part Approval
Production Validation
Testing
Packaging Evaluation
Production Control Plan
Quality Planning Sign-Off
and Management
Support

2014 Eaton. All Rights Reserved.

OUTPUTS:
Reduced Variation
Improved Customer
Satisfaction
Improved Delivery and
Service
Effective use of best
practice, lessons learned
Maximum ROI
Minimum Waste
Minimum CONC

10

Application to Different Mfg. Environments

High Volume
APQP plans and activities are organized by part number and
are very specific to the part

Low Volume
APQP plans may be specific to part families with activities
focused on the parent part
More limited validation would be done on child parts
Family part differences should be understood and higher risk
differences incorporated into APQP plans

Engineer to Order (ETO)

APQP plans may use a part family approach for
standardized elements
Consider a manufacturing process focus for non-standard
elements
Create FMEAs and Control Plans for manufacturing processes rather
than parts

2014 Eaton. All Rights Reserved.

11

APQP Summary:
What we do:

Design Quality
DFMEA / PFMEA /
DFM/A
Manufacturing Quality
Control Plans
Process Flows
Measurement System
Analysis
Capability Analysis
Process Validation
Run at rate
Supplier Qualification &
Quality Requirements
Product Qualification
1st Article Inspection
PPAP
Tooling & Gauges
Testing

How we do it:
APQP

What we get:

UP
FRONT
DETAILED

Defect Free Launches

Reduced Warranty
Claims
Zero Spills
Customer Satisfaction
Robust Products
Greater Supplier
Control
Reduced supplier cost

QUALITY
PLANNING

Leadership
Engagement is Critical
1
2014 Eaton. All Rights Reserved.

12

APQP Benefits:
Manufacturing process functions that are clearly planned,
validated, documented and communicated that result in:

CONC

$$ Total Cost of Quality

Robust and reliable designs

Reduced process variation
Enhanced confidence in suppliers
capabilities
Better controlled process changes
Defect free launches
Improved Customer satisfaction
Improved Delivery and Service
Maximum ROI
Minimum Waste
Minimum Cost of Nonconformance

Redesign
Re-qualifications
Escape Investigations

Prevention through APQP

Current state

Development

2014 Eaton. All Rights Reserved.

Production

Time

13

Key Take Aways:

APQP is cross-functional planning and execution to
produce product that fully meets the customers
expectations the first time
AIAG APQP phases are Planning, Product Design,
Process Design, Validation, Production
Phase approach ensures activities are completed in
the appropriate order
Can be applied to different manufacturing
environments High Volume, Low Volume, ETO
Its cross-functional
Marketing/Design/Manufacturing/SCM/Quality

2014 Eaton. All Rights Reserved.

14

Production Part Approval Process (PPAP)

2014 Eaton. All Rights Reserved.

What is a First Article Inspection?

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

16

2014 Eaton. All Rights Reserved.

16

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

2014 Eaton. All Rights Reserved.

17

Production Run
PPAP data must be submitted from a
production run using:

Production equipment and tooling

Production employees
Production rate
Production process
All data shall reflect the actual production
process that will be used at start-up!

2014 Eaton. All Rights Reserved.

18

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

2014 Eaton. All Rights Reserved.

19

Whats the Difference in PPAP vs. FAI?

FAI gives confidence regarding the sample.
In addition, PPAP gives confidence in future
product.

20

2014 Eaton. All Rights Reserved.

20

When is PPAP Required?

New part
Engineering change(s)
Durable Tooling: transfer, replacement, refurbishment,
or additional
Tooling inactive > one year

Correction of discrepancy
Change to optional construction or material
Sub-supplier or material source change
Change in part processing
Parts produced at a new or additional location

PPAP is required with any significant change

to product or process!
2014 Eaton. All Rights Reserved.

21

Benefits of PPAP Submissions

Helps to maintain design integrity
Identifies issues early for resolution
Reduces warranty charges and prevents cost of
poor quality
Assists with managing supplier changes
Prevents use of unapproved and nonconforming
parts
Identifies suppliers that need more development
Improves the overall quality of the product &
customer satisfaction

2014 Eaton. All Rights Reserved.

22

PPAP Submission Levels

Level 1

Production Warrant and Appearance Approval

Report (if applicable) submitted to Eaton

Level 2

Production Warrant, product samples, and

dimensional results submitted to Eaton

Level 3

Production Warrant, product samples, and

complete supporting data submitted to Eaton

Level 4

Production Warrant and other requirements as

defined by Eaton

Level 5

Production Warrant, product samples and

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

2014 Eaton. All Rights Reserved.

23

PPAP Submission Requirements

Requirement
Level 1
Level 2
Level 3
Level 4
Level 5
1.Design Record
R
S
S
*
R
2.Engineering Change Documents, if any
R
S
S
*
R
3.Customer Engineering approval, if required
R
R
S
*
R
4.Design FMEA
R
R each level,
S
Note: For
full* APQP Ris
5.Process Flow Diagrams
R
R
S
*
R
required.
The
PPAP
level
simply
6.Process FMEA
R
R
S
*
R
7.Control Plan
R
* you R
indicatesR which Selements
8.Measurement System Analysis studies
R
S
*
submit, Rand which
you retain
at Ryour
9.Dimensional Results
R
S
S
*
R
site.
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

Any customer specific requests fall

S = The organization shall submit to the customer and retain a copy of records or documentation items at appropriate
under Element
# 17
locations
R = The organization shall retain at appropriate locations and make available to the customer upon request
* = The organization shall retain at the appropriate location and submit to the customer upon request
2014 Eaton. All Rights Reserved.

24

PPAP Element 17: Eaton Requirements

Depending on the specific Eaton business, Eaton may
require:

APQP Kickoff - team

APQP Timeline Template
Action Item Log
Production Feasibility Agreement (PFA)
Gage Plan
Dimensional Correlation Matrix
Pass Through Characteristics (PTC)
Safe Launch Control Plan
AS 9102 Forms (Aerospace Industry)
Ramp Up & Down Plan
Packaging Specification Data Sheet
Submit Bar Code Label Packaging Approval
PPAP Interim Recovery Worksheet
Capacity R@R Worksheet
Production Readiness Review (PRR)

2014 Eaton. All Rights Reserved.

25

PPAP Status
Approved
The part meets all Eaton requirements
Supplier is authorized to ship production quantities of
the part

Interim Approval
Permits shipment of part on a limited time or piece
quantity basis

Rejected
The part does not meet Eaton requirements, based on
the production lot from which it was taken and/or
accompanying documentation

Production quantities shall

not be shipped before Eaton
Approval
2014 Eaton. All Rights Reserved.

26

Eaton PPAP Process

Eaton determines PPAP level based on component
risk
Submission requirements are increased for higher risk
components

Eaton communicates requirements to supplier (RFQ,

APQP Kick-off Meeting, and/or PPAP request PPAP
Workbook, etc.)
Eaton provides a standard PPAP workbook with all
necessary tools
Supplier can use their own templates and tools if they meet
the AIAG requirements

Supplier conducts APQP per AIAG requirements (Use

PPAP workbook forms as necessary)

2014 Eaton. All Rights Reserved.

27

Adapting PPAP for High Mix/Low Volume

and Engineer to Order Manufacturing
Group parts into part families
Which parts use the same manufacturing process
flow?
Which parts have 90%+ features in common?

Design and validate processes based on part

families
Look at individual processes use planning
and prevention tools such as PFMEA, Control
Plan by process
2014 Eaton. All Rights Reserved.

28

PPAP Element #1: Design Record

Includes:

Component drawings
Assembly drawings
Bill of Materials
Referenced engineering specifications
Material specifications
Performance or test specifications

Ensures manufacturer has the complete design record

at the correct revision levels
This requirement may be satisfied by attaching the
ballooned design record to the Production Feasibility
Agreement (PFA) located in the PPAP Workbook
Some Eaton businesses may use an alternate approach

2014 Eaton. All Rights Reserved.

29

PPAP Element #2:

Authorized Engineering Change Documents
The supplier shall provide authorized change
documents for those changes not yet recorded
in the design record, but incorporated in the
product, part or tooling, such as:

ECNs (must be approved, not pending)

Specification changes
Supplier change requests
Sub-assembly drawings
Life or reliability testing requirements

2014 Eaton. All Rights Reserved.

30

PPAP Element #3:

Customer Engineering Approval
Written statement from Customer Engineering
approving the parts
Example: supplier designed components in which
we require additional information for validation of
designsfor structural integrity
The engineering design requires approval
Other elements of the PPAP validate the
manufacturing process

2014 Eaton. All Rights Reserved.

31

PPAP Element #4: Design Failure Mode

and Effects Analysis (DFMEA)

Provide potential cause and effect relationships for the basic

design of the product
Helps to plan design needs for:

Materials selection
Tolerance stack-up
Software
Interfaces
DVP&R (life cycle tests)

Employs R.P.N rating system

High R.P.Ns and Severity> 8 need recommended Corrective Actions (CA)

PROLaunch element
Initial DFMEA in Phase 2
Complete DFMEA in Phase 3

May be Family based

2014 Eaton. All Rights Reserved.

32

Difference between DFMEA and PFMEA

DFMEA does not reference manufacturing
controls
Design controls include:

Tolerance stack-up analysis

Simulation
Finite Element Analysis
Testing

Recommended actions should be Design actions

Re-design
Testing
Analysis

2014 Eaton. All Rights Reserved.

33

DFMEA Common Pitfalls

One time document

Must be continuously reviewed and updated
What if the latest change or revision has a significant impact?

Not submitted or reviewed with supplier

The After Thought
Completed after drawing and production release
Doesnt 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

2014 Eaton. All Rights Reserved.

34

Good DFMEA Example

Potential
Failure
Mode(s)
Impeller
Failure

Potential Failure
Effects
Low Flow at High
Speeds & High Flows

Reduced Overall
Relief Valve
Efficiency due to
Open
Internal Leakage
Reduced Overall
Housing
Efficiency due to
Fracture
Internal Leakage

Class

S
E
V

Potential
Causes

O
C
C

Impeller Fracture

Relief Valve Stuck

due to
Contamination

Housing Fracture
due to Vibration

Actions Recommended

Action
Owner

Current
Controls
Prevent

Current Controls
Detect
Impeller stress analysis,
thermal limits, vibration
analysis
Relief valve force margin,
relief valve clearances,
sharp edges
Analyze housing vibration
modes in conjunction with
vibration requirements

Target
Date

Actions N S
e E
Taken

D
E
T

R
P
N

96

120

72

w V

N O
e C
w C

N D
e E
w T

N R
e P
w N

Perform Stack Up Analysis

with Transient / Steady State
Thermal Effects

Joe Smith 11-May-14

Stackups
complete

32

Perform Cartridge Static Load

& Deflection Analysis

Jan Doe

Analysis
complete

32

Perform Thermal Stack

Analysis and Thermal Shock
Test

Thermal
Joe Smith 12-Sep-14 analysis
complete

36

2014 Eaton. All Rights Reserved.

11-Aug-14

35

Progress Check: DFMEA

In which APQP phase would you first create a DFMEA?
APQP: Phase 2 Product Design

Which of the following activities should be done before

the DFMEA?

Create PFMEA
Customer CTQs After
identified
Suppliers Selected
Gage Plan CreatedAfter

Which FMEA risks need recommended actions?

After
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

2014 Eaton. All Rights Reserved.

36

PPAP Element #5: Process Flow

Diagram(s)
Step by Step designation of the process flow
required to produce the referenced product
which meets all customer requirements

Provide linkage to PFMEA and Control Plan

Traditional block diagram
May employ Family based diagrams
Should cover all steps from Receiving to Shipping

(for additional details reference Advance Product Quality Planning and

Control Plan AIAG Manual)

2014 Eaton. All Rights Reserved.

37

Process Flow Diagrams

PROCESS / INSPECTION FLOWCHART
Product Program
Supplier Name
Supplier Location

ORGANIZATION
CITY

STATE

Issue Date

ECL

Part Name

NAME

Part Number

ECL

NUMBER

Legend:

STEP

Operation

Transportation

Operation or Event

Inspection

Delay

Storage

Description of

Evaluation

Operation or Event

and Analysis Methods

The process flow diagram

utilizes these symbols to
clearly identify each step
in the process

2014 Eaton. All Rights Reserved.

38

Preparing the Process Map

Team Effort:

Engineers
Operators
Supervisors
Maintenance
Supply Chain

Possible Inputs to Mapping:

Engineering specifications
Lead time requirements
Target manufacturing costs
Operator experience
Observation
Brainstorming

2014 Eaton. All Rights Reserved.

39

Process Flow Diagrams

Reviewers Checklist
Process Flow must include all phases of the process

Receiving
Storage/ material handling
Manufacturing
Offline inspections and checks
Assembly
Testing
Shipping

Should include abnormal handling processes

Scrap
Rework
Extended Life Testing

May also include Transportation

2014 Eaton. All Rights Reserved.

40

Process Map and APQP

During which APQP phase would you first create a
process map?
APQP: Phase 1 Planning

Why not wait until later in the process?

A basic understanding of the process assists in cost
estimating/ quoting
Need to know process steps to understand what
equipment/tooling/gages may be required

Why would volumes and lead-times be important

to know?
Volumes and lead-times might influence the
manufacturing processes you select (i.e. automated
processes for high volume)

2014 Eaton. All Rights Reserved.

41

PPAP Element #6: Process FMEA (PFMEA)

What is It?
A tool used to identify and prioritize risk
areas and their mitigation plans.

Process Responsibility

Model Year(s)/Program(s)

APPLICATION

ORGANIZATION

Key Date

Requirements

Potential
Effect(s)
of Failure

Potential
Causes(s)
of Failure

Current
Process
Controls

Current
Process
Controls

Prevention

Detection

RPN

Potential
Failure
Mode

Detection

Process Step
/ Function

Occurrence

Core Team:

Objective or Purpose
Identifies potential failure modes,
causes, and effects. Inputs come from
the process flow diagram.
Identifies key inputs which affect quality,
reliability and safety of a product or
process.

Item:

Severity

POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)

Classification

When to Use It
New product launches
After completion of the process flow
diagram.
Prior to tooling for production

When troubleshooting production issues

When planning and closing preventive
and corrective actions

2014 Eaton. All Rights Reserved.

IMPORTANT!
The PFMEA should be completed
using a cross-functional team!

42

FMEA Origins

Initially developed by the

US Military as Failure
Mode Effects and
Criticality Analysis
(FMECA)
Widely adopted by NASA
during the 1960s to
prevent errors on the
Apollo program
Brought over to the
automotive industry by
Ford after issues with
Pinto fuel tanks

Ap

F
2014 Eaton. All Rights Reserved.

43

PFMEA - Step 1

Assemble Hardware Kit

Wrong and/or missing Customer unable to

parts/labeling (B)
install product

Assemble Hardware Kit Bad seal (B)

Using the completed

Process Flow Diagram,
enter the process step.

Current Controls

Customer unable to
install product, due
to missing hardware.

Prevent
What are the existing
process controls to
prevent the cause of
failure or failure mode
from occurring or
reduce the rate of
occurrence?
Should include an
SOP number.

Detect
What are the existing
process controls to
detect the cause of
failure or failure mode
and lead to corrective
action(s)?
Should include an
SOP number.

D
E
T
How well can you detect the cause of
failure mode? See DET table.

O
C
C

How often does the cause of the failure

mode occur? See OCC table.

Classify any special product or process

c haracteristics needing additional
c ontrols.

S
E
Potential Failure
Failure
Modes
V
Effects
Potential Causes
WhatFor
is theeach
impact Process Input,
What causes the input
on
the output
to go wrong?
determine
the ways in
variables (customer
which the input can
go
requirements)
What
could cause the
or internal
failure, in terms of
wrong.
requirements?
something that can be
corrected or controlled?
What are the effects
of the failure on the
function as perceived
by internal and
external customers?
How severe is the effect to the customer?
See SEV table.

Process Step
What is the process
step or input being
evaluated?

Potential Failure
Mode
In what way(s) could
the step or input fail to
meet the specificed
requirements?
Consider:
(A) No Function
(B)
Partial/Over/Degraded
Function
(C) Intermittent
Function
(D) Unintended
Function.

C
L
A
S
S

Operator places wrong

hardware and/or label
with kit

Work Instructions,
Pack Positive

Visual Inspection;
Scale to weigh kits

Bagger error

Work Instructions

Visual Inspection

TIP
There should be at least one failure mode for each input.
2014 Eaton. All Rights Reserved.

44

Potential Failure Mode

List all credible failure modes or ways the process/operation can fail in the
PFMEA document before addressing failure effects and failure causes
In each instance, the assumption is made that the failure could occur, but
will not necessarily occur
The failure mode:

is the manner in which the process could potentially fail to meet the process
requirements and/or design intent.
Is a description of nonconformance
Assumes incoming parts are correct
Considers subsequent operations

Typical failure modes could be, but are not limited to:

Bent
Open circuited
Dirty
Binding
Cracked
Improper setup
Burred
Deformed
Tool worn
Handling Damage

2014 Eaton. All Rights Reserved.

45

Example Failure Modes by Activity

Placement

Bend

Test

Insert

Missing Component

X Orientation

Accept NonConforming Part

Wrong Component

Z Orientation

Reject Conforming PartPartial Insertion

Multiple Components
X Location
Y Location
Z Location
Radial Orientation
Dirt Contamination
Damage
Upside down
Backwards

Y Orientation
Radial Orientation
Dirt Contamination
Damage
Flattened
Cracked
Folded
Broken fold
Scratch
Dents
Chips
Deformed
No bend

No test

No Insertion

Over Insertion

2014 Eaton. All Rights Reserved.

Remove / Unload

Index

Measure

Fails to Remove NonConforming Part

X-Y Orientation
Removes Conforming
Part
No index

Accept NonConforming Part

Miscategorization
No remove
Missed op
Damage
Contamination

No measure
Inaccurate Gaging

Reject Conforming Part

46

Example Failure Modes by Activity (cont.)

Stake

Dip

Package

No Stake

Missed Operation

Incorrect Qty

Under Stake
Over Stake

Partial Dip

Incorrect Label
Incorrect Box
Mixed Parts
Damage

Feed-Out
Wrong Wire
No Feed
Feed Too Short
Feed Too Long

Wind
Too Few Coils
Too Many Coils
Free Length Short
Free Length Long

Cut-Off
No Cut-Off

Initialize

Synchronize

Fail to Recognize
Fail to Clear Registers Station
Write Incorrect Value
to Register During
Clearing
No Synchronize

Press
High force
Low force
Tooling alignment
Too Fast Speed
Too slow speed
Short stroke
Over stroke

2014 Eaton. All Rights Reserved.

Load
Wrong part
Mix part
Dirty part
Wrong lane
Wrong orientation
Damage

Setup
Incorrect Setup

Pump-Up
Does not Pump-Up

Incomplete Setup
No Setup

Fill / Oil
Wrong fluid
Too much fluid
Too little fluid

Torque
Damaged component
No torque
Over torque

47

Example Failure Modes by Activity (cont.)

Rotate
Partial Rotation
Over Rotation
No rotation

Mark
Incomplete
Illegible
Wrong Mark

Grease

Mold

Wrong Grease
no grease
X-Y Orientation

Density variation
Dimension variation
Sink

Rotate to wrong side Missing Mark

Z Orientation

Flowlines

Damaged component Wrong location

Contamination

Damage
Too much
Too little
Contamination
Incorrect number of
greasing points

Shorts
Warp
Molded contamination
Weldlines
color variation
brittleness
scratches
drag marks
gate stubs
burns
flash
mixed parts
part count incorrect
bubbles
sirface contamination
voids
splay
damaged part
wrong part

2014 Eaton. All Rights Reserved.

48

PFMEA - Step 2
Potential Failure Effects
For each Failure Mode,
determine what effect
the specific failure
could have on the
process output.

TIPS
There should be at least one failure effect for each failure mode.
Effects should be specific, clear, and leave no doubt to the uninformed reviewer.
2014 Eaton. All Rights Reserved.

49

Potential Effect(s) of Failure

Effect of failure mode based on what customer
might notice/experience
Includes subsequent process operations
Typical effects may include, but are not limited to:
No Function
Partial/Over Function/Degraded over time
Intermittent Function
Unintended Function
Erratic operation

2014 Eaton. All Rights Reserved.

50

PFMEA Step 3

Class
Identify special product
or process
characteristics

2014 Eaton. All Rights Reserved.

51

PFMEA - Step 4

Potential Causes
For each Failure Mode,
determine the possible
cause of the failure.

TIP
There should be at least one potential cause for each failure mode.
2014 Eaton. All Rights Reserved.

52

Potential Cause(s) of Failure

how the failure could occur.

Described in terms of something that can be corrected/controlled
Requires determination of root cause
Sources of process variation that cause the failure mode to occur
Typical failure causes may include, but are not limited to:

Improper torque over, under

Improper weld current, time, pressure
Inaccurate gauging
Improper heat treat time, temperature
Inadequate gating/venting
Part missing or installed incorrectly
Thermocouple broken
Typographical error

2014 Eaton. All Rights Reserved.

53

PFMEA - Step 5

Current Controls
For each potential cause,
list the current method
used for preventing
and/or detecting failure.

TIPS

This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan.

If a procedure exists, enter the document number.

If no current control exists, list as none. There may not be both preventive and detection controls.
2014 Eaton. All Rights Reserved.

54

PFMEA - Step 6
Assign Detection
(How easily can the
cause or failure
mode be detected?)

Assign Severity
(How serious is the
effect if it fails?)

Assign
Occurrence
(How likely is
the cause to
occur?)

2014 Eaton. All Rights Reserved.

55

PFMEA - Definition of Terms

Severity (of Effect) - severity of the effect on the
Customer and other stakeholders (Higher Value =
Higher Severity)
Occurrence (of Cause) - frequency with which a given
Cause occurs and creates Failure Mode. (Higher Value
= Higher Probability of Occurrence)
Detection (Capability of Current Controls) - ability of
current control scheme to detect the cause before
creating the failure mode and/or the failure mode
before suffering the effect (Higher Value = Lower
Ability to Detect)
Caution: Notice the scale difference for Detection
2014 Eaton. All Rights Reserved.

56

Example: Severity Rating Definitions

Suggested PFMEA Severity Evaluation Criteria

Rank

10
9
8

6
5

Effect

Failure to Meet Potential failure mode affects safe Product operation and/or involves
noncompliance with government regulation without warning
Safety and/or
Regulatory
Potential failure mode affects safe Product operation and/or involves
Requirements
noncompliance with government regulation with warning
Loss or
Degradation of
Primary
Function

No Effect

May Endanger Operator (machine or assembly)

without warning
May Endanger Operator (machine or assembly) with
warning
100% of product may have to be scrapped. Line
shutdown or stop ship.

Degradation of primary function (Product operable, but at reduced

level of performance)

Significant
Disruption

A portion of the production run may have to be

scrapped. Deviation from primary process including
decrease line speed or added manpower.

Appearance or audible Noise, Product operable, item does not

conform and noticed by most customers (50%)
Appearance or audible Noise, Product operable, item does not
conform and noticed by most customers (<25%)

Failure to Meet
Safety and/or
Regulatory
Requirements
Major Disruption

Appearance or audible Noise, Product operable, item does not

conform and noticed by most customers (>75%)
Annoyance

Effect

Criteria:
Severity of Effect on Process
(Manufacturing / Assembly Effect)

Loss of primary function (Product inoperable, does not affect safe

Product operation)

Loss of secondary function (Product operable, but comfort /

Loss or
convenience functions inoperable)
Degradation of
Secondary
Degradation of secondary function (Product operable, but comfort /
Function
convenience functions at reduced level of performance)

4
3

Criteria:
Severity of Effect on Product
(Customer Effect)

No discernible effect

2014 Eaton. All Rights Reserved.

High Disruption

Moderate
Disruption

100% of production run may have to be reworked off

line and accepted
A portion of production run may have to be reworked
off line and accepted
100% of production run may have to be reworked in
station before it is processed.
A portion of production run may have to be reworked
in station before it is processed.

Minor Disruption Slight inconvenience to process operation or operator.

No Effect

No discernible effect

57

Example: Occurrence Rating Definitions

Suggested PFMEA Occurrence Evaluation Criteria

Rank

Likelihood of
Failure

10

Very High

9
8

High

Moderate

4
3
Low
2
1

=> 100 per Thousand

=> 1 in 10
50 per Thousand
1 in 20
20 per Thousand
1 in 50
10 per Thousand
1 in 100

6
5

Criteria:
Occurrence of Cause - DFMEA
(Incidents per Item / Products)

Very Low

2 per Thousand
1 in 500
0.5 per Thousand
1 in 2,000
0.1 per Thousand
1 in 10,000
0.01 per Thousand
1 in 100,000
=< 0.001 per Thousand
1 in 1,000,000
Failure is eliminated through preventive control
2014 Eaton. All Rights Reserved.

58

Example: Detection Rating Definitions

Suggested PFMEA Prevention / Detection Evaluation Criteria
Rank

Likelihood
of
Detection

Opportunity for Detection

10

Almost
Impossible

No Detection Opportunity

No Current Process Control; Cannot Detect or is not Analyzed

Very Remote

Not Likely to Detect at any Stage

Failure Mode and/or Error (Cause) is not easily detected (eg random audits)

Remote

Controls will probably not detect.

Problem detection post processing.

Failure Mode detection post processing by operator through visual tactile audible
means

Very Low

Controls have poor chance of detection

Problem detection at source.

Failure Mode detection in-station by operator through visual tactile audible means or
post processing through use of attribute gauging (go/no go, manual torque check /
clicker wrench etc.)

Low

Controls might detect.

Problem detection post processing.

Failure Mode detection post processing by operator through variable gauging or instation by operator through the use of attribute gauging (go/no go, manual torque
check / clicker wrench etc.)

Moderate

Controls might detect.

Problem detection at source.

Failure Mode or Error (Cause) detection in-station by operator through the use of
variable gauging or by automated controls in-station that will detect discrepant part
and notify operator (light buzzer etc.). Gauging performed on set-up and first piece
check (for set-up causes only)

Moderately
High

Controls may detect.

Problem detection post processing.

Failure Mode detection post processing by automated controls that will detect
discrepant part and lock part to prevent further processing.

High

Controls have a good chance to detect.

Problem detection at source.

Failure Mode detection in-station by automated controls that will detect discrepant
part and automatically lock part in station to prevent further processing.

Very High

Controls almost certain to detect.

Error detection and or problem prevention.

Error (Cause) detection in-station by automated controls that will detect error and
prevent discrepant part from being made.

Almost
Certain

Detection not applicable, error prevention.

Error (Cause) prevention as a result of fixture design, machine design or part design.
discrepant parts cannot be made because item has been error proofed by
process/product design.

Inspection Types
A - Error
BProofed Gauged

Criteria:
Likelihood of Detection by Design Control

CManual

2014 Eaton. All Rights Reserved.

59

PFMEA - Step 7
Process Step
Assemble Hardware Kit

Current Controls

Potential Failure
Mode

Potential Failure
Effects

Wrong and/or missing

parts/labeling (B)

Customer unable to
install product

Operator places wrong

hardware and/or label
with kit

Customer unable to
install product, due
to missing hardware.

Bagger error

Assemble Hardware Kit Bad seal (B)

TIPS

S
E
V

C
L
A
S
S

Potential Causes

O
C
C

D
E
T

R
P
N

Prevent

Detect

Work Instructions,
Pack Positive

Visual Inspection;
Scale to weigh kits

192

Work Instructions

Visual Inspection

128

Calculate the Risk Priority Number

RPN = Severity x Occurrence x Detection

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 - dont set an RPN
threshold
In addition to RPN, examine top Severity and Occurrence risks
2014 Eaton. All Rights Reserved.

60

PFMEA Remediation Guidelines

Severity can only be improved by a design
change to the product or process
Occurrence can only be reduced by a change
which removes or controls a cause. Examples are
redundancy, substituting a more reliable
component or function or mistake-proofing.
Detection can be improved by deploying better
controls. Examples are mistake-proofing,
simplification and statistically sound monitoring.
In general, reducing the Occurrence
is preferable to improving the Detection
2014 Eaton. All Rights Reserved.

61

FMEA Step 8
Current Controls

Prevent

Detect

Work Instructions,
Pack Positive

Visual Inspection;
Scale to weigh kits

Work Instructions

Visual Inspection

D
E
T

R
P
N

192

128

Actions
Recommended
Implement scale to
weigh hardware kits

Repair/replace worn
bagger

S
E
V

O
C
C

D
E
T

R
P
N

Responsible

Actions Taken

Kolumban

7/11/11 - Scale implmented to

weigh kits. SK.- Complete

120

Zindler

2010 Capital Plan - New HM

Autobagger. Follow status on
HM 2010 VSM implementation
plan.
7/11/11 - New Bagger
implemented 3Q 2010. APZ Complete

64

For the high risk items,

determine the
recommended actions.

2014 Eaton. All Rights Reserved.

62

FMEA Steps 9 and 10

Current Controls

Prevent

Detect

Work Instructions,
Pack Positive

Visual Inspection;
Scale to weigh kits

Resp
(responsibility)
Work Instructions
Visual Inspection
Assign a specific person
who will be responsible
for recommended actions.

D
E
T

R
P
N

192

128

Actions
Recommended

S
E
V

O
C
C

D
E
T

R
P
N

Responsible

Actions Taken

Kolumban

7/11/11 - Scale implmented to

weigh kits. SK.- Complete

120

Zindler

2010 Capital Plan - New HM

Autobagger. Follow status on
HM 2010 VSM implementation
plan.
7/11/11 - New Bagger
implemented 3Q 2010. APZ Complete

64

Implement scale to
weigh hardware kits

Repair/replace worn
bagger

Actions Taken
As actions are identified
and completed, document
in the Actions Taken
column.

2014 Eaton. All Rights Reserved.

SEV, OCC, DET, RPN

As actions are complete
reassess Severity,
Occurrence, and Detection
and recalculate RPN.
63

Summary Steps To Complete a FMEA

1.

For each Process Input, determine the ways in which the Process
Step can go wrong (these are Failure Modes)
2. For each Failure Mode associated with the inputs, determine
Effects on the outputs
3. Mark special characteristics (product and process)
4. Identify potential Causes of each Failure Mode
5. List the Current Controls for each Cause
6. Assign Severity, Occurrence and Detection ratings after creating
a ratings key appropriate for your project
7. Calculate RPN
8. Determine Recommended Actions to reduce high risks
9. Take appropriate Actions and Document
10. Recalculate RPNs
11. Revisit steps 7 and 8 to continually reduce risks

2014 Eaton. All Rights Reserved.

64

Example: Good PFMEA

PROCESS OR
Product Family XYZ
PRODUCT
TEAM
MEMBERS:
John Smith, Jane Doe, Sun Tzu, Szent Istv n, John of Gaunt

Process
step/Input

Potential
Potential
Failure Mode Failure Effects

S
E
V

C
l
a
s
s

Operator turns off

grease, grease not
pumping, or barrel
empty

7
No grease in
bearing sleeve

Op 35.
Test and
grease

No grease in
bearing
(Product Z
only)

Sleeve/bearing
wears out warranty claim

Customer will
not be able to
install

Damage to
mounting
holes

cosmetic issue
and potential
effect on bolt
torque

DATE (Orig)

O Current PROCESS Current PROCESS D

C
E
Controls
Controls
C
T
- Prevention - Detection -

Visual inspection

R
P
N

Actions
Recommended

Add message to
prompt the
operator that the
grease is off. Add
sensor to grease
280 valve to sense that
it is firing.

3/1/2002

Add sensors to
confirm correct
voume block is
used

Actions Taken

S
E
V

O
C
C

D
E
T

R
P
N

BPB. October
2004
Completed

New prompt and

sensor

120

96

Modified equipment
and changed
program to look at
sensors

64

64

64

Impropoer grease
volume block used

Visual inspection

112

Grease not
pumping or barrel
empty

Visual inspection

Add new sensors

PT. October 2010
112 to detect pumping
New sensors added
Completed
of air

TP12

Impropoer grease
volume block used

Visual inspection

112

Wrong set-up

100% inspection of
housing in tester

48

Part mislocated in
tester fixture

100% visual check

120

Add sensors to
confirm correct
voume block is
used

PT. October 2010

Completed

PT. October 2010

Completed

Modified equipment
and changed
program to look at
sensors

0
Modify program to
PT. December
prompt operator to
2010 Completed
check orientation
Change design of
fixture and
locators

2014 Eaton. All Rights Reserved.

(REV) 3/1/2011

Resp.

Add new sensors

PT. October 2010
to detect pumping
New sensors added
Completed
of air

Premature
bearing/sleeve
failure - warranty
claim
7

Wrong bearing
housing

Potential
Causes(s)
of Failure

RESPONSIBLE
TEAM LEADER: Jane Doe

PT. February
2011 Completed

Modified program

105

Installed March
2011

70

65

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
2014 Eaton. All Rights Reserved.

66

Progress Check: PFMEA and APQP

In which APQP phase would you first create a PFMEA?
APQP: Phase 3 Process Design

Which of the following activities should be done before

the PFMEA?

Purchase capital equipment

After
Create the DFMEA
Purchase End of Line Testers
Make Tools/Molds
After

Which FMEA risks After

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

2014 Eaton. All Rights Reserved.

67

PPAP Element #7: Control Plan

What is It?
A document that describes
how to control the critical
inputs (FMEA) to continue to
meet customer expectations

Objective? - Planning
Needed gaging, testing, error
proofing
Sampling and frequencies
How to react when something
fails a test or inspection

When to Use It
Implementing a new process
Implementing a process
change

Since processes are expected to be continuously

updated and improved, the control plan
is a living document!

2014 Eaton. All Rights Reserved.

68

Control Plan
Tool Interaction
Department/Group Project
High Level Process Map

Project Idea

6 Sigma Project
High Level Process Map

Process Step
Fill Out Master
Form
with Initial
Information

Get WO Assigned

Begin/Work
Project
Follow DMAIC or
DFSS process

6 Sigma Assigns
Project Number

Other Required
Signatures:
Segment CEO
Champion
Process Owner
BB or GB

Monitor Progress
through Power
Steering and
Monthly
Financial
Reviews

Finance Approval
and Signature

No

Finance Approval
and Signature
No

Enter Remaining
Information on
Master Form

Do you
have BB/GB to
Assist/Work the
project?

Monitor Progress
through BiWeekly Updates
and Monthly
Reviews

6 Sigma
Project

Does the
Project Involve
>2 Groups in
Eng?

Yes

Department
or Group
Project

Identify
Customer

Identify Invoice

Enter Remaining
Information on
Master Form

Does the
Project Involve
>3 Depts.
outside Eng?

Delay internal
mail

Potential
Failure Effects
AR balance does
not go down

Wire
Transfer
reference
line

Information not AR balance is

supplied
past due

Checks

Incorrect
invoice
supplied

Finance Approval
and Signature

Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB

No

Yes

Yes

Process Steps

Follow DMAIC or
DFSS process

Checks

Potential
Failure Mode

S
E Potential Causes
V
Inadequate
staffing in mail
7 room
Customer or bank
did not include
name and/or
10 account info on
wire transfer

Final Project
Review

No

No

Close
Project

Begin/Work
Project

Is Hard
Savings > $???

Does the
Project Involve
Only Your
Group?

Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB

Receive
Payment

Get DLN
Assigned

Complete Project
(Has to be fully
Documented)

Master Form Will

Generate
Contract

Finance Approval
and Signature

Complete all
Documentation
including a
(1) Page Closeout Sheet

Group Assigns
Project Number

Yes

Yes

Final Project
Review

Prefer to work
this project
within your
area?
Yes

Master Form Will

Generate
Contract

Complete Project
(Has to be fully
Documented

Other Required
Signatures:
Champion:
Process Owner
Project Owner
Dept GB/BB/MBB

Key
Process
Input

No

Close
Project

Complete all
Documentation
including a
(1) Page Closeout Sheet

Identify Invoice

New/Revised Process Steps

Checks

Invoice shows
outstanding (AR
balance does go
down)

Customer error

Invoice number Invoice shows

not supplied
outstanding (AR
balance does go
down)

Customer error

O
C
C

Current Controls

D
E
T

R
P
N

None
7

10 490

Acct identifies problem

when trying to apply
payment

E
O
C

Actions
Recommended
Investigate mail room
staffing and associated
processes

Poka-Yoke wire transer N

process
5

250

d
ze
i
it p
or Ste
i
Pr ss
sk ce
Ri ro
P

Customer might catch

it when reviewing the
5 next statement

Acct identifies problem

when trying to apply
10 payment

10 250

Provide payment stub

A.
with statement for each
invoice

Provide payment stub

S.
with statement for each
invoice

250

Process FMEA

Process Flowchart

Control Plan
Pr
oc
es

2014 Eaton. All Rights Reserved.

69

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

2014 Eaton. All Rights Reserved.

CONTROL
METHOD

REACTION
PLAN

70

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

Administrative Section
Identifies part number and description,
supplier, required approval signatures,
and dates.

2014 Eaton. All Rights Reserved.

71

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

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
2014 Eaton. All Rights Reserved.

72

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

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
2014 Eaton. All Rights Reserved.

73

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

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
2014 Eaton. All Rights Reserved.

74

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
2014 Eaton. All Rights Reserved.

75

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

Class refers to special characteristics

product or process. Should align with
FMEA

2014 Eaton. All Rights Reserved.

76

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

This is a specification from the Design Record or a key

process parameter

2014 Eaton. All Rights Reserved.

77

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

How is the characteristic or parameter going to

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

2014 Eaton. All Rights Reserved.

78

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

Organization Code

ORGANIZATION

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

How many parts will be measured and how often.

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

2014 Eaton. All Rights Reserved.

79

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

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

2014 Eaton. All Rights Reserved.

80

The Control Plan Form

Prototype

CONTROL PLAN

Pre-Launch

Production

Control Plan Number

Key Contact/Phone

FILE.XLS

Date (Orig.)

555-555-5555

Part Number/Latest Change Level

NUMBER

Date (Rev.)

1/1/1996

1/1/1996

Core Team

Customer Engineering Approval/Date (If Req'd.)

Organization/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

ECL

Part Name/Description

NAME
Organization/Plant

ORGANIZATION

Organization Code

CODE

MACHINE,
CHARACTERISTICS
METHODS
PART/ PROCESS NAME/
SPECIAL
DEVICE
SAMPLE
PROCESS
OPERATION
CHAR. PRODUCT/PROCESSEVALUATION/
JIG, TOOLS
NO. PRODUCT PROCESS CLASS
SPECIFICATION/ MEASUREMENT
NUMBER DESCRIPTION
SIZE
FREQ.
FOR MFG.
TOLERANCE
TECHNIQUE

CONTROL
METHOD

REACTION
PLAN

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
2014 Eaton. All Rights Reserved.

81

Control Plan Example

A supplier manufactures a circuit board with electronic components soldered on the board.
Properly soldered connections are the major product characteristics. Two major process
characteristics for the wave solder machine are solder level and flux concentration. An
automated feeder controls the solder level by sensing the level of solder and feeding in
additional solder as the level is reduced. This characteristic is measured 100% by
checking electrically for continuity. The flux must be sampled and tested for the
concentration level.

CONTROL PLAN
Prototype

Pre-Launch

Control Plan Number

002
Part Number/Latest Change Level
54321231 / D
Part Name/Description
Electronic Circuit Board
Supplier/Plant
Supplier Code
ACR Control
439412
Part /
Process
Number

Machine,
Process Name
Device,
/ Operation
Jig, Tools,
Description
for MFG.

Soldering
Connections

Wave
solder
machine

Production
Key Contact/Phone
T. Smith / 313-555-5555
Core Team
Erin Hope, Alan Burt, Ken Light
Supplier/Plant Approval/Date

Date:(Org.)
Date (Rev.)
11/29/2009
2/20/2010
Customer Engineering Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Characteristics
No.

Product

Customer Quality Approval/Date(If Req'd.)

Methods

Process

Wave
solder
height

Special
Char.
Class

Product/Process Evaluation /
Specification/ Measurement
Tolerance
Technique

2.0 +/- .25 mc

Flux
concen tration

Standard #302B

2014 Eaton. All Rights Reserved.

Sensor
continuity
check
Test sampling
lab
environment

Sample
Size

100%

1 pc

Freq.

Control
Method

Automated
inspection
(error
Continuous proofing)

4 hours

Reaction
Plan

Adjust and
retest

Segregate
x-MR chart and retest

82

Control Plan: Reviewers 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

All testing requirements - dimensional, material, and performance

All product and process characteristics at every step throughout the process

Specifications, tooling, etc.

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:
The control method should be based on an effective analysis of the
process
Control plans should reference other documentation

2014 Eaton. All Rights Reserved.

83

Control Plan and APQP

In what APQP Phase would you first create a
control plan?
Prototype CP in Phase 2: Product Design
Pre-production CP in Phase 3: Process Design
Production CP in Phase 4: Validation

How does the reaction plan help with process

design?
Identify rework needs, quarantine product location
needs, etc.

2014 Eaton. All Rights Reserved.

84

PPAP Element #8:

Measurement System Analysis (MSA)
What is It?
An MSA is a statistical tool used to
determine if a measurement system
is capable of precise measurement.
Objective or Purpose
To determine how much error is in
the measurement due to the
measurement process itself.

When to Use It
On systems measuring critical inputs
and outputs prior to collecting data for
analysis.
For any new or modified process in
order to ensure the quality of the data.
Who Should be Involved
Everyone that measures and makes
decisions about these measurements
should be involved in the MSA.

Quantifies the variability added by

the measurement system.
Applicable to attribute data and
variable data.
IMPORTANT!
Measurement System Analysis is
an analysis of the measurement
process, not an analysis of the
people!!

2014 Eaton. All Rights Reserved.

85

Inspection what do you really see?

2014 Eaton. All Rights Reserved.

86

Measurement System Analysis (MSA)

Observed Variation
Resolution
Precision

(Variability)

Repeatability
Reproducibility

Measurement
System
Variation
Linearity
Accuracy

Observed
Variation

(Central
Location)

Bias
Stability

Process
Variation

Calibration helps address accuracy

2014 Eaton. All Rights Reserved.

87

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.

2014 Eaton. All Rights Reserved.

88

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.

2014 Eaton. All Rights Reserved.

Equipment Variation

89

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

2014 Eaton. All Rights Reserved.

90

Variable MSA Gage R&R Study

Gage R&R is the combined estimate of
measurement system Repeatability and
Reproducibility
Typically, a 3-person study is performed
Each person randomly measures 10 marked parts per trial
Each person can perform up to 3 trials

There are 3 key indicators

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

2014 Eaton. All Rights Reserved.

91

Variable MSA AIAG GR&R VAR(Tol)

GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET
VARIABLE DATA RESULTS
Part Number

Gage Name

Appraiser A

GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET

VARIABLE DATA RESULTS
Part Number

NUMBER

Gage Name

Appraiser A

Gage Number

Appraiser B

Characteristic

Gage Type

Appraiser C

Characteristic Classification

Trials

NUMBER

Part Name

Gage Number

Appraiser B

Part Name

NAME

NAME

Characteristic

Specification

Gage Type

Appraiser C

Lower Upper
Characteristic Classification

Trials

Parts

APPRAISER/

Appraisers

Date Performed

PART

1. A

2.

10

Appraisers

Measurement Unit Analysis

AVERAGE

Included in PPAP Workbook

TRIAL #

Parts

Date Performed

% Tolerance (Tol)

Repeatability - Equipment Variation (EV)

EV

Trials

K1

0.8862

0.5908

3.

4.

AVE

5.

6. B

7.

8.

9.

AVE

b=

10.

b=

xa=
ra=

Automatically calculatesx
r
%GRR, %PV, ndc

R x K1

% EV

Reproducibility - Appraiser Variation (AV)

AV

1/2

{(xDIFF x K 2) - (EV /nr)}

% AV

n = parts

r = trials

K2

0.7071

0.5231

Repeatability & Reproducibility (GRR)

2

2 1/2

{(EV + AV )}

% GRR

Parts

K3

12.

0.7071

13.

0.5231

14.

AVE

0.4467

15.

0.4030

0.3742

0.3534

0.3375

Part Variation (PV)

PV

X=

16. PART

Rp=

AVERAGE
17.

(ra +

18.

x DIFF = (Max

19.

* UCLR =

R=

rb + rc ) / (# OF APPRAISERS) =
x - Min x) =

xDIFF =

R x D4 =

UCLR =

RP x K 3

Tolerance (Tol)
Tol

Upper - Lower / 6

0.3249

( Upper - Lower ) / 6

10

0.3146

100 (AV/Tol)

Appraisers

GRR

11. C

xc =
rc =

100 (EV/Tol)

% PV

ndc

100 (GRR/Tol)

100 (PV/Tol)

1.41(PV/GRR)

=
=

* 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:

2014 Eaton. All Rights Reserved.

92

Variable MSA Gage R&R Steps

Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Step 7

Step 8

Step 9

1.

Select 10 items that represent the full range of long-term process variation

2.

Identify the appraisers they should be operator who normally use the gage

3.

If appropriate, calibrate the gage or verify that the last calibration date is valid

4.

Open the GR&R VAR(Tol) worksheet in the AIAG Core Tools file to record data, or use
MiniTab

5.

Have each appraiser assess each part 3 times preferably in random order (Minitab can
generate a random run order)

6.

Input data into the GR&R VAR(Tol) worksheet or MiniTab

7.

Enter the number of operators, trials, samples and specification limits

8.

Analyze data and review GR&R and PV values

9.

Take actions for improvement if necessary.

2014 Eaton. All Rights Reserved.

93

Measurements Systems Analysis MSA

Tips and Lessons Learned
Important: An MSA is an analysis of the process, not an analysis of the

people. If an MSA fails, the process failed.

A Variable MSA provides more analysis capability than an Attribute MSA.
For this and other reasons, always use variable data if possible.
The involvement of people is the key to success.
Involve the people that actually work the process
Involve the supervision
Involve the suppliers and customers of the process

An MSA primarily addresses precision with limited accuracy information.

2014 Eaton. All Rights Reserved.

94

MSA: Reviewers 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

2014 Eaton. All Rights Reserved.

95

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

2014 Eaton. All Rights Reserved.

96

PPAP Element #9: Dimensional Results

Production Part Approval / Dimensional Test Results
Supplier 0
Supplier / Vender Code
Inspection Facility

Item

Dimension /
Specification

Corporate SCM Form-XX (Rev. A, 2014)

Part Number 0
Part Name
Design Record Change Level 0
Engineering Change Document
Specification /
Limits

Test
Date

Qty.
Tested

Measurement Method

Supplier Measurement
Results (DATA)

OK

Not
OK

Objective or Purpose

What is It?
Evidence that dimensional verifications
have been completed and results
indicate compliance with specified
requirements

To show conformance to the

customer part print on dimensions
and all other noted requirements
When to Use It

For each unique manufacturing

process (e.g., cells or production
lines and all molds, patterns, or
dies
2014 Eaton. All Rights Reserved.

97

Dimensional Results
Reviewers 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.

2014 Eaton. All Rights Reserved.

98

PPAP Element #10: Records of

Material/Performance Test Results
Material Test Results
The supplier shall perform tests for all parts and product
materials when chemical, physical, or metallurgical
requirements are specified by the design record or
Control Plan
For products with Eaton-developed material
specifications and/or an Eaton-approved supplier list,
the supplier shall procure materials and/or services from
suppliers on that list

Performance Test Results

The supplier shall perform tests for all parts or product
materials when performance or functional requirements
are specified by the design record or Control Plan

2014 Eaton. All Rights Reserved.

99

Material Results
Production Part Approval
Material Test Results
ORGANIZATION:

PART NUMBER:

SUPPLIER / VENDOR CODE:

PART NAME:

MATERIAL SUPPLIER:

DESIGN RECORD CHANGE LEVEL:

*CUSTOMER SPECIFIED SUPPLIER / VENDOR CODE:

ENGINEERING CHANGE DOCUMENTS:

*If source approval is req'd, include the Supplier (Source) & Customer assigned code.

NAME of LABORATORY:
QTY.
SUPPLIER TEST RESULTS (DATA) OK
TESTED

MATERIAL SPEC. NO. / REV / DATE

SPECIFICATION /
LIMITS

TEST
DATE

NOT
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

2014 Eaton. All Rights Reserved.

100

Performance Test Results

ORGANIZATION:

ORGANIZATION
SUPPLIER / VENDOR CODE:
CODE

PART NUMBER: NUMBER

PART NAME:
NAME

NAME of LABORATORY:

DESIGN RECORD CHANGE LEVEL:

*CUSTOMER SPECIFIED SUPPLIER / VENDOR CODE:

ENGINEERING CHANGE DOCUMENTS:

ECL

*If source approval is req'd, include the Supplier (Source) & Customer assigned code.

TEST SPECIFICATION / REV / DATE

SPECIFICATION /
LIMITS

TEST
DATE

QTY.
SUPPLIER TEST RESULTS (DATA)/
OK
TESTED
TEST CONDITIONS

NOT
OK

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

Blanket statements of conformance are unacceptable for any test results.

SIGNATURE

2014 Eaton. All Rights Reserved.

TITLE

DATE

101

PPAP Element #11: Initial Process Studies

Capability studies are measures

of how well the process is
meeting the design
requirements.
Is the process employed Stable
and Capable?

MSA before Cpk

MSA must be acceptable and
should represent tools/process
used for Initial Process Studies

>1.67 Cpk for SCs, >1.33 for

other characteristics
Cpk & Ppk minimums are
higher for initial release vs.
ongoing

2014 Eaton. All Rights Reserved.

102

PPAP Element #11: Initial Process Study

Purposes of Initial Process Study
To evaluate how well a process can produce product that
meets specifications
To provide guidance about how to improve capability
better process centering
reduced variation

Capability studies can be used to identify a problem or to

verify permanent corrective actions in the problem solving
process.

2014 Eaton. All Rights Reserved.

103

Process Capability:
The Two Voices

2014 Eaton. All Rights Reserved.

104

Examples of Non-Capable Processes

Product produced
beyond both
Upper and Lower
Spec Limits.

Product produced
above the
Upper Spec Limit.

2014 Eaton. All Rights Reserved.

Product produced
below the
Lower Spec Limit.

105

Capability Studies
Process Data for Co2
15
UCL=14.18

Individual Value

14
13

X=12.64

12
LCL=11.10

11
10
9
0

50

100

150

A short-term capability study

covers a relative short period of
time during which extraneous
sources of variation have been
excluded. (Guideline: 30-50
data points.)

Observation Number

Process Data for Co2

15
UCL=14.18

Individual Value

14
13

X=12.64

12
LCL=11.10

11
10
9
0

50

100

A long-term capability study

covers a longer period of time in
which there is more chance for a
process shift. (Guideline: 100-200
data points.)

150

Observation Number

2014 Eaton. All Rights Reserved.

106

Steps for Determining Process Capability

Step 1

Step 2 Step 3

Step 4

Step 5

Step 6 Step 7

1. Decide on the product or process characteristic to

be assessed
2. Verify the specification limits
3. Validate the measurement system
4. Collect data per sample size/frequency in Control
Plan
5. Assess data characteristics
6. Assess process stability
Lets take a closer look
at data characteristics
7. Calculate process capability
and process capability

2014 Eaton. All Rights Reserved.

107

Step 5: Data Characteristics

Step 5

Assess data characteristics

Histogram of Mfg Hours
Mean
StDev
N

20

Examine the shape of your data.

14.87
3.088
100

15
yc neuqer F

Is it what you would expect?

If not, investigate.

10

10

12

14
16
Mfg Hours

18

20

22

Bimodal Data
Histogram of Mfg Hours

Histogram of Mfg Hours

Mean
StDev
N

25

19.98
1.713
100

20

Mean
StDev
N

15

20

yc neuqer F

yc neuqerF

The shape of your data is

important for determining
which type of Capability
Analysis applies. If the
data exhibits a non-normal
shape, consult your
statistics reference.

15

10

10

5
5

16

18

20
Mfg Hours

22

Normal Data

2014 Eaton. All Rights Reserved.

24

-15

15

30
45
Mfg Hours

60

75

Skewed Data

108

20.19
18.87
100

Step 6: Process Stability

Step 6

Assess process stability in order to understand

how your process behaves over time. Control
charts are the recommended tool.

Control Chart Examples

Process is stable and in

control

Process is not stable and

therefore not in control

Capability is only valid

when the process being
studied is stable!

2014 Eaton. All Rights Reserved.

109

Difference between Cp & Cpk

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

Cp > 1.67
Cpk < 1.00
Capable,
Not Centered

Capable,
Centered
LSL

LSL

USL

USL

LSL

USL

Cp < 1.00
Cpk < 1.00

Cp < 1.00
Cpk < 0

Not Capable,
Centered

Not Capable,
Not Centered
LSL

2014 Eaton. All Rights Reserved.

USL

110

Acceptance Criteria
Acceptance criteria for critical vs. non-critical characteristics

Red (Bad)
Yellow (Marginal)
Green (Good)

Short-term

Long-term

<1.33

<1.00

1.33-1.67

1.00-1.33

>1.67

>1.33

Decision

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

2014 Eaton. All Rights Reserved.

111

Initial Process Study: Reviewers 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

2014 Eaton. All Rights Reserved.

112

PPAP Element #12:

Qualified Laboratory Documentation
Inspection and testing for PPAP shall be performed by
a qualified laboratory (e.g., an accredited laboratory).
The qualified laboratory (internal or external to the
supplier) shall have a laboratory scope and
documentation showing that the laboratory is qualified
for the type of measurements or tests conducted
When an external laboratory is used, the supplier shall
submit the test results on the laboratory letterhead or the
normal laboratory report format
The name of the laboratory that performed the tests, the
date(s) of the tests, and the standards used to run the tests
shall be identified.
Eaton to validate results to specifications.

2014 Eaton. All Rights Reserved.

113

PPAP Element #13:

Appearance Approval Report
What is It?

APPEARANCE APPROVAL REPORT

PART

DRAWING

NUMBER

NUMBER

PART

BUYER

NAME

APPLICATION
(VEHICLES)
E/C LEVEL

DATE

CODE

ORGANIZATION

MANUFACTURING

SUPPLIER / VENDOR

NAME

LOCATION

CODE

REASON FOR

PART SUBMISSION WARRANT

SPECIAL SAMPLE

RE-SUBMISSION

SUBMISSION

PRE TEXTURE

FIRST PRODUCTION SHIPMENT

ENGINEERING CHANGE

OTHER

APPEARANCE EVALUATION
AUTHORIZED CUSTOMER

ORGANIZATION SOURCING AND TEXTURE INFORMATION

A report completed by the supplier

containing appearance and color
criteria

PRE-TEXTURE REPRESENTATIVE
EVALUATION
SIGNATURE AND DATE
CORRECT AND
PROCEED
CORRECT AND
PROCEED

Objective or Purpose

APPROVED TO
ETCH/TOOL/EDM

COLOR EVALUATION
METALLIC COLOR
COLOR

TRISTIMULUS DATA

MASTER MASTER MATERIALMATERIAL

SUFFIX DL* Da* Db* DE* CMC NUMBER

DATE

TYPE

SOURCE

HUE
RED

YEL

GRN

VALUE
BLU

CHROMA

LIGHT DARK GRAY CLEAN

GLOSS
HIGH

LOW

BRILLIANCESHIPPING
HIGH

LOW

PART

SUFFIX DISPOSITION

To demonstrate that the part has

met the appearance requirements
on the design record
When to Use It
Prior to tooling for production

IMPORTANT!
Only applies for parts with color, grain,
or surface appearance requirements

2014 Eaton. All Rights Reserved.

114

Appearance Approval Report

APPEARANCE APPROVAL REPORT
PART

DRAWING

NUMBER

NUMBER

PART

BUYER

NAME

CODE

ORGANIZATION

APPLICATION
(VEHICLES)
E/C LEVEL

DATE

MANUFACTURING

NAME

SUPPLIER / VENDOR

LOCATION

CODE

REASON FOR

PART SUBMISSION WARRANT

SPECIAL SAMPLE

RE-SUBMISSION

SUBMISSION

PRE TEXTURE

FIRST PRODUCTION SHIPMENT

ENGINEERING CHANGE

OTHER

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
COLOR

TRISTIMULUS DATA

Administrative
Section
HUE
VALUE
CHROMA GLOSS
DATE
TYPE
SOURCE
Identifies part number and description,
supplier, required approval signatures, and
dates.

MASTER MASTER MATERIALMATERIAL

SUFFIX DL* Da* Db* DE* CMC NUMBER

RED

YEL

GRN

BLU

2014 Eaton. All Rights Reserved.

LIGHT DARK GRAY CLEAN

HIGH

LOW

METALLIC COLOR
BRILLIANCESHIPPING
HIGH

LOW

PART

SUFFIX DISPOSITION

115

Appearance Approval Report

APPEARANCE APPROVAL REPORT
PART

DRAWING

NUMBER

NUMBER

APPLICATION

NUMBER

PART

NAME

NAME

DATE

ECL
ADDRESS
CITY

MANUFACTURING

ORGANIZATION

NAME

E/C LEVEL

CODE

ORGANIZATION

APPLICATION

(VEHICLES)

BUYER

LOCATION

SUPPLIER / VENDOR

STATE

ZIP CODE

REASON FOR

PART SUBMISSION WARRANT

SPECIAL SAMPLE

RE-SUBMISSION

SUBMISSION

PRE TEXTURE

FIRST PRODUCTION SHIPMENT

ENGINEERING CHANGE

CODE

OTHER

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 MATERIALMATERIAL

SUFFIX DL* Da* Db* DE* CMC NUMBER

DATE

TYPE

SOURCE

HUE
RED

YEL

GRN

VALUE
BLU

CHROMA

LIGHT DARK GRAY CLEAN

GLOSS
HIGH

LOW

BRILLIANCESHIPPING
HIGH

LOW

PART

SUFFIX DISPOSITION

Appearance Evaluation Details

Identifies supplier sourcing, texture information
and submission customer signature.
COMMENTS

2014 Eaton. All Rights Reserved.

116

Appearance Approval Report

COLOR EVALUATION
METALLIC COLOR
COLOR

TRISTIMULUS DATA

MASTER MASTER MATERIALMATERIAL

SUFFIX DL* Da* Db* DE* CMC NUMBER

DATE

TYPE

SOURCE

HUE
RED

YEL

GRN

VALUE
BLU

CHROMA

LIGHT DARK GRAY CLEAN

GLOSS BRILLIANCESHIPPING
HIGH

LOW

HIGH

LOW

PART

SUFFIX DISPOSITION

COMMENTS

ORGANIZATION
SIGNATURE

PHONE NO.

DATE

AUTHORIZED CUSTOMER

DATE

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
2014 Eaton. All Rights Reserved.

117

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

2014 Eaton. All Rights Reserved.

118

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
Eaton Engineering, Manufacturing and Quality

2014 Eaton. All Rights Reserved.

119

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

2014 Eaton. All Rights Reserved.

120

PPAP Element #15: Master Samples

PPAP Element #16: Checking Aids

Master Sample (PPAP Element #15)

The perfect or golden sample that subsequent parts can be compared
against
Often the first good part off a new tool for injection molding or stamping
Is sometimes used to verify testing equipment and measurement systems
Master samples are not normal for every product or manufacturing
process

Checking aid (PPAP Element #16)

Tools, gages, or test equipment, used to inspect production parts
Examples include:
Visual standards for color or appearance
Shadow boards or templates used to verify general shape or presence of required
features
Custom gages

2014 Eaton. All Rights Reserved.

121

PPAP Element #17: Eaton Requirements

APQP Kickoff - team

APQP Timeline Template
These items all have templates in
Action Item Log
the PPAP Workbook many of
Production Feasibility Agreement (PFA)
which are self-explanatory
Gage Plan
Dimensional Correlation Matrix
Pass Through Characteristics (PTC)
Safe Launch Control Plan
Items in blue have
AS 9102 Forms (Aerospace Industry)
additional instructions
Ramp Up & Down Plan
embedded in the PPAP
Packaging Specification Data Sheet
Workbook
Submit Bar Code Label Packaging Approval
PPAP Interim Recovery Worksheet
Capacity R@R Worksheet
Production Readiness Review (PRR)
Lets take a closer look
at the items in red

2014 Eaton. All Rights Reserved.

122

Production Feasibility Agreement (PFA)

Production Feasibility Agreement (PFA)
Supplier Name: 0
Supplier Address:
Eaton Purchasing Rep.:
Signature and Date:

Part Number: 0
Part Name / Description
Part Family (if Applicable):
Revision Level: 0

Corporate SCM Form-XX (Rev. A, 2014)

Initial PFA:
Interim PFA:
Final PFA:
PFA Version:
Page:
1 of xx
Eaton Input Data

Eaton Plant:
Part Risk Level:
Date Submitted:
Any Issue:

Note: Eaton recommends that this agreement be completed by the quoting supplier's production, quality or engineering staff. Add rows as required.
Supplier Input Data

Special
Confirm supplier (you)
Measure and input at
Print Requirements
Evaluation
Characteristics
are capable of
the completion of
(Including all Dimensions,
Measurement
/ Critical To
manufacture and meet
PPAP run
Notes and Specifications or
Technique
Quality (CTQ) the require specification
as instructed by Eaton)
(Gage used)
(Yes or No)
(Yes / No)
SPC
PpK / CpK

Eaton Engineering or Quality Representative Only!

Supplier Comments
Eaton Agrees
(Yes / No)

Comment

Specification
Change Required

Eaton Agrees
(Yes / No)

Comment

Specification
Change Required

Eaton Agrees
(Yes / No)

Comment

Specification
Change Required

- 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
13
14
15
16
17
18
19
20
21
22
23
24
OTHER REQUIREMENTS: Please include any exceptions to print notes, referenced specifications, Gerber files, schematics, reference drawings , assembly drawings, plating,
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.
1
2
3
4
5
IMPORT SPECIFIC REQUIREMENTS: Add rows as required. Please refer to the Supplier Excellence Manual for further clarifications of governing requirements.

Material COA Requirement

(Raw Material Composition
Test)

Please identify material standard and where The test will Be

done (3rd party lab / supplier plant lab / material supplier)

Material Performance Test

Please identify which test can be done and where (3rd party
lab / supplier plant lab / material supplier)
For material part or Casting process part, please identify
whether the product's radiation conforms with all specific
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

Product safety requirement

3

4
5
#
Caliper 1
CMM 2
3
Color Chip
4
Drop Gage

Team Feasibility Commitment Questions

Consideration
Yes / No
Is product adequately defined (application requirements, etc. to enable feasibility evaluation?

Comments

Lessons Learned

Can Engineering Performance Specifications be met as written?

Can product be manufactured to tolerances specified on drawing?
Can product be manufactured with Cpk's that meet requirements?

Is there adequate capacity to produce product?

5
Gage Blocks
Does the design allow the use of efficient material handling techniques?
6
Height Gage
Is statistical process control required on the product?
7
Micrometer
Is statistical process control presently used on similar products?
Optical 8Comparator
Where statistical process control is used on similar products:
Overlay9
Are the processes in control and stable?
9a
Pin Gage
Are Cpk's greater than 1.33?
9b
Profilometer
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

The PFA is designed

to ensure the
supplier clearly
understands and can
meet all Eaton
design requirements
It also provides a
formal way to solicit
and track supplier
design input

2014 Eaton. All Rights Reserved.

123

PFA (cont.)

orporate 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

2014 Eaton. All Rights Reserved.

124

PFA (cont.)
Supplier Input Data

Evaluation
Special
Confirm supplier (you)
Measure and input at
Print Requirements
Measurem
Characteristics
are capable of
the completion of
(Including all Dimensions,
ent
/ Critical To
manufacture and meet
PPAP run
Notes and Specifications or
Technique
Quality (CTQ) the require specification
as instructed by Eaton)
(Gage
(Yes or No)
(Yes / No)
used)
SPC
PpK / CpK

Supplier Comments

- 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
2014 Eaton. All Rights Reserved.

125

PFA (cont.)
Eaton Input Data

Eaton Engineering or Quality Representative Only!

Eaton Agrees
(Yes / No)

Comment

Specification
Change Required

When requested, Eaton indicates a

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

2014 Eaton. All Rights Reserved.

126

PFA (cont.)
1

Team Feasibility Commitment Questions

Consideration
Yes / No
Is product adequately defined (application requirements, etc. to enable feasibility evaluation?

Can Engineering Performance Specifications be met as written?

Can product be manufactured to tolerances specified on drawing?

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

Is there adequate capacity to produce product?

Does the design allow the use of efficient material handling techniques?

Is statistical process control required on the product?

Is statistical process control presently used on similar products?

9 Where statistical process control is used on similar products:

9a Are the processes in control and stable?
9b Are Cpk's greater than 1.33?

Comments

Supplier answers general feasibility

questions and signs
Supplier may also make cost
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

2014 Eaton. All Rights Reserved.

127

Gage Plan
Gage Plan
Supplier

Part Revision

Manufacturing Location

Document Revision

Part Name

Eaton Plant

Part Number or Specification

Print Balloon
No.

example

Supplier
Characteristic
(Dimension and
Char. Type
tolerance)

999.999 +/- 0.9999

Critical

Eaton Quality
Suppliers
measurement
method

Eaton User Plant

Control Method

CMM

CMM

Team
Is measurement
method
acceptable?

Yes

Issues / Comments / Next Steps

Briefly describe planned actions.

Identify all gages to be utilized for product

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

2014 Eaton. All Rights Reserved.

128

Gage Correlation Matrix

Dimensional Correlation Matrix
Supplier 0

Supplier Representative:
Phone number:
Correlation Date:

Drawing Number:

Manufacturing Location

Part Revision and Date 0

Document Revision

Part Name
Part Number or Specification 0

Eaton Plant

Eaton
part/Assembly
number

Print feature
name

Example

Ball diameter

0.0025

0.0025

Example

Ball diameter

0.0025

0.0025

Example

Ball diameter

0.0025

0.0025

Example

Ball diameter

0.0025

0.0025

Sample
Upper Tolerance (+) Lower Tolerance (-) Total Tolerance Nominal target
Number

0.005
0.005
0.005
0.005

5.556
5.556
5.556
5.556

Bonus
Tolerance
Y/N

Eaton Measuring
equipment type

Beta laser mic

Beta laser mic

Beta laser mic

Beta laser mic

Eaton reading
5.5592
5.5612
5.5595
5.5597

Supplier
Measuring
Supplier reading
equipment type
Non contact laser
Non contact laser
Non contact laser
Non contact laser

5.5586
5.5601
5.5581
5.5582

Delta

% of tolerance
(if value is > or = to 25% or -25%,
correlation improvement
is recommended)

0.00063
0.00113
0.00142
0.00151

13%
23%
28%
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

2014 Eaton. All Rights Reserved.

129

Production Readiness Review (PRR)

Supplier Production Readiness Review
Supplier 0

Review Date

Mfg. Location
Status Intended for Use
Element
G/Y/R
Prior to
1
g

PPAP /
Production Run

Recovery Plan/Comments
(if status is Red or Yellow)

Readiness Criteria

2.1

g
g

Production Run
Production Run

Comments

Was an APQP project established and have required PPAP activities been completed
in the APQP process? For those activates that remain open, are they planned to be
completed in line with the APQP timeline?
Supplier
Complete

Due Date

Commodity
Responsible Person's
Name

Eaton
Reviewed

Did the supplier complete and did the plant / approving authority review the PPAP
package in details and there are no outstanding issues pending?
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

2014 Eaton. All Rights Reserved.

130

PPAP Element #18:

Part Submission Warrant (PSW)
Part Submission Warrant
Part Name

Cust. Part Number

Shown on Drawing Number

Org. Part Number

Engineering Change Level

Dated

Additional Engineering Changes

Dated
Yes

Safety and/or Government Regulation

Checking Aid Number

No

Purchase Order No.

Dated

CUSTOMER SUBMITTAL INFORMATION

Supplier Name & Supplier/Vendor Code

Customer Name/Division

Street Address

Buyer/Buyer Code

City

Weight (kg)

Checking Aid Eng. Change Level

ORGANIZATION MANUFACTURING INFORMATION

Region

Postal Code

What is It?
Required document in which the
supplier confirms the design and
validation of manufacturing
processes that will produce parts
to specification at a specific rate
Objective or Purpose
Used to :

Country

Application

MATERIALS REPORTING
Has customer-required Substances of Concern information been reported?

Yes

No

Yes

No

Submitted by IMDS or other customer format:

Are polymeric parts identified with appropriate ISO marking codes?

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 with product samples and limited supporting data submitted to customer.
Level 3 - Warrant with product samples and complete supporting data submitted to customer.
Level 4 - Warrant and other requirements as defined by customer.
Level 5 - Warrant with product samples and complete supporting data reviewed at organization's manufacturing location.
SUBMISSION RESULTS
dimensional measurements
The results for

material and functional tests

These results meet all design record requirements:

Yes

NO

appearance criteria

statistical process package

(If "NO" - Explanation Required)

document part approval

provide key information
declare that the parts meet
specification

When to Use It
Prior to shipping production parts

Mold / Cavity / Production Process

DECLARATION
I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets
all Production Part Approval Process Manual 4th Edition Requirements. I further affirm that these samples were 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

Print Name

Date
Phone No.

Title

Fax No.

E-mail
FOR CUSTOMER USE ONLY (IF APPLICABLE)

PPAP Warrant Disposition:

Approved

Rejected

Other

Customer Signature
Print Name

Date
Customer Tracking Number (optional)

2014 Eaton. All Rights Reserved.

131

Part Submission Warrant (PSW)

Part Submission Warrant
Part Name

Cust. Part Number

Shown on Drawing Number

Org. Part Number

Engineering Change Level

Dated

Additional Engineering Changes

Dated
Yes

Safety and/or Government Regulation

Checking Aid Number

No

Purchase Order No.

Checking Aid Eng. Change Level

ORGANIZATION MANUFACTURING INFORMATION

Customer Name/Division

Street Address

Buyer/Buyer Code

Region

Postal Code

Country

Dated

CUSTOMER SUBMITTAL INFORMATION

Supplier Name & Supplier/Vendor Code

City

Weight (kg)

Application

Administrative section containing basic

part information, including Part Number
and Revision

2014 Eaton. All Rights Reserved.

132

Part Submission Warrant (PSW)

Part Submission Warrant
Part Name

Cust. Part Number

Shown on Drawing Number

Administrative section identifying supplier

Org. Part Number
location and customer
location

Engineering Change Level

Dated

Additional Engineering Changes

Dated
Yes

Safety and/or Government Regulation

Checking Aid Number

No

Purchase Order No.

Checking Aid Eng. Change Level

ORGANIZATION MANUFACTURING INFORMATION

Customer Name/Division

Street Address

Buyer/Buyer Code

Region

Postal Code

Country

Dated

CUSTOMER SUBMITTAL INFORMATION

Supplier Name & Supplier/Vendor Code

City

Weight (kg)

Application

2014 Eaton. All Rights Reserved.

133

ORGANIZATION

CODE

Supplier Name & Supplier/Vendor Code

CUSTOMER

DIVISION

Customer Name/Division

ADDRESS
Street Address

Buyer/Buyer Code

Part Submission Warrant (PSW)

CITY
City

STATE

ZIP

Region

Postal Code

APPLICATION

Country

Application

MATERIALS REPORTING
Has customer-required Substances of Concern information been reported?

Yes

No

Yes

No

Submitted by IMDS or other customer format:

Are polymeric parts identified with appropriate ISO marking codes?

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 with product samples and limited supporting data submitted to customer.

Here
thesamples
supplier
is required
todata
identify
it
Level 3 - Warrant with
product
and complete
supporting
submittedhow
to customer.
Level 4 - Warrant and
requirements
as defined by customer.
hasother
reported
Substances
of Concern:
Level 5 - Warrant with product samples and complete supporting data reviewed at organization's manufacturing location.

IMDS, RoHS, REACH, Conflict Minerals, etc.

SUBMISSION RESULTS
dimensional measurements
The results for

material and functional tests

These results meet all design record requirements:

Yes

NO

appearance criteria

statistical process package

(If "NO" - Explanation Required)

Mold / Cavity / Production Process

DECLARATION

2014 Eaton. All Rights Reserved.

134

ORGANIZATION

CODE

Supplier Name & Supplier/Vendor Code

CUSTOMER

DIVISION

Customer Name/Division

ADDRESS
Street Address

Buyer/Buyer Code

Part Submission Warrant (PSW)

CITY
City

STATE

ZIP

Region

Postal Code

APPLICATION

Country

Application

MATERIALS REPORTING
Has customer-required Substances of Concern information been reported?

Yes

No

Yes

No

Submitted by IMDS or other customer format:

Are polymeric parts identified with appropriate ISO marking codes?

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 with product samples and limited supporting data submitted to customer.
Level 3 - Warrant with product samples and complete supporting data submitted to customer.
Level 4 - Warrant and other requirements as defined by customer.
Level 5 - Warrant with product samples and complete supporting data reviewed at organization's manufacturing location.
SUBMISSION RESULTS The supplier indicates the reason for the PPAP
dimensional measurements material and functional tests appearance criteria
statistical process package
The results for
submission
Yes
NO
These results meet all design record requirements:
(If "NO" - Explanation Required)
Mold / Cavity / Production Process
DECLARATION

2014 Eaton. All Rights Reserved.

135

ORGANIZATION

CODE

Supplier Name & Supplier/Vendor Code

CUSTOMER

DIVISION

Customer Name/Division

ADDRESS
Street Address

Buyer/Buyer Code

Part Submission Warrant (PSW)

CITY
City

STATE

ZIP

Region

Postal Code

APPLICATION

Country

Application

MATERIALS REPORTING

The supplier indicates the PPAP level

Yes andNo
certifies that the validation results meet all
Submitted by IMDS or other customer format:
design specifications.
This certification is by cavity, production
line,
Yes
No
Are polymeric parts identified with appropriate ISO marking codes?
etc.
Has customer-required Substances of Concern information been reported?

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 with product samples and limited supporting data submitted to customer.
Level 3 - Warrant with product samples and complete supporting data submitted to customer.
Level 4 - Warrant and other requirements as defined by customer.
Level 5 - Warrant with product samples and complete supporting data reviewed at organization's manufacturing location.
SUBMISSION RESULTS
dimensional measurements
The results for

material and functional tests

These results meet all design record requirements:

Yes

NO

appearance criteria

statistical process package

(If "NO" - Explanation Required)

Mold / Cavity / Production Process

DECLARATION

2014 Eaton. All Rights Reserved.

136

Level 1 - Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to customer.
Level 2 - Warrant with product samples and limited supporting data submitted to customer.
Level 3 - Warrant with 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 with product samples and complete supporting data reviewed at organization's manufacturing location.

SUBMISSION RESULTS
dimensional measurements
The results for

material and functional tests

Yes

These results meet all design record requirements:

NO

appearance criteria

statistical process package

(If "NO" - Explanation Required)

Mold / Cavity / Production Process

DECLARATION
I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets
all Production Part Approval Process Manual 4th Edition Requirements. I further affirm that these samples were 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

Organization Authorized Signature

Print Name

Date
Phone No.

Title

n/a

555-555-5555

Fax No.

E-mail

FOR CUSTOMER USE ONLY (IF APPLICABLE)

The supplier
declares that
the PPAP submission
Approved
Rejected
Other
PPAP Warrant Disposition:
is based on production processes run at a
Customer Signature
Date
normal or 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
2014 Eaton. All Rights Reserved.

137

Level 1 - Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to customer.
Level 2 - Warrant with product samples and limited supporting data submitted to customer.
Level 3 - Warrant with 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 with product samples and complete supporting data reviewed at organization's manufacturing location.

SUBMISSION RESULTS
dimensional measurements
The results for

material and functional tests

appearance criteria

statistical process package

Prior to submitting
the supplier
Yesthe PPAP,
NO
These results meet all design record requirements:
(If "NO" - Explanation Required)
representative signs the warrant, indicating the
Mold / Cavity / Production Process
part meets Eaton requirements
DECLARATION
I affirm that the samples represented
this warrant then
are representative
of our
whichthe
werePPAP
made by a process that meets
The by
customer
approves
or parts,
rejects
all Production Part Approval Process Manual 4th Edition Requirements. I further affirm that these samples were produced at the
and signs to confirm the decision
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.
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

Print Name

Date
Phone No.

Title

555-555-5555

Fax No.

E-mail
FOR CUSTOMER USE ONLY (IF APPLICABLE)

PPAP Warrant Disposition:

Approved

Rejected

Other

Customer Signature
Print Name

Date
Customer Tracking Number (optional)

2014 Eaton. All Rights Reserved.

138

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

2014 Eaton. All Rights Reserved.

139

PPAP Progress Check Final (True/False)

Eaton considers FAI to be better than
PPAP
FMEAs should have additional actions
identified
The supplier should complete the Control
Plan prior to the production trial run
The reaction plan part of Control Plan is
optional
The supplier should state the production
rate used during the production trial run
on the PSW

2014 Eaton. All Rights Reserved.

140

PPAP Summary
PPAP checks that any process changes have
been properly designed and validated, and the
resulting process is capable of repeatedly
producing parts to specification
The PPAP elements should be part of your Quality
Management System. PPAP shouldnt require
much extra effort, because youve already done
the work internally to manage your changes.
Reacting to later issues with the product or
process can be expensive and time-consuming!
2014 Eaton. All Rights Reserved.

141

 2014 Eaton. All Rights Reserved.

142