Production Part Approval Process (PPAP)

What is PPAP?

•Production Part Approval Process

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

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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

PPAP manages change and ensures

product conformance!

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When is PPAP Required?

New part

Engineering change(s)

Tooling: transfer, replacement, refurbishment, or additional

Correction of discrepancy

Tooling inactive > one year

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!

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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

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Production Run

•PPAP data must be submitted from a production run

using:
Production equipment and tooling

Production employees

Production rate

Production process

All data reflects the actual production

process to be used at start-up!

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Run @ Rate

•The purpose of a Run @ Rate is to verify the supplier’s

manufacturing process is capable of producing
components that meet ’s quality requirements, at
quoted tooling capacity, for a specified period of time
•Verification of the Run @ Rate will be at the Supplier
Quality Engineer’s (SQE) discretion. The supplier will
be notified of the need to perform a Run @ Rate as
early in the process as possible.
•The number of components to be produced during the
Run @ Rate should be sufficient to demonstrate
process capability and will be predetermined by the
SQE and the supplier.
 Factors such as product complexity, shelf life, storage, cost and
single shift vs. multiple shift operations will be taken into
consideration

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 Official PPAP Requirements
1. Design Records
2. Authorized Engineering Change Documents
3. Customer Engineering Approval, if required
4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations
5. Process Flow Diagram
6. Process Failure Modes and Effects Analysis (PFMEA)
7. Control Plan
8. Measurement Systems Analysis (MSA)
9. Dimensional Results
10. Records of Material / Performance Test Results
11. Initial Process Studies
12. Qualified Laboratory Documentation
13. Appearance Approval Report (AAR)
14. Sample Production Parts
Now, let’s take a closer look
15. Master Sample
at requirements
16. Checking Aids
17. Customer-Specific Requirements
18. Part Submission Warrant (PSW)

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 PPAP Requirements
1. Design Records
2. Authorized Engineering Change Documents
3. Customer Engineering Approval, if required
4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations
5. Process Flow Diagram
6. Process Failure Modes and Effects Analysis (PFMEA)
7. Control Plan
8. Measurement Systems Analysis (MSA)
9. Dimensional Results
10. Records of Material / Performance Test Results
11. Initial Process Studies
12. Qualified Laboratory Documentation
13. Appearance Approval Report (AAR) Supplier shall submit
14. Sample Production Parts these 18 items and
15. Master Sample
retain a copy of records
at appropriate locations
16. Checking Aids
17. Customer-Specific Requirements
18. Part Submission Warrant (PSW) – calls this the “Production Warrant”

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PPAP Submission Levels

Production Warrant and Appearance Approval

Level 1
Report (if applicable) submitted to

Production Warrant, product samples, and

Level 2
dimensional results submitted to

Production Warrant, product samples, and

Level 3
complete supporting data submitted to

Production Warrant and other requirements

Level 4
as defined by

Production Warrant, product samples and

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

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 PPAP Submission Level Table

PPAP Levels for Submission & Retention * = Supplier shall retain

Submission Level
at appropriate locations,
Requirement Level 1 Level 2 Level 3 Level 4 Level 5 and submit to upon
1. Design Records of Saleable Product R R R * R
S = Supplier
request. shall
will identify
a. For proprietary components/details
b. For all other components/details
R
R
R
R
R
R
*
*
R
R
submit
what istoneeded
& retain
for a
2. Engineering Change Documents, if any
3. Customer Engineering approval, if required
R
R
S
S
S
S
*
*
S
S
copy of records or
submission.
4. Design FMEA
5. Process Flow Diagrams
R
R
R
R
R
S
*
*
R
S
documentation items at
6. Process FMEA R R S * S
appropriate locations
7. Dimensional Results
8. Material, Performance, Test Results
S
R
S
S
S
S
*
*
S
S
R = Supplier shall retain
9. Initial Process Study
10. Measurement System Analysis Studies
R
R
R
R
R
S
*
*
R
S
at appropriate locations
11. Qualified Laboratory Documentation
12. Control Plan
R
R
R
R
S
S
*
*
S
S
and make readily
13. Part Submission Warrant (PSW)
14. Appearance Approval Report, (AAR) if applicable
S
S
S
S
S
S
*
*
S
S
available to upon
15. Bulk Material Requirements Checklist (for bulk
material only) R R R * R
request
16. Sample Product R S S * S
17. Master Sample R R R * R
18. Checking Aids R R R * R
19. Records of compliance with Customer-Specific
Requirements (DVP&R) R R R * R

S = The supplier shall submit to NCR and retain a copy of records or documentation items at appropriate locations.

R = The supplier shall retain at appropriate locations and make readily available to NCR upon request.

* = The supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is
needed for submission.

PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS .

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Definition of Risk

•High Risk
Parts associated with multiple critical features, complex
design, or high end technology that is not yet established in
the general manufacturing environment

Supplier’s quality system and/or quality performance is not to

satisfaction

•Medium Risk
Parts that have at least one critical feature

•Low Risk
Parts that have no critical features and can be manufactured
by any manufacturer in the commodity category

Supplier’s quality system and quality performance are

acceptable

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Submission Level Requirements

•New Parts
Level 2 is required for Low Risk Parts

Level 3 is required for Medium and High Risk Parts

•Part Changes
Level 3 is required for Parts produced at a new or
additional location

Supplier Quality Excellence will define the level required

for all other changes

Customer reserves the right to redefine

the submission level required

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PPAP Status

•Approved
 The part meets all 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 requirements, based on the production lot
from which it was taken and/or accompanying documentation

Production quantities may not be

shipped before Approval

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PRODUCTION WARRANT

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Production Warrant

Production Warrant What is It?

Part Name NCR Part Number • Document required for all newly
Shown on Drawing no. Supplier Part Number

Engineering Drawing Change Level

Additional Engineering Changes

Dated

Dated
tooled or revised products in which
Safety and/or Government Regulation

Checking Aid No.

Yes No Purchase order No.

Engineering Change Level

Weight (kg)

Dated
the supplier confirms that
SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION
inspections and tests on production
parts show conformance to
Supplier Name Supplier Code NCR Location

Street Address Buyer Buyer Code

City Region Postal Code Country Model Name / Number requirements

Note: Does this part contain any restricted or reportable substances? Yes No

Objective or Purpose
Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No

REASON FOR SUBMISSION

Initial Submission Change to Optional Construction or Material

Used to :
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 New or Additional Location

• document part approval

Tooling Inactive > than 1 year Other - please specify

REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements)

• provide key information

Level 1 - Production Warrant and Appearance Approval Report (if applicable) submitted to NCR

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

Level 3 - Production Warrant, product samples, and complete supporting data submitted to NCR

Level 4

Level 5
-

-
Production Warrant and other requirements as defined by NCR

Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location
• declare that the parts meet
SUBMISSION RESULTS

The results for dimensional measurements material and functional tests appearance criteria statistical process package
specification
These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required)

When to Use It
Mold / Cavity / Production Process:

DECLARATION

• Prior to shipping production parts

I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's
Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of
_____ pieces / _____ hours. I also certify that documented evidence of such compliance is on file and available for review. I have noted
any deviations from this declaration below.
EXPLANATION/COMMENTS:

Supplier Authorized Signature Date

Print Name Title

Email Phone No.

PPAP Warrant Disposition: Approved

FOR CUSTOMER USE ONLY (IF APPLICABLE)
Rejected Other ____________________________________________________ Now, let’s take a closer look
NCR Signature _____ Date
Print Name NCR Tracking Number (optional)

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 Production Warrant

Production Warrant

Part Name NCR Part Number

Shown on Drawing no. Supplier Part Number

Engineering Drawing Change Level Dated

Additional Engineering Changes Dated

Part Name / Part Number
Shown on DrawingEngineering released finished
Safety and/or Government Regulation Yes No Purchase order No. Weight (kg)
Number Supplier Part Number
end Engineering Change Level & Date
The design
Checking Aid record
No. thatitem part name and
specifies number
Engineering
Part Change Level
number defined Dated
Show the change level and date of by
the customer part number being the supplier, if any INFORMATION
SUPPLIER MANUFACTURING INFORMATION the Design Record NCR SUBMITTAL
submitted
Additional Engineering Changes
Safety
List alland/or
Supplier Name
authorized Government
Engineering Regulation
Supplier Code NCR Location
Purchase Order Number
“Yes”
changes if sonotindicated by the Design
yet incorporated inEnter Record,
this number as found on
otherwise “No”
Street Address
the design record but which arethe contract / purchase order
Buyer Buyer Code

incorporated in the partChecking Aid Number, Change Level, & Date

City Region Postal Code Country Model Name / Number
Enter if requested by the customer
Note: Does this part contain any restricted or reportable substances? Yes No

Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No

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 Production Warrant

Production Warrant

Part Name NCR Part Number

Supplier Manufacturing Information
Shown on Drawing no. Supplier Part Number
Show the name and code assigned to
Engineering Drawing Change Level Dated
the manufacturing site on the
purchase
Additional order /Changes
Engineering contract Dated

Safety and/or Government Regulation Yes No Purchase order No. Weight (kg)
Parts Identified with Appropriate Marking Codes
UL = Aid
Checking Underwriters
No. Laboratories safety standards
Engineering Change Level Dated

CE = Conformite Europeenne (European Conformity)

SUPPLIER MANUFACTURING INFORMATION
–
NCR SUBMITTAL INFORMATION
Certifies thatLocationa product has met European consumer
Restricted Substances
Safety, health, or environmental
Show requirements NCR Location
Supplier Name
Enter “Yes” orthe
“No” location where
Supplier Code
ISO = International Buyer
parts /Organization
will Buyer
be shipped Code to for Standardization
Enter
Street “Yes” orEnter
Address “No”the buyer’s name Buyer Buyer Code
Model Name / Number
and code
City Region Enter the
Postal Codemodel name
Country Model Name / Number
and number
Note: Does this part contain any restricted or reportable substances? Yes No

Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No

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 Production Warrant

Reason For Submission

REASON FOR SUBMISSION
Check the appropriate box(es)
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 New or Additional Location
Tooling Inactive > than 1 year Other - please specify
Requested Submission Level
REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements) Identify the submission level
Mold / Cavity / Production Process requested by
If production
Level 1 - parts will
Production beandproduced
Warrant from
Appearance Approval Report (if applicable) submitted to NCR

more than
Level 2 one mold,Warrant,
- Production cavity, tool,
product die,
samples, and dimensional results submitted to NCR
pattern, or
Level 3 production process,
- Production Warrant, product the and
Submission
samples, supplier
Results
complete supporting data submitted to NCR
shall complete
Level 4 a dimensional evaluation on
- Production Warrant and other requirements as defined by NCR boxes
Check the appropriate
one part from
Level 5
each. The specific molds,
- Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location
lines, etc. shall then be identified here.
SUBMISSION RESULTS

The results for dimensional measurements material and functional tests appearance criteria statistical process package
These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required)
Mold / Cavity / Production Process:

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 Production Warrant
Explanation / Comments Declaration Declaration
Provide any explanatory Entercommentsthe Affirmation
number onof that
the pieces the samples represented
submission results or manufactured by the during
any deviations warrant the are representative and
Supplier Authorized Signature
significant were made by run
production a process that meets ’s
from the Declaration. Attach additional
A DECLARATION
responsible supplier official,
and the PPAP after
time (in verifying
requirements
hours) taken
information as appropriate.
that the results show for the significantto
conformance all
production run
I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's
requirements and that all required documentation
Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of
is _____
available, shall
pieces / _____ hours. Iapprove
also certify thatthe declaration
documented evidence of such compliance is on file and available for review. I have noted
any deviations from this declaration below.
EXPLANATION/COMMENTS: For Use Only
To be completed by appropriate
PPAP Warrant DispositionSupplier Quality Engineer
Signature
Approved, Rejected,
Supplier Authorized Signature Other Date
Signed by Supplier
Print Name Title
Quality Engineer
Email Phone No.

FOR NCR USE ONLY

PPAP Warrant Disposition: Approved Rejected Other ____________________________________________________
NCR Signature _____ Date
Print Name NCR Tracking Number (optional)

The approved Production Warrant officially

warrants the parts ready for production

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AUTHORIZED ENGINEERING
CHANGE DOCUMENTS

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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)
Specifications

Feasibility studies
Supplier change requests
Sub-assembly drawings
Life or reliability testing requirements

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PROCESS FLOW DIAGRAM

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Process Flow Diagram

What is It?
Operator
Separate Cutting Evaluate for
• A visual diagram of the entire
process from receiving through
Tags Corrective Action
(31)

shipping, including outside

Yes
Operator Operator Operator Operator
Operator
Get Traveler and Operator Download Cutting Program Observe Cutting
Load Machine with Cutting Error?
Nest from Holding Prints Cut Tags Infomation Command Operation for

processes and services

Blanket (33)
Shelf (27) (2s to 2m) "Ready to Cut" Errors
(28)
(26) (29) (30) (32)

No

Operator
Remove Small
Plies from the
Cutting Table
Operator
Move to Kitting
Table
(37)
Operator
Tag Small Plies
(38)
Objective or Purpose
(36)

Operator
Small Plies

Large Operator Operator

Operator
No

To help people “see” the real process.

Process maps can be used to
Tag while Laying Remove Plies Traveler Operator
Cutting Operation Large or Small Plies Piies Move Plies to Yes
on the Cutting from the Cutting Complete? Stamp Traveler
Complete or Test Coupons? Kitting Table
And Table Table (42) (43)
(34) (35) (41)
Coupons (39) (40)

understand the following

characteristics of a process:
• Set-by-step process linkage
• Offline activities (measurement,
6 Sigma Project Project Idea Department/Group Project
High Level Process Map High Level Process Map

Fill Out Master

inspection, handling)
Form
with Initial
Information

Other Required Other Required

Signatures: Signatures:
6 Sigma Assigns Segment CEO Champion: Group Assigns Get DLN
Get WO Assigned
Project Number Champion Process Owner Project Number Assigned
Process Owner Prefer to work Project Owner
No this project

• Rework, scrap
BB or GB Dept GB/BB/MBB
within your
area?
Monitor Progress
Begin/Work Yes Monitor Progress Begin/Work
through Power
Project through Bi- Project
Steering and Finance Approval
Finance Approval Weekly Updates
Monthly and Signature
Follow DMAIC or and Signature and Monthly Fo llow DMAIC or
Financial
DFSS process Do you Reviews DFSS process
Reviews
No have BB/GB to
Assist/Work the
project?
Master Form Will
Complete Project Generate Yes Complete Project
(Has to be fully Co ntract Master Form Will (Has to be fully
Documented Generate Documented)
Contract

When to Use It
Yes Is Hard
Savings > $???

Enter Remain ing 6 Sigma

Final Project Final Project
Information on No
Review Project Review
Master Form

Does the Department

Yes Enter Remaining
Project Involve

• To understand how a process is

Only You r or Group Information on
Project Master Form
Group?
Finance Approval Finance Approval
and Signature and Signature
No

Other Required Does the Other Required

Project Involve No

done
Signatures: Signatures:
Champio n: Dir T&E >2 Groups in Champion: Dir T&E
Eng?
Process Owner Process Owner
Project Owner Project Owner
Dept BB or MBB Yes Dept BB or MBB

Complete all Complete all

Does the
Documentation Documentation

• Prior to completing the PFMEA

Close Yes Project Involve No Close
including a including a
Project >3 Depts. Project
(1) Page Close- (1) Page Close-
outside Eng?
out Sheet out Sheet

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Process Flow Diagrams

PROCESS FLOW DIAGRAM

Part Number: Date:

ECL:
Part Description: Prepared By:
Fabrication

Product and
Inspect

Item #

Item #
Operation
Move
Store

STEP Process Control Methods

Description
Characteristics

1 The process flow

2 diagram utilizes these
3 symbols to clearly
4 identify each step in
5 the process
6

10

11

12

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Process Flow Diagram - Example

LEO PROCESS FLOW DIAGRAM F/QA/05/0

Part No. : 484 -0100264 Customer Name : NCR Doc. No. : PFD/NCR/0264
Shaft Pressure
Part Name : : Page : 1 of 1 Rev. No. / Date : O / 10.08.09
Paddle

Incoming CNC Sliding Deburring & Cleaning

Final Isnpection
Inspection Machining
10 15 20
05

**RM receiving Patrol Insp.

Insp. report report Final Inspection
register
Pre delivery
Pre shipment Oiling, Packing & Layout
Despatch Inspection
audit Preservation Inspection

70 60 50 40 30

Pre shipment Layout Inspection Self Inspection

audit report Report Report

Not ok , Rejected
** Inspection as per 100%
Inspection as If Rejected If rework
Opertion layout Re-inspection
per RIQP possible Rework

Not ok , Rejected
Return to Note : Not ok Ok
supplier Tags to be provided
for OK, Rework, Inspection Scrap Next
& Rejection operation

PREPARED BY & DATE APPROVED BY &

- MOVEMENT - PATROL INSPECTION - STORAGE
DATE
- SUPPLIER END OPERATION - PROCESS - INSPECTION T T Arul V Raja

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Star Exercise

•Divide into teams

•Distribute supplies
−Paper for Stars

−Instructions for making Stars

−Scissors

•Using the instructions handed out in class, make 10

Shuriken Stars

•This exercise will prepare your team to complete future

exercises 45 Minutes

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Process Flow Diagram – Star Exercise

Incoming Paper Star Final

Folding Cutting Folding Tucking
Inspection Inspection

05 10 15 20 25 30

Patrol Insp
Report
Shipping Packing

40 35

Inspection as per If rework 100%

Rework
Operation layout possible Inspection

OK
Not OK

Scrap Next Operation

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Process Flow Diagrams

Reviewers Checklist
Process Flow must identify each step in the process
Should include abnormal handling processes
 Scrap
 Rework
Process Flow must include all phases of the process
 Receiving of raw material
 Part manufacturing
 Offline inspections and checks
 Assembly
 Shipping

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PROCESS FMEA

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 Process FMEA (PFMEA)

Failure Mode and Effects Analysis

What is It?
S ys te m / C o m po n e n t: D e s ig n R e s p o n s ib ilit y:
(Design FMEA) F M E A N um b e r:
P age
P re p a re d b y:
F M E A D a t e ( O rig .)
of

(R e v .)
• A tool used to identify and
prioritize risk areas
C o re Te a m :

Action Results
O D
Item / O D
S Potential Cause(s)/ c Current Design e R. Responsibility &
Process Potential Failure Potential Effect(s) Current Design Recom m ended

and their mitigation plans.

S c e R.
e Mechanism (s) of c Controls t P. Target Com ple tion
Mode of Failure Controls Detection Action(s) ActionsTaken e c t P.
v Failure u Prevention e N. Date
Function v u e N.
r c
r c

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

When to Use It
• After completion of the process
IMPORTANT! flow diagram.
The PFMEA should be completed • Prior to tooling for production
using a cross-functional team!

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FMEA Origin

•Created by NASA following Apollo 1 mission failure

•Allows us to take a proactive approach to what can go

wrong in a process and manage our risks better

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Process FMEA (PFMEA)

POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)

Print # Rev. FMEA Number

Item: Process Responsibility: Prepared by:
Model Year(s)/Vehicle(s) Key Date Date (Orig.)
Team: Date (Rev.)

Action Results
Potential
Potential

R.P.N.
Occur

Detec
Potential Failure Cause(s)/ Current Process Recommended Responsibility

Class
Sev

R.P.N.
Process Step Effect(s) of Actions

Occ
Sev

Det
Mode Mechanism(s) Controls Actions & Target Date
Failure Taken
of Failure

This is included in the

PPAP Playbook!

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 PFMEA - Step 1

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Failure Modes Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
For each Process
Failure Input,
of Failure
determine the ways in
which the
Op 70: Manual Insufficient wax Allows integrity 7 inputManually
can go 8 Variables check 5 280
application of coverage over breach wrong.
of inner inserted spray for film
wax inside door specified surface door panel head not thickness; Visual
panel inserter far check for
Corroded interior enough coverage
lower door
panels
Spray head 5 Variables check 5 175
Deteriorated life clogged: for film
Using the completed of door leading - Viscosity too thickness; Visual
Process Flow Diagram, to: high check for
enter the process step. - Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
to rust through low and after idle
paint over time periods and
- Impaired preventative
function of maintenance
interior door program to clean
hardware heads
TIPS
• There should be at least one failure mode for each input.

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PFMEA - Step 2

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
Failure
of Failure
Op 70: Manual Insufficient wax Allows integrity 7 Manually 8 Variables check 5 280
application of coverage over breach of inner inserted spray for film
wax inside door specified surface door panel head not thickness; Visual
panel inserter far check for
Potential Failure Effects
Corroded interior enough coverage
For each Failure Mode,
lower door
panels determine what effect
the specific failure
Spray head 5 Variables check 5 175
Deteriorated life could
clogged:
have on
for film
the
of door leading process
- Viscosity too output.
thickness; Visual
to: high check for
- Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
to rust through low and after idle
paint over time periods and
- Impaired preventative
function of maintenance
interior door program to clean
TIPS hardware heads

• 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.

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PFMEA - Step 3

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
Failure
of Failure
Op 70: Manual Insufficient wax Allows integrity 7 Manually 8 Variables check 5 280
application of coverage over breach of inner inserted spray for film
wax inside door specified surface door panel head not thickness; Visual
panel inserted far check for
Corroded interior enough coverage
Potential Causes
lower door
For each Failure Mode,panels
determine the possible
Spray head 5 Variables check 5 175
cause of the failure.Deteriorated life clogged: for film
of door leading - Viscosity too thickness; Visual
to: high check for
- Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
to rust through low and after idle
paint over time periods and
- Impaired preventative
function of maintenance
interior door program to clean
hardware heads

TIPS
• There should be at least one potential cause for each failure mode.

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PFMEA - Step 4

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
Failure
of Failure
Op 70: Manual Insufficient wax Allows integrity 7 Manually 8 Variables check 5 280
application of coverage over breach of inner inserted spray for film
wax inside door specified surface door panel head not thickness; Visual
panel Current Controls inserter far check for
For each
Corroded potential
interior enough coverage
cause, list the current
lower door
methodpanelsused for
preventing or detecting
Spray head 5 Variables check 5 175
Deteriorated
failure. life clogged: for film
of door leading - Viscosity too thickness; Visual
to: high check for
- Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
to rust through low and after idle
TIPS paint over time periods and
- Impaired preventativeor gaps in
• This step in the FMEA begins to identify initial shortcomings
function of
the
maintenance
current control plan. interior door program to clean
hardware
• If a procedure exists, enter the document number. heads

• If no current control exists, list as “none.”

Confidential 37
PFMEA - Step 5

Assign Severity, Occurrence, and Detection ratings

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
Failure
of Failure
Assign Severity
Op 70: Manual(HowInsufficient
serious waxis the
Allows integrity 7 Manually 8 Variables check 5 280
application effect
of coverage over breach of inner
if it fails?) inserted spray for film
wax inside door specified surface door panel Assign
headDetection
not thickness; Visual
panel (Howinserter far can the
easily check for
Corroded interior enough
cause or failure coverage
lower door mode be detected?)
panels
Spray head 5 Variables check 5 175
Deteriorated life
Assign Occurrence clogged: for film
of door leading
(How likely is the - Viscosity too thickness; Visual
to:
cause to occur?) high check for
- Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
to rust through low and after idle
paint over time periods and
- Impaired preventative
function of maintenance
interior door program to clean
hardware heads

Severity, Occurrence and Detection rating details on next slide

Confidential 38
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!
Detection

Confidential 39
An Example of Rating Definitions
Severity Occurrence Detection*
Rating
Hazardous Very high and Cannot detect
High 10 without almost or detection
warning inevitable with very low
probability
Loss of primary High repeated Remote or low
function failures chance of
detection
Loss of Moderate Low detection
secondary failures probability
function
Minor defect Occasional Moderate
failures detection
probability
Low 1 No effect Failure unlikely Almost certain
detection
*If No Controls Exist, Detection = 10

Create a rating system that makes sense for the

defects you are trying to prevent.

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PFMEA - Step 6

Potential
Potential

R.P.N.
Occur

Detec
Class
Potential Failure Cause(s)/ Current Process

Sev
Process Step Effect(s) of
Mode Mechanism(s) Controls
Failure
of Failure
Op 70: Manual Insufficient wax Allows integrity 7 Manually 8 Variables check 5 280
application of coverage over breach of inner inserted spray for film
wax inside door specified surface door panel head not thickness; Visual
panel inserter far check for
Calculate theinterior
Corroded Risk Priority Number coverage
enough
lower door
RPN = Severity x Occurrence x Detection
panels
Spray head 5 Variables check 5 175
Deteriorated life clogged: for film
of door leading - Viscosity too thickness; Visual
to: high check for
TIPS - Unsatisfactory - Temp too low coverage; Test
appearance due - Pressure too spray at start-up
• The RPN is used to to rust
prioritize thethrough
most critical
low risks identified
and after idlein the first half
paint over time periods and
of the FMEA. - Impaired preventative
function of maintenance
• High RPNs (125 or above) are flags
interior door to take effort to reduce
program tothecleancalculated
hardware heads
risk.

• Regardless of RPN, high Severity scores (9 or 10) should be given special

attention.

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 Analyzing the PFMEA

• Once the RPN Numbers are

Sort by RPN to determine determined, they can be used to
the most significant
failure modes
prioritize the most significant
failure modes.

• Sort the FMEA by the RPN

numbers. Graphical and statistical
tools can help the team select a

? How many items should be

the focus of the next steps?
“cut-off” RPN for the next steps.

60

50
Pareto Chart for RPN

100

80

40

Percent
60

Count
30
40

RPN Thresholds
20

20
10

• When using an RPN threshold, DO 0 0

NOT forget to address high Severity

rs
Defect 15 3 00 2 50 30 25 50 70 3 50 9 75 1 50 4 90
O the

Count 10 9 8 6 4 4 4 4 2 2 2 2 3

scores
Percent
Cum %
17
17
15
32
13
45
Pareto Chart
10
55
7
62
7
68
7
75
7
82
3
85
3
88
3
92
3
95
5
100

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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 reduced by improving detection.

Examples are mistake-proofing, simplification and
statistically sound monitoring.

In general, reducing the Occurrence

is preferable to improving the Detection

Confidential 43
FMEA – Step 7

• Determine Actions Recommended to reduce High RPNs

Action Results
Potential

R.P.N.
Potential Failure Recommended Responsibility &

R.P.N.
Process Step Effect(s) of

Occ
Sev

Det
Mode Actions Target Date Actions Taken
Failure

Op 70: Manual Insufficient wax Allows integrity 280 Add positive Mfg. Eng. By Stop added, 7 2 5 70
application of coverage over breach of inner depth stop to 5/10/10 sprayer checked
wax inside door specified surface door panel sprayer on-line
panel Automate Mfg. Eng. By Rejected due to
Corroded interior spraying 5/25/10 complexity of
For the high RPN numbers, lower door different doors on
determine the panels the same line
recommended actions. 175 Use DOE on Mfg. Eng. By Temp and press 7 1 5 35
Deteriorated life viscosity vs. 5/31/10 limits were
of door leading temp vs. determined and
to: pressure limit controls
- Unsatisfactory have been
appearance due installed - Control
to rust through charts show
paint over time process is in
- Impaired control Cpk =
function of 1.85
interior door
hardware

Confidential 44
FMEA – Steps 8 and 9

Action Results
Potential

R.P.N.
Potential Failure Recommended Responsibility &

R.P.N.
Process Step Effect(s) of

Occ
Sev

Det
Mode (responsibility)
Resp Actions Target Date Actions Taken
Failure
Assign a specific person
Op 70: Manual who will
Insufficient wax be responsible
Allows integrity 280 Add positive Mfg. Eng. ByStop added, 7 2 5 70
application of for recommended
coverage actions.
over breach of inner depth stop to 5/10/10 sprayer checked
wax inside door specified surface door panel sprayer on-line
panel Automate Mfg. Eng. By Rejected due to
Corroded interior spraying 5/25/10 complexity of
Actions
lower door Taken different doors on
As actions are identified
panels the same line
and completed, 175 Use document
DOE on Mfg. Eng. By Temp and press 7 1 5 35
Deteriorated life viscosity vs. 5/31/10 limits were
of in
doorthe “Actions
leading Taken”
temp vs. determined and
to:
column. pressure limit controls
- Unsatisfactory have been
appearance due installed - Control
to rust through
paint over time
SEV, OCC, DET,charts
RPN show
process is in
- Impaired As actions are control
complete
• Now recalculate your RPNs function of 1.85
reassess Severity,
Cpk =

based on mitigation plans. interior door

hardware Occurrence, and Detection
TIPS: and recalculate RPN.

Continue updating the actions taken and

resulting RPNs until all risks are at an acceptable level (below 125).

Confidential 45
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. Identify potential Causes of each Failure Mode.
4. List the Current Controls for each Cause.
5. Assign Severity, Occurrence and Detection ratings after creating a ratings
key appropriate for your project.
6. Calculate RPN.
7. Determine Recommended Actions to reduce High RPNs.
8. Take appropriate Actions and Document.
9. Recalculate RPNs.
10. Revisit steps 7 and 8 until all the significant RPNs have been addressed.

Confidential 46
Process FMEA (PFMEA)

Tips and Lessons Learned

• Collaborative Effort: Do not try alone, use a group
• Very laborious: Time consuming process. Take
necessary breaks.

• Action items are required for completion

• Train team ahead of time by explaining scoring criteria
• Proper preparation is needed for meetings
• Summarize often: FMEA is a living document

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CONTROL PLAN

Confidential 48
 Control Plan

What is It?
A document that describes how to
control the critical inputs to
continue to meet customer
expectations of the output.

Objective or Purpose
• Primary reference source for
minimizing process and product
variation.
• Description of how teams should
react to out-of-control situations.
NOTE
Since processes are expected to be continuously When to Use It
updated and improved, the control plan • Implementation of new process
is a living document! • Following a process change

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Control Plan

Tool Interaction

Key S O D R E
6 Sigma Project Project Idea Department/Group Project Potential Potential Actions
High Level Process Map Process Step Process E Potential Causes C Current C ontrols E P O Resp. Actions
High Level Process Map Failure Mode Failure Effects Recommended
Input V C T N C
Fill Out Master
Form

Process Steps
with Initial
Information Receive Checks Delay internal AR balance does Inadequate None Investigate mail room G. Lee
Other Required
Signatures:
Other Required
Signatures:
Payment mail not go down staffing in mail staffing and associated
Get WO Assigned
6 Sigma Assigns
Project Number
Segment CEO
Champion
Champion:
Process Owner
Group Assigns
Project Num ber
Get DLN
Assigned
7 room 7 10 490 processes
Process Owner Prefer to work Project Owner
BB or GB No this project Dept GB/BB/MBB
within your
area?
Monitor Progress
Identify Wire Information not AR balance is Customer or bank Acct identifies problem Poka-Yoke wire transer N. Peart
Begin/Work Yes Monitor Progress Begin/Work
through Power
Project through Bi- Project
Steering and Finance Approval
Weekly Updates
Monthly and Signature Finance Approval
Follow DMAIC or
DFSS process
Financial
Reviews Do you
and Signature and Monthly
Reviews
Follow DMAIC or
DFSS process Customer Transfer supplied past due did not include when trying to apply process
No have BB/GB to
Assist/Work the reference name and/or payment
10 account info on 5 5 250
project?

Complete Project
(Has to be fully
Master Form Will
Generate Yes Complete Proj ect
(Has to be fully
line
Contract Master Form Will
Documented Generate
Contract
Documented)
wire transfer
Yes Is Hard
Savings > $???

Final Project
Review
Enter Remaining
Information on
6 Sigma
Project
No
Final Project
Review
Identify Invoice Checks Incorrect Invoice shows Customer error Customer might catch Provide payment stub A. Lifeson
Master Form
invoice outstanding (AR it when reviewing the with statement for each
Does the
Project Involve Yes
Department
or Group
Enter Remaining
Information on supplied balance does go 5 5 next statement 10 250 invoice
Only Your
Project Master Form
Finance Approval
Group?
Finance Approval down)

New/Revised Process
and Signature and Signature
No

Identify Invoice Checks Invoice number Invoice shows Customer error Acct identifies problem Provide payment stub S. Hagar
Other Required
Signatures:
Does the
Project Involve No
Other Required
Signatures:
not supplied outstanding (AR when trying to apply with statement for each
Champion: Dir T&E
Process Owner
>2 Groups in
Eng?
Champion: Dir T&E
Process Owner balance does go 5 10 payment 5 250 invoice
Project Owner Project Owner
Dept BB or MBB Yes Dept BB or MBB
down)

Steps
Complete all Complete all
Does the
Documentation Docum entation
Close Yes Project Involve No Close
including a including a
Project >3 Depts. Project
(1) Page Close- (1) P age Close-
outside Eng?
out Sheet out Sheet

Process FMEA
Process Flowchart
z ed
i
Pr r it eps
oc io St
es Pr ss
N s i sk ce
Pr ew St R ro ed
ep P v
oc /R s r o ols
es e
v p tr
s
St ise I on
m
C
ep d
s

Control Plan

Confidential 50
’s Control Plan

CONTROL PLAN
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)

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

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

This is included in the

PPAP Playbook!

Confidential 51
 Control Plan

3 Distinct Phases

CONTROL PLAN
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)

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

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

3 Distinct Phases3 Distinct Phases

3 Distinct Phases
1. Prototype – a2.description
Pre-Launch 3. the
of –Production
a description
– aofcomprehensive
the
dimensionaland
dimensional measurements measurements
documentationand of product/process
material and
material and performance testsperformance
characteristics,
that tests
process
that controls,
will occur duringwill occur after
Prototype tests,
build.Prototype
and measurement
and before systems that
full Production.will occur during mass production

Confidential 52
 Control Plan

Administrative Section

CONTROL PLAN
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)

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

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

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

Confidential 53
 Control Plan

Process, Machine/Tools, Characteristics

CONTROL PLAN
Characteristics
Part/Process Define the characteristics
Prototype Pre-Launch Production
Use this area to define of the product or process
Controlpart/process
Plan Number number and Key Contact/Phone Date:(Org.) Date (Rev.)
description.
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

Machine/Tools
List the machine, device, jig, or tools
that will be used in the
manufacturing process

Confidential 54
 Control Plan

Specifications, Measurement, Sample Size & Frequency

Sample Size
What is the size of the
CONTROL PLAN sample you should gather
data from?
Prototype Pre-Launch Production
Control Plan Number
Specifications/Tolerance
Key Contact/Phone Date:(Org.) Date (Rev.)
Use this area to define upper/lower
Part Number/Latest Change Level spec limits for each
Core Teamcontrol element. Customer Engineering Approval/Date (If Req'd.)

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

Measurement Technique
For each line in the control plan, list the
measurement procedure that will be
Frequency
used (may list R&R Gage Plan or Poka- Define the frequency for
Yoke). which the measurement
will be taken.

Confidential 55
 Control Plan

Control Method, Reaction Plan

Control Method
Method that will be used
CONTROL PLAN to control the process

Prototype Pre-Launch Production

Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)

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

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

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

Characteristics Methods
Machine,
Process Special Evaluation Sample
Part/Process Device, Product/Process Reaction
Name/Operation Char. /Measure Control
Number Jig, Tools, No. Product Process Specification/ Plan
Description Class ment Size Freq. Method
for MFG. Tolerance
Technique

Reaction Plan
Actions to be taken if
controls fail

Confidential 56
Control Plan

Audit Plans
•Audit plans should be included in the control plan as a separate
line.

•Auditing is an important tool for control.

•Process auditing should be a key element of the quality system

of a business.

•Audits generally cover:

 Effectiveness of controls

 Control plan (say) vs. what is actually done (do)

•Audits should be objective (done by internal or external third

parties if possible).

•Audit frequencies should be based on balancing level of risk

(FMEA) and cost.

Confidential 57
 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
Sample SizeMethod
Frequency
Product
Product==Automated
100% inspection
CONTROL PLAN
Characteristics
Product
Process
Process
= Continuous
= x-MR chart
= 1 pc= 4 hours
Process
Product = Wave solder height
Prototype Machine/Tools
Part/Process Pre-Launch Production
Process = Flux concentration Reaction Plan
Specifications/Tolerance
Control Plan Number
Soldering Wave solder machine Smith /mc
Connections Key Contact/Phone
002 Product = 2.0 +/-T.0.25 313-555-5555
Date:(Org.)
Product = Adjust and
11/29/2009
Date retest
(Rev.)
2/20/2010
Process
Part Number/Latest Change Level = Standard
Core Team #302B Process = Segregate
Customer and retest
Engineering Approval/Date (If Req'd.)
54321231 / D Erin Hope, Alan Burt, Ken Light
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.)
Electronic Circuit Board
Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
ACR Control 439412
Characteristics Methods
Machine,
Part / Process Name Special Sample
Device, Product/Process Evaluation / Reaction
Process / Operation Char. Control
Number Description
Jig, Tools, No. Product Process 3 Distinct Phases
Class
Specification/ Measurement
Size Freq. Method
Plan
for MFG. Tolerance Technique
Production
Automated
Wave Wave Sensor inspection
Soldering solder solder continuity (error Adjust and
2 Measurement Technique
Connections machine height 2.0 +/- .25 mc check 100% Continuous proofing) retest
Product = Sensor continuity check
Flux Test sampling
concen -
Process = Test sampling lab environment lab Segregate
tration Standard #302B environment 1 pc 4 hours x-MR chart and retest

Confidential 58
Control Plan

Reviewer’s Checklist
Use process flow diagram and PFMEA to build the control plan; keep them
aligned

Controls must be used to be effective. Keep it simple.

Ensure that the control plan is in the document control system of the
business

Good control plans address:

All testing requirements - dimensional, material, and performance
All product and process characteristics at every step throughout the process
The control method should be based on an effective analysis of the process
Such as SPC, Error Proofing, Inspection, Sampling Plan
Control plans should reference other documentation
Specifications, tooling, etc.

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MEASUREMENT SYSTEM
ANALYSIS (MSA)

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 Measurement System Analysis (MSA)

What is It?
An MSA is a statistical tool used to
determine if a measurement system
is capable of precise measurement.

Objective or Purpose
• To determine how much error is in
the measurement due to the
When to Use It measurement process itself.
• On the critical inputs and outputs • Quantifies the variability added by
prior to collecting data for analysis. the measurement system.
• For any new or modified process in • Applicable to attribute data and
order to ensure the quality of the variable data.
data.
IMPORTANT!
Who Should be Involved Measurement System Analysis is
an analysis of the measurement
Everyone that measures and makes process, not an analysis of the
decisions about these measurements people!!
should be involved in the MSA.

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Attribute and Variable MSA

– Attribute Data Examples:

 Count, Pass/fail, yes/no, red/green/yellow,
timekeeping buckets

– Variable Data Examples:

 Physical measurement (length, width, area, …)
 Physical conditions (temperature, pressure…)
 Physical properties (strength, load, strain…)
 Continuous or non-ending

Unless approved by an SQE, attribute data

is not acceptable for PPAP submission

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Measurement System Analysis (MSA)

Measuremen
The observed variation in t
process output System
measurements is not Variation
simply the variation in the
process itself; it is the
variation in the process
Observed
plus the variation in Variation
measurement that results
from an inadequate
measurement system.
Process
Variation

Conducting an MSA reduces the likelihood of

passing a bad part or rejecting a good part

Confidential 63
Measurement System Analysis (MSA)

Observed Variation

Measuremen
t
System
Variation

Observed
Variation
The output of the process
measured by:

Process • Cycle time

Variation • Dimensional data
• Number of defects
and others

Confidential 64
Measurement System Analysis (MSA)

Observed Variation Resolution

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

Process
Variation Calibration addresses accuracy

Confidential 65
Measurement System Analysis (MSA)

Observed Variation Resolution

Precision Repeatability
(Variability)

Measuremen Reproducibility
t
System
Variation
Linearity
Accuracy
Observed (Central Bias
Variation Location)
Stability

Process Calibration Addresses Accuracy

Variation Let’s take a closer look at
Precision
Confidential 66
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.

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Measurement System Analysis (MSA)

Repeatability
Error in Repeatability
The inability to get the same
answer from repeated
measurements made of the
same item under absolutely
identical conditions.

Possible Cause
Lack of standard operating
procedures (SOP), lack of
training, measuring system
variablilty.
Equipment Variation

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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

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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

EV or Equipment Variation

AV or Appraiser Variation

Overall % GRR

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Variable MSA – ’s Gage R&R Form

Gage Repeatability and Reproducibility

This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells.

Number of operators Upper specification limit

Number of trials Lower specification limit
Number of samples

Data Operator 1 Operator 2 Operator 3

Trial Trial Trial
Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range
1 0.000 0.000 0.000
2 0.000 0.000 0.000
3 0.000 0.000 0.000
4 0.000 Automatically calculates
0.000 0.000
5 0.000 0.000 0.000
6 0.000 EV, AV, and % GRR!
0.000 0.000
7 0.000 0.000 0.000
8 0.000 0.000 0.000
9 0.000 0.000 0.000
10 0.000 0.000 0.000
Range average 0.000 0.000 0.000
Sample average #DIV/0! #DIV/0! #DIV/0!

Tolerance analysis
Average range 0.000 Repeatability (EV) #N/A #N/A
X-bar range #DIV/0! Reproducibility (AV) #DIV/0! #DIV/0!
Repeatability and Reproducibility (R&R) #N/A #N/A
Control limit for individual ranges #N/A
Note: any ranges beyond this limit may be the result
of assignable causes. Identify and correct. Discard
values and recompute statistics.

Do not modify this table

Trials D4 K1 K2 Included in PPAP Playbook!
2 3.27 4.56 3.65
3 2.58 3.05 2.7

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Variable MSA – Gage R&R Steps

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10

1. Select 10 items that represent the full range of long-term process variation.
2. Identify the appraisers.
3. If appropriate, calibrate the gage or verify that the last calibration date is
valid.
4. Open the Gage R&R worksheet in the PPAP Playbook to record data.
5. Have each appraiser assess each part 3 times (trials – first in order, second
in reverse order, third random).
6. Input data into the Gage R&R worksheet.
7. Enter the number of operators, trials, samples and specification limits
8. Analyze data in the Gage R&R worksheet.
9. Assess MSA trust level.
10. Take actions for improvement if necessary.

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Steps 1 and 2: Variable MSA - Gage R&R

Select 10 items that represent

Step 1 the full range of long-term process
variation.

Step 2 Identify the appraisers.

– Should use individuals that actually do the

process being tested.
– Can also include other appraisers
(supervisors, etc.).
– Should have a minimum of 3 appraisers.

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Steps 3 and 4: Variable MSA – Gage R&R

If appropriate, calibrate the gage

Step 3 or verify that the last calibration

date is valid.

Step 4 Open the Gage R&R worksheet in the

PPAP Playbook to record the data

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Step 5: Variable MSA – Gage R&R

Have each appraiser assess each item 3

Step 5 times.
– Each appraiser has to work
independently.
– Items should be evaluated in random
order.
– After each appraiser completes the first
evaluation of all items – repeat the
process at least 2 more times.
– Do not let the appraisers see any of the
data during the test !!

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Steps 6 and 7: Variable MSA – Gage R&R

Step 6 Input data into the Gage R&R

worksheet

Step 7 Enter the number of operators, trials,

samples and specification limits

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Steps 8 and 9: Variable MSA – Gage R&R

Step 8 Analyze data in the Gage R&R worksheet

Step 9 Assess MSA Trust Level.

% Tolerance*
– Red: > 30% (fail)
30%
– Yellow: 10-30% (marginal)
10%
– Green: < 10% (pass)

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Step 10: Variable MSA – Gage R&R

If the Measurement System needs improvement:

Step 10
– Brainstorm with the team for improvement solutions.
– Determine best “practical solution” (may require some experimentation).
– Pilot the best solution (PDSA)
– Implement best solution – train employees.
– Re-run the study to verify the improvement.

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Variable MSA – Gage R&R Example

Problem Statement
• The sulfuric acid concentration in process tank 8 is measured at least
once per day
• Additions/deletions of chemicals and decisions to shut down the
process are dependent on these results.
• Based on current data, we need to do an MSA.

MSA Process
A Gage R&R was conducted in order to validate
the process.

MSA Parameters
» (3) Operators
» (3) Trials
» (10) Samples

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 Variable MSA – Gage R&R Example
Entered upper and
Entered the number lower specification
of operators, trials, limits
and samples Gage Repeatability and operators
Chose 3 to
Reproducibility
be appraisers
This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells.

Number of operators 3 Upper specification limit 27

Number of trials 3 Lower specification limit 22
Number of samples 10

Data Operator 1 Operator 2 Operator 3

Trial Trial Trial
Sample # 1 2 3 Range 1 2 3
Had each appraiser
Range 1 2 3 Range
1 25.250 measure each
25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840
2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420
3 22.370 sample 3 times
22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140
4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660
5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230
6 24.610 Results calculated
25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570
7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580
8 26.100 automatically
26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810
9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290
10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240
Range average 0.355 0.516 0.578
Sample average 25.043 25.211 25.248
Selected 10 samples
to be measured Tolerance analysis
Average range 0.483 Repeatability (EV) 1.4732 29.46%
X-bar range 0.205 Reproducibility (AV) 0.4827 9.65%
Repeatability and Reproducibility (R&R) 1.5502 31.00%
Control limit for individual ranges 1.2461
Note: any ranges beyond this limit may be the result
of assignable causes. Identify and correct. Discard
values and recompute statistics.

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 Variable MSA – Gage R&R Example

Gage Repeatability and Reproducibility

This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells.

Number of operators 3 Upper specification limit 27

Number of trials 3 Lower specification limit 22
Number of samples 10

Data Operator 1 Operator 2 Operator 3

Trial Trial Trial
Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range
1 25.250 25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840
2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420
3 22.370 22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140
4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660
5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230
6 24.610 25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570
7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580
8 26.100 26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810
9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290
10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240
Range average 0.355 0.516 0.578
Sample average 25.043 25.211 25.248

Repeatability
Average range = 0.483
(EV) Repeatability (EV) 1.4732
Tolerance analysis
29.46%
% Tolerance*
Reproducibility
X-bar range =0.205
(AV) Reproducibility (AV) 0.4827 9.65%
Equipment Variation
Repeatability & Repeatability and Reproducibility (R&R) 1.5502 31.00%
Appraiser Variation Control limit for individual ranges
30%
1.2461
Reproducibility = R&R Note: any ranges beyond this limit may be the result
% Tolerance is > 30%
of assignable causes. Identify and correct. Discard
values and recompute statistics.
MSA fails! 10%

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Gage R&R Exercise - Setup Instructions

•Divide into teams

•Distribute stars (10 per team), measurement devices (1
per team), and markers (1 per team).
•Number the stars from 1-10.
•Mark the 2 points to be measured on each star (see
diagram on next page)
•Determine and document the measurement process.
•Be sure everyone has a clear understanding of the
process.
•Determine roles.
−(3) inspectors, (1) data recorder, (1) customer

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Gage R&R Exercise - Dimensional Information

Each star will be measured as shown.

Mark the 2 points

to be measured

Dimension

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Gage R&R Exercise – Inspection Instructions

1. All inspectors need to wait outside the room when it is not their
turn to evaluate the stars.
2. Open the PPAP Training Templates.xls file, then select the Gage
R&R worksheet to record the data.
3. Round 1
Have the 1st inspector come in the room and measure all 10 stars in
order. Data collector record the data in the Gage R&R worksheet.
» Do not give any additional information to the inspector
4. Repeat Step 3 with the 2nd inspector
5. Repeat Step 3 with the 3rd inspector
6. Round 2
Change the inspection to reverse order and repeat.
7. Round 3
Change the inspection to random order and repeat.

Use the file PPAP Training Templates.xls

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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.

Confidential 85
MSA

Reviewer’s Checklist

If the gage/inspection affects quality, 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
If you question that gage, then
−Question the technique and part sampling
−Ask for additional studies

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DIMENSIONAL RESULTS

Confidential 87
Dimensional Results

FAI Non-Critical Dimensions

Date: Supplier Name: Date Code: What is It?
Part Number: Facility Location: Inspected By:

Revision: Supplier Code: Verified By: Evidence that dimensional

The number of non-critical data points required for part qualification is 5. The non-critical data points
must be taken from the same 35-piece sample as the critical data points. Five parts from a production verifications have been completed
run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to
verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts
are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered
and results indicate compliance with
below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The
supplier should make every effort to ship 5 parts that represent both the low and high ends of the specified requirements.
specifications for the non-critical dimensions.
Cpk less than 1.33 will require action for improvement
Print zone or Nominal
spec note Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

Objective or Purpose
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

• To show conformance to the

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

customer part print on dimensions

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

and all other noted requirements.

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
When to Use It
#DIV/0! #DIV/0!

• For each unique manufacturing

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

process (e.g., cells or production

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
lines and all molds, patters, or
List Gage R&R value: Name and ID of gage(s) used for measurement:
dies

Confidential 88
 Dimensional Report (Critical)

FAI Critical Dimensions

Date: Supplier Name: Date Code: The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a
production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical Cpk less than 1.67 will
Part Number: Facility Location: Inspected By:
dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must require action for
Revision: Supplier Code: Verified By:
be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every improvement
effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions.

Print zone or
spec note
Nominal
Value Tol + Tol - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Sample

18 19 20 21
Automatically
22 23 24 25 26 27 28 29 30 31 32 33 34 35 Cp Cpk Pass/Fail

Calculates Cpk!
#DIV/0! #DIV/0!

The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!

production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!

be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!

effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

List Gage R&R value: Name and ID of gage(s) used for measurement:

Requires 35 data points

Cpk must be greater

than or equal to 1.67

This is included in the

PPAP Playbook!

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 Dimensional Report (Non-Critical)

FAI Non-Critical Dimensions

Date: Supplier Name: Date Code:

Part Number: Facility Location: Inspected By:

Revision: Supplier Code: Verified By:

The number of non-critical data points required for part qualification is 5. The non-critical data points
The number
must be of non-critical
taken from the same 35-piecedata points
sample required
as the critical for
data points. Fivepart qualification
parts from a production is 5. The non-critical data points
run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to
must beverify
taken fromandthe
both critical same
non-critical 35-piece
dimensions. sample
The supplier as the
must clearly identifycritical
which of thedata
35 partspoints. Five parts from a production
run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to
are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered
below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The
verify both critical
supplier should makeandeverynon-critical
effort to ship 5 partsdimensions.
that represent both theThelow andsupplier must clearly identify which of the 35 parts
high ends of the
specifications for the non-critical dimensions.
are being shipped. Non-critical Cpk less than 1.33dimensional
will require action for results
improvementfor the 5 parts being shipped must be entered
Nominal Automatically
below. CriticalValue dimensional results must
Sample 3 be entered into the
Cpk "FAI Critical Dimensions" worksheet. The
Print zone or
spec note Tol + Tol - Sample 1 Sample 2 Sample 4 Sample 5 Cp Pass/Fail

supplier should make every effort to ship 5 parts that#DIV/0!

#DIV/0! #DIV/0!
represent
#DIV/0! both theCalculates Cpk!
low and high ends of the
Requires
specifications for the non-critical dimensions. 5 data points #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

Cpk must be greater #DIV/0!

#DIV/0!
#DIV/0!
#DIV/0!

than or equal to 1.33

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

This is included in the

#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

PPAP Playbook!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!

List Gage R&R value: Name and ID of gage(s) used for measurement:

Confidential 90
Acceptance Criteria

Acceptance criteria for critical vs. non-critical characteristics

Critical Non-Critical Decision

Red (Bad) <1.33 <1.00
Yellow (OK) 1.33-1.67 1.00-1.33

Green (Good) >1.67 >1.33

Cpk must be greater than or equal to

1.67 for critical processes

Cpk must be greater than or equal to

1.33 for non-critical processes

Confidential 91
Dimensional Report Example

FAI Non-Critical Dimensions

Date: Supplier Name: Date Code:

Part Number: Facility Location: Inspected By:

Revision: Supplier Code: Verified By:

The number of non-critical data points required for part qualification is 5. The non-critical data points
must be taken from the same 35-piece sample as the critical data points. Five parts from a production
run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to
verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts
areNominal
being shipped.
ValueNon-critical dimensional results for the 5 parts being shippedCp
Tolerance & be
must Cpkentered
Sample Data
below. Critical dimensional results must be entered into the "FAI Critical Dimensions" PassThe
worksheet. / Fail
Calculations
supplier should make every effort to ship 5 parts that represent both the low and high ends of the
specifications for the non-critical dimensions.
Cpk less than 1.33 will require action for improvement
Print zone or Nominal
spec note Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail
35 0.50 0.50 34.86 34.78 34.88 34.86 34.82 4.167 2.833 Pass
76 0.50 0.50 75.96 76.08 75.92 75.93 76.09 2.017 2.001 Pass
3 0.50 0.50 3.175 3.18 3.156 3.168 3.178 17.118 11.250 Pass
3 0.50 0.50 3.18 3.156 3.178 3.175 3.18 16.406 10.703 Pass
3 0.50 0.50 3.18 3.175 3.174 3.18 3.156 16.836 11.011 Pass
3 0.50 0.50 3.156 3.18 3.173 3.175 3.18 16.862 11.034 Pass

Cpk > 1.33 for all non-critical

dimensions = Pass!
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 RECORDS OF
MATERIAL /
PERFORMANCE TEST
RESULTS

Confidential 93
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 -developed material specifications and/or an
-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

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Material Results

Production Part Approval - Material Results

Supplier Part Number Revision Level

Laboratory Outside laboratory Name of Laboratory Part Name

In-house testing
Type of
Material Spec. No./Date/Specification Supplier Test Results OK Not OK
Test

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

Signature Title Date

Confidential 95
Module Test Results

Production Part Approval - Module Test Results

Supplier Part Number Revision Level

Laboratory Outside laboratory Name of Laboratory Part Name

In-house testing

Type of Test Test description Parameters Tested Supplier Test Results OK Not OK

Module 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

Signature Title Date

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INITIAL PROCESS STUDY

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Initial Process Study

PPAP Levels for Submission & Retention

Submission Level
Requirement Level 1 Level 2 Level 3 Level 4 Level 5

1. Design Records of Saleable Product R R R * R

a. For proprietary components/details R R R * R
b. For all other components/details R R R * R
2. Engineering Change Documents, if any
3. Customer Engineering approval, if required
R
R
S
S
S
S
*
*
S
S
Even though Initial
4. Design FMEA R R R * R Process Study is coded
as an “R” on the PPAP
5. Process Flow Diagrams R R S * S
6. Process FMEA R R S * S

Submission Level Table,

7. Dimensional Results S S S * S
8. Material, Performance, Test Results R S S * S
9. Initial Process Study
10. Measurement System Analysis Studies
R
R
R
R
R
S
*
*
R
S we felt it was important
11. Qualified Laboratory Documentation
12. Control Plan
R
R
R
R
S
S
*
*
S
S to provide a brief
13. Part Submission Warrant (PSW)
14. Appearance Approval Report, (AAR) if applicable
S
S
S
S
S
S
*
*
S
S overview during training
15. Bulk Material Requirements Checklist (for bulk
material only) R R R * R
16. Sample Product R S S * S
17. Master Sample R R R * R
18. Checking Aids R R R * R
19. Records of compliance with Customer-Specific
Requirements (DVP&R) R R R * R
R = Supplier shall retain at
appropriate locations, including
S = The supplier shall submit to designated customer product approval activities and retain a copy of records or
documentation items at appropriate locations, including manufacturing manufacturing and make readily
R = The supplier shall retain at appropriate locations, including manufacturing, and make readily available to the available to the customer
customer representative upon request
representative upon request
* = The supplier shall retain at appropriate locations, and submit to customer upon request. The customer will identify
what is needed for submission base on changes and conditions

PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS .

Confidential 98
Initial Process Study

Capability Analysis
What is It?
A set of tools used to understand
process capability.

Objective or Purpose
• To evaluate the performance of
your process as compared to
specification limits.
• To determine if the production
process is likely to produce product
that will meet customer
requirements

When to Use It
1. To establish baseline capability.
2. To validate process
improvements.

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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. Validate the specification limits

3. Validate the measurement system

4. Collect data

5. Assess data characteristics

6. Assess process stability

7. Calculate process capability

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Step 1: Which Characteristic

Decide on the product or process characteristic to be assessed.

Step 1  Required for all critical characteristics
 If no critical characteristics exist, reserves the right to require
demonstration of initial process capability on other characteristics

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Step 2: Specification Limits

Step 2 Validate the specification limits by

talking to:

– Customers, suppliers, controlling agencies

Why is validation of the specification

limits important?
– They may not represent what the customer truly
desires/needs.

– May contain “guard banding” as a result of past

problems or measurement error.

– They may be based on previous designs and no

longer be valid.

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Step 3: Measurement System

Validate the measurement

Step 3 system through the appropriate
MSA

Why is validation of the

Measurement System important?
– If there is significant error in your
measurement system, then decisions are
influenced by the error not just the
measurements themselves.

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Step 4: Data Collection

Step 4 When collecting data, consider the

following:
– Short term data
» Free of special causes
» Collected across a narrow inference space i.e.
one shift, one machine, one operator, etc..

– Long term data

» Subjected to the effects of both random and
special cause variation

» Collected across a broad inference space i.e.

multiple shifts, machines, operators, etc.

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Step 4: Data Collection

When collecting data, consider the following:

Step 4
– Rational sub-grouping
» A group of units produced under the same set of
conditions
» Mean to represent a “snapshot” of the process
Example: » Must be taken close together in time, but still be
independent of each other
A die cut machine produces
» Use subgroups 100 plastic
to separate parts
the 2 types per
of variation in a
hour. The quality engineer measures 5 randomly
process:
selected parts at thesubgroup:
Within beginning Theof everyamong
variation hour.measurements
Each
sample of 5 parts is a
within subgroup.
subgroups; also known as common cause
variation
 Between subgroup: variation between subgroups that
may be caused by specific identifiable factors, or
special causes
» To improve process quality, every effort should be made
to eliminate between subgroup variation and reduce
within subgroup variation

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Step 5: Data Characteristics

Step 5 Assess data characteristics

Histogram of Mfg Hours
Mean 14.87
20
StDev 3.088

Examine the shape of your data.

N 100

15

Frequency
– Is it what you would expect? 10

If not, investigate. 5

0
8 10 12 14 16 18 20 22
Mfg Hours

Bimodal Data
Histogram of Mfg Hours Histogram of Mfg Hours
Mean 19.98 20 Mean 20.19
25 StDev 1.713 StDev 18.87
N 100 N 100

The shape of your data is 20 15

important for determining

Frequency

Frequency
15
10

which type of Capability 10

Analysis applies. 5
5

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

Normal Data Skewed Data

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Step 6: Process Stability

Assess process stability in order to understand

Step 6 how your process behaves over time. Control
charts are the recommended tool.

Control Chart Examples

Process is stable and in Process is not stable and

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

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Step 7: Process Capability

Calculate the appropriate statistical metrics in

Step 7
order to determine how the “Voice of the
Process” compares to the “Voice of the
Customer.”

Capability Metrics: PPM, DPMO, Cp, Cpk, Pp,

& Ppk ; Sigma Levels (Z Scores)

Specification Limits Specification Limits

Process is capable Process is not capable

If you were driving a truck, and the dotted lines were the
construction barriers, what would be happening in each situation?

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Focus on Variable Data

The initial process study should be focused on variable,

variable
not attribute data
 Assembly errors, test failures, and surface defects are examples of
attribute data, which is important to understand, but is not covered
in this initial study

 To understand the performance of characteristics monitored by

attribute data will require more data collected over time

 Unless approved by an authorized representative, attribute data

are not acceptable for PPAP submission

Focus on variable data

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Capability Indices

Capability
Formula What it shows
Index
Relates short term (within subgroup) standard
(USL – LSL) deviation to tolerance
Cp
6*s
Cp/Cpk
short-term
Sometimes
are used to called “Entitlement,” meaning it is the
best the current process can do, if centered
estimate potential
Relates short term mean & short term (within
process capability
Min{(USL – X), (X – LSL)}
subgroup) standard deviation to tolerance
Cpk
3*sshort-term Only tells you about the nearest spec limit; doesn’t
tell anything about the other side

(USL – LSL)
PP Relates long term (overall) standard deviation to
6*slong-term tolerance
Pp/Ppk are used to
measure actual Relates mean & long term (overall) standard
Ppk process
Min{(USL – X), (X p erformance
– LSL)} deviation to tolerance

3*slong-term Only tells you about the nearest spec limit; doesn’t
tell anything about the other side

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Capability Indices - Cpk

Cpk predicts capability

Based on short term within subgroup variation
Does not include the effect of process variability between
subgroups

Cpk should be used when:

when
−Developing new parts
−Revising specifications on a part
−Materials, processes, manufacturing location, or equipment
have significantly changed
−Material suppliers have changed (include certificate of
analysis)

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Capability Indices - Ppk

Ppk indicates past performance

Based on long term total variation
Unlike Cpk, Ppk is not limited to variation within subgroups
However, Ppk cannot isolate within subgroup variation
from between subgroup variation
When calculated from the same data set, Cpk and Ppk can
be compared to analyze the sources of process variation

Ppk should be used when:

– The supplier is new to , but has already been
manufacturing a part
– The supplier is existing, but has produced a number of
nonconforming parts

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Difference between Cp & Cpk

Cp – determines capability of producing to specification

Cpk – same as Cp, but also measures how centered the process is
It is important to look at both!

Cp > 1.67 Cp > 1.67

Cpk > 1.67 Cpk < 1.00

Capable, Capable,
Centered Not Centered

LSL USL LSL USL

Cp < 1.00 Cp < 1.00

Cpk < 1.00 Cpk < 0

Not Capable, Not Capable,

Centered Not Centered

LSL USL LSL USL

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Acceptance Criteria

Acceptance criteria for critical vs. non-critical characteristics

Critical Non-Critical Decision

Red (Bad) <1.33 <1.00
Yellow (OK) 1.33-1.67 1.00-1.33

Green (Good) >1.67 >1.33

Cpk must be greater than or equal to

1.67 for critical processes

Cpk must be greater than or equal to

1.33 for non-critical processes

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Initial Process Study

Reviewer’s Checklist
Ensure that the results are acceptable, and that the
process is stable and capable of producing a quality
part

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

More information about capability is available in the

Appendix at the end of this presentation

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QUALIFIED LABORATORY
DOCUMENTATION

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Qualified Laboratory Documentation

•Inspection and testing for PPAP shall be performed by

a qualified laboratory as defined by requirements
(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.

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APPEARANCE APPROVAL
REPORT

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 Appearance Approval Report

Appearance Approval Report What is It?

Part Number

Part Name
Drawing Number

Buyer E/C Level

Application

Date
• A report completed by the supplier
Supplier Name Manufacturing Location Supplier Code containing appearance and color
criteria
Reason for Part Submission Warrant Special Sample Re-Submission
Other
Submission
Pre Texture First Production Shipment Engineering Change

Appearance Evaluation
Pre-Texture Customer Representative
Supplier Sourcing and Texture Information
Evaluation signature and Date

Correct and Proceed Objective or Purpose

Correct and Resubmit

Approved to Texture • To demonstrate that the part has

met the appearance requirements
Color Evaluation
Color
Color Master Master Material Material Metallic Part
Tristimulus Data Hue Value Chroma Gloss Shipping

on the design record

Suffix Number Date Type Source Brilliance Disposition
Suffix
DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low

When to Use It
Comments: • Prior to tooling for production
Supplier Signature Phone No. Date Customer Representative Signature Date

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

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 Appearance Approval Report

Administrative Section

Appearance Approval Report

Part Number Drawing Number Application

Supplier Sourcing & Texture Information
Part Name List all first surface tools, grainingBuyer Pre-Texture
E/C Level Evaluation
Date

Supplier Name Source(s), grain type(s), and grainLocation

Manufacturing and To be completed by Supplier
SQE Code
Gloss masters used to check part
Reason for Part Submission Warrant Special Sample Re-Submission
Other
Submission
Pre Texture First Production Shipment Engineering Change

Appearance Evaluation
Pre-Texture Customer Representative
Supplier Sourcing and Texture Information
Evaluation signature and Date

Correct and Proceed

Correct and Resubmit

Approved to Texture

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 Appearance Approval Report

Master
Master
Material
Number
DateType
Material Source Color Shipping Suffix
Color Suffix
Enter
Enter
Identify
alphanumeric
the date
first
Identify
on
surface
which
firstfinish
surface
andand Color part number
Alphanumeric or
master numeric
thesubstrate
master
identification
was
substrate
(e.g.
approved
paint
suppliers
/ ABS) suffix or color number
color identification

Color Evaluation
Color
Color Master Master Material Material Metallic Part
Tristimulus Data Hue Value Chroma Gloss Shipping
Suffix Number Date Type Source Brilliance Disposition
Suffix
DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low

Tristimulus Data
Part Disposition
List numerical (colorimeter) Hue, Value, Chroma, Gloss, and
To be determined by
data of submission part as Metallic Brilliance
(approved or
compared
Comments: to the customer- Visual assessment by
rejected)
authorized master

Supplier Signature Phone No. Date Customer Representative Signature Date

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SAMPLE PRODUCTION
PARTS

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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

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Sample Production Parts

•The sample parts provided should be the same parts

measured for the dimensional results

•Default quantity for all submissions is 3 parts unless

otherwise requested

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Sample Production Parts

Sample production parts MUST be properly identified

– Include the following information on the part label:
• Date parts were packed
• part number
• Quantity See part label examples on
the next slide
• Serial number
• Supplier part number (optional)
• Part description
• Country of origin
• Indication of RoHS compliance
• Approval markings (UL, CE, etc.) where applicable

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Part Label Example

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PPAP Summary

•The Production Part Approval Process is an extensive

approval process for new or changed designs or
processes

•It is very formalized, so it inevitably causes some

administrative work

•Later changes to the product or process can be

expensive and time-consuming!

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