Transcript Donaldson EMEA Supplier Quality Assurance

PPAP TRAINING
January 2013
Donaldson EMEA
Supplier Quality Assurance
CORP MAN 006 PPAP WORKBOOK TRAINING – Rev 5– dd 03/04/2013
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 is part of the Donaldson Supplier Business Operating
Standard (S.B.O.S.S.)
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!
When is PPAP Required?
New part
Engineering change(s)
Tooling: transfer, replacement, refurbishment, or additional
Correction of discrepancy
Tooling inactive > one year (needs Cpk study)
Change to optional construction or material
Sub-supplier or material source change
Change in part processing
Parts produced at a new or additional location
PPAP is required with any
significant change to product or
process!
Benefits of PPAP Submissions
•
•
•
•
•
•
•
Helps to maintain design integrity
Identifies issues early for resolution
Reduces warranty charges and prevents cost of poor quality
Assists with managing supplier changes
Prevents use of unapproved and nonconforming parts
Identifies suppliers that need more development
Improves the overall quality of the product & customer
satisfaction
DBV = online supplier monitoring
● After a successful submitted and approved PPAP, part can be
supplied to the Donaldson organization
● Each supply get’s monitored and deliveries are measured in ppm
and in % on-time
● When defect parts are found, an NCR and 8D is executed
● Monthly the DBV committee communicates supplier ranking
● Yearly SQA management at headquarter organizes an supplier
PPM improvement event, based on a 6 months supplier base
performance.
● Our purchase department has an active role encouraging our
suppliers to be the best in class
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!
Readiness Review (R-R)
• The purpose of a R-R is to verify the supplier’s manufacturing
process is capable of producing components that meet Donaldson’s
quality requirements, at quoted tooling capacity, for a specified period
of time
• Verification of the R-R will be at the Supplier Quality Engineer’s
(SQE) discretion. The supplier will be notified of the need to perform
a R-R as early in the process as possible.
• The number of components to be produced during the R-R 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
The start of using the PPAP workbook
PPAP Submission
Due Date
● Safe the “Workbook template” as an
Excel Workbook.
File name = Donaldson Part number
followed by Donaldson Part rev
number.
E.g. P566611-rev8-……(+ free suffix)
● Fill out the sheet: “PPAP Submission
Info”
To do so, headers of other sheets are
filled out automatically.
● Most of the fields are filled out by the
Donaldson PPAP team
Part Name (Donaldson
Part Number (Donaldson)
Revision (Donaldson)
Revision date (Donaldson)
Supplier Part Number (optional)
PPAP Assigned Quality Engineer
Supplier Name
Supplier Number
Street Address
City
Postcode / Zip code
Country
Phone Number
Supplier Contact
Supplier PPAP
Remarks
If designated appearance part,
appearance compliance will be
identified via a special purchase
order notification.
va
SC
lev
LEVEL 3
Requirements
Part Submission Warrant
Submit
Appearance approval Report
Submit
Design records
Authorized change documents
Part Dimensional approval
List of checking aids
Part Material approval
Process Flow Map
Design and or Process FMEA
Control Plan
Submit
Submit
Submit
Required
Submit
Submit
Submit
Submit
Please execute and show evidense
Process Capability Study, Cpk Calculation
of capabillity
Measuring System Study, Gage R&R
Sample parts
Master Sample (If applicable)
Customer Engineering Approval Form
PPAP Level 5 Checklist
Submit
Submit
Submit
Official PPAP Requirements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Design Records
Authorized Engineering Change Documents
Customer Engineering Approval, if required
Design Failure Modes and Effects Analysis (DFMEA) applied in special situations
Process Flow Diagram
Process Failure Modes and Effects Analysis (PFMEA)
Control Plan
Measurement Systems Analysis (MSA)
Dimensional Results
Records of Material / Performance Test Results
Initial Process Studies
Qualified Laboratory Documentation
Appearance Approval Report (AAR)
Sample Production Parts
Master Sample
Checking Aids
Customer-Specific Requirements
Part Submission Warrant (PSW)
Have a closer look
Donaldson’s PPAP Requirements
Supplier shall submit
12 items and retain a
copy of 12 + 2 (R)
records at appropriate
locations
For PPAP Level 5, SQA will witness at supplier
location and will fill out PPAP level 5 work
sheet.
PPAP Submission Levels
Level 1
Production Warrant and Appearance Approval
Report (if applicable) submitted to Donaldson
Level 2
Production Warrant, product samples, and
dimensional results submitted to Donaldson
Level 3
Production Warrant, product samples, and
complete supporting data submitted to
Donaldson
Level 4
Production Warrant and other requirements
as defined by Donaldson
Level 5
Production Warrant, product samples and
complete supporting data (a review will be
conducted at the supplier's manufacturing
location)
PPAP Submission Level Table
* = Supplier shall retain
at appropriate locations,
and submit to
Donaldson upon
request. Donaldson will
identify what is needed
for submission.
S = Supplier shall
submit to Donaldson &
retain a copy of records
or documentation items
at appropriate locations
R = Supplier shall retain
at appropriate locations
and make readily
available to Donaldson
upon request
Definition of Risk and PPAP level
• 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 Donaldson
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
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
Donaldson reserves the right to redefine
the submission level required
PPAP Status
Approved
- The part meets all Donaldson requirements
- Supplier is authorized to ship production quantities of the part
Interim Approval
-
Donaldson permits shipment of part on a limited time and quantity clearly in
writing defined.
On Hold
-
SQA needs more info
Rejected
- The part does not meet Donaldson requirements, based on the production
lot from which it was taken and/or accompanying documentation
Production quantities may not be
shipped before Donaldson Approval
Electronic Submission Requirements
• Donaldson requires that all PPAPs be submitted electronically 
[email protected]
• Use of paper submission must have prior approval by the SQA
• Submission must be received on or prior to the PPAP due date
• Review and Approval Process:
Donaldson will attempt to review and provide feedback within
3 business days
Donaldson requires all
submissions to be electronic
Donaldson PPAP book
• What is the Donaldson PPAP book?
An Excel spreadsheet containing templates of the documents
suppliers are required to submit to Donaldson.
Organization formats are allowed as long these documents are
providing the same. (Preferred language is English)
• Why use the PPAP book?
Simplifies the process for suppliers by serving as a “checklist”
of what needs to be submitted to Donaldson
Reduces the number of files to manage
Enables the SQA / PPAP team to quickly see if anything is
missing
Show PPAP book “CORP SQADOC 004”
Part Submission Warrant
Part Submission Warrant
What is It?
• Document required for all newly
tooled or revised products in which
the supplier confirms that inspections
and tests on production parts show
conformance to Donaldson
requirements
Objective or Purpose
Used to :
• document part approval
• provide key information
• declare that the parts meet
specification
When to Use It
• Prior to shipping production parts
Have a closer look
Part Submission Warrant
Product weight
Enter the product weight
Donaldson Part Number
Engineering
released finished
Engineering
Change Level & Date
end item part
number
Show the change level and date of
Shown on Drawing Number the Design Record
The design record that specifies
Additional Engineering Changes
the
customer part
number being
Safety
Government
Regulation
List alland/or
authorized
Engineering
Purchase Order Number
submitted
“Yes”
if sonot
indicated
by the Design
Record,
changes
yet incorporated
inEnter
this number as found on
otherwise
“No”
the design record but which are
the contract / purchase order
Checking Aid Number, Change Level, & Date
incorporated in the part
Enter if requested by the customer
Part Submission Warrant
Supplier Manufacturing Information
Show the name and code assigned to
the manufacturing site on the
purchase order / contract
Parts Identified with Appropriate Marking Codes
UL = Underwriters Laboratories safety standards
CE = Conformite Europeenne (European Conformity) –
Certifies that
a productLocation
has met European consumer
Donaldson
Restricted
Substances
Safety, health,
or
environmental
requirements
Showorthe
location where
Enter “Yes”
“No”
ISO = International
for Standardization
Buyer
/Organization
Buyer
Code to
parts
will
be shipped
Enter “Yes” orEnter
“No”the buyer’s name
Model Name / Number
and code
Enter the model name
and number
Part Submission Warrant
Reason For Submission
Check the appropriate box(es)
Mold / Cavity / Production Process
If production parts will be produced from
more than one mold, cavity, tool, die,
pattern, or production process,
the supplier
Submission
Results
shall complete a dimensional
evaluation
on
Check the appropriate
boxes
one part from each. The specific molds,
lines, etc. shall then be identified here.
Requested Submission Level
Identify the submission level
requested by Donaldson
Part Submission Warrant
Declaration
Declaration
Explanation / Comments
Affirmation
that
the samples represented
Entercomments
the
number
pieces
Provide any explanatory
onof
the
by the during
warrant
are representative and
manufactured
the
submission results or
any deviations
Supplier Authorized
Signature
were
made by run
a process that meets Donaldson’s
significant
production
from the Declaration.
Attach
additional
A responsible supplier
official,
after
verifying
requirements
and the PPAP
time (in
hours) taken
information as appropriate.
that the results show
conformance
all Donaldson
for the significantto
production
run
requirements and that all required documentation
is available, shall approve the declaration
For Donaldson Use Only
To be completed by appropriate
PPAP Warrant Disposition
Donaldson Supplier Quality Engineer
Donaldson
Approved,Signature
Rejected, Other
Signed by Donaldson Supplier
Quality Engineer
The approved Production Warrant officially
warrants the parts ready for production
Part Submission Warrant
●Reviewers Checklist
Must be completely filled out
Must be signed by the supplier
Part Number must match the PO
Submitted at the correct revision level
Submitted at the correct submission level
Specify the reason for submission
Report the approval / Reject to the PPAP team and the
APD team
AUTHORIZED ENGINEERING
CHANGE DOCUMENTS
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 (ECO)
Feasibility studies
Supplier change requests
Sub-assembly drawings
Life or reliability testing requirements
PROCESS FLOW DIAGRAM
Process Flow Diagram
What is It?
Operator
Separate Cutting
Tags
(31)
Evaluate for
Corrective Action
Yes
Operator
Get Traveler and
Nest from Holding
Shelf
(26)
Operator
Load Machine with
Blanket
(28)
Operator
Prints Cut Tags
(27)
Operator
Download Cutting
Infomation
(2s to 2m)
(29)
Operator
Program
Command
"Ready to Cut"
(30)
Operator
Observe Cutting
Operation for
Errors
(32)
Cutting Error?
(33)
No
Operator
Remove Small
Plies from the
Cutting Table
(36)
Operator
Move to Kitting
Table
(37)
Operator
Tag Small Plies
(38)
No
Small Plies
Operator
Cutting Operation
Complete
(34)
Large or Small Plies
or Test Coupons?
(35)
Operator
Tag while Laying
on the Cutting
Table
And
(39)
Coupons
Large
Piies
Operator
Remove Plies
from the Cutting
Table
(40)
Operator
Move Plies to
Kitting Table
(41)
Traveler
Complete?
(42)
Operator
Stamp Traveler
(43)
Department/Group Project
High Level Process Map
Project Idea
6 Sigma Project
High Level Process Map
Yes
Fill Out Master
Form
with Initial
Information
Get WO Assigned
Begin/Work
Project
Follow DMAIC or
DFSS process
6 Sigma Assigns
Project Number
Monitor Progress
through Power
Steering and
Monthly
Financial
Reviews
Other Required
Signatures:
Segment CEO
Champion
Process Owner
BB or GB
No
Yes
Finance Approval
and Signature
Finance Approval
and Signature
No
Master Form Will
Generate
Contract
Complete Project
(Has to be fully
Documented
Do you
have BB/GB to
Assist/Work the
project?
Monitor Progress
through BiWeekly Updates
and Monthly
Reviews
6 Sigma
Project
Does the
Project Involve
Only Your
Group?
Final Project
Review
Yes
Department
or Group
Project
Enter Remaining
Information on
Master Form
Finance Approval
and Signature
No
Does the
Project Involve
>2 Groups in
Eng?
Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB
No
Yes
Close
Project
Yes
Follow DMAIC or
DFSS process
Is Hard
Savings > $???
No
Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB
Get DLN
Assigned
Begin/Work
Project
Complete Project
(Has to be fully
Documented)
Master Form Will
Generate
Contract
Finance Approval
and Signature
Complete all
Documentation
including a
(1) Page Closeout Sheet
Group Assigns
Project Number
Yes
Yes
Enter Remaining
Information on
Master Form
Final Project
Review
Other Required
Signatures:
Champion:
Process Owner
Project Owner
Dept GB/BB/MBB
Prefer to work
this project
within your
area?
Does the
Project Involve
>3 Depts.
outside Eng?
No
Close
Project
Complete all
Documentation
including a
(1) Page Closeout Sheet
• A visual diagram of the entire
process from receiving through
shipping, including outside processes
and services
Objective or Purpose
• To help people “see” the real
process. Process maps can be used
to understand the following
characteristics of a process:
• Set-by-step process linkage
• Offline activities (measurement,
inspection, handling)
• Rework, scrap
When to Use It
• To understand how a process is
done
• Prior to completing the PFMEA
Process Flow Diagrams
The process flow
diagram utilizes these
symbols to clearly
identify each step in
the process
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
PROCESS FMEA
Process FMEA (PFMEA) CORP QEHSDOC 014
What is It?
Failure Mode and Effects Analysis
(Design FMEA)
S ys t e m / C o m po ne nt :
F M E A N um be r:
P a ge
P re pa re d by:
F M E A D a t e ( O rig.)
D e s ign R e s po ns ibilit y:
of
( R e v .)
C o re T e a m :
Item /
Process
Potential Failure
Mode
Function
Potential Effect(s)
of Failure
S
e
v
Potential Cause(s)/
Mechanism (s) of
Failure
O
c
c
u
r
Current Design
Controls
Prevention
Current Design
Controls Detection
D
e
t
e
c
R.
P.
N.
Recom m ended
Action(s)
Responsibility &
Target Com pletion
Date
Action Results
O
S
c
e
c
v
u
r
ActionsTaken
D
e
t
e
c
R.
P.
N.
• A tool used to identify and prioritize
risk areas
and their mitigation plans.
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
IMPORTANT!
The PFMEA should be completed
using a cross-functional team!
• After completion of the process
flow diagram.
• Prior to tooling for production
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
Process FMEA (PFMEA)
This is included in the
PPAP book!
PFMEA - Step 1
R.P.N.
Current Process
Controls
8
Variables check
for film
thickness; Visual
check for
coverage
5 280
5 Variables check
for film
thickness; Visual
check for
coverage; Test
spray at start-up
and after idle
periods and
preventative
maintenance
program to clean
heads
5 175
Detec
Occur
Class
Potential Failure
Mode
Sev
Process Step
Potential
Potential
Failure
Modes Cause(s)/
Effect(s)
of
Mechanism(s)
For each Process
Input,
Failure
of Failure
determine the ways in
Op 70: Manual Insufficient wax Allows integrity
7 inputManually
which the
can go
application of
coverage over breach wrong.
of inner
inserted spray
wax inside door specified surface
door panel
head not
panel
inserter far
Corroded interior
enough
lower door
panels
Using the completed
Process Flow Diagram,
enter the process step.
Deteriorated life
of door leading
to:
- Unsatisfactory
appearance due
to rust through
paint over time
- Impaired
function of
interior door
hardware
Spray head
clogged:
- Viscosity too
high
- Temp too low
- Pressure too
low
TIPS
• There should be at least one failure mode for each input.
PFMEA - Step 2
R.P.N.
Current Process
Controls
Detec
Deteriorated life
of door leading
to:
- Unsatisfactory
appearance due
to rust through
paint over time
- Impaired
function of
interior door
hardware
7
Potential
Cause(s)/
Mechanism(s)
of Failure
Occur
Op 70: Manual Insufficient wax Allows integrity
application of
coverage over breach of inner
wax inside door specified surface
door panel
panel
Corroded interior
lower door
panels
Class
Potential
Effect(s) of
Failure
Sev
Process Step
Potential Failure
Mode
Manually
8 Variables check 5 280
inserted spray
for film
head not
thickness; Visual
inserter far
check for
Potential Failure
Effects
enough
coverage
For each Failure Mode,
determine what effect
the specific failure
Spray head
5 Variables check
5 175
could
have
on
the
clogged:
for film
process
output.
- Viscosity
too
thickness; Visual
high
- Temp too low
- Pressure too
low
check for
coverage; Test
spray at start-up
and after idle
periods and
preventative
maintenance
program to clean
heads
TIPS
• There should be at least one failure effect for each failure mode.
• Effects should be specific, clear, and leave no doubt to the uninformed reviewer.
PFMEA - Step 3
Spray head
clogged:
- Viscosity too
high
- Temp too low
- Pressure too
low
R.P.N.
of door leading
to:
- Unsatisfactory
appearance due
to rust through
paint over time
- Impaired
function of
interior door
hardware
Manually
inserted spray
head not
inserted far
enough
Current Process
Controls
8
Variables check
for film
thickness; Visual
check for
coverage
5 280
5 Variables check
for film
thickness; Visual
check for
coverage; Test
spray at start-up
and after idle
periods and
preventative
maintenance
program to clean
heads
5 175
Detec
determine the possible
cause of the failure.Deteriorated life
7
Potential
Cause(s)/
Mechanism(s)
of Failure
Occur
Op 70: Manual Insufficient wax Allows integrity
application of
coverage over breach of inner
wax inside door specified surface
door panel
panel
Corroded interior
Potential Causes
lower door
For each Failure Mode,panels
Class
Potential Failure
Mode
Sev
Process Step
Potential
Effect(s) of
Failure
TIPS
• There should be at least one potential cause for each failure mode.
PFMEA - Step 4
8
Variables check
for film
thickness; Visual
check for
coverage
R.P.N.
Op 70: Manual Insufficient wax Allows integrity 7
Manually
application of
coverage over breach of inner
inserted spray
wax inside door specified surface
door panel
head not
Current Controls
panel
inserter far
For
each
potential
Corroded
interior
enough
lower door
cause,
list the current
panelsused for
method
Current Process
Controls
Detec
Potential
Cause(s)/
Mechanism(s)
of Failure
Occur
Class
Potential
Effect(s) of
Failure
Sev
Process Step
Potential Failure
Mode
5 280
Spray head
preventing or detecting
Deteriorated
life
clogged:
failure.
TIPS
• This step in the FMEA
current control plan.
5 Variables check
5 175
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
begins
to identify initial shortcomings
or gaps
program to clean
hardware
heads
• If a procedure exists, enter the document number.
• If no current control exists, list as “none.”
in the
PFMEA - Step 5
● Assign Severity, Occurrence, and Detection ratings
Manually
8 Variables check
inserted spray
for film
headDetection
not
thickness; Visual
Assign
inserter
far can the
check for
(How
easily
enough
coverage
cause or failure
R.P.N.
Current Process
Controls
Detec
7
Potential
Cause(s)/
Mechanism(s)
of Failure
Occur
Assign Severity
Op 70: Manual
Insufficient
waxis the
Allows integrity
(How
serious
application effect
of
coverage
over breach of inner
if it fails?)
wax inside door specified surface
door panel
panel
Corroded interior
lower door
panels
Class
Potential Failure
Mode
Sev
Process Step
Potential
Effect(s) of
Failure
5 280
mode be detected?)
Spray head
Deteriorated
life
Assign Occurrence
clogged:
of
door
leading
(How likely is the - Viscosity too
to:
cause
to occur?) high
- Unsatisfactory
- Temp too low
appearance due
- Pressure too
to rust through
low
paint over time
- Impaired
function of
interior door
hardware
5 Variables check
for film
thickness; Visual
check for
coverage; Test
spray at start-up
and after idle
periods and
preventative
maintenance
program to clean
heads
5 175
Severity, Occurrence and Detection rating details on next slide
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!
An Example of Rating Definitions
Rating
High
Low
10
1
Severity
Occurrence
Detection*
Hazardous
without
warning
Very high and
almost
inevitable
Cannot detect
or detection
with very low
probability
Loss of primary
function
High repeated
failures
Remote or low
chance of
detection
Loss of
secondary
function
Moderate
failures
Low detection
probability
Minor defect
Occasional
failures
Moderate
detection
probability
No effect
Failure unlikely
Almost certain
detection
*If No Controls Exist, Detection = 10
Referring too 4th Edition FMEA Manual
and the scales in Donaldson PPAP workbook.
PFMEA - Step 6
Op 70: Manual Insufficient wax Allows integrity 7
Manually
8 Variables check
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
the
Risk
Priority
Number
Corroded interior
enough
coverage
lower door
= Severity
panelsx Occurrence x Detection
R.P.N.
Current Process
Controls
Detec
Potential
Cause(s)/
Mechanism(s)
of Failure
Occur
Class
Potential Failure
Mode
Sev
Process Step
Potential
Effect(s) of
Failure
5 280
RPN
TIPS
• The RPN is used to
FMEA.
• High RPNs (150 or above) are flags to take
Spray head
clogged:
- Viscosity too
high
- Temp too low
- Pressure too
low
5 Variables check
5 175
for film
thickness; Visual
check for
coverage; Test
spray at start-up
after idle
risks identifiedand
in
the
periods
and first half of the
preventative
maintenance
program to clean
effort to reduce heads
the calculated risk.
Deteriorated life
of door leading
to:
- Unsatisfactory
appearance due
to rust through
prioritize the
most
paint over
timecritical
- Impaired
function of
interior door
hardware
• Regardless of RPN, high Severity scores (9 or 10) should be given special
attention.
Analyzing the PFMEA
Sort by RPN to determine
the most significant
failure modes
?
How many items should be
the focus of the next steps?
• Once the RPN Numbers are
determined, they can be used to
prioritize the most significant failure
modes.
• Sort the FMEA by the RPN numbers.
Graphical and statistical tools can help
the team select a “cut-off” RPN for the
next steps.
RPN Thresholds
• When using an RPN threshold, DO NOT
forget to address high Severity scores
Pareto Chart
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 mistakeproofing, simplification and statistically sound monitoring.
In general, reducing the Occurrence
is preferable to improving the Detection
FMEA – Step 7
• Determine Actions Recommended to reduce High RPNs
Action Results
175 Use DOE on
viscosity vs.
temp vs.
pressure
Mfg. Eng. By
5/31/10
recommended actions.
Deteriorated life
of door leading
to:
- Unsatisfactory
appearance due
to rust through
paint over time
- Impaired
function of
interior door
hardware
Mfg. Eng. By
5/25/10
R.P.N.
Mfg. Eng. By
5/10/10
Det
Op 70: Manual Insufficient wax Allows integrity 280 Add positive
application of
coverage over breach of inner
depth stop to
wax inside door specified surface
door panel
sprayer
panel
Automate
Corroded interior
spraying
For the high RPN numbers,
lower door
determine the
panels
Actions Taken
Occ
Recommended Responsibility &
Actions
Target Date
Sev
Potential Failure
Mode
R.P.N.
Process Step
Potential
Effect(s) of
Failure
Stop added,
7 2 5 70
sprayer checked
on-line
Rejected due to
complexity of
different doors on
the same line
Temp and press
7 1 5 35
limits were
determined and
limit controls
have been
installed - Control
charts show
process is in
control Cpk =
1.85
FMEA – Steps 8 and 9
Action Results
R.P.N.
Op 70: Manual
application of
wax inside door specified surface
panel
Det
Assign a specific person
who will
responsible
Insufficient
wax be
Allows
integrity 280 Add positive
coverage
over breach of inner
depth stop to
for recommended
actions.
Actions Taken
Occ
Recommended Responsibility &
Actions
Target Date
Sev
Potential
Potential Failure
Effect(s) of
Mode (responsibility)
Resp
Failure
R.P.N.
Process Step
Mfg. Eng. By
5/10/10
Stop added,
7 2 5 70
sprayer checked
door panel
sprayer
on-line
Automate
Mfg. Eng. By
Rejected due to
Corroded interior
spraying
5/25/10
complexity of
Actions
lower
door Taken
different doors on
panels
As
actions are identified
the same line
175 Use document
DOE on
Mfg. Eng. By
Temp and press
7 1 5 35
and completed,
Deteriorated life
viscosity vs.
5/31/10
limits were
“Actions
Taken”
of in
doorthe
leading
temp vs.
determined and
to:
column.
pressure
limit controls
- Unsatisfactory
have been
appearance due
installed - Control
to rust through
show
SEV, OCC, DET,charts
RPN
paint over time
process is in
- Impaired
As actions are control
complete
Cpk =
function of
1.85
reassess Severity,
interior door
Occurrence, and Detection
hardware
• Now recalculate your RPNs
based on mitigation plans.
TIPS:
and recalculate RPN.
Continue updating the actions taken and
resulting RPNs until all risks are at an acceptable level (below 100).
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.
Process FMEA (PFMEA)
Tips and Lessons Learned
• Collaborative Effort: Do not try alone, use a group
• Very comprehensive: 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
Process FMEA (PFMEA)
●Reviewers Checklist
Verify there is a system for prioritizing risk of failure such as RPN
numbers of 150 or above
Make sure that high RPN process concerns are carried over into the
control plan
Make sure that all critical failure modes are addressed
 Safety
 Form, fit, function
 Material concerns
CONTROL PLAN
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
NOTE
Since processes are expected to be continuously
updated and improved, the control plan
is a living document!
• Primary reference source for
minimizing process and product
variation.
• Description of how teams should
react to out-of-control situations.
When to Use It
• Implementation of new process
• Following a process change
Control Plan
Tool Interaction
Department/Group Project
High Level Process Map
Project Idea
6 Sigma Project
High Level Process Map
Process Step
Fill Out Master
Form
with Initial
Information
Get WO Assigned
Begin/Work
Project
Follow DMAIC or
DFSS process
6 Sigma Assigns
Project Number
Other Required
Signatures:
Segment CEO
Champion
Process Owner
BB or GB
Monitor Progress
through Power
Steering and
Monthly
Financial
Reviews
Finance Approval
and Signature
No
Finance Approval
and Signature
Do you
have BB/GB to
Assist/Work the
project?
Monitor Progress
through BiWeekly Updates
and Monthly
Reviews
6 Sigma
Project
Final Project
Review
No
Yes
Department
or Group
Project
Does the
Project Involve
>2 Groups in
Eng?
Finance Approval
and Signature
Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB
No
Yes
Yes
Potential
Failure Effects
Receive
Payment
Checks
Delay internal
mail
Identify
Customer
Wire
Transfer
reference
line
Information not AR balance is
supplied
past due
AR balance does
not go down
Does the
Project Involve
>3 Depts.
outside Eng?
No
Identify Invoice Checks
Incorrect
invoice
supplied
Identify Invoice Checks
Invoice number Invoice shows
not supplied
outstanding (AR
balance does go
down)
Enter Remaining
Information on
Master Form
No
Close
Project
Process Steps
Potential
Failure Mode
S
O
E Potential Causes C
V
C
Inadequate
staffing in mail
7 room
Customer or bank
did not include
name and/or
10 account info on
wire transfer
Current Controls
D
E
T
R
P
N
None
7
5
10 490
Acct identifies problem
when trying to apply
payment
E
O
C
Actions
Recommended
Resp.
Actions
Investigate mail room G. Lee
staffing and associated
processes
Added anoth
clerk. Adjus
schedule.
Poka-Yoke wire transer N. Peart
process
Contacted b
established w
transfer proc
2112)
5 250
Is Hard
Savings > $???
Does the
Project Involve
Only Your
Group?
Other Required
Signatures:
Champion: Dir T&E
Process Owner
Project Owner
Dept BB or MBB
Get DLN
Assigned
Begin/Work
Project
Follow DMAIC or
DFSS process
Complete Project
(Has to be fully
Documented)
Master Form Will
Generate
Contract
Finance Approval
and Signature
Complete all
Documentation
including a
(1) Page Closeout Sheet
Group Assigns
Project Number
Yes
Yes
Enter Remaining
Information on
Master Form
Final Project
Review
Prefer to work
this project
within your
area?
Yes
No
Master Form Will
Generate
Contract
Complete Project
(Has to be fully
Documented
Other Required
Signatures:
Champion:
Process Owner
Project Owner
Dept GB/BB/MBB
Key
Process
Input
Close
Project
Complete all
Documentation
including a
(1) Page Closeout Sheet
New/Revised Process
Steps
Process Flowchart
Control Plan
Invoice shows
outstanding (AR
balance does go
down)
Customer error
Customer might catch
it when reviewing the
5 next statement
10 250
Provide payment stub A. Lifeson
with statement for each
invoice
Revised stat
include paym
with each inv
Customer error
Acct identifies problem
when trying to apply
10 payment
5 250
Provide payment stub S. Hagar
with statement for each
invoice
Revised stat
include paym
with each inv
5
5
Process FMEA
Control Plan
This is included in the
PPAP book!
Control Plan
3 Distinct Phases
3 Distinct Phases
3 Distinct Phases
3 Distinct Phases
Pre-Launch
3. the
–Production
a description
– aofcomprehensive
the
1. Prototype – a2.description
of
dimensionaland
measurements
documentationand
of product/process
dimensional measurements
material and
performance
characteristics,
tests
process
that controls,
material and performance
tests
that
occur after
tests,
Prototype
and measurement
and before systems that
will occur duringwill
Prototype
build.
full Production.
will occur during mass production
Control Plan
Administrative Section
Administrative Section
Identifies part number and description,
supplier, required approval signatures,
and dates.
Control Plan
Process, Machine/Tools, Characteristics
Part/Process
Use this area to define
part/process number and
description.
Machine/Tools
Characteristics
Define the characteristics
of the product or process
List the machine, device, jig, or tools
that will be used in the
manufacturing process
Control Plan
Specifications, Measurement, Sample Size & Frequency
Sample Size
What is the size of the
sample you should gather
data from?
Specifications/Tolerance
Use this area to define upper/lower
spec limits for each control element.
Measurement Technique
For each line in the control plan, list the
measurement procedure that will be
used (may list R&R Gage Plan or PokaYoke).
Frequency
Define the frequency for
which the measurement
will be taken.
Control Plan
Control Method, Reaction Plan
Control Method
Method that will be used
to control the process
Reaction Plan
Actions to be taken if
controls fail
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.
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
An periodical Audit. (Audit Frequency indicated and data stamp for next Audit given!)
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.
MEASUREMENT SYSTEM
ANALYSIS (MSA)
Measurement System Analysis (MSA) Gage R&R
What is It?
An G R&R is a statistical tool used
to determine if a measurement
system is capable of precise
measurement.
Objective or Purpose
When to Use It
• On the critical inputs and outputs
prior to collecting data for analysis.
• For any new or modified process in
order to ensure the quality of the
data.
Who Should be Involved
Everyone that measures and makes
decisions about these measurements
should be involved in the MSA.
• To determine how much error is in
the measurement due to the
measurement process itself.
• Quantifies the variability added by
the measurement system.
• Applicable to attribute data and
variable data.
IMPORTANT!
Measurement System Analysis is
an analysis of the measurement
process, not an analysis of the
people!!
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 Donaldson SQA, attribute data
is not acceptable for PPAP submission
Measurement System Analysis (MSA)
The observed variation in
process output measurements
is not simply the variation in
the process itself; it is the
variation in the process plus
the variation in measurement
that results from an
inadequate measurement
system.
Measurement
System
Variation
Observed
Variation
Process
Variation
Conducting an MSA reduces the likelihood of
passing a bad part or rejecting a good part
Measurement System Analysis (MSA)
Observed Variation
Measurement
System
Variation
Observed
Variation
The output of the process
measured by:
Process
Variation
• Cycle time
• Dimensional data
• Number of defects
and others
Measurement System Analysis (MSA)
Observed Variation
Resolution
Precision
(Variability)
Repeatability
Reproducibility
Measurement
System
Variation
Linearity
Accuracy
Observed
Variation
(Central
Location)
Bias
Stability
Process
Variation
Calibration addresses
accuracy
Measurement System Analysis (MSA)
Resolution
Observed Variation
Precision
(Variability)
Reproducibility
Measurement
System
Variation
Observed
Variation
Repeatability
Accurac
y
(Central
Location)
Linearity
Bias
Stability
Process Calibration Addresses Accuracy
Variation
Let’s take a closer look
at Precision
Measurement System Analysis (MSA)
Resolution
Error in Resolution
The inability to detect small
changes.
Possible Cause
Wrong measurement device
selected - divisions on scale not
fine enough to detect changes.
Measurement System Analysis (MSA)
Repeatability
Error in Repeatability
The inability to get the same
answer from repeated
measurements made of the same
item under absolutely identical
conditions.
Possible Cause
Lack of standard operating
procedures (SOP), lack of training,
measuring system variability.
Equipment Variation
Measurement System Analysis (MSA)
Reproducibility
Error in Reproducibility
The inability to get the same
answer from repeated
measurements made under
various conditions from different
inspectors.
Possible Cause
Lack of SOP, lack of training.
Appraiser Variation
Variable MSA – Gage R&R Study
• Gage R&R is the combined estimate of measurement
system Repeatability and Reproducibility
• Typically, a 3-person study is performed
Each person randomly measures 10 marked parts per
trial
Each person can perform up to 3 trials
• There are 3 key indicators
EV or Equipment Variation
AV or Appraiser Variation
Overall % GRR
Donaldson’s Gage R&R Form
Automatically calculates
EV, AV, and % GRR!
Included in PPAP
Playbook!
Variable MSA – Gage R&R Steps
Step 1
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Step 8
Step 9 Step 10
Select 10 items that represent the full range of long-term process variation.
Identify the appraisers.
If appropriate, calibrate the gage or verify that the last calibration date is valid.
Open the Gage R&R worksheet in the PPAP book to record data.
Have each appraiser assess each part 3 times (trials – first in order, second in reverse
order, third random).
Input data into the Gage R&R worksheet.
Enter the number of operators, trials, samples and specification limits
Analyze data in the Gage R&R worksheet.
Assess MSA trust level.
Take actions for improvement if necessary.
Steps 1 and 2: Variable MSA - Gage R&R
Step 1
Step 2
Select 10 items that represent
the full range of long-term process
variation.
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.
Steps 3 and 4: Variable MSA – Gage R&R
Step 3
Step 4
If appropriate, calibrate the gage
or verify that the last calibration
date is valid.
Open the Gage R&R worksheet in the
PPAP book to record the data
Step 5: Variable MSA – Gage R&R
Step 5
Have each appraiser assess each item 3 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 !!
Steps 6 and 7: Variable MSA – Gage
R&R
Step 6
Step 7
Input data into the Gage R&R worksheet
Enter the number of operators, trials, samples and
specification limits
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)
– Yellow: 10-30% (marginal)
– Green: < 10% (pass)
30%
10%
Step 10: Variable MSA – Gage R&R
Step 10
If the Measurement System needs improvement:
• 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.
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
Variable MSA – Gage R&R Example
Entered the number
of operators, trials,
and samples
Entered upper and
lower process
specification limits
Chose 3 operators to
be appraisers
Had each appraiser
measure each
sample 3 times
Results calculated
automatically
Selected 10 samples
to be measured
Variable MSA – Gage R&R Example
Repeatability = (EV)
Reproducibility = (AV)
Equipment Variation
Repeatability
&
Appraiser
Variation
Reproducibility = R&R
% Tolerance*
% Tolerance is > 30%
MSA fails!
30%
10%
Tips and Lessons Learned
Important: An MSA is an analysis of the process, not an analysis of the
people. If an MSA fails, the process failed.
A Variable MSA provides more analysis capability than an Attribute
MSA. For this and other reasons, always use variable data if possible.
The involvement of people is the key to success.
Involve the people that actually work the process
Involve the supervision
Involve the suppliers and customers of the process
An MSA primarily addresses precision with limited accuracy
information.
MSA – Gage R&R
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
DIMENSIONAL RESULTS
Dimensional Results
What is It?
Evidence that dimensional
verifications have been completed
and results indicate compliance with
specified requirements.
Objective or Purpose
• To show conformance to the
customer part print on dimensions
and all other noted requirements.
When to Use It
• For each unique manufacturing
process (e.g., cells or production
lines and all molds, patters, or
dies
Donaldson Dimensional Report (Critical)
Automatically
Calculates Cpk!
Requires 35 data points
Cpk must be greater
than or equal to 1.67
This is included in the
PPAP book!
Acceptance Criteria
Acceptance criteria for critical vs. non-critical characteristics
Red (Bad)
Yellow (OK)
Green (Good)
Critical
Non-Critical
<1.33
<1.00
1.33-1.67
1.00-1.33
>1.67
Decision
>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
Donaldson Dimensional Report Example
Nominal Value
Tolerance
Sample Data
Cp & Cpk
Pass / Fail
Calculations
Cpk > 1.33 for all non-critical
dimensions = Pass!
Dimensional Results
Reviewer’s Checklist
 Thirty-five critical data points & 5 non-critical data points are required for part
qualification
 Critical and non-critical data points must be taken from the same 35-piece
sample
 Five parts from a production run must be shipped to Donaldson for verification
of form, fit, and function
 The same 5 parts will be used to verify both critical and non-critical dimensions
 Supplier must clearly identify which of the 35 parts are being shipped
 Supplier should make every effort to ship 3 parts that represent both the low and
high ends of the specifications for non-critical dimensions
 Capability must be greater than 1.67 for critical dimensions and greater than 1.33
for non-critical dimensions
RECORDS OF MATERIAL
/ PERFORMANCE TEST
RESULTS
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 Donaldson-developed material specifications and/or an
Donaldson-approved supplier list, the supplier shall procure materials
and/or services from suppliers on that list
Performance Test Results
 The supplier shall perform tests for all parts or product
materials when performance or functional requirements are
specified by the design record or Control Plan
Material Results
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
Module Test Results
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
QUALIFIED LABORATORY
DOCUMENTATION
Qualified Laboratory Documentation
• Inspection and testing for PPAP shall be performed
by a qualified laboratory as defined by Donaldson
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.
APPEARANCE APPROVAL
REPORT
Appearance Approval Report
What is It?
• A report completed by the supplier
containing appearance and color
criteria
Objective or Purpose
• To demonstrate that the part has met
the appearance requirements on the
design record
When to Use It
• Prior to tooling for production
IMPORTANT!
Typically only applies for parts with color, grain,
or surface appearance requirements
Appearance Approval Report
Administrative Section
Supplier Sourcing & Texture Information
List all first surface tools, graining
Source(s), grain type(s), and grain and
Gloss masters used to check part
Pre-Texture Evaluation
To be completed by SQE
Appearance Approval Report
Master
Master
Material
Number
DateType
Material Source
Color Suffix
Enter
Enter
Identify
alphanumeric
the date
first
Identify
on
surface
which
firstfinish
surface
andand
Alphanumeric
or
numeric
master
thesubstrate
master
identification
was
substrate
(e.g.
approved
paint
suppliers
/ ABS)
color identification
Color Shipping Suffix
Color part number
suffix or color number
Color Evaluation
Color
Suffix
Tristimulus Data
Master Master Material Material
Number Date
Type
Source
DL* Da* Db* DE CMC
Red Yel
Tristimulus Data
List numerical (colorimeter)
data of submission part as
compared
to the customerComments:
authorized master
Supplier Signature
Hue
Phone No.
Grn Blu
Value
Chroma
Gloss
Color
Metallic
Part
Shipping
Brilliance
Disposition
Suffix
Light Dark Gray CleanHigh Low High Low
Part Disposition
Hue, Value, Chroma, Gloss, To
and
be determined by
Metallic Brilliance
Donaldson
Visual assessment by Donaldson
(approved or
rejected)
Date
Customer Representative Signature
Tristimulus data
Date
SAMPLE PRODUCTION
PARTS
Sample Production Parts
What is It?
Actual samples that reflect the parts
documented in the PPAP.
Objective or Purpose
• Confirm cosmetic or functional part
approval.
When to Use It
• Sample parts should be delivered
WITH the PPAP submission
Sample Production Parts
• The sample parts provided should be the
same parts measured for the dimensional
results
• Default quantity for all submissions is 3 parts
unless otherwise requested
Sample Production Parts
● Sample production parts MUST be properly identified
• Include the following information on the part label:
- Shipping date
- Donaldson part number
- Quantity submitted
- Supplier part number (optional)
- Donaldson Part name
- Carrier name
- Country of origin
- Tracking number
- Approval markings (UL, CE, etc.) where applicable
See Donaldson part label
examples on the next slide
Part Label Example
PPAP sample submission To:
Shipping date
Shipping quantity
Country of origin
Supplier Name
Part Name
Part Number
Part revision level
Sample with PPAP?
Sample Parts separate submitted
Shipping Carrier
Tracking Number
Donaldson Italia S.r.l., Via Dell’Industria 17, I46035 Ostiglia (Mantova), Italy
0
0
0
0
Yes
Yes
No
No
Name
Number
PPAP Workbook includes these PPAP samples submission
labels.
Where applicable, fields get filled out automatically by filling out
the PPAP submission sheet.
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!
PPAP to prevent loosing an
opportunity for saving costs