Professional Documents
Culture Documents
Concept
Initiation Approval
Program
Approval
Prototype
Planning
Design & Development
Planning
Pilot
Product
Process
Launch
Product
Process Product &
Design & Design & Process
Dev.
Dev.
Validation
Verification Verification
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Design Goals
Reliability and Quality Goals
Market Research
Historical Warranty and Quality
Information
Team Experience
Phase 1
Phase 2
Product/Process Assumptions
Product Reliability Studies
Customer Inputs
Service
Management Support
Outputs by Design
Responsible Activity
Outputs by Advanced
Product Quality
Planning Team
Design FMEA
DFM and DFA
Design for Manufacturability
Design for Assembly
Design Verification
Design Reviews
Prototype Build Control Plan
Engineering Drawings (including Math data)
Packaging Standards
Engineering Specifications
Material Specifications
Characteristics Matrix
Process Instructions
Subcontractor build
Supplier build
Packaging Specifications
Phase 3
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Market Research
Historical Warranty and Quality
Information
Team Experience
Design Goals
Reliability and Quality Goals
Preliminary Bill of Material
Preliminary Process Flow Chart
Phase 1
Customer Inputs
Service
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Phase 1 Outputs
(Phase 2 Inputs)
Design Goals
Reliability and Quality
Goals
Preliminary Bill of
Material
Preliminary Process
Flow Chart
Preliminary Listing of
Special Product and
Process Characteristics
Product Assurance Plan
Phase 2 Outputs
(Phase
3 Inputs)
Outputs
by
Phase 2
Design
Responsible
Activity
Outputs by
Advanced
Product Quality
Planning Team
Design for
Manufacturability
Design for Assembly
Design Verification
Design Reviews
Prototype Build Control Plan
Engineering Drawings (including
Math data)
Engineering Specifications
Material Specifications
Drawing and Specification
Changes
New equipment, tooling and
facilities requirements
Special product and process
characteristics
Gage and testing equipment
requirements
Team feasibility commitment
and management support
Subcontractor build
Management Support
Supplier build
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Phase 2 Design
Activity Outputs
Design FMEA
DFM and DFA
Outputs by Design
Responsible Activity
Outputs by Advanced Product
Quality Planning Team
Phase 3
Phase 3 Outputs
(Phase 4 Inputs)
Phase 2 APQP
Team Outputs
Packaging Standards
Product / Process Quality System Review
Process Flow Chart
Floor Plan Layout
Characteristics Matrix
Process Failure Mode and Effects Analysis
Pre-Launch Control Plan
Process Instructions
Measurement Systems Analysis Plan
Preliminary Process Capability Study Plan
Packaging Specifications
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Packaging Standards
Product / Process Quality
System Review
Process Flow Chart
Phase 4 Outputs
(Phase 5 Inputs)
Phase 4
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Phase 5 Outputs
Phase 5
Reduced Variation
Customer Satisfaction
Delivery and Service
Packaging Evaluation
Production Control Plan
Quality Planning Sign-off
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External and
Internal
Customers
Cultural Needs
Unintended
Uses
Functional
Needs vs.
Technical
Features
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Customer
interviews
Market Research
Customer
questionnaires
and surveys
New product
quality and
reliability studies
Competitive
product quality
studies
Things Gone
Right reports
Interior Appearance
Front Room
Front Seat Comf ort
Entry & Exit f rom Front
Cargo Capacity
Cargo loading, unloading
Exterior Appearance
Front View
Side View
Rear View
Paint
Moldings
Seat Appearance
Instrument Panel
Door Panels
Carpeting
Handling
Handling on Highway
Handling in City , Parking
Visibility in Rear
Steering
Brakes
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Things gone
Wrong reports
Warranty reports
Capability
indicators
Supplier plant
internal quality
reports
Problem
Steering & Handling
resolution reports
Steering noisy
Customer plant
returns and
rejections
Field return
product analysis
Exterior Paint
Paint mist or soray ov er body f inish
Color dif f erence between body panels
Unev en color on one body panel
Paint ot tape stripes coming of f , missing
Rust, corrosion
Other paint troubles. Please describe.
Chipped paint
Scratched paint
Sags, runs in paint
Dirt in paint
Body paint on moldings, ornaments
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Durability
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Customer Inputs
Next users provide information about
needs and expectations
Possibility of previous conducted
reviews and studies
Used to develop measure of customer
satisfaction
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Inter-Relationships
Elsmar.com
QFD
Business
Quality
Objectives
Process
Improvemen
t
QOS
8-D
Problem
Solving
SPC
Tools
Control
Plan
DOE
FMEA
Special / Critical
Characteristics
FTA
RFTA
Problem
Prevention
APQP
Customer Specified
Special / Critical
Characteristics
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Relationships
Customer
Requirements
DFMEA
PFMEA
Control Plan
Warrant
PPAP
Conceptual
Structural
Warrant Sample
Product Condition
Time
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Process FMEA
(On ALL Processes)
Critical Characteristics
& Failure Effects Issues
CC Matrix
Critical Characteristics
& Characteristic Control Issues
Design FMEA
(On Intended Use)
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Document Links
Process Flow Chart
PFMEA
Operation Number
Operation Number
Product/Process Characteristic
Incoming Sources of Variation
(Variation Class)
Control Plan
Operation Number
Product/Process Characteristic
Incoming Sources of Variation
(Variation Class)
Operation Number
Work Instruction
Operation Number
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PFMEA
DFMEA
May or may not identify
an input to the Process
FMEA
Control Plan
Work Instruction
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Model Y ear/Vehicle(s):
Part Number:
PFMEA Date:
Quality Assurance Engineer
Operations Manager
Rev .
Take TPPE
Material Held In
Storage Area
Fragmented Container
Improper Handling
Current Controls
18
10
90
Recommended
Actions And Status
Actions
Taken
Sev erity
Occured
Wrong Material
SIR
Container
RPN
Potential Failure
Mode
Detection
Elsmar.com
Process Function
Sev erity
Part Name
Operation
Number
Occured
Approv als:
1 - 10
RPN
Detection
Process:
Low - High
Responsible
Activ ity
Out Of Spec
Material
Contaminated
Fragmented Container
Supplier Material
Visual Inspection
63
Fragmented Container
Engineering Change
10
70
Supplier Change
Fragmentation
Untrained LTO
10
50
10
30
Material
Change
2
Mov e To
Unreleased
Periodic Audit Of
Open Boxes
Fragmented Container
Material
Composition
Approv ed
Untrained Personnel
Storage
Hold In Approv ed
Contamination
Storage Until
Needed
Fragmentation
Open Containers
Process Problems
Housekeeping
Area Maintenance
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PFMEA
Change in Detection
Change in Occurrence
Change in Severity
And
Or
Elsmar.com
Control Plan
Design Change
Other Action
When making a change to a document, it is important to consider the effects of that change on
other documents. Typically the engineering change system in a company and/or corrective action
system ensures these occur. But this is not always the case. Review your company engineering
change procedure / system and see if it does so.
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Process
FMEA
FMEA
revised in
response to
an 8-D
investigation
Year 1
FMEA
revised in
response to
an 8-D
investigation
Year 2
Process
FMEA
Production Life
Year 1
FMEA
revised in
response to
an 8-D
investigation
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Machine or
Cell 1
Machine
or Cell 2
Machine
or Cell 3
Pack
& Ship
Internal or
External
Customer
Receiving
Pack
& Ship
Covers entire flow while product is under the control of the FAB
including return of the product (if return is applicable)
A Technology/Family Control Plan / Device FMEA follows an entire flow for a technology
through a defined entity. This is in contrast with a process flow where there is an individual
Control Plan for each piece of equipment or a manufacturing cell (company definition). A
Technology consists of many similar devices.
Receiving in FAB FMEAs consists of what the FAB looks at when materials arrive. Received
materials, such as gasses, liquid chemicals and related materials must be addressed. Registrar
interpretation Q5 1/12 (AEC-A100): ...So in effect, supplier's control plans will include wafers,
gases, and chemicals...
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Machine or
Cell 1
Machine
or Cell 2
Machine
or Cell 3
Pack
& Ship
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<-----------------------
------------------------->
Receiving
FAB 1
FAB 2
Control
Plan &
FMEA
Responsibility
=
FAB
Responsibility
=
FAB
Responsibility
=
ASSY
Responsibility
=
Materials?
SQA?
Assembly
Final Pack
Ship
Control
Plan &
FMEA
Warehouse
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Discrete Documents
Early on I stressed that each APQP is unique both between companies and within a
company. The same is true of document changes. On the previous page I discussed some
of the expected effects of a change to the process FMEA. Because of the differences in
how companies structure their documentation it is only possible in a course document
such as this to address the effect of changing one document on another. Another reason
this is true is because every change to a process FMEA does not automatically require a
change to, for example, the control plan. When the evaluation is made it may turn out that
the risk number (the RPN) may be low and thus may not require a control.
In speaking of differences in company documentation, there are companies which (for
example) combine their control plan and their process flow diagram into one document.
This said, there is no process flow diagram per se to change. Because of the possible
permutations of how a document system is set up, it is next to impossible in a course to
predict how a company will react within their documentation to a change in any given
document.
Another example is where a company uses the Ford Dynamic Control Plan (APQP and
Control Plan manual, page 100) methodology where the control plan is combined with the
process FMEA.
As we proceed through this presentation, keep in mind that where we discuss the changes
in one document and its effects on another you will have to look at your companys
documentation structure and determine equivalencies.
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Develop Process
Flow Listing
Process
FMEA
Develop FMEA(s)
Element for Every
Process
Give careful consideration
to defining Control Plan
stages:
Prototype
Pre-launch
Production
Develop the
Control Plan with
Critical
characteristics
Process
Control Plan
Develop control
mechanisms appropriate
for Critical
characteristics.
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Base Documentation
Critical Characteristics Matrix
Process Flow Diagram
Design FMEA
Process FMEA
Control Plan
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It is Process Dominated
Pre-Launch
Update After Prototype and Before Production
Production
Comprehensive
Process Controls
Test and Measurement Systems Used
Reaction Plan
Sampling Plans
SPC Requirements
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Example Control Plans included in the APQP Manual (starting on page 47):
Equipment
Set-Up Dominant Process
Machine Dominant Process
Fixture/Pallet Dominant Process
Tooling Dominant Process
People
Operator Dominant Process
Material
Material or Component Dominant Process
Methods
Preventive Maintenance Dominant Process
Environment
Climate Dominant Process
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PRODUCT ENGINEERING
DESIGNATED
CONTROL ITEM
PRODUCER:
SUPPLIER CODE:
PLANT:
NO.
Process Flow
Process name
Machine
Device Jig
Tools for
Manufacturing
No.
Link to flow
diagram & PFMEA
Characteristics
Process
Product
Parameters
Characteristics
Process
Engineering
Class
) YES
Product/Process
Specification
REVISION DATE:
( X ) NO
Methods
Evaluation
Methods
Sample Size/
Frequency
Analysis
Methods
PFMEA,
Drawing
Process
Engineering
Quality
Engineering
Process
Engineering,
Quality
Engineering
Link to
Drawing
Characteristics
Matrix
Process
Note that in your company, you might label departments or functional areas
Engineering
differently, or you may assign responsibilities differently. Process
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I
I
I
A
I
I
I
I
I
A
I
R
R
R
R
A
I
A
I
I
I
I
I
I
I
A
R
R
R
A
A
A
A
I
I
I
A
A
A
I
I
I
I
I
A
A
A
A
A
A
R
A
A
A
A
A
I
I
I
I
I
R
R
I
I
I
I
I
I
F
I
R
I
R
A
A
A
A
A
R
A
R
R
A
R
A
A
R
R
A
A
A
A
A
A
A
R
T
R
I
I
I
I
I
I
Customer
I
I
I
I
Sales
F
A
A
A
I
I
I
Quality Assurance
R
A
A
R
A
A
R
A
A
A
R
I
R
R
R
I
R
A
R
A
I
Purchasing
Production
F
A
A
A
I
I
I
Program Manager
Materials
F
I
I
I
A
R
A
Design Engineering
Manufacturing Engineering
Responsibility
A
A
A
A
I
A
I
A
A
I
A
I
I
I
I
A
Elem ent
Market Research Information
Quality History Review
Engineering Research Data
Advanced Quality Planning Schedule
Preliminary Product/Process Design
Feasibility Analysis
Design FMEA
Process FMEA
Prototype Build and Verific ation
Signific ant Characteristics
Final Product and Process Design
Measurement and Test Equipment Needs & Costs
Process Control Plan
Process Flow Chart
Audit and QA Work Instructions
Order Production Tooling, Gages, Test Equipment
Selec t & Rate Suppliers
Train Quality Personnel
Supplier PSW Review & Sign-Off
Set-Up & De-Bug Produc tion and Inspec tion Equipment
Preliminary Capability Studies For Production Processes
Process Optimization (Design Of Experiments)
Process Review (PFMEA Walk Through)
Product Training
Work Instructions (Manufac turing)
Measurment and Test Equipment Verific ation
Pac kaging
Part Sample Warrant
A = Assistance
I = Input
R = Responsibility
F = Sac hs - Florence
T = Sachs - Troy
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QS 9000
APQP Involves:
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
4.9 Process Control
4.10 Receiving (Incoming)
4.11 Inspection, Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Nonconforming Product
4.14 Corrective Action
4.15 Handling, Storage, Packaging and Delivery
4.16 Quality Records
4.18 Training
4.19 Servicing
4.20 Statistical Techniques
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Enter Every
Major Process
from Flow Listing
into FMEA Form
Develop FMEA(s)
Element for Every
Process
Develop the
Control Plan with
Critical
characteristics
Develop control
mechanisms appropriate
for Critical
characteristics.
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Design
X
X
X
X
X
X
X
Manufacturing
X
Service Supplier
X
X
X
X
X
X
X
X
X
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Benefits of APQP
Ensures early planning takes place
Directs resources to the customer
Identifies required changes early in the
process
Provides quality product on time and at
lowest cost
Enables cross-functional inputs and outputs
Addresses potential problems early in
Design
Manufacturing
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Progressive Fundamentals
KEY**
Concern resolution
Includes analytical techniques
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Teams
Small Teams!
Big Teams!
Communication!
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Training
Customer Needs and Expectations
Working as a Team
Group process skills
Development skills
Requirements of APQP
FMEA
APQP
PPAP
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Advanced
Business
Statistical
Process Control
Production Floor,
Production Staff &
Management,
All of Quality
& Engineering
Measurement
System Analysis
Design of
Experiments
Specific Production
Staff,
Quality Engineers&
QA Manager
& Product
Engineering
*Your APQP Team should attend as many classes as time will allow
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Program
Approval
Prototype
Planning
Design & Development
Planning
Pilot
Product
Process
Launch
Product
Process Product &
Design & Design & Process
Dev.
Dev.
Validation
Verification Verification
AIAG APQP & Ctrl Plan Reference Guide, Page 5
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Task Name
Visit 1
Dur
5d
Start
4/28/97
Finish
April
May
June
July
August
Apr
May
Jun
Jul
Aug
S ep
5/2/97
2d
4/28/97
4/29/97
100%
2d
4/28/97
4/29/97
100%
Feasibility Determination
2d
5/1/97
5/2/97
1d
5/2/97
5/2/97
September
100%
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Mission
Scope
Objectives
Requirements
How to measure
Timeline
Control system
Team
Cost Estimate
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Title
Customer
Model/Y ear
Part #
Date
Project Mission
Project Scope
Project Objectiv es
Contractural Requirements
Product Def inition & Spec.
Current Capability
Timeline
Control Sy stem
Team Def inition
Specific
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Analytical Techniques
Assembly Build Variation Analysis
Benchmarking
Cause & Effect Diagram
Characteristics Matrix
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Characteristics I
CHARACTERISTIC: A distinguishing feature, dimension or property of a process or its output (product) on which variable or
attribute data can be collected. (P39 APQP)
CHARACTERISTIC, CRITICAL, CHRYSLER DEFINITION: Characteristics applicable to a component, material, assembly, or
vehicle assembly operation which are designated by Chrysler Corporation Engineering as being critical to part function and having
particular quality, reliability and/or durability significance. These include characteristics identified by the shield, pentagon, and
diamond. (49 PPAP)
CHARACTERISTIC, CRITICAL (INVERTED DELTA), FORD DEFINITION: Those product requirements (dimensions, performance
tests) or process parameters that can affect compliance with government regulations or safe vehicle/product function, and which
require specific supplier, assembly, shipping, or monitoring and included on Control Plans. (P49 PPAP)
Characteristics II
CHARACTERISTIC, PROCESS: Core team identified process variables (input variables) that have a cause and
effect relationship with the identified Product Characteristic(s) which can only be measured at the time of occurrence.
(6.3 #20 APQP)
CHARACTERISTIC, PRODUCT: Features or properties of a part, component or assembly that are described on drawings or other
primary engineering information. (6.3 #19 APQP)
CHARACTERISTIC, PRODUCT, CRITICAL (D), CHRYSLER DEFINITION: A defect which is critical to part function and having
particular quality, reliability, and durability significance. (QS-9000)
CHARACTERISTIC, PRODUCT, MAJOR, CHRYSLER DEFINITION: A defect not critical to function, but which could materially
reduce the expected performance of a product, unfavorably affect customer satisfaction, or reduce production efficiency. (QS-9000)
CHARACTERISTIC, PRODUCT, MINOR, CHRYSLER DEFINITION: A defect, not classified as critical or major, which reflects a
deterioration from established standards. (QS-9000)
CHARACTERISTIC, PRODUCT, SAFETY/EMISSION/NOISE (S), CHRYSLER DEFINITION: A defect which will affect compliance
with Chrysler Corporation and Government Vehicle Safety/Emission/Noise requirements. (QS-9000)
CHARACTERISTIC, SAFETY, CHRYSLER DEFINITION Shield <S>: Specifications of a component, material, assembly or vehicle
assembly operation which require special manufacturing control to assure compliance with Chrysler Corporation and government
vehicle safety requirements. (QS-9000)
Characteristics III
CHARACTERISTIC, SAFETY, CHRYSLER DEFINITION: Specifications which require special manufacturing control to
assure compliance with Chrysler or government vehicle safety requirements. (P50 PPAP)
CHARACTERISTIC, SIGNIFICANT, CHRYSLER DEFINITION: Special characteristics selected by the supplier through knowledge
of the product and process. (QS-9000)
CHARACTERISTIC, SPECIAL: Product and process characteristics designated by the customer, including governmental regulatory
and safety, and/or selected by the supplier through knowledge of the product and process. (P104 APQP)
CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION Diamond <D>: Specifications of a component, material, assembly or
vehicle assembly operation which are designated by Chrysler as being critical to function and having particular quality, reliability and
durability significance. (QS-9000)
CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION Diamond <D>: Specific critical characteristics that are process driven
(controlled) and therefore require SPC to measure process stability, capability, and control for the life of the part. (Appendix C QS9000) & (Appendix C APQP)
CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION Pentagon <P>: Limited to highlighting Critical characteristics on
(Production) part drawings, tools and fixture, and tooling aid procedures where ongoing process control is not automatically
mandated. (Appendix C QS-9000) & (Appendix C APQP)
CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION Shield <S>: Engineering designated specifications or product
requirements applicable to component material, assembly operation(s) which require special manufacturing control to assure
compliance with governmental vehicle safety, emissions, noise, or theft prevention requirements. (Appendix C QS-9000) &
(Appendix C APQP)
Characteristics IV
CHARACTERISTIC, SPECIAL, FORD DEFINITION Critical Characteristic <Inverted Delta>: Those product requirements
(Dimensions, Specifications, Tests) or process parameters which can affect compliance with government regulations or safe
Vehicle/Product Function and which require specific producer, assembly, shipping or monitoring actions and inclusion on the
Control Plan. (Appendix C QS-9000) & (Appendix C APQP)
CHARACTERISTIC, SPECIAL, FORD DEFINITION Significant Characteristic - SC <None>: Those product, process, and test
requirements that are important to customer satisfaction and for which quality planning actions shall be included in the Control Plan.
(Appendix C QS-9000)
CHARACTERISTIC, SPECIAL, FORD DEFINITION Significant/Characteristic - S/C <None>: Characteristics that are important to
the customer and that must be included on the Control Plan. (Appendix C APQP)
CHARACTERISTIC, SPECIAL, GM DEFINITION Fit/Function <F/F>: Product characteristic for which reasonably anticipated
variation is likely to significantly affect customer satisfaction with a product (other than S/C) such as its fits, function, mounting or
appearance, or the ability to process or build the product. (Appendix C QS-9000) & (Appendix C APQP)
CHARACTERISTIC, SPECIAL, GM DEFINITION Safety/Compliance <S/C>: Product characteristic for which reasonably
anticipated variation could significantly affect customer the products safety or its compliance with government regulations (such as:
flammability, occupant protection, steering control, braking, etc. . .), emissions, noise, radio frequency interference, etc. . .
(Appendix C QS-9000)
CHARACTERISTIC, SPECIAL, GM DEFINITION Safety/Compliance <S>: Product characteristic for which reasonably anticipated
variation could significantly affect customer the products safety or its compliance with government regulations (such as:
flammability, occupant protection, steering control, braking, etc. . .), emissions, noise, radio frequency interference, etc. . .
(Appendix C APQP)
Characteristics V
CHARACTERISTIC, SPECIAL, GM DEFINITION Standard <None>: Product characteristic for which reasonably
anticipated variation is unlikely to significantly affect a products safety, compliance with governmental regulations,
fit/function. (Appendix C QS-9000) & (Appendix C APQP)
CHARACTERISTIC, SPECIAL, PROCESS (e.g., CRITICAL, KEY, MAJOR, SIGNIFICANT): A process characteristic for which
variation must be controlled to some target value to ensure that variation in a special product characteristic is maintained to its target
value during manufacturing and assembly. (P57 FMEA)
CHARACTERISTIC, SPECIAL, PRODUCT: Core team compilation of important product characteristics from all sources. All
Special Characteristics must be listed on the Control Plan. (6.3 #19 APQP)
CHARACTERISTIC, SPECIAL, PRODUCT (e.g., CRITICAL, KEY, MAJOR, SIGNIFICANT): A product characteristic for which
reasonably anticipated variation could significantly affect a products safety or compliance with governmental standards or
regulations, or is likely to significantly affect customer satisfaction with a product. (P55 FMEA)
CHARACTERISTIC, SPECIAL, TOOLING, CHRYSLER DEFINITION Pentagon <P>: Critical tooling symbol used to identify
special characteristics of fixtures, gages, developmental parts, and initial product parts. (QS-9000)
CONTROL ITEM PART, FORD DEFINITION: Product drawings/specifications containing Critical Characteristics. Ford Design and
Quality Engineering approval is required for changes to Control Item FMEAs and Control Plans. (QS-9000)
Title
Part #
Customer
Date
Our advanced quality planning team has considered the following questions in Phase 1
of our APQP process. The documents provided have been used as a basis for analyzing
the ability to meet all specified requirements. All 'NO' answers are supported with attached
comments identifying our c oncerns and/or proposed changes to enable us to meet
specified requirements.
Yes
No
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Checklist Item
Has historical data and experience concerning customer needs been considered?
Has full consideration been given to the overall business plan and marketing strategy?
Have product/process benc hmark data been considered?
Have the product/process assumptions been identified and challanged?
Have product reliability studies been c onducted?
Have there ben appropriate customer inputs into the process?
Do the design goals reflect the data generated?
Do the quality and reliability goals reflect appropriate standards?
Is the preliminary bill of materials sufficiently thorough?
Does the preliminary process flow chart relate to the primary BOM and
product/process assumptions?
Are all special product and process characteristics lited?
Does the produxct assuranc e plan inc lude and outline of program requirements, goals,
factors that may place the program at risk, FMEA, and preliminary enginering
standards requirements?
Feasible
Feasible
Not Feasible
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
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MIS
Materials
Maintenance
HR
Production
Sales
Laboratory
Quality
Engineering
Purchasing
Management
Output
Design Goals
Reliability and Quality Goals
Preliminary BOM
Preliminary process flow chart
Preliminary list of special product and
process characteristics.
Product assurance plan
Management Support
ThisSlide
form is
60on course disk
Planning
Design & Development
Product
Process
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Phase 2 Outputs
Outputs by Design Responsible Activity
Outputs by Advanced Product Quality
Planning Team
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Design Verification
Design Reviews
Prototype Build - Control Plan
Engineering Drawings (including Math data)
Engineering Specifications
Material Specifications
Drawing and Specification Changes
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Inspection layout
Prototype validation testing
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FMEAs
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DFMEA
Disciplined analytical tool
Assess probability of failure
Effect of failure
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PFMEA Example
Process Failure Mode And Ef f ects Analy sis
PFMEA Date:
Process Function
Potential Failure
Mode
Wrong Material
SIR
Take TPPE
Container
Material Held In
Storage Area
Fragmented Container
Improper Handling
Misidentif ied Material
Current Controls
Material Certif ication
RPN
Detection
Operations Manager
Sev erity
Part Name
Operation
Number
Occured
Approv als:
18
10
90
Recommended
Actions And Status
1 - 10
Rev .
Actions
Taken
RPN
Part Number:
Detection
Engineer:
Model Y ear/Vehicle(s):
Sev erity
Occured
Process:
Low - High
Responsible
Activ ity
Out Of Spec
Material
Contaminated
Fragmented Container
Supplier Material
Visual Inspection
63
Fragmented Container
Engineering Change
10
70
Supplier Change
Fragmentation
Untrained LTO
10
50
10
30
Material
Change
2
Mov e To
Unreleased
Periodic Audit Of
Open Boxes
Fragmented Container
Material
Composition
Approv ed
Untrained Personnel
Storage
Hold In Approv ed
Contamination
Storage Until
Needed
Fragmentation
Open Containers
Process Problems
Housekeeping
Area Maintenance
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Design, concept,
function and
sensitivity
(tolerancing) to
manufacturing
variation
Manufacturing
and/or assembly
process
Dimensional
tolerances
Performance
requirements
Number of
components
(complexity)
Process
adjustments
Material
handling
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Design Verification
Inspection methods
Testing methods
Ensure that all design outputs meet
design input requirements
Alternate calculations
CAD/math data
Review design stage documents before release
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Product/process validation of
components
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Inspect
Store
Move
Step
Fabrication
Part Number:
Part Description:
Prepared By:
Date: 4/5/93
Rev. : C
Approved By:
QA Manager
Operations Manager
Senior Advisor
QA Engineer
Operation Description
Item #
1.0
Material Specs
1.0
2.0
Tearstrip In Cover
2.1
2.2
Tool Setup
Machine Setup
3.0
2.1
2.2
Tool Setup
Machine Setup
4.0
2.1
2.2
Tool Setup
Machine Setup
5.0
2.1
2.2
Tool Setup
Machine Setup
6.0
2.1
2.2
Tool Setup
Machine Setup
7.0
8.0
9.0
2.1
2.2
2.1
2.2
2.2
Tool Setup
Machine Setup
Tool Setup
Machine Setup
Machine Setup
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Control Plan
Ensure Control Plan is aligned to, and
correlates with, DFMEA, Process Flow,
PFMEA
Control Methods appropriate to variation
type(s)
Incorporates Lessons Learned,
Statistical Data
Use A-8 Control Plan checklist
in APQP manual to evaluate
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Date (Orig.)
Core Team
Supplier/Plant Apoproval/Date
Supplier/Plant
Supplier Code
Characteristic s
Part/
Process Name/
Proc ess
Operation
Number
Description
Machine,
Devic e,
Jig, Tools
for Mfg.
No.
Produc t
Special
Char.
Process
Class
Date (Rev.)
Methods
Produc t/
Proc ess
Spec /
Toleranc e
Evaluation
Measurement
Technique
Size
Frequency
Control
Method
Reac tion
Plan
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Supplier Code:
Telephone:
Title:
Part Number:
Part Description:
Date: 4/5/93
Process Capability
Process Perf ormance
Controls
(Short Term Capability )
(Long Term Capability )
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
Item Key Product Key Control Operation
Gage
Attr./ Last R&R % Gage Process
% Process
Cpk or Dev Process % ProcessCpk or Dev Ty pe Of Freq. Of
Characteristic/CharacteristicsDescription Operation Variable
Date
R&R Capability
Capability
From
Perf orm. Perf orm
From
Control
Inspect.
Spec
Date
Target/Nom. Date
Target/Nom. Method
1.0
Viny l Material
Spec
2.0
Tear Strip
(Cov er)
1 = 0.41mm
.+/- 0.11mm
Gage Study
Auto
Injection
Mold
Cov er
In TL#
2-7 = 0.685mm
.+/- 0.135mm
[7]
2.1
2.2
3.0
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[1]
[2]
[3]
[4]
[5]
[6]
[7]
Tool Setup
Machine
Setup
Hole Diameter
(Cov er)
4.60mm
.+/- 0.25mm
Auto
Injection
Mold Cov er
TL#
[1]
[2]
[3]
[4]
[5]
[6]
[1]
[2]
[3]
[4]
[5]
[6]
Check
Ev ery
Vendor
Box
Cert(s).
X bar and Start Of
R Charts Each Run
And Each
SQC
Shif t
Database
Verif y To
Spec
Sheet
X bar and 5 Pieces
R Charts Ev ery 6
Months
SQC
Database
[17]
[18]
Operator
Process
Set-Up
Audit
Gage
Method
Instruction
and
(Proced. #) Frequency
Green "OK"
Release,
Each Box
3.607
3.609
ThisSlide
form is80
on course disk
Prototype Build
Make -buy decisions
Part inspections
Assemble prototypes
Perform layout inspection
Validation testing (Who will do testing?)
Redesign as required
Update DFMEA and SFMEA if required
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Material Specifications
Review Material Specifications for
Special Characteristics
Physical properties
Performance
Environmental
Handling
Storage
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Elsmar.com
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Elsmar.com
Complete check list in AIAG APQP & Control Plan reference manual
Appendix A-3
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Elsmar.com
Additional sources
DFMEA
SFMEA if applicable
PFMEA
Previous history
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Elsmar.com
Complete in time to conduct measurement
systems analysis
Equipment builder
Pilot build
Production trial run
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Elsmar.com
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Where to be produced
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MIS
Elsmar.com
Materials
Maintenance
HR
Production
Sales
Laboratory
Quality
Engineering
Purchasing
Management
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Title
Part #
Customer
Date
Our advanc ed quality planning team has c onsidered the following questions in Phase 2
of our APQP proc ess. The doc uments provided have been used as a basis for analyzing
the ability to meet all spec ified requirements. All 'NO' answers are supported with attached
comments identifying our c oncerns and/or proposed changes to enable us to meet
specified requirements.
Elsmar.com
Yes
No
1.
2.
3.
4.
5.
6.
6a
6b
6c
7.
8.
8a
8b
Feasible
Feasible
Not Feasible
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
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Prototype
Planning
Design & Development
Pilot
Planning
Product
Process
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Phase 3 Outputs
Packaging Standards
Product / Process Quality System Review
Process Flow Chart
Floor Plan Layout
Characteristics Matrix
Process Failure Mode and Effects Analysis
Pre-Launch Control Plan
Process Instructions
Measurement Systems Analysis Plan
Preliminary Process Capability Study Plan
Packaging Specifications
2003 The Elsmar Cove - Rev U
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Packaging standards
Characteristics matrix
PFMEA
Process instructions
Measurement systems
analysis plan
Preliminary process
capability study plan
Management support
Salable units?
Additional Outputs
Update tooling, equipment and
facilities list
Update process flow chart
Update PFMEA
Quote in-house gages, tooling and
equipment
Order gages, tooling and equipment
Delivery of gages in time for MSA
plan
Delivery of equipment
Must consider approval at
equipment subcontractor, in-house
installation, debugging and process
potential studies (runoff)
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Packaging Standards
From customer
Developed during prototype or prelaunch runs
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Inspect
Store
Move
Step
Fabrication
Part Number:
Part Description:
Prepared By:
Date: 4/5/93
Rev. : C
Approved By:
QA Manager
Operations Manager
Senior Advisor
QA Engineer
Operation Description
Item #
1.0
Material Specs
1.0
2.0
Tearstrip In Cover
2.1
2.2
Tool Setup
Machine Setup
3.0
2.1
2.2
Tool Setup
Machine Setup
4.0
2.1
2.2
Tool Setup
Machine Setup
5.0
2.1
2.2
Tool Setup
Machine Setup
6.0
2.1
2.2
Tool Setup
Machine Setup
7.0
8.0
9.0
2.1
2.2
2.1
2.2
2.2
Tool Setup
Machine Setup
Tool Setup
Machine Setup
Machine Setup
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Characteristics Matrix
Displays relationship between:
Process parameter
Manufacturing stations
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Process FMEA
To the extent possible, potential failure modes
have been considered and addressed
May be started after design FMEA in Phase 2
Needs to be updated regularly
Must be done prior to committing new tools and
equipment
Living document
Typically started too late!
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PFMEA Date:
Process Function
Potential Failure
Mode
Wrong Material
SIR
Take TPPE
Container
Material Held In
Storage Area
Fragmented Container
Improper Handling
Misidentif ied Material
Current Controls
Material Certif ication
RPN
Detection
Operations Manager
Sev erity
Part Name
Operation
Number
Occured
Approv als:
18
10
90
Recommended
Actions And Status
1 - 10
Rev .
Actions
Taken
RPN
Part Number:
Detection
Engineer:
Model Y ear/Vehicle(s):
Sev erity
Occured
Process:
Low - High
Responsible
Activ ity
Out Of Spec
Material
Contaminated
Fragmented Container
Supplier Material
Visual Inspection
63
Fragmented Container
Engineering Change
10
70
Supplier Change
Fragmentation
Untrained LTO
10
50
10
30
Material
Change
2
Mov e To
Unreleased
Periodic Audit Of
Open Boxes
Fragmented Container
Material
Composition
Approv ed
Untrained Personnel
Storage
Hold In Approv ed
Contamination
Storage Until
Needed
Fragmentation
Open Containers
Process Problems
Housekeeping
Area Maintenance
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Date (Orig.)
Core Team
Supplier/Plant Apoproval/Date
Supplier/Plant
Supplier Code
Characteristic s
Part/
Process Name/
Proc ess
Operation
Number
Description
Machine,
Devic e,
Jig, Tools
for Mfg.
No.
Produc t
Special
Char.
Process
Class
Date (Rev.)
Methods
Produc t/
Proc ess
Spec /
Toleranc e
Evaluation
Measurement
Technique
Size
Frequency
Control
Method
Reac tion
Plan
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MIS
Materials
Maintenance
HR
Production
Sales
Laboratory
Quality
Engineering
Purchasing
Management
Output
Packaging Standards
Product/Process Quality System Review
Process Flow Chart
Floor Plan Layout
Characteristics Matrix
PFMEA
Pre-Launch Control Plan
Process Instructions
Measurement Systems Analysis Plan
Preliminary Process Capability Study Plan
Packaging Specifications
Management Support
Slide 117
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Title
Part #
Customer
Date
Our adv anced quality planning team has considered the f ollowing questions in Phase 3
of our APQP process. The documents prov ided hav e been used as a basis f or analy zing
the ability to meet all specif ied requirements. All 'NO' answers are supported with attached
comments identif y ing our concerns and/or proposed changes to enable us to meet
specif ied requirements.
Yes
No
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Feasible
Feasible
Not Feasible
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
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Planning
Design & Development
Planning
Pilot
Product
Launch
Process
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Phase 4 Outputs
Production trial run
Measurement system evaluation (complete)
Preliminary process capability study
Production part approval
Production validation testing
Packaging evaluation
Production control plan
Quality planning sign-off and management
support
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Process Instructions
Sources:
FMEAs
Control plans
Material specifications
Visual standards
Industry standards
Characteristic matrix
Packaging standards
Process parameters
Producer expertise
Handling requirements
Operators of process
Accessible operators
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MSA Studies
Measurement uncertainty determined
Gage R&R, Bias, Stability, and Linearity
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Inspector
Sample
Collection
Methods
Test Method
Training
Sample
Preparation
Workmanship
Parallax
Practice
Samples
Reproducibility
Ergonomic
s
Standards
Measurement
Discrimination
Vibration
Bias
Repeatability
Calibration
Linearity
Instrument
Temperature
Lighting
Humidity
Environment
Measurement Precision
Indicates
Poor
Precision
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Imprecise
Accurate
Inaccurate
Bias
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Packaging Evaluation
Packaging must conform to specifications
developed by customer or supplier
Assess protection of product
Customer specified packaging must be
evaluated by team
Pilot or production trial run parts usually
used in evaluation
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Packaging Specifications
For individual products
Customer packaging
Generic standards where appropriate
Must ensure delivery quality
Compatible with all material handling
equipment used
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PPAP
Sub-Set
PPAP Submission
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PPAP
Production parts are manufactured at the
production site using production tooling,
gaging, equipment, operators, etc
Parts from production run are analyzed.
Test results and records from APQP are
submitted with Part Submission Warrant.
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Purpose of PPAP
For the supplier to demonstrate:
All design records and specification.
Requirements are properly understood.
The process has the capability to produce
product that meets requirements.
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Feeds
Speeds
Cycle times
Pressures
Temperatures
Default level is 3
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PPAP Scope
Production parts - generally 300 pieces
Service subcontractors - fulfill requirements
Bulk material
Includes internal and external sources for
information
Submission required prior to first production
shipment
PPAP Manual Section I.3 Customer Notification and
Submission Requirements (starting on page 11) for
guidance
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Application
AIAG PPAP Manual Defines
When PPAP Submission is
Required
Something
Changed
New part
Correction to discrepancy in previous
submission
Design or process change
Change in source of subcontracted
materials or services
Transfer or rearrangement of tooling &
equipment
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Methodology
Buyer enters PPAP
submission date on
purchase order.
Approver determines
submission level.
Default level 3
Default level 4 for raw material
Approver evaluates
PPAP package.
Level 5 at supplier site
Approver determine
part submission
status.
Notify supplier and
manufacturing of
status.
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DFMEA
Control Plan
Print/Design Record
Engineering Change
Documents
Check fixtures/aids
Process Flow
Diagram
PFMEA
2003 The Elsmar Cove - Rev U
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Flow Chart
Linkage of Product Characteristics from
DFMEA to Operational Steps.
Operation numbers consistent with PFMEA,
Control Plan, Operator Instructions.
Ensure identification of
inspection and rework.
Use A-6 Process Flow Chart
checklist in APQP manual to
evaluate.
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DFMEA
Assess Feasibility, Risk, Design Intent
Issues
Confirm Manufacturing Process
Capability Considered
Focus on Critical Characteristics
Lessons Learned Incorporated
Use A-1 Design FMEA Checklist
in APQP Manual to Evaluate
2003 The Elsmar Cove - Rev U
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PFMEA
Linkage with DFMEA, Process Flow,
Control Plan, Operator Instructions, etc
Degree to which high RPNs are
addressed with preventive strategies
Action Plans assigned,
implemented, effectiveness
assessed and RPN recalculated
Use A-7 Process FMEA
checklist in APQP manual
4
0
5
=
N
RP
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Elsmar.com
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Histogram Animation
Elsmar.com
Courtesy of The Red Road
http://www.sci.fi/~leo/
2003 The Elsmar Cove - Rev U
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Elsmar.com
2003 The Elsmar Cove - Rev U
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Interpretation
Conclusion
Process probably Current control plan
meets customer sufficient
requirements
100% inpection is
needed until Cpk>1.33
achieved
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Rejected
Corrected submission required
before production quantities may be
shipped.
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production tooling
and meet specs, not
all PPAP
requirements have
been met.
BParts from
production tooling and
require rework to meet
specs.
Slide 155
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Title
Part #
Customer
Date
Our adv anced quality planning team has considered the f ollowing questions in Phase 4
of our APQP process. The documents prov ided hav e been used as a basis f or analy zing
the ability to meet all specif ied requirements. All 'NO' answers are supported with attached
comments identif y ing our concerns and/or proposed changes to enable us to meet
specif ied requirements.
Yes
1.
2.
3.
4.
5.
6.
7.
No
Checklist Item
Has the production trial run been conducted and does it indicate the need for any change?
Does the evaluation of the measurement systems indicate any need to modify the
control plan characteristics?
Does the preliminary process capability study indicate any potential problems?
Has the production part been approved?
Has the production validation testing indicated any problems?
Has the evaluation of the packaging of test shipments, where feasible, and test methods
indicated any difficulty?
Has the control plan methodology check list indicated any problems with that document?
Feasible
Feasible
Not Feasible
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
ThisSlide
form is
on course disk
157
MIS
Materials
Maintenance
HR
Production
Sales
Laboratory
Quality
Engineering
Purchasing
Management
Output
Production Trial Run
Measurement Systems Evaluation
Preliminary Process Capability Study
Production Part Approval
Production Validation Testing
Packaging Evaluation
Production Control Plan
Quality Planning Sign-Off
Management Support
ThisSlide
form is
on course disk
158
Planning
Design & Development
Product
Process
Launch
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Continuing Production
Continuing
Production
Continuing
Production
Measure
Customer
Satisfaction
Cpk >
or = 1.33
Develop QOS
Measurement
Continuous
Improvement
Plan &
Feedback
2003 The Elsmar Cove - Rev U
Rendered Thursday, December 22, 2016
Determining
Ongoing
Capability
Fords Interpretation
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Phase 5 Outputs
Reduced variation
Customer satisfaction
Delivery and service
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Reducing Variation
Identify process variation
take corrective action to reduce
variation
Develop proposal for customer review
Gain customer decision to implement,
negotiate or change design
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Customer Satisfaction
Product or service must perform in
customers environment
Supplier must participate
Supplier and customer must be
partners
Reference QS 9000 Element 4.1.6
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Customer rating
Returns
Concerns reports
Nonconforming
material reports
Corrective actions
PPM
Response time
On time delivery
Tech calls
On-site
representative
Market share
Cost control (total
cost)
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MIS
Materials
Maintenance
HR
Production
Sales
Laboratory
Quality
Engineering
Purchasing
Management
Output
Reduced Variation
Customer Satisfaction
Delivery and Service
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Title
Part #
Customer
Date
Our adv anced quality planning team has considered the f ollowing questions in Phase 5
of our APQP process. The documents prov ided hav e been used as a basis f or analy zing
the ability to meet all specif ied requirements. All 'NO' answers are supported with attached
comments identif y ing our concerns and/or proposed changes to enable us to meet
specif ied requirements.
Yes
No
1.
2.
3.
Checklist Item
Has a system for reducing future variation been developed and is it in place?
Is there a system for ensuring continuing customer satisfaction?
Is there a process in place for monitoring delivery and service so that it continues
to met customer needs?
Feasible
Feasible
Not Feasible
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
Team Member/Title/Date
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Summary
AIAG PPAP Manual Defines Requirements
APQP Product and Process Validation
Supplier submits PPAP to proper level
PPAP package evaluated and status
determined
Supplier and customer manufacturing site
notified of PPAP approval status
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