Automotive

Core
Tools
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Automotive Core Tools

Advanced Product Quality Planning

(APQP)

Failure Mode and Effects Analysis (FMEA)

Control Plan

Production Part Approval Process ( P PA P )

Statistical Process Control (SPC)

Measurement System Analysis (MSA)

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Automotive Core Tools

Examples: AIAG “Blue Book” Manuals

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Automotive Core Tools
Examples: Other Manuals

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 Core Tools in IATF 16949:2016

APQP: 8.3.2.1

FMEA: 8.3.2.1, 8.3.5.2

Control Plan: 8.5.1.1, Annex A

Product Approval Process (PPAP): 7.3.6.3

SPC: 9.1.1.2, 9.1.1.3

MSA: 7.1.5.1.1

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 APQP
Advanced Product Quality
Planning

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 APQP
What is it?
Management of product development

Why do we use it?

To understand what our customer wants and
fulfill those wants

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Advanced Product Quality Planning
CONCEPT
INITIATION/ PROGRAM
APPROVAL APPROVAL
PROTOTYPE PILOT LAUNCH

PLANNING
PLANNING
PRODUCT DESIGN AND DEV.

PROCESS DESIGN AND DEVELOPMENT

PRODUCT & PROCESS VALIDA TION

PRODUCTION

FEEDBACK AS SESSMENT AND CO RRECTIVE ACTION

Planning Product
INPUTS Design & Product &
| Dev. INPUTS Process Design Feedback,
Planning & Process Assessment &
| Dev. INPUTS
OUTPUTS Validation Corrective Action
Product | INPUTS INPUTS
Design & Process Design
Dev. | |
OUTPUTS & Product &
Dev. OUTPUTS Feedback,
Process Assessment &
Validation Corrective Action
OUTPUTS OUTPUTS

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APQP Plan a n d D e fin e Ph a s e

Concept Initiation/Approval
Inputs:
• Voice of the Customer
• Market Research (Including OEM Vehicle Timing and
Volume Expectations
• Historical Warranty and Quality Information
• Team Experience
• Business Plan/Marketing Strategy
• Product/Process Benchmark Data
• Product/Process Assumptions
• Product Reliability Studies
• Customer Inputs

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APQP Plan a n d D e fin e Ph a s e

Concept Initiation/Approval

Outputs:
• Design Goals
• Reliability and Quality Goals
• Preliminary Bill of Materials
• Preliminary Process Flow Chart
• Preliminary Listing of Special Product and Process
Characteristics
• Product Assurance Plan
• Management Support

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APQP P r o d u c t D e s ig n a n d D e v e l o p m e n t Ph ase

Program Approval
Design Outputs: APQP Outputs:
• Design Failure Mode and Effects
• New Equipment, Tooling and
Analysis (DFMEA)
Facilities Requirements
• Design for Manufacturability and
• Special Product and Process
Assembly
Characteristics
• Design Verification
• Gages / Testing Equipment
• Design Reviews Requirements
• Prototype Build -- Control Plan • Team Feasibility Commitment
& Management Support
• Engineering Drawings (Including
Math Data)
• Engineering Specifications
• Material Specifications
• Drawing and Specification
Changes
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APQP P r o c e s s D e s ig n a n d D e v e l o p m e n t Ph a s e

Prototype

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

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APQP P r o d u c t a n d P r o c e s s Va l i d a t i o n Ph a s e

Pilot

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

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APQP F e e d b a c k , A s s e s s m e n t a n d C o r r e c t i v e A c t i o n Ph a s e

Launch

Outputs:
• Reduced Variation
• Improved Customer Satisfaction
• Improved Delivery and Service
• Effective Use of Lessons Learned/Best Practice

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ADVANCED PRODUCT QUALITY PLANNING

Pitfalls
• APQP treated as a “Quality Department Responsibility”
• APQP a separate process, not integrated into product
development
• Key stakeholders brought in late (quality, production,
suppliers)
• Milestones and deliverables ignored
• No top management involvement/support

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 FMEA
Failure Mode and Effects
Analysis

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 FMEA
What is it?
A risk analysis of a part or process

Why do we use it?

To find and fix a problem before
something breaks or someone gets hurt

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Types of FMEAs

Design FMEA

Process FMEA

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Types of FMEAs

Others:
System FMEA
Concept FMEA
Environmental FMEA
Machinery FMEA
Software FMEA

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 FMEA Process
Subsystem C Potential O D
Current
Potential Potential S l Cause(s)/ c e a e R. Recommended t Responsibility Action Results
Controls
Failure Effect(s) of Mechanism(s) c v s P. Action(s) & Target Actions S O D R.
Function Mode Failure of Failure u Prevention Detection e N. Completion Date Taken e c e P.
Requirements s r c v c t N.

What can be
What are How bad done?
the Effects? is it?
–Design
What are the
Changes
Functions, Features
or Requirements?
– Process
Changes

– Special
Controls

How – Changes to
What are Standards,
often
the Procedures, or
does it
What can go Cause(s)? guides
happen?
wrong?
–No function
– Partial / Over
/Degraded
Function
How can this be How good is
– Intermittent
prevented and this method at
Function
detected? detecting it?
– Unintended
Function

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Risk Action Strategies

1st Priority is Severity. Severity has a direct impact on the customer.

2nd Priority is Criticality (Severity times Occurrence: S x O). Criticality

evaluates the risk that an event with a high impact on the customer
will occur.

3rd Priority is RPN. RPN evaluates the ability to detect and contain
poor quality.

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Failure Mode and Effects Analysis

Pitfalls
• FMEA started late in the development process (just in time
for PPAP!)
• FMEA never updated after release
• FMEA not updated from nonconformity corrective actions
• Right side (action area) is blank
• RPN thresholds
• FMEA written by one person
• FMEA treated as a “Quality Department Responsibility”

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Control Plan

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 Control Plan
What is it?
A summary of controls used to make sure my
customer gets good product

Why do we use it?

To make sure controls are used and stay in
place

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 Control Plan

CONTROLPLAN
Prototype Pre-Launch Production
Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)

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

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

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

MACHINE,
CHARACTERISTICS METHODS
PART/ PROCESSNAME/ DEVICE, SPECIAL
PROCESS OPERATION JIG,TOOLS, CHAR. PRODUCT/PROCESS EVALUATION/ SAMPLE REACTION
NUMBER DESCRIPTION FOR MFG. NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT SIZE FREQ. CONTROL PLAN
TOLERANCE TECHNIQUE METHOD

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Control Plan Elements
IATF 16949 Annex A
A.2 Elements of the control plan
The organization shall develop a control plan that includes, as a minimum, the following contents.
a) General data
⎯control plan number,
c) Process control
⎯ issue date and revision date, if any,
⎯ process parameters,
⎯ customer information (see customer requirements),
⎯ process-related special characteristics,
⎯ organization's name/site designation,
⎯ machines, jigs, fixtures, tools for manufacturing.
⎯ part number(s),
d) Methods
⎯ part name/description,
⎯ evaluation measurement technique,
⎯ engineering change level,
⎯ error-proofing,
⎯ phase covered (prototype, pre-launch, production),
⎯ sample size and frequency,
⎯ key contact,
⎯ control method.
⎯ part/process step number,
e) Reaction plan and corrective actions
⎯ process name/operation description.
⎯ reaction plan (include or reference),
b) Product control
⎯ corrective action.
⎯ product-related special characteristics,
⎯ other characteristics for control (number, product or process),
⎯ specification/tolerance.

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Control Plan

Pitfalls
• Control plan and PFMEA not aligned
• Control plan and operator instructions not aligned
• Control plan out of date
• Control plan not updated from nonconformity corrective
actions

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 PPAP
Production Part Approval
Process

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 PPAP
What is it?
Requirements for approval of production parts.

Why do we use it?

To make sure that I understand all my customer
requirements, and that I can meet them under
actual production conditions.

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PPAP

1 Design Records
11 Initial Process Study
2 Authorized Engineering Change Documents
12 Qualified Laboratory Documentation
3 Customer Engineering Approval
13 Appearance Approval Report
4 Design FMEA
14 Sample Production Parts
5 Process Flow Diagrams
15 Master Samples
6 Process FMEA
16 Checking Aids
7 Control Plan
17 Customer-Specific Requirements (Records)
8 Measurement System Analysis Studies
18 Part Submission Warrant
9 Dimensional Results
Bulk Material Requirements Checklist
10 Material / Performance Test Results

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Production Part Approval Process

Pitfalls
• PPAP is treated as a separate process, rather than integrated
into product development
• Incomplete PPAP
• Assuming that submission levels are what’s required, rather
than what’s submitted

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 SPC
Statistical Process
Control

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 SPC
What is it?
A collection of statistical methods, especially
control charts, used to analyze and control a
process

Why do we use it?

To know when processes change and respond
accordingly

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Variation

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Distributions can vary in Location

Location (Center): 3 key measures

Mean = Average or X

Median = Middle (by count)

Mode = Most often

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Distributions can vary in Spread

Spread: 3 key measures

Range = R

Standard Deviation =  or s
Variance =  2

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Distributions can vary in Shape

Normal Distribution
68.25%

95.46%

99.73%

 3  2  X  2 3

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Control vs. Capability C o m m o n a n d S p e c i a l C a u s es

If only common causes of variation

are present, the output of a process
forms a distribution that is stable
over time and is predictable

If special causes of variation are

present, the process output is not
stable over time

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Control vs. Capability

Statistical Control

In- Control Out-of-Control

(Common Cause) (Special Cause)

Acceptable Case 1 Case 3

Variation
(Capability)
Unacceptable Case 2 Case 4

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Cp, Cpk, Pp & Ppk

Cp / Pp: can the car

fit into the garage?

Cpk / Ppk: does the

car fit into the garage?

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Measures of Process Capability
(Capability Index)
Within
Overall Subgroup
Within Variation Variation
Subgroup
Overall Variation Variation
if stable

Performance Ppk Cpk

Capability
Pp Cp
If centered
Overall Within

Kenneth J Kortge

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Capability Metrics – Acceptance Criteria

Typical:

Index  1.67 Acceptable

1.33 ≤ Index ≤ 1.67 May Be Acceptable

May require an improvement plan

Index  1.33 Not Acceptable

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2 Types of Data

Va r i a b l e

Attribute

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Variables Charts
Typical:

Chart X-Bar & R Median Individual & Moving

Type Range (MR)

Routine monitoring of Usually used as a

Primary manufacturing monitoring tool for Used when only one
Usage processes product or processes sample is possible

Plots the average size Plots the individual Plots the sample size
What Is and the range of the sizes of the parts and and the moving range
Charted part sizes the median of the part of the sample size
sizes

Sample
Subgroup Usually 3 to 6 Should be an odd One
Size number: 3, 5, 7, etc.

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Attribute Charts
Typical:
Chart Type P Chart nP Chart C Chart U Chart
Primary Used for Used for Used for Used for
Usage analyzing analyzing the analyzing analyzing
proportion or number nonconformities nonconformities
percent nonconforming or defects per unit
nonconforming or defective
or defective parts parts

What is Plots the Plots the Plots the count Plots the
Charted proportion or number of of all average number
percent of the nonconforming nonconformities of
nonconforming items found in the nonconformities
units sample in each sample

Sample Variable Fixed Fixed Variable

Subgroup
Size

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X & R Chart

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How Control Charts Work

UCLX • •
• •

•
•
X
•
• •
•
•
•
LCLX

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Special Cause Criteria

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Special Cause Criteria

1. Most measurements cluster around the center (average) line

2. A few measurements approach the edges (control limits)
3. No measurements outside the control limits
4. Same number of measurements on both sides of the center
(mirror image)
5. Random (no patterns)

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Statistical Process Control

Pitfalls
• Ignoring out of control conditions
• Comparing control limits to spec limits
• Making process adjustments without understanding the
source of the special cause variation
• Putting SPC charts on everything

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 MSA
Measurement Systems
Analysis
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 MSA
What is it?
A collection of statistical methods used to assess
how much I can trust the information from a
gauge

Why do we use it?

Since all my information about a part/process
comes from gauges, I need to know when the
gauge information is dependable, and do
something when it’s not
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Bias: difference between the measurement
and the "true" value

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Stability: change in bias over time

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Linearity: change in bias across expected range of
measurements

Note that unacceptable linearity can happen in a variety of ways.

Do not assume a constant bias.

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Gage Repeatability and Reproducibility = GRR = R&R

Variable, replicable measurements

Typical:

10 Parts
3 Appraisers
3 Trials

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GRR / R&R

 GRR =
2

 Reproducibility
2

+
 2
Repeatability

% Total Variation vs. % Tolerance

Number of Distinct Categories (NDC)

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Repeatability: gage-induced variation

Appraiser A

Repeatability

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Reproducibility: operator-induced variation

Reproducibility

Appraiser A C B

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The Effect of Measurement Error
“Observed” “Actual”
Total Variation = Process Variation + Measurement Variation

 2 2
=  Process + 
2
Total Measurement

Think of a
right triangle

Measurement
Variation

Process Variation
Kenneth J Kortge

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The Effect of Measurement Error

Total Variation = Process Variation + Measurement Variation

 2
=
2

2
Total Process + Measurement

Measurement
Variation

What You Want to Know

Kenneth J Kortge

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Gage R&R Acceptance Criteria (Typical)

% R&R
Under 10% error – Acceptable
10% - 30% error – May be acceptable based upon
importance of application, cost of measurement device, cost
of repair, etc.
Over 30% error – Not Acceptable. Every effort should be
made to improve the measurement system

Number of Distinct Categories (NDC):

Greater than or equal to 5 – Acceptable
Less than 5 – Generally Not Acceptable

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Measurement Systems Analysis

Pitfalls
• Using MSA to obtain a number, rather than to understand
gage variation
• Not documenting a conclusion and any actions needed, as
part of the study
• Not conducting MSA for all gages on the control plan
(IATF 16949 requirement)
• Not validating Software (IATF 16949 requirement)
• Using wrong analysis method (non-replicable, attribute, etc.)

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Automotive Core Tools

Advanced Product Quality Planning

(APQP)

Failure Mode and Effects Analysis (FMEA)

Control Plan

Production Part Approval Process ( P PA P )

Statistical Process Control (SPC)

Measurement System Analysis (MSA)

ASQ Automotive Division 68 Webinar Series

QUESTIONS

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