Quality Assurance: Applying Methodologies For Launching New Products, Services, and Customer Satisfaction

Quality
Assurance
Applying Methodologies for
Launching New Products, Services,
and Customer Satisfaction
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Quality
Assurance
Applying Methodologies for
Launching New Products, Services,
and Customer Satisfaction
D. H. Stamatis
CRC Press
Taylor & Francis Group
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To my friend

(Thanasi)
Contents
List of Figures...................................................................................................... xvii
List of Tables......................................................................................................... xix
Preface.................................................................................................................... xxi
Acknowledgments............................................................................................ xxvii
Author.................................................................................................................. xxix
Introduction........................................................................................................ xxxi
Section IOriginal Equipment Manufacturing (OEM)

Responsibilities
1. Timing (Product Development).................................................................... 3
Overview............................................................................................................3
Principles of Organizational Timing.............................................................6
APQP (Based on the Automotive Industry).................................................. 8
Typical Example of Timing in the Automotive Industry............................ 8
References........................................................................................................ 11
Selected Bibliography..................................................................................... 12
2. Basic OEM Quality System......................................................................... 13
Overview.......................................................................................................... 13
International Industry- and Customer-Specific Standards...................... 13
Certification to ISO 9001........................................................................... 13
Annex A: Control Plan Requirements............................................... 14
Certification to ISO 14001.......................................................................... 15
Certification to Industry Standards........................................................ 15
Customer-Specific Standards................................................................... 21
Disposition....................................................................................................... 23
Disposition Required................................................................................. 24
Working toward the Quality System...................................................... 24
Approval Denied........................................................................................ 24
Approval Achieved.................................................................................... 25
Approval Revoked..................................................................................... 25
Tier 2............................................................................................................ 25
Waived......................................................................................................... 25
Nonmanufacturing Site............................................................................ 26
References........................................................................................................ 26
Selected Bibliography..................................................................................... 26
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Contents
3. Manufacturing (Facility) Site Assessment (MSA).................................. 27

Overview.......................................................................................................... 27
Typical MSA Form.......................................................................................... 29
Selected Bibliography.....................................................................................34
4. Sourcing........................................................................................................... 35
Overview.......................................................................................................... 35
Supplier Sourcing Begins.............................................................................. 36
Priority Suppliers Selected....................................................................... 36
Cross-Functional Teams Formed............................................................. 36
Team Kickoff Meetings Begin.................................................................. 37
General Procedures for Sourcing.................................................................43
New/Initial Sourcing and Nonemergency Resourcing.......................43
Sourcing to Sites with a Waiver...............................................................43
Emergency Resourcing to a Nonqualified Facility...............................44
5. Segmentation.................................................................................................. 45
Overview.......................................................................................................... 45
Segmentation Definition................................................................................ 45
Segmentation Model....................................................................................... 47
Overlays............................................................................................................ 48
Quality Overlay.......................................................................................... 48
Launch Overlay.......................................................................................... 48
Limited Involvement Overlay.................................................................. 48
Applications..................................................................................................... 49
6. Supplier Development.................................................................................. 51
Overview.......................................................................................................... 51
Understanding the Fundamentals of Supplier Development.................. 52
Benefits of Supplier Development................................................................54
References........................................................................................................ 55
7. Role of Supplier Technical Engineer......................................................... 57
Overview.......................................................................................................... 57
Specific Responsibilities of the Stakeholders.............................................. 58
Specific Categories of a Supplier Technical Engineer................................ 59
Miscellaneous Functions...............................................................................64
Strategy and Business....................................................................................64
Section II Supplier Responsibilities

8. Commitment to Continual Improvement................................................. 69
Overview.......................................................................................................... 69
Process Teams............................................................................................. 71
Contents
ix
Key Items of Concern in the CI Process...................................................... 74

One-Piece Flow........................................................................................... 74
Step 1....................................................................................................... 74
Step 2....................................................................................................... 75
Step 3....................................................................................................... 76
Step 4.......................................................................................................77
Traditional Process Flow Diagram..........................................................77
As Is.........................................................................................................77
Should Be................................................................................................ 79
Could Be................................................................................................. 85
Value Stream Map...................................................................................... 86
Visual Factory (6S).......................................................................................... 92
Strategies of Control..................................................................................... 101
Visual Management and Relationships..................................................... 101
Reference........................................................................................................ 102
Selected Bibliography................................................................................... 102
9. Lean Manufacturing................................................................................... 103
Overview........................................................................................................ 103
Lean Goals and Strategy.............................................................................. 105
Steps to Achieve Lean Systems................................................................... 106
Easier Application for Lean......................................................................... 108
Warning.......................................................................................................... 112
References...................................................................................................... 113
10. Quality Operating System (QOS)............................................................ 115
Overview........................................................................................................ 115
Quality Operating System........................................................................... 117
QOS Implementation.................................................................................... 122
QOS Meeting Summary.............................................................................. 122
11. Certification to the International Standard and CustomerSpecific Requirements................................................................................ 127
Overview........................................................................................................ 127
ISOs Key Elements....................................................................................... 129
Individual Certifiable Clauses.................................................................... 131
Section 4: General Requirements for the Management System........ 131
Section 5: Requirements for Management............................................ 132
Section 6: Resource Requirements......................................................... 133
Section 7: Requirements for Services or Products
(Requirements for Realization).............................................................. 133
Section 8: Requirements for Analysis, Measurement, and
Improvement............................................................................................ 134
Contents
Pending Changes for the 2015 Revision.................................................... 135

References...................................................................................................... 136
12. Statistical Process Control (SPC).............................................................. 139
Overview........................................................................................................ 139
Model of SPC................................................................................................. 139
Step 1. Identify and Define the Process................................................ 141
Step 2. Establish Process Ownership and Responsibilities............... 141
Step 3. Define and Establish Process Controls..................................... 144
Step 4. Continuously Improve Process Performance.......................... 146
SPC and Six Sigma........................................................................................ 148
References...................................................................................................... 149
13. Problem-Solving Methodology................................................................ 151
Overview........................................................................................................ 151
Definition of a Problem................................................................................ 158
Problem-Solving Cycle................................................................................. 160
Step 1: Select the Problem (or Opportunity) That Represents a
Waste or a Bottleneck in the Area......................................................... 163
Step 2: Find the Root Cause of the Problem......................................... 163
Step 3: Correct the Problem.................................................................... 163
Step 4: Verify Correction......................................................................... 164
Step 5: Prevent Recurrence of the Problem.......................................... 164
Recycle....................................................................................................... 165
Tools for Problem Solving............................................................................ 165
Process Improvement Cycle........................................................................ 167
Step 1. Identify the Output..................................................................... 168
Step 2. Identify the Customer................................................................. 168
Step 3. Identify the Customer Requirements....................................... 168
Step 4. Translate Requirements into Product Specifications............. 170
Step 5. Identify the Work Process.......................................................... 170
Step 6. Select the Process Measurements............................................. 170
Step 7. Determine the Process Capability............................................. 171
Step 8. Decide If the Process Is Capable................................................ 171
Step 9. Problem Solved to Improve the Work Process........................ 171
Step 10. Produce the Output................................................................... 172
Step 11. Evaluate the Results................................................................... 172
Step 12. Decide If There Is a Problem.................................................... 172
Step 13. Solve the Problem to Improve Results.................................... 172
Step 14. Recycle......................................................................................... 173
Comments on Problem Solving versus Process Improvement.............. 173
References...................................................................................................... 176
Contents
xi
14. Internal Audits............................................................................................. 179

Overview........................................................................................................ 179
Types of Audits............................................................................................. 180
Performing an Audit.................................................................................... 182
Product Audit........................................................................................... 183
Process Audit............................................................................................ 184
Layered Audit........................................................................................... 188
Error-Proofing Audit............................................................................... 193
General Comments about the Audits........................................................ 193
References...................................................................................................... 196
15. Poka-Yoke...................................................................................................... 199
Overview........................................................................................................ 199
Historical Perspective................................................................................... 199
Strategy of Mistake Proofing....................................................................... 200
Mistake-Proof Systems................................................................................. 202
Essentials of Poka-Yoke................................................................................ 204
Zero Defect Concept in Mistake Proofing................................................. 210
Poka-Yoke Steps and Application............................................................... 210
Approaches to Correcting Human Mistakes............................................ 213
Red Flag Conditions..................................................................................... 220
Corrective Action.......................................................................................... 221
Presenting Findings..................................................................................... 224
Next Steps......................................................................................................225
References......................................................................................................225
16. Measurement System Analysis (MSA)................................................... 227
Overview........................................................................................................ 227
Types of Data................................................................................................. 229
Using Minitab.............................................................................................. 230
MSA: Gauge R&R..................................................................................... 230
Attribute MSA: Using Minitab............................................................. 235
Variable MSA: Using Minitab............................................................... 241
Conducting the Study......................................................................... 241
Trials and Data Collection................................................................. 242
Manipulate the Data........................................................................... 242
Prepare the Analysis........................................................................... 243
Choose a Method of Analysis........................................................... 244
MSA Graphical Six Panel................................................................... 245
Minitab Graphical Output............................................................... 245
What to Look For..................................................................................... 253
Repeatability Issues (within Operator)............................................ 253
Reproducibility Issues (between Operators)................................... 253
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Contents
Key to Successful MSA............................................................................ 253

Possible Causes for Bias..........................................................................254
Possible Issues with Linearity................................................................254
References......................................................................................................254
17. Suppliers Perspective of APQP............................................................... 257
Overview........................................................................................................ 257
APQP Initiatives............................................................................................ 258
APQP Reporting........................................................................................... 259
Fundamental Elements of APQP................................................................ 260
Risk Assessment........................................................................................... 262
Control Plans................................................................................................. 263
Supplement K................................................................................................ 263
References...................................................................................................... 275
18. Suppliers Perspective on the PPAP......................................................... 277
Overview........................................................................................................ 277
PPAP Submission Levels and Approvals.................................................. 281
Flow of Verification....................................................................................... 282
Capacity Analysis......................................................................................... 283
Capacity Report............................................................................................. 285
Misconceptions about PPAP........................................................................ 285
Actual Requirements.................................................................................... 286
Key Clarifications for PPAP......................................................................... 286
References...................................................................................................... 287
19. Capacity Analysis........................................................................................ 289
Overview........................................................................................................ 289
Goal of Capacity............................................................................................ 289
Environment for Capacity Planning.......................................................... 291
Overall Equipment Effectiveness (OEE).................................................... 293
Evaluating the OEE....................................................................................... 294
Some Specific Actions for Improving OEE............................................... 295
Improving Demonstrated OEE.............................................................. 295
Some Specific Improvements on the Components of OEE..................... 296
For Availability......................................................................................... 296
For Performance Efficiency..................................................................... 296
For Quality Rate....................................................................................... 296
Demonstrated OEE....................................................................................... 296
Enablers to Improve the Demonstrated OEE............................................ 298
Other Enablers.......................................................................................... 298
Contents
xiii
Analyze Results and Implement Actions............................................. 298

Required OEE................................................................................................ 298
Improving Required OEE............................................................................ 299
Shared Loading Analysis............................................................................ 299
Total Allocation.............................................................................................300
Reaction and Plan Expectations.................................................................300
Capacity Information Maintenance........................................................... 301
Thought Starters to Improve Supplier Capacity Volume........................ 302
References......................................................................................................304
20. Geometric Dimensioning and Tolerancing (GD&T)...........................305
Overview........................................................................................................305
Language of GD&T.......................................................................................306
Types of Drawings........................................................................................ 313
Title Block and Notes.................................................................................... 314
Diamond P and D Requirements............................................................... 315
Tolerance Types............................................................................................. 316
Basic Dimensions..................................................................................... 317
Line Conventions on Production Drawings........................................ 319
Feature of Size (FoS)..................................................................................... 319
Maximum Material Condition (MMC)...................................................... 321
Least Material Condition (LMC)................................................................. 322
Virtual Condition.......................................................................................... 322
Datum and Target Datum Symbols........................................................... 323
Tolerance Modifying Symbols.................................................................... 323
Independency................................................................................................ 323
Feature Control Frames (FCF)..................................................................... 323
Datum............................................................................................................. 324
Datum Targets.......................................................................................... 325
Things to Remember: Datums............................................................... 326
Things to Remember: Form.................................................................... 326
Orientation..................................................................................................... 327
Rules Applied to Orientation................................................................. 327
Things to Remember: Orientation......................................................... 327
Projected Tolerance Zone ( P )............................................................... 328
Things to Remember: Position............................................................... 328
Profile Controls............................................................................................. 329
Circle U Modifier ( U )............................................................................ 329
Things to Remember: Profile.................................................................. 329
Coaxial Controls Overview......................................................................... 330
Key Elements to Review GD&T by Asking the Following
Questions................................................................................................... 330
MMC (M) and LMC (L)........................................................................... 332
MMC (M).............................................................................................. 332
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Contents
LMC (L)................................................................................................. 332

Regardless of Feature Size (RFS)........................................................... 332
Features That Require Datum................................................................ 333
References......................................................................................................334
Selected Bibliography...................................................................................334
21. 8D.................................................................................................................... 335
Overview........................................................................................................ 335
8D Application Criteria................................................................................ 336
D0: Prepare for the Problem-Solving Process........................................... 337
D1: Establish the Team: Process Flow........................................................ 339
Team Composition...................................................................................340
Champion.............................................................................................340
Team Members.................................................................................... 341
Team Leader......................................................................................... 341
Recorder................................................................................................ 341
Facilitator.............................................................................................. 341
D1: Process Guidelines............................................................................342
Warming Up.............................................................................................343
Membership..............................................................................................343
D2: Describe the Problem............................................................................344
D2: Process Guidelines............................................................................346
How to Develop a Problem Description...............................................348
D2: Evaluating Questions....................................................................... 351
D3: Develop the Interim Containment Action (ICA)............................... 352
D3: Process Guidelines............................................................................ 353
D3: Evaluating Questions.......................................................................354
D4: Define and Verify Root Cause and Escape Point.............................. 355
Determining Root Cause........................................................................ 356
D4: Guidelines.......................................................................................... 356
Generic Simple Root-Cause Analysis.................................................... 358
Determination of the Root Cause.......................................................... 358
Verify Root Cause.................................................................................... 361
Helpful Supplemental Tools................................................................... 361
D5: Choose and Verify PCAs for Root Cause and Escape Point............ 362
D6: Implement and Validate PCAs.............................................................364
Removing the ICA................................................................................... 365
D7: Prevent Recurrence................................................................................ 367
Contents
xv
D7: Evaluating Questions........................................................................ 371

D8: Recognize Team and Individual Contributions................................ 372
8D Summary Evaluation.............................................................................. 375
Prepare for the 8D Process...................................................................... 375
Establish the Team................................................................................... 375
Describe the Problem.............................................................................. 375
Develop the Interim Containment Action............................................ 376
Define and Verify Root Cause and Escape Point................................. 376
Choose and Verify Permanent Corrective Actions for Root
Cause and Escape Point.......................................................................... 377
Implement and Verify Permanent Corrective Actions....................... 377
Prevent Recurrence.................................................................................. 378
Recognize Team and Individual Contributions.................................. 378
8D Success Factors........................................................................................ 378
References...................................................................................................... 379
22. Miscellaneous............................................................................................... 381
Overview........................................................................................................ 381
Typical Total Production System (TPS)...................................................... 381
Fords Approach to TPS................................................................................ 382
Toyota Production System (TPS).................................................................384
Suppliers and TPS.................................................................................... 385
Suggested Implementation of a Production System................................ 386
Production System Model Based on an American Engine Plant........... 387
Supplier Request for Engineering Approval (SREA)............................... 388
Service Unique Products......................................................................... 390
Temporary SREA...................................................................................... 390
Supplier Risks for Not Following an SREA.......................................... 391
Warranty........................................................................................................ 391
Weibull Distribution..................................................................................... 393
FMEA.............................................................................................................. 397
Six Sigma........................................................................................................ 398
Six Sigma Methodology.......................................................................... 399
DMAIC.................................................................................................. 399
DMADV................................................................................................400
Levels of Six Sigma Mastery................................................................... 401
Systems Engineering.................................................................................... 402
Value Engineering........................................................................................404
References...................................................................................................... 406
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Contents
Epilogue................................................................................................................ 409
Glossary................................................................................................................ 415
Appendix I: Typical Detailed Expectation List of a Site Assessment
by the Customer to the Suppliers Facility..................................................... 439
Appendix II: PPAP Checklist........................................................................... 449
Appendix III: Mistake Proofing...................................................................... 453

Appendix IV: Preparation of an Audit........................................................... 463
Appendix V: Miscellaneous Items.................................................................. 505
Selected Bibliography........................................................................................ 601
Index...................................................................................................................... 605
List of Figures
Figure 3.1 Typical MSA form......................................................................... 30
Figure 5.1 Basic model of segmentation...................................................... 47

Figure 8.1 Typical fast response board.........................................................72
Figure 8.2 Typical form to generate or summarize events of the
PDCA model................................................................................. 74
Figure 8.3 Typical value stream process flow chart.................................. 87
Figure 8.4 Typical 6s/visual factory matrix................................................ 94
Figure 8.5 Typical 6s action item list............................................................ 95
Figure 8.6 Visual management and relationships....................................102
Figure 10.1 Generic QOS model.................................................................... 118
Figure 12.1 Classic SPC model......................................................................140
Figure 12.2 Seven-step approach to SPC implementation........................ 147
Figure13.1 John Boyds OODA loop............................................................ 154
Figure13.2 Typical 35 Why form..............................................................157
Figure13.3 Summary of the 5-step model..................................................162
Figure13.4 The 14-step process improvement cycle model.....................169
Figure 14.1 Partial process audit................................................................... 186
Figure 14.2 Typical format for layer audit focusing on high-risk
processes..................................................................................... 189
Figure 14.3 Typical form of management layered audit............................190
Figure 14.4 Typical layered audit indicating documentation and
progress from shift to quarterly improvement..................... 191
Figure 14.5 Typical partial error-proofing layered audit...........................194
Figure 14.6 Typical form for tracking nonconformances in an LPA....... 196
Figure 15.1 Comparison of prevention and detection approaches......... 207
Figure 15.2 Functions of mistake-proofing devices.................................. 220
Figure 16.1 Typical Minitab truth table......................................................237
Figure 16.2 Typical worksheet where the data is entered.........................237
Figure 16.3 Minitab screen showing the attribute gauge R&R.............. 238
Figure 16.4 Minitab screen showing the selection options for
attribute gauge R&R...................................................................239
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List of Figures
Figure 16.5 Minitab screen showing the assessment agreement for

an attribute gauge R&R............................................................. 239
Figure 16.6 Data in worksheet....................................................................... 242
Figure 16.7 Process for stacking the data.................................................... 243
Figure 16.8 Data stacked and ready for analysis....................................... 243
Figure 16.9 Selection process for crossed gauge R&R.............................. 244

Figure 16.10 Selection process for method of analysis............................... 244
Figure 16.11 Selection process for adding tolerance (optional)................. 245
Figure 16.12 Minitab output for variable MSA output............................. 246
Figure 16.13 Typical graphical output of Minitab for variable data
MSA............................................................................................. 247
Figure 16.14 Typical output of the health and troubleshooting side
of the graphical output............................................................. 249
Figure 16.15 Nested gauge R&R......................................................................250
Figure 16.16 Bar chart for components..........................................................251
Figure 16.17 Evaluation of the R chart and the Xbar chart by operator. ...... 251
Figure 16.18 More R chart indicators.............................................................252
Figure 16.19 Minitab output of an ANOVA MSA analysis...................... 252
Figure 17.1 Typical risk assessment form.................................................. 263
Figure 20.1 Options of drawing callout the circle U modifier..................329
Figure 21.1 Pictorial view of the three possibilities of something
changed...................................................................................... 338
Figure 21.2 Three-Legged 5 Whys analysis format................................... 345
Figure 21.3 Determine root cause of the problem..................................... 359
Figure 21.4 Validation model of removing the ICA.................................. 365
Figure22.1 Typical systems engineering V-model....................................402
Figure III.1 Reactive approach.......................................................................457
Figure III.2 Proactive approach.................................................................... 458
FigureV.1 Typical physical layout...............................................................583
FigureV.2 Typical layout configuration.................................................... 584
FigureV.3 Typical combination layout to take advantage of both
equipment and operators.......................................................... 585
List of Tables
Table 1.1 Typical Example of APQP/PPAP and Expectations.................... 9
Table 2.1 Summary of ISO 14001 Key Elements.......................................... 15

Table 4.1 Summary of On-Site Evaluation #1.............................................. 38
Table 4.4 Summary of On-Site Evaluation #4..............................................42
Table 7.1 Summary of Roles and Responsibilities of the Lead.................65
Table 8.1 Overview of Enterprise Alignment and Continual
Process Improvement..................................................................... 93
Table 10.1 Potential QOS Measurables......................................................... 120
Table 10.2 QOS Implementation Steps......................................................... 123
Table 10.3 Requirements of Each Step.......................................................... 124
Table 12.1 Summary of SPC Utilization in the DMAIC Model................ 149
Table 12.2 Summary of SPC Utilization in the DCOV Model................... 149
Table13.1 Comparison of Several Problem-Solving Methodologies....... 161
Table13.2 Inventory List of 38 of the Most Commonly Used Tools........ 166
Table13.3 Problem Solving versus Process Improvement
SelectionChart.............................................................................. 174
Table 15.1 Comparison between Error and Defect..................................... 206
Table 15.2 Comparison of Improvement Cycle and Zero Defect Flow
and Cycle........................................................................................ 211
Table 15.3 Zero Defect Process Overview................................................... 212
Table 15.4 Typical Comparison of Poka-Yoke Approaches........................ 213
Table 15.5 Generic Approach of Selecting Appropriate Level of Control.....214
Table 15.6 Effective System of Poka-Yoke That Works Best....................... 214
Table 15.7 Comparison of Self and Successive Checks.............................. 217
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List of Tables
Table 15.8 Comparison between Defect and Mistake................................ 218

Table 16.1 Minitab Screen Showing the Numerical Analysis of the
Attribute Data Gauge R&R.......................................................... 240
Table 17.1 Aims, Expectations, and Requirements Based on
Schaefflers Characterization of APQP...................................... 264
Table18.1 Flow of PPAP Implementation.................................................... 283

Table 20.1 Major Changes from ASME Y14.5-1994 to ASME Y14.5-2009..... 306
Table 20.2 Summary of Categories Used in GD&T.................................... 307
Table 21.1 Typical Format for the IS/IS NOT.............................................. 347
Table 21.2 Typical Comparison of Determining Root Cause Using
Two Approaches............................................................................ 359
Table22.1 Relationship of Sigma and Defect.............................................. 399
Table22.2 Typical Tools Used in the DMAIC Model.................................400
TableE.1 Summary of Growth in Quality Perception............................. 411
Table III.1 Examples of Mistakes and Defects............................................. 456
TableV.1 Typical Supply Survey Form....................................................... 569
TableV.2 Typical Order Form...................................................................... 570
TableV.3 Typical Reorder Kanban Card.................................................... 570
Preface
Since the early 1980s, everyone has talked about continual improvement (CI).
However, to talk about it is not enough. It must be engrained in an organization with a three-prong approach. That approach is based on the following:
(1) a consistent philosophy of improvement by management, (2) a receptive
organizational culture, and (3) the entire culture of the organization must be
willing to make decisions based on measurement and data.
These three basic approaches are necessary for the organization to develop
an attitude for doing things right the first time, whether it will be for a product
or a service. This attitude must be incorporated into the processes of any
organization and create products or services for the marketplace that will
delight the customers rather than just satisfy them. It is interesting to note
here that even though we all know these fundamental principles, products
and services fail or at least miss their launching deadlines, and for some
reason even though we claimed that we were short on time, now after the
failure we find the time to do it again. The question is why? We think that the
answer is one or more of the following five categories. They are
1. Design and development. We rush to bring products and services
into market before they are ready for mass production and/or
marketing.
2. Process design. We design products and services with specific
requirements and not robustness. We design and we expect the customer will tell us how to improve the products and services once
they hit the market.
3. Problem solving. We focus on fixing the problems after the fact and
even then we fail to use a systematic (standardized) and consistent
approach for the organization.
4. Share knowledge systematically. We preach corporate knowledge
but we do not systematically use it for the benefit of the organization. Quite often, once the launch is complete, we do not even hold
debriefing meetings to evaluate Things Gone Wrong (TGW) or
Things Gone Right (TGR). In fact, in most cases, the launch team is
replaced by a new one and we start the process all over again.
5. Leaders are not involved with the development of others. We practice and encourage silo development within our organizations.
Leaders focus on financial metrics and they seem to spend very little
time on mentoring upcoming talent. We forget that one of the most
important tasks of leadership is to build and train new leaders for
the future.
xxi
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Preface
To circumvent these deficiencies, the concept of CI must be an active philosophy in the management of any organization. In fact, that philosophy
must be interpreted through a strategy and implemented in such a way that
superb results will be accomplished. If the strategy is great, everything else
will work to positive results. Unfortunately, most organizations circumvent
a good strategy and depend on managing broken processes to have good
results with additional procedures and/or requirements.
We are not suggesting that there is a specific policy within organizations that encourages cheating in any way, shape, or form. Absolutely not!
However, we do suspect that many organizations, due to time and cost constraints, sometimes look the other way. After all, they assume acts that have
welcomed benefits are good and the sooner they reach the market the better. We suggest that this kind of thought is 100% wrong. When this happens, organizations must look at the bigger picture internally. It is a system
problem! The problem is not that individuals cut corners, or cheat, or coerce
someone to do something unethical. The problem is that the idea of doing it
right the first time is only a slogan and many organizations have developed
the ridiculous notion that you can hide or reinvent reality by creating new
requirements and policies and trying to enforce them. This approach has not
worked and it will not work.
To be sure, one of the risks we take in a free society is to allow ourselves
and others to make mistakes. Why? Because no one is perfect! One can never
be certain when something is a mistake, oversight or not. So what do we do?
Technology is emerging and rapidly growing in all industries and service
organizations. The opportunity exists for all organizations to grow as well.
However, for that growing to take place, the same organizations must recognize the consumers needs and wants and align them to their priorities. One
good way to do that is to follow the seven principles:
1. Research/plan: Research for innovations that will delight the consumer. Always scan/survey the consumers to find their needs and
wants. Remember that current wants become needs in the future
(Kano model).
2. Assure: The consumer has to be assured that the product you are
selling is reliable (engineers language) and durable (customers language) because we want products that last.
3. Explain: Why a particular feature and innovation are important and
how they will facilitate the customers safety and/or comfort.
4. Prioritize: Product performance; it should work better if it is really
good.
5. Demonstrate: The product is environmentally safe and friendly
and its performance is better than a competitors product or
service.
Preface
xxiii
6. Confirm: The material used in the product is the best, so the quality
metric is what we want and expect.
7. Show: How you value and deliver product safety.
Based on 35 years of experience dealing with OEMs and suppliers this

book covers the essential items for doing the right thing the first time especially when launching a good product and/or service to the customer. The
requirements have been split into two sections. Section I covers the original equipment manufacturer (OEM)/customer requirements and Section II
covers supplier requirements. In both sections, we do not take a deep dive
in the content because each chosen topic requires its own book. We have
chosen, however, to identify key indicators and methodologies that will help
attain excellent performance, delivery, and cost for both the customer and
the supplier. In other words, if you follow these methodologies and indicators, the job will get done right the first time. Specifically, each chapter covers
the following:
Chapter 1: Timing (Product Development). The significance of timing is discussed. Emphasis is placed on setting the milestones of
deliverables.
Chapter 2: Basic OEM Quality System. The significance of a customer
quality system is explained and the need for such a system to
exist before a customer makes demands on a supplier for quality
products/services.
Chapter 3: Manufacturing (Facility) Site Assessment (MSA). The
significance of a customer knowing what to expect from a supplier and how it should validate its requirements in the suppliers
facility.
Chapter 4: Sourcing. The significance of having the right supplier with
which to do business and a discussion of how to go about selecting
the right supplier.
Chapter 5: Segmentation. The significance of categorizing suppliers
with which to do business depending on their own capability, capacity, and quality requirements.
Chapter 6: Supplier Development. The significance of supplier development by the customer, so that the supplier can meet the customers
requirements.
Chapter 7: Role of Supplier Technical Engineer. The significance of the
customer designating a specific individual to make sure that the
supplier is meeting all the requirements of the customer. It defines
several roles and responsibilities that the supplier technical engineer
must do for success.
xxiv
Preface
Chapter 8: Commitment to Continual Improvement. This chapter discusses the significance of the continual improvement philosophy
and how it affects the supplier and customer relationship.
Chapter 9: Lean Manufacturing. This chapter introduces the philosophy of Lean and several methods of reducing waste.
Chapter 10: Quality Operating System (QOS). This chapter discusses
one of the key systems in pursuing quality. It focuses on key processes and key indicators of these processes.
Chapter 11: Certification to the International Standard and CustomerSpecific Requirements. This chapter gives a cursory review of the
fundamental principles of the ISO standard and how the supplier
can use it to improve quality.
Chapter 12: Statistical Process Control (SPC). This chapter gives a cursory review of the SPC fundamentals and explains the need for the
supplier to have a system in place to evaluate its processes. Without
SPC, the voice of the process will never be known.
Chapter 13: Problem-Solving Methodology. This chapter discusses the
role of problem-solving methodology in any organization. It also
addresses several key points about definition of the problem and
the characteristics of problem solving and the process improvement
cycle.
Chapter 14: Internal Audits. This chapter explains the validation process of fulfilling the requirements of both standards and customer
requirements by explaining the concept of an audit and specifically
elaborates on several types that may be used by either the customer
or the supplier.
Chapter 15: Poka-Yoke. This chapter extends the discussion of Chapter
13 by providing a specific approach to problem solvingthe mistakeproofing approach. This discussion covers the rationale, method,
and several approaches to mistake proofing.
Chapter 16: Measurement System Analysis (MSA). This chapter discusses the rationale for measurement, approaches to measurement
by differentiating attribute and measurable data, and provides a
mini-tutorial on gauge R&R via Minitab.
Chapter 17: Suppliers Perspective of APQP. This chapter discusses the
fundamental reasons for the existence of APQP and emphasizes the
significance of the milestones. It further discusses the measuring
effectiveness of each milestone.
Chapter 18: Suppliers Perspective on the PPAP. This chapter discusses
the elements of the PPAP process, the rationale for them, and the PSW
significance. It also delineates the levels of the PPAP as well as the significance of capacity as part of the PPAP process for some customers.
Preface
xxv
Chapter 19: Capacity Analysis. This chapter discusses the need for a
capacity study and explains the components of it as well as giving
a rationale for incorporating overal equipment effectiveness (OEE)
as part of the capacity evaluation. The chapter also discusses the
required OEE, demonstrated OEE, shared loading analysis, and total
allocation.
Chapter 20: Geometric Dimensioning and Tolerancing (GD&T). This
chapter gives a cursory overview of GD&T and focuses primarily
on the most common characteristics: form, profile, orientation, location, and runout. It also discusses the concepts of tolerances, dimensions, datums, maximum material condition (MMC), least material
condition (LMC), and feature of size (FoS).
Chapter 21: 8D. This chapter is also an extension of Chapter 13. It discusses a very specific approach to problem solving, which is very
popular in many industries. Specifically, it discusses the individual steps of the method but it also covers an evaluation process for
effectiveness at the completion of all the steps by giving the reader
a series of questions to make sure that the key areas of the methodology have been covered.
Chapter 22: Miscellaneous. This chapter covers some unique topics
that most organizations need to practice. They are very important
and many customers demand that their supplier practice them.
Specifically, the topics are production system, supplier request engineering approval (SREA), failure mode and effect analysis (FMEA),
warranty, Weibull distribution, and Six Sigma.
Epilogue: Here we close the book with a discussion of some essential
items that both customers and suppliers must keep in mind in order
to continue the journey to flawless launches.
Appendix I: A typical detailed expectation list of a site assessment by the
customer to the suppliers facility is given.
Appendix II: A typical PPAP checklist is given to make sure that all
elements are covered appropriately.
Appendix III: Mistake proofing.
Appendix IV: Auditing requirements, criteria, and evaluation.
Appendix V: Many Six Sigma and Lean explanations of specific concepts and typical forms/tools are given to help suppliers with their
data or selection methodologies to pursue continual improvement.
The book concludes with a glossary and selected bibliography.
Acknowledgments
No book is the result of one person. Many individuals both directly and indirectly contribute in subtle ways that make the formal book worth printing.
This book is the result of many years contemplating what is necessary to
have a launch that is as flawless as possible. Recognizing that nothing is perfect and that the unexpected always finds its way into any given situation, I
decided that I would try to identify the key indicators to guide an organization through the cultural change that is necessary to pursue a way of life that
expects doing it right the first time.
I concluded that this cultural change takes two parties. The first one is the
customer, and the second one is the supplier. The more I looked at these two,
the more I realized I was not too far from the target of improvement. My
experience as an academician, trainer, and consultant over the last 35 years
guided me in the direction to pursue this endeavor. In the process, I met
many individuals I cannot possibly give credit to but for whom I am grateful
for their suggestions and discussions about the key indicators that make an
organization perform at a level that is indeed exceptional.
In addition to these silent names, there are also individuals who encouraged me to pursue the project, reviewed rough drafts, gave me advice, helped
me focus on the points of interest and content in individual chapters, and
helped with typing, printing, drawing graphs, software, and so on. High on
the list are the following:
ASME for giving me permission to reprint some of the symbols and definitions from the ASME Y14.5 2009 standard. Specifically, figures C.5, C.6,
and C.7. Special thanks also go to Ivette Estevez, CAP administrator, ASME,
for helping in the process of granting the permission.
G. Kontos, PhD; R. Munro, PhD; and J.J. Yu, PhD; for their relentless encouragement and support. They were always there to bounce thoughts, ideas,
and content. I appreciate their effort.
C. Stamatis and S. Stamatis, PhD, my sons, for helping with software and
computer work. I do not think that this book would have been completed
without their constant helpespecially when problems arose due to power
failures.
K. Kukor (Freudenberg-NOK), E. Voskuhl (DANA), R. Horner (DANA), R.
Landreth (Stant), C. Sanchez (Federal Mogul), A. Barnett (Quantiles), J. Methot
(Methot Associates), S. Mitchell (SJM Associates), J. Lapolla (General Physics),
C. Cunitz (MPC), and K. Little (Bosch) for their advice on supplier issues/perspectives as well as ideas on specific content that makes suppliers more efficient and effective in their roles to satisfy the customer.
E. Liasi, PhD (Ford), R. Jiang (Ford, China), J. Tassis (Ford), Y. Yin (Ford),
A. Katakis (GM), B. Mooridian (GM), J. Kapur, PhD (Six Sigma Solutions),
xxvii
xxviii
Acknowledgments
G. Polychronis (Chrysler), K. Shankar (Parker), M. Lutz (Kostal), A. Allen

(Weirton), M. Mihas (Chrysler), S. Gikas (Chrysler), N. Papazoglou (Chrysler),
and B. Anagnostou (GM) for their detailed suggestions and advice to make
the requirements of the original equipment manufacturers (customers) more
concise and easily understood.
G. Kissonergis (Process Product Consulting), N. Simons (Performance
Innovation), V. Simmers (Quality Performance), J. Worley (Worley Associates),
and A. Woodley (Woodley Consulting) for reviewing and recommending
suggestions to improve flow and content.
Whereas all their suggestions and advice were considered, the final product is the authors responsibility. I have incorporated many of their ideas and
suggestions throughout the chapters.
I also thank the editors of the book for designing it in such a way that made
the final product look professional and easier to read.
Furthermore, I thank all my clients (both original equipment manufacturers and suppliers) that have given me the opportunity to learn from their
processes and transfer that learning into the ideas of this book.
My list would not be complete without recognizing the most important
supporter, editor, motivator, and life partner, my wife, Carla. As always, she
has been there to motivate me and encourage me to go on even at the lowest
points of my writing. Thank you so much, Carla Jeanne. Without you, this
project would not have been completed.
All screens shown in Minitab are inputs contained in this particular software and used in this book with permission of Minitab Inc. All material
remains the exclusive property and copyright of Minitab Inc. All rights
reserved, Minitab and all other trademarks and logos for the companys
products and services are the exclusive property of Minitab Inc. All other
marks referenced remain the property of their respective owners. See
minitab.com for more information.
Author
D. H. Stamatis is the president of Contemporary Consultants Co., in
Southgate, Michigan. He is a specialist in management consulting, organizational development, and quality science. He has taught project management,
operations management, logistics, mathematical modeling, economics, management, and statistics at both graduate and undergraduate levels at Central
Michigan University, the University of Michigan, Anhui University (Bengbu,
China), the University of Phoenix, and the Florida Institute of Technology.
With over 30 years of experience in management, quality training, and
consulting, Dr. Stamatis has serviced numerous private sector industries
including but not limited to steel, automotive, general manufacturing, tooling, electronics, plastics, food, U.S. Navy, U.S. Department of Defense, pharmaceutical, chemical, printing, healthcare, and medical device.
He is a certified quality engineer through the American Society of
Quality Control, certified manufacturing engineer through the Society of
Manufacturing Engineers, certified Master Black Belt through IABLS, Inc.,
and a graduate of BSIs ISO 900 Lead Assessor training program.
Dr. Stamatis has written over 70 articles, presented many speeches, and
participated in both national and international conferences on quality. He is
a contributing author on several books and the sole author of 52 books.
xxix
Introduction
The world of quality has been involved with quality ideas since prehistoric
times, from primitive approaches to craftsmanship, to MIL-STDs, to general industry standards, to international standards, and to specific industry
standards.
However, none of them has been successful enough to say with a sense
of certainty that quality has overcome its nemesis of timing and price. (We
purposely mention price because that is the cost per unit on which most
organizations focus. Organizations should focus instead on the lifecycle cost
for a best estimate for the true cost.) To be sure, quality has evolved to levels
of unprecedented magnitude, but we still have a long way to go.
In fact, for years we have been conditioned to think that a successful organization is one that will have a good product and a fast way to bring it to
market. It may have worked in the past for some. However, in the world of
today, the options of price, time, delivery accuracy, and dependability from
both OEMs (customers) and suppliers may be summarized in three categories. They are

1. Good and fast delivery of a finished product: This implies quality

and expensive product or service. In everyday language, we think
of this option as a way to bring all resources together with top priority. This means we will not cut corners but rather we will encourage
and use human and technological resources to ensure the product is
completed on time and will be of the highest quality. The cost may
be high up front, but in the end it will be more cost-effective and it
will gain favorability from the ultimate customer. This option is by
far the best!
2. Good and cheap delivery of a finished product: This implies slow and
mass production of a product or service. In everyday language, we
think of this option as a potential discounted product and as a consequence, we give it less priority and certainly less human and technology resources. The result of this option is that the quality is going to
be acceptable; however, it will take a long time to accomplish based on
delays in design or manufacturing, and/or delivery concerns.
3. Fast and cheap delivery of a finished product: This implies inferior
product or service. In everyday language, we think of this option as
you get what you pay. Obviously, this option is lacking in many ways,
but predominantly in lower priority and fewer allocated resources.
Its purpose is to deliver it at all costs on time regardless of quality.
This is the worst option.
xxxi
xxxii
Introduction
Unfortunately, many organizations follow Option 2 or 3. How else can we

explain major mishaps in so many industries and in some cases fatalities
because of lack of quality? The latest disasters in the automotive industry
because of some fundamental mistakes (oversights?) prove the point. They are

Power steering failures

Accelerator problems (unintentional acceleration)
Transmission gear jumps from park to reverse
Ignition issues (fire incidents)
Wiring issues (fire incidents)
Brake issues (unusual corrosion)
Nondeployment of air bags
These failures include automakers from United States, Germany, France,

Sweden, and Japan, and involve millions of recalls in a variety of models
over the last 10 years. What is interesting about these failures is the fact that
all of the failures have occurred to critical or essential items in the automobile. In fact, after over 100 years of producing these cars, one would think
that they would have perfected the items in question. Obviously, they have
not. The question is why? There are many reasons for it, but we believe the
primary reasons are the desire to cut costs and to shrink the time from development to Job 1 (the production date). Furthermore, artificial due dates end
up in failuresquite often in fatalitiesdue to the tendency to compromise
(cut corners) the standards, procedures, and practices that define the quality
of the products/services.
It is interesting to note here that even compliance with international standards, recipients of the Malcolm Baldrige National Quality Award or strong
followers of the Six Sigma methodology have not prevented catastrophic
failures. The reason is that systems exist for fundamental improvement of
quality, but a strong strategy for its implementation and sustainability is
lacking. We must note here that even the certification to international and/
or industry standards is not a guarantee that failures will not occur.
This book is focused on doing things right the first time including the launching requirements for a flawless implementation of a program and/or service. We have addressed some generic issues, especially from the automotive
industry, which we believe transcend industries and may in fact be equally
applied to service organizations with minor modifications.
In a sense, we have tried to summarize this effort in the following
principles:
More service. More service means real-time problem solving by
experienced and dedicated customer service groups that are on site
at each facility.
Introduction
xxxiii
More reliability. More reliability means strategically located production facilities that offer the same flexibility, quality, and service every
time everywhere.
More quality. More quality means quality management systems are
in place that, coupled with state-of-the-art appropriate and applicable processes and unparalleled attention to detail, will ensure that a
product meets the highest standards.
More flexibility. More flexibility means a lean organization with
the ability to quickly adapt to instantly changing business environments and production design requirements.
We also have recognized that the engines of change in both OEMs (customers) and suppliers are the leaders of management. It is managements role
to direct and influence the organization. This leadership must be displayed
on a daily basis through commitment and behaviors. Without managements
commitment, there is no do it right the first time. The necessary behaviors for
strong leadership are
Integrity (does the right thing)
Exemplifies honesty and maintains trustworthiness
Exercises principled judgment, especially on the tough calls
Keeps ones word despite the consequences
Courage (takes action in the face of challenge)
Offers new ideas that question the status quo
Takes risks in championing better ideas
Demonstrates judgment and self-confidence, even in stressful
situations
Teamwork (collaborates to achieve results)
Values team members with different ideas, points of view, and
backgrounds
Acts to break down barriers and chimneys (silos) to innovative
team ideas
Demands team-oriented behavior and insists on personal
accountability for such behavior
Durability (perseveres despite hardship)
Maintains originality and creativity in staying the course to
achieve agreed upon objectives
Shows tenacity and boldness in securing and using resources
Maintains inspiration, focus, intensity, and persistence, even
under adversity
xxxiv
Introduction
Communication (exchanges information and ideas that impact and

influence others)
Listens completely, and then confidently speaks up on the issues
Provides concise, compelling, and innovative evidence to support positions
Demonstrates sensitivity to language and cultural communication requirements
Systemic thinking (sees beyond the details)
Thinks cross-functionally about ideas that impact the business
Boldly pursues ways to improve processes and incorporate new
ideas
Inspires systemic change efforts that make a difference
People development (teaches, develops, and motivates people)
Values and confidently promotes a diversity of new ideas and a
diverse workforce
Acts to enhance the creativity and professional development of
self and others
Treats everyone with fairness and respect regardless of position
or social status
Desire to serve (demonstrates personal commitment)
Seeks new ways to ensure ultimate customer enthusiasm
Determined to achieve the organizations objectives and act in
the organizations best interests.
Accepts willingly the challenge of different functional and geographical assignments
Drive for results (gets the job done)
Develops challenging, innovative objectives and accepts personal responsibility for accomplishing them
Prioritizes resources, inspires performance, and measures
outcomes
Negotiates agreements that move the business forward
Focuses on prevention rather than detection methods to
improvement
Innovation (applies learning for competitive advantage)
Demonstrates adaptability and flexibility in evaluating creative
ideas
Applies lessons learned from successes as well as failures to
inspire new ideas
Dares to dream about and implement new ways of doing business
Introduction
xxxv
Business acumen (understands the essential requirements of our

business)
Knows the organizations business operations and the global
business context in which the organization operates
Knows the basic business principles used to achieve quality, customer, and profit outcomes in a global competitive environment
Demonstrates functional and technical proficiency
Quality methods (understands what it takes to do quality work)
Shows passion for achieving quality
Measures and monitors quality on an ongoing basis
Demonstrates resolve for meeting the ultimate customers quality requirements
Hopefully, the reader will agree with our approach.

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What are some of the leadership qualities discussed in the introduction?

What are some of the leadership qualities discussed in the introduction?

What are some of the methods for achieving quality work mentioned?

What are some of the methods for achieving quality work mentioned?

Quality

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Section IOriginal Equipment Manufacturing (OEM)

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3. Manufacturing (Facility) Site Assessment (MSA).................................. 27

Section II Supplier Responsibilities

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Key Items of Concern in the CI Process...................................................... 74

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Pending Changes for the 2015 Revision.................................................... 135

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14. Internal Audits............................................................................................. 179

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Key to Successful MSA............................................................................ 253

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Analyze Results and Implement Actions............................................. 298

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LMC (L)................................................................................................. 332

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D7: Evaluating Questions........................................................................ 371

Appendix III: Mistake Proofing...................................................................... 453

Figure 5.1 Basic model of segmentation...................................................... 47

Figure 16.5 Minitab screen showing the assessment agreement for

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Figure 16.9 Selection process for crossed gauge R&R.............................. 244

Table 2.1 Summary of ISO 14001 Key Elements.......................................... 15

Table 15.8 Comparison between Defect and Mistake................................ 218

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Table18.1 Flow of PPAP Implementation.................................................... 283

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Based on 35 years of experience dealing with OEMs and suppliers this

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G. Polychronis (Chrysler), K. Shankar (Parker), M. Lutz (Kostal), A. Allen

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1. Good and fast delivery of a finished product: This implies quality

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Unfortunately, many organizations follow Option 2 or 3. How else can we

Power steering failures

These failures include automakers from United States, Germany, France,

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Communication (exchanges information and ideas that impact and

Section IOriginal Equipment Manufacturing (OEM)

Figure 16.5 Minitab screen showing the assessment agreement for