vii
Contents
List of Figures ..................................................................................................... xvii
List of Tables ........................................................................................................ xix
Preface ................................................................................................................... xxi
Acknowledgments ...........................................................................................xxvii
Author ................................................................................................................. xxix
Introduction ....................................................................................................... xxxi
Section I Original 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-Specic Standards .....................13
Certication to ISO 9001 ..........................................................................13
Annex A: Control Plan Requirements............................................... 14
Certication to ISO 14001 .........................................................................15
Certication to Industry Standards........................................................15
Customer-Specic 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
viii 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 Nonqualied Facility ..............................44
5. Segmentation .................................................................................................45
Overview .........................................................................................................45
Segmentation Denition ............................................................................... 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
Benets of Supplier Development ...............................................................54
References .......................................................................................................55
7. Role of Supplier Technical Engineer ........................................................57
Overview .........................................................................................................57
Specic Responsibilities of the Stakeholders ............................................. 58
Specic 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
ixContents
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
Selected Bibliography .................................................................................. 114
10. Quality Operating System (QOS) ........................................................... 115
Overview ....................................................................................................... 115
Quality Operating System .......................................................................... 117
QOS Implementation ...................................................................................122
QOS Meeting Summary .............................................................................122
Selected Bibliography .................................................................................. 126
11. Certication to the International Standard and Customer-
Specic Requirements ...............................................................................127
Overview ....................................................................................................... 127
ISO’s Key Elements ...................................................................................... 129
Individual Certiable 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
x Contents
Pending Changes for the 2015 Revision ...................................................135
References .....................................................................................................136
Selected Bibliography ..................................................................................137
12. Statistical Process Control (SPC) ............................................................. 139
Overview ....................................................................................................... 139
Model of SPC ................................................................................................139
Step 1. Identify and Dene the Process ............................................... 141
Step 2. Establish Process Ownership and Responsibilities............... 141
Step 3. Dene and Establish Process Controls .................................... 144
Step 4. Continuously Improve Process Performance ......................... 146
SPC and Six Sigma ....................................................................................... 148
References ..................................................................................................... 149
Selected Bibliography .................................................................................. 150
13. Problem-Solving Methodology ............................................................... 151
Overview ....................................................................................................... 151
Denition 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 Specications ............ 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
Selected Bibliography .................................................................................. 177
xiContents
14. Internal Audits ............................................................................................ 179
Overview ....................................................................................................... 179
Types of Audits ............................................................................................ 180
Performing an Audit ................................................................................... 182
Product Audit .......................................................................................... 183
Process Audit ...........................................................................................184
Layered Audit ..........................................................................................188
Error-Proong Audit .............................................................................. 193
General Comments about the Audits ....................................................... 193
References ..................................................................................................... 196
Selected Bibliography ..................................................................................197
15. Poka-Yoke ..................................................................................................... 199
Overview ....................................................................................................... 199
Historical Perspective ..................................................................................199
Strategy of Mistake Proong ......................................................................200
Mistake-Proof Systems ................................................................................202
Essentials of Poka-Yoke ............................................................................... 204
Zero Defect Concept in Mistake Proong ................................................ 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
Selected Bibliography .................................................................................. 226
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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