Quality Assurance Applying Methodologies for Launching New Products, Services, and Customer Satisfaction Quality Assurance Applying Methodologies for Launching New Products, Services, and Customer Satisfaction D. H. Stamatis CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2016 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20150305 International Standard Book Number-13: 978-1-4987-2870-6 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. 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Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com To my friend Αθανασιον Καλοζουμη (Thanasi) 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-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 vii 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 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 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. Certification to the International Standard and Customer- Specific Requirements ...............................................................................127 Overview .......................................................................................................127 ISO’s 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 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 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 Selected Bibliography ..................................................................................150 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 Selected Bibliography ..................................................................................177