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Quality Management System Guidelines Under the Direction of Dale Wegner, PE, Project Manager in FTA’S Office of Engineering

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Quality Management System Guidelines Under the Direction of Dale Wegner, PE, Project Manager in FTA’S Office of Engineering Prepared for: Department of Transportation Federal Transit Administration 1200 New Jersey Avenue, SE Washington, DC 20590 Prepared by: Urban Engineers, Inc. 530 Walnut Street Philadelphia, PA 19106 i Acknowledgments ............................................................................................................................................. viii List of Acronyms ................................................................................................................................................... x Bibliography ................................................................................................................................................ xiv Executive Summary ......................................................................................................................................... xvii Introduction ..................................................................................................................... 1-1 1.1 Objectives and Background .......................................................................................................... 1-1 1.2 Quality Definitions ........................................................................................................................ 1-2 1.3 A Historical Overview of Quality ................................................................................................... 1-4 1.4 Quality in the Context of Project and Construction Management ............................................... 1-5 1.5 Quality Management System (QMS) ............................................................................................ 1-5 1.5.1 Characteristics of a QMS .................................................................................................... 1-5 1.5.2 Involvement ....................................................................................................................... 1-6 1.5.3 Implementation Process .................................................................................................... 1-6 1.5.4 Tools ................................................................................................................................... 1-7 1.5.5 Root Cause Analysis ........................................................................................................... 1-8 1.6 Quality from Service Provider and User Perspectives .................................................................. 1-8 1.6.1 Product Characteristics ...................................................................................................... 1-9 1.6.2 Service Characteristics ....................................................................................................... 1-9 1.6.3 The Service Provider .......................................................................................................... 1-9 1.6.4 The User ........................................................................................................................... 1-10 1.6.5 Benefits to the Service Provider....................................................................................... 1-10 1.6.6 Benefits to the User ......................................................................................................... 1-10 1.7 Inter-relationships and Balances among Quality, Cost, and Schedule ....................................... 1-10 1.7.1 Quality Attributes or Dimensions .................................................................................... 1-10 1.7.2 Quality Costs .................................................................................................................... 1-11 1.7.3 Balancing Quality, Costs, and Schedules .......................................................................... 1-13 1.8 Barriers to Quality and Suggested Resolutions........................................................................... 1-13 1.8.1 Management Awareness ................................................................................................. 1-13 1.8.2 Cost and Schedule Concerns ............................................................................................ 1-13 1.8.3 Resistance to Change ....................................................................................................... 1-14 1.8.4 Lack of Training ................................................................................................................ 1-14 1.9 How to Use These Guidelines ..................................................................................................... 1-14 ii Essential Elements of a Quality Management System ....................................... 2-1 2.1 Background ................................................................................................................................... 2-2 2.2 The Fifteen Elements of a Quality Program .................................................................................. 2-5 2.2.1 Element 1: Management Responsibility ............................................................................ 2-5 2.2.2 Element 2: Documented Quality Management System .................................................... 2-7 2.2.3 Element 3: Design Control ................................................................................................. 2-7 2.2.4 Element 4: Document Control ........................................................................................... 2-9 2.2.5 Element 5: Purchasing...................................................................................................... 2-11 2.2.6 Element 6: Product Identification and Traceability ......................................................... 2-13 2.2.7 Element 7: Process Control .............................................................................................. 2-14 2.2.8 Element 8: Inspection and Testing ................................................................................... 2-14 2.2.9 Element 9: Inspection, Measuring, and Test Equipment ................................................. 2-16 2.2.10 Element 10: Inspection and Test Status ........................................................................... 2-17 2.2.11 Element 11: Nonconformance ......................................................................................... 2-17 2.2.12 Element 12: Corrective Action ......................................................................................... 2-18 2.2.13 Element 13: Quality Records ............................................................................................ 2-19 2.2.14 Element 14: Quality Audits .............................................................................................. 2-20 2.2.15 Element 15: Training ........................................................................................................ 2-21 Organization of a Quality Management System ................................................... 3-1 3.1 General Principles ......................................................................................................................... 3-1 3.2 Project Management Plan ............................................................................................................ 3-3 3.3 Alternative Organizational Structures .......................................................................................... 3-3 3.4 Quality Program for Construction with a Project/Construction Management Consultant .......... 3-4 3.4.1 Quality Program with In-house Construction Management.................................................. 3-5 3.4.2 Quality in Design .................................................................................................................... 3-7 3.4.3 Quality for Small Projects ....................................................................................................... 3-8 3.4.4 Quality in Equipment Procurement ....................................................................................... 3-9 3.4.5 Quality in Design-Build Projects ............................................................................................. 3-9 3.5 Independent Assurance Program ............................................................................................... 3-12 3.5.1 Description ........................................................................................................................... 3-12 3.5.2 Advantages and Disadvantages of an Independent Assurance Program ............................ 3-12 3.5.3 Methods of Control .............................................................................................................. 3-13 iii 3.6 Test Lab Accreditation and Quality Personnel Qualifications ..................................................... 3-13 3.6.1 Test Lab Accreditation ......................................................................................................... 3-13 3.6.2 Accreditation Agencies ........................................................................................................ 3-13 3.5.2.1 American Association for Laboratory Accreditation (A2LA) ................................................ 3-14 3.5.2.2 National Voluntary Laboratory Accreditation Program (NVLAP) ......................................... 3-14 3.6.3 Quality Personnel Qualifications .......................................................................................... 3-15 3.6.4 Software Quality Assurance (SQA) ......................................................................................
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