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

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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