00378i by CRBD-Biblioteca Digital

Contents List of Figures......................................................................................xvii List of Tables.........................................................................................xix Preface...................................................................................................xxi Chapter 1 Organizing for Quality....................................................... 1 Objectives......................................................................................1 Terminology..................................................................................1 Introduction..................................................................................2 Categorizing Duties.....................................................................2 Leadership.................................................................................3 Product or Service Producing................................................3 Support......................................................................................4 Incongruence............................................................................4 Breaking Categories into Classifications...................................5 Leadership Classifications......................................................5 Product- or Service-Producing Classifications...................5 Support Classifications...........................................................6 Basic Functional Structure..........................................................6 Quality Function Considerations..........................................7 Authority, Accountability, and Responsibility.........................8 Authority Principles.....................................................................9 Revise and Adjust.........................................................................9 Communication..........................................................................10 Summary.....................................................................................10 Review Questions.......................................................................10 Chapter 2 Planning for Quality......................................................... 13 Objectives....................................................................................13 Terminology................................................................................13 Introduction................................................................................14 Business Quality Planning........................................................15 Elements of an Effective Quality System............................15 ix ÂŠ 2010 by Taylor and Francis Group, LLC

x • Contents Marketing...............................................................................15 Setting Objectives..................................................................15 Long- and Short-Range Objectives.....................................17 Setting Business Metrics...........................................................19 Process Quality Planning..........................................................19 General Information............................................................ 20 Details.................................................................................... 20 Failure Modes.........................................................................21 Control....................................................................................22 Project Planning.........................................................................24 General Information.............................................................24 Status Reporting....................................................................26 Detail.......................................................................................26 Product Quality Planning.........................................................26 General Information.............................................................26 Detail.......................................................................................27 Product Verification and Validation Planning...................... 28 Responsibility and Interfaces.............................................. 28 Information Accessibility.................................................... 28 Files and Records...................................................................29 Validation Facilities...............................................................29 Validation Personnel............................................................ 30 Validation Procedures.......................................................... 30 Scheduling and Revising Validation Plans....................... 30 Policies, Procedures, and Objectives...................................... 30 Policies.....................................................................................31 Procedures and Rules............................................................32 Forms and Records.....................................................................32 Blueprints (Product Specifications).........................................33 Process Flowcharting.................................................................33 Standardization of Symbols.................................................35 Normal Logic Flow................................................................35 Process Flow...........................................................................35 Communication..........................................................................36 Summary.....................................................................................36 Review Questions.......................................................................37

Contents • xi Chapter 3 Controlling for Quality.................................................... 39 Objectives....................................................................................39 Terminology................................................................................39 Introduction............................................................................... 40 Long-Range Objectives........................................................ 40 Short-Range Objectives........................................................ 40 A Cascade Approach.............................................................41 Concerns of Control..............................................................41 Written Reports.................................................................... 42 Preparing Reports................................................................. 42 Correcting for Deviations................................................... 42 Importance of Value............................................................. 42 Basic Concepts........................................................................... 43 Organizational Responsibility................................................. 43 The Role of Quality Management............................................45 Introduction to Quality-Reporting Basics..............................45 The Business Quality Report................................................... 46 Underlying Concepts................................................................ 48 Activity Reporting......................................................................49 Journalizing Procedure.............................................................51 Posting........................................................................................ 54 Product Performance Reporting..............................................55 Analysis....................................................................................... 56 Ranked Order Analysis........................................................ 56 Fishbone Diagram.................................................................57 Controlling Nonconformance Identification.........................58 Identification during Work..................................................58 Completion of Work..............................................................58 Inspection...............................................................................58 Identification of Nonconforming Product.........................58 Segregation..................................................................................58 Short-Run Production...........................................................58 Long-Run Production...........................................................59 Risk..........................................................................................59 Disposition..................................................................................59 Responsibilities for Disposition...........................................59

xii • Contents Corrective and Preventive Action (CAPA) Methodology... 60 Immediate Action Required............................................... 60 Magnitude of the Nonconformity...................................... 60 CAPA Methodology............................................................. 60 Summary.....................................................................................61 Review Questions.......................................................................62 Chapter 4 Staffing for Quality........................................................... 63 Objectives....................................................................................63 Terminology................................................................................63 Forecasting Human Resources Needs.................................... 64 Job Descriptions.........................................................................67 Job Analysis............................................................................67 Methods............................................................................. 68 Results.................................................................................69 Position Requirement............................................................69 Education and Training.............................................................70 Systems of Formal Education...............................................70 Primary Education...........................................................70 Secondary Education........................................................71 Higher Education..............................................................71 Adult Education................................................................72 Alternative Education......................................................72 Training.......................................................................................73 Training Records...................................................................74 Summary.....................................................................................76 Review Questions.......................................................................76 Chapter 5 Motivating for Quality...................................................... 77 Objectives....................................................................................77 Terminology................................................................................77 Lead, Coach, and Guide............................................................78 Leadership Styles...................................................................81 Autocratic...........................................................................81 Paternalistic.......................................................................81 Democratic........................................................................82

Contents • xiii Laissez-Faire......................................................................82 Rewards Based upon Performance..........................................82 Praise and Censure Fairly.........................................................83 Performance Appraisals.......................................................83 Provide a Motivating Environment.........................................85 Deficiency Needs...................................................................85 Physiological Needs...............................................................85 Safety Needs.......................................................................... 86 Social Needs...........................................................................87 Esteem Needs.........................................................................87 Self-Actualization................................................................. 88 Summary.................................................................................... 90 Review Questions.......................................................................91 Chapter 6 Special Topics in Quality.................................................. 93 Overview of Statistical Methods..............................................93 History....................................................................................93 Overview.................................................................................94 Statistical Methods................................................................95 Experimental and Observational Studies......................95 Levels of Measurement.....................................................97 History of SPC......................................................................102 General..................................................................................102 Risk Analysis.............................................................................106 Risk Analysis and the Risk Workshop.............................107 Facilitated Risk Analysis Process......................................109 Reliability Engineering............................................................110 Reliability Theory................................................................110 Reliability Program Plan....................................................111 Reliability Requirements....................................................111 System Reliability Parameters.......................................112 Reliability Modeling............................................................112 Reliability Test Requirements............................................113 Requirements for Reliability Tasks...................................114 Design for Reliability..........................................................115 Fault Tree Diagrams............................................................115 Reliability Testing................................................................116

xiv • Contents A Reliability Sequential Test Plan.................................116 Accelerated Testing.............................................................118 Software Reliability.............................................................118 Reliability Operational Assessment................................. 120 Reliability Organizations....................................................121 Certification.....................................................................121 Reliability Engineering Education................................... 122 Systems Analysis...................................................................... 122 Characterization of Systems.............................................. 122 LTI Systems...........................................................................125 Auditing.....................................................................................125 Audit Planning and Scheduling....................................... 126 Auditor Education and Training................................. 126 Audit Initiation.............................................................. 126 Audit Scope..................................................................... 126 Audit Objective.............................................................. 126 Frequency and Timing.................................................. 128 Long-Term Planning..................................................... 128 Pre-Audit Review of System......................................... 128 Working Papers.............................................................. 128 Result.................................................................................... 128 Sampling Plans............................................................... 128 Audit Implementation Steps..........................................130 Notification to Auditee..................................................131 Opening Meeting............................................................131 Information, Verification, and Evaluation..................131 Audit Observations.........................................................131 Audit Supervision...........................................................132 Audit Follow-Up.............................................................132 Preparation of the Report..............................................132 Content of the Report.....................................................132 Reporting the Audit............................................................132 Review and Distribution................................................132 Audit Completion...........................................................133 Record Retention............................................................133 Cost of Quality..........................................................................133 Origins................................................................................. 134

Contents • xv Appendix A: Business Quality Plan................................................... 137 Appendix B: Process Quality Plan..................................................... 139 Appendix C: Product Quality Plan.................................................... 141 Bibliography......................................................................................... 143