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List of Figures | p. xvii |
List of Tables | p. xix |
Preface | p. xxi |
Organizing for Quality | p. 1 |
Objectives | p. 1 |
Terminology | p. 1 |
Introduction | p. 2 |
Categorizing Duties | p. 2 |
Leadership | p. 3 |
Product or Service Producing | p. 3 |
Support | p. 4 |
Incongruence | p. 4 |
Breaking Categories into Classifications | p. 5 |
Leadership Classifications | p. 5 |
Product-or Service-Producing Classifications | p. 5 |
Support Classifications | p. 6 |
Basic Functional Structure | p. 6 |
Quality Function Considerations | p. 7 |
Authority, Accountability, and Responsibility | p. 8 |
Authority Principles | p. 9 |
Revise and Adjust | p. 9 |
Communication | p. 10 |
Summary | p. 10 |
Review Questions | p. 10 |
Planning for Quality | p. 13 |
Objectives | p. 13 |
Terminology | p. 13 |
Introduction | p. 14 |
Business Quality Planning | p. 15 |
Elements of an Effective Quality System | p. 15 |
Marketing | p. 15 |
Setting Objectives | p. 15 |
Long-and Short-Range Objectives | p. 17 |
Setting Business Metrics | p. 19 |
Process Quality Planning | p. 19 |
General Information | p. 20 |
Details | p. 20 |
Failure Modes | p. 21 |
Control | p. 22 |
Project Planning | p. 24 |
General Information | p. 24 |
Status Reporting | p. 26 |
Detail | p. 26 |
Product Quality Planning | p. 26 |
General Information | p. 26 |
Detail | p. 27 |
Product Verification and Validation Planning | p. 28 |
Responsibility and Interfaces | p. 28 |
Information Accessibility | p. 28 |
Files and Records | p. 29 |
Validation Facilities | p. 29 |
Validation Personnel | p. 30 |
Validation Procedures | p. 30 |
Scheduling and Revising Validation Plans | p. 30 |
Policies, Procedures, and Objectives | p. 30 |
Policies | p. 31 |
Procedures and Rules | p. 32 |
Forms and Records | p. 32 |
Blueprints (Product Specifications) | p. 33 |
Process Flowcharting | p. 33 |
Standardization of Symbols | p. 35 |
Normal Logic Flow | p. 35 |
Process Flow | p. 35 |
Communication | p. 36 |
Summary | p. 36 |
Review Questions | p. 37 |
Controlling for Quality | p. 39 |
Objectives | p. 39 |
Terminology | p. 39 |
Introduction | p. 40 |
Long-Range Objectives | p. 40 |
Short-Range Objectives | p. 40 |
A Cascade Approach | p. 41 |
Concerns of Control | p. 41 |
Written Reports | p. 42 |
Preparing Reports | p. 42 |
Correcting for Deviations | p. 42 |
Importance of Value | p. 42 |
Basic Concepts | p. 43 |
Organizational Responsibility | p. 43 |
The Role of Quality Management | p. 45 |
Introduction to Quality-Reporting Basics | p. 45 |
The Business Quality Report | p. 46 |
Underlying Concepts | p. 48 |
Activity Reporting | p. 49 |
Journalizing Procedure | p. 51 |
Posting | p. 54 |
Product Performance Reporting | p. 55 |
Analysis | p. 56 |
Ranked Order Analysis | p. 56 |
Fishbone Diagram | p. 57 |
Controlling Nonconformance Identification | p. 58 |
Identification during Work | p. 58 |
Completion of Work | p. 58 |
Inspection | p. 58 |
Identification of Nonconforming Product | p. 58 |
Segregation | p. 58 |
Short-Run Production | p. 58 |
Long-Run Production | p. 59 |
Risk | p. 59 |
Disposition | p. 59 |
Responsibilities for Disposition | p. 59 |
Corrective and Preventive Action (CAPA) Methodology | p. 60 |
Immediate Action Required | p. 60 |
Magnitude of the Nonconformity | p. 60 |
CAPA Methodology | p. 60 |
Summary | p. 61 |
Review Questions | p. 62 |
Staffing for Quality | p. 63 |
Objectives | p. 63 |
Terminology | p. 63 |
Forecasting Human Resources Needs | p. 64 |
Job Descriptions | p. 67 |
Job Analysis | p. 67 |
Methods | p. 68 |
Results | p. 69 |
Position Requirement | p. 69 |
Education and Training | p. 70 |
Systems of Formal Education | p. 70 |
Primary Education | p. 70 |
Secondary Education | p. 71 |
Higher Education | p. 71 |
Adult Education | p. 72 |
Alternative Education | p. 72 |
Training | p. 73 |
Training Records | p. 74 |
Summary | p. 76 |
Review Questions | p. 76 |
Motivating for Quality | p. 77 |
Objectives | p. 77 |
Terminology | p. 77 |
Lead, Coach, and Guide | p. 78 |
Leadership Styles | p. 81 |
Autocratic | p. 81 |
Paternalistic | p. 81 |
Democratic | p. 82 |
Laissez-Faire | p. 82 |
Rewards Based upon Performance | p. 82 |
Praise and Censure Fairly | p. 83 |
Performance Appraisals | p. 83 |
Provide a Motivating Environment | p. 85 |
Deficiency Needs | p. 85 |
Physiological Needs | p. 85 |
Safety Needs | p. 86 |
Social Needs | p. 87 |
Esteem Needs | p. 87 |
Self-Actualization | p. 88 |
Summary | p. 90 |
Review Questions | p. 91 |
Special Topics in Quality | p. 93 |
Overview of Statistical Methods | p. 93 |
History | p. 93 |
Overview | p. 94 |
Statistical Methods | p. 95 |
Experimental and Observational Studies | p. 95 |
Levels of Measurement | p. 97 |
History of SPC | p. 102 |
General | p. 102 |
Risk Analysis | p. 106 |
Risk Analysis and the Risk Workshop | p. 107 |
Facilitated Risk Analysis Process | p. 109 |
Reliability Engineering | p. 110 |
Reliability Theory | p. 110 |
Reliability Program Plan | p. 111 |
Reliability Requirements | p. 111 |
System Reliability Parameters | p. 112 |
Reliability Modeling | p. 112 |
Reliability Test Requirements | p. 113 |
Requirements for Reliability Tasks | p. 114 |
Design for Reliability | p. 115 |
Fault Tree Diagrams | p. 115 |
Reliability Testing | p. 116 |
A Reliability Sequential Test Plan | p. 116 |
Accelerated Testing | p. 118 |
Software Reliability | p. 118 |
Reliability Operational Assessment | p. 120 |
Reliability Organizations | p. 121 |
Certification | p. 121 |
Reliability Engineering Education | p. 122 |
Systems Analysis | p. 122 |
Characterization of Systems | p. 122 |
LTI Systems | p. 125 |
Auditing | p. 125 |
Audit Planning and Scheduling | p. 126 |
Auditor Education and Training | p. 126 |
Audit Initiation | p. 126 |
Audit Scope | p. 126 |
Audit Objective | p. 126 |
Frequency and Timing | p. 128 |
Long-Term Planning | p. 128 |
Pre-Audit Review of System | p. 128 |
Working Papers | p. 128 |
Result | p. 128 |
Sampling Plans | p. 128 |
Audit Implementation Steps | p. 130 |
Notification to Auditee | p. 131 |
Opening Meeting | p. 131 |
Information, Verification, and Evaluation | p. 131 |
Audit Observations | p. 131 |
Audit Supervision | p. 132 |
Audit Follow-Up | p. 132 |
Preparation of the Report | p. 132 |
Content of the Report | p. 132 |
Reporting the Audit | p. 132 |
Review and Distribution | p. 132 |
Audit Completion | p. 133 |
Record Retention | p. 133 |
Cost of Quality | p. 133 |
Origins | p. 134 |
Business Quality Plan | p. 137 |
Process Quality Plan | p. 139 |
Product Quality Plan | p. 141 |
Bibliography | p. 143 |
Index | p. 145 |
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