Quality Management: Theory and Application

In the past, when goods and services were simpler, measurement of quality was self-evident. As business became more complicated, so too did the implementation of quality management and our ability to measure it. Ultimately, the practice of quality strayed from being a business practice to become much more of an engineering discipline producing plenty of data, but little actual improvement.

In Quality Management: Theory and Application, highly respected quality management specialist Peter Mauch shows you how to set up a Quality Management System (QMS) that will stay aligned with your business goals. Using examples from actual situations that can be readily applied in any industrial situation, these pages will show you how to:

• Plan for quality by setting objectives and metrics, and creating effective flexible blueprints, and procedures
• Get staff involved by understanding how to motivate and train them
• Establish responsibility and accountability across your entire organization
• Create the right reporting mechanisms and learn how to analyze them
• Understand the value and particulars of certification

QMS is a performance-reporting system designed to accumulate and report data useful for the achievement of management’s objectives. Combining the technical aspects of quality engineering with successful business management practices, this book will teach you that quality is an ongoing practice, and that it must be implemented throughout an organization rather than stand as the responsibility of one department. Ultimately, through this system, you will align individual departments to continuously maximize quality throughout your entire organization.

Table of Contents

Organizing for Quality
Objectives
Terminology
Introduction
Categorizing Duties
Leadership
Product or Service Producing
Support
Incongruence
Breaking Categories into Classifications
Leadership Classifications
Product- or Service-Producing Classifications
Support Classifications
Basic Functional Structure
Quality Function Considerations
Authority, Accountability, and Responsibility
Authority Principles
Revise and Adjust
Communication
Summary
Review Questions

Planning for Quality
Objectives
Terminology
Introduction
Business Quality Planning
Elements of an Effective Quality System
Marketing
Setting Objectives
Long- and Short-Range Objectives
Setting Business Metrics
Process Quality Planning
General Information
Details
Failure Modes
Control
Project Planning
General Information
Status Reporting
Detail
Product Quality Planning
General Information
Detail
Product Verification and Validation Planning
Responsibility and Interfaces
Information Accessibility
Files and Records
Validation Facilities
Validation Personnel
Validation Procedures
Scheduling and Revising Validation Plans
Policies, Procedures, and Objectives
Policies
Procedures and Rules
Forms and Records
Blueprints (Product Specifications)
Process Flowcharting
Standardization of Symbols
Normal Logic Flow
Process Flow
Communication
Summary
Review Questions

Controlling for Quality
Objectives
Terminology
Introduction
Long-Range Objectives
Short-Range Objectives
A Cascade Approach
Concerns of Control
Written Reports
Preparing Reports
Correcting for Deviations
Importance of Value
Basic Concepts
Organizational Responsibility
The Role of Quality Management
Introduction to Quality-Reporting Basics
The Business Quality Report
Underlying Concepts
Activity Reporting
Journalizing Procedure
Posting
Product Performance Reporting
Analysis
Ranked Order Analysis
Fishbone Diagram
Controlling Nonconformance Identification
Identification during Work
Completion of Work
Inspection
Identification of Nonconforming Product
Segregation
Short-Run Production
Long-Run Production
Risk
Disposition
Responsibilities for Disposition
Corrective and Preventive Action (CAPA) Methodology
Immediate Action Required
Magnitude of the Nonconformity
CAPA Methodology
Summary
Review Questions

Staffing for Quality
Objectives
Terminology
Forecasting Human Resources Needs
Job Descriptions
Job Analysis
Methods
Results
Position Requirement
Education and Training
Systems of Formal Education
Primary Education
Secondary Education
Higher Education
Adult Education
Alternative Education
Training
Training Records
Summary
Review Questions

Motivating for Quality
Objectives
Terminology
Lead, Coach, and Guide
Leadership Styles
Autocratic
Paternalistic
Democratic
Laissez-Faire
Rewards Based upon Performance
Praise and Censure Fairly
Performance Appraisals
Provide a Motivating Environment
Deficiency Needs
Physiological Needs
Safety Needs
Social Needs
Esteem Needs
Self-Actualization
Summary
Review Questions

Special Topics in Quality
Overview of Statistical Methods
History
Overview
Statistical Methods
Experimental and Observational Studies
Levels of Measurement
History of SPC
General
Risk Analysis
Risk Analysis and the Risk Workshop
Facilitated Risk Analysis Process
Reliability Engineering
Reliability Theory
Reliability Program Plan
Reliability Requirements
System Reliability Parameters
Reliability Modeling
Reliability Test Requirements
Requirements for Reliability Tasks
Design for Reliability
Fault Tree Diagrams
Reliability Testing
A Reliability Sequential Test Plan
Accelerated Testing
Software Reliability
Reliability Operational Assessment 1
Reliability Organizations
Certification
Reliability Engineering Education 1
Systems Analysis. 1
Characterization of Systems. 1
LTI Systems
Auditing
Audit Planning and Scheduling 1
Auditor Education and Training 1
Audit Initiation 1
Audit Scope 1
Audit Objective 1
Frequency and Timing 1
Long-Term Planning 1
Pre-Audit Review of System 1
Working Papers 1
Result 1
Sampling Plans 1
Audit Implementation Steps
Notification to Auditee
Opening Meeting
Information, Verification, and Evaluation
Audit Observations
Audit Supervision
Audit Follow-Up
Preparation of the Report
Content of the Report
Reporting the Audit
Review and Distribution
Audit Completion
Record Retention
Cost of Quality
Origins 1

Appendix A: Business Quality Plan 1
Appendix B: Process Quality Plan 1
Appendix C: Product Quality Plan. 1

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