Quality Management: Theory and Application - PQM-online

1 QualityManagementTheory and ApplicationPETER D. MAUCH 2010 by Taylor and Francis Group, LLCCRC PressTaylor & Francis Group6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 2010 by Taylor and Francis Group, LLCCRC Press is an imprint of Taylor & Francis Group, an Informa businessNo claim to original Government worksPrinted in the United States of America on acid-free paper10 9 8 7 6 5 4 3 2 1 International Standard Book Number: 978-1-4398-1380-5 (Hardback)This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use.

2 The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future as permitted under Copyright Law, no part of this book may be reprinted, reproduced, trans-mitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the permission to photocopy or use material electronically from this work, please access ( )

3 Or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to of Congress Cataloging-in-Publication DataMauch, Peter D., 1954- Quality management : Theory and Application / Peter D.

4 Bibliographical references and 978-1-4398-1380-5 (hardcover : alk. paper) 1. Total Quality management . 2. Quality control. I. 013--dc22 2009042044 Visit the Taylor & Francis Web site the CRC Press Web site 2010 by Taylor and Francis Group, LLCvDedicationThis book is dedicated to those Quality professionals, past, present, and future, who seek to advance the Quality sciences through traditional education and scientific research. This book is also dedicated to my close friends and family members, who gave and did not take, built and did not destroy. Especially to my wife Julie, who believed in me.

5 2010 by Taylor and Francis Group, LLCviiEpigraphThe ThinkerBack of the beating hammerBy which the steel is wrought,Back of the workshop s clamorThe seeker may find the Thought The Thought that is ever masterOf iron and steam and steel,That rises above disasterAnd tramples it under heel!The drudge may fret and tinkerOr labor with lusty blows,But back of him stands the Thinker,The clear-eyed man who knows;For into each plow or saber,Each piece and part and whole,Must go the Brains of Labor,Which gives the work a soul!Back of the motors humming,Back of the belts that sing,Back of the hammers drumming,Back of the cranes that swing,There is the eye which scans themWatching through stress and strain,There is the Mind which plans them Back of the brawn, the Brain!

6 Might of the roaring boiler,Force of the engine s thrust,Strength of the sweating toiler Greatly in these we back of them stands the Schemer,The thinker who drives things through;Back of the Job the DreamerWho s making the dreams come true!Berton Braley 2010 by Taylor and Francis Group, LLCixContentsList of Figures ..xviiList of Tables ..xixPreface ..xxi1 Chapter 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.

7 5 Leadership Classifications ..5 Product- or Service-Producing 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 ..102 Chapter Planning for Quality ..13 Objectives ..13 Terminology ..13 Introduction ..14 Business Quality Planning ..15 Elements of an Effective Quality System ..15 2010 by Taylor and Francis Group, LLCx ContentsMarketing ..15 Setting Objectives ..15 Long- and Short-Range Objectives.

8 17 Setting Business 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.

9 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 2010 by Taylor and Francis Group, LLCC ontents xi3 Chapter Controlling for ..39 Terminology ..39 Introduction ..40 Long-Range Objectives ..40 Short-Range Objectives ..40A Cascade Approach ..41 Concerns of Control ..41 Written Reports ..42 Preparing Reports ..42 Correcting for of Value ..42 Basic Concepts ..43 Organizational Responsibility ..43 The Role of Quality management .

10 45 Introduction to Quality -Reporting Basics ..45 The Business Quality Report ..46 Underlying Concepts ..48 Activity Reporting ..49 Journalizing ..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 2010 by Taylor and Francis Group, LLCxii ContentsCorrective and Preventive Action (CAPA) Methodology.