1356_Cianfrani.indd i Cracking the Case of ISO 9001:2008 for Service 11/11/09 12:59:46 PM 1356_Cianfrani.indd ii 11/11/09 12:59:47 PM Also available from ASQ Quality Press: ISO 9001:2008 Explained, Third Edition Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals ISO 9001:2008 Explained, Third Edition (Spanish) Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals Cracking the Case of ISO 9001:2008 for Manufacturing John E (Jack) West and Charles A Cianfrani The ASQ ISO 9000:2000 Handbook Charles A Cianfrani, John E (Jack) West, and Joseph J Tsiakals ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step Guidelines for Successful Internal Audits, Second Edition Ann W Phillips How to Audit the Process-Based QMS Dennis R Arter, John E (Jack) West, and Charles A Cianfrani Unlocking the Power of Your QMS: Keys to Business Performance Improvement John E (Jack) West and Charles A Cianfrani The ASQ Auditing Handbook, Third Edition J.P Russell, editing director Quality Audits for Improved Performance, Third Edition Dennis R Arter The Quality Toolbox, Second Edition Nancy R Tague Mapping Work Processes, Second Edition Bjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E Onsøyen Lean Kaizen: A Simplified Approach to Process Improvements George Alukal and Anthony Manos Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T Westcott, editor To request a complimentary catalog of ASQ Quality Press publications, call 800-2481946, or visit our Web site at http://www.asq.org/quality-press 1356_Cianfrani.indd iii 11/11/09 12:59:47 PM 1356_Cianfrani.indd iv 11/11/09 12:59:47 PM 1356_Cianfrani.indd v Cracking the Case of ISO 9001:2008 for Service A Simple Guide to Implementing Quality Management in Service Organizations Second Edition Charles A Cianfrani and John E (Jack) West ASQ Quality Press Milwaukee, Wisconsin 11/11/09 12:59:47 PM American Society for Quality, Quality Press, Milwaukee 53203 © 2010 by American Society for Quality All rights reserved Published 2009 Printed in the United States of America 12 11 10 09 08 07 06 Library of Congress Cataloging-in-Publication Data Cianfrani, Charles A Cracking the case of ISO 9001:2008 for service : a simple guide to implementing quality management in service organizations / Charles A Cianfrani and John E (Jack) West — 2nd ed p cm Originally published under title: Cracking the case of ISO 9001:2000 for service Includes bibliographical references and index ISBN 978-0-87389-762-4 (alk paper) Quality control—Standards ISO 9001 Standard I West, Jack, 1944– II Cianfrani, Charles A Cracking the case of ISO 9001:2000 for service III Title TS156.C73 2009 658.4’013—dc22 2009043600 No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher Publisher: William A Tony Project Editor: Paul O’Mara Acquisitions Editor: Matt Meinholz Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, videotapes, audiotapes, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O Box 3005, Milwaukee, WI 53201-3005 To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, including ASQ membership information, call 800-248-1946 Visit our Web site at www asq.org or http://www.asq.org/quality-press 1356_Cianfrani.indd vi Printed on acid-free paper 11/11/09 12:59:47 PM Contents Chapter Why Do ISO 9001:2008? Chapter Principles and Key Concepts Quality Management Principles Customers—Customer Focus and Measuring Satisfaction Process Approach—Activities, Process Management, and the System Approach to Management Alignment—Quality Objectives, Process Measurement, and Communications Continual Improvement Process Control to Facilitate Learning, Innovation, and Improvement Leadership and Involvement at All Levels 5 14 15 Chapter Implementing ISO 9001:2008 Introduction Changes in ISO 9001:2008 from ISO 9001:2000 Scope 1.1 General 1.2 Application Normative Reference Terms and Definitions 17 17 18 21 21 21 23 23 1356_Cianfrani.indd vii 12 13 vii 11/11/09 12:59:47 PM viii Contents 4.1 General Requirements 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness and Training 6.3 Infrastructure 6.4 Work Environment 7.1 Planning of Product Realization 7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 1356_Cianfrani.indd viii 24 27 27 29 30 32 35 38 39 41 43 45 46 48 50 50 52 54 56 58 58 60 62 63 65 68 70 73 74 74 76 79 11/11/09 12:59:47 PM Contents ix 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring Devices Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action 81 83 85 87 88 90 92 94 98 100 102 104 106 111 111 114 114 117 121 123 126 129 132 132 133 136 Chapter Tools Tools Discussed in This Section Tool 1: Flowchart Tool 2: Process Mapping Tool 3: Brainstorming 139 139 140 144 148 1356_Cianfrani.indd ix 11/11/09 12:59:47 PM x Contents Tool 4: Gantt Chart Tool 5: Run or Trend Chart Tool 6: Histogram Tool 7: Pareto Chart Tool 8: Failure Modes and Effects Analysis Tool 9: Sampling Inspection Tool 10: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram) Tool 11: Problem Solving Tool 12: How to Conduct an Improvement Project 150 153 156 160 162 165 172 176 178 Glossary 183 Additional Reading 199 Index 201 1356_Cianfrani.indd x 11/11/09 12:59:47 PM 190 Glossary P Pareto chart: a basic tool used to graphically rank causes from most significant to least significant It utilizes a vertical bar graph in which the bar height reflects the frequency or impact of causes plan-do-check-act (PDCA) cycle: a four-step process for quality improvement In the first step (plan), a plan to effect improvement is developed In the second step (do), the plan is carried out, preferably on a small scale In the third step (check), the effects of the plan are observed In the last step (act), the results are studied to determine what was learned and what can be predicted The plan-docheck-act cycle is sometimes referred to as the Shewhart cycle because Walter A Shewhart discussed the concept in his book Statistical Method from the Viewpoint of Quality Control and as the Deming cycle because W Edwards Deming introduced the concept in Japan The Japanese subsequently called it the Deming cycle ppm: parts per million preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation problem solving: a rational process for identifying, describing, analyzing, and resolving undesirable situations procedure: specified way to carry out an activity or a process process: set of interrelated or interacting activities which transforms inputs into outputs 1356_Cianfrani.indd 190 11/11/09 12:59:57 PM Glossary 191 process management: the collection of practices used to implement and improve process effectiveness; it focuses on holding the gains achieved through process improvement and ensuring process integrity process mapping: the flowcharting of a work process in detail, including key measurements process owner: the manager or leader responsible for ensuring that the total process is effective and efficient product: result of a process Q quality: degree to which a set of inherent characteristics fulfills requirements quality council: (sometimes called “quality steering committee”) the group driving the quality improvement effort and usually having oversight responsibility for the implementation and maintenance of the quality management system quality function deployment (QFD): a structured method in which customer requirements are translated into appropriate technical requirements for each stage of product development and production The quality function deployment process is often referred to as listening to the voice of the customer quality loop: conceptual model of interacting activities that influence quality at the various stages ranging from the identification of needs to the assessment of whether those needs are satisfied 1356_Cianfrani.indd 191 11/11/09 12:59:57 PM 192 Glossary quality management system: management system to direct and control an organization with regard to quality quality manual: document specifying the quality management system of an organization quality objective: something sought, or aimed for, related to quality quality plan: the document setting out the specific quality practices, resources, and sequence of activities relevant to a particular product, project, or contract quality policy: overall intentions and direction of an organization related to quality as formally expressed by top management R radar chart: a visual method to show in graphic form the size of gaps among a number of current organization performance areas and ideal performance areas; the resulting chart resembles a radar screen range: measure of dispersion; highest value minus lowest value record: document stating results achieved or providing evidence of activities performed reengineering: completely redesigning or restructuring a whole organization, an organizational component, or a complete process It’s a “start over from the beginning” approach, sometimes called a “breakthrough.” In terms of improvement approaches, reengineering is contrasted with incremental improvement (kaizen) 1356_Cianfrani.indd 192 11/11/09 12:59:57 PM Glossary 193 Registrar Accreditation Board (RAB) U.S.: an organization that evaluates the competency and reliability of registrars (organizations that assess and register companies to ISO 9001) registration to standards: a process in which an accredited, independent third-party organization conducts an on-site audit of a company’s operations against the requirements of the standard to which the company wants to be registered Upon successful completion of the audit, the company receives a certificate indicating that it has met the standard requirements repeatability and reproducibility (R&R): a measurement validation process to determine how much variation exists in the measurement system (including the gage used to measure and the individuals using the gage) requirement: need or expectation that is stated, generally implied or obligatory risk assessment/management: the process of determining what risks are present in a situation (for example, project plan) and what actions might be taken to eliminate or mediate them root cause analysis: a quality tool used to distinguish the source of defects or problems It is a structured approach that focuses on the decisive or original cause of a problem or condition run chart: a line graph showing data collected during a run or an uninterrupted sequence of events A trend is indicated when the series of collected data points head up or down 1356_Cianfrani.indd 193 11/11/09 12:59:57 PM 194 Glossary S self-assessment: a carefully considered evaluation resulting in an opinion or judgment of the effectiveness and efficiency of the organization and the maturity of the quality management system (see ISO 9004:2000 annex A) seven basic tools of quality: tools that help organizations understand their processes in order to improve them The tools are the cause-and-effect diagram, check sheet, control chart, flowchart, histogram, Pareto chart, and scatter diagram seven management tools of quality: the tools used primarily for planning and managing are activity network diagram (AND) or arrow diagram, affinity diagram (KJ method), interrelationship digraph, matrix diagram, priorities matrix, process decision program chart (PDPC), and tree diagram Six Sigma approach: a quality philosophy; a collection of techniques and tools for use in reducing variation; a program of improvement Six Sigma quality: a term used generally to indicate that a process is well controlled, that is, process limits ±3 sigma from the centerline in a control chart, and requirements/ tolerance limits ±6 sigma from the centerline The term was initiated by Motorola statistical process control (SPC): the application of statistical techniques to control a process 1356_Cianfrani.indd 194 11/11/09 12:59:57 PM Glossary 195 statistical thinking: a philosophy of learning and action based on fundamental principles: • All work occurs in a system of interconnected processes • Variation exists in all processes • Understanding and reducing variation is vital to improvement strategic planning: a process to set an organization’s longrange goals and identify the actions needed to reach the goals supplier: organization or person that provides a product system: set of interrelated or interacting elements T team: a number of people with complementary skills who are committed to a common purpose technical expert: (audit) person who provides specific knowledge or expertise to the audit team TL 9000: handbooks pertaining to the quality management system for telecommunication suppliers; ISO 9001 is embedded in TL 9000 tolerance: the variability of a parameter permitted and tolerated above or below a nominal value top management: person or group of people who directs and controls an organization at the highest level 1356_Cianfrani.indd 195 11/11/09 12:59:57 PM 196 Glossary total quality management (TQM): a term initially coined by the Naval Air Systems Command to describe its management approach to quality improvement Total quality management (TQM) has taken on many meanings Simply put, total quality management is a management approach to longterm success through customer satisfaction Total quality management is based on the participation of all members of an organization in improving processes, products, services, and the culture they work in Total quality management benefits all organization members and society The methods for implementing this approach are found in the teachings of such quality leaders as Philip B Crosby, W Edwards Deming, Armand V Feigenbaum, Kaoru Ishikawa, J M Juran, and others traceability: ability to trace the history, application or location of that which is under consideration trend: consecutive points that show a nonrandom pattern trend analysis: refers to the charting of data over time to identify a tendency or direction V validation: confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled variation: a change in data, a characteristic, or a function that is caused by one of four factors: special causes, common causes, tampering, or structural variation 1356_Cianfrani.indd 196 11/11/09 12:59:57 PM Glossary 197 verification: confirmation, through the provision of objective evidence that specified requirements have been fulfilled vision: a statement that explains what the company wants to become and what it hopes to achieve vital few/useful many: a term used by J M Juran to describe his use of the Pareto principle, which he first defined in 1950 (The principle was used much earlier in economics and inventory control methodologies.) The principle suggests that most effects come from relatively few causes; that is, 80 percent of the effects come from 20 percent of the possible causes The 20 percent of the possible causes is referred to as the “vital few”; the remaining causes are referred to as the “useful many.” When Juran first defined this principle, he referred to the remaining causes as the “trivial many,” but realizing that no problems are trivial in quality assurance, he changed it to “useful many.” voice of the customer: an organization’s efforts to understand the customers’ needs and expectations (“voice”) and to provide products and services that truly meet such needs and expectations W work environment: set of conditions under which work is performed work instruction: a document that answers the question: How is the work to be done? 1356_Cianfrani.indd 197 11/11/09 12:59:57 PM 198 Glossary world-class quality: a term used to indicate a standard of excellence: best of the best Y yield: ratio between salable goods produced and the quantity of raw materials and/or components put in at the beginning of the process 1356_Cianfrani.indd 198 11/11/09 12:59:58 PM Additional Reading The following books and standards publications can be used for more in-depth coverage of the ISO 9000 standards: ANSI/ISO/ASQ Q9004-2000: Quality management systems—Guidelines for performance improvement Milwaukee, WI: ASQ Quality Press Arter, D R., J E West, and C A Cianfrani 2003 How to Audit the Process-Based QMS Milwaukee, WI: ASQ Quality Press Cianfrani, C A., J J Tsiakals, and J E West, eds 2000 The ASQ ISO 9000:2000 Handbook Milwaukee, WI: ASQ Quality Press Cianfrani, C A., J E West, and J J Tsiakals 2009 ISO 9001:2008 Explained Third edition Milwaukee, WI: ASQ Quality Press West, J E., and C A Cianfrani 2005 Unlocking the Power of Your QMS Milwaukee, WI: ASQ Quality Press For additional information on quality management systems and quality tools, including sampling: ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes Milwaukee, WI: ASQ Quality Press ANSI/ASQ Z1.9-2008: Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming Milwaukee, WI: ASQ Quality Press 1356_Cianfrani.indd 199 199 11/11/09 12:59:58 PM 200 Additional Reading ANSI/ISO/ASQC A3534-2-2006: Statistics—Vocabulary and Symbols— Applied Statistics Milwaukee, WI: ASQ Quality Press Delbecq, A L., H H Van de Ven, and D H Gustafson 1975 Group Techniques for Program Planning: A Guide to Nominal Group and Delphi Processes Glenview, IL: Scott, Foresman and Company ISO/TR 10017:2003: Guidance on Statistical Techniques for ISO 9001:2000 Geneva, Switzerland: ISO Juran, J M., and A B Godfrey 1998 Juran’s Quality Handbook Fifth edition New York: McGraw-Hill Professional Publishing Tague, N R 2005 The Quality Toolbox Second edition Milwaukee, WI: ASQ Quality Press 1356_Cianfrani.indd 200 11/11/09 12:59:58 PM Index brainstorming, 148–49 continual improvement, 13–14, 132–33 controls for documents, 30–32 for records, 32–35 corrective actions, for nonconforming products, 133–35 customer communication, 73–74 customer focus, 7–9, 38–39 customer property, protecting and safeguarding, 102–4 customer requirements, top managers and, 38–39 C D cause-and-effect diagrams, 172–75 cells, determining number of, 159 commitment, top managers and, 35–38 communication customer, 73–74 internal, 48–50 communication processes, 48–50 competency, determining, 60–61 data analysis, 129–32 data points, determining number of, 157–59 design and development control of changes in, 87–88 inputs, 76–78 outputs, 79–81 planning, 74–76 reviews, 81–83 A alignment, 12–13 analysis of data, 129–32 planning and implementing processes for, 111–14 audits, internal, 117–21 authority, defining, top managers and, 45–46 B 1356_Cianfrani.indd 201 201 11/11/09 12:59:58 PM 202 Index design and development (continued ) validation, 85–87 verification, 83–85 documentation controls, 30–32 quality manuals, 27–29 of quality policies, 39–41 record controls, 32–35 requirements, 29–30 E employees See workers F failure modes and effects analysis (FMEA), 137, 162–65 fishbone diagrams, 172–75 flowcharts, 140–43 symbols for, 141 G Gantt charts, 150–53 H histograms, 156–60 human resources determining competency and, 60–61 general requirements for, 58–60 training and, 60–61 I identification, 100–102 improvement projects, conducting, 178–82 1356_Cianfrani.indd 202 improvements continual, 132–33 corrective actions, 133–35 planning and implementing processes for, 111–14 preventive actions, 136–38 infrastructure, determining and providing necessary, 62–63 internal audits, 117–21 internal communication, 48–50 Ishikawa diagrams, 172–75 ISO 9000:2005, 23–26 ISO 9001:2000, 18–20 ISO 9001:2008 changes in, from ISO 9001:2000, 18–20 general requirements of, 24–26 normative reference in, 23–24 reasons for embracing, 1–4 scope of, 21–23 L leadership, 15–16 M management, systems approach to, 9–12 management representatives, 16, 46–48 management reviews inputs for, 52–54 outputs for, 54–56 of quality management systems, 50–52 managers See middle managers; top managers 11/11/09 12:59:58 PM Index measurement for customer satisfaction, 114–17 planning and implementing processes for, 111–14 of processes, 121–23 of product, 123–26 measuring devices, control of, 106–11 middle managers, benefits of ISO 9001:2008 for, 2–3 See also top managers monitoring customer satisfaction, 114–17 planning and implementing processes for, 111–14 of product, 123–26 of quality management system processes, 121–23 monitoring devices, control of, 106–11 N nonconforming products controlling, 126–29 corrective actions for, 133–35 normative reference, 23–24 P Pareto charts, 160–62 personnel See workers preventive actions, 136–38 problem solving, 176–78 process approach, 9–12 process controls, 14–15 process mapping, 144–47 products controlling conditions for provision of, 94–97 controlling monitoring and measuring devices for, 106–11 1356_Cianfrani.indd 203 203 determining requirements related to, 68–70 measuring, 123–26 monitoring, 123–26 nonconforming, controlling, 126–29 planning realization, 65–68 preservation of, 104–6 purchasing information for, 90–92 purchasing processes for, 88–90 reviewing requirements related to, 70–73 validating processes for provision of, 98–100 verifying purchased, 92–94 property, customer, safeguarding, 103–4 purchasing information, 90–92 processes, 88–90 Q quality management principles, 5–7 quality management systems, 11 involvement in, 16 monitoring and measuring processes of, 121–23 planning, 43–45 reviewing, 50–52 quality manuals, 27–29 quality objectives, top managers and, 41–43 quality policies, top managers and, 39–41 R records, control of, 32–35 resources, provision of, 56–58 11/11/09 12:59:58 PM 204 Index responsibilities, defining, top managers and, 45–46 reviews, quality management system, 50–52 run charts, 153–56 S sampling inspections, 165–72 scope, of ISO 9001:2008, 21–23 services See also products controlling conditions for provision of, 94–97 validating processes for provision of, 98–100 symbols, flowchart, 141 systems approach to management, 9–12 T top managers See also middle managers benefits of ISO 9001:2008 for, 3–4 commitment and, 35–38 customer requirements and, 8, 38–39 1356_Cianfrani.indd 204 defining roles of personnel and, 45–46 internal communication and, 48–50 planning quality management systems and, 43–45 quality management system reviews and, 50–52 quality objectives and, 41–43 quality policies and, 39–41 responsibilities of, 15–16 traceability, of products, 100–102 training, determining requirements for, 60–61 trend charts, 153–56 W work environments, determining, 63–65 workers benefits of ISO 9001:2008 for, 1–2 defining roles for, 45–46 roles of, 16 11/11/09 12:59:58 PM ... Cataloging -in- Publication Data Cianfrani, Charles A Cracking the case of ISO 9001:2008 for service : a simple guide to implementing quality management in service organizations / Charles A Cianfrani... William A Tony Project Editor: Paul O’Mara Acquisitions Editor: Matt Meinholz Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual, organizational,... This approach is easy to implement and has many advantages: • It maintains focus on the creation of value by managing across the functional departments of the organization, thereby reducing the