Beyond Compliance Design of a Quality System , livre ebook

ASQ Quality Press - Robert Alvarez , Janet Bautista Smith

Découvre YouScribe en t'inscrivant gratuitement

Je m'inscris

Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus

141 pages

English

Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus

A propos
Informations
Extrait

Description

Next Level Results for Your QMS
You don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight.
Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and templates you can customize for your organization and begin using immediately, including:
Implementing layered metrics to align with the auditor's perspective
Employing DMAIC analysis to process customer complaints
Discovering hidden factories through a Process Grid Walk
Addressing common pitfalls of documentation systems with lean solutions
Achieving operational compliance and excellence within processes
Determining QMS, customer, and auditor satisfaction
Fostering synergy among the QMS, customer, and auditor perspectives
Engaging management review for critical support

Sujets

Business

Qualité, hygiène, sécurité, environnement

Auditing

Economie gestion

Economics

QMS

Informations

Publié par	ASQ Quality Press
Date de parution	01 mars 2020
Nombre de lectures	0
EAN13	9781951058258
Langue	English
Poids de l'ouvrage	3 Mo

Informations légales : prix de location à la page 0,2000€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

Extrait

BEYOND COMPLIANCE
DESIGN OF A QUALITY SYSTEM
TOOLS AND TEMPLATES
FOR INTEGRATING AUDITING PERSPECTIVES
JANET BAUTISTA SMITH
WITH ROBERT ALVAREZBeyond Compliance
Design of a
Quality System
Tools and Templates for
Integrating Auditing Perspectives
—— ——Auditing titles from Quality Press
The Certiﬁed Quality Auditor, Fifth Edition
Ed. Lance B. Coleman Sr.
Advanced Quality Auditing
Lance B. Coleman Sr.
How to Audit ISO 9001:2015: A Handbook for Auditors
Chad Kymal
Also from Janet Bautista Smith
Auditing Beyond Compliance: Using the Portable Universal Quality Lean Auditing Model
The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing
New from Quality Press
Connected, Intelligent, Automated: The Deﬁnitive Guide to Digital Transformation
and Quality 4.0
N. M. Radziwill
Culture Is Everything: How to Become a True Culture Warrior and Lead Your
Organization to Victory
Jeff Veyera
Data Quality: Dimensions, Measurement, Strategy, Management, and Governance
Rupa Mahanti
Data Integrity and Compliance: A Primer for Medical Product Manufacturers
José Rodríguez-Pérez
Root Cause Analysis: The Core of Problem Solving and Corrective Action, Second Edition
Duke Okes
A Practical Field Guide for ISO 13485:2016: Medical Devices–Quality Management
Systems–Requirements for Regulatory Purposes
Erik V. Myhrberg and Joseph Raciti, with Brandon L. Myhrberg
The ASQ Certiﬁed Quality Improvement Associate Handbook, Fourth Edition
Eds. Grace L. Duffy and Sandra L. Furterer
ISO 56000: Building an Innovation Management System: Bring Creativity and
Curiosity to Your QMS
Peter Merrill
For more information on Quality Press titles, please visit our website at:
http://www.asq.org/quality-pressBeyond Compliance
Design of a
Quality System
Tools and Templates for
Integrating Auditing Perspectives
—— ——
Janet Bautista Smith
with Robert Alvarez
Quality Press
Milwaukee, WisconsinAmerican Society for Quality, Quality Press, Milwaukee 53203
© 2020 by Janet Bautista Smith
All rights reserved. Published 2020
Printed in the United States of America
25 24 23 22 21 20 7 6 5 4 3 2 1
Publisher’s Cataloging-in-Publication Data
Names: Smith, Janet Bautista, author. | Alvarez, Robert, contributor.
Title: Beyond compliance design of a quality system : tools and templates for
integrating auditing perspectives / Janet B. Smith ; Robert Alvarez.
Description: Includes bibliographical references and index. | Milwaukee, WI:
Quality Press, 2020.
Identifers: LCCN 2020940659 | ISBN 978-1-951058-23-4 (pbk.) |
978-1-951058-24-1 (epub) | 978-1-951058-25-8 (pdf)
Subjects: LCSH Quality control—Auditing. | Auditing. | Total quality management.
| BISAC BUSINESS & ECONOMICS / Auditing | BUSINESS & ECONOMICS / Quality
Control | BUSINESS & ECONOMICS / Total Quality Management
Classifcation: LCC HF5667 .B268 2020 | DDC 657/.45—dc23
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: Seiche Sanders
Managing Editor: Sharon Woodhouse
Sr. Creative Services Specialist: Randy L. Benson
ASQ advances individual, organizational, and community excellence worldwide
through learning, quality improvement, and knowledge exchange.
Bookstores, wholesalers, schools, libraries, businesses, and organizations: Quality
Press books are available at quantity discounts for bulk purchases for business,
trade, or educational uses. For more information, please contact Quality Press at
800-248-1946 or books@asq.org.
To place orders or browse the selection of all Quality Press titles, visit our website
at: http://www.asq.org/quality-press
Printed on acid-free paperThis book is dedicated to
my son, Cosmo, and to Gaaelya.
– Janet Bautista SmithContents

Figures, Tables, and Templates ........................................ ix
Preface ........................................................ xii
Acknowledgments ................................................. xv
Chapter 1 Creation of Quality Management Systems (QMS)
Reﬂecting the Two Sides of Auditing: The QMS Designer’s and
the External Auditor’s Perspectives ................................ 1
Lessons Learned ............................................. 5
Auditor’s Perspective .......................................... 9
Chapter 2 Measurement of the QMS Effectiveness and
Alignment with the Auditor’s Perspective Using Layered Metrics ..... 11
Questions About Quality Objectives ............................ 12
Quality Objectives Using Layered Metrics ....................... 13
Lessons Learned ............................................ 17
Auditor’s Perspective ......................................... 18
Chapter 3 Customer Feedback and the QMS ...................... 19
Highlights of the DMAIC Analysis Model ........................ 20
Common Pitfalls of Customer Complaints Processing ............. 20
Converting Customer Feedback into Operational Excellence ....... 23
Lessons Learned 28
Auditor’s Perspective 30
Chapter 4 Identiﬁcation of Risks and Improvement
Opportunities— Discovering Hidden Factories and Using
the Process Grid Walk .......................................... 33
Process Grid Walk ........................................... 36alk Scenarios .................................. 43
Lessons Learned ............................................ 45
Auditor’s Perspective ......................................... 47
Chapter 5 An Effective and Efﬁcient Documentation System to
Support a QMS and Satisfy an Auditor ............................ 49
Common Pitfalls and Lean Solutions ........................... 49
Lessons Learned ............................................ 57
Auditor’s Perspective 58
viiviii TABLE OF CONTENTS
Chapter 6 QMS Operational Compliance and Excellence
Within Processes ............................................... 61
A Tool for Achieving Operational Compliance and Excellence ...... 64
Lessons Learned ............................................ 64
Auditor’s Perspective ......................................... 64
Chapter 7 Resolution of Nonconformances to Maintain Integrity
of the QMS and Preserve a Positive Auditor’s Review ............... 67
Lessons Learned 69
Auditor’s Perspective 72
Chapter 8 Process Performance—Indicators of QMS, Customer,
and Auditor Satisfaction ........................................ 73
Lessons Learned ............................................ 77
Auditor’s Perspective ......................................... 77
Chapter 9 Auditing Beyond Compliance—A Dynamic Tool to Foster
Synergy Among the QMS, Customer, and Auditor’s Perspectives ...... 79
Auditing Beyond Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Lessons Learned 88
Auditor’s Perspective ......................................... 88
Chapter 10 Management Review—Critical Support for
QMS Success and Auditor’s Acceptance ........................... 89
Lessons Learned ............................................ 96
Author’s Perspective 96
T emplates ...................................................... 97
Glossary 107
References ..................................................... 109
Bibliography ................................................... 111
Index ......................................................... 113
About the Author ................................................ 117List of Figures, Tables, and Templates

Figures
1.1 The Lean Express: Example of a QMS showing typical
QMS elements .............................................. 2
3.1 Customer complaints—examples of common causes ............. 20
4.1 Pictorial depiction of gap or risk ............................... 33
4.2 Discovery of risks disguised as a “hidden factory” through
auditing beyond compliance ................................. 34
4.3 Guidelines: How to detect and measure risks . . . . . . . . . . . . . . . . . . . . 35
4.4 Process grid walk—identify core processes ..................... 37
4.5 Overview of the PGW model—a tool to help detect risks .......... 40
4.6 Example of PGW log ........................................ 41
4.7 Process grid walk overview ................................... 43
5.1 Typical documentation model ................................ 50
5.2 Sample document format .................................... 51
5.3 Clustering of related documents .............................. 53
6.1 Sample DMAIC path to help achieve operational compliance
and excellence within a process ............................... 63
6.2 Assessing process capability to determine and mitigate any
gap to continually achieve customer satisfaction ................ 65
7.1 The adventures of Inspector Leanne N. Green: Process
requirements and training effectiveness ........................ 68
7.2 The adventures of Inspector Leanne N. Green: 5S program ........ 70
7.3 The adventures of Inspector Leanne N. Green: Scope creep
(no process control for prevention) ............................ 71
8.1 Sample DMAIC path to help achieve operational compliance
and excellence within a process ............................... 75
ixx LIST OF FIGURES, TABLES, AND TEMPLATES
9.1 The strategic planning, process metric, risk mitigation, and
auditing interrelationship as foundation of a successful
business model ............................................ 79
9.2 Model of auditing beyond compliance ........................ 81
9.3 Phases of implementing auditing beyond compliance ........... 82
9.4–9.8 Step-by-step tutorial to start the implementation of
auditing beyond compliance (ABC)
9.4 Step 1: Identify core process to be audited .................. 83
9.5 Step 2: Create simple input/output fowchart of the
core process to be audited ................................ 83
9.6 Step 3: Evaluate the 6Ms as the common input variables
likely to affect the desired output ........................