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ASQ Quality Press - Robert Alvarez , Janet Bautista Smith

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75 pages

English

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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	9781951058241
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 Alvarez

Quality Press Milwaukee, Wisconsin

Beyond Compliance Design of a Quality System
© 2020 by Janet Bautista Smith
All rights reserved. Published 2020
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.Identifiers: 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 Classification: 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 paper

This book is dedicated to
my son, Cosmo, and to Gaaelya.
– Janet Bautista Smith

Preface

T he development and maintenance of a quality management system (QMS) is based on many variables, such as company goals, market trends, company workforce, technology capability, and customer requirements (including quality/industry certifications like ISO, the U.S. Food and Drug Administration (FDA), military, etc.).
This book provides case studies, models, and templates on selected core elements that are common in the quality field, based on the combined perspectives and hands-on experiences of the quality system designer and internal and external auditors. This unique combination of real-life lessons learned can be easily applied in any industry regardless of size, product, or service.
The validity and effectiveness of the models presented in this book have been scrutinized and accepted by customers and auditors in manufacturing, government, and service businesses, and in environments as varied as medical devices, automotive, military, and customs security. The models and case studies compiled by the author come from years of hands-on experiences, reflecting the two sides of an audit—that of the quality system designer, or the auditee, and that of the external auditor.
Validation of a Quality Management System
One common source of QMS validation is the integration of available information, such as the internet or published documents, in the design of a quality system. These may be good sources, but they are almost always based on a one-sided view, that is, the voice of the quality system designer (e.g., quality assurance (QA) management or a consultant) sharing the lessons learned throughout the design and deployment of a system. The limitation of these sources introduces the possibility of biased input. One can design a million-dollar quality system, but if it is not effective or efficient, it is not worth a cent.
So, how does one validate a quality system’s efficacy? One unbiased measure of success for validating a quality system is the evaluation of customers and/or external auditors such as ISO auditors, the FDA, etc.
The concept of enhancing results through the merging of views and expertise in collaboration was also explored in a paper called “Lessons Learned from Employing Multiple Perspectives in a Collaborative Virtual Environment for Visualizing Data” (Park, Kapoor, and Leigh 2000):
“Reapplying important lessons to prevent future mistakes is a core reason why organizations capture lessons learned. Although the concept of lessons learned has evolved into a formal and structured management practice, as an idea, the practice of capturing and archiving knowledge is not new. Using this practice involves performing two essential activities: capturing important lessons learned and making effective use of these.”
Why reinvent models when you can reference time-tested, ageless concepts already polished through years of scrutiny from both customers and external party audits? Sharing these techniques and lessons learned from two perspectives is what makes this book different from other published documents in this domain.

Acknowledgments

Janet Smith
My gratitude to my husband, Chet, and my son, Cosmo, for their patience and inspirational support while I burned the midnight oil during the completion of this project.
I also thank my sister, Cynthia Santos, and my nephew, Bryan Santos, who provided support reflected by their positive interest and enthusiasm on the project.
Many thanks to my friends Xin Xiang and Andrew Welling, whose friendship included keeping me healthy by walking with me for fresh air or eating a meal with me during lunch breaks for a change of scenery. These friends also went above and beyond work by providing valuable critique to my various hobby art projects. I also thank my friends Sandy Nix and Joy Hannan for providing encouraging support for this project.
I am also grateful to my “plant buddies” who added beautiful plants to my office. We shared and exchanged interesting plant challenges. They are: Lynn Russell, Mary Kavette, Sharon Crouch, Todd Hoehn, and others.
My gratitude goes to my quality assurance team and friends (Rodolfo Nava, Ramiro Chacon, Victor Garcia, Jorge Molina, and Mariann Kay) for diligently working with me in the creation and execution of quality initiatives in support of compliance and continuous improvement. They are always available to lend a hand with a smile. Thanks to the ProTrans family: Craig Roeder, Gary Cardenas, Shawn Masters, Ratnam Philip, Lisa Doerner, Chris Blunk, Kathy Joy, Riley McGaughey, Benjamin Mathis, Barbara Carothers, Eracleo Vallejo, Jeremy Garrett, Bradford C. Smoot, George Gephart, Joe Garcia, Paul Chiszar, Marco Prieto, and many others for supporting the deployment and integration of quality programs in the ProTrans Quality Management System. It was an enjoyable journey.
The American Society for Quality (ASQ) organization is a critical platform for sharing knowledge such as the publication of this book—many thanks to the dedicated leadership, divisions, and members in maintaining this portal as a contributor to the society’s growth. Special thanks to the peer reviewers and ASQ’s staff in providing dedicated guidance in completing this book.
Robert Alvarez
The journey of being a quality assurance professional is without destination. Although I have excelled in my profession, I acknowledge the countless ASQ members, mentors, supervisors, and peers that have supported me in achieving such a level of competence. As a result of this, it is with this competence, that I enthusiastically share my knowledge, guidance, and experiences, in the hope of facilitating a career path for future individuals in pursuing such an extremely rewarding profession.

Creation of Quality Management Systems (QMS) Reflecting the Two Sides of Auditing: The QMS Designer’s and the External Auditor’s Perspectives

T he design of a perfect quality management system (QMS) is one of the quality goals and the crowning glory of a QMS designer (typically the function of a quality team). A QMS designer can create a quality management program purportedly worth a million dollars and in full compliance with the designer’s own requirements, and, yet, if the QMS is not aligned with the expectations of the stakeholders—management, customers, business partners, etc.—then it is not worth a cent.
The million-dollar question, then, is, “What are some indicators that will help show the QMS design’s successful alignment with the stakeholders’ requirements and expectations?”
The validation of the QMS by internal and external compliance audits is one of the most visible and dynamic ways of achieving that stamp of certification and implementation of the industry’s best practices. Audit validation of the QMS as the path to implementing best practices is the focus of this book. What follows is dedicated to sharing lessons learned in the deployment of time-tested QMS systems from both the QMS designer’s and the auditors’ experiences. This holistic perspective benefits both beginners and advanced quality professionals.
External audit certification of a QMS model (i.e., quality certification under an industry standard from ISO, FDA, a military organization, environmental agencies, etc.) offers added validation of a system’s effectiveness and increases a company’s market competitiveness. There are many variations of the QMS model, but which one has the highest rate of success? The optimal QMS model for a situation depends on many variables, such as company vision, resource availability, market competition, regulatory requirements, etc.
This chapter offers samples and guidelines in the selection of the QMS elements that are easy to create and have been validated through ye