The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

Janet Bautista Smith

Description

The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics—are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system.
Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles.
The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system’s effectiveness. The catalysts for this goal are:
Auditing beyond compliance to include identification of improvement opportunities
Use of process metrics as feedback mechanism in the discovery of hidden factories and risks
Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings’ generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success.
Workshop modules for ‘training the trainers’ are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Auditing
• Economie gestion
• Economics
• QMS

Informations

• Publié par: ASQ Quality Press
• Date de parution: 10 mars 2016
• Nombre de lectures: 0
• EAN13: 9781953079633
• Langue: English
• Poids de l'ouvrage: 11 Mo

Extrait

The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

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To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http://www.asq.org/quality-press.

The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

J. B. Smith

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee, WI 53203 © 2016 by ASQ. All rights reserved. Published 2015. Printed in the United States of America.

21 20 19 18 17 16 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Names: Smith, Janet B., 1954- author. Title: Integration of strategic planning, performance metrics, and auditing / Janet B. Smith. Description: Milwaukee, WI : ASQ Quality Press, 2016. | Includes index. Identiîers: LCCN 2015049945 | ISBN 9780873899253 (hardcover; cd : alk. paper) Subjects: LCSH: Strategic planning. | Performance—Measurement. | Auditing,  Internal. | Management. Classiîcation: LCC HD30.28 .S5695 2016 | DDC 658.4/012—dc23 LC record available at http://lccn.loc.gov/2015049945

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 Acquisitions Editor: Matt T. Meinholz Managing Editor: Paul Daniel O’Mara 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.

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To place orders or to request ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.org/quality-press.

Printed on acid-free paper

Dedication

This book is dedicated to Daniel and Scott.

Contents

List of Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART I

Chapter 1

Chapter 2

Chapter 3

Chapter 4

Strategic Planning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Core Elements of the Vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Critical Factors Inuencing Development of Vision. . . . . . . . . . .

First Deîne Vision; Then Develop Strategic Plan. . . . . . . . Life Cycle of the Strategic Plan (DMAIC Model). . . . . . . . . . . . . . What is the Lean DMAIC Model? . . . . . . . . . . . . . . . . . . . . . . . . . . Translation of High-Level Strategy into Day-to-Day  Measurable Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Roadmap to Successful Strategic Planning and  Alignment with Vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Strategy: Measurement of Eectiveness Through Initiatives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Starting Point. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benchmark versus Goal. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . .

Initiatives to Support Strategies: Measurement Through Process Metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Layered Process Metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Methods for Creating a Layered Process or  Performance Metric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

vii

xiii

x

v

xix

xxiii

1

3 3 5

9 10 10

12

14

17 17 20

23 23

24

viiiContents

PART II

Chapter 5

Chapter 6

Chapter 7

Chapter 8

Chapter 9

Chapter 10

PART III

Chapter 11

Chapter 12

Process Metrics and Risk Mitigation . . . . . . . . . . . . . . . . . . .

Process Metrics and Risk Mitigation . . . . . . . . . . . . . . . . . . . Feedback Mechanism to Go Beyond Compliance and  Beyond Sustainability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process Metrics: Success Factors, Risk Mitigation, Failure  Modes, and Countermeasures. . . . . . . . . . . . . . . . . . . . . . . . . . .

Process Metrics: Why Do They Fail?. . . . . . . . . . . . . . . . . . . . Risk and Failure Mode: Process Capability and Customer  Requirements May be Perfectly Aligned, but Process  Owners are Not . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Risk and Failure Mode: Process is Barely Capable . . . . . . . . . . . . Risk and Failure Mode: Process is Not Capable or Not Stable . . Risk and Failure Mode: Process Metrics Are Not Calibrated  for Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No Periodic Review of Process Metrics After Deployment to  Detect Hidden Factories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Moment of Truth: Another Expression of Risks, Possible Failure Mode, and Process Metric . . . . . . . . . . . . . .

Process Metrics: Measurement of Risk and Failure Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Many Faces of Ineective Process Metrics. . . . . . . . . . The Many Faces of Ineective Process Metrics. . . . . . . . . . . . . . . Can 1% Metric Rule? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance Metrics Without Sustainability . . . . . . . . . . . . . . . . . Process Metric: Two Faces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process Metric Expectation is Misunderstood;  a Moving Target?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Leverage on Measurable Results; Act on Process Indicators! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Root Cause Analysis Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . Deîning the Problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other Triggers of Root Cause Analysis . . . . . . . . . . . . . . . . . More than Non-conformances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Root Cause Analysis Trigger: External Forces. . . . . . . . . . . . . . . . Root Cause Analysis Trigger: Internal Processes . . . . . . . . . . . . . . Root Cause Analysis Trigger: Nonconformance or Variance (Friend or Foe?). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .

3

3

5

7

37

37

4

5

45 46 48

50

50

5

5

3

7

63 63 65 66 67

71

7

7

3

7

79 79

85 85 85 86

87

Chapter 13

PART IV

Chapter 14

PART V

Chapter 15

Chapter 16

Chapter 17

Chapter 18

Part VI

Contentsix

Root Causes and Process Metrics. . . . . . . . . . . . . . . . . . . . . . . Which Came First? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lessons Learned (A Lasting Impression). . . . . . . . . . . . . . . . . . . .

Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verifying Compliance, Performance, and Continuous  Improvement Opportunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lean Six Sigma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Creation of a Dynamic Audit Roadmap . . . . . . . . . . . . . . . . . . . . . Auditing Beyond Compliance Model . . . . . . . . . . . . . . . . . . . . . . .

Beyond Compliance and Beyond Sustainability . . . . . . . . .

Process Metrics: Beyond Compliance, Beyond Sustainability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes and Realignment with the Vision . . . . . . . . . . . . . .

How Do You Promote Sustainability of an Initiative to the Grassroots Level?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Integration of Strategic Planning, Risk Mitigation, Process Metrics, and Auditing . . . . . . . . . . . . . . . . . . . . . . . . . Challenge Run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Challenge Run Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Templates: Basic Quality and Lean Tools. . . . . . . . . . . . . . . . 14.3 Brainstorming Worksheet: Departmental or  Process Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.4 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.5 Internal Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.6 SIPOC Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.7 5 Whys: Root Cause Analysis Worksheet . . . . . . . . . . . . . 14.8 Identiîcation of Roadblocks or Bottlenecks. . . . . . . . . . . 14.9 Data Collection for Process Metrics . . . . . . . . . . . . . . . . . . 14.10 Process Waste Walk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.11 Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.12 Project Charter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

91 91 99

103

105

105 106 107 110

119

121

125

129

133 133 134

137

139 140 141 142 143 144 145 146 147 149