Proactive Supplier Management in the Medical Device Industry

John A. Freije, James B. Shore

Description

In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect.
The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors.
In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world.
Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it's a requirement or a tool to help achieve compliance. The Lessons from the Road” icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• Food and Drug Administration
• Engineering
• Technology
• FDA
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 27 avril 2016
• Nombre de lectures: 0
• EAN13: 9781953079657
• Langue: English
• Poids de l'ouvrage: 8 Mo

Extrait

PrOactiVE SUppliEr MaNaGEmENt iN tHE MEdical DEVicE INdUstrY

Also available from ASQ Quality Press:

Handbook of Investigation and Effective CAPA Systems, Second Edition José Rodríguez-Pérez

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements: A Comprehensive Guide to Designing a ProcessBased Document Control System Stephanie L. Skipper

Quality Risk Management in the FDARegulated Industry José Rodríguez-Pérez

Statistical Process Control for the FDARegulated Industry Manuel E. Peña-Rodríguez

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals José Rodríguez-Pérez

A Practical Field Guide to ISO 13485 Erik V. Myhrberg and Joseph Raciti

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition Amiram Daniel and Ed Kimmelman

Implementing ISO/IEC 17025:2005 Bhavan “Bob” Mehta

The Biomedical Quality Auditor Handbook, Second Edition Biomedical Division and Bruce Haggar, editor

The Quality Toolbox, Second Edition Nancy R. Tague

Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug

The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor

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

PrOactiVE SUppliEr MaNaGEmENt iN tHE MEdical DEVicE INdUstrY

James B. Shore and John A. Freije

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 © 2016 by ASQ All rights reserved. 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: Shore, James B., 1965– author. | Freije, John A., 1964– author. Title: Proactive supplier management in the medical device industry / James  B. Shore and John A. Freije. Description: Milwaukee, Wisconsin : ASQ Quality Press, [2016] | Includes  bibliographical references and index. Identifiers: LCCN 2016010120 | ISBN 9780873899314 (hardcover : alk. paper) Subjects: LCSH: Medical instruments and apparatus industry—Management. |  Production control. Classification: LCC HD9994.A2 S56 2016 | DDC 681/.7610687—dc23 LC record available at https://lccn.loc.gov/2016010120

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 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.

Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, 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, visit our website at http://www.asq.org/quality-press.

Printed on acid-free paper

TablE Of CONtENts

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CD Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1 Introduction: Why Do We Need to Do This?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction to the FDA, ISO, GHTF, and NBOG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intent of Purchasing Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA and ISO Regulations Pertaining to Purchasing Controls and Their Differences . . . . . . . . NBOG Expectations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GHTF SG3 Document and Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of FDA Enforcement Trends Specific to Supplier Controls . . . . . . . . . . . . . . . . . . . . . Importance of Establishing an Effective Purchasing Controls Process . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 2 Planning: What Do We Need?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Topics Covered in This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start with the End in Mind . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Before You Go Too Far . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start with Your Road Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Form the Team: Who Is Going to Participate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Planning—Project Charter: What Are We Looking For? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selection—Business Needs: What Do We Need to Support the Project Charter and Quality Requirements? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evaluation—Attributes: What Are the Competencies That Support the Business Needs? . . . . Assessment and Identification—Identify Indicators: What Attributes Are Relevant to Each Business Need? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Objective Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Finished Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3 Selection of Suppliers: Which Ones Do We Need?. . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Takeaways from This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Type of Product or Service Obtained: Using Risk in Selection of Suppliers . . . . . . . . . . . . . . . . Supplier Selection Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using Risk the Right Way: TRF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wait, I Thought Risk Management Was Used Only in Design and Process FMEAs?. . . . . . . . . Factor: Product Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factor: Supplier’s Quality System Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factor: Supplier’s Financial Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factor: Lead Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

V

ix xi xiii xv 1 2 3 5 5 7 7 8 10 14 15 15 16 16 17 17 18

18 19

20 21 21 21 23 24 24 26 27 28 28 29 30 31

Vi

Table of Contents

Factor: Order Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial TRF: Basic Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial TRF: Weighted Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial TRF (Weighted Approach): Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial TRF: Recommended Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Onboarding Your Potential Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process Control and Quality Control Plans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What’s Next? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4 Evaluation: Do They Meet Our Needs?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Takeaways from This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Will Not Be Part of This Chapter? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Determine What Will Be Evaluated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evaluation of Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pre-evaluation Discussion with Supplier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Desktop Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Consultants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . On-Site Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exit Evaluation Discussion with Supplier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evaluating the Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Documenting Your Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Approved Supplier List (ASL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Items to Consider. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What’s Next? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 5 Controls: Are They Still Meeting Our Needs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Takeaways from This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Strategic Supplier Map: Begin with the End in Mind . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Implement the Strategic Supplier Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the SIPOC Method to Implement the Strategic Supplier Map . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6 Controls: What Are Contractual Requirements?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contracts/Agreements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Main Topics Covered in This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Why Do I Need This? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Is It? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Must It Do? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Content Is Needed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Who Will Do It? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Needs to Be Done? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . When Will It Be Done? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Where Will It Be Done? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How Will It Be Done? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Why Will It Be Done? (Not Every SQA Element Requires a WHY) . . . . . . . . . . . . . . . . . . . . . . . SQA Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 7 Supplier Consolidation: Do We Still Need Them? . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main Takeaways from This Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Termination versus Consolidation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32 32 33 34 34 35 35 35 36

37 38 38 38 39 40 41 42 42 43 43 44 45 46 51 52 52

53 53 55 58 58 58 87 89 89 90 92 92 92 93 93 94 94 95 95 95 96 97 99 99 100

T ABLEOF C ONTENTS

Start with the End in Mind: What Is the Goal?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Consolidation: How Do I Start the Analysis? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Consolidation: Initial Brainstorming Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Consolidation: Data Analysis with Total Cost of Ownership (TCO) Models . . . . . . . Supplier Consolidation: What Other Factors Drive This Decision? . . . . . . . . . . . . . . . . . . . . . . . Supplier Consolidation: Exit Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deactivating and Reactivating Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary/Takeaway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary of the Book. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1—Purchasing Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 2—Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3—Selection of Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4—Evaluation of Suppliers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 5—Process Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6—Quality Agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 7—Consolidation of Suppliers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vii

100 101 102 102 105 105 107 109

111 111 111 111 112 112 112 113

115 117

Figure 1.1 Figure 1.2 Table 1.1 Table 1.2 Figure 1.3 Figure 1.4 Figure 1.5 Figure 1.6 Table 1.3 Table 2.1 Figure 2.1 Table 2.2 Table 2.3 Table 2.4 Table 2.5 Table 2.6 Table 2.7 Table 3.1 Table 3.2 Table 3.3 Table 3.4 Table 3.5 Table 3.6 Table 3.7 Table 3.8 Table 3.9 Table 3.10 Table 3.11 Table 3.12 Table 3.13 Table 3.14 Table 3.15

List Of FiGUrEs aNd TablEs

Icons used in this book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intent of purchasing controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of ISO standards and FDA regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of ISO standard and FDA regulation similarities and differences. . . . . . . . GHTF phase overview for supplier controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warning letters with purchasing controls cites (2004–2014) . . . . . . . . . . . . . . . . . . . . . . Breakdown of purchasing controls cites (2004–2014) . . . . . . . . . . . . . . . . . . . . . . . . . . . Nurse with a newborn and several devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Self-assessment of your company’s quality system to the GHTF elements . . . . . . . . . Example supplier category and risk rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of supplier road map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Project charter and team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business needs and attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business needs, attributes, and relevant indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier selection road map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Completed supplier selection road map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example supplier category and risk rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example of ongoing supplier monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design FMEA severity table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example TRF assessment criteria form with severity populated. . . . . . . . . . . . . . . . . . Example of supplier quality system detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example TRF assessment form with supplier QS detection populated . . . . . . . . . . . . Example of financial stress factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example TRF assessment form with financial strength populated . . . . . . . . . . . . . . . . Example of lead time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example TRF assessment form with supplier lead time populated . . . . . . . . . . . . . . . Example of order capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Example TRF assessment form with order capacity populated. . . . . . . . . . . . . . . . . . . Example TRF assessment form populated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TRF assessment criteria form, weighted approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Combined initial supplier assessment rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iX

2 5 5 6 9 10 10 11 13 16 17 18 19 19 20 21 22 25 25 28 29 29 30 30 31 31 31 32 32 32 33 33