Failure Mode and Effects Analysis (FMEA) for Small Business Owners and Non-Engineers : Determining and Preventing What Can Go Wrong 9781953079510, 9780873899185

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Failure Mode and Effects Analysis (FMEA) for Small Business Owners and Non-Engineers

Also available from ASQ Quality Press: The ASQ Pocket Guide to Failure Mode and Effect Analysis (FMEA) D. H. Stamatis The ASQ Quality Improvement Pocket Guide: Basic History, Concepts, Tools, and Relationships Grace L. Duffy, editor The ASQ Pocket Guide to Root Cause Analysis Bjørn Andersen and Tom Natland Fagerhaug Quality Risk Management in the FDA-Regulated Industry José Rodríguez-Pérez Product Safety Excellence: The Seven Elements Essential for Product Liability Prevention Timothy A. Pine Achieving a Safe and Reliable Product: A Guide to Liability Prevention E.F. “Bud” Gookins Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug Root Cause Analysis: The Core of Problem Solving and Corrective Action Duke Okes The Certified HACCP Auditor Handbook, Third Edition ASQ Food Drug and Cosmetic Division The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell T. Westcott, editor The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor The Quality Toolbox, Second Edition Nancy R. Tague 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.

Failure Mode and Effects Analysis (FMEA) for Small Business Owners and Non-Engineers Determining and Preventing What Can Go Wrong

Marcia M. Weeden, MS, CQE, CQT

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee, WI 53203 © 2015 by ASQ. All rights reserved. Published 2015. Printed in the United States of America. 20  19  18  17  16  15         5  4  3  2  1 Library of Congress Cataloging-in-Publication Data Weeden, Marcia M., 1952Failure mode and effects analysis (FMEA) for small business owners and non-engineers: determining and preventing what can go wrong / by Marcia M. Weeden. pages cm Includes index. ISBN 978-0-87389-918-5 (hardcover: alk. paper) 1. Small business—Management. 2. Failure mode and effects analysis. I. Title. HD62.7.W44 2015 658.4’013—dc23              2015031687 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: Lynelle Korte 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. 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 ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.org/quality-press. Printed on acid-free paper

Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Guidelines for Using FMEAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 When to Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Stages of an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Flowchart – FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 High-Level Risk Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Graphic – Fishbone (Ishikawa) Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Planning and Design Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Process Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Flowchart – Tasks of an FMEA Investigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Failure Rankings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Criteria for Severity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Flowchart – Determining Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Criteria for Occurrence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Flowchart – Determining Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Criteria for Detectability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Flowchart – Determining Detectability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Criteria for Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Flowchart – Criticality Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Processes, Stages, Tasks, and Steps Defined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

v

vi  Contents

Graphic – Example of Receiving Process, Stages, Tasks, and Steps. . . . . . . . . . . . . . . . 107 How to Conduct an FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Flowchart – Conducting an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Graphic – FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Worksheet’s Structure and Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 The Value of the Worksheet Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Before Starting the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Rating Scales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Using the FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 Wrapping up the FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 Appendix A – Pareto Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 Appendix B – Fishbone Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Appendix C – FMEA Worksheet Examples*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199   Welding Receiving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200   Ultrasonic Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201    Ultrasonic – Part Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202    Ultrasonic – Water Cleanliness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203    Restaurant – New Seafood Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204    Cleaning Service – Commercial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

*Also available in MS Word format on accompanying CD.

List of Figures and Tables

Table 1. The Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Table 2. Contributor Roles & Contributions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Table 3. Records Pertaining to an FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Table 4. Sampling of FMEA Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Table 5. Sampling of FMEA Guides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Flowchart – FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Table 6. 5Ms & 1E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Graphic – Fishbone (Ishikawa) Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Table 7. Fishbone Questions for a Design Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Flowchart – Tasks of an FMEA Investigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Table 8. Types of Operational Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Table 9a. Subjective Criteria Example for Severity as it Would Impact a Customer . . . . . . . . . . 66 Table 9b. S ubjective Criteria Example for Severity as it Would Impact the Organization/Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Flowchart – Determining Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Table 10a. Subjective Criteria Example for Occurrence in General . . . . . . . . . . . . . . . . . . . . . . 84 Table 10b. Subjective Criteria Example for Occurrence at a Small Organization/Business . . . . . 84 Flowchart – Determining Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Table 11a. Subjective Criteria Example for Detectability in General . . . . . . . . . . . . . . . . . . . . . 91 Table 11b. Subjective Criteria Example for Detectability at a Small Organization . . . . . . . . . . . 91 Flowchart – Determining Detectability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Table 12. Subjective Criteria Example for Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 Flowchart – Criticality Assessments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Graphic – Example of Receiving Process, Stages, Tasks, and Steps. . . . . . . . . . . . . . . . . . . . . . 107 Table 13. Completing an FMEA Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Flowchart – Conducting an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Graphic – FMEA Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Table 14. Sections of an FMEA Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

vii

viii  List of Figures and Tables

Table 15. Purchasing Task – Make Purchase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Table 16. Start Purchase Request (Purchasing Task 1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 Table 17. Find Supplier (Purchasing Task 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 Table 18. Place Order (Purchasing Task 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Table 19. Process Header Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Table 20. Contributor Header Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Table 21. Completing the Worksheet Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Table 22. Examples of Inputs & Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Table 23. Examples of Inputs, Results, & Impacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Table 24. Examples of Inputs, Results, & Causes or Sources. . . . . . . . . . . . . . . . . . . . . . . . . . . 150 Table 25. Examples of Inputs, Results, & Prevention Controls. . . . . . . . . . . . . . . . . . . . . . . . . . 151 Table 26. Examples of Inputs, Results, & Detection Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 152 Table 27. Typical Monthly Expenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 Table 28. Typical Monthly Expenses and Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Table 29. Monthly Expenses Sorted by Percentages from Largest to Smallest. . . . . . . . . . . . . . 175 Table 30. Reorganized Monthly Expense Categories by Percentages . . . . . . . . . . . . . . . . . . . . 178 Table 31. 5Ms & 1Es. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 Table 32. Ice cream stand example, potential areas for failure. . . . . . . . . . . . . . . . . . . . . . . . . 193 Table 33. Specify What to Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

Overview

Introduction

Most people take pride in the work that they do. Hand-in-hand with the pride of job well done is work that is “done right,” meaning meeting and satisfying expectations in a timely manner and without problems. When setting out to establish specifications or decide what is best for an organization, its customers, or its clients, initial efforts pursue, “What do we want? What do our customers need?” “Getting it right” entails more than knowing what is needed or desired. It also entails preventing problems, because along with achieving the desirable, it is important to know what is not wanted. Addressing the undesirable includes avoiding minor problems as well as worst case scenarios, such as: • the risks that could be incurred if business, regulatory, and safety mandates are unrecognized or overlooked, and • the types of error possibilities in operations, process, or everyday tasks. Once the areas at risk or the activities presenting potential problems are identified, then it becomes possible to mitigate or eliminate harm by: • implementing new designs or policies • changing current designs, work methods, processes, or policies • clarifying workflows, responsibilities, or how to perform tasks • designing tests that would prohibit errors from continuing through the workflow • designing “stops” that would shut down the process or system until corrections can be made, or • designing “corrections” that would automatically correct errors after they have occurred so that the work activities can continue uninterrupted.

1

2  Overview

Contents

This section contains the following topics: Topic

Page

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Why an FMEA?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 What Does an FMEA Indicate? . . . . . . . . . . . . . . . . . . . . . . 3 What Value Does an FMEA Contribute? . . . . . . . . . . . . . . . 4 When Can an FMEA be Used? . . . . . . . . . . . . . . . . . . . . . . 4 FMEA Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 FMEA Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Tolerating Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 The FMEA Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Role Contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Team Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Outside Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Purpose

This book is intended for small business owners and non-engineers such as researchers, business analysts, project managers, small non-profits, community groups, religious organizations, and others who want an assessment tool that can provide methods for: • identifying the areas or actions that may be at risk for failure • ranking the risks that they may be facing, and • determining the degree of threat being faced.

Overview  3

Scope

While an FMEA is a tool of reliability engineering, this book is not intended to provide the in-depth information (A–Z approach) that reliability engineering can provide, nor does it cover all aspects and applications of an FMEA. This book provides sufficient information about FMEAs, and how to use them to establish specifications and for making other informed decisions without requiring the expertise of an engineer or statistical analyst. While there is also information given in this book that shows the broad applicability for using FMEAs, it is not anticipated that most users will ever find themselves in those situations. The examples are given to help the user understand the versatility of using an FMEA.

FMEA

A Failure Mode and Effects Analysis, commonly known as an FMEA (F-M-E-A, as the letters are usually spelled out), is a formal risk assessment tool used to identify: • every possible way something might fail, and • the effects (impacts) that such failures would have on a system, its owners, or people in general.

Why an FMEA?

An FMEA can be used for developing policies, specifications, and controls that will prevent the negative consequences from happening or escalating.

What Does an FMEA Indicate?

By knowing ahead of time what can go wrong, as well as how severe the failures would be, the premise of an FMEA is: 1. design and planning can be made sufficient to prevent or mitigate these failures, thus 2. preventing costly or irreversible harm.

4  Overview

What Value Does an FMEA Contribute?

FMEAs are valuable for: • developing policies and standard operating procedures (SOPs) • developing system, design, and process requirements that eliminate or minimize the likelihood of failures •

developing designs, methods, and test systems to ensure that – errors or failures are automatically corrected – errors or failures are flagged for correction – the potential for errors or failures have been eliminated, or – risks are reduced to acceptable levels

• developing and evaluating of diagnostic systems, and • helping with design choices (trade-off analysis)

When Can an FMEA be Used?

FMEAs work on general principles and have the flexibility to be tailored to suit a specific need, organization, or industry. Because of this flexibility and the widespread use of FMEAs, there are various programs and forms associated with FMEAs, but all are intended to determine the likelihood of failure and the degree of risk.

FMEA Scope

The scope, or boundaries, of an FMEA are determined by need. Note: It is neither necessary nor advisable to delve into every possibility.

FMEA Limitations

FMEAs can give a false sense of security that all risks have been addressed. It must be remembered that educated guesses are used in making certain assessments. Therefore, there are no guarantees. However, when used in conjunction with other tools, FMEAs can provide confidence that the most important aspects have been analyzed to minimize or eliminate risks entirely in most instances. Note:  An educated guess to determine the possible impact of a decision or action is far better than a wild guess or no consideration at all.

Overview  5

Tolerating Failures

As improbable or as astonishing as it may seem upon first being heard, there are failures that can and will be tolerated by an organization. These types of failures include, but are not limited to, something that: • is so minor in nature that it would be cost-prohibitive to prevent or correct it • will be obsolete or replaced soon, making it cheaper to cull out or correct the non-conformances for the time being • will be rectified automatically later on in the process, and/or • has a very low chance of occurring. An FMEA investigation is set up to help determine those things.

The FMEA Team

The FMEA team is typically drawn from a minimum of three different departments, although who is involved will vary depending on the intent of the FMEA and the size of the organization. In a smaller organization, such as a small business, there may be only one or two people involved. If the team is very small, the FMEA is still considered from the perspectives of the roles shown in Table 1. Those typically involved and their departments are shown in Table 1. Note: A customer, group of customers, shareholders, and investors might also be considered stakeholders.

ROLE FMEA Coordinator

DEPARTMENT • Quality Assurance & Reliability • Business owner • Engineering

Stakeholders

• Have an interest or area of responsibility that would be impacted by adverse conditions or fallout

Subject Matter Experts (SMEs)

• Have responsibility for the tasks in the areas under the FMEA’s review • Have oversight or control of a main element under review, e.g., databases, sales, or regulatory compliance • May actually conduct the tasks being analyzed

Implementers Table 1. The Team.

• Those responsible for carrying out the recommended improvements or changes

6  Overview

Role Contributions

The contributions of the various roles associated with an FMEA are shown in Table 2.

ROLE FMEA Coordinator

CONTRIBUTIONS • Identifies and assembles the team for the FMEA study • Performs the actual FMEA study • Calculates the FMEA figures • Brings concerns to the appropriate individuals • Makes the final FMEA report • Archives the finalized report and any relevant data or documents

Stakeholders

• Give insight into the organization’s goals or plans that may impact current operations or customer base • Give insight into regulatory, industry, or technology changes or trends that may impact current operations or organization’s customer or client base • Convey any current failure concerns of their customers, both internal and external • May indicate others who may have input for the investigation

Subject Matter Experts (SMEs)

• Provide the expertise for the operations and tasks in their respective areas • May relate knowledge of past failures • Convey any current failure concerns of their customers, both internal and external • Provide the expertise for preventing or resolving failures, including workarounds, in their respective areas • May indicate others who may have input for the investigation

Implementers

• Do the hands-on work for making changes or improvements • Alert the FMEA Coordinator of any issues that arose from making the changes or improvements • Report back to the FMEA Coordinator about the efficacy or success of the changes or improvements

Table 2. Contributor Roles & Contributions.

Overview  7

Team Constraints Because an FMEA is examining vulnerabilities and an organization typically does not want to make its vulnerabilities public, the FMEA team is almost always drawn from within an organization.

Outside Inputs

If warranted, external stakeholders and SMEs may contribute information as well. There are instances when customers or regulatory representatives are asked for input for future planning or continuous improvement efforts. There may also be situations when collaborative efforts between different organizations, with eliminating vulnerabilities as a major goal of a project, that may require considerable transparency. As a general rule, though, external contributors are usually unaware that their comments or other information are being used in an FMEA.

Records

FMEA records and supporting data are extremely important as they: • can help to speedily identify potential problem areas if an issue arises • eliminate the need for redundant work in a future FMEA • help pinpoint areas that would benefit from a continuous improvement effort, and • contribute proof showing due diligence if a liability issues arises. The records pertaining to an executed FMEA are shown in Table 3.

DOCUMENT TYPE

DESCRIPTION

LOCATION

Executed FMEA Form

FMEA Template

Determined by FMEA Coordinator

Supporting data & documents

Varies

Archived with executed FMEA

Table 3. Records Pertaining to an FMEA.

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Guidelines for Using FMEAs

Introduction

An FMEA is about prevention, not detection, because it: • defines what can fail • identifies the things that most likely would cause these failures • provides an in-depth analysis of how far a failure would have an impact, and • indicates where the severest risks lie so that they may be mitigated or eliminated before they occur. This section provides what should be taken into consideration before performing an FMEA.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Not a Requirement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Prevention vs. Cure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Information of Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Past Experience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Is It Significant?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Statistically Significant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Pareto Principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Critical Few. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Biggest Headaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 FMEAs & 80/20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Subjectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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10  Guidelines for Using FMEAs

Topic

Page

Eye of the Beholder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Verify the Understanding . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Be in Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Ratings Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Not a Requirement

An FMEA is an investigation and risk assessment tool.

Tool

An FMEA can be applied to many different kinds of situations.

Unless an FMEA is stipulated by a contract or a regulation, there is no requirement to use an FMEA.

With new elements, requirements, designs, or root cause investigations, it may be a highly desirable tool. However, it is not intended or called for in every instance regarding specifications or processes. Since an FMEA entails costs and time, use it when appropriate. Common sense should prevail.

Prevention vs. Cure

An FMEA typifies “an ounce of prevention is worth a pound of cure.”

Information of Value

As a tool, an FMEA should be used when the investigation and process will provide information that is of value to an investigator or a decision maker. “No action necessary” is a decision and does contribute value as it helps to switch focus to what does need to be addressed, so an FMEA showing no vulnerabilities is a worthwhile study when going through a process of elimination.

Guidelines for Using FMEAs  11

Past Experience

It is not necessary to start from scratch with every FMEA. Past experiences are valuable assets when performing an FMEA. If prior work has already made certain determinations, and nothing has changed, the work does not need to be done again. If past experiences have shown certain vulnerabilities reoccur, the vulnerabilities should be reconsidered.

Is It Significant?

Be careful using general, vague terms such as saying that something is “significant.” It can be argued that if a matter is important enough to study, the matter holds significance on some level and is therefore “significant.” Note: This applies even if the decision is made that the matter is not currently enough of a concern to pursue at the moment. Significant is also a relative term, as in “significant with respect to what?” It is possible that something holds no significance to one thing or situation, but it is significant to something else. When determining significance, it is important to define how the thing is significant.

Statistically Significant

There are statistical methods that can determine if something is “statistically significant,” but these methods cannot be applied to everything. These tools are also beyond the intention of this book. If something is so important or critical that statistical certainty is required, an engineer or qualified quality professional would know the tools to be able to determine if something is statistically significant. There are simpler tools that can be used, such as the Pareto Principle, to separate the areas that should receive priority attention.

12  Guidelines for Using FMEAs

Pareto Principle

There are simpler statistical tools that can be used, such as the Pareto Principle, to determine the areas that need priority attention. The origins of the Pareto Principle are found in Italy. In 1906, an Italian economist, Vilfredo Pareto, concluded that 80% of Italian land was owned by 20% of the population. In 1937, quality guru Joseph M. Juran adapted the premise to show that 80% of quality problems are caused by only 20% of the factors impacting the situation. Juran called his observation the “Pareto Principle.” Juran named the 20% “the critical few.” The remaining 80% were initially called “the trivial many,” but later revised to “the informative many” in recognition that the remaining 80% are not inconsequential. Today, the Pareto Principle is more widely known as the 80–20 rule.

Critical Few

In layman’s terms, the critical few are the biggest headaches. Modifying or eliminating the elements in the 20% that are causing the quality issues produces the biggest returns and improvements. Once the problems associated with the critical few are eliminated, the remaining 80%, if desired, can be addressed. This remaining group is then broken into the 20% comprising the critical few of that group, with the remaining 80% set aside until addressed later. Theoretically, the process repeats until all issues are resolved. In reality, other issues will take priority. By focusing on the critical few, many of the remaining of 80% will be consequently resolved as well. Note:  See Appendix A on how to create and use a Pareto diagram.

Biggest Headaches

Why the 20% are the biggest headaches varies. It could be due to: • costs • efforts required to remedy • confusing, conflicting, obsolete, absent, or inadequate specifications or instructions • risks to the organization or humans • impacts on the customer or user, etc., or • the broad scope of inputs over which the organization has little or no control.

Guidelines for Using FMEAs  13

FMEAs and 80–20

While the remaining 80% provide opportunities for improvement as well, the best return for an improvement effort is to first concentrate on the 20%. The remaining 80% can be resolved later and those instances may be reduced, sometimes considerably, if the 20% are resolved first. An FMEA takes work. To get the best return from conducting an FMEA, consider the critical few before pursing improving the informative many.

Subjectivity

Certain classifications in an FMEA are subjective. For example, what determines if a failure is “too severe” or happens “too often?” Since people will define these categories based on their understanding of a term, agreement should be made with the team members and even possibly the stakeholders as to what comprises a classification so everyone is defining things the same way.

Eye of the Beholder

The perspective of managers, supervisors, or engineers regarding frequency of severity may differ from first-line workers for a number of reasons. First-line workers may view issues, non-conformances, and problems differently than other employees because they may: • not know how report certain issues or whom to contact • not know an issue does not exist because they –  have not personally encountered it themselves –  have not heard anyone else raise the issue • believe the situation is tolerable because they have developed their own personal workarounds to the problem and nobody has ever come to fix it • believe that “this is the way things are supposed to be” and what they are dealing with is correct • not want to get anybody into trouble by reporting a problem • be afraid of looking stupid or incompetent • be afraid of saying the wrong thing, so they state what they think the investigator wants to hear • believe the organization wants them to give an investigator or an auditor the impression that all is good and there are no problems, or • simply tolerate less-than-optimal situations because “nothing’s perfect.”

14  Guidelines for Using FMEAs

Verify the Understanding

Just because the words are the same, it does not follow that people mean the words in the same way. It may be necessary to first establish or verify that you and your audience are talking about the same thing. Start by stating your goals. Reassure your audience that there are no wrong answers. Then, if it is asked, “How bad is this?” or “Does this happen often?,” the investigator and subject will have a better chance of being in agreement with the answer.

Be in Agreement

Above all else, when using a broadly used term that is vague or general in nature, ensure that everyone has the same understanding regarding the term’s meaning. Remember: What may appear obvious or significant to one person or department may not be obvious or may appear insignificant to others.

Ratings Values

The numerical values assigned to the ratings classifications are subjective and, consequently, vary from one organization to another. Therefore do not be concerned if an organization states that a Risk Priority Number, or RPN, over a certain number is too high a risk for it but your organization uses a different number for its own unacceptable risk point. The values are according to what is important to, and what is specified by the organization using them. These may not be in agreement with another organization’s priorities. On the other hand, if two organizations are working together regarding risk, such as a manufacturer with a customer, it may be helpful if both organizations synch their rating systems to be in agreement in order to eliminate confusion and avoidable risks.

General Information

Introduction

Before starting an FMEA, it is helpful to know: • why FMEAs are used • what the various parts of an FMEA are used for • a brief history of FMEAs • where to use FMEAs, and • who benefits from an FMEA. Further information is found in the sections “FMEAs – When to Use” and “How to Conduct an FMEA.” This section provides general background information pertaining to FMEAs.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Cost Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 What If?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Three Formal Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Risk Assumption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 How Bad is Bad?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Failure Threat Importance. . . . . . . . . . . . . . . . . . . . . . . . . . 17 Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Risk Priority Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 When to Mitigate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Root Cause Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Mil–Std–1928A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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16  General Information

Topic

Page

Tiered Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Other Approaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 New Projects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Broad Applicability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 How Does This Apply to the Small Business?. . . . . . . . . . . . 20 The Morphing of Mil–Std–1629A. . . . . . . . . . . . . . . . . . . . 21 Sampling of FMEA Standards by Industry . . . . . . . . . . . . . . 21 Sampling of FMEA Guides. . . . . . . . . . . . . . . . . . . . . . . . . . 22

Cost Saver

Since it costs far less to prevent something than detecting, analyzing, and correcting a failure after the fact, an FMEA saves money. When it comes to specifications, prevention is best done at the planning and design stages.

What If?

An FMEA can be useful at feasibility and conception stages because it provides a structured method to answer questions such as “what if we did this?” or “what if this were eliminated or added?”

Three Formal Parts

For the purposes of this book, an FMEA consists of three formal parts: 1. Identification of a. potential failures b. the likelihood of them occurring c. what currently exists to prevent them d. what needs to be developed so they can be averted, and e. the impacts that can occur 2. Analysis of impacts and ranking their severity, should the failures occur. 3. Assessment of criticality – given all that is known after the evaluations, a determination is made of how adversely the organization would be impacted if the failure(s) occurred. Knowing the criticality of the impacts determines the level of efforts needed to avoid the failures.

General Information  17

Risk Assumption

The degree of how adverse an outcome or how much of a chance an organization is willing to take before that outcome or chance is considered unacceptable is known as “risk assumption.” Because all risks can never be eliminated, and some are far less likely to occur than others and/or are less likely to have a severe impact, risk assumption can also be thought of as how many problems and difficulties an organization can “live with” or is willing to absorb or assume.

How Bad is Bad?

Sometimes, an organization may already know where its limits lie. Those limits may have been set on experience, a comfortable guess, or internal or external directives. When risk limits are already known or established, an FMEA can show whether a proposition or change is acceptable (e.g., we can assume this because it falls short of the worst of what we are willing to accept), or is unacceptable (e.g., this exceeds how far we are willing to take a chance on something). If something is entirely new, risk limits may not yet be established. In that case, FMEAs can help organizations establish their risk limits by showing potential issues and problems.

Failure Threat Importance

If no threats of failure are determined, then there is no reason to follow-up with mitigation efforts. If failure threats are determined, the Risk Priority Number (RPN) indicates: • what must be addressed, and • what can be tolerated (what risks can be assumed).

Criticality Analysis

A formal analysis by which each potential failure mode is ranked according to the combined influences of severity and probability of occurrence.

18  General Information

Risk Priority Number

The Risk Priority Number, or RPN, is the FMEA analysis figure calculated by multiplying: • Severity number – how severe the occurrence would be to the organization, customer, system, operation, function, or a human being • Frequency number – how often the occurrence happens, and • Detection number – how easy it is to detect that the failure is likely to occur or how easy it is to locate the failure after it has occurred. The RPN is calculated at least once to determine how high a risk is present. If mitigation or corrective action efforts are implemented, then the RPN is calculated again to determine: • how much the risk was lowered, and • if the risk was lower to an acceptable level.

When to Mitigate

If the analysis reveals gaps, possibilities of failures, or things in need of corrective or preventive actions, the RPN helps to indicate what must be corrected or prevented. There are instances where some things are so minor or rare that the costs to correct or prevent them outweigh any advantages gained by corrective or preventive actions.

Root Cause Analysis

If a failure happens later on, an executed FMEA is a valuable contribution to a root cause analysis because: • much of the work has been done already • areas most likely to fail have already been identified • efforts to mitigate the failures are known, and • control and prevention gaps are easier to identify. Many times, an executed FMEA is used as a starting point for a root cause analysis.

General Information  19

Mil–Std–1629A

The US military’s Mil–Std–1629A, Procedures for Conducting a Failure Mode, Effects, and Criticality Analysis, is the basis for many FMEA procedures that have developed worldwide over the years. Mil–Std–1629A’s foreword stresses that, while the objective of an FMEA is to identify all modes of failure within a system design, its first purpose is: • the early identification of all catastrophic and critical failure possibilities so… • they can be eliminated or minimized through design correction at the earliest possible time.

Tiered Approach

Mid–Std–1629A takes a tiered approached, stating that the Failure Mode, Effects, and Criticality Analysis (FMECA) should be: • initiated as soon as preliminary design information is available at the higher system levels, and • extended to the lower levels as more information becomes available on the items in question.

Other Approaches

Other departments within an organization are also concerned with preventing errors and mitigating risks. Organizations typically do this via: • high-level policies implemented as standard practices for conducting business • data handling and safeguards • computer and website security, and • fully understanding customers’ standard practices and specifications. FMEAs related to a project or root cause analysis typically take into consideration or build on the above.

New Projects

AN FMEA is an ideal tool when developing new programs.

20  General Information

Broad Applicability

An FMEA has broad applicability. Mid–Std–1629A emphasizes that the use of the FMEA is called for in: • maintainability • safety analysis • survivability • vulnerability • logistics • support analysis • maintenance • plan analysis • failure detection, and • isolated or subsystem design.

How Does This Apply to the Small Business?

It may be tempting to dismiss military concerns as not applying to a small business, but take a quick look at some examples of how the military’s categories can also apply to a small business: • Maintainability – Small businesses need to keep certain operations and equipment. What are the backup plans if something goes wrong or is unavailable? • Safety analysis – Safety spans from people not getting hurt on the job or by using a product to protecting information or unauthorized access. • Survivability – If a catastrophe hits a small business, which plans make the most sense to ensure that the business can continue? • Vulnerability – What exists that could harm or undermine the company? • Logistics – Could anything be done more quickly or cheaper by other means? • Support analysis – Could things be done more efficiently by other means? • Maintenance – What needs to be maintained, when, and is it affordable? • Plan analysis – What would be needed to add a new product or service? • Failure detection – If something fails, would we know it? • Isolated or subsystem design – What are the special considerations a unique system or process needs beyond “business as usual,” can we meet them, and how will they impact what we have already?

General Information  21

The Morphing of Mil–Std–1629A was canceled on August 4, 1998, because its use had Mil–Std–1629A become so highly valued that different industries had adopted it to create their own versions of the standard. In other words, its value was wellrecognized and broadly adopted beyond military applications. The new standards provided cost savings to the military. It no longer had to maintain the standard; the industries and publishing organizations had assumed that. In addition to providing the next generation of risk assessment standards, the organizations that had adopted Mil–Std–1629A conduct periodic reviews and professional studies regarding how to improve and apply the standards. Sampling of FMEA Standards by Industry

A sampling of current FMEA standards and the organizations which publish them are shown in Table 4. Note:  There are many more FMEA standards besides these.

TITLE IEC 60812: Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA) IEC/TR 62343-6-6:2011(E) – Dynamic Modules – Part 6-6 – Failure Mode Effects Analysis for Optical Units of Dynamic Modules ISO 12132:1999 – Plain bearings – Quality assurance of thin-walled half bearings – Design FMEA ISO 14971 – Risk Analysis and Use of a DFMEA (Design FMEA) SAE J 1739-2009 (SAE J1739-2009) – Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA) Table 4. Sampling of FMEA Standards.

PUBLISHING ORGANIZATION IEC – The International Electrotechnical Commission is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic, and related technologies – a.k.a. “electrotechnology."

ISO – The International Organization for Standardization is an international standardsetting body composed of representatives from various national standards organizations.

SAE International is a global association of more than 138,000 engineers and related technical experts in the aerospace, automotive and commercial-vehicle industries.

22  General Information

Sampling of FMEA Guides

Many guides exist for using FMEAs and may be found in articles, books, and standards. Some of these are shown in Table 5. Note: An Internet search will pull up a cornucopia of information, training, and help.

TITLE Failure Mode and Effect Analysis: FMEA from Theory to Execution, Stamatis, D.H

ORGANIZATION American Society for Quality

Failure Mode and Effects Analysis (FMEA) – Training FMEA for Beginners – Training ISO Guide 73, Risk Management Terminology, 2009 ISO Standard 31000-2009, Risk Management – Principles and Guidelines, 2009 ISO Standard 31010, Risk Management Techniques, 2009 Table 5. Sampling of FMEA Guides.

ISO – The International Organization for Standardization is an international standardsetting body composed of representatives from various national standards organizations.

When to Use

Introduction

FMEAs provide tremendous benefits and guidance in many areas. This section provides guidance on the general areas where an FMEA can be utilized.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Known High Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Unknowns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 New Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Conception & Feasibility. . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Before Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 During Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 During Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Before Implementing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Assisting Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 New Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Policies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 After a Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Continuous Improvement Efforts. . . . . . . . . . . . . . . . . . . . . 25 Quality Recognition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Malcolm Baldrige National Quality Award. . . . . . . . . . . . . . 26

23

24  When to Use

Known High Risks

Certain elements are known to always present high risks. These are typically controlled by policies, requirements, and standard operating procedures. If there is any uncertainty regarding the adequacy of these controls, then an FMEA is advisable. However, if the organization has confidence that these controls are sufficient, an FMEA would be a redundant and wasted effort.

Unknowns

If something is introduced that is an unknown and its impact on the organization has not been fully examined, an FMEA is an excellent tool for determining adverse impacts.

New Regulations Systems, policies, and methods are subject to changes from outside an organization. New regulations may alter what was previously identified at risk and what was not. An FMEA would help to determine if any new risks have appeared that need to be controlled. Conception & Feasibility

An FMEA can be extremely useful in conception or feasibility stages. Many organizations routinely utilize FMEAs at these points.

Before Design

Before beginning to design something such as a product, plan, compliance effort, or service, an FMEA can help identify how to best approach the design.

During Design

FMEA can be useful during design to evaluate a particular approach, idea, or method from a broad, general level down to detailed specifics.

During Modifications

If something is to be modified, an FMEA can help identify which modifications would best meet the desired changes.

Before Implementing

Implementing a policy, method, part, product, or service has its own sets of risks and requirements. An FMEA can be useful here.

When to Use  25

Assisting Customers

When responding to a customer’s or client’s inquiry, an FMEA can be used to address their concerns. The FMEA methodology can reassure the organization that their customers’ or clients’ concerns have been heard and taken into consideration.

New Products

An FMEA is recommended for all stages of new products from concept to customer or consumer use.

Policies

An FMEA may be used for assessing the adequacy of policies and manuals.

After a Failure

An executed, completed FMEA can be helpful during a root cause analysis. An executed FMEA presents previously identified risks and controls that were in place to prevent the failures.

Continuous Improvement Efforts

Quality Recognition

Many organizations seek to improve their reputations with customers or clients via continuous improvement efforts. An FMEA helps to determine which investments would be the most beneficial for enhancing the organization’s reputation in the community or with its customers and clients. Some organizations plan on becoming recognized as industry leaders or being the best in their fields. An FMEA is useful for planning the most effective approaches to achieve quality awards for excellence: • in one’s industry or field • given by customers or clients, or • awarded by government agencies, such as the Malcolm Baldrige Award.

26  When to Use

Malcolm Baldrige What is the Malcolm Baldrige (as it is commonly known)? National Quality “The Malcolm Baldrige National Quality Award is the highest level of national Award recognition for performance excellence that a U.S. organization can receive. Congress established the Baldrige Program in 1987 to recognize U.S. companies for their achievements in quality and business performance and to raise awareness about the importance of quality and performance excellence in gaining a competitive edge. “Congress originally authorized the Baldrige Award to include manufacturing, service, and small business organizations; Congress expanded eligibility to education and health care organizations in 1998. Nonprofit organizations, including government agencies, became eligible for the award in 2007. “A total of 18 awards may be given annually across the six categories— manufacturing, service, small business, education, health care, and nonprofit. Within the overall limit of 18, there is no limit on awards in individual categories. “To receive the Baldrige Award, an organization must have a role-model organizational management system that ensures continuous improvement in the delivery of products and/or services, demonstrates efficient and effective operations, and provides a way of engaging and responding to customers and other stakeholders. The award is not given for specific products or services. “The Baldrige Criteria for Performance Excellence provide a framework that any organization can use to improve overall performance. The Criteria are organized into seven categories: Leadership; Strategic Planning; Customer Focus; Measurement, Analysis, and Knowledge Management; Workforce Focus; Operations Focus; and Results.1” National Institute of Standards and Technology’s website, “Baldrige FAQs.” http://www.nist.gov/baldrige/about/baldrige_faqs.cfm

1

Stages of an FMEA

Introduction

This section provides explanations of the stages of an FMEA’s general process.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

FMEA’s Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Assemble the Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Verify Critical Concerns. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Identify the Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Identify Tasks & Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Identify Risks & Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Calculate Initial RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Making Improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Effectiveness of Improvements . . . . . . . . . . . . . . . . . . . . . . 30 Re-calculating the RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Control Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Control Plan Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Final Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Completing the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

27

28  Stages of an FMEA

FMEA’s Start

An FMEA starts by identifying the general area that will be examined, analyzed, or investigated. Among the infinite possibilities where an FMEA can be used, an FMEA analyst may want to: • examine what currently exists to get a better idea of what exactly is impacting an organization or happening within it • analyze how proposed changes may affect the organization, its customers or clients, or any operations • review processes, tasks, and any related steps for clarity, weaknesses, or possible areas for improvement, or • investigate why failures have occurred, customers are dissatisfied, or why the organization is not making the profits or achieving the goals it had anticipated.

Assemble the Team

Once what the FMEA analyzed has been identified, the next stage is to identify the team members, which are typically: • stakeholders • subject matter experts • managers, and • possibly customers or clients, if warranted.

Verify Critical Concerns

While most organizations believe they know their critical concerns and those belonging to their customers, systematic identification and verification of these concerns do not always occur. The FMEA provides the opportunity that the concerns related to regulatory authorities, the organization, and/or its customers’ or clients’ are formally: • identified, and • verified as current. Verifying the critical concerns strengths the value of conducting an FMEA and greatly assists in knowing which areas to target.

Stages of an FMEA  29

Identify the Target

Once the critical concerns are verified, the next stage is to fine-tune what is known up to this point in order to create a specific target. Precisely identifying what to analyze becomes easier once it is established: • where the analyst will begin looking • who are the stakeholders and others involved with the area, and • what concerns will be specifically addressed.

Identify Tasks & Steps

Once the target has been identified, the next stage is to: • break the target down into its tasks, and • identify the steps involved within each task.

Identify Risks & Rate

Once the tasks and the steps are identified, the next stage is to identify and rate: • any failures that can occur • where these failures can occur • what currently exists to prevent or detect these failures • how severely the organization, its customers, or clients would be impacted if these failures happened • the frequency of how often the failures occur, and • how easy it is to detect the failures.

Calculate Initial RPN

Once the risks, their severity, occurrence, and the ability to detect them have been identified and rated, the Risk Priority Number is calculated to determine if the organization needs to take action. If no action is necessary, then the FMEA is closed.

30  Stages of an FMEA

Making Improvements

If the organization determines that the risks are too high to assume, then improvements must be made to reduce or eliminate those risks. At this point, depending on the FMEA Coordinator’s expertise and authority, he or she may: • make a general recommendation that improvements are necessary and turn those efforts over to those who will determine where, how, and who will make the improvements, and • specify what exactly needs to be improved or changed and determine who will make those changes. Note: In some instances, the FMEA Coordinator may be the individual who carries out the improvements.

Effectiveness of Improvements

An FMEA does not simply identify risks and determine if improvements are needed or not. If improvements are required, the FMEA continues by determining if the improvement efforts have been effective in reducing the risks. This follow-up: • ensures that improvements have been implemented, and • determines if more action beyond the initial improvements is required.

Re-calculating the RPN

Once the improvements have been implemented, the risks to the organization are assumed to have been reduced. What is still unknown is how much the improvement actions changed the risks. It must still be determined if the risks: • have been brought down to an acceptable level, or • are still a threat to the organization. The FMEA Coordinator repeats the process of identifying what risks are now present and determining their severity, occurrence, and detectability. Once these are known, then the RPN is re-calculated.

Stages of an FMEA  31

Control Plan

If an issue or concern being addressed is complex, a series of actions or efforts in a number of different areas may be warranted. It may not be enough to prevent or mitigate only one thing. To ensure that the whole system, or process, has been addressed, a “control plan” is established. In order to ensure that no failure risks are involved with a final product or project, certain industries have developed standards and procedures to make certain all possibilities of failures have been identified and addressed. FMEAs are often tools used in these efforts. Note: Certain organizations and industries have established minimum requirements to ensure that risks have been identified and addressed. It is important to understand that “control plan” is a broad concept and specific definitions regarding what constitutes a control plan vary.

Control Plan Examples

While beyond the scope and intention of this book, examples of several types of commonly recognized control plans for identifying and mitigating risk are: • the US automotive industry’s – APQP—Advanced Product Quality Planning, and – PPAP—Production Part Approval Process, and •

the FDA’s medical device manufacturing requirements for – I/Q—Installation Qualification – O/Q—Operation Qualification, and – P/Q—Process Performance (Production) Qualification.

Final Report

Once the FMEA Coordinator is satisfied that the area or concern has been fully addressed, a summary and final report is made to the appropriate departments or individuals.

Completing the FMEA

The FMEA is completed after all of its relevant information is assembled and archived.

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Flowchart – FMEA Stages Identify the areas likely involved.

Assemble the FMEA team.

Organization’s

Identify & rate initial risks.

Yes

Are there risks that need to be controlled?

Identify critical concerns.

Determine what to analyze.

No

Prioritize & select controls.

Identify & rate new risks.

Implement the controls.

Test & verify that controls work.

33

FMEA completed.

Customers’ or Clients’

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High-Level Risk Assessments Introduction

General information can be sufficient to decide to do or not do something, or it can point to the direction that would be the wisest course to examine in detail or keep under a watchful eye. High-level risk assessments are therefore useful for brainstorming, either when broad-range changes may occur or when considering which future paths to take. Examples of when high-level risk assessments are useful include, but are not limited to: • implementation of new laws or policies • expanding business lines • considering new technology, or • changing suppliers. This section provides guidance on what is involved with high-level risk assessments and how to perform them.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

High-Level Matters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Fishbone Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Simple Cause and Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . 36 5Ms and 1E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Staying in Balance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Determine Investigation’s Level. . . . . . . . . . . . . . . . . . . . . . 38 Examples of High-Level Risk Questions . . . . . . . . . . . . . . . . 40

35

36  High-Level Risk Assessments

High-Level Matters

High-level risk assessments: • will be more general and less detailed than an FMEA dealing with a design or a process, and • may involve subject matter experts outside of the organization.

Fishbone Analysis

Since a high-level use of an FMEA does not usually permit changing anything outside of an organization, a fishbone analysis, a.k.a. Ishikawa diagram or a fishbone diagram, is a useful tool for evaluating the situation for risks. A fishbone analysis is called such because graphically it looks like a bony outline of a fish. The “head” of the fish is the situation under investigation. The “bones” of the fish are the six most common areas that quality professionals have identified as influencing the outcome of a situation. Note:  The “bones” are arbitrary classifications. They may be modified to suit the situation. As a general rule, a good place to start is with the standard categories on a fishbone diagram: • manpower, a.k.a. people • machines • methods • materials • measurements, and • environment.

Simple Cause and Effect

A fishbone diagram helps to visually identify in a simple, obvious way the elements that are contributing to a situation. For an illustration of a fishbone diagram, see the fishbone/Ishikawa graphic following this section. For instructions on how to create a fishbone diagram, see Appendix B.

High-Level Risk Assessments  37

5Ms and 1E

The six common fish bones are sometimes called “the 5Ms and 1E.” They are described in Table 6.

FISH “BONE”

DESCRIPTION

Manpower, a.k.a. “people”

The people involved with the matter

EXAMPLES High level • Lawmakers, stockholders, board of directors • Customers, market, general public • Clients, patients, consumers, users Lower level • Trainers, sales people, customer representatives • Operators, technicians, processors • Contactors, temporary help

Materials

The materials affecting the matter

High level • Laws • Press releases, announcements • Certifications, reports, audits Lower level • Raw materials used in manufacturing • In-take forms, registration forms, claim forms • Application forms, regulatory paperwork

Methods

The methods involved in the situation

High level • Regulatory requirements • Customer requirements Lower level • SOPs, work instructions • Hand assembly, computerized, voice, person-toperson

Measurements

The measurements related to the matter

High level • Compliance audits • Customer satisfaction surveys Lower level • Weights, lengths, time etc.

Table 6. 5Ms & 1E. (continued)

38  High-Level Risk Assessments

(continued)

FISH “BONE” Machines

DESCRIPTION The machines related to the matter

EXAMPLES High level • Computer systems • Transportation systems Lower level • Manufacturing equipment, office equipment

Environment

The environment impacting the situation

High level • Government regulations • Import/export • Political situations • Labor disputes Lower level • Physical location, utilities, lighting, ventilation, temperature • Employee base, education, repetitive work, training • Work demands & safety considerations

Table 6. 5Ms & 1E.

Staying in Balance

Like a child’s mobile, if one of these elements is changed, or if one of an element’s subcategories is changed, then the whole system can be thrown off-balance, sometimes subtly or, in a worst-case scenario, radically. A risk assessment will help to keep an organization in balance.

Determine Investigation’s Level

First, identify if the FMEA will address a high-level matter or something involving a design or a process.

High-Level Risk Assessments  39

Examples of High-Level Risk Questions

A high-level risk is something that occurs at or impacts the top of an organization with repercussions that flow downward. High-level risks can occur externally, such as deciding against pursuing a certain path because of the regulatory requirements associated with it and losing a customer, or internally, such as the loss of an executive or locating a business near an environmentally protected area. The types of high-level questions that an FMEA can help answer are: • If a certain law gets passed, how will that impact our organization and what would be needed to become compliant? • How we will be impacted if the city (or a competitor) decides to do X? • What will be impacted if a new building or the road changes will go through? • What happens if we fail to do Y? • If we choose to follow a certain path, what are the ramifications to ourselves, our customers, and our suppliers if we do?

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Graphic – Fishbone (Ishikawa) Diagram Manpower

Materials

Methods

Problem/situation

Measurements

Machines

Environment

41

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Planning and Design Risk Assessments Introduction

It is common for a small organization or business to say that it has plans for the future. When an organization plans for something to happen, it is creating a design. These plans are not always well thought out. Sometimes, the plans are more reactions to whatever recently happened. Little thought is given to consequences or effectiveness of what may be regarded as knee-jerk reactions because “action must be taken!” (In the quality field, this is known as “firefighting.”) Plans that are reactions often result in leading the organization as opposed to the organization controlling the path that will be taken. In addition to identifying, anticipating, and preventing failures, another benefit of an FMEA is that it helps guide an organization with its planning. This section providence guidance and examples of how design risk analyses can be used by the small business owner.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Broad Applications of Design . . . . . . . . . . . . . . . . . . . . . . . 44 Dealing with Problems as They Occur. . . . . . . . . . . . . . . . . 44 Plan for Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Obvious and Not-So-Obvious Designs. . . . . . . . . . . . . . . . . 45 FMEAs and the Organization’s Future. . . . . . . . . . . . . . . . . 45 Organization’s Identity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Examples of Shaping an Organization’s Identity. . . . . . . . . . 46 Fishbone Diagram for Identity. . . . . . . . . . . . . . . . . . . . . . . 46

43

44  Planning and Design Risk Assessments

Broad Applications of Design

“Design” is not necessarily limited to what is typically thought of as a creative endeavor, such as engineering effort to create a new widget or machine. Design also applies to situations when an organization decides how it wants to grow, what to add to its services or offerings, and even creating its identity. Design risk assessments are useful when addressing questions such as “What if we did this…?” or “What if we eliminated that…?” Design risk assessments can also take into consideration things such as “What if that bill becomes law?” or “What if such-and-such a business moves into our area?”

Dealing with Problems as They Occur

Many small businesses start out with one or two offerings. Naturally, all organizations would like to succeed. While every possible problem cannot be anticipated, assuming that the only way to deal with problems is when they occur is not true. Many potential pitfalls and obstacles can be identified and consequently prevented if a risk analysis is done during the design or planning stage.

Plan for Changes Changes occur constantly in an organization. Most changes stem from ideas, which mean somebody “designed” the ideas. Consider using an FMEA when planning for the future or when a change is unavoidable or desired.

Planning and Design Risk Assessments  45

Obvious and Not-So-Obvious Designs

Some design efforts are obvious, such as those that occur in Research and Development (R&D), product development, or design engineering. In organizations sophisticated enough to have those departments, regulatory requirements are usually in existence that require FMEAs or encourage their use. Other types of designing are not so obvious, such as creating an organization’s reputation or its identity. Other examples of when designs might not be obvious to a small business include: • changing the menu • adding a new product • extending or reducing the hours when the organization is open • rearranging the floor layout • adding or reducing personnel, and • adopting a business trend.

FMEAs and the Organization’s Future

Many business owners have vague dreams of expanding at some point, but the particulars are put off for now or will be addressed later. Dreams are inspiring, but the nitty-gritty details of getting an organization started can obscure the future, especially when resources are in short supply. Identifying future goals helps to determine if the organization is doing what is necessary to achieve those ends and if the actions taken today make sense in the long run.

Organization’s Identity

An organization’s identity gets molded by its customers and how well its products and services are received. But by planning for the less-direct influences, a pro-active organization can shape its future, reputation, and success. Knowing the path that an organization would like to take or intends to take in the future is important to making decisions today.

46  Planning and Design Risk Assessments

Examples of Shaping an Organization’s Identity

For example, does a company want to be known as environmentally friendly or “green”? That can influence: • which suppliers to do business with • which raw materials to buy • what manufacturing processes to use • what environmental controls would be required • where to locate a facility, or • which markets to target. Other examples are organizations that may want to: • help a particular group of people or businesses • offer something to a specific age group, or • be known as a leader in its field. Whatever an organization wants to consider as a possibility for its future can benefit from a design risk assessment. In other words, if an organization wants to be identified in a certain way, it can identify and better plan for what it would take to achieve that identity.

Fishbone Diagram for Identity

Knowing how an organization wants to be perceived is a tremendous asset for guiding employees and directing internal efforts and operations. In Table 7 are questions applied to the “bones” of a fishbone diagram that can be useful for determining what might be needed for an organization to achieve a certain public perception, market reputation, or identity. Notes: • These questions are not shown in any particular order. • Not all the questions would apply to every organization or business. • The questions are given as considerations; not every question needs to be answered. • These questions may also prompt other questions not given here.

Planning and Design Risk Assessments  47

TITLE Manpower, a.k.a. “People”

ORGANIZATION • What kind of expertise is needed? • When would this expertise be needed? • Do we have the expertise already? • Can the expertise be contracted? If so, what is the right contractor? • Would permanent expertise be needed? • Would it be possible to train current personnel to have the expertise?

Materials

• Would we be required or restricted to using certain materials? • Can we use the materials that we have on-hand today? • Would certain materials be forbidden for use? • How would our current customers be impacted if we changed our materials? • How much money would we need (money is a material) if we go this route? • Do we have sufficient funding to carry out such an effort? • Can we secure the necessary funding?

Methods

• What would we gain if we changed our method(s)? • Do we have the methods now that are needed? • Can our current methods be modified to achieve the desired goals? • What kind of training would be required? • How would our customers be impacted if we changed our methods? • Would any of our products or offerings be adversely impacted if we changed our methods? • Would changes to the methods require special handling of raw materials, byproducts, or waste?

Measurements

• What measurements would show if we are being successful? • What measurements would show if we were encountering issues? • What would we measure to determine profits or losses? • What measurements or data do we need to report elsewhere if we adopt what we are proposing? • How would we capture the information and data that is required? • Who would analyze that information? • Who would make the reports and at what frequencies and to whom?

Table 7. Fishbone Questions for a Design Plan. (continued)

48  Planning and Design Risk Assessments

(continued)

TITLE Machines

ORGANIZATION • Do we have the necessary machines and equipment if we make this change? • Would our current machines and/or equipment need to be modified? • What additional machine or equipment would be needed? • Would any of our current methods need to be changed or modified because of these machines? • Do we have the room to add new equipment or machines? • If we opt for this machine, would we eliminate others? • Would anything else be impacted if we eliminated machines that are currently in use or added new ones?

Environment

• Would our reputation be enhanced by making this change? • Would our reputation be adversely impacted by making this change? • If we ignore this matter, would our reputation be enhanced or adversely impacted in any way? • What is our competition doing? • Would this change make us a leader in any way? • If we don’t make this change, would we fall behind our competition in any way? • Would this change improve company morale? • What regulatory compliance issues would factor into this change? • Will there be added regulatory compliance issues if we make this change or ignore it? • Would additional licenses or certifications be required? • Would special processes or handling be subject to regulatory reviews or audits? • Are our customers requiring these changes? • In what direction is our customer moving?

Table 7. Fishbone Questions for a Design Plan.

Process Risk Assessments Introduction

Identifying what can go wrong and the risks that these failures present means progressively breaking down the components of what is under investigation. Once the FMEA Coordinator has identified the stages in the area under investigation, the next areas to be identified are: • the tasks involved with each stage, and • the steps involved with each task. This section providence guidance on identifying the general tasks in a stage.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Determine the Process to Assess. . . . . . . . . . . . . . . . . . . . . 49 General Process Areas to Evaluate. . . . . . . . . . . . . . . . . . . . 50 High Level Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Determine the Process to Assess

If a business or organization is brand new and going through its initial development stages, performing a risk assessment of every process is invaluable for planning and development. For established businesses or organizations, it is usually not necessary to evaluate every process within an organization. As mentioned in the “Guidelines for Using FMEAs” section, the Pareto Principle is an excellent tool for determining what is most important in terms of needing attention or evaluation. Within a process, the Pareto Principle can be used again to focus on what is most important. 49

50  Process Risk Assessments

General Process Areas to Evaluate

The general areas in a process to evaluate typically are one or more of the following: • What presently exists? • Is everything current or has anything become obsolete? • Will the current process be compatible with proposed changes or business plans? If not, what impacts will the changes make? • Where are there gaps in the process? • Why do these gaps exist? • Are the gaps tolerable? • What would be achieved if we eliminated the gaps? • What is needed in the process that is not currently present? • Is the current process the most efficient, best way, or cheapest way that the work or service can be done?

High-Level Matters

High-level matters: • will be more general and less detailed than an FMEA dealing with process, and • may involve subject matter experts outside of the organization.

Flowchart – Tasks of an FMEA Investigation What are the tasks of each stage?

What are the stages in the process?

Something needs to be assessed for potential failures.

What could fail at each step?

What could cause each of these failures?

What risks are assumed if failures were NOT mitigated?

Can these risks be tolerated?

What would the impacts be if these failures occurred?

How easy is it to detect the failures?

What exists now to prevent these failures?

What can be done to mitigate these risks?

No

Yes

Yes Does anything else need to be mitigated?

No

Would any failures occur now? No

FMEA completed.

Yes Continue assessing all stages until completed.

No

Develop mitigation actions.

Yes

Yes

Do other stages need to be considered?

Implement approved control plan(s).

Would any failures occur now?

No

Should control plans be considered collectively.

Develop control plan if necessary.

Yes

51

No

Evaluate control plans as a collective unit.

Obtain approvals for control plan(s) if necessary.

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Reliability

Introduction

Reliability is primary for companies. Their existence depends upon it. Without being able to rely on procedures and equipment that produce dependable results, an organization risks going out of business. Reliability is often used synonymously with “dependability.” Many methods have been developed to determine the reliability of the various aspects and functions of an organization. As organizations grow in size, complexity, and sophistication, full-time reliability engineers may be employed. Reliability engineers have an extensive set of tools available to perform their work. Which tools reliability engineers use and apply depends on the issues that their organizations are encountering or wish to avoid. For a small organizations, there is no need for a full-time engineer. The simple tools provided in this book, i.e., FMEAs, Pareto charts, and fishbone diagrams, can provide sufficient guidance and information to ensure reliability. For FMEA purposes, reliability is defined as the ability of something to perform as intended over a stated period of time.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Reliability Declines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Reliability Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Form, Fit, or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 One-Time Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Average Time Between Failures. . . . . . . . . . . . . . . . . . . . . . 55

53

54  Reliability

Reliability Declines

It is known that reliability declines. Nothing is static. Everything changes with time. Even though something may be operating as intended and is in optimal condition, reliability can still be affected or reduced due to: • obsolescence • changes in personnel • introduction of outside elements, and • new requirements, priorities, objectives, etc.

Reliability Goals

The goals of reliability are evaluated against a specified time period and include, but are not limited to: • an item is fit for its intended first and continued use • the capacity of a designed, produced, or maintained item to perform as required • the resistance to failure • the probability that an item will perform as intended, and • the durability of the item.

Form, Fit, or Function

When a failure is encountered, reliability engineers typically ask if the failure would affect the “form, fit, or function” of the item in question. It is assumed that the item’s form, fit, or function are the optimal design unless proven otherwise. Sometimes, unanticipated failures can bring about revisions that improve the item’s form, fit, or function. If the form, fit, or function would be affected, then the next step is to determine if a design change or some kind of safeguard could be put in place to prevent the impact.

One-Time Failures

A problem with determining reliability is that many times, a second failure never happens. The part is replaced or the situation is corrected. Would the failure happen again if interventions were not made? That is unknown. What is known is that the failure occurred once, and certain corrective and preventive actions were taken to prevent its reoccurrence. This information is invaluable when creating something new that may involve this kind of situation.

Reliability  55

Average Time There are instances when reliability engineers perform studies to determine Between Failures the average time between how often the same failure will occur. These studies are known as Mean Time Between Failures studies, or as they are more commonly known, MTBF studies. There are established methods and formulas for conducting MTBF studies.

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Failures

Introduction

In order to know what can go wrong, it is important to know first what constitutes a failure and what kinds of failures apply to the situation. This section provides information on failures.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Failure Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Failure Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 For the Want of a Nail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Hackers & Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Hind Sight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Types of General Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Types of Operational Failures. . . . . . . . . . . . . . . . . . . . . . . . 60 Failure Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Failure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Worst Case is Subjective. . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Why Worst-Case Scenario. . . . . . . . . . . . . . . . . . . . . . . . . . 61

57

58  Failures

Failure

A failure is the loss of an intended function under stated conditions. In layman’s terms, if something does not work as intended when wanted, then there is a problem. In the user’s or owner’s eyes, the item has failed. A failure is high-level because it is often not apparent: • what caused the failure • what the reason is behind the failure, and • how far the failure’s impact has reached. Example: If the doorbell doesn’t ring when pressed, all that is known at this point is that the doorbell did not ring.

Failure Effect

We do not know why the doorbell failed. We also do not know who, what, or how something was impacted by the doorbell not sounding its alert.

A failure’s effect is the immediate consequences on an operation, function or functionality, or status of some item. Example: The doorbell failing to ring caused the visitor not to make the delivery. While it is tempting to think that the only consequence of a failed delivery is that the delivery person must return another time, there are in fact many possible impacts and inconveniences caused by this failure.

Failure Levels

It is important to investigate what else might be impacted because the immediate impacts may seem minor in comparison to the far-reaching consequences of a failure. Example: The doorbell failing to ring causing the delivery person to leave may delay the recipient receiving important power-of-attorney papers on time, which, in turn, may cause a financial crisis due to the recipient now being unable to provide proof that he or she may sign and deposit a check in time to stop a foreclosure.

Failures  59

For the Want of a Nail

Unknown consequences are depicted in the poem, For the Want of a Nail.

Hackers and Failures

Former hackers and other software experts conduct studies and hold convention to identify and prevent vulnerabilities.

For want of a nail the shoe was lost. For want of a shoe the horse was lost. For want of a horse the rider was lost. For want of a rider the message was lost. For want of a message the battle was lost. For want of a battle the kingdom was lost. And all for the want of a horseshoe nail.

http://news.yahoo.com/hacker-barnaby-jack-unexpectedly-dies-ahead-hacking-com

Hind Sight

While some consequences of a failure may only be recognized in hindsight, the bulk of undesirable consequences from failures are already known and recognized. For example, it is common knowledge that certain consequences should be avoided. A partial list of these includes: • loss of human life • maiming of a person • access to or loss of confidential information • confidential information being sent to the wrong person or organization • access to or loss of money, and • lawsuits or regulatory sanctions due to failure to ensure certain safeguards.

Types of General Failures

The types of general failures include: • unanticipated • chronic • frequent • noticeable • hidden • costly, and • minor.

60  Failures

Types of Operational Failures

The types of operational failures are shown in Table 8.

TYPE Binomial

DESCRIPTION • Either works or it doesn’t

EXAMPLE Light bulb

• Failure is not noticed until item fails • May be able to anticipate failure • Regular maintenance may circumvent failure • May be cheaper to replace than to maintain Multinomial

• Contains multiple parts

Automobile

• Any part could fail • One part failing may not be detected or noticed • Other parts may still function despite one failure • System capability may continue • Multiple part failures may be required before whole system shuts down Continuous

• Consumption may be involved

Battery

• Deterioration or decline in function or ability may be noted and/or measurable • Lifespan is known • Failure can be anticipated • Maintenance and scheduled replacement can circumvent failure Table 8. Types of Operational Failures.

Failure Criticality

FMEAs assign levels of criticality to failures. There are standard, recognized levels of failure criticality. Many companies use only these while other companies may modify them to suit their business purposes.

Failures  61

Failure Mode

The specific manner (or way) a failure occurs in the function under investigation. Example: The doorbell doesn’t ring when pressed because, e.g., the battery is dead, the electricity has been cut off, a critter ate through the wire, the wire became corroded, sticky fingers caused the doorbell to jam, etc. Note: A failure mode can have multiple causes.

Worst Case is Subjective

The determination of a worst-case scenario is subjective. What may be the worst case to someone or something may be advantageous to another person or different situation. The worst case can be, but is not limited to: • loss of life • financial impact • disruption of business, or • upheaval of regular operations.

Why WorstCase Scenario

FMEAs look for the worst-case scenario because the assumption is: • if one can determine the worst case that can be happen, and • if the worst case can be prevented, then • the other failures that are not the worst-case scenario will be prevented as well.

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Failure Rankings

Introduction

Failure rankings are considered according to: • the severity of impact • the frequency of impact, and • the ability to easily detect the failure.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Failure Criticality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Determining Criticality . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Risk Priority Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 RPN Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Failure Criticality

FMEAs assign levels of criticality to failures. There are standard, recognized levels of failure criticality. Many companies use only these while other companies may modify them to suit their business purposes.

Determining Criticality

In order to know how critical an effect is, the risk assessor asks: • how severe would the impact be on the customer, people, system, or product • how often does something like this happen, and • how easy is it to know if something has failed?

63

64  Failure Rankings

Risk Priority Number

The Risk Priority Number, or RPN as it is more frequently known, is calculated by multiplying the values assigned from a severity rating scale. The values multiplied are: • Severity • Frequency, and • Detectability.

RPN Threshold

RPN values are guidance. Common sense must prevail to determine whether or not action must be taken. There is no RPN threshold that establishes when the RPN is: • above a certain value, action must be taken, and • below a certain value, action need not be taken.

Criteria for Severity

Introduction

The criteria against which to evaluate how severe a potential failure may be measured against are: • the life and safety of a person or the organization • the financial impacts of such a failure (lost income, regulatory fines, lawsuits, etc.) • the financial costs to repair such a failure • the loss of confidence by the business owners or customers with such a failure, and • the degree of harm inflicted.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Subjective Severity Criteria . . . . . . . . . . . . . . . . . . . . . . . . . 66 Damage Not Always Evident. . . . . . . . . . . . . . . . . . . . . . . . 67 Costs Not Always Obvious . . . . . . . . . . . . . . . . . . . . . . . . . 68 Catastrophic Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Salvageable or Not. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Major Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Salvageable for Major Failures. . . . . . . . . . . . . . . . . . . . . . . 70 Impact Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Moderate Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Moderate Failures – Ability to Repair. . . . . . . . . . . . . . . . . . 70 Minor Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Minor Failures – Ability to Repair. . . . . . . . . . . . . . . . . . . . . 71

65

66  Criteria for Severity

Subjective Severity Criteria

The severity of a failure can be measured objectively, but there are subjective failures as well. Subjectivity typically is relative. What an organization may not hold as noteworthy, because its process or products are not impacted, may have considerable impact on a customer using that organization’s products or services. (This is a major driver of configuration management.) A sample table showing subjective criteria for evaluating the severity of an organization’s failure on a customer is shown in Table 9a. A sample table showing subjective criteria for evaluating the severity of an organization’s failure on the organization/business is shown in Table 9b. Note: There is a classification of “Significant,” but aren’t all the classifications, with the exception of “None,” significant to one degree or another? “Significant” needs to be defined.

EFFECT

RATING

CRITERIA

Extreme

6

Fails to comply with regulatory requirements

Major

5

Customer experiences downtime or excessive failure rates, and substantial costs are incurred

Significant

4

Failure is significant and customer rejects

Moderate

3

Failure results in confrontation with customer, and additional costs are incurred

Slight

2

Customer is dissatisfied, but still uses the products or services

None

1

Would have no effect on the customer

Table 9a. Subjective Criteria Example for Severity as it Would Impact a Customer.

Criteria for Severity  67

EFFECT

RATING

CRITERIA

Extreme

6

The organization would cease to exist/go out of business.

Major

5

Major loss of market share or competition gains major advantage

Significant

4

Significant sales lost and/or customer base; organization develops poor reputation

Moderate

3

Reduction of sale and less repeat purchases or orders

Slight

2

Some inconvenience and increased costs to organization

None

1

Would have no effect on the organization/business

Table 9b. Subjective Criteria Example for Severity as it Would Impact the Organization/Business.

Damage Not Always Evident

Most people know of someone, or have heard of someone, whose car was in an accident and was designated “totaled” by an insurance company, but the car looks like it could be used again with only a little repair. Some may reason that the car is going to waste, but there are other factors to consider besides repair. Damage can occur on many levels. Some levels are not easily detectable and some can never be seen. We know from experience the consequences that can and do result from unseen damage. The reliability experts take these into consideration. Part of what insurance companies consider is if a component or element can be guaranteed to operate or function as intended after repairs are made. Rather than putting safety at risk, an insurance company will total the insured item as opposed to letting it go back into use. FMEAs look beyond the harm that was obviously done and consider the possible hidden damages as well.

68  Criteria for Severity

Costs Not Always Obvious

As with damages, the cost of a failure is not always obvious. Failure costs include the cost of not being able to conduct business, but can also include the costs of: • regulatory fines • lost or damaged reputation • personal injury lawsuits • competitor lawsuits • time • failure-to-deliver or perform-as-intended lawsuits • sanctions, and • loss of personnel and expertise.

Catastrophic Failures

Catastrophic failures mean the whole entity has been impacted. When a product fails to perform as intended, resulting in the loss of a human life, it is easy to regard that failure as catastrophic. Businesses have also lost their “lives” due to catastrophic failures happening to or originating within their companies. Examples: Acts of Nature – A tornado that physically wipes away a business that had stood in one location for years is a catastrophe happening to a business. Acts of People – Unethical practices, such as what happened with Enron, is an example of a catastrophe originating within a business. The financial costs are prohibitive, substantial, or may entail bankruptcy.

Criteria for Severity  69

Salvageable or Not

There are some catastrophes that can be overcome. These would be considered salvageable failures. Examples: Acts of Nature – If an act of nature destroys the physical building of an organization, but the organization has sufficient means to rebuild, and its data, procedures, and other business information are stored away from the physical location that was destroyed, it is possible to salvage that business. The organization’s reputation has not been lost. It can still thrive. Acts of People – Should an organization deliberately commit one or more acts so grievous that its reputation is permanently destroyed and it no longer has any creditability, regardless of any physical structures and information remaining intact, the organization has, for all intents and purposes, been wiped away. This type of catastrophic failure is typically not salvageable. On the other hand, the loss of a major customer, perhaps caused by failing to listen to the customer’s needs or requirements, may be catastrophic to an organization, but possibilities exist that the organization: • has enough resources to tide the organization over until new customers or clients can be obtained • learned from the incident and made enough internal changes to prevent such a loss from happening again with other customers or clients, or • was able to rebuild its relationship with the lost customers or clients to eventually gain back some or all of its business. In this case, the catastrophic failure is salvageable, but at significant costs.

Major Failures

A defining line between catastrophic and major failures is the totality of the impact: • A catastrophic failure is complete. It impacts the total of something (the whole thing). • A major failure is severe, but it impacts only part of something. The loss is not total. There are parts that were not impacted by the failure at all. Examples: Object – It may be necessary to replace the brake lines on a car while the rest of the vehicle is fully operational. Business – An organization may need to revise its confidentiality controls while its processing system is fully functional. As with catastrophic failures, the financial costs are prohibitive, substantial, or may entail bankruptcy.

70  Criteria for Severity

Salvageable for Major Failures

As with catastrophic failures, some major failures are salvageable and some are not.

Impact Differences

The difference between catastrophic and major failures is how much of the organization has been impacted. The financial costs alone may be the defining factor. Some things may cost so much to fix that they are not worth the investment.

Moderate Failures

A moderate failure falls short of being a major failure, but is more than a minor annoyance. Examples: Object – It may be necessary to replace a seatbelt on a car. The part most likely needs to be ordered, the car is out of service while the seatbelt is being replaced, and the cost is more than simple maintenance. Business – An organization may need to revise how a department handles something while the rest of the departments require no changes.

Moderate Failures – Ability to Repair

Moderate failures mean: • repair is possible • the item or thing can be restored to its original operating state • there is some inconvenience involved that may disrupt business, and • the cost involved is more than would be for a minor correction.

Minor Failures

A minor failure needs to be corrected, but the inconvenience and cost would be minimal. Examples: Object – The windshield wipers need to be replaced on a car. The parts are standard, in stock, can be quickly changed, and the cost is minimal. Business – An organization may need to correct the wording on a field, which is limited to one file and does not impact anything else.

Criteria for Severity  71

Minor Failures – Ability to Repair

Minor failures mean: • repair is possible • the item or issue can be resolved to its intended state • there is little inconvenience, and • the cost involved is negligible.

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Flowchart – Determining Severity Something needs to be assessed for severity.

Would the failure result in death or non-survivable harm?

Yes

No

Is failure severe & does it impact everything?

Yes

Failure is catastrophic.

No

Alert company of risk.

Are parts of business untouched, but impacts and costs to fix considerable?

Yes

Failure is major.

Yes

Failure is moderate.

No

Are business impacts and costs to fix less than considerable, but more than an annoyance?

No

Failure is minor.

73

Rate for severity.

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Criteria for Occurrence

Introduction

Occurrence rates the likelihood of failure. When determining the likelihood of a failure, reviewing prior failures of similar situations, processes, or products is helpful. The criteria for occurrence rankings fall under the categories of: • persistency of occurrence • frequency of occurrence, and • likelihood of occurrence.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Situational Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Remedies for Situations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Unavoidable Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . 77 Financial Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . 77 How Often?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Tolerating Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Measuring Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Is a One-time Failure OK?. . . . . . . . . . . . . . . . . . . . . . . . . . 78 The Importance of Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Taking Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Is “Too Often” Too Much? . . . . . . . . . . . . . . . . . . . . . . . . . 80 According to Whom?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Determining Acceptability. . . . . . . . . . . . . . . . . . . . . . . . . . 81

75

76  Criteria for Occurrence

Topic

Page

Guard Against Becoming Over Zealous. . . . . . . . . . . . . . . . 81 Good Enough. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Parts per Million. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 How Much Control is Enough?. . . . . . . . . . . . . . . . . . . . . . 82 Weigh the Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Too Stringent or Too Lax. . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Subjective Frequency of Occurrence Criteria . . . . . . . . . . . . 83 Tolerable Occurrences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Situational Occurrences

The circumstances under which a failure occurs constitute the “situational occurrence.” For example, if a tire goes flat on an automobile, that is considered a failure. However, what were the circumstances under which the tire went flat? Did the tire go flat because of: •

a blowout due to – hitting an obstruction in the road – the tire tread becoming too thin – the tire was a re-tread – a collision

•

a slow leak due to – picking up a nail in the tread – the tire being improperly mounted on the rim – the air valve was broken or dislodged – improper maintenance of the tire, or

• a blowout or slow leak due to – driving too fast on poor road conditions, or – incorrect tire size, model, or style being used

Criteria for Occurrence  77

Remedies for Situations

Identifying the situation under which the failure may occur helps to determine how to prevent or correct the occurrence. In the above example with the automobile tires, some of the failures: • may be unavoidable (collision, picking up a nail in the tire, or hitting an obstruction in the road), • could be prevented entirely (regular maintenance, using the correct specifications), or • could be avoided via training (don’t drive on certain types of roads, lower speed of vehicle under certain conditions, etc.).

Unavoidable Occurrences

If a failure is possible, but the occurrence is unavoidable, certain preventive measures might be possible to safeguard against the failure, but the costs of doing so need to be weighed.

Financial Considerations

Even if it is known that a failure may occur, how the failure occurs may be so infrequent that an organization is willing to assume the cost of replacing or fixing the item as opposed to preventing what will cause the failure to occur. There are a number of reasons for this, such as but not limited to: • the organization is waiting for a new generation of the item to be released • preventing what may cause the problem is actually more expensive than replacement or fixing, and • the failure is associated with something that is already designated for retirement.

How Often?

Determining how long something will run without failing is determining the frequency of occurrence. Studies can show that something will run as intended for X amount of hours, weeks, years, etc. Mean Time Between Failure (MTBF) is an engineering formula that is used when controlled failures can be forced or studied. When feasible, an average occurrence time can be established.

78  Criteria for Occurrence

Tolerating Occurrences

A common gut reaction is “one time is one time too many,” but when conducting an FMEA, every attempt is made to somehow quantify the frequency of failure. An example of a failure that is well-tolerated and would not fall under “one time is one time too many” is the loss of power due to a circuit breaker tripping: • The loss of power is considered the failure. • The circuit breaker performed as intended and therefore did not fail. • Switching the circuit breaker off-then-on to re-establish power is considered acceptable.

Measuring Occurrences

The frequency at which a failure occurs can be measured objectively. Those are stand-alone figures. It is possible to determine that something will fail after so many hours, weeks, days, months, years, etc. of operation. The time between failures does not determine acceptability.

Is a One-Time Failure OK?

A failure occurring once is usually one time too many. However, this is not always the case. Example: If a light bulb goes out in a display containing many light bulbs, such as a marquee at a movie theater, one or two failures may be aesthetically displeasing, but the functionality of the display remains acceptable. This partial loss of acceptability may be tolerable for a long period of time. It is even possible that it may never be repaired.

Criteria for Occurrence  79

The Importance of Logs

An example of the importance of logs can be seen in a vehicle that sometimes needs several attempts before it finally starts. Once the vehicle is operational, it is common to forget about the multiple attempts it took to get it started. If struggling to get the vehicle started happens only once or very infrequently, most likely the failure is tolerable – and forgettable. Be aware, though, that a partial loss of acceptability, e.g., sometimes it takes several attempts to get the vehicle started, can be the proverbial tip of the iceberg and indicate serious problems elsewhere. If these are not corrected in a timely manner, expensive repairs or complete loss of functionality may result either temporarily or permanently. This underscores the importance of keeping equipment logs, such as for maintenance, calibration, and operability. Many manufacturers use shift logs to communicate what happens from one shift to another. A one-time incident, by definition, means that it will not happen again. It may even be possible to forget the incident occurred. Multiple “one-time incidents” are actually “repeat occurrences,” and when viewed collectively may point to an underlying or more severe problem promising a much larger, negative impact.

Taking Action

Action to bring certain things back to their optimal state typically occurs when functionality is close to being or is completely lost. People tend to tolerate a lot until something is lost entirely. This is not acceptable from a reliability standpoint since one of reliability’s objectives is to continually satisfy the user. Therefore, while a user may tolerate that something is less than optimal, reliability seeks to: • define what would be considered reliable on a consistent basis, and • correct anything that might be detrimental to maintaining that state.

80  Criteria for Occurrence

Is “Too Often” Too Much?

Because problems are usually corrected shortly after they occur, generalities are often used to describe how often the failures are occurring. Since failures are not often recorded and typically are ignored if they do not directly impact somebody, people develop their own idea of how often they occur. Examples of how often failures happen, i.e., their occurrences, are usually described as: • “too often” • “once in a while” • “not that often,” and • “sometimes.” Generalities are not enough on which to base a decision. The investigator next needs to determine: • what is meant by the generalities used, and • the conditions under which the speaker envisions them.

According to Whom?

Acceptability of occurrences may vary from individual to individual simply because one person may be affected by the failure and another is not. The person who is not affected may assume that, since he or she is not aware of any adverse impacts, none happened. When it comes to reliability, this is a dangerous assumption to make. This is why it is so critical to research the failures and the history of similar items before assessing something as acceptable or not acceptable. Input from multiple users and stakeholders may bring an awareness of concerns or potential problems not otherwise known.

Criteria for Occurrence  81

Determining Acceptability

So how is occurrence acceptability determined? Many factors are taken into consideration, including but not limited to: • past performance • previous downtime • complaints, and • customer needs or expectations.

Guard Against Becoming Overzealous

In a desire to be the best, some organizations become overzealous with their stated quality goals.

“Good Enough”

If a mother orders wooden pencils with her child’s name imprinted on each pencil, and one in five pencils, or 20%, has a slight print imperfection, is this acceptable? For most adults, yes – and a child might never notice. There is, then, latitude within this situation to determine what is “good enough?”

It is not necessary for everything to be perfect. In fact, perfection can harm an organization by imposing unnecessary costs and cutting into the profits. Many situations and people can be satisfied with “good enough.”

On the other hand, if a parachute fails to open every 1,000 jumps, or every 0.1%, is this acceptable? Never. Parts per Million

There are quality programs that push for measuring defects by measuring how many are found out of every million items, a.k.a. parts per million. When it comes to a school child’s pencil, parts per million may be impractical because it requires too much effort or costs too much to make that achievable, and the consumer may not be willing to pay for the item with such a failure occurrence, as a pencil tip breaking, because it is a minor inconvenience. When it comes to protecting against the loss of human life or ensuring personal safety, parts per million makes sense.

82  Criteria for Occurrence

How Much Control is Enough?

The question now becomes, “What kind of control?” Again, that is relative and depends on “How important is it?” To determine that answer, consider how the purchaser of a custom-printed pencil would react to a misprint that occurs one in a hundred, one in a thousand, or one in a million pencils, and how much the purchaser would be willing to pay for each defect level of occurrence. For a cheap, disposable item that will be consumed, such as a pencil, the cost for preventing defects that run in 1 per million is impractical. Is it possible? Probably, but does it make sense for the organization or the consumer? It could overburden an organization while the consumer might refuse to purchase an item with the inevitable high mark-up passed along for achieving such a low instance (occurrence) of defects. Remember that there are always exceptions. If a parent or grandparent is special-ordering the pencil and is expecting the child’s name to be a first quality imprint, it might make sense to utilize some controls to ensure there are no misprints.

Weigh the Costs

Again, the frequency of occurrence, how and when the item will be used and by whom – and quite possibly the frequency of complaints – should be taken into consideration. Is there any acceptable number for loss of life due to the malfunctioning of an item? Certainly never to the deceased or those otherwise affected. However, public transportation carriers and the agencies that oversee them, along with the military, unofficially tolerate a certain number of lost lives. They will focus on safety and do their best to achieve it. They do not want any unintentional loss of life, but as we all know, it happens. There will never be a documented value for a tolerable number of lost lives.

Criteria for Occurrence  83

Too Stringent or Too Lax

A specification can be: • too stringent, causing unnecessary expenses and configuration impacts, or • too lax, resulting in preventable harm. When applying a numerical value for a tolerable or unacceptable number of occurrences, make certain that the numerical specification is reasonable or appropriate for the failure in question. It is understandable to seek and use what others have done, but caution must be executed; it is not always appropriate to implement another organization’s scales without questioning if the scale is appropriate. Adopting the criteria for occurrence can require modification because, for example, some organizations may use 50,000 or even 250,000 occurrences for a level. Since this book is intended for small business owners and nonengineers, “too many” occurrences may be as low as 5 or 10. There are no hard rules when it comes to knowing what to use for “occurrence.” To determine the appropriate number of occurrences, one must look at: • the situation, including complaints and past failures, and • the organization, its goals, and its policies.

Subjective Frequency of Occurrence Criteria

Frequency of occurrences depends on the item or issue in question. While it may be acceptable for a pencil point to break “every so often,” even several times a day, a parachute failing to open is never acceptable. A sample table showing subjective criteria for rating the occurrences of failures in general is shown in Table 10a. A sample table showing subjective criteria for rating the occurrences of failures at a small organization/business is shown in Table 10b. Note: As always, the rating scale, failure rate, and descriptions are arbitrary. For example, Table 10a could easily be modified into having only five ratings with no more than “20” as the rating for the effect.

84  Criteria for Occurrence

EFFECT

RATING

FAILURE RATE

CRITERIA

10

1 in 3

Failures almost certain to occur; history shows many failures

Very high

9

1 in 5

Very high number of failures

High

8

1 in 10

High number of failures

Moderately high

7

1 in 20

Frequent failures

Medium

6

1 in 80

Moderate number of failures

Low

5

1 in 400

Occasional number of failures

Slight

4

1 in 2,000

A few failures

Very slight

3

1 in 4,000

Very few failures

Remote

2

1 in 10,000

Remote number of failures

Almost never

1

1 in 30,000

Failures very unlikely

Almost certain

Table 10a. Subjective Criteria Example for Occurrence in General.

EFFECT

RATING

FAILURE RATE

CRITERIA

Almost certain

5

1 in 5

Failures seem to occur all the time

High

4

1 in 15

Failures occur frequently or too often

Medium

3

1 in 30

Failures occur more times than we like, but not always

Low

2

1 in 50

Once in a while, a failure will occur

Never

1

1 in 100

A failure has never occurred with this

Table 10b. Subjective Criteria Example for Occurrence at a Small Organization/Business.

Criteria for Occurrence  85

Tolerable Occurrences

There is no doubt that certain failure occurrences are tolerable. If the seat of a pair of pants wears out after five years of use, chances are good that most people will find this satisfactory. There are also individuals who place more value on how fashionable an item is as opposed to how long the clothing piece will last before it shows signs of wear. Since fashion is constantly changing, five years’ use of an item may be unimaginable. Therefore, what is tolerable depends on the item as well as the circumstances. In another example, nobody expects a flashlight’s batteries to last forever. Although users do not usually define a specific time period for the life of a battery, they do have certain expectations that battery replacements should not to happen “too often” and the longer the batteries last, the happier the users. Users understand that a flashlight’s batteries will fail eventually and that there will be a cost to replace the batteries, which are typically regarded as a minor inconvenience. However, if the flashlight’s batteries fail during a storm, a crisis situation, or an electric power loss, if there are no replacement batteries present or available, the failure is unacceptable, no matter how inexpensive it might be to replace the batteries.

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Flowchart – Determining Occurrence Something needs to be assessed for occurence.

Failure beyond control of system or process?

Determine when, where, & how often failure happens.

Yes

Can outside failure be anticipated?

Any previous failures for similar situations?

No

No

Are safeguards cost effective?

Failure element mechanical, training, etc.?

Rate for occurence.

Yes Yes

Yes

No

Can safeguard(s) be implemented?

Yes

Yes Use root cause CAPA as basis for improvement.

Determine how often failure occurs.

Yes

No

Was the root cause determined?

No

No

No

Yes

Yes

Can safeguards prevent or detect the outside failure?

Establish safeguards to prevent, correct, or detect failures.

Is the failure design related?

No No

87

Determine frequency of failure now.

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Criteria for Detectability

Introduction

Knowing when, how easily, and where a failure can be detected determines its rating for detectability. Some failures can be anticipated, in which case, prevention controls can be designed to prevent the failure from happening. Some failures are tolerable and, if detected after the fact, can be easily corrected.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Detecting When?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Detecting What?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Yes/No . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Subjective Detectability Criteria. . . . . . . . . . . . . . . . . . . . . . 91 Caution with Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Root Cause of Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

89

90  Criteria for Detectability

Detecting When?

Detectability of failures is easier to determine than the other criteria, because failures are often obvious. However, it is important to remember that detecting a failure will not always be possible. For example, building remodelers hoping to make a simple improvement or repair encounter problems that were hidden beneath a surface that appeared to be without issues or that a small repair would fix. In cases where detecting the failure is not easy or always possible, turn to what is the known reliability, for example, a roof will be good for 20 years, as well as taking into consideration what is known to cause damage, such as ice dams on a roof. When detectability is not easy, it becomes important to maintain logs and perform regular, recommended maintenance.

Detecting What?

Some failures are detected by controlling and monitoring the specifications. Other times, it may be cost prohibitive or impossible to check for an actual specifications, but it is possible to monitor or check the process which the item is going through to ensure that it is correctly processed. Examples: A Social Security Number (SS#) has a specific format, XXX-XX-XXXX. When setting up a field for a SS#, the field can be: • limited to accept only numerical characters • set-up to test for the presence of nine characters, and • set-up to test for certain numbers in certain placements that are never used by Social Security. When processing a member’s eligibility, one factor alone (a specification) does not determine if the member is eligible or not. Multiple requirements must be entered and if all of these test “true” as a collective unit, then eligibility is established.

Yes/No

Detectability of failure is often a simple case of yes or no: • Yes – something is present, something works as intended, etc., or • No – something is not present, something is not permitted, or something is not working as intended, etc.

Criteria for Detectability  91

Subjective Detectability Criteria

A sample table showing subjective criteria for rating the occurrences of failures in general is shown in Table 11a. A sample table showing subjective criteria for rating the occurrences of failures at a small organization/business is shown in Table 11b. Note:  As always, the rating scale, failure rate, and descriptions are arbitrary.

EFFECT

RATING

CRITERIA

Almost impossible

5

We have no controls in place to detect a failure.

Low

4

We have some controls in place that can detect certain types of failures.

Medium

3

We constantly monitor what we know has the potential to fail.

High

2

We have controls in place that will detect most potential problems so we can stop them from happening.

Almost certain

1

We know exactly what needs to be controlled; our prevention efforts eliminate the need to detect.

Table 11a. Subjective Criteria Example for Detectability in General.

EFFECT

RATING

CRITERIA

Almost impossible

5

We don’t detect failures; when they happen, we deal with them; they’re a part of life.

Low

4

If a customer complains, we respond, but we don’t change how we normally do things.

Medium

3

We usually notice when problems keep repeating and go looking for why the problems keep happening in order to make them stop.

High

2

Employees are trained to identify potential issues and log them in so we can respond swiftly.

Almost certain

1

We have systematically looked at all our processes, corrected potential problem areas, and implemented controls to alert us of any problems.

Table 11b. Subjective Criteria Example for Detectability at a Small Organization.

92  Criteria for Detectability

Caution with Definitions

Table 11a illustrates another problem with subjective criteria for detectability. Note that in the “Almost Impossible” category (rating 10), the definition states, “No controls in place to detect the failure.” This implies that controls, had they been in place, could have detected the failure. Situations can exist where no controls are possible, which is different from the above. In quality engineering, a “closed system” is one example of this. Note: A closed system is a process within a machine where there is no way to determine if the item undergoing processing is changing as it should. Proper processing can only be determined after the item has been completed process (after the fact). Examples of a closed system would be plating or pottery baked in a kiln. While there may be no way to detect how the item is responding in a closed-system process, it is possible to control the elements/variables controlling that process. Other controls include ensuring that the raw materials or pro-processing of the item are correct and optimal before the item entered the closed-system. “Almost impossible” can also include events or actions beyond the realm of, or control of, the item in question.

Root Cause of Failure

If something fails due to being impacted by an unanticipated unknown outside of its intended use, there would be no way that controls could have been in place to detect that failure. Rather, the failure is due to the unknown being able to reach or impact the item. Therefore, the failure is not actually due to the item. Example: If my fully functional automobile gets crushed by a meteorite falling from the sky and is no longer operational, the failure is not due to the car. Furthermore, no vehicle is ever going to be equipped with controls to detect falling meteorites. A better definition would be, “Failure is beyond the scope of the item.”

Flowchart – Determining Detectability Something needs to be assessed for detectability.

Identify where failures can occur.

Could design modifications eliminate failure?

Do controls detect if a failure occurs?

Identify where failures can occur.

No

Could design modifications detect failure?

Yes Yes

Could design modifications correct failure? Any remaining failure risks?

Process

No

Yes

Modify design to eliminate failure.

Does this apply to design or process?

Design

Yes

Modify design to detect failure.

Yes

Modify design to correct failure.

No No

No Rate for detectability risk.

93

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Criteria for Criticality

Introduction

“Criticality” is a word with multiple meanings and is often interchanged with “critical.” How critical something is to an organization is a relative consideration. An issue or a concern can be critical at one point and yet, at another point, not critical at all. For example, what is critical in a start-up phase differs from what is critical in the design or operational phases. Critical can be arbitrary, such as when an organization has designated its reputation as critical; a business owner may decide that the organization will be known as best in its city or for providing 24-hour service, friendly customer service, on-time delivery, etc. Critical can also be subjective, as when people go with a gut feeling, such as, “I don’t like the sound of that,” or “something isn’t right here.” There may or may not be any hard evidence backing these conclusions, but individuals will pursue them until they are satisfied no risk exists. A gut feeling is not necessarily unreliable. People can intuitively and accurately respond to something based on their training, skills, and experience.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Standard Critical Classifications. . . . . . . . . . . . . . . . . . . . . . 96 Critical is Subjective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Criticality is Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Once Can be Enough. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Moving Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Conformance to Requirements. . . . . . . . . . . . . . . . . . . . . . 97

95

96  Criteria for Criticality

Topic

Page

Not that Important. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Doing It Right the First Time. . . . . . . . . . . . . . . . . . . . . . . . 98 Short-Sightedness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Preventive Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 Sample Subjective Criticality Table. . . . . . . . . . . . . . . . . . . . 99 Standard Critical Classifications

Many organizations have adopted some version of the US Department of Defense’s classifications for criticality. Without applying these classifications to a specific industry or organization, they are generally regarded as follows: • Category I: Catastrophic – Involves loss of life or renders something so useless that it is beyond any recovery or repair • Category II: Critical – Involves severe personal injury, major property damage, or major system or functional damage that will cause significant downtime to the organization or company • Category III: Marginal – Involves minor injury, minor property damage, or minor system damage that would result in delays or loss of availability • Category IV: Minor – No personal injuries, property damage, nor system damage, but does cause unscheduled maintenance or requires minor repairs.

Critical is Subjective

Certain things are always important to an organization and would therefore be considered critical. For example, not violating laws and being in regulatory compliance. Making money would be another as companies exist to be profitable. What is critical to an organization, individual, or a customer is determined by those entities, and, therefore, is subjective.

Criteria for Criticality  97

Criticality is Objective

“Criticality” is more objective. It is not arbitrary. It pertains more to “either it is or it isn’t.” Criticality is concerned about: • continued functionality • low risk, and • probability of occurrence.

Once Can be Enough

A one-time determination of criticality can be enough and it may not necessarily take a formal study to conclude that. For example, ordering the wrong components, sub-standard raw materials, or processing a claim incorrectly. A one-time formal study to determine the effect of something may be desired in certain cases, such as “if we pursue this route, what negative impacts would doing X have on Y?”

Moving Target

Since what is critical or important can be a moving target, it is important to verify that anything that is considered critical at the time of the FMEA assessment is: • identified • still current, and • sufficiently defined to prevent misinterpretations.

Conformance to Requirements

For reliability professionals, quality is conformance to requirements, not “goodness,” “nice to have,” or something that might be considered superior. In order to have conformance to requirements, one must first have the requirements. While that sounds simple and obvious, the fact is that often guesses and “good enough” are used for requirements. Requirements often deal only with “what we want” as opposed to also considering “what we don’t want.”

98  Criteria for Criticality

Not that Important

There is a mindset that certain things are just “not that important.” This is sometimes interchanged with certain aspects being “not that critical.” It can happen that the classification “not that critical” is applied because looking into the matter would require some effort as well as delays. However, if dismissal ultimately costs an organization a loss of products, services, deadline adherence, reputation, customer satisfaction, or market share, or results in fines or sanctions, what was once considered “not that important” or “not that critical” is elevated, in hindsight, as something that should not have been overlooked. It is the lack of understanding of what is required, and failing to prevent the failures or failing to ensure that the desirable will happen, which adversely impacts an organization financially. The time, money, and effort that goes into correcting an unacceptable development far exceeds any time, money, or effort that would have gone into studying and designing to avoid such developments.

Doing It Right the First Time

Quality guru Phil Crosby dryly noted that, “There is never enough time to do it right the first time, but there is always enough time to do it over.” His book, Quality is Free, was based on the premise that if you know the risks, the needs, and concerns, you can design to prevent failures from happening and thus eliminate the costs of repair, delays, warranties, product failures, or dissatisfied customers. Crosby advocated that it is not good (the desired) quality that adversely impacts an organization financially; it is the cost of correcting and regaining ground lost by poor quality. These costs are unnecessary and avoidable.

ShortSightedness

While no organization has unlimited resources and time, dismissing something because it would require effort is short-sighted. Short-sighted thinking has resulted in avoidable costs and loss of business reputations. Phil Crosby called the short-sighted thinking “the cost of poor quality.”

Criteria for Criticality  99

Preventive Efforts

As an organization initially adjusts to routinely conducting in-depth analyses, because that type of analysis was not routinely done before, there is a demand on time and resources. Fortunately, most companies offer standardized products and services. Once standardized policies, products, and services are in place, future preventive efforts can reliably draw off of previous work. It will not be necessary to “re-invent the wheel” every time. The demands on research and development are reduced. The preventive efforts that ensure the good and prevent the bad are why Crosby said that “quality is free.”

Sample Subjective Criticality Table

EFFECT

Subjective criteria that could be used for a criticality table are shown in Table 12. In this example, the organization is considering a new product line.

RATING

CRITERIA

Severe

4

Cannot effectively compete in the market

Undesirable

3

A significant advantage has not been identified

Moderate

2

Would equalize standing with competitors

Minor

1

Slight advantage over current offerings

Table 12. Subjective Criteria Example for Criticality.

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Flowchart – Criticality Assessments Something needs to be assessed for criticality.

Identify what failures can occur.

Assessing for failure impact or reliablility?

Failure impact

Determine how far the failure impacts can reach.

Determine severity of impacts.

Yes

Reliability

Is failure easily detected?

Is risk tolerable?

Identify where failures can occur.

What are the current controls?

No

Can cost effective controls be created?

Yes

No

Alert company of risk.

Any remaining failure risks?

Yes

No

FMEA completed.

101

What is the probability of occurrence?

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Processes, Stages, Tasks, and Steps Defined Introduction

In order to effectively perform an FMEA investigation, it is important to be able to identify the main process involved and then break the process down into its stages and tasks, and then the steps that compose each task. Process, stage, task, and step all can be defined in multiple ways. The section defines process, stage, task, and step, as well as provides guidance on how to distinguish them from each other.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Process Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Stage Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Task Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Step Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Drilling Down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Outline Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Stages, Tasks, and Steps Examples. . . . . . . . . . . . . . . . . . . . 105 Process Definition

For the purposes of this book, process is a noun defined as a series of highlevel actions grouped into stages, also known as “phases,” directed toward achieving a general goal or objective.

Stage Definition

For the purposes of this book, stage is a noun defined as a group of actions within one high-level phase of a process.

103

104  Processes, Stages, Tasks, and Steps Defined

Task Definition

For the purposes of this book, task is a noun defined as one of a series of specific or clearly defined jobs or work efforts within one stage of a process.

Step Definition

For the purposes of this book, step is a noun defined as one action in a sequence of consecutive actions to accomplish a specific task.

Drilling Down

Moving from process to stages to tasks to steps is a “drilling down” effort. In other words, the FMEA investigator is moving from general, high-level information to specific activities in a progressive, more-detailed manner.

Outline Structure

One way to view how a process, stages, tasks, and steps relate to each is in an outline structure, as depicted below. Process 1. Stage 1 a. Task 1 i. Step 1 ii. Step 2 iii. Step 3 etc. b. Task 2 i. Step 1 ii. Step 2 iii. Step 3 etc. 2. Stage 2 a. Task 1 i. Step 1 ii. Step 2 iii. Step 3 etc. b. Task 2 i. Step 1 ii. Step 2 iii. Step 3 etc. 3. Stage 3 (continue by sequential stage with tasks and steps as appropriate)

Processes, Stages, Tasks, and Steps Defined  105

Stages, Tasks, and Steps Examples

Examples of the stages of a process, such as receiving a shipment, and some of its related tasks and steps are given below. Process – Receiving a Shipment Receiving Stages 1) Verify 2) Unload 3) Break apart 4) Re-palletize 5) Route 6) Stock Tasks in Verifying Shipment a. Verify the shipping destination is correct (if multiple delivery points) b. Items’ descriptions match items on purchase order c. Amount received matches amount indicated as delivered d. Cartons are inspected for obvious damage e. Sign for the shipment Steps in Signing for the Shipment 1. Amount delivered matches amount ordered 2. Carton labeling is correct and properly placed on cartons 3. Purchase order is indicated on paperwork 4. Sign & date 5. Route paperwork to Accounts Payable

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Graphic – Example of Receiving Process, Stages, Tasks, and Steps Introduction

A graphical depiction of a receiving process’ stages, tasks, and steps is shown below.

Receiving (Stages in a process)

Verify shipment (Tasks in a stage)

Signs for Items (Steps within a task)

107

• • • • • •

Verify shipment Unload Break shipment apart by need Re-pallatize by need Route according to need Stock any surplus inventory

• Verify shipping destination is correct (if multiple locations) • Items’ description matches purchase order • Amount received matches delivery papers • Items inspected for damage • Sign for items • • • • •

Verify delivered amount matches amount ordered Verify carton labeling & positioning are correct Verify purchase order is indicated on paperwork Sign & date Route paperwork to Accounts Payable

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How to Conduct an FMEA

Introduction

This section provides general guidance on how to conduct an FMEA. The flowchart following the section gives an illustrated breakdown of the main stages of an FMEA.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Identify What to Analyze. . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Identify the Stakeholders. . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Assemble the Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Verify Critical Concerns. . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Determine What to Analyze . . . . . . . . . . . . . . . . . . . . . . . . 111 Past Efforts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 FMEA Stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Advising Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Implemented Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Final RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Archive FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

109

110  How to Conduct an FMEA

Identify What to Analyze

Determine specifically what needs to be analyzed; in other words, identify the scope of the investigation. It should not be too broad, but detailed enough to provide information on which to base reasoned decisions. An FMEA can be used for an entire process or just certain elements of it. Also, there is no need to repeat a whole effort if a satisfactory investigation into something quite similar has been done previously and the information is still current. If an FMEA is still desired, consider limiting the FMEA to the area that adds new information to the study. If a scope has been examined and its limits have been reached, questions may still remain or new concerns may have arisen. In these cases, it is better to generate a new FMEA than to broaden the scope of the present one.

Identify the Stakeholders

Determine who has oversight of the areas that might be adversely impacted should a failure occur. Inform them of the proposed study and ask if they can assign someone to be the point person for the FMEA.

Assemble the Team

The team typically is comprised of: • the FMEA Coordinator (the person actually conducting the FMEA) • stakeholders or their designated representatives, and • subject matter experts.

Verify Critical Concerns

While certain concerns or requirements may have already been stipulated, certain things may have been overlooked. Before going further, verify that the following have been identified: • Product- or service-specific requirements • Departments, operations, personnel, etc., involved in the process • Any concerns, needs, and expectations of the above • Any security requirements • Any confidentiality requirements • Any other organization policies that might apply • Any other corporate policies that might apply • Customer needs, concerns, and expectations as appropriate, and • Any outside governances such as regulatory requirements.

How to Conduct an FMEA  111

Determine What to Analyze

After taking the critical concerns into consideration and meeting with the FMEA team, determine exactly what needs to be analyzed.

Past Efforts

Once the FMEA’s target has been identified, research and collect any information regarding past failures or efforts that relate to the matter or are similar in nature. Sources of information include: • Complaint records • Operational logs • Maintenance records • Gap analyses • Root cause analyses • CAPAs, and • Executed FMEAs.

FMEA Stages

The stages of an FMEA are shown in Table 13.

STAGE

DESCRIPTION

1

Identify what will be analyzed and why.

2

Identify the stakeholders, subject matter experts, and approvers.

3

Identify the tasks and their respective steps involved.

4

Identify the inputs/actions that can go wrong.

5

Identify the ways the failures can affect other things.

6

Identify the potential causes or sources of the failures.

7

Identify any controls in place to prevent failures.

8

Identify any controls currently in place to detect the failures.

9

Calculate the initial RPN and determine if improvement actions are desired.

10

If no improvements are required, the FMEA is closed; otherwise, recommendations follow.

11

Recommend needed changes and identify the individual(s) responsible for addressing the recommendations.

12

Identify the mitigation efforts and implemented controls.

13

Recalculate the RPN after the mitigation controls are in place.

Table 13. Completing an FMEA Template.

112  How to Conduct an FMEA

Advising Changes

Advising needed changes are recommendations.

Implemented Changes

Implementing changes will improve the RPN.

Final RPN

The final RPN is either:

Specific changes will be made by the appropriate subject experts in accordance with their policies and methods.

Recalculate the RPN after the prevention and detection controls have been implemented.

• the RPN determined when no changes are required, or • the recalculated RPN after changes have been implemented. Archive FMEA

Archive the completed FMEA along with its related materials, e.g., documents, policies, etc.

Flowchart – Conducting an FMEA Identify the areas likely involved.

Identify stakeholders.

Assemble the FMEA team

Organization’s

Complete investigation section on FMEA worksheet.

Identify any related executed FMEAs, root cause investigations, & CAPAs.

Calculate initial RPN.

Make report(s) as appropriate.

Make recommendation for changes.

Yes

Are there risks that need to be controlled?

Identify individuals responsible for developing and/or making changes.

Ensure mitigations & controls have been implemented.

Recalculate RPN after implementations.

113

Verify critical concerns.

Customers’ or Clients’

Determine what to analyze.

No

Complete FMEA form & archive FMEA-related documents.

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Graphic – FMEA Worksheet Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

Customer

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Process Stage – Describe the process stage under development or study. Potential Failure Mode – In what ways can the key input(s)/ actions go wrong?

1. 2. 3. 4.

Potential Failure Effects – In what ways can the above failures affect other things?

1. 2. 3. 4.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA.

1.

Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

1.

2. 3. 4. 2. 3. 4.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. 2. 3. 4.

Initial Rating – Create & use rating scales

Severity (S) – measure of the possible consequences of a failure to a user, customer, process, sub-process, or finished output. Frequency (F) – The probability of the cause of the failure mode occurring. Detectability (D) – The probability that the failure mode will be detected before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D

Recommended Changes – What are the recommended improvements?

1. 2. 3. 4.

Responsibility – Who is responsible for the recommended action(s)?

1.

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

1.

2. 2. 3. 4.

Updated Rating – Use the rating scales

Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item. Frequency (F) – The probability of the cause of the failure mode occurring. Detectability (D) – The probability that the failure mode will be detected before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D

Criticality Comments

1. 2. 3.

115

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Worksheet’s Structure and Purpose Introduction

The FMEA worksheet’s objective is to capture as much information as possible relevant to an FMEA analysis. This section describes: • how an FMEA worksheet is laid out • the differences between worksheet orientations • the importance of dating information • how to handle attachments and supplemental information, and • the main sections of an FMEA worksheet.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

The Layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 Worksheet’s Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 Worksheet’s Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . 118 Preferred Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 All the Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Beyond the Worksheet – Attachments & Supplemental Information. . . . . . . . . . . . . . . . . . . . . . . . . . 119 Types of Attachments & Supplemental Information. . . . . . . 119 Important. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Historical Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Preserving as Much as Possible. . . . . . . . . . . . . . . . . . . . . . 120 How Much to Preserve. . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Worksheet Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

117

118  Worksheet’s Structure and Purpose

The Layout

The FMEA worksheet is laid out in the logical progression of an FMEA investigation and analysis. In other words, the worksheet starts with the initial information and works through to the end of the study.

Worksheet’s Purpose

The worksheet’s objective is to ensure that all steps in the study have been addressed.

Worksheet’s Orientation

FMEA worksheet samples often show a worksheet laid out in a landscape (horizontal) format, which can be cumbersome if the user does not normally scan for information from left-to-right, but from top-to-down instead. Some assume that a left-to-right, horizontal orientation is the only way that an FMEA worksheet may be laid out. Since most English-speaking readers are used to documents being in a portrait (vertical) orientation, and scan for information from the top down, a vertical orientation is often an easier way to determine one’s progress through an FMEA, which is why the worksheet is presented vertically.

Preferred Orientation

A worksheet set up with a horizontal orientation means the reader must read long rows of information. Certainly, this is possible, but it is not the norm for most people, which can make the reader uncomfortable. An uncomfortable reader may miss important information or find it difficult to locate information previously read. None of these obstacles are so large that they preclude using a horizontal orientation if that is what is desired. Use the orientation that: • suits (matches) the formats of the materials associated with the analysis, and • is easier for those who will be reading the FMEA analysis. In the end, it is irrelevant for the success of an FMEA analysis if the worksheet information is laid out horizontally or vertically. It often comes down to personal preference.

Worksheet’s Structure and Purpose  119

All the Information

A worksheet is a summary sheet of the information used in an FMEA situation. It may not be possible or practical to include all the information relevant to an FMEA analysis on the worksheet, especially when that information: • contains one or more databases • are policies belonging to a customer or an outside authority, or • is published on a website or in a book.

Beyond the Worksheet – Attachments & Supplemental Information

Attachments or supplemental information may make up a part of an FMEA investigation. The attachments or supplemental information typically show: • what provided direction for the FMEA analysis • what the FMEA conclusions were based on, and • what information and/or policies were relevant at the time of the investigation.

Types of Attachments & Supplemental Information

Types of attachments or supplemental information may include: • hard copies of the relevant data (remember that data may be constantly update or fields revised – the objective is to capture the data that was used for the FMEA analysis) • links to databases • links to internal or Internet websites • screenshots of relevant information • blueprints or drawings • hard copies of policies, and • other documents.

Important

Always provide a date, revision (if applicable), view (if applicable), and source for every attachment or supplemental information used in the FMEA.

Historical Accuracy

Particularly for gap analyses or liability issues, an FMEA’s file demonstrates what was relevant and considered at the time of the FMEA analysis. Therefore, it is critical to cite, usually by date or/or revision, exactly what was valid at the time of, or used for, the analysis.

120  Worksheet’s Structure and Purpose

Preserving as Keep in mind that policies and methods change over time, sometimes Much as Possible frequently. Websites and databases can be in a continuous state of flux. Websites, databases, and any links can eventually disappear entirely. The FMEA investigator will understand that it will be impossible to capture everything that might be relevant or used in an FMEA, and it is also impossible to anticipate every future need for the information. Therefore, the FMEA investigator might want to: • create documents with the most pertinent information, e.g., screenshots pasted into Word documents and then saved, or • write up as a separate report what was found and record the sources of that information. How Much to Preserve

How much to preserve depends on the scope and purpose of the FMEA. Preserve enough so that anyone needing to review a completed FMEA will conclude that “due diligence” was exercised. Those who would determine what needs to be preserved may be: • the FMEA investigator • the FMEA’s approver • the customer requesting the FMEA, or • legal counsel.

Worksheet Sections

The main sections of the FMEA worksheet and their contents are shown in Table 14.

Worksheet’s Structure and Purpose  121

NO. 1

SECTION Header

CONTENTS Identification of: • what is being investigated • where investigation is being conducted • who contributed to the investigation, and • who conducted the investigation

2

Descriptions of Current Situation

Descriptions of: • what can go wrong • how things can go wrong • the sources of the potential failures, and • what is currently in place to prevent failures from happening (detection controls)

3

Rankings of Current Situation

Fields to enter the rankings of the: • severity of the impacts should the failures occur • frequency of failures occurring, and • the ease of detecting the possible failures

4

Recommendations for Improvements

Initial recommendations for the: • controls or changes to reduce or eliminate the failures, and • individuals, roles, or departments responsible for making these improvements

5

Actual changes

Description of what actually was done to mitigate or eliminate the possible failures

6

Rankings after Improvements

Fields to re-assess (rank again) the: • severity of the impacts should the failures occur • frequency of failures occurring, and • the ease of detecting the possible failures

Table 14. Sections of an FMEA Worksheet.

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The Value of the Worksheet Header Introduction

The FMEA worksheet header contains a goldmine of information for the FMEA investigator, quality professionals, developers, managers, auditors, and other interested parties. In order to understand the value of what the worksheet header offers, this section explains: • the importance of the header information • the differences between tasks and steps • why the information is so important, and • how future users may benefit from the information.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Completing the Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 N/A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 Optional Header Information . . . . . . . . . . . . . . . . . . . . . . . 124 Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 High Process Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Operational Processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Operational Task Examples . . . . . . . . . . . . . . . . . . . . . . . . . 126 Task Steps Example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 Header Process Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Process Header Information . . . . . . . . . . . . . . . . . . . . . . . . 128 Header Contributor Information. . . . . . . . . . . . . . . . . . . . . 130 Contributor Header Information. . . . . . . . . . . . . . . . . . . . . 130

123

124  The Value of the Worksheet Header

Completing the Header

Completing the header thoroughly and accurately is important for a number of reasons, including but not limited to: • efforts will not be unnecessarily repeated in future FMEA studies • the decision makers, i.e., the individuals involved, are readily identified • there is a record that all steps identified in the area under investigation were addressed and not inadvertently overlooked, and • in the case of a liability issue or major failure, a record of mitigation efforts exists.

N/A

To show that the field was taken into consideration and not overlooked, do not leave it blank. Instead, enter “N/A” (not applicable) in the field to indicate that particular field does not apply to the FMEA.

Optional Header Information

The header contains fields for entering information, but those fields may not apply to a particular FMEA investigation. The individual conducting the FMEA analysis must determine the appropriate optional fields to complete. The optional fields are: • Customer – the situation may not pertain to one particular customer or any customers at all • Design – sometimes a specific design is being assessed, but other times, a design may not be involved at all – complete as appropriate • Design Rev # – a design and its revision number may not be involved • Project ID # – sometimes an FMEA is part of a project that has its own ID number; if that is the case, include the number here for traceability purposes • Process Step & Process Name – A process may not be involved; for example, the situation may involve “what would happen to our market reputation if we did X or did not do Y” • Design Rev # – Applies only if a specific design and its revision are involved • SME #2 & SME #3 – It may not be necessary to involve a second or third subject matter expert or department

The Value of the Worksheet Header  125

Header

Below is the header on the FMEA worksheet. It is divided into two main sections: • Process section • Contributor section The process section identifies the process undergoing the FMEA analysis. The contributor section contains fields for the responsible job function or department contributing the FMEA.

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

Customer

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

High Process Levels

If the issue under the FMEA investigation is very high level, it may be regarded as an action, or inaction, as opposed to a process. Examples of high-level impacts would be, but are not limited to: • if X becomes law, how would that impact the organization • failing to disclose known hazards, or • offering a discount at a certain time of the year. In cases such as these, the intent is simply to determine the impacts and the possible risks if such events happened or failed to happen. There would be no process involved, and consequently, there would be no need for any tasks or steps.

126  The Value of the Worksheet Header

Operational Processes

All companies have their ways of conducting business, which are their “operational processes.” Note:  These should not be confused with “Operations,” which is concerned with how the organization maintains itself apart from the production or services the organization provides to its customers. All operations have at least three tasks: • receiving the work • doing the work, and • handling the completed work. Each of these tasks has at least three steps, activities that: 1. start the task 2. perform the task work, and 3. finish and route the work to the next task. Note: Section “Processes, Tasks, & Steps” provides detailed information on the above.

Operational Task Examples

An example of an operational task is needing to purchase something. The example of Engineering needing a certain type of software is shown in Table 15.

STEP

ACTION

1

Verify purchase request information is complete and accurate

2

Find supplier to make purchase from

3

Complete purchase form

4

Route purchase order to designated locations

Table 15. Purchasing Task – Make Purchase.

The Value of the Worksheet Header  127

Task Steps Example

In the above examples, Purchasing would not have only three tasks involved. Within each task would be a series of steps that would need to be followed to complete the task. The steps are the detailed activities. For the above example tasks, Purchasing may use the steps as shown in Tables 16, 17, and 18.

STEP

ACTION

1

Ensure that the purchase request has been approved.

2

Ensure that the information regarding what to buy and how much is accurate and complete.

3

Verify the “needed by” date.

Table 16. Start Purchase Request (Purchasing Task 1).

STEP

ACTION

1

Determine if there is anything unique about the item that it can only be purchased from one source, a.k.a. “sole supplier.”

2

Determine if any of the organization’s approved suppliers offer the item for sale at a price that meets the approved expense.

3

If approved suppliers offer the item, determine which supplier is offering the best terms for purchasing.

4

If no approved suppliers exist, find a supplier which would meet the organization’s purchasing policies, a.k.a. qualifying as a supplier.* *Qualifying a supplier has its own set of tasks, each with its own set of steps.

5

Select supplier based on the best matches determined from above appropriate steps.

Table 17. Find Supplier (Purchasing Task 2).

128  The Value of the Worksheet Header

STEP

ACTION

1

Obtain supplier’s ordering information for item.

2

Complete information on purchase order.

3

Send purchase order to supplier.

4

Route copy to Accounts Payable.

5

Upload purchase order into system so Receiving can access it when shipment is received.

Table 18. Place Order (Purchasing Task 3).

Header Process Section

Process Header Information

Below is the section of the header that pertains to the process under the FMEA investigation. These are grouped together for ease of reference. FMEA #

Task Name

Start Date

Total Steps

Process Name

Step #

The fields for the process header information, and the reasons why this information is provided, are shown in Table 19.

The Value of the Worksheet Header  129

FIELD NAME FMEA #

INFORMATION The number assigned to the FMEA study

REASONS FOR INFORMATION • Every FMEA study should be assigned its own unique number as part of document control • Serves as a quality control that the correct FMEA was obtained for a reference • A unique Identification number makes it easy to track down the information at a later date • Consider using two digits to identify the year in which the study was conducted in the identification number

Start Date

The date the FMEA was started

• FMEAs always have a start date, but they are not always completed • Be consistent with dating things – people can interpret dates differently • Without a date, FMEA study is meaningless because one cannot determine what time period the information applies to

Process Name

Task Name

Identifies the name of the process where FMEA applies

• Identifies what process this applies to, e.g., Receiving, Assembly, Claims, Finishing etc.

Identifies the task within the process

• Processes usually contain multiple tasks

• A process may have risks or needs for controls that other processes do not require

• Serves as a quality control that ensures that all tasks were identified • A separate worksheet should be used for each task in a process • Serves as a quality control that ensures that all tasks are addressed • Identifies if only one or a limited number of tasks were investigated

Table 19. Process Header Information. (continued)

130  The Value of the Worksheet Header

(continued)

FIELD NAME Total Steps

Step #

INFORMATION

REASONS FOR INFORMATION

Identifies how many steps in the task

• Identifies how many steps there are in a task

Identifies which step is being investigated

• Depending on the issue, it make be necessary to investigate every step in a task; this ensures each step is accounted for

• One task may be under investigation, but it is conceivable it is, for example, the fourth or another task in the overall process

• Depending on the issue, it may necessary to investigate only one step in task; this identifies which step was investigated and help to ensure the correct step received the investigation Table 19. Process Header Information.

Header Contributor Information

Contributor Header Information

Below are the fields in the header that contribute in some way to the FMEA. These are grouped together for ease of reference.

Facility

Project ID #

SME #1 / Department

Customer

Department

Manager

SME #2 / Department

Completed By

Design Rev #

Design

SME #3 / Department

Approved by

Certain factors and individuals provide parameters for or contribute to an FMEA analysis. The fields for the contributor header information, and the reasons why this information is provided, are shown in Table 20.

The Value of the Worksheet Header  131

FIELD NAME Facility

INFORMATION The name of the facility involved with the FMEA

REASONS FOR INFORMATION • An organization may own multiple facilities • An organization may move its facility to a new location – a change of location can alter or increase risks • A process can be spread across multiple facilities • Certain steps may be outsourced • The FMEA may be conducted off-site, such as at a supplier’s or customer’s facility

Department

Design Rev #

Name of the department the step belongs to

• Steps can flow through multiple departments

Input the design’s revision number

• Designs are sometimes repeatedly assessed by revision

• Serves as a quality control that the step was associated with the correct department

• A revision to a design can significantly increase, mitigate, or eliminate a risk; it is paramount to know which design revision was used Project ID#

The ID number relevant to the FMEA

• Some companies keep track of efforts by project ID numbers • There may be concerns or situations unique to one project only

Manager

Design

Name of the manager responsible for area under investigation

• Identifies the decision maker in the area under the FMEA investigation

Name of the design being assessed

• An FMEA can be used to evaluate a single, specific design

• Provides the go-to person if any questions arise or if improvements are to be implemented

• FMEAs can be used to evaluate a series of different designs • Sometimes, the design and its revision are critical contributors to the FMEA Table 20. Contributor Header Information. (continued)

132  The Value of the Worksheet Header

(continued)

FIELD NAME SME #1 & Department

INFORMATION Name of the second Subject Matter Expert and/or the department involved

REASONS FOR INFORMATION • The person conducting the FMEA may be the only subject matter expert involved with the FMEA • Readily identifies who contributed the most information to the FMEA • Sometimes the name of the department is more valuable than the name of the individual – for example, the name of a government representative who answered a question may not matter, but government agency that provided the information is

SME #2 or 3 & Departments

Customer

Name of the second and third SME and/or the department involved

• Readily identifies who contributed the second and third most information to the FMEA respectively

Name of the customer for whom the FMEA is being conducted

• Sometimes, because of liability risks the customer may be facing, it may request an FMEA to be included as proof that it being diligent

• As with SME #1, identifying the department, as opposed to an individual, may be the significant information

• Sometimes, a customer may have a request so out of the norm of the organization’s regular activities that the organization might wish to see what kind of risks the customer’s needs may impose Completed by

Approved by

Name of who entered the information on the FMEA form

• The individual conducting the FMEA is almost always the person who completes the FMEA form

Name of the individual responsible for approving the conclusions of the FMEA

• An FMEA may be requested by someone who does not conduct the FMEA

Table 20. Contributor Header Information.

• Sometimes, a person might be assigned to complete an FMEA on behalf of somebody else

• Identifies who took responsibility for the risks determined by the FMEA and any subsequent mitigation or improvement efforts

Before Starting the FMEA Introduction

Before starting the FMEA, it must be set up administratively. This section covers what must done before conducing an FMEA.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Tracking FMEAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 Information Will Get Lost. . . . . . . . . . . . . . . . . . . . . . . . . . 134 FMEA Unique Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 FMEA Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Departments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Responsibilities & Activities Change. . . . . . . . . . . . . . . . . . . 136

133

134  Before Starting the FMEA

Tracking FMEAs

The easiest way to track FMEAs is by creating an FMEA log or database. A log or database allows for fast information retrieval when researching historical FMEA activities. Include in the log or database information: • the unique number assigned to each FMEA • a brief description of the FMEA’s study • synopsis of the results, and • start and end dates More fields for information may be added if deemed helpful, such as: • main determinations from the study • actions that were taken • when the implementations were concluded, and • comments.

Information Will Get Lost

When involved with an FMEA, it may seem impossible to forget what was done, how, when, or why, but as time goes on and other things demand attention, details become blurred and it does become easy to forget. Memory is not the only concern. The individuals involved may leave the company, for any number of reasons, or may be unavailable when information is needed. Responsibilities change as well. Save yourself headaches, time, and unnecessary costs by keeping a log of the FMEAs.

Before Starting the FMEA  135

FMEA Unique Number

The easiest way to assign an FMEA number is by using an established format that changes sequentially. An example would be FMEA-YY-XXX, where: • FMEA indicates that the matter pertains to an FMEA analysis and helps to ensure the information will get filed correctly • YY is a two-digit number for the year, and • XXX is the sequential number. Thus, the respective numbers for first three FMEAs conducted in 2015 would be: • FMEA-15-001 • FMEA-15-002, and • FMEA-15-003.

FMEA Log

An example of how an FMEA log may appear is shown below. The main purpose is to establish a system for keeping track of FMEAs by assigning each one a unique number. What else is included and how much detail depends on the needs of the organization. FMEA Log

FMEA #

Description

Start Date

Determinations

Implemented Actions

Completed

FMEA-15-001

Evaluate FDA revision

1/16/2015

Update XYZ policy

Revision B, training, and release

3/21/2015

FMEA-15-002

New product proposal

1/20/2015

Market receptive

Recommend development

2/17/2015

FMEA-15-003

Difficulty processing orders

1/23/2015

New field required

Modify program

2/4/2015

FMEA-15-004

136  Before Starting the FMEA

Departments

Because job responsibilities and employees change, it is usually wisest to identify a department rather than an individual or specific job title. For example, Accounting identifies what job must be done, for example, reconciling an account, but who is responsible for performing the actual job, e.g., cost accountant, accounts payable clerk, may change for any number of reasons. When a job title is unlikely to change, e.g., design engineer, use the title instead of the name of the person. A side benefit to using a job title or department instead of specifying a particular individual is the elimination of the situation becoming personal. Note:  The name of the individual may be recorded as a subject matter expert or in the FMEA’s notes.

Responsibilities & Activities Change

As a company grows or changes, responsibilities emerge or others are assigned to new or different job functions. Activities and even departments will change or can be eliminated entirely. Workflows may be expanded or reduced. Sometimes, work is outsourced. Payroll may have originally been done in-house, but later transferred to an external organization. It is important to remember that whatever is being investigated at the time that an FMEA is being conducted, it may change considerably later on, may no longer exist at all, or new elements may have been added since its conclusion. An FMEA needs to be regarded as a snapshot in time. It is good to know what happened before because sometimes companies return to what they eliminated or reduced earlier. Records of FMEAs save time and reduce the need to repeat efforts.

Rating Scales

Introduction

Rating scales can be: • adopted from elsewhere • imposed upon the organization, or • developed internally. Regardless of where a rating scale is obtained from, keep in mind that the scales are arbitrary and were created by humans. People can be intimidated or overwhelmed by the scales. Rating scales are customizable and should make sense to the user. There is nothing infallible about a rating scale obtained elsewhere. This section provides guidance for creating rating scales for FMEAs.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Numbers Making Sense . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Applying Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Revisiting Table 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Rate Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Less is More . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Worth the Effort?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Address Gaps in the Ratings. . . . . . . . . . . . . . . . . . . . . . . . 140 Test for the ROI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 Beware of Hair-Splitting . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 If Hair-Splitting is Necessary. . . . . . . . . . . . . . . . . . . . . . . . . 141

137

138  Rating Scales

Numbers Making People often use 3, 5, and 10 without much regard to the impact these Sense numbers have on the item in question. Odd numbers have an appeal because it is simpler to find the middle than if even numbers were used. .

Why is this done? Because it is easy. Does it make sense? Not necessarily. It depends. What’s the problem? There are quite a number of issues involved, which are beyond the scope of this book. Suffice it to say that arbitrarily assigning numbers can result in avoidable costs because something is based on “an educated guess” as opposed to having research and data to back up the decision. Applying Percentages

It is not uncommon for companies to arbitrarily assign numbers to designate classifications, such as 1 in 3 or 10%. Applying a percent is dangerous because as the population size changes, so does the number of unacceptable events, which can easily become statistically significant.

Revisiting Table 10a

EFFECT

Below is Table 10a, which is also found in the section on Occurrence. This table is being revisited here because it illustrates some of the potential issues associated with rating scales. RATING

FAILURE RATE

CRITERIA

10

1 in 3

Failures almost certain to occur; history shows many failures

Very high

9

1 in 5

Very high number of failures

High

8

1 in 10

High number of failures

Moderately high

7

1 in 20

Frequent failures

Medium

6

1 in 80

Moderate number of failures

Low

5

1 in 400

Occasional number of failures

Slight

4

1 in 2,000

A few failures

Very slight

3

1 in 4,000

Very few failures

Remote

2

1 in 10,000

Remote number of failures

Almost never

1

1 in 30,000

Failures very unlikely

Almost certain

Table 10a. Subjective Criteria Example for Occurrence in General.

Rating Scales  139

Rate Numbers

The range of the failure rate numbers in Table 10a is 1 to 30,000. For some organizations, especially certain manufacturing environments, 30,000 is a reasonable number. In other organizations, 30,000 would never be reached and is illogical to use in the scale. Whatever rating scales are created, ensure that they are relative to the organization. For example, in Table 10a, 1 in 30,000 and “failures very unlikely” may sound acceptable, but if the information refers to fatal hospital surgeries, the occurrences are unacceptable.

Less is More

Table 10a illustrates the good intentions of attempting to rate occurrence, but there is usually very little perceptible difference between: • “very high” and “high” (ratings 9 & 8), and • “moderately high” and “medium” (ratings 7 & 6). In a case such as Table 10a, a better approach would be: • grouping together, instead of breaking out into more categories, the definitions that people would have difficulty easily distinguishing from one and other, and • using fewer categories.

Worth the Effort?

If people end up struggling over what something means, or cannot define it among themselves, these are indications that the differences are insignificant. A test for “would it help to split this further” would be to determine: • what would be gained by more refinements • can these be easily defined, and • can the differences be easily understood. If nothing or very little is gained, or if the knowledge does not contribute to notable improvements, the effort expended into breaking the information down into more categories brings little for the effort. Remember:  An FMEA is not an exact science; it is an approximation. Do not get hung up squabbling over minor details when the objective is an educated guess.

140  Rating Scales

Address Gaps in the Ratings

There are gaps in Table 10a.

Test for the ROI

Every time somebody must deal with something that is unclear, difficult, or providing little value, the organization is incurring costs that can be avoided.

If an occurrence is determined to be other than exactly as stated, how is it classified? A better way of presenting these failure rates, rather than “1 in X,” is to provide a range, e.g., 1-3 failures is “almost certain,” 4-10 failures is “very high.”

Another test for the value returned is simply to ask, “What would the organization gain by investing in attempting to achieve this knowledge?” If something is not worth the effort, i.e., the return on the investment (ROI) of time and manpower gains very little, do not expend the effort. Note: That does not mean the issue in question does not need to be addressed; it simply means that particular method for addressing the issue does not give a good return for the effort involved. Beware of Hair-Splitting

Resist the temptation to “split hairs” when creating categories, especially at the beginning of a study. When people “split hairs” to an extreme degree, there is often a mistaken belief that they have done a better job or have gained more information. In Table 10a, where 1 in 3 is “almost certain” and 1 in 5 is “very high,” but 1 in 30,000 is “almost never,” the difference between 1 and 30,000 is extremely broad; therefore, two categories of 1 in 3 and 1 in 5, comparatively, are so close together that they would most likely add very little value to the information studied. While hair-splitting can promote a warm, fuzzy sense of a job well-done and that everything was addressed, in practical terms, it often wastes resources and money. Beware of “hair-splitting.” If the information gained has little or no value, do not waste the money or manpower to define it or chase it down.

Rating Scales  141

If Hair-Splitting is Necessary

The initial question to ask is, “How much would many categories add to the information desired by conducting the study?” Sometimes many categories serve a good purpose and can contribute much to understanding the study. It depends on what the purpose of the study is; what are the seekers attempting to know? There is nothing that excludes many categories. However, there is no reason to add more categories than necessary as that results in using more labor and time to produce information that adds no or very little value to the study. If it becomes evident that more information would be helpful, then that is the time to refine the study. For starters, start simply.

(This page intentionally left blank.)

Using the FMEA Worksheet Introduction

The FMEA worksheet is a tool used to guide an FMEA investigation. It cannot anticipate all possible situations. This section: • provides guidance on how to complete a worksheet • indicates what to do with certain types of supplemental information • indicates the optional fields on an FMEA worksheet • provides guidance on creating ranking scales, and • shows how to calculate the RPN.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Completing the Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . 144 Sections of the Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . 145 Completing the Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Investigation Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Numbered Lists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 FMEA Drivers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Potential Failure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Potential Failure Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 CAUTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Cause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 143

144  Using the FMEA Worksheet

Topic

Page

Preliminary Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Potential Failure Causes or Sources. . . . . . . . . . . . . . . . . . . 149 Current Prevention Controls. . . . . . . . . . . . . . . . . . . . . . . . 151 Current Detection Controls. . . . . . . . . . . . . . . . . . . . . . . . . 152 Identifying Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 Criteria for Rankings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Be Consistent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Initial & Updated Rankings . . . . . . . . . . . . . . . . . . . . . . . . . 153 Remember the Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 RPN Decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 Eliminating Possibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 No Improvements Necessary. . . . . . . . . . . . . . . . . . . . . . . . 154 Improvement Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 FMEA Efforts Not Shown . . . . . . . . . . . . . . . . . . . . . . . . . . 155 Follow the Trail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 Authority for Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 Recalculating the RPN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 Comparing the RPNs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 Criticality Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Completing the Worksheet

The purpose of the FMEA, i.e., the intent of the study, is the driving factor of the FMEA, not the worksheet. The worksheet is a document to record and guide the activities of the FMEA. The format of the FMEA worksheet can be modified to fit the organization’s needs as well as the study’s scope. Unfortunately, an FMEA worksheet’s format found in a book or online may be as unchangeable. The worksheet’s layout is not what makes the FMEA. While it is important to complete certain steps in an FMEA, if it suits the purposes of the study or the organization, it is permissible to: • not to include certain information • supplement information, and • even change the format of the worksheet.

Using the FMEA Worksheet  145

Sections of the Worksheet

The worksheet is divided into six main sections that are arranged progressively from start-to-finish. These sections are: 1. header 2. investigation section 3. initial rating 4. improvement section 5. final rating, and 6. criticality comments.

Completing the Header

Review “The Value of the Worksheet Header” presented previously and complete the header using the steps shown in Table 21.

STEP

ACTION

1

Verify purchase request information is complete and accurate

2

Find supplier to make purchase from

3

Complete purchase form

4

Route purchase order to designated locations

Table 21. Completing the Worksheet Header.

146  Using the FMEA Worksheet

Investigation Section

After the header, the next section to complete on the FMEA worksheet is the process stage and its relevant information, as shown below.

Process Stage – Describe the process stage under development or study. Potential Failure Mode – In what ways can the key input(s)/ actions go wrong?

1. 2. 3. 4.

Potential Failure Effects – In what ways can the above failures affect other things?

1. 2. 3. 4.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA.

1.

Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

1.

2. 3. 4. 2. 3. 4.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. 2. 3. 4.

Numbered Lists

While the worksheet has numbered lists of 1-4 available for completion, the blank areas are provided for convenience. At least one line in each category will be completed. When nothing applies, enter “N/A” on the first line. The remaining lines, 2-4, may be left blank. When more than four responses are in order, continue the list elsewhere and indicate where that continued list is found.

Scope

Before starting the FMEA, it is important to determine the limits of the investigation – just how much needs to be investigated by the team. FMEAs can: • get bogged down by being too detailed • miss important factors by being “too light,” that is, not digging deeply enough into the matter, or • be “just right,” by digging as deeply as needed without overloading or distracting from the objective with too much information.

Using the FMEA Worksheet  147

FMEA Drivers

Enter a description of the area under analysis, which is determined by the scope. Remember: • the purpose of the FMEA drives the worksheet • the scope determines how far the investigation will go, and • the FMEA may require subsequent FMEAs based on the conclusion(s) from the present study.

Failures

The potential failure mode describes what can go wrong. There may be multiple: • things that can go wrong, e.g., wrong data is uploaded, wrong calculations result, wrong fields are populated • ways that a failure can occur, e.g., information is not relayed to departments A, B, and C, or • locations where failures can occur, such as in a cascading or domino effect.

Potential Failure Mode

Describe the ways that things can go wrong. Since the key inputs or actions are under investigation, there needs to be an A (input) and a B (result.) Examples of inputs and results are shown in Table 22. Remember:  An input can result in multiple failures and these failures can occur in multiple locations. A – INPUT

B – RESULT

Pressed “On”

• Nothing happens

Entered Data

• Field will not accept information

Entered figures

• Calculation is incorrect • Incorrect calculation is uploaded • Final monthly figures are incorrect

Clicked on link

• Directed to wrong location

Response time not specified

• Customer angry

Paperwork not filed

• Fined for non-compliance

Table 22. Examples of Inputs & Results.

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Potential Failure Effects

A – INPUT Pressed “On”

After identifying what can go wrong, next determine the failures’ impacts. Examples of impacts are shown in Table 23. B – RESULT • Nothing happens

C – IMPACT(S) • Manufacturing process shuts down • Costs added – In-process goods must be reworked or scrapped • Deliveries are not made on time

Entered data

• Field will not accept information

• Work cannot proceed any further

Entered figures

• Calculation is incorrect

• Cost estimates are too high or too low

• Directed to wrong location

• Wrong information is uploaded

• Customers angry

• The organization is regarded as not caring about its customers

Clicked on link Response time not specified

• The organization faces financial hardships • Cascade of problems result

• Customers take business elsewhere • Employees think the organization does not know what it is doing Paperwork not filed

• Fined for noncompliance

• Investors pull their money out of the organization • The organization prohibited from bidding

Table 23. Examples of Inputs, Results, & Impacts.

CAUTION

While the potential failure mode and the potential failure effects may seem straightforward, in terms of correcting or preventing failures, analysts sometimes confuse the impacts with the results. By preventing or correcting the results in column B, the impacts of column C do not occur or are mitigated. It is highly unlikely that the impacts in column C can be mitigated if no actions are taken to remedy the results in column B. In short, B leads to C, and most likely, something can be done about B.

Using the FMEA Worksheet  149

Source

As stated on the FMEA worksheet, “Source” means that the failure occurred due to something outside of the area under investigation. In other words, the “source” of the failure lies elsewhere. Examples of failures occurring elsewhere include, but are not limited to: • electrical transformer blew up • supplier changed formula of a raw material, and • manufacturer mislabeled part.

Cause

As stated on the FMEA worksheet, “cause” means that the failure occurred in the area under analysis, has been identified, and the problem can be addressed by the FMEA. Examples of failures occurring in the area under investigation include, but are not limited to: • parameters were never identified • an impact was overlooked, and • a specification was omitted.

Preliminary information

At this point, the analyst is gathering preliminary information that will be used to determine the severity, occurrence, and detection rankings. In-depth investigations into why the failures could occur is done after the RPN has been calculated and the risk has been deemed unacceptable. The in-depth investigations will determine the recommended improvement actions.

Potential Failure Causes or Sources

After determining the impacts, next determine if the area under analysis caused the failure or if the source of the failure occurred elsewhere. A failure can have: • a cause, but not a source, • a source, but not a cause, or • multiple causes and sources. Examples of causes and sources are shown in Table 24.

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A – INPUT Pressed “On”

B – RESULT • Nothing happens

CAUSE OR SOURCE • Cause – the wrong switch was installed • Cause – the correct switch was installed incorrectly • Source – the wrong switch was ordered • Source – the wrong switch was shipped

Entered data

Entered figures

• Field will not accept information

• Cause – field size is too small

• Calculation is incorrect

• Cause – formula was entered incorrectly

• Source – field size previously not a requirement

• Source – developer given wrong formula • Cause or Source – formula was never validated

Clicked on link

• Directed to wrong location

• Source – application has software glitch

Response time not specified

• Customers angry

• Source – response time never considered important enough to specify

Paperwork not filed

• Fined for noncompliance

• Cause – work overload; insufficient time for filing

• Source – link is no longer valid

• Cause – no central location to route paperwork • Cause – access to files is not restricted • Cause – release of documents is not controlled • Source – external requirements not routinely reviewed for new filing requirements Table 24. Examples of Inputs, Results, & Causes or Sources.

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Current Prevention Controls

Preventative controls may already be in place to address failures that are known to be likely, or presumed likely, to occur. The FMEA study usually includes research to determine the preventive measures that guard against failures from occurring. For instance, an organization may use a checklist to ensure that each preventive measure is in place and working. Such a checklist can be regarded as a prevention control. Examples of prevention controls are shown in Table 25.

A – INPUT

B – RESULT

PREVENTION CONTROLS

Pressed “On”

• Nothing happens

• Machine is verified as functional at the start of each shift

Entered data

• Field will not accept information

• Minimum field size must be determined when developing applications

Entered figures

• Calculation is incorrect

• Calculation formulas are copied and pasted from validated formulas instead of manually inputted • Formulas are tested before application goes “live”

Clicked on link

• Directed to wrong location

• SOPs are reviewed annually to ensure that their links are still current • Links are tested on an annual basis to ensure that they are still “live”

Response time not specified

• Customers angry

Confirmation email: • Is immediately sent that communique was received • Includes name and contact information of employee or department that will respond within a stipulated timeframe, e.g., 24-hours, two business days, etc. • Further contact information is provided if customer’s matter is urgent

Paperwork not filed

• Fined for noncompliance

• The organization maintains internal website with procedures, updates, and changes in customer or regulatory areas

Table 25. Examples of Inputs, Results, & Prevention Controls.

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Current Detection Controls

Sometimes, detection controls are in place that indicate a failure has occurred. This could be due to prevention not being possible. In many instances, however, detection is a quick, “firefighting” response because time and effort were not put into examining whether prevention is possible. Examples of detection controls that could be used are shown in Table 26.

A – INPUT Pressed “On”

B – RESULT • Nothing happens

DETECTION CONTROLS When pressing “on” is successful: • a green light comes on, and/or • an operating bell sounds

Entered data

• Field will not accept information

• Software can detect if information does not meet certain parameters, and • A pop-up screen says information is invalid

Entered figures

• Result will not calculate

• Program can detect if math formula is improper

Clicked on link

• Directed to wrong location

• Program that alerts when link is no longer valid

Response time not specified

• Customers angry

• Sales people or customer service representative receive complaints • Satisfaction surveys have low ratings

Paperwork not filed

• Fined for noncompliance

• Calendar is set up to warn that filing is due in 30 days • Calendar is set up with progressive warnings that action is needed

Table 26. Examples of Inputs, Results, & Detection Controls.

Identifying Procedures

If there are procedures applicable to either the prevention or detection controls, make sure that these are stated in the FMEA. Since a procedure can relate to only one or more controls, there are configuration management concerns related to procedures. Consequently, verify that the procedure is still applicable to a particular control.

Using the FMEA Worksheet  153

Criteria for Rankings

If ranking classifications have not already been established for severity, occurrence, and detection, now is the time to create them. Refer to the previous sections entitled “Criteria for Severity,” “Criteria for Occurrence,” and “Criteria for Detection” for guidance on how to establish these ranking classifications.

Be Consistent

As a reminder, criteria rankings are subjective and the numbers assigned to the classifications vary by organization. For the sake of consistency, use the same ranking classifications for all FMEAs.

Initial & Updated The purpose of using initial and updated rankings to provide an assessment Rankings method is to determine how the implemented changes have mitigated the risks. There may be instances where the implemented changes indicate that more changes are needed to reduce the risks to an acceptable level. In such a case, a second FMEA may be required with the second FMEA using the implemented changes from the first. Remember the Purpose

Avoid the temptation to reduce paperwork by simply going straight to the final implemented changes and not recording the efforts that came before. An engineer or quality professional may need to know what did not work to the degree desired, particularly when working on a future project. There may be information in the progression of efforts that they would find helpful. Since procedures, software, equipment, and parts are continuously changing, it is helpful to the engineer or quality professional to know what was in place related to the prevention and detection controls at the time of an FMEA. If a liability issue arises, records of efforts that failed to mitigate the risk show the organization recognized the risk and due diligence was taken to reduce or eliminate the risk. In other words, multiple FMEAs required to ultimately eliminate or mitigate a risk show that the organization “did its job.”

154  Using the FMEA Worksheet

RPN Decisions

Enter the S, F, and D rankings, and calculate the RPN using the formula shown.

Initial Rating – Create & use rating scales

Severity (S) – measure of the possible consequences of a failure to a user, customer, process, sub-process, or finished output. Frequency (F) – The probability of the cause of the failure mode occurring. Detectability (D) – The probability that the failure mode will be detected before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D

Determine if the RPN number is low enough to close the FMEA or if more effort is required. Again, the decision to close or put in more effort is arbitrary and may require input from others before a final decision is made. Eliminating Possibilities

A series of FMEAs systematically identifies possible problem areas and does so in a progressive fashion. One of the possible outcomes of an FMEA is the indication that something in question no longer needs to be considered; the FMEA has shown it is not an area of concern. When initial or revised RPN numbers indicate that no further efforts are required, the FMEA can be closed. If applicable, the investigation can proceed to the next area or stage in question.

No Improvements The improvement section is used only if the initial RPN indicates that Necessary improvement efforts are required. If no improvements are necessary, complete the FMEA by: • indicating N/A in the improvement section’s fields • including any final notes, if applicable • completing the log or tracking sheet from which the FMEA’s number was assigned • forwarding the FMEA final report to the appropriate individuals, and • filing or archiving the FMEA’s relevant documents.

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Improvement Section

When the RPN indicates the need for improvements, the FMEA worksheet’s improvement section follows the initial RPN determination and is shown below.

Recommended Changes – What are the recommended improvements?

1. 2. 3. 4.

The improvement section: • records the recommended changes • indicates who is responsible for ensuring that these changes have been implemented, and • reports what was ultimately done to eliminate or mitigate the risks. FMEA Efforts Not Shown

If a decision is made, based on the RPN, that there is a need for an improvement effort, the bulk of an FMEA effort, which is typically an in-depth investigation, occurs at this point. It is at this time that the analyst will begin delving into why things do or do not happen. Extensive research may go into finding the causes of the potential failures, or efforts may be applied to finding how to stay abreast with changes happening at the sources of failures. To ensure that the FMEA file is as complete as possible, some kind of record must be included showing what was researched and how the conclusions were reached.

Follow the Trail

How far to go with these investigative efforts depends on what is involved with the issue. The analyst needs to follow the trail wherever it leads. At this point, a root cause analysis is being conducted because in order to prevent, mitigate, or eliminate a risk, the root cause of the potential failure must be determined.

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Authority for Changes

Depending on who is conducting the FMEA, the recommended changes may: • simply be recommendations, or • the analyst may have the expertise to determine what must be changed as well as have the authority to require that the changes be made.

Recalculating the RPN

If the initial RPN determined an unacceptable risk that warranted mitigation or corrective action, it is logical to recalculate the RPN after the improvements have been implemented to determine if the improvements were effective enough to bring the risks down to an acceptable risk level. The worksheet provides an area to calculate the second RPN in the area entitled “Updated Rating,” as shown below.

Updated Rating – Use the rating scales

Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item. Frequency (F) – The probability of the cause of the failure mode occurring. Detectability (D) – The probability that the failure mode will be detected before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D

Comparing the RPNs

In most cases, the improvements will lower the RPN to an acceptable risk level. If not, as stated above, further decisions will be required. Possibilities are the organization may: • decide to scrap the idea, or • require that more improvement efforts be taken. In either case, the current FMEA is closed.

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Criticality Comments

When addressing a matter over a length of time, it can seem like the details will never be forgotten. However, as new demands replace current ones, memories fade. Almost everyone has encountered a situation where they have wondered why something was done or questioned what people were thinking when a past decision was made. What is critical, important, or vital to an organization can change over time, and often does. Sometimes a decision seems foolish or illogical, but almost always it was the best or a very good decision based on what was known or happening at the time the decision was made. At the bottom of the FMEA worksheet is an area to record what was critically important at the time of the FMEA investigation. Recording what is known while working on the FMEA increases its historical value. Be sure to complete this section if: • the details or contributions are unique in some way that they elevated the matter to a critical level, e.g., the organization received notice from a federal authority that something was amiss, or • a change elsewhere could change the conclusions drawn from the FMEA (e.g., the customer or client is requiring a modification).

Criticality Comments

1. 2. 3.

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Wrapping up the FMEA

Introduction

Just as there were initial things to be done before starting an FMEA, there are activities associated with completing an FMEA. This section provides guidance on: • closing the FMEA • dealing with supplemental information • how to handle links internally and to the Internet • archiving the FMEA, and • what might be encountered from an audit.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Closing the FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Supplemental Information. . . . . . . . . . . . . . . . . . . . . . . . . . 160 Internet Links. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Archiving the FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Closing the FMEA

Close the FMEA by: • completing the FMEA worksheet • completing the log or tracking sheet from which the FMEA’s number was assigned • completing a summary report of the FMEA efforts • forwarding the FMEA’s final report to the appropriate individuals, and • filing or archiving the FMEA’s relevant documents.

159

160  Wrapping up the FMEA

Supplemental Information

If at any time there is insufficient space to document information or it is deemed important to include information not asked for on the worksheet, attach more sheets with this information. Remember to indicate somewhere on the front of the worksheet, in a readily observable location, that: • more information is available • what type of information is available, e.g., data, chart, graphic, blueprint, report, and • where that information is found or filed. To the extent possible, all information relevant to an FMEA is archived with the FMEA report.

Internet Links

While it may seem logical to copy and paste in a link to an Internet source of information, links change and websites disappear. If the information is critical to understanding the FMEA investigation or its conclusions, then: • take as many screen shots as necessary • paste them into Word documents, and • save them for archiving purposes. Note:  Keep in mind that even internal links may change if an organization upgrades its system or applications, or is bought out by another organization.

Archiving the FMEA

Archive the completed FMEA along with its copies of related materials and information, e.g., documents, policies etc.

Audits

The worksheet is not the FMEA investigation. It is a tool used to record information pertaining to the FMEA. For the FMEA investigator and quality assurance professional, it is important that: • all relevant information is supplied, and • traceability in terms of dates, people, designs, policies, and revisions are included. Auditors are concerned that the information is complete and correct and that the FMEA was conducted properly.

Definitions

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

a.k.a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 CAPA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Cause – FMEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Closed System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Configuration Management. . . . . . . . . . . . . . . . . . . . . . . . 163 Consumers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Drill Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Due Diligence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 End Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 External Customer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Failure Cause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Failure Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Failure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Firefighting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Five Whys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Form, Fit, or Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Internal Customer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 MTBF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

161

162  Definitions

Topic

Page

Normal Use-and-Abuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 Pareto Principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 Probability of Occurrence . . . . . . . . . . . . . . . . . . . . . . . . . . 166 Qualitative Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . . 166 Quantitative Criticality Analysis. . . . . . . . . . . . . . . . . . . . . . 167 Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Reliability Engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Required/Shall/Must . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Risk Assumption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Risk Tolerance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Robust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Root Cause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 RPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Severity Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 Source – FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

a.k.a.

Also known as

CAPA

Corrective Action (CA) and Preventive Action (PA) – Two specific, independent investigations that determine the root cause (the initiating cause) that resulted in a string of events that led to the undesired outcome followed by efforts to both correct the immediate problem as well as prevent it from happening again, or if impossible to prevent the problem entirely, then to mitigate any potential negative impacts. The separate investigations ensure that efforts have addressed all possible negative outcomes.

Cause – FMEA

The failure occurs in the area under review in the FMEA, has been definitively identified, and will be addressed under the FMEA.

Closed System

A process where what is happening internally cannot be observed.

Definitions  163

Configuration Management

The systematic evaluation of the relationships between parts, subsystems, and systems for effectively controlling the impacts of changes and to minimize any adverse effects they may impose on themselves or things dependent upon them, e.g., finished products used by consumers. For an FMEA, the impacts include those affecting the customer.

Consumers

Ultimate recipients of finished product or work efforts.

Corrective Action

1. When part of a CAPA, corrective action (CA) is one part of a three-part investigation and remedy to correct whatever initiated the string of events that ultimately resulted in an undesirable outcome or situation and is done in conjunction with preventive action, which investigates where further occurrences of the undesired outcome can occur. Note:  The other two parts of a CAPA is determining the root cause and preventive action (PA.) When CA and PA are done in response to an undesirable outcome that has already occurred, and are not part of an FMEA, they are known as a CAPA. 2. When they are done in an FMEA, they are known as corrective and preventive actions and not as a CAPA. Note:  An FMEA can be used in multiple ways so an undesirable outcome may or may not have occurred. If an undesirable outcome has not occurred, it is possible to make corrections and/or take preventive action to prevent or mitigate the undesired outcome.

Customers

Recipients of work efforts or products that are still in-process.

Drill Down

Digging deeper into a matter or investigation to determine what else might be present or contributing to the situation.

Due Diligence

The attempt made to validate something based on its unique characteristics.

End Effect

The consequence(s) of a failure mode on the operation, function, or status of the highest indenture level.

164  Definitions

External Customer

Anyone who receives a product or service who is not directly related to the organization or a organization department. Example 1: A organization or individual to whom a product or service is directly sold. Example 2: A department that receives for further handling something that was partially completed or processed in a previous department. Note:  The definition depends on the context in which the term is used.

Failure

The loss of an intended function under stated conditions. The loss of ability of a system, device, or process to perform a required function. The manifestation of a fault. Example:  The doorbell doesn’t ring when pressed.

Failure Cause

The defect(s) which is/are the underlying cause or sequence of causes that lead(s) to a failure mode over a certain time. Causes typically stem from, but are not limited to, requirements, design, process, quality, handling, application, or use. Example: The doorbell doesn’t ring when pressed because it is not protected from the elements; normal-use-and-abuse was also not taken into account. Note:  A failure may have multiple causes.

Failure Effect

The immediate consequences of a failure on operation, function, or functionality, or status of whatever is under investigation. Example:  The doorbell failing to ring caused the visitor not to make the delivery.

Failure Mode

The specific manner (or way) a failure occurs in the function under investigation. Example:  The doorbell doesn’t ring when pressed because, e.g., the battery is dead, the electricity has been cut off, a critter ate through the wire, the wire became corroded, or sticky fingers caused the doorbell to jam etc. Note: A failure mode can have multiple causes.

Definitions  165

Firefighting

The quality term for responding to a problem by fixing or repairing what occurred, i.e., “putting out the fire,” without looking into the underlying factors and ultimately discovering and correcting the root cause of the issue; it is regarded as an ineffective, short-term fix that provides immediate satisfaction that “something was done,” but ultimately does not fix anything in the long run because the root cause of the problem was not identified nor addressed.

Five Whys

A drill-down quality investigative technique that identifies a problem then asks a series of five iterative “whys” as to “why did this occur” to determine a possible root cause. Example:  Problem X occurred – why? Because of A. Why did A occur? Because of B. Why did B occur? Because of C. Why did C occur? Because of D. Why did D occur? Because of E.

Form, Fit, or Function

Three areas reliability experts independently address when ensuring the adequacy or robustness of an item, part, or system, i.e., how does something affect the form, fit, or function of what is being evaluated?

Internal Customer

Anyone who receives a product or service who is directly related to the organization or an organization department. Example 1: A department or individual within the same organization to whom a product or service is relayed for further handling. Example 2: An individual within a department who receives for further handling something that was partially completed or processed within the same department. Note: The definition depends on the context in which the term is used.

MTBF

Mean Time Between Failures – The average time something will function between failures. MTBF is sometimes predicted • based on experience, or • by analyzing known factors such as raw data supplied by manufacturers. MTBF is meaningless if the • definition of failure is not clear, or • assumptions are unrealistic or misinterpreted.

166  Definitions

Normal Useand-Abuse

The generally anticipated, recognized ways that something may be used, properly and improperly, under normal or typical conditions or situations. Examples: Sticky, dirty fingers causing a doorbell to jam would fall under normal use-and-abuse; taking a sledge hammer to a doorbell to ring it would not.

Pareto Principle

Quality guru Joseph M. Juran’s determination that 80% of quality problems are caused by only 20% of the factors impacting the situation. Juran called his observation the “Pareto Principle.” Today, the Pareto Principle is more widely known as the 80–20 rule.

Preventive Action

1. If done as part of a CAPA, preventive action (PA) is the effort taken to prevent or mitigate reoccurrence of the root cause of the events that ultimately resulted in a specific undesirable outcome or situation which has already occurred. Note:  In a CAPA, PA investigates further to determine where else in the system the same type of problem, based on the root cause, could occur and ensures the root cause correct is effective enough to prevent occurrences elsewhere. PA can reveal more areas which need correcting. These new discoveries can indicate that the original corrective action (CA) was not robust enough and needs to be modified. 2. If done in conjunction with an FMEA, it is whatever actions or controls are implemented to prevent a known or potential problem from occurring.

Probability of Occurrence

The likelihood that something will occur after factoring together the frequency of occurrence and the level of detectability.

Qualitative Criticality Analysis

The analysis used to determine risks and prioritize corrective action by rating: • the severity of the potential effects of failures, and • the likelihood of occurrence for each potential failure mode.

Definitions  167

Quantitative Criticality Analysis

The analysis conducted to determine: • the reliability/unreliability for each item at a given operating time • the portion of the item’s unreliability that can be attributed to each potential failure mode, and • the probability that each failure mode will result in a system failure.

Reliability

The ability of something to perform its required functions under stated conditions for a stated period of time.

Reliability Engineering

The evaluation and prediction of performance to improve the safety, reliability, and maintainability of products and/or systems.

Required/ Shall/Must

Indicates organization policy with which associates must comply.

Risk

The feasible detrimental outcome of an activity or action subject to hazards.

Risk Assumption

The amount of risk a company is willing to assume, a.k.a. risk tolerance.

Risk Tolerance

The amount of risk a company is willing to tolerate, a.k.a. risk assumption.

Robust

An effort that is effective enough, or has sufficient impact, that it addresses all concerns.

Root Cause

The initiating cause that started a series of events or action that led to an undesirable outcome.

RPN

Risk Priority Number – The calculated risk figure determined by multiplying the FMEA values assigned to Severity, Frequency, and Detectability.

168  Definitions

Severity Effect

The consequences of a failure mode. Severity considers the worst potential consequence (worst case scenario) of a failure, determined by the degree of: • personal injury • business damage • property damage • system damage • confidentiality damage • financial damage • time lost, and/or • costs to repair the failure.

Source – FMEA

The failure did not occur in the area under review in the FMEA and further investigation is needed beyond the current FMEA study.

Appendix A – Pareto Charts Introduction

As was discussed in the section Guidelines for Using FMEAs, Joseph M. Juran introduced the Pareto Principle when he realized that 80% of quality issues were caused by 20% of the factors impacting or contributing to them. This 80:20 ratio is now accepted as a business maxim. Note: Another way that this is expressed is 20% of whatever an organization is dealing with is causing 80% of its headaches (problems.) The important point to remember is that problems are not distributed evenly. Most of what an organization is providing is happening as intended, which means it is wasting money to keep focusing on these areas to improve them. Since the main issues are concentrated in a few small areas, and manpower and financial resources are limited, the best return on the investment is identifying the most troublesome areas. This section provides guidance on: • what goes into to creating a Pareto chart, and • how to use a Pareto chart when performing an FMEA.

169

170  Appendix A – Pareto Charts

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

Pareto Charts & FMEAs. . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Budget as the Driver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Identify What to Examine. . . . . . . . . . . . . . . . . . . . . . . . . . 171 Monthly Expenses Example. . . . . . . . . . . . . . . . . . . . . . . . . 171 Creating a Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 First Calculations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Initial Data Plotted in a Chart . . . . . . . . . . . . . . . . . . . . . . . 174 First Glance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Next Step. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175 Largest to Smallest %. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Regrouping the Categories. . . . . . . . . . . . . . . . . . . . . . . . . 176 Clustering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Reducing Category Groups. . . . . . . . . . . . . . . . . . . . . . . . . 178 Pareto with New Categories. . . . . . . . . . . . . . . . . . . . . . . . 179 Charting the Percentages. . . . . . . . . . . . . . . . . . . . . . . . . . 180 Omissions Become Apparent. . . . . . . . . . . . . . . . . . . . . . . . 180 Transportation Example. . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 Using with an FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Pareto Charts & FMEAs

A Pareto chart is an excellent tool for identifying which problems are having the biggest negative impacts on a business and its products, systems, or services. A Pareto chart can also be used to identify which: • employee is having the most… (difficulties, sales, sick days, overtime, etc.) • department is having the most… (turnover, delays, complaints, etc.), and • costs might benefit from a closer examination. Note:  Pareto charts can also identify what is working, where the most praise is received, and what customers like the best. Sometimes solutions to problems in one area can be found in the areas demonstrating success.

Appendix A – Pareto Charts  171

Budget as the Driver

It is rare that an organization has unlimited funds to address problems.

Identify What to Examine

The first objective when creating a Pareto diagram is to pick an area or topic to examine. This can be anything, such as:

Budgets rule most organizations so it makes sense, when seeking to address what to improve, to identify the area(s) or issue(s) that will provide the most benefit for the efforts expended.

• how many errors on invoices • sales per department or salesperson • returns by product category • products or services that receive complaints, or • the distances that the delivery trucks drive. Suggestion: If you do not know where to start, try an informal poll. Ask your employees, customers, even friends or families, where they think problems or issues may lay. Now that you have identified a tentative area, begin by writing down the main topics that keep repeating. Monthly Expenses Example

In order to present an example that most people can relate to, consider your personal income and expenses. Chances are you will readily agree that 80% of your income (and perhaps even more) goes out to paying 20% of your bills, such as the rent and your transportation. Without regard to any particular order, or who might be contributing to the income, Table 27 depicts how an income might be spent.

172  Appendix A – Pareto Charts

AREA

AMOUNT

Rent (mortgage)

$1,500

Car payment

$250

Food

$600

Electricity

$105

Clothing

$50

Personal expenses

$125

Entertainment

$240

Heat and/or A/C

$350

Cable & internet

$150

Cell phone

$100

Savings

$300 Total

$3,770

Table 27. Typical Monthly Expenses.

Creating a Pareto Chart

Pareto charts can be created by hand or by using a software program. Steps on How to Create a Pareto Chart in MS Excel 2010 can be found at www.wikihow.com. In Microsoft’s Excel program, clicking on the question mark (?) for help and searching for “Pareto Chart” provides instructions for installing the add-in, Analysis ToolPak, and creating a Pareto chart. The charts in this section were created in Excel, although they could have also been created by hand by: • using simple mathematical formulas for addition and percentage, and • sorting from the largest percent to the smallest. Note:  Pareto charts are frequently depicted with a line showing the cumulative percentages. A cumulative line is optional and not required.

Appendix A – Pareto Charts  173

First Calculations

After assembling the initial data, the next step in a Pareto diagram to determine the percentage (x%) each category represents out of the whole (100%). Using the above expenses, tally up all the costs, which in this case comes to $3,770. Then, figure out what percentage each category constitutes out of that 100%, i.e., the $3,770. Note: Percentage is calculated by dividing the dollar amount for each category by the total dollar amount, in this case $3,770, and multiplying by 100. To double-check if your calculations are correct, the individual percentages should add up to a total of 100%. Table 28 shows the percentage value of each category out of the total.

CATEGORY

AMOUNT

Rent (mortgage)

PERCENTAGE

$1,500

40%

Car payment

$250

7%

Food

$600

16%

Electricity

$105

3%

Clothing

$50

1%

Personal expenses

$125

3%

Entertainment

$240

6%

Heat and/or A/C

$350

9%

Cable & internet

$150

4%

Cell phone

$100

3%

Savings

$300

8%

$3,770

100%

Total

Table 28. Typical Monthly Expenses and Percentages.

174  Appendix A – Pareto Charts

Initial Data Plotted in a Chart

If we were to plot the above data in a bar chart, either by hand or using a computer program, it would appear such as below. Initial Information 100%

100% 90% 80% 70% 60% 50% 40%

40% 30% 20%

16%

rn te

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in

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To t

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4%

t en m

vin

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En

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gs

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s se

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Fo

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8%

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7%

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Note: The tall bar on the right, showing 100% of the costs by percentage, it to put the individual categories into perspective when compared against the whole. First Glance

At first glance, it may not be obvious how 80% can be found in the above. After all, the largest category is only 40% and most categories are only in the single digits. Immediately, there are two things to consider: 1. Is there another way that the information could be grouped (categorized?) 2. Has everything been taken into consideration? Which two of these questions is considered first is the investigator’s choice. We will begin by seeing if grouping the many specific areas into smaller, more general areas will produce the 80%.

Appendix A – Pareto Charts  175

Next Step

It is easiest to evaluate data when it is presented in a logical sequence, so the next step is to order the categories by percentages, which is done in Table 29 below. Here, the categories are grouped from the largest percent (40%) to the smallest (1%). CATEGORY

AMOUNT

Rent (mortgage)

PERCENTAGE

$1,500

40%

Food

$600

16%

Heat and/or A/C

$350

9%

Savings

$300

8%

Car payment

$250

7%

Entertainment

$240

6%

Cable & Internet

$150

4%

Electricity

$105

3%

Personal expenses

$125

3%

Cell phone

$100

3%

$50

1%

$3,770

100%

Clothing Total

Table 29. Monthly Expenses Sorted by Percentages from Largest to Smallest.

176  Appendix A – Pareto Charts

Largest to Smallest %

How does this data compare to the original set? The easiest way is to now arrange the above data in a bar chart, from largest to smallest percent. Again, this can be done by hand or by using a computer program. Sorted from Highest Percentage to Lowest 100%

100% 90% 80% 70% 60% 50% 40%

40% 30% 20%

16%

na

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hi

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ng

1%

ot

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3%

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Regrouping the Categories

3%

Cl

3%

ll

4%

0%

en

6%

Ce

7%

xp

8%

le

9%

10%

We are keeping in mind that a Pareto provides opportunities to look at situations from multiple perspectives – and the 80:20 rule has not yet appeared. We can reach that point, but more steps are required. Notice in the above categories that some of them can be grouped into larger categories, such as housing and utilities (“housing” for short,) entertainment, and “other.” We have been certain that “transportation” must be absorbing an appreciable amount of the income, so we will add that category as well. Opening our minds to possibilities that we had not considered is one of the benefits of a Pareto study. Therefore, keeping in mind that more might be learned, try grouping the categories in new ways to see if a pattern or a certain picture might begin to emerge. By regrouping the categories, we may discover that, much to our surprise: • we had overlooked or forgotten to include other categories or costs • an area that we felt sure was substantial turned out to be not so significant when compared with the other categories, or • some costs can be attributed to more than one category.

Appendix A – Pareto Charts  177

Clustering

Assembling the expenses into broader categories, i.e., clustering the groups, helps to identify the 80:20 ratio. Exception: The 80:20 ratio is not always found in one category. Sometimes, it appears in the two highest percentages (or in rare cases, the top three.) Looking at the monthly expenses categories, it is possible to group them into: • Housing • Transportation • Entertainment, and • Other.

Reducing Category Groups

By clustering the old categories (now called “Area” below) into new categories, the percentages for each area in the new category are added together (subtotaled) and the percentages are now based on these new subtotals, as shown in Table 30.

178  Appendix A – Pareto Charts

AREA

NEW

AMOUNT

Rent (mortgage)

CATEGORY

$1,500

Housing

Electricity

$105

Housing

Heat and/or A/C

$350

Housing

$1,955

Housing

Subtotal Car payment

$250

Transportation

$250

Transportation

$600

Other

$50

Other

Personal expenses

$125

Other

Cell Phone

$100

Other

Savings

$300

Other

$1,175

Other

Subtotal Food Clothing

Subtotal

PERCENTAGE

52%

7%

31%

Entertainment

$240

Entertainment

Cable & internet

$150

Entertainment

Subtotal

$390

Entertainment

Total

$3,770

All

10%

100%

Table 30. Reorganized Monthly Expense Categories by Percentages.

Pareto with New Categories

The new groupings, of which there are now only four, are next arranged from highest percent to the lowest, and would appear in a Pareto chart as below. Note: It is not mandatory to add the 100% column. However, many prefer it because of the reference it provides.

Appendix A – Pareto Charts  179

New Categories and Percentages 100%

100% 90% 80% 70% 60% 50%

52%

40% 31%

30% 20%

10%

10%

7%

0% Housing

Charting the Percentages

Other

Entertainment

Transportation

All

Pareto percentages are often displayed in a chart, although this is not necessary if one is comfortable with looking at percentage numbers alone. Plotting percentages in a chart, also known as a Pareto chart, is helpful to obtain a visual grasp of what the numbers mean. In presentations particularly, a slide containing a Pareto chart is a dramatic means to drive home certain points. Percentages are arranged from highest-to-lowest, from left-to-right. In addition, many overlay a line showing the percentages as they accumulate to 100%. This line curves upwards to 100% and is optional, although it is frequently used. In the above chart, which was created with the information from the initial re-grouping, the 80:20 rule is still not apparent if we were looking for only one category to equal 80%. Certainly there are instance where it is only one category, but chances are the first two (less rarely, the first three) categories, when grouped together, reach or exceed 80%. Since Housing equals 52% and Other equals 31%, these two categories add up to 83%. The next step is to determine if any categories (the category could be anything, such as defects, complaints, missed calls, returns, etc.) could be modified or enlarged. Note: It might also make sense to add more categories due to information being overlooked or omitted, as shown on the following pages.

180  Appendix A – Pareto Charts

Omissions Become Apparent

Re-grouping helps to point to areas, in this case, expenses, that were omitted. After regrouping the categories into broader ones, it becomes evident that: • certain expenses were overlooked, or • it may be better to move an expense to a different (broader) category. Examples of what could have been omitted, should have been included, or point to moving an expense to another category, are given below. Omissions • Transportation – Expenses for gasoline, car maintenance, parking fees, and car insurance were not included • Food/Dining Out – Lunch is bought daily at work and at school, five days per week – Dining out on the weekends happens as well – How much does that add up to? If paying for a child’s school lunches, where would be the better place to assign that cost – Food/Dining Out or Child Care? • Child care costs – Daycare, babysitting, activities (sports, music, etc.) • Medical costs – Co-payments, medical supplies and equipment, lab fees, prescriptions, dental, vision • Taxes – Taxes do not appear as a separate category. Were they included as part of the mortgage? Are there additional taxes, such as a vehicle excise tax, that would be included under Transportation? • Other fees – Are there other fees, such as sewer fees or community or maintenance dues? • Donations – Are donations, such as to a religious organization or favorite cause, made on a predictable basis? Change Categories • Cable and Internet – The Internet has become a necessity in many homes today, especially if working from home or when related to school work – Would it be better to move that category under “Housing”? • Dining Out – Dining out has become less of an entertainment function and more of a way of eating due to convenience, scheduling, and time demands. Maybe it should be grouped together with Food?

Appendix A – Pareto Charts  181

Transportation Example

Under Transportation, we could revise that category to include the following: • Gasoline: $60/week * 4 weeks. . . . . . . . . . . . . . = $240 • Maintenance: – Oil change at ($30*4/year) ÷ 12. . . . . . . . . . . = $10/month – Tires, wipers, etc. ~ $360/year ÷ 12. . . . . . . . = $30/month • Parking: $15/day * 20 days/month. . . . . . . . . . . = $300 • Car insurance: $1,380/year ÷ 12. . . . . . . . . . . . . = $115/month • Registration: $60/year ÷ 12. . . . . . . . . . . . . . . . . = $5/month • Motor vehicle excise tax: $120/year ÷ 12 . . . . . . = $10/month Additions to Transportation

= $710

Car payment

= $250

New total for Transportation = $960 Using with an FMEA

A Pareto chart is not a required element for an FMEA. It is a tool that aids with determining where to apply efforts. Assembling the information into a Pareto chart reinforces where the biggest issues lay. Once you are satisfied that all the variables have been identified and included, the investigator now has a better idea of where to apply an FMEA. Remember that for an FMEA, a Pareto chart is simply a starting point, even if the only issue is to identify quantity. Even so, one incident or event that is severe enough to put an organization out of business is not going to show up as a high percentage on a Pareto, if at all. A Pareto chart does have its limitations and is not appropriate for all situations. This is why FMEAs also deal with severity, detectability, and criticality.

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Appendix B – Fishbone Diagrams Introduction

This section provides guidance on: • what a fishbone diagram is • how a fishbone diagram is structured • how to construct a fishbone diagram, and • the benefits of a fishbone diagram.

Contents

The topics given in this section and the page numbers on which they are found are: Topic

Page

What is a Fishbone Diagram. . . . . . . . . . . . . . . . . . . . . . . . 184 Diagram’s Appearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 Cause and Effect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 Value of a Fishbone Analysis. . . . . . . . . . . . . . . . . . . . . . . . 185 Fishbone Diagram as a Map . . . . . . . . . . . . . . . . . . . . . . . . 186 5Ms and 1E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 Layered Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 Omitting Layers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Higher and Lower Layers. . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Adding the Bones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 Bones with Specific Examples. . . . . . . . . . . . . . . . . . . . . . . 191 Wealth of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192 Other Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192 Consistency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194 Time Wasters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194 Money Drainers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195 183

184  Appendix B – Fishbone Diagrams

Topic

Page

Determine What is Wanted . . . . . . . . . . . . . . . . . . . . . . . . 195 Preventing Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196 If It is Not on the List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197 Not Enough Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197 Time to Do It Over . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197 Reinforcing Your Priorities. . . . . . . . . . . . . . . . . . . . . . . . . . 198 Roadmap to Success. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

What is a Fishbone Diagram

A fishbone diagram, also known as simply as a “fishbone,” is a graphical tool that helps to break down and sort of the various elements that either make up and/or contribute to a situation or a problem. The term “fishbone” comes from the skeletal appearance of a fish that the diagram presents. Note:  A fishbone can also be called an Ishikawa diagram after Kaoru Ishikawa, who developed the technique.

Diagram’s Appearance

The term “fishbone” comes from the skeletal appearance of a fish that the diagram presents.

Manpower

Machines

Methods

Investigation Area

Materials

Measurements

Environment

Appendix B – Fishbone Diagrams  185

The “skeleton” is comprised of three main parts: • The head – where the problem or situation under investigation is summarized in a few words • The spine – which links the head with the main categories, and • The ribs – which are the main categories, often referred to as the 5Ms and 1E. The “ribs” are arbitrary classifications; they may be modified to suit the situation. There is no particular order in which the categories are presented. Often, these are arranged because of space considerations. The investigation builds on the ribs with the subcategories being added to them. The ribs and their subcategories are sometimes collectively known as the “bones” of a fishbone diagram. Typically, only the head, spine, and the bones are depicted. The head is usually found on the right, although this is not mandatory. The actual shape of the fish is understood to be present, but is usually not shown except possibly once, when initially when presenting the concept to those who may not be familiar with it. Cause and Effect

A fishbone diagram is a starting point. It is a springboard that prompts ideas and other factors to consider. Once the main elements and subcategories have been identified, further analysis is performed to determine what is potentially or actually impacting, either significantly or negatively, the situation or matter under investigation. This “digging deeper” to find out what is actually going on, or where the gaps may be, amounts to discovering the causes that are creating the undesirable effects; hence, fishbone diagrams are also known as cause-andeffect diagrams.

Value of a Fishbone Analysis

When performing an FMEA, the goal is to identify the root cause(s) of potential failures. Often what appears to be the “obvious” reason why something failed or is not functioning as desired is not the reason at all. A fishbone diagram is an excellent tool for determining the root cause(s). A fishbone diagram’s value lies in its ability to break down the factors that could possibly be: • contributing to less-than-optimal conditions, i.e., failures, or • impacting a small organization that would require vigilance or some kind of response. By separating out the various elements that make up a situation, it becomes easier to see the other factors that are contributing to it.

186  Appendix B – Fishbone Diagrams

Fishbone Diagram as a Map

A fishbone diagram can be thought of as a map giving a general overview of the landscape. Subcategories provide landmarks for further investigation.

5Ms and 1E

The “ribs” of the fish are the six most common areas that quality professionals have identified as influencing the outcome of a situation.

The investigator explores these areas to find the details. Once an investigator starts digging, what becomes obvious is that there are many possibilities and factors contributing to the situation.

As a general rule, a good place to start is with the standard categories on a fishbone diagram: • manpower, a.k.a. people • machines • methods • materials • measurements, and • environment. Layered Considerations

It is helpful to also consider the fishbone as having multiple layers along the lines of a stacked pancake effect. The higher-layer requirements often, although not always, drive the lowerlayer requirements. For example, federal requirements for worker safety may be the basis for equipment selection or operator qualification. There may be instances where the lower layer requirements must sync with the higher layers, such as a facility may have a union present which creates its requirements, but under state law, these requirements must be in alignment with the state’s labor and training laws. If there were no union, the state’s requirements would not apply. The graphic on the following page, Tiered Environmental Considerations, shows how the Environment category on a fishbone may actually have multiple layers that impact that category.

Appendix B – Fishbone Diagrams  187

Tiered Environmental Considerations

Federal Regulations Example: OSHA (Occupational Safety and Health Administration)

Layer 1

State and / or City Regulations & Licenses Examples: Toxic Waste Disposal, Certified Welder

Layer 2

Plant or Shop Examples: Utilities, Warehousing, Waste Handling

Layer 3

Customer Requirements & Needs Examples: Customer-specific Raw Materials, Skidding

Layer 4

Department Examples: Location, Accessibility

Operation Examples: Ventilation, Lighting, Power

Employee Examples: Tools, Safety, Fatigue, Comfort, Union

Layer 5

Layer 6

188  Appendix B – Fishbone Diagrams

Omitting Layers

Layers may be omitted if they do not apply, but you might want to make note that you took them into consideration and found them to be “not applicable.” If liability issues are a potential concern, consider documenting why you deemed them not applicable. A few sentences noting that the requirements were considered and deemed not applicable may be sufficient to prove due diligence in the event of a lawsuit. Failure to provide records that you knew about the requirements may amount to neglect or failure to demonstrate due diligence. Protect yourself and your organization.

Higher and Lower Layers

Any layer may be considered the “top” layer, but remember that the placement is relational only and does not indicate priority in terms of cause. For the purpose of a fishbone, all layers have priority, but which dominates in terms of possible causes varies. What the business owner can control typically lies within the organization. The differences between layers are that they have different considerations and they typically require different types of responses. If it is easier, think of the layers as being a higher or lower to each other. Separating the requirements into different layers makes it easier to identify where the requirements are coming from and how to respond effectively to them. For complicated matters, drawing a fishbone for each layer can help to ensure that everything was taken into consideration and this might be something the investigator chooses to do; however, this is not required. Fishbone diagrams are tools meant to assist so use them when they make sense. Table 31, 5Ms and 1E, which is represented on the next page, provides examples for the six common categories that could be considered “higher level” and “lower level.”

Appendix B – Fishbone Diagrams  189

FISH “BONE”

DESCRIPTION

Manpower, a.k.a. “people”

The people involved with the matter

EXAMPLES High level • Lawmakers, stockholders, board of directors • Customers, markets, general public • Clients, patients, consumers, users Lower level • Trainers, sales people, customer representatives • Operators, technicians, processors • Contractors, temporary help

Materials

The materials affecting the matter

High level • Laws • Press releases, announcements • Certifications, reports, audits Lower level • Raw materials used in manufacturing • In-take forms, registration forms, claim forms • Application forms, regulatory paperwork

Methods

The methods involved in the situation

High level • Regulatory requirements • Customer requirements Lower level • SOPs, work instructions • Hand assembly, computerized, voice, person-toperson

Measurements

The measurements related to the matter

High level • Compliance audits • Customer satisfaction surveys Lower level • Weights, lengths, time, etc.

Table 31. 5Ms & 1Es. (continued)

190  Appendix B – Fishbone Diagrams

(continued)

FISH “BONE” Machines

DESCRIPTION The machines related to the matter

EXAMPLES High level • Computer systems • Transportation systems Lower level • Manufacturing equipment, office equipment

Environment

The environment impacting the situation

High level • Government regulations • Import/export • Political situations • Labor disputes Lower level • Physical location, utilities, lighting, ventilation, temperature • Employee base, education, repetitive work, training • Work demands & safety considerations

Table 31. 5Ms & 1Es.

Adding the Bones

Adding the “bones” to the “ribs” of a fishbone diagram is essentially a “drilling down” exercise. The bones simply reflect what is going on in a particular area. There are no minimum or maximum requirements of what must be present. Without showing the specifics, the structure would appear along the lines of the following figure. Note:  Some categories may have nothing or very little indicated while other categories might appear overloaded with information.

Appendix B – Fishbone Diagrams  191

Manpower

Machines

Methods

Subcategory

Subcategory Subcategory Side Consideration 1 Side Consideration 2

Subcategory Subcategory

Major Consideration Investigation Area Subcategory

Subcategory Subcategory Side consideration 1

Major Consideration 1

Sideconsideration 2

Major Consideration 2 Materials

Bones with Specific Examples

Measurements

Environment

Major Consideration 1

The fishbone below shows an example of an ice cream stand with some specifics that may pertain to it. Note that: • not every possible consideration is shown, and • one category can act as the springboard for identifying other elements or contributors.

192  Appendix B – Fishbone Diagrams

Dish Manpower

Machines

Paper

Methods

Waffle Bowl

Maintenance Display Freezer

Uniform Server

Hand Scoop

Weekly Monthly

Storage Freezer

Sugar

Seasonal

Waffle

Soft Serve Dispensing Experienced

Start-Up

Cleaning

Inexperienced Training

Shut Down

Each Use

Cone

Frequency

Scheduling

Order Payments

1-Flavor

End of Day Paychecks

Soft

2-Flavor

Seasonal Machine

Ice Cream Stand

Most Popular Small Flavors

Store

Medium

Appearance

Sizes

Manager Seasonal

Cones Servers Bowls Cleaners

Kiddie Large

Sundays Drinks

Walk-Up Window Dining Room

Products Prices Drinks Sales

Materials

Customers

Staff

Promptness

Drive Through

Sundaes

Measurements

Environment

Location

Wealth of Information

While the above fishbone did not capture every possibility for potential failures at a restaurant that specializes in short order food and ice cream, what is present are landmarks to identify other areas to investigate so, if possible, failures can be averted.

Other Considerations

It is difficult to recall everything when one has multiple tasks to perform and/or when dealing with multiple individuals, each with his or her own concerns and needs. One or more categories may bring to mind other elements to consider. Table 32 provides examples of considerations that an owner may undoubtedly be well aware of, but might not have delved into deeply in order to set up policies, systems, or instructions to prevent potential problems or ensure repeated success.

Appendix B – Fishbone Diagrams  193

CATEGORY Manpower

SUB-CATEGORY Uniform

ELEMENTS

CONSIDERATIONS

• Hair

• Neatness

• Apron

• Cleanliness • Name Tag

Scheduling

• Store hours • Staff availability

Payroll

Machines

Methods

Operating

Soft Serve

• Duties – opening and closing, peak hours, slow periods

• Tracking employee hours

• Approvals

• Pay rates

• Direct deposit

• Safety

• Dismantling

• Hygiene

• Reassembling

• Cleaning

• Repairing

• Number of twists

• Dips

• Cutting checks

• Toppings Order Payments

Measurements

Flavors

Sundaes

• Cash register

• Payment entry

• Credit & debit cards

• Accounting method

• Supplier

• Hold times

• Made-on-site

• Freezer temperatures

• Seasonal

• Rotating stock

• Specialties

• Reordering – lead time

• Elements

• Amount to use

• Toppings – flavors

• Order of addition

• Whipped cream

• Toppings – heated, room temp, chilled

• Options

• Equipment – set-up, running, safety, hygiene, cleaning Drinks

• Elements

• Amount to use

• Flavors

• Order of addition

• Options

• Cup size • Equipment – set-up, running, safety, hygiene, cleaning

Table 32. Ice cream stand example, potential areas for failure.

(continued)

194  Appendix B – Fishbone Diagrams

(continued)

CATEGORY Machines

SUB-CATEGORY Sizes

ELEMENTS • Cones • Bowls • Sundaes • Drinks

Environment

Appearance

CONSIDERATIONS • How measured – scale, twists, spoon count, spoon size • Pricing product by size

• Furniture

• Cleanliness

• Counter

• Certifications & inspections

• Staff

• Handling customers Table 32. Ice cream stand example, potential areas for failure.

Consistency

Simply by sitting down to rough out what else to consider or specify, an owner is in a much better position to create consistency within the organization. Even something as simple as “how to wear a name tag” is a specification, as in “the name tag is always worn while on duty, is positioned horizontally, and is centered across the top of the left breast pocket.” By roughing out what else to consider, an owner is in a much better position to identify where policies are needed and what needs to be specified.

Time Wasters

Examples of what wastes time, slows down delivery, and impairs customer satisfaction, include: • not having clear policies • not having any policies at all • not establishing priorities • giving only partial instructions • not specifying locations, and • expecting an experienced person to remember everything when training a new hire.

Appendix B – Fishbone Diagrams  195

Money Drainers

Examples of what ultimately result in avoidable errors and consequently use money that does not need to be wasted include: • not having clear policies • not having any policies at all • expecting people to know • believing what is obvious to you is obvious to everybody else • expecting people to use common sense • giving only partial instructions • expecting memories to never fail and that an experienced person will remember everything when training a new hire

Determine What is Wanted

The kinds of problems that can arise are limitless. Therefore, it is futile to attempt to specify everything that should be avoided. People often speak in negative generalities, but achieving the negative is difficult if not impossible. Instead, concentrate on what is desired.

INSTEAD OF SAYING… Never ignore the customer

DETERMINE DESIRED SPECIFICS What constitutes “giving the customer attention”?

EXAMPLES • Saying hello • Smiling • Greeting the party within one minute • Seating the customers with menus • Immediately asking if they would like water or coffee • Repeating their orders once taken

Don’t forget to do “X”

What exactly is the issue with “X”?

“X” needs to be done: • before the end of closing, within the next half hour, before punching out • because “Y” is backing up • a customer complained • it needs to be ready when so-and-so comes in tomorrow

Table 33. Specify What to Do. (continued)

196  Appendix B – Fishbone Diagrams

(continued)

INSTEAD OF SAYING… Don’t overload the shelves

DETERMINE DESIRED SPECIFICS

EXAMPLES

Why do we want this?

• We need room for other items

How do we achieve it?

• Too much weight and the shelf will fall down • Keep a maximum of ten on the shelf and store the rest underneath

Don’t let it get too dirty

What is clean?

• Dirty to the eye? • Dirty to the touch? • Is it washed? Washed with what? How often? Is it rinsed as well? • Is it replaced on a regular basis with a new one? How frequently?

Don’t use toxic materials

What is non-toxic?

• X may cause burns or explosions • Label must state “non-toxic” • Use only specified materials • Ensure material is within its expiration date

Table 33. Specify What to Do.

Preventing Failures

It is far easier for employees to follow one or two things that are required than to remember a list of all the things that they should not do. For example, for an ice cream shop: • customers should be acknowledged within one minute of appearing at the store • tables should be cleared and washed down within five minutes of the customers leaving • the manager or supervisor notes when servers are busy and attends to the customers themselves • serving customers takes priority over refilling sugar containers and saltand-pepper shakers, or • a state-certified food handler must be present on every shift.

Appendix B – Fishbone Diagrams  197

If It is Not on the List

Getting back to the list of “what not to do,” direct the attention back to what is required. If a situation appears that is not covered by the policy or specifications, then it is: • not applicable • the business does not do this, or • someone in authority decides how it needs to be handled. Since it is not possible to anticipate all possibilities, management should be made aware of the matter. It will decide how to proceed from there.

Not Enough Time

Frequently, supervisors and other individuals in authority claim that they are too busy to draw up a table or a diagram. It may be easier to verbally answer questions as they arise, but this: • permits opinions to replace policies • feeds into laziness, and • guarantees that there will misunderstandings, incorrect information, or omissions.

Time to Do It Over

There is an adage in the quality assurance field that “there is never enough time to do it right the first time, but there is always enough time to do it over.” If you have time to do a task over, or correct an error or problem, or address an unhappy customer, you have time to do it correctly in the first place. Remember that a fishbone diagram does not need to be completed in one sitting. Put it aside and work on it as time permits, but get it completed.

198  Appendix B – Fishbone Diagrams

Reinforcing Your Priorities

If you find yourself doing the same things repeatedly and are lacking opportunities for accomplishing your other goals, make the time for a hard look at what you are doing so you can get policies and procedures down in writing. Then, should questions arise, answer them with, “What does the (manual, worksheet, SOP, etc.) say?” and by directing the employees to come back to you with that information. This teaches the employees what needs to be done and how, as well as reinforces that: • policies and procedures do exist • policies and procedures do not change on somebody’s whim • employees are expected to take initiative and be responsible • the answers are available whenever employees need them • memories are not the best sources of information, and • a manager or supervisor will be available to answer questions after things are first done “the right way.”

Roadmap to Success

Whether used as part of an FMEA or independently to determine exactly what is happening within an organization, a fishbone diagram provides an immense amount of information. A fishbone diagram is a very inexpensive investment that goes far to contributing to an organization’s success. You owe it to your peace of mind to utilize this most valuable tool.

Appendix C – FMEA Worksheet Examples The worksheets on the following pages are available in MS Word format on the accompanying CD.

199

200  Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-15-001

Receipt of Kits

Plant A

N/A

John Anderson – Welding

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

6/1/15

7

Welding

John Anderson

Bethany Trask – Engineering

Nick Jenkins

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Welding

1

N/A

Bethany Trask

Matt Hudson – Welder

Patrick Mercier

Kits are received from outside of the welding department. Kits are usually assembled from parts located in the stock room. Sometimes, the kits come into Welding directly from the production floor.

Process Stage – Describe the process stage under development or study.

1. Parts may be mixed either on floor or in stock room. Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. The count is incorrect. 3. Parts may be dirty due to long storage or frequent handling. 4. The paperwork does not match the parts. 1. The parts are unusable due to damage or incomplete processing prior to Welding’s receipt.

Potential Failure Effects – In what ways can the above failures affect other things?

2. Incorrect number of parts creates a “short” lot. 3. Parts incorrect cleaned or not cleaned at all. 4. Downtime may result in delayed shipment.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA. Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. S – Miscount, dirt, and broken parts occur prior to the kits entering Welding. 2. S – Incorrect part selection occurs prior to the kits being received by Welding. 3. 4. 1. Traveler contains part numbers, count numbers, customer, and delivery date. 2. Cleaned parts are protected in plastic bags. 3. Kitters trained to identify parts, dirty and broken parts and how to count correctly. 4. Welders verify kit contents with paperwork – non-conforming parts put on hold. 1. Employees handling are trained to ID and isolate broken and dirty parts.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

2. Kitters are trained on how to verify the kit’s contents and counts before submitting to Welding. 3. Welders check each kit for correct paperwork, correct count, undamaged parts, and clean parts. 4. Severity (S) – measure of the possible consequences of a hazard to a user, customer, process, sub-process, or finished output.

Initial Rating – Create & use rating scales

2

Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer.

1

Risk Priority Number (RPN) = S x F x D

10

1. None at this time Recommended Changes – What are the recommended improvements?

2. System appears sufficient to catch any discrepancies 3. May revise determination after further investigation into other areas 4.

Responsibility – Who is responsible for the recommended action(s)?

1. Quality assurance 2. 1.

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. 3. 4. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Failure to detect incorrect parts may mean parts assembled incorrectly, creates waste of materials and labor, and need to do-over.

Criticality Comments

5

Frequency (F) – The probability of the cause of the failure mode occurring.

2. Need to do-over entails avoidable costs at company’s expense. 3. Need to do-over delays shipment – customer’s production hindered by incorrect or delayed parts – potential loss for future sales.

Appendix C – FMEA Worksheet Examples  201

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-15-022

Ultrasonic Cleaning

Plant A

N/A

Cindy McGuirl

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

8/17/15

8

Cleaning

Rachel Harris

Steve Patel – QA

Nick Jenkins

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Ultrasonic

Overall Process

N/A

N/A

N/A

Patrick Mercier

Parts are received for ultrasonic cleaning Parts are assembled on trays for cleaning Parts undergo three washes, one rinse, and one dry Parts released from department

Process Stage – Describe the process stage under development or study.

1. Part orientation on trays prevents proper cleaning or creates pockets that hold water. Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. Detergent – amount incorrect or not used at all. 3. Tank fluids too dirty or not replenished frequently enough. 4. Calibration results are not understood – failure to properly respond. 1. Parts may be improperly cleaned or air dried.

Potential Failure Effects – In what ways can the above failures affect other things?

2. Improperly cleaned parts may leave department. 3. Poor sonic operation will not clean sufficiently. 4. Drying may not be sufficient if there are pockets of water on parts.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA. Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. C – Proper orientation of parts not identified prior to cleaning. 2. C – Tank water cleanliness is based on experience of operators. 3. C – Management not alerted the sonic equipment is not operating sufficiently 4. C – Studies have not been performed to determine optimal drying. 1. Training for part orientation is one employee showing another. 2. Only authorized personnel are permitted to operate cleaning system. 3. Tank water must be changed after three lots – earlier if the water appears excessively dirty. 4. Detergent amounts are weighed – Washing and drying have minimum time controls. 1. Operators using subjective (eyesight) assessment of how dirty the water is, when tank water needs replenishing, and if parts are sufficiently dried. 2. Training relies on memory and people remembering to show new hires what to look for or do. 3. Sonic calibration is performed, but operators do not know how to interpret the foil results. 4. Severity (S) – measure of the possible consequences of a hazard to a user, customer, process, sub-process, or finished output.

Initial Rating – Create & use rating scales

5

Frequency (F) – The probability of the cause of the failure mode occurring.

3

Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer.

1

Risk Priority Number (RPN) = S x F x D

15

1. Develop training program for calibrating ultrasonic performance – develop if/then action plan. Recommended Changes – What are the recommended improvements?

Responsibility – Who is responsible for the recommended action(s)?

2. Perform study to determine if current (subjective) assessments of dirty water and need to replenish the tank water are reliable. 3. Develop a standard training program (PowerPoint?) that includes visual examples of how to orient parts and how to handle tank water and detergents. 4. Develop a standard training program (PowerPoint?) that includes visual examples of how to orient parts and instructions for handling water, detergents, drying, and sonic calibrations. 1. Quality assurance 2. 1.

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. 3. 4. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Unclean parts can cause customer dissatisfaction and loss of sales.

Criticality Comments

2. Unclean part can impact patient health or cause death. 3.

202  Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-15-024

Part Orientation

Plant A

N/A

Cindy McGuirl

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

8/17/15

8

Cleaning

Rachel Harris

Steve Patel – QA

Nick Jenkins

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Ultrasonic Cleaning

3

N/A

N/A

N/A

Patrick Mercier

Process Stage – Describe the process stage under development or study.

Parts are assembled on trays for cleaning. Parts undergo three washes, one rinse, and one dry. 1. Part orientation on trays prevents proper cleaning or creates pockets that hold water.

Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. Detergent – amount incorrect or not used at all. 3. Tank fluids too dirty or not replenished. 4. Calibration results are not understood – failure to properly respond. 1. Parts may be improperly cleaned, rinse, or dried.

Potential Failure Effects – In what ways can the above failures affect other things?

2. Machine oil and dirt can remain on parts. 3. Improperly cleaned parts may leave department. 4.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA.

1. C – Proper orientation of parts not identified prior to cleaning. 2. C – Tank water cleanliness is based on subjective analysis and experience of operators. 3. C – Formal training on ultrasonic cleaning never occurred. 4. C – No follow-up ever occurred to see if initial part orientation instructions were adequate. 1. Training for part orientation is one employee showing another.

Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

2. Only authorized personnel are permitted to operate cleaning system. 3. Machining origin area, including solvents and oils used, are noted on traveler. 4. Detergent amounts require weighing – Washing and drying have minimum time controls. 5. Tank water is changed after three lots – earlier if the water appears excessively dirty.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. Operators using subjective (eyesight) assessment of how dirty the water is. 2. Training on part orientation relies on memory. 3. 4. Severity (S) – measure of the possible consequences of a hazard to a user, customer, process, sub-process, or finished output.

Initial Rating – Create & use rating scales

5

Frequency (F) – The probability of the cause of the failure mode occurring.

3

Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer.

1

Risk Priority Number (RPN) = S x F x D

15

1. Develop a training program (PowerPoint?) that includes visual examples of how to orient parts. Recommended Changes – What are the recommended improvements?

2. Perform studies – determine if subjective assessments of dirty water and drying are reliable. 3. Enforce operator-only use of system. 4. Determine if more specialized racks are need to properly orient parts for cleaning.

Responsibility – Who is responsible for the recommended action(s)?

1. Engineering & QA – training and studies. 2. Management – improper use of equipment – must demonstrate support for operators. 1.

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. 3. 4. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Floor managers bypass cleaning operators and process steps to clean parts “their way”, i.e., walk-in, hand-dunk parts in tanks, give quick, hand-dunk rinses, and shake off water.

Criticality Comments

2. Understanding of process is not understood by operators and floor personnel. 3. Operators and process are disrespected – process criticality not enforced by management.

Appendix C – FMEA Worksheet Examples  203

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-15-025

Water Cleanliness

Plant A

N/A

Cindy McGuirl

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

8/17/15

8

Cleaning

Rachel Harris

Steve Patel – QA

Nick Jenkins

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Ultrasonic

3

N/A

N/A

N/A

Patrick Mercier

Process Stage – Describe the process stage under development or study.

Loaded trays are lifted and moved from one tank to another for cleaning

1. Detergent is not weighed – the amount is measured by volume (cup) or by eyeballing amount Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. Some parts dirtier than others – the kinds of dirt can vary – dirt contaminates the water 3. Back-up of lots to be cleaned may temp operators to overload the trays 4. The draining method and time, from tank-to-tank, varies by operator 1. “Drag” can occur (dirty water is carried from one tank to the next for a variety of reasons)

Potential Failure Effects – In what ways can the above failures affect other things?

2. Insufficient detergent hampers cleaning 3. Excessive detergent hampers rinsing 4. Contaminants may not be visible to the naked eye

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA. Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. C – Water changed according to the “magical” number of “3” – not scientific basis for “3” 2. C – Tank water cleanliness is based on subjective analysis and experience of operators 3. C – Tray draining time is not specified. 4. C – Instructions (SOP) written five years ago – have not been revised 1. Training consists of one employee showing another. 2. Experienced operators rely on “what they know works”. 3. Volume (cups) are used instead of weight – volume measuring methods vary by operator. 4. Custom-made racks are used on trays to help orient pieces in optimal positions for cleaning 1. Operators using subjective (eyesight) assessment of how dirty the water is.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

2. Operators using subjective (eyesight) assessment to determining sufficient draining. 3. Travelers cite prior machining methods – operators know that certain machining methods require different types of cleaning solvents. 4. Severity (S) – measure of the possible consequences of a hazard to a user, customer, process, sub-process, or finished output.

Initial Rating – Create & use rating scales

5

Frequency (F) – The probability of the cause of the failure mode occurring.

3

Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer.

3

Risk Priority Number (RPN) = S x F x D

45

1. Establish minimum draining time and minimum frequency for changing tank water. Recommended Changes – What are the recommended improvements?

2. Determine if all machining processes have their cleaning methods specified. Correlate cleaning methods with prior machining steps. Implement as step for future travelers. 3. Determine suitability of SOP – incorporate operator experience & knowledge as appropriate. 4. Perform studies to determine type and amount of contaminants that remain on the parts after cleaning, if any.

Responsibility – Who is responsible for the recommended action(s)?

1. Quality assurance – all. 2. Engineering – all. 1.

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. 3. 4. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Not all dirt and oil are visible to the eye – water may be too dirty to clean despite appearance; contaminants may remain on parts despite being visually clean.

Criticality Comments

2. Ultrasonic cleaning depends on accessibility to all nooks and crannies of the parts. 3.

204  Appendix C – FMEA Worksheet Examples

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-16-002

New Food Line

Restaurant

N/A

Kyle Richards – Chef

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By Phil Twombly

1/24/16

N/A

Kitchen

Joe Muniz

N/A

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Menu

N/A

N/A

N/A

N/A

Phil Twombly

Process Stage – Describe the process stage under development or study.

Considering adding new seafood food line to menu.

1. Customer interest will be low, not a big seafood area – recipes will not appeal to customers. Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. Chef/cooks will not know how to properly prepare and cook. 3. Will lack equipment and supplier for fresh seafood. 4. Will lack safe seafood handling methods. 1. Food will not move – food will not taste good or will go bad – will need to throw out.

Potential Failure Effects – In what ways can the above failures affect other things?

2. New equipment needs space to operate – will cramp or slow down current kitchen operations. 3. May need to qualify personnel on safe seafood handling. 4. Customer might get sick if seafood is not prepared properly.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA. Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

1. C – Cooks need training in seafood preparation and safe handling. 2. C – Restaurant lacks space for new equipment – refrigeration and cooking. 3. S – Seafood supplier is not local – extra charge for delivery – raw seafood may not be fresh. 4. C – Unknown customer preferences for seafood. 1. Chef - culinary school graduate – knows seafood – certified in safe seafood handling. 2. Kitchen already has refrigerator capacity. 3. Kitchen has room for preparation area for raw seafood. 4. Cooking equipment has flexibility for new cooking temperatures and methods. 1. Recipes are taste-tested and assessed against current menu prior to adoption.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

2. Have rough/general idea of customers’ interest in seafood. 3. Recipes assessed for needed equipment and ingredients as well as prep and serving methods. 4. Chef has broad experience in using different types of seafood – can ID seafood issues. Severity (S) – measure of the possible consequences of a hazard to a user, customer, process, sub-process, or finished output.

Initial Rating – Create & use rating scales

50

Frequency (F) – The probability of the cause of the failure mode occurring.

1

Detect (D) – The probability that the failure mode will be identified before used internally or served to the customer

2

Risk Priority Number (RPN) = S x F x D

100

1. Assess seafood restaurant competition within 3-mile radius Recommended Changes – What are the recommended improvements?

2. Find local seafood supplier 3. If seafood line is a go, need to develop training methods for kitchen staff & selling points for servers 4. Determine if seafood sells better on certain days than others 1. Chef – locate local seafood supplier & make recommendations for recipes & presentations

Responsibility – Who is responsible for the recommended action(s)?

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. Owner – determine local competition – decide if restaurant should offer special seafood dishes 3. Manager – determine selling points for servers, if seafood sells better on some days than others, & how new line will impact operations and serving 1. 2. 3. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Bad seafood, handling, or preparation can illness, death, or waste money.

Criticality Comments

2. May be little or no market if area is already saturated with seafood restaurants or there is no demand. 3. May not sell dishes if customer traffic is not interested in the menu or dislikes offerings.

Appendix C – FMEA Worksheet Examples  205

Failure Mode & Effects Analysis Worksheet FMEA #

Task Name

Facility

Project ID #

SME #1 / Department

FMEA-16-008

Expansion

Commercial Facilities

N/A

N/A

Customer N/A

Start Date

Total Steps

Department

Manager

SME #2 / Department

Completed By

2/3/16

N/A

Varies

Rachel Plover

N/A

Matt O’Reilly

Process Name

Step #

Design Rev #

Design

SME #3 / Department

Approved by

Commercial Line

N/A

N/A

N/A

N/A

Matt O’Reilly

Process Stage – Describe the process stage under development or study.

Considering expanding cleaning line from residential into commercial facilities.

1. Commercial facilities may have hazardous materials (hazmats). Potential Failure Mode – In what ways can the key input(s)/actions go wrong?

2. Commercial facilities may have confidentiality issues – access, client information etc. 3. Current equipment and/or staff may be insufficient to clean large commercial areas. 4. Current staff may not be able to work off-hours. 1. Protective clothing or special equipment may be required – cleaning products may require special handling – potential for toxic or undesirable reactions.

Potential Failure Effects – In what ways can the above failures affect other things?

2. Bonded employees and/or proof of work eligibility may be required. 3. Company may not be able to accept work due to equipment limitations – may lack capability to adequately clean due to restricted areas. 4. May need to add staff and/or let go current employees due to workload or scheduling conflicts.

Cause or Source of Potential Failure – Indicate (C) for Cause or (S) for Source. Cause means the cause of the potential failure has been identified as located in the area under investigation and will be addressed under this FMEA. Source means the source of failure must be located outside the area under review and there is a need for further investigation independent of this FMEA. Current Prevention Controls – What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? State procedure (number) that exists or note if there are no controls.

Current Detection Controls – What are the existing controls and procedures (inspection and test) that detect the Failure Mode? State procedure (number) that exists or note if there are no controls.

Initial Rating – Create & use rating scales

1. S – Hazmats located at commercial facilities. 2. S – Restricted areas and confidentiality issues vary by facility. 3. C – Cleaning solutions may adversely react with materials onsite at commercial facilities. 4. C or S – Waste disposal requirements may vary or require special handling. 1. Employees are trained to read labels before use. 2. Prior to signing contract, clients show areas that need to be cleaned and specify type of cleaning (vacuuming, washing, dusting etc.) – Specific needs and requests are obtained. 3. Clients specify hours permitted to be on-site and how to access building and areas and lockup. 4. Client’s on-call and emergency contact information are obtained prior to starting contract. 1. Company provides own cleaning products and equipment. Cleaning trucks have standardized equipment and cleaning materials. 2. Cleaning crew is trained on handling cleaning products, equipment, and client’s needs and expectations. 3. Set-up and clean-up areas, electric, and water are identified before starting contract. 4. Crews receive written instructions for each client – must complete before and after checklists for each assignment. Severity (S) – measure of the possible consequences of a hazard to a user, customer, 50 process, sub-process, or finished output. Frequency (F) – The probability of the cause of the failure mode occurring.

10

Detect (D) – The probability that the failure mode will be identified before occurring.

10

Risk Priority Number (RPN) = S x F x D

5,000

1. Determine type of facilities able to current clean – size, type of business etc. Recommended Changes – What are the recommended improvements?

Responsibility – Who is responsible for the recommended action(s)?

Mitigation Action/Control Implemented – What were the actions for reducing the occurrence of the cause or improving detection?

2. Create a client interview checklist for hazmats, waste, and confidentiality issues with standard questions – types, locations, handling. 3. Create training program for employees – determine method for conveying precautions and restrictions. 4. Determine types of equipment and cleaning products needed for adequate and safe cleaning. Determine safe waste handling and disposal methods. 1. Owner 2. 1. 2. 3. Severity (S) – measure of the possible consequences of a failure to a user, customer, the organization, sub-assembly, process, task, or finished item.

Updated Rating – Use the rating scales

Frequency (F) – The probability of the cause of the failure mode occurring. Detect (D) – The probability that the failure mode will be identified before used internally or dispatched to the customer. Risk Priority Number (RPN) = S x F x D 1. Employees may not be able to read English – unable to read labels, procedures, or restrictions.

Criticality Comments

2. Employees may inadvertently cause damage or harm to clients’ facilities. 3. Business insurance must be adequate to cover new locations and clients.

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Index

Page numbers in italics refer to figures or tables.

criticality arbitrary nature of, 95 assessment flowchart, 101f conformance to requirements, 97 defined, 95 as a moving target, 97 “not that critical” (classification), 98 objective nature of, 97 one-time determination of, 97 preventive efforts, 99 standard classifications, 96 subjective nature of, 95, 96, 99t criticality analysis, 17 Crosby, Phil, 98, 99 customer assistance, 25 customers, 163

A

acts of nature, 68, 69 acts of people, 69 American Society for Quality, 22t average time between failures, 55. See also Mean Time Between Failures (MTBF)

B

Baldrige Award, 26 Baldrige Criteria for Performance Excellence, 26 binomial failure, 60t

C

CAPA (Corrective Action and Preventive Action), 162, 163, 166 catastrophic failure, 68–70, 96 cause – FMEA, 162 change, plan for, 44 closed systems, 92, 162 conception phase, 24 configuration management, 163 conformance to requirements, 97 consumers, 163 continuous failure, 60t continuous improvement efforts, 25 control plan, 31 corrective action, 18, 156, 162, 163, 166 Corrective Action (CA) and Preventive Action (PA), 162, 163, 166 cost of poor quality, 98 cost of quality, 98, 99 cost savings, 16 criteria subjectivity, 138t critical concerns, verification of, 28, 29 “the critical few,” 12

D

damages, hidden, 67 design, defined, 44 design phase, 24 design plan, 45, 47–48f detectability flowchart, 93f root cause of failure, 92 RPN value, 64 specifications, 90 subjective criteria, 91t, 92 timing, 90 yes/no, 90 detection number, 18 drilling down, 104, 163, 165, 190 due diligence, 163

207

208  Index

E

80–20 rule, 12, 13, 169 end effect, 163 environment, 38t, 48f equipment logs, 79 external customers, 164 external stakeholders, 7

F

failure acceptability of, 80, 81 acts of nature, 68, 69 acts of people, 69 average time between, 55 catastrophic, 68–70, 96 consequences of, 59 cost of, 68 criticality, 60, 63 defined, 58, 164 detection, 20 frequency of, 77, 79, 80 in hindsight, 59 major, 69 Mean Time Between Failures (MTBF), 55, 77, 165 minor, 70, 71 moderate, 70 one-time, 54, 78, 79 operational, 60t parts per million, 81 rating scales, 137–141 RPN threshold, 64 salvageable, 69, 70 specification criteria, 83 threat assessment, 17 tolerating, 5 types of, 59 worst-case scenarios, 1, 61 failure cause, 164 failure effect, 58, 164 failure levels, 58 failure mode, 60, 164 Failure Mode, Effects, and Criticality Analysis (FMECA), 19 Failure Mode and Effects Analysis. See FMEA failure rankings, 63–64 feasibility phase, 24 firefighting, 43, 165 first-line workers, 13 fishbone analysis, 36, 185 fishbone diagrams 5Ms and 1E, 37t, 186, 189t appearance, 184, 190, 191f, 192f bones, 190, 191f cause and effect, 185 consistency, 194

defined, 184 design plan questions, 47–48f example, 192f failure prevention, 196 focus on the positive, 195, 196t graphic, 41f ice cream stand example, 192f, 193t for identity, 46 layers, 186, 187f, 188 as a map, 186 money drainers, 195 other considerations, 192 parts of, 185 priority reinforcement, 198 roadmap to success, 198 time wasters, 194 value of, 185 five “whys,” 165 5Ms and 1E, 37t, 186, 189t FMEA (Failure Mode and Effects Analysis) administrative preparation, 133–136 applicability, 20 approaches to, 19 completion of, 31 critical concerns, 110 defined, 3, 10 final steps, 159–160 guidelines for using, 9–15 guides sampling, 22t limitations, 4 “no action necessary,” 10 numbering system, 135, 138 past efforts, 111 process, 109–112, 113f purposes of, 3 ratings classifications, 13, 14 requirement for use, 10 role contributions, 5, 6t scope and flexibility, 4, 110 stages, 27–31, 33f, 111t stakeholders, 110 standards by industry, 21t three formal parts of, 16 value of, 4 FMEA coordinator, 5, 6, 30, 49 FMEA investigation flowchart, 51f FMEA log/database, 134, 135 FMEA methodology, uses of, 24–25 FMEA team, 5, 28, 110 FMEA template, 111t FMEA worksheet archiving step, 160 audits, 160 authority for change, 156 cause, 149 consistency, 153

Index  209 contributor information, 130, 131–132t criticality comments, 157 detection controls, 152 drivers, 147 examples, 199–205 failures, 147 format, 144–145 header, 123–131, 126t, 127t, 128t, 129t, 132t, 145 high process levels, 125 improvements, 155 inputs, results, and causes/sorces, 150t inputs, results, and detection controls, 152t inputs, results, and impacts, 148t inputs, results, and prevention controls, 151t inputs and outputs, 147t Internet links, 160 investigation section, 145 numbered lists, 146 operational processes, 126 outcomes, 154 potential failure causes or sources, 149 potential failure effects, 148 potential failure mode, 147, 148 preliminary information, 149 prevention controls, 151 procedure identification, 152 process header information, 128, 129t purpose, 153 ranking criteria, 153 rankings, 153 RPN decisions, 154 RPN recalculation and comparison, 156 scope, 146 source, 149 structure and purpose, 117–120, 121t supplemental information, 160 tasks, 126, 127t, 128t FMECA (Failure Mode, Effects, and Criticality Analysis), 19 “For the Want of a Nail” (poem), 59 form, fit, or function, 54, 165 frequency, of problems, 13, 14, 64 frequency number, 18 future goals, 45

G

“good enough,” 81

H

hackers, 59 hindsight, 59

I

identity, organizational, 45, 46 IEC (International Electrotechnical Commission Standardization), 21t implementers, 5, 6 improvements, effectiveness of, 30 “the informative many,” 12 internal customers, 165 Ishikawa diagram, 36, 41f, 184. See also fishbone diagrams ISO (International Organization for Standardization), 22t isolated design, 20

J

Juran, Joseph M., 12, 169

K

knee-jerk reactions, 43 known risks, 24

L

logistics, 20

M

machines, 38t, 48f maintainability, 20 maintenance, 20 maintenance logs, 79 major failure, 69 Malcolm Baldrige National Quality Award, 26 manpower (people), 37t, 47f materials, 37t, 47f Mean Time Between Failures (MTBF), 55, 77, 165 measurements, 37t, 47f methods, 37t, 47f Mil–Std–1629A, 19, 20, 21 minor failure, 70, 71 mitigation, RPN and, 18 moderate failure, 70 modification phase, 24 multinomial failure, 60t

N

new product design, 25 new regulations, 24 normal use-and-abuse, 166 “not that critical” (classification), 98

210  Index

O

occurrence acceptability of, 80, 81 action taken, 79 control and, 82 criteria subjectivity, 83, 84t financial considerations, 77 flowchart, 87f frequency and cost, 82 frequency of, 77, 80, 83 “good enough,” 81 logs, 79 Mean Time Between Failures (MTBF), 77 measuring, 78 one-time, 78 overzealousness, 81 parts per million, 81 ranking criteria, 75 rating scales, 137–141 reliability and, 79, 80 ROI and, 140 situational, 76 specification criteria, 83 tolerable numbers, 78, 82, 83, 84t, 85 unavoidable, 77 one-time occurrence, 78, 79 operational failure, 60t organizational identity, 45, 46 outside inputs, 7 overzealousness, 81

P

Pareto charts budgets as drivers, 171 category changes, 180 category reconfiguration, 178 category reduction, 177 category regrouping, 176 clustering, 177 and FMEAs, 170, 181 focus selection, 171 initial data and calculations, 172, 174 introduction, 169 manual or software preparation, 172 monthly expense example, 171, 172t, 173t, 174t, 175t, 176t, 178t, 179 omissions, 180 percentages, 179 Pareto Principle Juran and, 166 origins, 11–12 in process risk assessment, 49 reliability and, 53 parts per million, 81 past experience, 11

performance recognition, 26 plan analysis, 20 planning and design, risk assessment in, 43–48 policy development, 25 prevention, timing of, 16 preventive action, 166 preventive efforts, 99 probability of occurrence, 166 Procedures for Conducting a Failure Mode, Effects, and Criticality Analysis (Mil–Std–1629A), 19 process defined, 103 outline structure, 104 risk assessment, 49–50, 51f stages, tasks, and steps, 105, 107f

Q

qualitative criticality analysis, 166 Quality is Free (Crosby), 98 quality recognition, 25 quantitative criticality analysis, 167 questions, high-risk, 39

R

rating scales, 137–141, 138t ratings classifications, 13, 14 records, 7 regulatory requirements, 45 reliability, 54–55, 167 reliability engineering, 167 remedies, for situations, 77 repeat occurrences, 79 required/shall/must, 167 risk, defined, 167 risk assessment 5Ms and 1E, 37t brainstorming, 35 fishbone analysis, 36 fishbone analysis diagram, 41f high-level, 35–41 high-level questions, 39 organizational balance, 38 planning and design, 43–48 process, 49–50, 51f simple cause and effect, 36 risk assumption, 17, 30, 167 risk identification, 29 risk limits, 17 risk priority number (RPN), 18, 29, 30, 167 risk questions, high-level, 39 risk tolerance, 167 robustness, 167 root cause, 167 root cause analysis, 18, 25 root cause of failure, 92

Index  211

RPN (risk priority number) calculation, 29 defined, 18, 167 re-calculating, 30 RPN threshold, 64

S

SAE International, 21t safety analysis, 20 salvageable failure, 69–70 severity catastrophic failures, 68–70, 96 cost of, 68 flowchart, 73f hidden damages, 67 major, 69, 70 minor, 70, 71 moderate, 70 of problems, 13, 14, 64 salvageable, 69–70 subjective criteria, 66, 66t, 67t severity effect, 168 severity number, 18 “significant” (term of use), 11 situational occurrence, 76 small business, FMEA applicability and, 2, 5, 20, 26, 43–45, 83 software vulnerabilities, 59 source – FMEA, 168 specification criteria, 83 splitting hairs, 140–141 stage, defined, 103 stakeholders, 5, 6, 28 “statistically significant” (term of use), 11 step, defined, 104 subject matter experts (SMEs), 5, 6, 7, 28 subjectivity, 13, 14 subsystem design, 20 support analysis, 20 supporting data, 7 survivability, 20

T

target identification, 29 task, defined, 104 task identification, 29 team constraints, 7 terminology, 11, 13 tiered approach, 19 Tiered Environmental Considerations diagram, 186, 187f “the trivial many,” 12

U

undesirable outcomes, addressing, 1 unknowns, 24, 92

V

vague terminology, 11 vehicle logs, 79 vulnerability, 20

W–Z

“what if” questions, 16, 44 worst-case scenarios, 1, 61

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