Effective FMEAs
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Series Editor's Foreword xvii
Copyrights and Permissions xix
Acknowledgments xxi
Introduction xxiii
Chapter 1 The Case for Failure Mode and Effects Analysis 1
In This Chapter 1
1.1 The Need for Effective FMEAs 1
1.2 FMEA Application by Industry 4
1.3 The Factor of 10 Rule 5
1.4 FMEA Successes 6
1.5 Brief History of FMEA 8
1.6 FMEA Standards and Guidelines 8
1.7 How to Use This Book 9
1.8 Web Companion to Effective FMEAs 10
1.9 End of Chapter Problems 10
References 11
Chapter 2 The Philosophy and Guiding Principles for Effective FMEAs 12
In This Chapter 12
2.1 What Is Philosophy and Why Does It Matter to FMEAs? 12
2.2 Guiding Principles for Effective FMEAs 13
2.3 The Role of FMEA in Design for Reliability 17
2.4 You Can't Anticipate Everything 18
2.5 End of Chapter Problems 19
References 20
Chapter 3 Understanding the Fundamental Definitions and Concepts of FMEAs 21
In This Chapter 21
3.1 Definition of FMEA 21
3.2 Primary Objective of FMEA 22
3.3 Definition of Failure Mode Effects and Criticality Analysis 22
3.4 Types of FMEAs 23
3.5 FMEA Definitions and Examples 25
3.6 Is It a Failure Mode, Effect, or Cause? 48
3.7 FMEA Glossary 49
3.8 Web Companion to Effective FMEAs 51
3.9 End of Chapter Problems 51
References 55
Chapter 4 Selection and Timing of FMEA Projects 56
In This Chapter 56
4.1 Guidelines for When to Do FMEAs 56
4.2 FMEA Project Selection Criteria 58
4.3 Preliminary Risk Assessment 59
4.4 When to Do Different Types of FMEAs 60
4.5 Responsibility for FMEAs between OEMs and Suppliers 62
4.6 Introducing the All-Terrain Bicycle Case Study 63
4.7 End of Chapter Problems 64
Chapter 5 How to Perform an FMEA Project: Preparation 66
In This Chapter 66
Use of the Bicycle Examples in the Chapter 66
5.1 The Subject of FMEA Preparation 67
5.2 Preparation Tasks Done Once for All FMEA Projects 67
5.3 Preparation Tasks for Each New FMEA Project 78
5.4 End of Chapter Problems 103
References 106
Chapter 6 How to Perform an FMEA Project: Procedure 107
In This Chapter 107
Use of the Bicycle Examples in the Chapter 107
6.1 FMEA Procedure Sequence of Steps 108
6.2 Basic FMEA Procedure 109
6.3 FMEA Linkages 152
6.4 End of Chapter Problems 158
References 161
Chapter 7 How to Develop and Execute Effective Risk Reduction Actions 162
In This Chapter 162
Use of the Bicycle Examples in the Chapter 162
7.1 Prioritize Issues for Corrective Action 163
7.2 Develop Effective Recommended Actions 165
7.3 Action Strategies to Reduce Risk 166
7.4 Examples of Recommended Actions 176
7.5 FMEA Execution Enablers 176
7.6 The Essence of Execution 182
7.7 Documenting Actions Taken 182
7.8 Ensuring Risk Is Reduced to an Acceptable Level 183
7.9 End of Chapter Problems 183
References 186
Chapter 8 Case Studies 187
In This Chapter 187
8.1 Case Study: Shock Absorber Assembly 188
8.2 Case Study: Strudel Pastry Manufacturing 190
8.3 Case Study: Motorola Solutions "Press-to-Talk" Feature 193
8.4 Case Study: Flashlight 200
8.5 Case Study: DC-10 Cargo Door Failure 200
8.6 Case Study: Space Shuttle Challenger O-Ring Failure 204
8.7 Case Study: Projector Lamp 206
8.8 Case Study: All-Terrain Bicycle 206
8.9 Case Study: Resin Lever 213
8.10 Case Study: Power Steering 217
8.11 Other Case Studies and Examples 217
8.12 Web Companion to Effective FMEAs 221
8.13 End of Chapter Problems 221
References 224
Chapter 9 Lessons Learned for Effective FMEAs 226
In This Chapter 226
9.1 The Most Common FMEA Mistakes: How to Avoid Them and Audit Them 226
9.2 Summary of FMEA Quality Objectives 235
9.3 FMEA Quality Audit Procedure 235
9.4 End of Chapter Problems 236
Chapter 10 How to Facilitate Successful FMEA Projects 241
In This Chapter 241
10.1 FMEA Facilitation 241
10.2 Effective Meetings 242
10.3 Primary FMEA Facilitation Skills 243
10.4 Unleashing Team Creativity 252
10.5 FMEA Facilitation Roles and Responsibilities 255
10.6 How to Reduce FMEA In-Meeting Time 261
10.7 Difficulty Getting Consensus on Competing Ideas 261
10.8 End of Chapter Problems 263
References 265
Chapter 11 Implementing an Effective Company-Wide FMEA Process 266
In This Chapter 266
11.1 What is a Company-Wide FMEA Process and Why is it Important? 266
11.2 Management Roles and Responsibilities 267
11.3 Effective FMEA Process 268
11.4 Lessons Learned in Implementing a Company-Wide FMEA Process 279
11.5 Company Climate for Sharing Failure Information 281
11.6 End of Chapter Problems 282
Chapter 12 Failure Mode Effects and Criticality Analysis (FMECA) 285
In This Chapter 285
12.1 Introduction to FMECA 285
12.2 When to Use FMECA 286
12.3 Brief History of FMECA 286
12.4 Types of FMECA 287
12.5 Quantitative Criticality Analysis 287
12.6 Qualitative Criticality Analysis 289
12.7 FMECA Criticality Matrix 292
12.8 FMECA Worksheet 292
12.9 Summary Output of FMECA 292
12.10 End of Chapter Problems 294
References 296
Chapter 13 Introduction to Design Review Based on Failure Mode (DRBFM) 297
In This Chapter 297
13.1 What Is DRBFM? 297
13.2 Change Point Analysis 300
13.3 Conducting DRBFM Projects 302
13.4 How DRBFM Integrates with FMEA 304
13.5 DRBFM Worksheet 304
13.6 DRBFM Examples and Case Studies 304
13.7 Design Review Based on Test Results 309
13.8 DRBFM Glossary 311
13.9 DRBFM Resources for Further Study 312
13.10 End of Chapter Problems 313
References 315
Chapter 14 Introduction to Fault Tree Analysis (FTA) 316
In This Chapter 316
14.1 What Is Fault Tree Analysis? 316
14.2 FTA and FMEA 317
14.3 Brief History of FTA 318
14.4 Models 318
14.5 Events and Gates 318
14.6 FTA Example 319
14.7 FTA Glossary 320
14.8 FTA Procedure 323
14.9 FTA Handbooks and Standards 324
14.10 Use of FTA on Software 324
14.11 FTA Benefits and Limitations 324
14.12 End of Chapter Problems 326
References 327
Chapter 15 Other FMEA Applications 328
In This Chapter 328
15.1 Reliability-Centered Maintenance 328
15.2 Hazard Analysis 340
15.3 Concept FMEA 347
15.4 Software FMEA 348
15.5 Failure Modes, Mechanisms, and Effects Analysis 356
15.6 Failure Modes, Effects, and Diagnostic Analysis 358
15.7 End of Chapter Problems 361
References 363
Chapter 16 Selecting the Right FMEA Software 365
In This Chapter 365
16.1 Characteristics of Excellent FMEA Software 365
16.2 Why Not Just Use Spreadsheet Software? 368
16.3 Advantages of Relational Database 368
16.4 Using the Criteria for Selecting Relational Database Software 369
16.5 End of Chapter Problems 369
Reference 370
Appendices 371
Appendix A FMEA Scales 371
Appendix B FMEA Worksheet Forms 376
B.1 Design FMEA Worksheet Forms 377
B.2 Process FMEA Worksheet Forms 382
Appendix C All-Terrain Bicycle Documents 388
Appendix D Lists and Checklists 392
D.1 FMEA Preparation Checklists 392
Checklist 393
D.2 Lists of Failure Mechanisms (excerpts from book) 396
D.3 FMEA Quality Objectives 399
D.4 FMEA Facilitation Checklists 400
D.5 FMEA Action Strategy Checklist 405
D.6 FMEA Quality Audit Procedure 409
D.7 FMEA Quality Survey Form 413
Appendix E FMEA Glossary 414
References 418
Index 419
Chapter 2
The Philosophy and Guiding Principles for Effective FMEAs
In matters of style, swim with the current; in matters of principle, stand like a rock.
—Thomas Jefferson
IN THIS CHAPTER
One of the keys to effective Failure Mode and Effects Analyses (FMEAs) is for the entire FMEA process to be driven by the correct philosophy, meaning that the approach is based on the vital few guiding principles that support achieving high reliability in today’s competitive environment. This chapter lays out the primary focus areas for doing timely FMEAs effectively. The remaining chapters in this book build on these guiding principles.
2.1 WHAT IS PHILOSOPHY AND WHY DOES IT MATTER TO FMEAs?
We are boxed in by the boundary conditions of our thinking.
—Albert Einstein
Philosophy is a theory or attitude that guides one’s behavior. FMEA is a tool that exists in the larger framework of quality and reliability processes. If one’s approach to achieving quality and reliability is sound, then it will properly guide the use of the FMEA tool. Basing one’s approach to FMEAs on wrong principles, such as fixing existing problems rather than anticipating and preventing them, or on incorrect objectives, such as “to fill out a form” or “to comply with a mandate,” will reap unsatisfactory results.
The guiding principles below originate from the overall philosophy of FMEA as communicated in the Introduction to this book. Again:
Through the synergy engendered by the right team of experts, and by implementing correct and proven methods and procedures, problems can be anticipated and prevented resulting in safe and trouble-free products and processes, with the inherent risk in any system or process reduced to a very low level.
2.2 GUIDING PRINCIPLES FOR EFFECTIVE FMEAs
Each of the following is an important guiding principle, applicable to any type of FMEA, which should direct the FMEA process and FMEA practitioners. The remainder of this book embraces these principles.
2.2.1 Having the Right Objectives
If you don’t know where you are going, you will wind up somewhere else.
—Yogi Berra
Focus on Problem Prevention
Preventing problems saves money and improves products. Fixing problems is necessary when they occur, but is substantially more expensive than problem prevention. There is a different mindset in an organization that focuses on problem prevention, and the tools and timing are different. FMEA is a key tool to prevent problems before designs reach testing or processes reach the plant floor, and to improve tests and controls to be sure problems do not reach consumers. The emphasis for this entire book is problem prevention.
Focus on Design and Process Improvements
In order to achieve safe and reliable product and process designs in a timely manner, it is essential for FMEAs to drive design and process improvements as the primary objective. Safe and trouble-free designs and stable, capable, and error-proof manufacturing processes must be the primary goal. FMEAs need to drive action strategies that improve designs and processes. Chapter 7 describes many action strategies that can be employed to improve designs and processes, and reduce risk to a very low level.
Leverage FMEAs to Improve Test Plans and Process Controls
Effective product testing and manufacturing process controls are essential elements of successful product development. Tests and process controls must accurately detect all possible failures and their causes based on the entire range of operating profiles and customers usages. FMEAs can and should improve test plans and process controls. Chapter 6 shows how FMEAs link to design verification and process controls.
Select FMEA Projects Based on Preliminary Risk Assessment
FMEAs take time and cost money. It is not possible to perform FMEAs on every subsystem and component. A company should use the FMEA tool for projects that present a threshold level of risk based on a preliminary risk assessment. Chapter 4, Section 4.2, explains how to select FMEA projects.
Keep It Simple
Some FMEA practitioners complicate FMEAs with extraneous and nonvalue information. Columns can be added to FMEAs that may seem like a good idea, but add time without corresponding value. Risk ranking scales can have too many ranking levels and complex criteria that lack clarity. Each and every worksheet column, scale, preparation task, and procedure step must pass this simple test: does it add sufficient value to justify the time that is expended? One of the overriding principles of effective FMEAs is to keep to the essential elements. This book intends to empower FMEA practitioners with knowledge about all aspects of FMEAs so they can make the right choices at each stage and keep the procedure as simple as possible.
2.2.2 Having the Right Resources
When every physical and mental resource is focused, one’s power to solve a problem multiplies tremendously.
—Norman Vincent Peale
FMEA Is a Team-Based Activity
To be successful, FMEAs need the right team of subject matter experts. Even the best engineers have blind spots and only a team composed of the right disciplines can provide the necessary input and discussion to ensure all concerns are surfaced and addressed. FMEAs should not be performed by one or two individuals, or with the wrong team composition. Chapter 5, Section 5.3.4, provides guidance in establishing the correct FMEA team and ensuring they are properly trained.
Fully Understand the Basics of FMEAs
There is no shortcut to understanding the definitions and concepts of FMEAs. Knowing the basics of FMEAs, such as key definitions and concepts, is essential for learning the proper application of FMEAs to achieve safe, reliable, and economical products and processes. FMEA teams need to be well trained on the fundamentals of FMEA and the correct procedures. Chapter 3 covers all of the key definitions, with many real-world examples.
Provide Skilled FMEA Facilitation and Unleash FMEA Team Creativity
The skill set needed to perform FMEAs is not the same as the skill set needed to facilitate FMEA projects. Good facilitation is crucial for attaining the best results from FMEA teams, shortening FMEA in-meeting time, and maximizing the contributions from subject matter experts. Chapter 10 outlines and explains the unique skills for facilitating successful FMEA projects.
Albert Einstein said, “I am enough of an artist to draw freely upon my imagination. Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world.” When he said that, he certainly did not mean knowledge is not important. What he meant is that creativity and imagination play significant roles in developing new technology, new products, and new solutions. Many high-risk problems require thinking “outside the box,” and the FMEA team can solve very difficult problems when a skilled facilitator energizes its power of creativity. Chapter 10 covers how to facilitate productive FMEA meetings, unleash creativity, and move the team through the FMEA process to excellent results in a timely manner.
Benefit from Real-World Lessons Learned
FMEA has been around for over 50 years and there have been many important lessons learned. Based on the knowledge from thousands of FMEAs and hundreds of companies, certain mistakes are seen to occur repeatedly. FMEA practitioners should not keep repeating these same mistakes. Chapter 9 reveals the most common FMEA mistakes and tells how to translate them into FMEA quality objectives so that results are uniformly exceptional. This chapter also describes an FMEA audit process based upon the FMEA quality objectives.
Another part of lessons learned is the field problems discovered after an FMEA analysis has been completed. No company has ever introduced products with no field problems or failures. An effective process must be in place to capture the test and field failures missed by FMEAs and provide these as input to future FMEA teams.
Management Plays a Key Role in Establishing and Supporting an Effective FMEA Process
Individual FMEA practitioners can do their very best to perform FMEAs correctly, but there are certain vital activities that are the proper role of management to implement an effective FMEA process. Without these management-supported steps, FMEAs can flounder and miss the mark. These include establishing the strategy, providing the resources, implementing reviews of high-risk issues, supplier management, FMEA quality audits, integrating FMEAs with other businesses process, and providing the right FMEA software. Chapter 11 outlines the best practices of successful companies in achieving uniformly great results with FMEAs and explains some of the common FMEA implementation mistakes and how to avoid them. Chapter 16 shows how to select the right FMEA software that optimizes FMEA team effectiveness.
Support the Natural Passion and Energy of Employees to Achieve Trouble-Free Products
FMEAs have had a reputation for being long, drawn out, and uninteresting. This does not have to be the case and it is hoped that this book will change that reputation where it exists. Every person in a company or organization wants to support safe and trouble-free designs and processes. By following the steps in this book, everyone involved with FMEAs can be part of a...
