Effective FMEAs: Achieving Safe, Reliable, and Economical Products and Processes using Failure Mode and Effects Analysis

By Carl Carlson

Outlines the correct procedures for doing FMEAs and how to successfully apply them in design, development, manufacturing, and service applications

There are a myriad of quality and reliability tools available to corporations worldwide, but the one that shows up consistently in company after company is Failure Mode and Effects Analysis (FMEA). Effective FMEAs takes the best practices from hundreds of companies and thousands of FMEA applications and presents streamlined procedures for veteran FMEA practitioners, novices, and everyone in between.

Written from an applications viewpoint—with many examples, detailed case studies, study problems, and tips included—the book covers the most common types of FMEAs, including System FMEAs, Design FMEAs, Process FMEAs, Maintenance FMEAs, Software FMEAs, and others. It also presents chapters on Fault Tree Analysis, Design Review Based on Failure Mode (DRBFM), Reliability-Centered Maintenance (RCM), Hazard Analysis, and FMECA (which adds criticality analysis to FMEA).

With extensive study problems and a companion Solutions Manual, this book is an ideal resource for academic curricula, as well as for applications in industry. In addition, Effective FMEAs covers:

• The basics of FMEAs and risk assessment

• How to apply key factors for effective FMEAs and prevent the most common errors

• What is needed to provide excellent FMEA facilitation

• Implementing a "best practice" FMEA process

Everyone wants to support the accomplishment of safe and trouble-free products and processes while generating happy and loyal customers. This book will show readers how to use FMEA to anticipate and prevent problems, reduce costs, shorten product development times, and achieve safe and highly reliable products and processes.

• Language: English
• Publisher: Wiley
• Release date: Apr 11, 2012
• ISBN: 9781118312582

Carl Carlson

Carl Carlson’s childhood was marked by neglect, abuse, and trouble with the law, eventually landing him in prison. There he found Christ and dedicated his life to helping other men in prison turn their lives around. He is the founder of Men of Valor, a successful prison ministry serving the Nashville community.

Book preview

Chapter 1

The Case for Failure Mode and Effects Analysis

I haven’t failed; I’ve found ten thousand ways that don’t work.

—Thomas Edison

IN THIS CHAPTER

Companies and industries across the globe are cutting costs and shortening development times. Yet high reliability and impeccable safety are essential to customer satisfaction and financial viability. This chapter introduces Failure Mode and Effects Analysis (FMEA), highlights FMEA successes, and illustrates how FMEA improves reliability and safety while reducing warranty costs in a variety of industries. This chapter makes the case for FMEA.

1.1 THE NEED FOR EFFECTIVE FMEAs

One only has to look at past news headlines to see the huge cost of product failures for businesses.

Headline in CNET News:

Microsoft to Extend Xbox 360 Warranty, Take $1 Billion Hit

Microsoft said … it will take a $1 billion charge as it extends the warranty on the Xbox 360, after an investigation showed the game console can be prone to hardware failures.[1]

U.S. Consumer Product Safety Commission:

PC Notebook Computer Batteries Recalled Due to Fire and Burn Hazard

Name of Product: Lithium-Ion Batteries used in Hewlett-Packard, Toshiba and Dell Notebook Computers. Hazard: These lithium-ion batteries can overheat, posing a fire and burn hazard to consumers.[2]

Headline in CNN Money:

Firestone Tires Recalled

Bridgestone Corp. … recalled 6.5 million of its Firestone-brand tires—the second largest tire recall in U.S. history—in response to complaints the tires may be linked to fatal crashes involving sport utility vehicles.[3]

U.S. Consumer Product Safety Commission:

Yamaha Recalls Snowmobiles Due to Loss of Steering Control

Name of Product: 2009 Model Year FX10 Snowmobiles. Hazard: A bolt in the right front A arm can loosen in the suspension/steering system, resulting in the sudden loss of steering control. This poses a risk of injury or death to riders.[4]

Product recalls, in-service warranty problems, and safety issues can ruin the reputation of companies and put them out of business, in addition to the potential harm or loss to consumers. At minimum, they place a huge financial burden on the bottom line. Can FMEA prevent product failures such as these? The answer is Yes. FMEAs, when properly performed on the correct parts with the correct procedure during the correct time frame with the correct team, can prevent costly failures before products enter the marketplace. It is far less costly to prevent problems through the proper use of FMEA than to pay for expensive field problems or expensive litigation, and suffer from loss of reputation. Once lost, reputation is very difficult to earn back.

Today, companies face unprecedented worldwide competition through three ever-present challenges: the mandate to reduce costs, faster development times, and high customer expectations for the reliability of products and processes. One of the most powerful tools to meet all three of these challenges is FMEA. Properly done, FMEA will reduce costs by making products more reliable, thus lowering warranty costs and the costs associated with product failures. FMEA will shorten product development times by addressing problems early in the process thus reducing the costly, and time-consuming, test-and-fix treadmill. FMEA will help companies meet customer high expectations for reliability by eliminating or mitigating failures before users or consumers discover them.

Companies already using FMEAs know their value and understand the necessity of doing them. The question is, are the FMEAs being done correctly, with the highest possible quality, and are the powerful results of which they are capable being achieved? Are product designs and manufacturing processes uniformly improving through use of FMEAs? Is field warranty going down? Is rock solid safety being achieved? In business terms, what is the return on investment? This book will enhance the effectiveness of FMEAs where currently in use, and reinforce correct application.

Companies not yet doing FMEAs or that are having questionable results from FMEA programs should take a hard look at the cost of quality and reliability failures. Both should seriously consider implementing effective FMEAs as part of their product development process or quality improvement systems. Those having questionable results need to modify their approach and conduct their FMEAs more effectively, which this book is meant to facilitate.

Most corporate and military applications require some form of FMEA, yet questions persist about the overall effectiveness of FMEA as applied in many companies and organizations today. Today, with good reason, results in FMEA applications are mixed. Few reliability tools elicit stronger responses from quality and reliability professionals than FMEA. As for reactions to FMEA around the virtual water cooler, one may hear comments like waste of time, lack of support, and don’t want anything to do with it, at one end, to powerful tool, effective way to prevent problems, and needs to be done across the board, at the other end. So why is there so much variation in the application of a tool that has been around for many decades? How can results be achieved more uniformly and successfully?

The purpose of this book is to teach clearly and simply the entire subject of FMEAs, including the best practice procedures for doing FMEA projects, the pitfalls, the lessons learned to make FMEAs more effective, and how to implement an effective FMEA process in any company or industry.

Take the analysis Figure 1.1, which shows the cost of warranty servicing at Hewlett-Packard from 2003 to 2010. The chart is based on actual warranty expenses, which is lost revenue and demonstrates one of the costs of product failures and customer dissatisfaction. As can be seen from the chart, billions of dollars per year were spent servicing warranty claims, averaging over 3% of total sales.[5]

FIGURE 1.1 Hewlett-Packard warranty claims and accruals 2003–2010.

(Source: Warranty Week from SEC data.)

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Figure 1.2 shows the warranty costs at the top 20 U.S.-based companies.[6]

FIGURE 1.2 Top 20 U.S.-based warranty providers: 2010 annual warranty costs and accrual rates (in $ millions and as a percent of sales).

(Source: Warranty Week from SEC data.)

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It is easily seen that many companies are spending huge amounts of money servicing warranty claims, money that could be much better spent designing higher quality products that result in higher customer satisfaction. FMEA used properly is a highly effective tool for accomplishing this objective. The potential cost savings is enormous.

Well-done FMEAs improve reliability, ensure safety, and reduce risk to organizations. They are an essential part of doing business.

1.2 FMEA APPLICATION BY INDUSTRY

FMEA is a vital task supporting reliability programs in nearly every industry worldwide. Based on a survey of approximately 500 reliability professionals across the globe, FMEA is the most important task in their reliability programs.[7]

The American Society of Quality (ASQ) certifies Six Sigma Black Belt candidates. One of the primary topics in ASQ’s published Six Sigma Certification Body of Knowledge is FMEA.[8]

The automotive industry uses the International Organization for Standardization Technical Specification (ISO/TS 16949:2009) as the quality standard for its suppliers. This standard specifies the precise quality system requirements for suppliers in the automotive sector. FMEA plays a central role in the implementation of this standard.[9]

Advanced Product Quality Planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly the automotive industry. According to the Automotive Industry Action Group (AIAG), the purpose of APQP is to produce a product quality plan which will support development of a product or service that will satisfy the customer. FMEA is a key requirement of APQP.[10]

The Joint Commission Resources (JCR) is a not-for-profit affiliate of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and has as its mission to continuously improve the safety and quality of care in the United States and in the international community through the provision of education and consultation services and international services. The Joint Commission and JCR were named as the first World Health Organization Collaborating Centre for Patient Safety Solutions. In the JCR publication titled Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, it says FMEA can improve the safety for individuals receiving care by helping to identify failures and near misses and by protecting individuals from harm when, despite an organizations best efforts, failures do occur. The publication goes on to say, It can narrow or eliminate gaps in quality and performance and yield improved outcomes. It is easy to learn and enhances organization-wide collaboration and understanding. Simply stated, its use is good business practice.[11]

A type of FMEA called Hazard Analysis plays a central role in the risk assessment approach required in ISO 14971:2007 for medical devices.[12]

Reliability-Centered Maintenance (RCM) is the analytical process used by most companies to determine preventive maintenance (PM) requirements and ensure safe and cost-effective operations of any system. The core of an RCM project is an FMEA on selected manufacturing or operational equipment.

All branches of the military require FMEAs for joint programs and supplied parts. The type of FMEA often required by the military is Failure Mode Effects and Criticality Analysis (FMECA), which is covered in Chapter 12 of this book.[13, 14]

Regardless of what industry one is involved in—aerospace, medical, appliances, electronics, automotive, chemical, energy, services, information, and so on—FMEA is a key tool that supports high reliability, ensures safety, and achieves customer satisfaction.

1.3 THE FACTOR OF 10 RULE

Figure 1.3 describes the increasing costs of finding and fixing problems depending on when the problems are discovered. The later problems are found in the product development process, the more it costs to fix them, symbolized by factors of 10.[15]

FIGURE 1.3 Factor of 10 rule.

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What can be learned from the Factor of 10 Rule about how FMEA supports product improvement?

FMEAs can assess which designs are best from a feasibility standpoint.

FMEAs can ensure designs are safe, robust, and have inherently high reliability.

FMEAs can support streamlined development of products and anticipate problems before being discovered in testing.

FMEAs can improve the effectiveness of testing to ensure no problems are conveyed to the customer.

FMEAs can ensure the manufacturing process is stable and in control.

FMEAs can ensure operation of equipment is safe and cost-effective.

If a company budget cannot support reliability improvement during product development, how can the company expect to budget for the costs of warranty, recalls, and other expensive corrective actions?

In practice, there are a number of sound business reasons to implement an effective FMEA process. A well-done FMEA is a proven tool to reduce life cycle warranty costs. Well-done FMEAs will reduce the number of oops during product development. It is far less expensive to prevent problems early in product development than to fix problems after launch. FMEAs can identify and address safety issues before a potential catastrophe.

Figure 1.4 illustrates how FMEA shifts problem discovery to much earlier in the Product Development Process timeline.

FIGURE 1.4 FMEA shifts problem discovery earlier in the product development process.

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1.4 FMEA SUCCESSES

Many companies have had great benefits from the use of FMEAs. The following are brief synopses of five company successes, minus specific details in order to protect confidentiality. Chapter 8 gives detailed case studies and other case studies are interspersed throughout the book.

FMEA Case Study 1

Cooling systems are an important part of vehicles and residential and commercial buildings. In this example, an FMEA was done on the cooling system of a complex vehicle system. The FMEA team discovered 24 safety-related failure modes with the potential for high frequency in service. If these failure modes were not properly addressed, they could have been dangerous to the customer and catastrophic to the company. All of the safety-related failure modes were addressed with actions recommended by the FMEA team. One example of a failure mode discovered by this FMEA team was a radiator leak caused by corrosion, which was almost certain to occur. The cause of the problem was resolved when the FMEA team recommended changing the design of the radiator using a new corrosion-resistant material.

FMEA Case Study 2

An exercise company was developing a new product with considerable innovation and new technology. The company wanted to ensure their equipment was both safe and reliable. In this example, a System FMEA was conducted on the new exercise equipment. The FMEA team discovered nine failure modes with potential to cause injury to the user. All of these potential failure modes were addressed with specific corrective actions. One of the failure modes had the potential to cause injury to the user due to improper stride length limits. This was resolved by redesigning the stride length feature, making it safe for all users.

FMEA Case Study 3

A company performed a System FMEA on new equipment that uses food products. Particular attention was paid to ensure there were no safety problems due to contamination. The FMEA team uncovered 20 failure modes with potential for bacterial harm to customers. All of them were addressed with adequate action plans. An example was a potential failure mode of a valve leaking due to high pressure in the system. A valve redesign resolved the problem.

FMEA Case Study 4

A company that makes small electronic devices was developing a new product that utilized a tiny speaker. A Design FMEA was done on the speaker subsystem. In this example, seven failure modes were discovered that could potentially result in complete loss of performance, and the FMEA team believed they were very likely to occur. All of these potential failure modes were addressed with specific actions. One example was a diaphragm that was too stiff due to a narrow racetrack. The racetrack was redesigned with better stiffness parameters, resolving this problem.

FMEA Case Study 5

A Process FMEA was done on a vehicle door hanging operation, where the door assembly is bolted onto the vehicle in the assembly plant. At the time of this FMEA, door fit was not possible within specifications without using an unusual and expensive adjustment procedure. The FMEA team raised this issue to management for review and correction, resulting in a new robust door opening design that no longer required the expensive in-plant adjustment.

In the first four of these case studies, actions were taken to eliminate or mitigate the failures before testing was begun, ensuring the products were safe and reliable, and generating considerable cost savings. When FMEAs are done this way, testing can be done with the objective of confirmation rather than initial discovery. In the fifth case study, an expensive plant operation was eliminated.

1.5 BRIEF HISTORY OF FMEA

FMEA was formalized in 1949 by the U.S. Armed Forces by the introduction of Military Procedures document (MIL-P)-1629, Procedures for Performing a Failure Mode Effect and Criticality Analysis. The objective was to classify failures according to their impact on mission success and personnel/equipment safety.[16] It was later adopted in the Apollo space program to mitigate risk due to small sample sizes. The use of FMEA gained momentum during the 1960s, with the push to put a man on the moon and return him safely to earth. In the late 1970s, the Ford Motor Company introduced FMEA to the automotive industry for safety and regulatory consideration after the Pinto affair. They also used it to improve production and design. In the 1980s, the automotive industry began implementing FMEA by standardizing the structure and methods through the Automotive Industry Action Group. Although developed by the military, the FMEA method is now extensively used in a variety of industries including semiconductor processing, foodservice, plastics, software, automotive, and healthcare to name a few.[17]

1.6 FMEA STANDARDS AND GUIDELINES

There are many standards and guidelines published that cover the scope and general procedure for doing FMEAs or FMECAs.* Some of the more common and relevant guidelines are:

Society of Automotive Engineers (SAE) J1739, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA) [2009]

AIAG, PotentialFailure Mode and Effects Analysis (FMEA) Reference Manual Fourth Edition [2008]

Military Standard (MIL-STD)-1629A, Procedures for Performing a Failure Mode Effects and Criticality Analysis (cited for cancellation in 1994, but still used in some military and other applications)

SAE ARP5580, Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Applications [2001]

International Electrotechnical Commission (IEC) 60812, Analysis techniques for system reliability—Procedure for failure mode and effects analysis (FMEA) [2006]

Many other standards and guidelines promote or mandate the use of FMEA. These will be referenced when relevant to the topics covered in this book.

1.7 HOW TO USE THIS BOOK

Most people will benefit from reading the entire book in sequence, chapter by chapter. However, understanding the limited availability of time in people’s lives, here are a few suggestions to accommodate those whose scope of application is limited.

Chapter numbers and titles are recapped here for ease in reviewing the section below.

Chapter 1: The Case for Failure Modes and Effects Analysis

Chapter 2: The Philosophy and Guiding Principles for Effective FMEAs

Chapter 3: Understanding the Fundamental Definitions and Concepts of FMEAs

Chapter 4: Selection and Timing of FMEA Projects

Chapter 5: How to Perform an FMEA Project: Preparation

Chapter 6: How to Perform an FMEA Project: Procedure

Chapter 7: How to Develop and Execute Effective Risk Reduction Actions

Chapter 8: Case Studies

Chapter 9: Lessons Learned for Effective FMEAs

Chapter 10: How to Facilitate Successful FMEA Projects

Chapter 11: Implementing an Effective Company-Wide FMEA Process

Chapter 12: Failure Mode Effects and Criticality Analysis (FMECA)

Chapter 13: Introduction to Design Review Based on Failure Modes (DRBFM)

Chapter 14: Introduction to Fault Tree Analysis (FTA)

Chapter 15: Other FMEA Applications

Reliability-Centered Maintenance (RCM)

Hazard Analysis

Concept FMEA

Software FMEA

Failure Modes, Mechanisms, and Effects Analysis

Failure Modes, Effects, and Diagnostic Analysis

Chapter 16: Selecting the Right FMEA Software

Students who are using the book to learn the fundamentals of FMEA as part of a course of study such as engineering should read at least through Chapter 9 and further, depending on the individual course of study and its unique objectives. The student should perform the end of chapter problems.

In academia, teachers who would like to integrate FMEA into engineering or other curricula should utilize the material in the book at least through Chapter 9. Instructors may want to add other applications, such as FMEA facilitation, RCM, DRBFM, and so on, as per individual course of study needs. However, it is important to ensure the student understands the basics and applications of FMEA up through Chapter 9, as the unique application chapters build on the foundation established in those chapters.

Industry professionals and practitioners who wish to learn how to perform FMEAs, if new to the subject, or want to improve their results if already experienced with the subject matter, should read at least through Chapter 10. End of chapter problems are optional. Later chapters cover unique applications such as FMECA, FTA, DRBFM, RCM, Hazard Analysis, and so on, and build on the knowledge base of the earlier chapters up through Chapter 10. Therefore, it is important to understand the material from the first 10 chapters, regardless of one’s focus on a unique application.

The application of FMEAs to product designs is usually called System or Design FMEAs. The application of FMEAs to manufacturing or assembly processes is called Process FMEAs. These applications share many of the same definitions, concepts, and procedures. Therefore, material relating to both System/Design FMEAs and Process FMEA applications is integrated into each of the chapters in the book. However, wherever there are unique definitions, concepts, or procedures between System/Design FMEAs and Process FMEAs, these are clearly identified.

Managers or executives who will be involved in implementing FMEA processes should read Chapters 2, 4, 9, 10, and 11. Chapters 3 and 5 through 8 are optional, depending on how deeply the manager wishes to learn the fundamentals of FMEA. It is the author’s opinion, based on managing engineering and reliability groups for many years, that managers are well served to understand the fundamentals of FMEA as part of implementing a successful FMEA process. However, as mentioned in the beginning of this section, time is limited, and the above chapters are the minimum required for good understanding and application.

1.8 WEB COMPANION TO EFFECTIVE FMEAs

There is a companion web site to this book. Students and practitioners are encouraged to visit http://www.wiley.com/go/effectivefmeas. Additional resources will be posted on this web site as they become available, including more exam­ples of FMEA definitions, case studies, related FMEA material, illustrations, and useful links.

1.9 END OF CHAPTER PROBLEMS

Beginning with Chapter 2, end of chapter problems are included to support FMEA application knowledge.

Note

* Throughout this book, there will be many references to the acronyms FMEA and FMECA. The grammatical convention used will be to refer to an FMEA, and a FMECA. The reason for this is most practitioners say ef-em-ee-ae when referring to FMEA; however, most practitioners say fah-mee-kah when referring to FMECA. Therefore, the convention will be to refer to an FMEA and a FMECA.

REFERENCES

 1. Fried, Ina. Microsoft to Extend Xbox 360 Warranty, Take 1$ Billion Hit [Online] 2007. Available at http://news.cnet.com/Microsoft-to-extend-Xbox-360-warranty%2C-take-1-billion-hit/2100-1014_3-6195058.html?tag=contentMain;contentBody;1n, Article date July 5, 2007 CNET News.

 2. PC Notebook Computer Batteries Recalled Due to Fire and Burn Hazard. Available at http://www.cpsc.gov/cpscpub/prerel/prhtml09/09035.html, Bulletin date October 30, 2008; Release #09-035, U.S. Consumer Product Safety Commission.

 3. Firestone Tires Recalled. [Online] 2000. Available at http://money.cnn.com/2000/08/09/news/firestone_recall/, Article date August 9, 2000, CNN Money.

 4. Yamaha Recalls Snowmobiles Due to Loss of Steering Control. Available at http://www.cpsc.gov/cpscpub/prerel/prhtml10/10719.html, Bulletin date January 27, 2010; Alert #10-719, U.S. Consumer Product Safety Commission.

 5. Computer Warranty Claims and Accruals. Product Warranty Series [Online] 2010. Available at http://www.warrantyweek.com/archive/ww20100916.html, Warranty Week, based on SEC data.

 6. Warranty Claims & Accruals in Financial Statements. [Online] 2011. Available at http://www.warrantyweek.com/, Warranty Week, based on SEC data.

 7. Carlson, Carl, Georgios Sarakakis, David Groebel, and Adamantios Mettas, 2010, Best Practices for Effective Reliability Program Plans, in Reliability and Maintainability Symposium.

 8. ASQ. Six Sigma Black Belt Certification Certification [Online] 2011 [cited 2011]. Available at http://asq.org/certification/six-sigma/bok.html.

 9. ISO, 2009, ISO/TS 16949 Quality Management Systems—Particular Requirements for the Application of ISO 9001:2008 for Automotive Production and Relevant Service Part Organizations.

10. AIAG, 2008, Advanced Product Quality Planning and Control Plan (APQP), AIAG.

11. JCR, Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, 3rd ed. Joint Commission Resources, 2010.

12. ISO, 2007, ISO 14791 Medical devices—Application of Risk Management to Medical Devices.

13. Military, United States, 1980, MIL-STD-1629A: Procedures for Performing A Failure Mode Effects And Criticality Analysis, Department of Defense.

14. SAE, 2001, SAE ARP5580: Recommended Failure Mode and Effects Analysis (FMEA) Practices for Non-Automotive Applications, copyright 2001 SAE International.

15. DFR Fundamentals: An Introduction to Design for Reliability. 2007. ReliaSoft Corporation.RS 560 DFR Fundamentals, Copyright ReliaSoft Corporation.

16. Military, United States, 1949, Mil-P 1629 Procedures for Performing a Failure Mode Effect and Criticality Analysis.

17. Fadlovich, Erik. Performing Failure Mode and Effect Analysis [Online] 2007 [cited 2010]. Available at http://www.embeddedtechmag.com/component/content/article/6134, Embedded Technology.

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 dynamic, interesting, and engaging process. Properly done, FMEAs harness the inherent passion and energy that employees have for helping consumers and users receive safe and reliable products.

Utilize the Wealth of Knowledge in the Fields of Quality and Reliability 

The fields of quality and reliability are fortunate to have professional standards, books, journals, societies, symposiums, and web sites offering a wealth of knowledge and experience. An effective FMEA process should be infused with the best possible knowledge base. FMEA teams need access to the most credible and effective tools and methods to support each stage of the FMEA. This book provides industry case studies (Chapter 8), examples for each of the key concepts (Chapters 3, 5, and 6), end of chapter problems to challenge the FMEA student (all chapters), a companion web site, and refers to many valuable sources of experience and information.

2.2.3 Having the Right Procedures

The desire to know is natural to good men.

—Leonardo da Vinci

Make It Visible 

FMEA is an engineering analysis with conceptual ideas about real parts and processes. Using drawings, diagrams, charts, and real parts to focus the intellect and ideas of the expert team is a necessary element for meaningful discussion and successful outcomes. Making the scope of the project visible will ensure that key elements such as interfaces, integration, key characteristics, functions, and other essential information are not missed. This should be done upfront as part of FMEA preparation and throughout the actual team meetings. Chapter 5, Sections 5.3.2 and 5.3.3 cover how to make the scope of the project visible.

Ensure FMEAs Are Requirements Driven and Data Driven 

Good requirements are a key part of designing for reliability and FMEAs must integrate seamlessly with requirements-driven designs and processes. Likewise, good data are a key element of good product designs and manufacturing processes. Well-organized data from technical specifications, past projects, field history, and other sources drive good FMEAs. Chapter 5 outlines the details of how to integrate FMEAs with requirements and what specific data are needed in preparation for FMEA projects.

Ensure FMEAs Always Get to Root Cause and Actual Failure Mechanisms for High-Risk Issues 

The heart of an FMEA is the cause. Well-defined causes provide the opportunity to drive the right behaviors and changes to achieve safe and reliable designs and processes. Essential to defining causes for high-risk issues is to get to the level of the failure mechanism. Chapter 6 describes the correct FMEA procedure, including the Five Whys and the basis for arriving at root causes and failure mechanisms that drive effective actions.

Keep the Focus on Areas of Concern and Risk 

In the past, some FMEA teams have been allowed to wander into ever-increasing levels of detail and to spend an inordinate amount of time on low-risk issues. If an FMEA team has lots of spare time and extra budget, performing FMEAs on all subsystems and components and taking up failure modes and causes that are of little or no concern is possible. Most companies are limited in their time, budget, and skilled resources. Therefore, provided the FMEA team has the correct membership and is led by a skilled facilitator, it is good practice to limit FMEA entries to areas of genuine concern to one or more of the team members. Additionally, it serves FMEA teams well to spend more time on areas of higher risk and less time on areas of lower risk. This is further explained in Chapter 10, which covers FMEA facilitation.

Perform FMEAs Within the Right Time Frame 

FMEAs drive design improvements to products and processes and therefore must be done early in the product development process in order to have the greatest impact on product and process designs and support improved test and control methods. Late FMEAs have diminished value. Chapter 4 explains when to do FMEAs to get the best results.

Fully Execute All Actions to Ensure Risk Reduction to an Acceptable Level 

Ignoring FMEA results or not effectively implementing the recommended actions can waste all the work of the FMEA. FMEA issues remain open until each identified risk is reduced to an acceptable level. Chapter 7 shows how to define recommended actions so they are executable, and how to follow up to ensure risk is addressed.

2.3 THE ROLE OF FMEA IN DESIGN FOR RELIABILITY

FMEA is an essential tool in Design for Reliability (DFR). DFR is the set of strategies and tools that design-in reliability to products and processes.

Three important statements summarize the reliability philosophy of successful companies:

1. Reliability must be designed-in to products and processes using the best available science-based methods.

2. Knowing how to calculate reliability is important, but knowing how to achieve reliability is more important.

3. DFR practices must begin early in the design process and must be integrated well into the overall product development cycle.

The overriding philosophy of FMEA supports the Product Development Process and the tools of DFR.

Figure 2.1 shows the relationship of FMEA with DFR.[1]

FIGURE 2.1 FMEA relationship with DFR tasks.

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FMEA, driven by requirements and data, supports key design reliability tools, drives design and process improvements, and supports improvements in test regimens and process control methods.

Figure 2.2 shows a reliability equation. Consider for a moment, where the majority of the effort should be to improve reliability. The most fruitful effort is on the right side of the equation, by defining, adjusting, and controlling the factors that influence the design, environment, and customer usage. Certainly, it is helpful to calculate or measure reliability; however, focusing on the left side of the equation, while avoiding the right side, does little to improve reliability. FMEAs should attempt to impact the right side of the reliability equation in order to have the greatest impact on achieving reliability objectives.

FIGURE 2.2 Reliability equation.

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2.4 YOU CAN’T ANTICIPATE EVERYTHING

Prediction is very difficult, especially if it’s about the future.

—Niels Bohr

FMEAs are intended to anticipate potential risk and develop actions that will reduce risk to acceptable levels. However, as pointed out in an article written by Daniel Simmons entitled You Can’t Anticipate Everything, there is a danger in overconfidence[2]:

A standard approach to safety engineering is to try to define all of the potential risks in advance and to design protocols that, if followed precisely, will avoid all of the known hazards. Such safety-by-protocol is great in principle, but it has a critical failing: The illusion of knowledge. The approach assumes that we can know and anticipate all of the potential risks.

In his article, Simmons draws from an experiment in which he shows a video of young people passing basketballs back and forth, and asks the viewer to count the number of times the players in white uniforms pass the ball. Midway through the video, a person in a gorilla costume walks in the middle of the action. It is remarkable that most people who watch the video and focus on counting the passes will entirely miss seeing the gorilla.

In fairness to the participants in this experiment, they were told what to anticipate (i.e., were given blinders, in effect), and so they watched for the passing basketball, and therefore did not see the gorilla walking through. FMEA teams are not given such blinders or limits as to what they may anticipate. Nevertheless, they are vulnerable to not anticipating certain rare or unexpected events, such as the 9.0

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