What is a Hazard Analysis?
“The danger which is least expected soonest comes to us.” Voltaire
This article discusses the application of Hazard Analysis, why it is used, and the similarities and differences with FMEA.
Inside FMEA
With the Inside FMEA series of articles, my intention is to bring to life the subject of FMEA, and provide value to readers from all levels of experience.
Whether you are new to FMEA, or an FMEA expert, it is my sincere desire that each and every person who reads Inside FMEA articles will discover new insights about FMEA, and experience improved success in FMEA applications.
The first article, called “Welcome to Inside FMEA”, will introduce the series, and provide a glimpse of what is to come.
Readers are encouraged to contact me with any questions about FMEA, or feedback on Inside FMEA articles. Questions, feedback, and ideas for future articles can be sent to carl.carlson@effectivefmeas.com. I will personally respond to all questions and feedback.
I’m excited to bring this new series to Accendo, and hope you enjoy reading the articles, as much as I enjoy writing them. As I say to readers of my book, "best wishes for effective FMEAs."
Carl S. Carlson
Understanding Software FMEA
Understanding Software FMEA
“My software never has bugs. It just develops random features.” Anonymous
More and more mechanical and electrical systems include software integration. The FMEA methodology applies very well to software as well as hardware. It is possible to include software functionality in the System FMEA as part of the functional descriptions. However, for complex software functionality such as embedded control systems, it may be useful to perform a separate software FMEA.
Legal Guidelines for FMEAs
Outlining Legal Guidelines for FMEAs
FMEAs are legal documents that support the demonstration of due care in product development. FMEA teams should ensure their worksheets are consistent with good legal practices for documents, and follow company legal guidelines.
“Common sense often makes good law.” William Orville Douglas, past Justice of the Supreme Court
PFMEAs can Identify Special Process Characteristics
Using Process FMEAs to Identify and Control Special Process Characteristics
[This is a companion article to “Using Design FMEAs to Identify Special Product Characteristics.” These two articles should be read in sequence.]
Identification and application of special product and process characteristics help to focus assembly and manufacturing processes on the most important areas, in order to achieve the right outcomes.
“Science is the process that takes us from confusion to understanding” – Brian Greene
DFMEAs can Identify Special Product Characteristics
Using Design FMEAs to Identify Special Product Characteristics
One of the most important principles in reliability engineering and management is the differentiation between the vital few and the trivial many. The application of special product characteristics uses that principle.
“The whole of science is nothing more than the refinement of thinking.” – Albert Einstein
Using FMEA quality objectives to audit FMEAs
Auditing FMEAs using quality objectives
In last month’s article we discussed the most common FMEA mistakes and how to convert them into quality objectives. This month we will focus on how to audit FMEAs, using the FMEA quality objectives as a guideline.
“Twice and thrice over, as they say, good is it to repeat and review what is good.” Plato
The Most Common FMEA Mistakes and How to Convert Them into Quality Objectives
The Most Common FMEA Mistakes
“Good judgment comes from experience and experience comes from poor judgment.” Will Rogers
Much is learned by observing the mistakes companies have made in doing FMEAs. Based on the experience of over 2,000 FMEAs and working with many companies in a wide variety of applications, certain common mistakes show up repeatedly. In this article, I’ll share ten common FMEA mistakes and how to convert them into quality objectives.
Using “Mode of Operation” in FMEA
Using “Mode of Operation” in FMEA Applications
More than one operational mode may need to be considered to ensure that all important failure modes are identified and analyzed in the FMEA. This article focuses on what you need to know about modes of operation when performing FMEAs.
“My favorite mode of transport is hot-air ballooning. It’s so graceful to be blown by the wind, to go where the wind takes you.” Richard Branson
What is Unique about System FMEA?
What is Unique About a System FMEA?
Many companies miss out on the value of System FMEA and begin with lower level sub-assemblies or components. This article explains why it is usually best to begin with a properly done System FMEA.
“Big whirls have little whirls,
That feed on their velocity;
And little whirls have lesser whirls,
And so on to viscosity.”
Lewis Fry Richardson
Can You Anticipate Everything?
Is it possible to anticipate everything that could go wrong?
“Prediction is very difficult, especially if it’s about the future.” Niels Bohr
In an FMEA, is it possible to think of everything that might happen in the future? What strategies can be used by FMEA teams to maximize the opportunity to anticipate what can go wrong, so risk can be reduced to an acceptable level?
Gathering Information
[Author note: This article is being published mid-month, and is part of the FMEA Preparation series. It was earlier written, but inadvertently omitted from publication, as part of this series.]
Gathering Information for FMEA Preparation
One of the most important steps in FMEA preparation is gathering all of the relevant documents and information. If this step is missed or done inadequately the FMEA meetings will be burdened with extra tasks related to missing information, the time of the subject-matter experts will be wasted, and the FMEA results potentially compromised.
“True genius resides in the capacity for evaluation of uncertain, hazardous, and conflicting information.” – Winston Churchill
Using Process FMEAs to Improve Process Control Plans
Using Process FMEAs to improve Process Control Plans
“Science is the process that takes us from confusion to understanding…” – B
Properly done, Process FMEAs should improve manufacturing and assembly processes and corresponding process controls. This article describes how PFMEAs can be used to improve process controls, which are embodied in the Process Control Plan (PCP).
Using Design FMEAs to improve Design Verification Plans
Using DFMEAs to improve Testing and Analysis
“I didn’t fail the test, I just found 100 ways to do it wrong.” Benjamin Franklin
Properly done, Design FMEAs should improve product designs and test plans. This article describes how DFMEAs can be used to improve testing and analysis, which are embodied in the Design Verification Plan (DVP).
Application Tip – Begin with Concerns
Stay Focused on Areas of Concern
“It is not possible for minds degraded by a host of trivial concerns to ever rise to anything great.” Jean-Jacques Rousseau
One of the most important elements of excellent FMEAs is to stay focused on areas of concern. What does this mean and how should it be applied?
Action Strategies to Reduce Detection Risk
What strategies can reduce detection risk in an FMEA?
“Strategy without tactics is the slowest route to victory. Tactics without strategy is the noise before defeat.” Sun Tzu
The Oxford English dictionary defines “detection” as “discovery (of what is unknown or hidden); finding out.”
Reference the article Understanding FMEA Detection – Part 1 which discusses how Detection is defined and applied in FMEA.