exida explains Blog

Entries tagged with: FMEDA

IEC 62443 Cybersecurity Certification for Medical Devices

IEC 62443 Cybersecurity Certification for Medical Devices

Most Failures are Systematic - NOT!
  • by Dr. William Goble, CFSE
  • Wednesday, April 16, 2014
  • Certification

Most Failures are Systematic - NOT!

We have studied hundreds of sets of field failure data from various sources here at exida.  Some of these data sets have indicated differences in failure rates by over an order of magnitude for the same product type.  After tracing through the data collection process for many of…

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OLD component data = Bad FMEDAs

OLD component data = Bad FMEDAs

When we first invented the FMEDA technique in the late 1980s the biggest problem was the component failure rate and failure mode data.  Still is.  I picked up a well-known standard for component failure rates and saw a date of 2010.  The technology world has gone through an order of…

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Product Stewardship and Engineering Ethics

Product Stewardship and Engineering Ethics

Recently I witnessed something I never thought I would in the engineering profession: I was told by a system designer that even though they knew the safety reliability data for one device was too optimistic, they were going to use it because it meant they didn’t need to…

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Random vs. Systematic?
  • by Dr. William Goble, CFSE
  • Wednesday, May 07, 2014
  • Certification

Random vs. Systematic?

Most of you know that exida gathers field failure data from many sources including manufacturers’ warranty return data and end user maintenance/failure records.  At this point we have nearly 100 billion unit operating hours of data.  This is probably the largest process industry data set in the world.  And…

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Realistic Failure Rate Data – Necessary

Realistic Failure Rate Data – Necessary

Reliability engineers have known for decades that realistic data must ultimately come from one source, quality field failure data for devices operating in a similar application. 

Perhaps that is why IEC 61511:2016, Clause 11.9.3 states

“The reliability data used when quantifying the effect of random failures shall…

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SILSafe Data Website

SILSafe Data Website

exida has launched the web site www.silsafedata.com. SILSafe Data is a web site listing a number of product categories used in process control and the expected range of failure rates for process industry applications. The use of realistic and application appropriate failure rate data has a significant…

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Site Safety Index™ (SSI) – A Simple Model for Site Variations in Safety
  • by Dr. William Goble, CFSE
  • Monday, April 11, 2016
  • Certification

Site Safety Index™ (SSI) – A Simple Model for Site Variations in Safety

In several of our technical papers over the years, we have noticed that failure rates for the manufacturer, model number are different at different sites, even when the processes were quite similar.  When I have mentioned this to end users and manufacturers, often the response is “Yes, I have…

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The exida FMEDA Process - Accurate Failure Data for the Process Industries

In this blog, I will talk about the FMEDA method and how it can generate realistically accurate failure rate data.

The first question we have to ask is “why do you need failure rate data ?”

One of the fundamental concepts in today’s functional safety standard, IEC 61508 and…

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Using SILSafeData to Check Your Failure Data Source
  • by Dr. William Goble, CFSE
  • Monday, October 29, 2018
  • Certification

Using SILSafeData to Check Your Failure Data Source

www.SILSafeData.com is a complimentary resource that contains the upper and lower bounds failure rates for many categories of automation equipment, as well as the methodology used by exida to derive the numbers.  

Many of you have asked how to…

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Why Does My Risk Assessment Require an FMEDA?

Why Does My Risk Assessment Require an FMEDA?

If you find yourself faced with this question you might be wondering why it is that having successfully used risk assessments without FMEDA your team are suddenly faced with the complexity of executing FMEDAs.

Maybe us safety people answer with a follow…

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“Data is King” – Introducing the Sovereign of Component Reliability Databases
  • by Todd Stauffer
  • Thursday, August 12, 2021
  • Software

“Data is King” – Introducing the Sovereign of Component Reliability Databases

With the drive for digitalization and the Internet of Things the expression “Content is King”, coined by Bill Gates, has now been replaced by “Data is King”. This is especially TRUE in functional safety where the safety and reliability predictions generated from a Failure Modes, Effects & Diagnostics Analysis…

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