Inside FMEA

“Innovation has a lot to do with timing.” — Steve Jobs

When FMEAs are done is just as important as how they are done. In this article, I’ll share evaluation criteria for the FMEA Quality Objective regarding timing.

In FMEAs, what is meant by timing?

FMEAs need to be completed through Recommended Actions, Actions Taken, and risk reduced to an acceptable level by certain dates. Meeting the timing objectives of FMEAs means they were started and completed by the required dates. [Read more…]

 “In the middle of difficulty lies opportunity.” Albert Einstein

There is no more important outcome from an FMEA than identifying and addressing high-risk issues. In this article, I will outline how to evaluate an FMEA against the FMEA Quality Objective for addressing high-risk failures.

What is meant by “address high-risk failures”?

The level of risk in an FMEA is identified in the Risk Priority column. For each failure mode and corresponding effect and cause, the FMEA team designates the level of risk, such as “high” or “medium” or “low.” High-risk failures are those that the FMEA teams assigns the highest level of risk, based on appropriate FMEA standard or company policy.

“Address” means “to deal with, handle, or give attention to a problem, issue, or topic in a deliberate and effective way.”

In an FMEA, each of the high-risk failure modes must be addressed by effective actions that reduce risk to an acceptable level. [Read more…]

“Evaluate what you want – because what gets measured, gets produced.”   James A. Belasco

Years ago, many FMEAs did not recommend actions to improve product designs or testing. They identified risk, which is important; but missed opportunities to actually improve product designs and test plans. In this article, I will outline how to evaluate an individual Design FMEA or Process FMEA against the FMEA Quality Objective for test improvements.

What is meant by “test improvement”?

The concept is to take specific action to add new tests and/or revise current tests, in order to address high detection risk. [Read more…]

Progressive improvement beats delayed perfection. Mark Twain

In this article, I will outline how to evaluate an individual Design FMEA or Process FMEA against the FMEA Quality Objective for design improvements.

What is meant by “design improvement”?

An essential part of FMEA procedure is for the FMEA team to recommend and implement actions to reduce risk to an acceptable level. For Design FMEAs, this includes actions to improve the product design. For Process FMEA, this includes actions to improve the design of the manufacturing or assembly process. Of course, there are other types of actions that can be recommended, such as test improvements; but this quality objective is focused on design improvements. [Read more…]

“Always remember, your focus determines your reality” – George Lucas

In this article, I will outline how to evaluate an FMEA against the FMEA Quality Objective for identifying special characteristics. Special characteristics are often not well understood by FMEA teams, and yet have potential to be highly useful in FMEA applications.

[Read more…]

“Risk comes from not knowing what you’re doing” – Warren Buffett

In this article, I will outline how to evaluate an FMEA against the FMEA Quality Objective for identifying high-risk failures.

One definition for “risk” is “the possibility of loss or injury;” and “high” means “of a greater degree, amount or cost than expected.” Putting these words together, “high risk” means the anticipated loss or injury is too great. [Read more…]