Inside FMEA

 “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…]

“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…]

“Risk analysis is the art of turning uncertainty into actionable insight.” — Anonymous

In this article, I will outline how to evaluate an FMEA against the FMEA Quality Objective for Technical Risk Analysis.

By definition, “risk analysis” is “the systematic process of identifying, evaluating, and estimating the levels of risk involved in a situation, process, or system, in order to inform decision-making. [Read more…]

Many ideas grow better when they are transplanted into another mind than the one where they sprang up.  Oliver Wendell Holmes

In this article, I will outline how to evaluate an FMEA against the FMEA Quality Objective for FMEA Team. I’ll include relevant information from the chapter in the FMEA Preparation series called “Assembling the Correct FMEA Team.”

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A picture is worth a thousand words. An interface is worth a thousand pictures. Ben Shneiderman

In this article, I will outline how to evaluate an individual Design FMEA (DFMEA) against the FMEA Quality Objective for Interfaces. [Read more…]

Good fortune is what happens when opportunity meets with planning   Thomas Edison

As summarized in the first article in this series, “New Series – The Quality of FMEAs,” each month, I will write an article focusing on one of the 14 FMEA Quality Objectives. The intent is to provide insights and application tips for evaluating how well an FMEA meets the quality objectives. By learning to apply FMEA quality objectives, you can help to ensure that product designs and manufacturing processes are safe and reliable. If you didn’t read the introductory article, now is a good time to read it, since it explains FMEA Quality Objectives, and how they are used to create high-quality FMEAs.

In this article, I will outline how to evaluate an FMEA Plan against the FMEA Quality Objective for FMEA Plans.

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“Quality is not act.  It is a habit.”  – Aristotle

This month will begin a new series of articles on the quality of FMEAs, part of the Inside FMEAs series. The series will provide insights and application tips for evaluating how well an FMEA meets quality objectives. The intent is to create FMEAs that add value by accomplishing the objectives for FMEA, not filling out a form.

What is an FMEA Quality Objective?

We’ll begin with definitions from the Oxford English dictionary. “Quality” is defined as “the standard of something as measured against other things of a similar kind; the degree of excellence of something.” “Objective” is “a thing aimed at or sought; a goal.”

Building from the above definitions, FMEA quality objectives are specific goals or aims that measure the degree of excellence of an FMEA. [Read more…]