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Carl S. Carlson — Thought Leader

Author of Inside FMEA articles, FMEA Resources page, and multiple books, and a co-host on Speaking of Reliability.


This author's archive lists contributions of articles and episodes.

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Quality Objective 7: HIGH-RISK FAILURES IDENTIFIED

“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…]

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Quality Objective 6: TECHNICAL RISK ANALYSIS

“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…]

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Quality Objective 5: TEAM

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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Quality Objective 4: Lessons Learned

Every failure is a lesson learned about your strategy. Thomas Edison

In this article, I will discuss how to evaluate an FMEA against the FMEA Quality Objective for Lessons Learned.

By definition, a “lesson” means “something learned by study or experience,” and “learn” means “to gain knowledge or understanding of by study, instruction or experience.”

What are Lessons Learned?

Lessons Learned are specific data from the field (or from manufacturing plant history in the case of Process FMEAs) that documents relevant information about failures, from which knowledge can be gained and used in support of future product programs. [Read more…]