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.
Why are Lessons Learned Important in FMEA?
It is essential that the FMEA team does not miss any important failure modes. If the FMEA is disconnected from field lessons learned, this is a problem, and must be remedied. The only exception is if the FMEA is being performed on an entirely new product, with entirely new technology. In most cases, there are important field data that should be brought into the analysis. The key is to hold the FMEA team responsible to ensure that major field problems are not repeated.
How can field lessons learned be brought into an FMEA?
For Design FMEAs, the best way is to research past field and customer data to identify failures for similar systems and configurations. This can be warranty data, customer service records, or other data that documents past failures. For Process FMEAs, you can research manufacturing or assembly plant records to identify past failures during production for similar processes. The concept here is that if a failure has happened in the past, it can happen again, unless the design or manufacturing process being analyzed prevents or mitigates the same failure.
What is the Quality Objective related to Lessons Learned?
FMEA Quality Objective 4: Lessons Learned
“The FMEA considers all major “lessons learned” (such as high warranty or field failures, for Design FMEAs, or manufacturing history for Process FMEAs) as input to failure mode identification.”
How can you assess how well a FMEA meets the Quality Objective for Lessons Learned?
There are three simple steps to assess this quality objective.
- Ask for records for past failures for similar products or processes. Randomly select a representative set of field failures.
- Ask the FMEA team to show you where in the FMEA the past problems are documented. It is usually in the Failure Mode column. Be sure you can see the past failure mode(s) in the FMEA.
- Verify that the FMEA addresses the potential past failure modes, so that there is no repeat of serious failures.
What is an example of assessing Lessons Learned in an FMEA?
Tip
Some FMEA teams add an optional column to the FMEA, where they can identify Failure Modes that were input from past field data. They enter the word “seen” in this column for each potential Failure Mode that came from field data, so there can be visible follow-up to ensure no repeats.
Summary
An important role of an FMEA is to be certain that no serious field failures from past products are repeated on the new product program. This article shows how the corresponding quality objective can be evaluated.
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