“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.
What is the FMEA Quality Objective related to addressing high-risk failures?
FMEA Quality Objective 11: The FMEA addresses all high-risk Failure Modes, as identified by the FMEA team, with executable actions. The result is risk reduced to an acceptable level.
How can you assess how well an FMEA meets the Quality Objective for Test Improvements?
This can be done in 3 steps.
1. For a sampling of high-risk failures/causes, are the Recommended Actions adequate to reduce risk to a level that is acceptable?
2. Were each of the reviewed Recommended Actions implemented to a result of acceptable risk?
3. Ask the FMEA team what they are most concerned about, concerning the item being analyzed with the FMEA. Was the concern properly addressed in the FMEA?
What is an example of assessing Quality Objective # 11?
As an example, we’ll use an excerpt from a fictitious Design FMEA on a bicycle handbrake to assess Quality Objective 11.
Based on the excerpt of the handbrake DFMEA, here is an example of the evaluation of FMEA Quality Objective # 11: Addressing High-Risk Failures.
Tip
When evaluating this quality objective, always ask the FMEA team if there are any high-risk issues that are not fully addressed to their satisfaction. See how these issues were taken up and addressed in the FMEA.
Summary
A primary objective of FMEA is to identify and reduce risk to a level that is acceptable. This quality objective is evaluated by selecting a sample of high-risk issues, and verifying that they are fully addressed in the FMEA.
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