“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.
What is meant by “high risk” in an FMEA?
FMEA procedure requires the consequences (effects) of all potential failure modes to be evaluated for severity, and the causes to be evaluated for likelihood of occurrence and ability to detect during product development. Risk prioritization combines the influence of severity, occurrence and detection risk to determine the relative risk, and priority for corrective actions.
High-risk in an FMEA means the risk prioritization determines the combination of severity, occurrence, and detection risk is unacceptably high.
Implicit when determining if all high-risk failures are identified is that there are no high-risk failures that are omitted from the analysis. This means the preparation must be well done, and the meetings well facilitated.
Why is evaluating the quality of FMEA Technical Risk Analysis important?
There is no more important objective for FMEA procedure than ensuring that all high-risk issues are identified and addressed. That is why FMEAs are being done. All risk in an FMEA must be reduced to an acceptable level, and this begins with identifying high-risk issues.
What is the quality objective for identification of high-risk failures in FMEA?
FMEA Quality Objective 7: All potential high-risk failure modes and associated causes are properly identified and prioritized, including past field issues (for similar items) and potential new issues.
How can you assess how well an FMEA meets the quality objective for identifying high-risk failures?
This should be done in three ways.
- The first way is to examine the FMEA, and talk with the team, to see if severity, occurrence, and detection are properly assessed for risk, and if the combined influence is properly determined, based on company policy and FMEA standards. In other words, how well does the FMEA surface high risk?
- The second way is to ask FMEA team members for what is their highest concerns, and then ask the team leader where in the FMEA that concern is addressed.
- The third way is to ask to see the field history, and one or two examples of the most troublesome or highest risk issues from the field, for similar products. Followed by tracing the high-risk field issues through the FMEA to be sure they are identified.
What is an example of assessing how well the FMEA identifies high risk?
As an example, I’ll use an excerpt from a fictitious bicycle hand brake subsystem (below)
Evaluation criteria # 1. Examine the FMEA, and talk with the team, to see if severity, occurrence, and detection are properly assessed for risk, and if the combined influence is properly determined.
The team missed the lower severity risk associated with the second failure mode. If the Effect is correct, the severity is rated too high. The team assessed the occurrence properly, but had a misunderstanding on how to assess detection risk. They thought they were evaluating whether there were tests or not. Properly rating of severity, occurrence, and detection for the second failure mode would have resulted in a medium risk priority.
Evaluation criteria # 2. Ask FMEA team members for what is their highest concerns, and then ask the team leader where in the FMEA that concern is addressed.
One of the team members mentioned a serious concern about the new brake pad material disintegrating in low humidity areas. The team leader could not show where this was considered in the FMEA.
Evaluation criteria # 3. Ask to see the field history, and one or two examples of the most troublesome or highest risk from the field.
Most of the highest risk field issues were properly brought into the FMEA. One issue was missed, due to an administrative oversight.
Based on this assessment, FMEA Quality Objective 7 is assessed at 2.
Tip
When assessing how well an FMEA meets this quality objective, always examine the FMEA itself, as well as interviewing the FMEA team.
Summary
Essential to effective FMEAs is properly identifying high-risk issues. By using the three recommended evaluation criteria from this article, you can determine how well an FMEA meets this objective.
