“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.
What is mean by “Technical Risk Analysis” in an FMEA?
To illustrate what is meant by FMEA Technical Risk Analysis, refer to Step 3 of the FMEA Process in the image below:
FMEA Technical Risk Analysis is the body of the FMEA as an analysis, and is documented in the columns or data elements from the FMEA standard being used (such as Item, Functions and associated Requirements, Failure Modes, Effects, Causes, etc.). It does not include the risk rating scales or recommended actions.
Why is evaluating the quality of FMEA Technical Risk Analysis important?
There is no substitute for learning and applying the fundamental concepts and definitions of FMEA. Even the most experienced FMEA practitioners are always improving their understanding of the basics. Each column of data element in an FMEA is essential to getting proper results.
For example, if the Item is not properly identified, the FMEA team will not be able focus on its overall objective. If the Functions are not properly described, it will be difficult to identify the corresponding failure modes. If the Failure Modes are not properly described, it will be difficult to determine the Effects and Causes. Etc. Every element in the FMEA has a role to play in the progression of the FMEA. If each of the elements are identified or described properly, according to FMEA fundamentals, the FMEA results will be excellent.
What is the quality objective for FMEA Technical Risk Analysis?
FMEA Quality Objective 6 Technical Risk Analysis: Each portion of the FMEA technical risk analysis has been properly performed, based on correct FMEA fundamentals and procedure.
How can you assess how well an FMEA meets the quality objective for FMEA Technical Risk Analysis?
When I am evaluating this quality objective, I randomly select a small sample for each of the data elements, and compare each one to FMEA fundamentals. For example, I’ll look at one or two functions, and see how well they meet the FMEA definition for function. Same for failure mode, effect, cause, etc. I’ll keep notes to support the assessment rating for this quality objective.
Whoever does this evaluation needs to have an excellent understanding of FMEA fundamentals and definitions.
What is an example of assessing the quality of FMEA Technical Risk Analysis?
As an example, I’ll use an excerpt from a fictitious bicycle hand brake subsystem (below)
ExcerptDFMEAonbicyclehandbrake
List the primary columns or data elements on the left side, and assess how well a sample of the FMEA meets the definitions and application methodology.
Based on this assessment, FMEA Quality Objective 6 is assessed at 3.
Tip
You don’t have to review every FMEA entry; just enough so that you can see if the FMEA team is using the right definitions and fundamentals to inform the entries for each FMEA column or data element.
Summary
FMEA can be a very powerful tool to achieve safe and reliable products and processes. However, it has to be applied correctly, and one of the most important elements is correct definitions and concepts. Following the advises in this chapter, you can assess how well the FMEA team meets this quality objective.
Leave a Reply