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Home » Articles » Quality Objective 6: TECHNICAL RISK ANALYSIS

by Carl S. Carlson Leave a Comment

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.

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:

FMEAProcessMap

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.

BicycleDFMEAAssessment

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.

Filed Under: Articles, Inside FMEA Tagged With: FMEA Quality Objectives

About Carl S. Carlson

Carl S. Carlson is a consultant and instructor in the areas of FMEA, reliability program planning and other reliability engineering disciplines, supporting over one hundred clients from a wide cross-section of industries. He has 35 years of experience in reliability testing, engineering, and management positions, including senior consultant with ReliaSoft Corporation, and senior manager for the Advanced Reliability Group at General Motors.

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Articles by Carl Carlson
in the Inside FMEA series

Logo Info

Information about FMEA Icon

Inside FMEA can be visually represented by a large tree, with roots, a solid trunk, branches, and leaves.

- The roots of the tree represent the philosophy and guiding principles for effective FMEAs.
- The solid trunk of the tree represents the fundamentals for all FMEAs.
- The branches represent the various FMEA applications.
- The leaves represent the valuable outcomes of FMEAs.
- This is intended to convey that each of the various FMEA applications have the same fundamentals and philosophical roots.

 

For example, the roots of the tree can represent following philosophy and guiding principles for effective FMEAs, such as:

1. Correct procedure         2. Lessons learned
3. Trained team                 4. Focus on prevention
5. Integrated with DFR    6. Skilled facilitation
7. Management support

The tree trunk represents the fundamentals of FMEA. All types of FMEA share common fundamentals, and these are essential to successful FMEA applications.

The tree branches can include the different types of FMEAs, including:

1. System FMEA         2. Design FMEA
3. Process FMEA        4. DRBFM
5. Hazard Analysis     6. RCM or Maintenance FMEA
7. Software FMEA      8. Other types of FMEA

The leaves of the tree branches represent individual FMEA projects, with a wide variety of FMEA scopes and results.

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