Risk Identification

Ken:

Are you familiar with the recently issued AIAG/VDA FMEA? It has some excellent tools and a somewhat different methodology to creating SOD with the resultant Action Priority list, which should, I believe, address what you need to achieve. I like the approach a lot. It will, however need some facilitation/training on the methodology. Where are you located geographically?

 

Please connect with a good friend of the QFO - Jan Roovers. https://www.janroovers.com/index.php

 

Try performing a Change Point Analysis prior to starting your FMEA and focusing the FMEA efforts on those change points. See the three cases below:

• Case 1: New designs, design change, new technology, or new process
  • Design change: Changing the fundamental function of the design
  • Scope of FMEA is complete design, technology or process

• Case 2: Modifications to existing design or process
  • Design Modification: Changing the form or qualities of the design without changing the function
  • Design Refresh: Replacement of obsolete components. One for one component upgrade with no change to design
  • Scope of FMEA should focus on the modification, possible interactions due to the modification, and field history

• Case 3: Use of existing design or process in a new environment, location or application
  • Scope of FMEA is the impact of the new environment or location on the existing design or process

 

first I never calculate occurrence or detection. we focus solely on severity. It is logically impossible to use judgement a priori of the fact to determine the occurrence or the detectability. This keeps us form endless nonproductive debates.
the DFMEA should be a springboard for identifying the high risk failure modes (critical output characteristics) of your design and then lead to characterization that identifies the real critical input characteristics and the tolerances needed to ensure that you meet your output requirements. In this scenario, occurrence is an an output of the design process. and detection is a mitigation that can be directly quantified through a measurement systems analysis.

attached is the presentation on this topic that I presented at the ASQ world quality conference last year. I am presenting it at this year's ASQ Lean and Six Sigma conference in Phoenix If you are attending...

 

If I may, I've found that performing a SWOT analysis (or very similar) with the principles is sufficient to identify the one, two or three most significant risks/opportunities that everyone can agree to work on. Doesn't require any more rocket science than that. Let's not overlook that a) countries which don't have a sophisticated approach to management have to be able to implement the ISO 9001 requirements and b) ISO/TS 9002 mentions these simple to use tools and techniques, specifically, over more rocket science (like FMECA). I like FMECA - especially the VDA-AIAG version - but it's overkill, IMHO, for many reasons.

 

I agree with you when discussing business risk or project risk. so if the OP is using dfmea for these then that is overkill.

When developing a new product or assessing a change to the product we are in fact doing 'rocket science'. or semiconductor science, or medical device science...since the OP mentioned dfmea and "how you define your design risks" I inferred that they are talking about a product design.

it would be helpful if the OP could clarify their situation...

 

Agreed! I may have (inadvertently) thrown a risk wrench in the works!

 

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