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Risk Identification

Discussion in 'FMEA - Failure Modes and Effects Analysis' started by Ken Johnson, Feb 4, 2020.

  1. Ken Johnson

    Ken Johnson Member

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    My company is looking to improve our DFMEA process. Currently we define our risks in an FMEA session where we list the components and discuss them one at a time and assign risks based on functions & requirements. This typically creates a very long list of risks and we end up spending an exhaustive amount of time assigning RPM values to items that are not major risks. I am thinking that it would be better to have a Peer review of the design concept and allow a group of experienced engineers discuss the major risks and restrict the DFMEA content to just those big risks. It seems to me that we spend so much time and effort looking at every possible risk that it makes the entire process drudgery and it becomes a "check in the box" of our product development process and the high risk items do not get the focused attention and critical thinking required to mitigate them.

    In short, I'd like to hear from the community about how you identify your design risks for your DFMEA and any methods you may use to "filter out" the minor risks to avoid wasting time.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    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?
     
  3. Ken Johnson

    Ken Johnson Member

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    Andy, I am located in Harrisburg, PA. If you have any links to this new method I would be very interested. Thanks a lot for your input.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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  5. Miner

    Miner Moderator Staff Member

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    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
     
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  6. Bev D

    Bev D Moderator Staff Member

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    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...
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    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.
     
  8. Bev D

    Bev D Moderator Staff Member

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    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...
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed! I may have (inadvertently) thrown a risk wrench in the works! ;)
     
  10. G650ER

    G650ER Member

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    Great thread...timely, OP =?
     
  11. Miner

    Miner Moderator Staff Member

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    Original Poster
     
  12. G650ER

    G650ER Member

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    Thank You Miner...acronyms acronyms....if I only stopped to think of what this was WRT...
     

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