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FMEA users?

Discussion in 'FMEA - Failure Modes and Effects Analysis' started by Claes Gefvenberg, Aug 12, 2015.

?

How are you going to assess risks and opportunities as required in ISO 9001:2015?

  1. We already use FMEA.

    14 vote(s)
    63.6%

  2. We will introduce FMEA for risk assessment

    3 vote(s)
    13.6%

  3. We will use another tool (Please let us know what you have in mind).

    2 vote(s)
    9.1%

  4. We don't know yet...

    7 vote(s)
    31.8%
Multiple votes are allowed.
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  1. Eric Twiname

    Eric Twiname Well-Known Member

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    So true.

    Recognizing the risks (FMEA), Considering the risks in the decision making process (RBT), and managing the risks are close together...but are tree different things.
     
    Eric Twiname, Aug 27, 2015
    #21
  2. Scott

    Scott Member

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    We have begun the use of FMEA's (process and design)

    The design ones are being done in retrospect for the majority of our products given the products have already been designed and released however we are adding it as a requirement into our NPI system that we conduct a DFMEA and create a library of P Diagrams to accompany these.

    We are not doing it to meet ISO requirements but to improve as a business as a whole given the industry is years behind others in which i have worked
     
    Scott, Sep 1, 2015
    #22
    Ravi Khare and Claes Gefvenberg like this.
  3. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    Which is the best of reasons, of course. :)
     
    Claes Gefvenberg, Sep 2, 2015
    #23
    Eric Twiname and Scott like this.
  4. MCW8888

    MCW8888 Well-Known Member

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    As we already have the Bow Tie Barrier thinking formally implemented in HSSE, we just extended the Quality piece to it. After identifying the SWOT of the system we identified all the weaknesses and threats and implement barrier thinking to improve the system.
     
    MCW8888, Mar 7, 2016
    #24
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    I'd like to say we use FMEA in my current organization, but...it would require me to spin it in such a way, everyone here would think I was running for politics. I've actually been asked to create FMEAs for several years based on projects that I've managed. *sigh* Here's a novel idea...formalize the FMEA process if we're required to have one done annually (no, this is not an ISO requirement but it a requirement for another external standard to which we conform - she said tongue-in-cheek). How about an FMEA for not doing an FMEA? Okay, so that one wasn't so tongue-in-cheek. To be honest, I'm a little perturbed that "thou shalt do, as a minimum, one FMEA per year" is a requirement...or so I'm told. Every time I have asked to see a copy of the standard, the individual who is responsible for spearheading our conformance to it promises to send...and then fails to follow through.

    I was called into a meeting last week and asked "So how's that FMEA coming along that you were to do a couple of years ago?" *sigh* Is there a politically correct way to say that an FMEA was never one of my deliverables?

    So, getting back to the question, I'd love to say we do it...but we really don't...but we say we do...

    My saving grace is that we're not ISO 9001...but in a way, I wish we were so that I could shake some sense into the process owners for QMS aspects. I probably should have kept that to my inside voice...
     
    Last edited: Mar 7, 2016
    RoxaneB, Mar 7, 2016
    #25
  6. Bev D

    Bev D Moderator Staff Member

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    wow. It never ceases to amaze how utter useless some people make their quality systems. We do have a form of FMEA that is required for every product or process change. It has saved us millions of dollars in the last 5 years. we are only now starting to require them for new designs but that is slower going...
     
    Bev D, Mar 7, 2016
    #26
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  7. RoxaneB

    RoxaneB Moderator Staff Member

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    Off topic, but if I opted to put together a business case about creating a value-added BMS - that just happened to conform to ISO 9001 - I think our "Quality" department would be in fear for their jobs.
     
    RoxaneB, Mar 7, 2016
    #27
  8. Eric Twiname

    Eric Twiname Well-Known Member

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    I don't remember who "coined" it...perhaps PaulJSmith...but it is a perfect description of things...

    QMS is NOT the Management of the Quality System
    QMS is the Quality of the Management System

    Funny how that thought keeps cropping up...
     
    Eric Twiname, Mar 8, 2016
    #28
  9. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I have not seen any responses on how one wishes to use FMEA on opportunity yet. That was the point of the survey question right? We have used FMEA for risk assessment for years, but we have not yet developed a tool for opportunities other than simple SWOT. Nowhere near in depth as FMEA. Like others, FMEA is part of every product and process package getting PPAP treatment (RAMS too for that matter). Here, 'opportunities' are generally discussed in the upper office. They are not considered 'public' knowledge, (business threats and environment too). Process opportunities are a different story, those are followed up in some way.
     
    hogheavenfarm, Mar 9, 2016
    #29
    Claes Gefvenberg likes this.
  10. MCW8888

    MCW8888 Well-Known Member

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    We started with a SIPOC process analysis. Then we also added a column on RISK ( Activities that could have an impact to the quality objectives); then the next column is the Opportunities for Improvement followed by Applicable Documents. We are not doing FMEA at this time.
     
    MCW8888, May 11, 2016
    #30
    Claes Gefvenberg likes this.
  11. Irishlazz

    Irishlazz New Member

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    I have to ask.... what product? what sort of "known problem" would be released?
     
    Irishlazz, May 13, 2016
    #31
  12. Bev D

    Bev D Moderator Staff Member

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    my organization makes diagnostic tests for the veterinary market (as well as water coliform testing and milk anti-biotics testing)

    there are some problems that cannot be reworked or repaired, are relatively low severity (workflow interruption but not a misdiagnosis) and are intermittent, meaning that the failure rate is fairly low (which also makes detection very difficult). When these conditions exist and are proven with data we can decide to continue shipment until we can determine a cause and either repair or replace the product. sometimes it is better overall for everyone to have an intermittent problem go into the field than taking the entire product line off market. that is what the product release risk assessment is for...
     
    Bev D, May 13, 2016
    #32
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