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

  1. We already use FMEA.

    13 vote(s)
    61.9%
  2. We will introduce FMEA for risk assessment

    3 vote(s)
    14.3%
  3. We will use another tool (Please let us know what you have in mind).

    2 vote(s)
    9.5%
  4. We don't know yet...

    7 vote(s)
    33.3%
Multiple votes are allowed.
  1. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    While we have been waiting for the release of ISO 9001:2015, there has been a lot of talk about FMEA / FMECA as the tool for risk assessment. So, I was wondering...
     
  2. Bev D

    Bev D Moderator Staff Member

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    we use FMEA - well a modified version anyway for product and process changes, also for when we are deciding on releasing product that has known 'problems'. we use a type of risk assessment based on FMEA for supply chain risk as well. we still have work to do to mature the system tho, so teh new emphasis in 9000:2015 will be welcome.
     
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  3. David Bradley

    David Bradley Member

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    I voted, "We don't know yet" because we don't limit risk analysis to just the FMEA. We have a variety of tools and will apply a different tool depending on the issue at hand. For example, doing a project with this particular customer involves one of our folks working closely with them. What is the likelihood of that customer stealing our person? (Just an example) An FMEA might not be the best tool to analyze the risk.
     
  4. Eric Twiname

    Eric Twiname Well-Known Member

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    I voted "We don't know yet" as well...for much the same reason.

    as an example, over on the RBT thread, Risk based approach is used far outside of design and process (though it is used in those as well)...and it would be a bit of a waste to formally document and score a commercial decision via FMEA.
    FMEA can be a great tool where it is a great tool...but it isn't a globally effective tool.
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think it's going to be dependent on the size/complexity of the organization. In my interest in motorcycling, which I recently started, after a 40 year hiatus, I did some risk-based thinking. I didn't sit down and do an FMEA, but I did research biking a lot, (reasons for "accidents" in the USA), bought/wear protective clothing (see my picture), went on a safety training course, bought a brightly colored bike and use my 40+ years of driving experience. I cannot "out-source" the risk (I'm not going to ride "b*tch"), won't avoid it - the opportunities are too much like fun - but can mitigate many of the risks I could encounter...
     
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  6. Eric Twiname

    Eric Twiname Well-Known Member

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    LOL...handlebars in hands or not ride. Totally on board with that.

    All the same...the back seat passenger still has RBT to do :p...it is just different from the driver.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Oh and no-one on the back...even if she's good looking!;)
     
  8. Tom Waite

    Tom Waite Member

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    I asked a manufacturer of business management software about the idea of adding a risk mitigation module to their software - their answer...?

    It's already in there - it's the FMEA.

    I think organization that do not desire to use risk management to improve their business (the ones that just want a flag flying but could really care less about it) or companies that do not apply resources effectively on risk management will default to the easy answer of a FMEA and stumble through it. Others will create tools that work for them and their organization. It's going to be great to see all the methods people are, and will be, using for risk management - all designed to get to pretty much the same place.
     
  9. Chris Glover

    Chris Glover Active Member

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    "I asked a manufacturer of business management software about the idea of adding a risk mitigation module to their software - their answer...?

    It's already in there - it's the FMEA."

    Interesting...Would be interested who would make such a statement...
     
  10. David Bradley

    David Bradley Member

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    One of my thoughts on this is with small companies, they have done well over the years without a formal risk management process. They will evaluate risks of products, projects or jobs, but nothing formal. So if their current system is serving them well, why go through the extra steps of a formal system? I can see them believing this is just another thing they will have to do just to satisfy their auditor, even though it has no value. Much like Andy's motorcycle buddies who don't believe in wearing safety gear. The problem is, the one time not using risk management bites them, it could be a fatal bite. Just like safety gear on a bike. Those who know me, know I took a really bad spill back in '11. My gear took most of the brunt and most of the damage. But, I had employed risk management and my brain bucket (helmet) kept my brain safely inside my head.
     
  11. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    My Vote would be for;
    Our Business already works by assessing risks and opportunities; It's inherent in our process and we can demonstrate that in various aspects. Perhaps a brainstorming on how to demonstrate this to Auditors of new ISO 9001 will do.
    FMEA, agreed, is a systematic tool for Risk management; But we will keep it only for designing product and manufacturing process, as we are already dealing with many murkier discussion on FMEA and can't take more:eek:
     
  12. MCW8888

    MCW8888 Well-Known Member

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    We have a process of conducting an HSSE-Q risk assessment. Are we on the right tract? Thanks.
     
  13. Claes Gefvenberg

    Claes Gefvenberg Moderator Staff Member

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    As there is no particular tool specified in 9001 I would imagine so, but I am not familiar with HSSE-Q. Maybe someone who knows it could chip in?
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    There will no doubt be all sorts of applications made available to apply RBT but I think the FMEA approach will still dominate because there is so much guidance available on the subject. This is fine as long as managers don't lock themselves in to a rigid format and make decisions solely on RPN. I have one or two clients that took the FMEA format and turned it into a road map that also listed applicable regulations and procedure numbers. This would allow a new supervisor or manager to begin navigating the system right away.
     
  15. MCW8888

    MCW8888 Well-Known Member

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    The FMEA is a visible tool to show the auditor that the company is risk-based thinking.
     
  16. Tom Waite

    Tom Waite Member

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    I have seen many versions of a FMEA used for other things and it can be a handy tool. the plus is if you know how to use a FMEA and you use the template for other things it is not a steep learning curve to utilize the same tool for other things.
     
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  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I may have posted something similar before, but in the context of this discussion, I use my personal like of motorcycling as an indicator of RBT. You can see many of the things I considered when I recently bought my first "big bike". There are others, no so obvious, but needed to mitigate risk. Nothing is written down. However, if you were to interview me, you'd get a comprehensive answer, though...
     
  18. MCW8888

    MCW8888 Well-Known Member

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    You can be very creative. Jen published a Safety FMEA. I took some best practice from that and combine some elements of process FMEA and called it HSE-Q.
     
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  19. MCW8888

    MCW8888 Well-Known Member

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    We need to thank Jennifer for all the resources she provides.
     
  20. Marcelo Antunes

    Marcelo Antunes Active Member

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    And we will continue the erroneous trend of equating failure analysis tools such as FMEA and other to risk management :p (although thereĀ“s also still the debate that RBT is not risk management :p)
     
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