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FMEA or eq. Risk analysis on internal and external issues

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Hatem, Jun 23, 2017.

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  1. Hatem

    Hatem Member

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    Hi everyone.
    I am considering the analysis of identified threats (thus risks)from internal and external issues' assessment using a formal method such as FMEA or something equivalent and then plan corrective actions accordingly as I believe to conform to 6.1.
    Could you please give me some feedback on this?
    Thank you
     
    Hatem, Jun 23, 2017
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do a SWOT, I suggest. FEMA isn't really appropriate, since you should be considering internal and external issues, needs and expectations of interested parties, not just "threats".
     
    Andy Nichols, Jun 24, 2017
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  3. Hatem

    Hatem Member

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    Thanks Andy,
    I'm planning to do SWOT, but was wondering if 6.1.2 applies also to risks identified through internal and external issues' assessment.
     
    Hatem, Jun 24, 2017
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  4. Nick1

    Nick1 Member

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    I completely agree with Andy. Just use the SWOT analysis for this. FMEA could be used for you risk analysis though, but even then it heavily depends on your business. FMEA is a great fit for production companies to manage the risks involved in their products. Overal business risk could be managed with FMEA but I haven't seen much that work well.

    For some more information SWOT analysis you could read a blogpost we wrote on this:
    http://blog.qooling.com/swot-analysis-context-of-the-organisation/

    Good luck!
     
    Nick1, Jun 24, 2017
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  5. Hatem

    Hatem Member

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    Thank you Rick for your valuable input. I'll just do SWOT and leave simplified FMEA to process risks analysis.
     
    Hatem, Jun 24, 2017
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  6. MCW8888

    MCW8888 Well-Known Member

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    Just completed first ISO9001:2015 surveillance audit. The auditor made note worthy comment on the SWOT. Thanks to all the consultants in this forum.
     
    MCW8888, Jun 25, 2017
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  7. Hatem

    Hatem Member

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    Well noted MCW8888 and Congrats for your certificate re-conduction.
     
    Hatem, Jun 25, 2017
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  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I put modified SWOT forms in my Risk Based QMS Planner.
     
    Jennifer Kirley, Jun 25, 2017
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  9. Hatem

    Hatem Member

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    Hi Jennifer,
    Could you elaborate please?
     
    Hatem, Jun 25, 2017
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A SWOT looks at internal and external issues, so nothing else needs to be done in addition. SW is internal OT is external in nature.
     
    Andy Nichols, Jun 25, 2017
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  11. Hatem

    Hatem Member

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    Sure thing Andy, but in SWOT only identification of S, W, O, T are made, no prioritization, no analysis of root causes, no corrective actions planning and no close follow-up of measures taken nor evaluation of their effectiveness are made.
    How is SWOT really fit into all this ?
     
    Hatem, Jun 26, 2017
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  12. Bev D

    Bev D Moderator Staff Member

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    FMEA provides a 'canned' formula for prioritizing (although it's mathematically and logically flawed) but it doesn't analyze root causes or create action items or follow up. YOU do that. YOU have to do those things as part of SWOT as well. There is no mathematical formula or computer program that will do this hard work for you.
     
    Bev D, Jun 26, 2017
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  13. Hatem

    Hatem Member

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    How so? I thought in FMEA, you should end up taking actions and following them up. And before taking these actions, you need to make some kind of root cause analysis. Then you put all this in a register. Things you don't do really in a SWOT analysis.
     
    Hatem, Jun 26, 2017
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  14. Hatem

    Hatem Member

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    BTW, I never said that FMEA will do all the work by itself.
     
    Hatem, Jun 26, 2017
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  15. Bev D

    Bev D Moderator Staff Member

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    There is no law that says you can't do those things in a SWOT analysis and indeed it is expected. Else what's the point?
    If you're not doing those things in a SWOT, you aren't doing it right...
     
    Bev D, Jun 26, 2017
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, that's true, but having done one, does anyone really need to be told to analyze what the SWOT indicates and take action? If you have a weakness that you have an ageing workforce and you rely on the strength of their knowledge, isn't it obvious that action needs taking?
     
    Andy Nichols, Jun 26, 2017
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  17. Hatem

    Hatem Member

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    My question then, isn't 6.1 requiring us to do risk analysis and take actions on weaknesses and threats found during internal and external issues' identification, and not doing so, or doing SWOT without it would lead to a non conformance to this chapter ?
     
    Hatem, Jun 27, 2017
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  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    There is a very strong correlation between section 4 and 6.1, as you suggest. I'm not sure how any specific auditor would handle or even understand the correlation. If you can show how you do it, then you should be good...
     
    Andy Nichols, Jun 27, 2017
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  19. Hatem

    Hatem Member

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    Thank you Andy and all the moderators for your assistance. This has been a useful chat with all of you
     
    Hatem, Jun 27, 2017
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  20. MCW8888

    MCW8888 Well-Known Member

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    I think if you can walk the auditor to your SWOT, Interested Parties, Issues and Risk and Opportunity, it will be OK.
     
    MCW8888, Jul 2, 2017
    #20
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