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Identifying Risk

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by KyleG, Nov 28, 2018.

  1. KyleG

    KyleG Active Member

    Nov 7, 2018
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    Reno Nevada
    I am having a hard time identify risk as far as when developing or changing a process, when we develop or change a process one of two things happens
    A) the process works better and we use it. or
    B) the process is inefficient and we switch back to the older process or try again.
    so i guess the question is what other risk is there? sure production will slow or pick up.
    I just see them as obvious outcomes i am unsure of that they actually want
  2. John C. Abnet

    John C. Abnet Well-Known Member

    May 23, 2017
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    Upper Midwest- USA
    Good day @KyleG ;
    Assume you are referring to ...
    6.3 a) or...
    8.1 e)
    (please clarify)

    As with many aspects of the standard, I would council you don't overthink this.

    Think about what is driving this requirement. Do you suppose that "good" changes within an organization sometimes actually cause problems? Obviously the answer is "yes", and these occurrences drive these type of requirements.

    Instead of how you described it, think of it like this...

    1- The Quality Manager wants to improve the lighting in the manufacturing and sorting areas and initiates a change of the lighting.
    2- Six months after the lights are changed, the Quality Manger proudly announces that sorting "misses" are down by 8% and first time through-put is up by 6% (YEAH!)
    3- Then the maintenance manager announces that the monthly electric bill has increased by $42k (Boooh!)

    So, the organization may believe that the extra $42k/month is worth it to gain the quality improvements. However, was this "potential consequence" of change considered? Was this extra cost included in the ROI ($ or satisfaction) equation? Likely not. Thus the requirement .

    Hope this helps.
    Be well
    Nicholas777, BufferMess and Artem like this.
  3. tony s

    tony s Well-Known Member

    Sep 10, 2015
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    Laguna Philippines
    Probably you identified an "opportunity" which resulted to A).
    Maybe you failed to identify the "risk" which resulted to B).
    Jennifer Kirley likes this.
  4. BufferMess

    BufferMess Member

    Aug 27, 2018
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    Hi KyleG.

    You should elaborate on "works better" when considering a change in the process. Which parameters will work better if you change the process? Some of them might be your already KPIs like, nonconformances, losses, process efficiency, production capacity or costs. Do you expect the indicators to perform better after the change? You should evaluate and address risks and opportunities associated to the change. Any risks and opportunities expected during and after the change should be considered before the changing activities start.
    Jennifer Kirley likes this.
  5. Neo113016

    Neo113016 Member

    Jul 9, 2018
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    In your current process, have you establish targets or KPI? If yes, what are those things you think that can happen that will hinder your organization achieving those targets and KPI?

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