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Process Risk

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by SEGKnight, Mar 22, 2018.

  1. SEGKnight

    SEGKnight Member

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    Could anyone weigh in on how they are approaching process risks & opportunities? I'm not sure if I'm looking at it correctly.

    For example, we have a "Bookings" as a core process. I'm thinking an example of risk would be human error associated with taking/recording bookings.
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Hi, SEGKnight.

    If you use the 'Search' feature in the upper right, you will find that we've had some discussions already on Risks. Perhaps some of those will provide you with the answer's you're looking for. Some organizations have registers or lists, some do full-blown FMEAs, and so on. My own organization, for example, puts the risks (and consequences) directly into our documentation. Then again, my organization is in healthcare and if we don't do something properly, well, the risks can be fatal.

    My own take, however, is that "human error" is not a risk...it is something that could lead to a risk. A risk is "Scheduling the wrong product or delivery date".
     
    judegu likes this.
  3. Qualmx

    Qualmx Well-Known Member

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    SEGKnight, I agree with Roxaneb, and if you want to know why you are facing the risk,that may be a reason, the human error, other May be your application, maybe your Network, etc.
    Roxaneb
    According the way you manage risks.
    When is time to evaluate the residual risk,
    How you declare the closeout?
    Low risk value is closed, maybe totally closed , or monitored.
    medium value continue applying mitigation plans and is kept open? Or is closed ineffective and start new risk evaluation on the same risk?.
    High risk value, same treatment as medium risk?

    All criteria for the closeout, I think should be documented.

    Please share your thoughts
    Thanks
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, happy to! Firstly by not addressing "process" risks and opportunities because that's not what the requirement is. You'll find yourself wrapped up in knots if you start there. Take it from me, it's not meant to be that complex. ISO 9001:2015 is written for any type of organization in any part of the World. Simply take your internal/external issues, your interested parties and see what risks and opportunities develop... Put them into your management review. Monitor them. Identify the process(es) in your QMS which need to be developed to address the significant risk(s) and opportunity (ies). Implement the plan. Job done.
     
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  5. Qualmx

    Qualmx Well-Known Member

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    Andy, why no to follow the approach Iso suggested?Iso doesn't require directly to look risks in internal/external issues and interested parties, instead...
    It states "when planning , consider int/ext issues and IP and then look for risks and opportunities".this approach has been mentioned by Tony s (iso based) in this forum several times. What do you think about it?
     
  6. Neo113016

    Neo113016 Member

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    I agree with Mr. Nichols, determine first your context then to the processes.