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Evidences for risk addressing?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jul 31, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all

    Regarding of documented evidences in 6.1.1

    Would it be needed to have only a list of identified and treated risks, the evaluated impact, treatment and evidences of the follow-up and action plans?

    But I wonder if is needed, say, an evidence of a brainstorming session (special format), then a fishbone with employees when determining risk? and also a sheet/format for every risk detected en each process, the responsibles, due dates for actions,etc,including sign off of them?.

    Please give some feedback
    Pd I have determined to use fishbone for the analysis of risk insted of FMEA.

    Thanks
     
  2. MCW8888

    MCW8888 Well-Known Member

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    Hi, The ISo9001:2015 does not require you to have a formal Risk Analysis. The standard requires a risk-based thinking. One way is to add a Risk and Opportunity section in the SOPs to detect a potential risk in the process. But because we ate IATF we have to include this risk-based work instruction in our FMEA. I hope this helps.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Just to be clear, this WI isn't a requirement of IATF 16949, but your approach to meeting a requirement...
     
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  4. Qualmx

    Qualmx Well-Known Member

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    Thanks MCW and Andy, ok I could add this section to procedures, but to be consistent, what to do when there is a risk in an activity which doesnt have a procedure or WI?, for example I dont have procedure for e.g., 7.1.4 Environment for the operation of processes, for these cases, would it be recommended to have a list of risks detected for all the System?, say for risk coming from the context, from third party, and all the processes? wouldn´t be more practical, since in that list is defined who is responsible, the follow-up, due dates and so on?
    Please share your opinion. ( Im attaching a sample downloaded form the web).
     

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  5. MCW8888

    MCW8888 Well-Known Member

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  6. MCW8888

    MCW8888 Well-Known Member

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    Yes thank you
    Hello there. Your spread sheet is really good. I used a similar spreadsheet for our ISO9001 certified plants. I used your example of PURCHASING for Risk and Opportunity. We already went through a transition audit, and the presentation, story behind it and the objective evidence was acceptable. Here look at the ones I typed in RED.
     

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  7. tony s

    tony s Well-Known Member

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    A simple risks/opportunities analysis like the one below can serve as documented evidence:
    upload_2017-8-7_21-34-51.png
    Further documented information can be presented by integrating the "actions to address risks/opportunities" in a company's documented procedure (see clause 6.1.2b.1 and 4.4.1f), including records that the "actions..." are actually implemented.
     
  8. Qualmx

    Qualmx Well-Known Member

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    Thanks Tonys

    I´ll plan to include a brainstorming format, where I include ideas of risks of members under a process
    After evaluating all the risk mentioned by people, I´ll select the ones which may apply.

    and because my business is not so risky, as a methodology , I have selected the fishbone method.

    In the head of fishbone, is the process or the issue, and in each bone, is the possible cause of the problem or process.

    After that, I evaluate the impact and decide how to mitigate it.
    I have the option to give a value of the risk as a whole or evaluate each cause and have an average value

    Thanks
     

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