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  • 1.  New risks from risk control measures

    This message was posted by a user wishing to remain anonymous
    Posted 01-Sep-2023 09:03
    This message was posted by a user wishing to remain anonymous

    Hello,

    Please advise.

    If there are new risks arising from the risk control measures, are these to be captured as separate risk items or will it need to be linked to the original risk item , along the same row on the risk matrix? However , note that the new risks arising from the risk control measure are different to the original risk.  

    Thanks



  • 2.  RE: New risks from risk control measures

    Posted 01-Sep-2023 09:10

    New risks arising from risk control measures are new risks, so they need to be treated separately.

    Also, this has nothing to do with a risk matrix.



    ------------------------------
    Marcelo Antunes
    Regulatory Strategy Consultant, HAS (Harmonised Standards) Consultant for the European Commission
    Jundiai
    Brazil
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    Original Message


  • 3.  RE: New risks from risk control measures

    Posted 01-Sep-2023 09:12

    They are captured as new risk items, i.e., a separate row in the hazard analysis.

    I recommend to my clients that use the spreadsheet model to include a column that asks about new risks from risk control. If there are none, enter No. If there is one, enter its row number. (I recommend unique row numbers.) Then, for the new row follow the standard practice of hazard, sequence of events, hazardous situation, risk estimate, etc.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: New risks from risk control measures

    Posted 02-Sep-2023 09:21

    Each risk needs to be managed separately through the Risk Analysis process ( note there is no Hazard Analysis in 14971 only Risk is analyzed in the standard). In a Traceability Summary (sometimes called a matrix) you would have a separate line item for each risk.

    The Standard requires traceability be maintained so you would provide information on where the new risk originated which in this case is another risk control. This is a Knowlege Management step providing the history so that if the original risk control is changed or removed you can locate any other control measures that may be impacted. 



    ------------------------------
    Edwin Bills
    Edwin Bills Consultant
    ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


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