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  • 1.  Risk Management Report

    This message was posted by a user wishing to remain anonymous
    Posted 03-Nov-2022 11:27
    This message was posted by a user wishing to remain anonymous

    Hello,

    Looking to see if anyone can point me in the direction of a Risk Management Report template? Have a class III IVD and need to complete the Risk Management Report for PMA. Can anyone share additional information with how this report is suppose to look? ISO 14971 doesn't really explain it too well in my opinion. Thanks to all!


  • 2.  RE: Risk Management Report

    Posted 03-Nov-2022 12:35

    The Risk Management Report is simple. There are four Yes/No questions.

     

    Has the risk management plan been appropriately implemented?

     

    Is the overall residual risk acceptable?

     

    Are appropriate methods in place to collect and review information in the production phase?

     

    Are appropriate methods in place to collect and review information in the post-production phase?

     

    The review address each one and the report is the results of the review.

     

    The report should be one page, but some companies use a separate signature page.

     

    Do not make it complicated. Also, early version of the standard had more complicated requirements, but the current version makes it simple.



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


  • 3.  RE: Risk Management Report

    Posted 04-Nov-2022 12:58
    The intent of the requirements of ISO 14971:2019 Clause 9-Risk management review, is to have a documented Formal Review of risk management at the end of the process to provide Top Management with information that the product is ready to release from a Risk Management perspective.

    The process is to have a team of qualified individuals who were appointed in the Risk Management Plan, review the Risk Management Plan and compare it to the Design-development activities performed.  They will look for objective evidence the actual activities performed during device design-development demonstrate  1) the Plan was implemented appropriatley, 2) the Overall Residual Risk Evaluation (Clause 8) results met the requirements, and 3) the process to perform Production and Post-production Activities (Clause 10) is ready to accept the information on the new product and process it as required.  

    As Dan indicated, the report should be short, as it is to Top Management, and they are looking to release the product and want assurance that the product is ready.  They do not want to go through a lengthy document.  Some companies provide references to supporting documents in a table at the bottom of the report so that if questions arise the references are provided. Use the KISS principal, "Keep it Simple" and don't get complicated, just meet the requirements.

    ------------------------------
    Edwin Bills MEd, BSc, RAC, CQA, CQE, CQM/OE, ASQ Fellow
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


  • 4.  RE: Risk Management Report

    Posted 04-Nov-2022 17:55
    Thanks, Dan and Ed, for your excellent responses.

    Quick question for the group: 

    We usually state in the report that the benefits of use of the product outweigh the risks when used according to the instructions for use.

    Now that potential misuse of the product has to be considered, I am wondering if we need to drop the "when used according to the instructions for use" part.

    Comments?

    TIA

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    John Minier, RAC
    Consultant, Principal
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    Original Message


  • 5.  RE: Risk Management Report

    Posted 04-Nov-2022 18:29

    There are few things going on here, some of which are "hot buttons".

    Overall residual now includes "taking into account the contributions of all residual risks, in relation to the benefits of the intended use". If the risk management review determines that the overall residual risk is acceptable, then, you have included that the benefits outweigh the risk. No need to say it two times, so I would not put it into the report.

    The guiding principle here is what I tell my clients undergoing an audit. "Answer the question asked, not the question the auditor should have asked". If the authors of the standard wanted an explicit statement, they would have included it.

    Potential misuse is a dangerous topic. The standard says to consider reasonably foreseeable misuse and offers a definition. What scares me is the concept that reasonably foreseeable misuse is, in some regulatory jurisdictions, off-label use. There are issues if a device manufacturer condones off-label use. For example, if your hazard analysis considers a misuse that is an off label use. Have you condoned it?

    This leads to product liability issues if a patient were to receive a harm from a (reasonably foreseeable) off label misuse. It will be an issue in discovery.

    I have not kept up with the current regulatory thinking, so perhaps I'm overly nervous.

    My recommendation is to exclude potential misuse from the report under the audit guiding principle above. The standard doesn't require it, so don't.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


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