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  • 1.  Risk Management Software

    Posted 21-Sep-2020 03:59
    Hi all,
    I am looking for a proper software for Risk Management. Could you please suggest some software except Excel?​

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    Maryam Tajziehchi

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  • 2.  RE: Risk Management Software

    Posted 21-Sep-2020 12:54
    Edited by Adam Atherton 21-Sep-2020 12:56
    Warning: You may not like my answer. I have used many different commercial tools, including Excel. Any of them work, whatever one you choose make sure to validate it for its intended use within your quality system. Don't stop there.

    Just in case someone reading this assumes the correct tool automatically results in an effective risk management process, I offer the following. You can be compliant, yet ineffective (Unfortunately, this describes most organization's risk management process). Using a validated tool helps ensure compliance, but in no way guarantees effectiveness.

    Vent: On.

    I always caution organizations to not look at risk management as a tool or as a FMEA. To collapse risk management to filling in areas or cells in a tool is to undermine the significance and impact of risk management. Risk management is a cross-functional brain exercise, not a fill-in-the-blank one and not a series of meetings squeezed between core team meetings and lunch. It requires a team to think deeply, holistically, systemically, and clinically. Risk management done well, early and often will result in complete understanding of the system, its risks, and the identification, implementation, and verification of effective risk controls. All medical devices end with some residual risk, our job is to manage it proactively. Do risk management well, then fit your chosen tool around it.

    Vent: Off.

    Persevere.

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 3.  RE: Risk Management Software

    Posted 22-Sep-2020 02:57
    Thank you for sharing your experience. I completely agree. Actually, I am not looking for a tool to guide me HOW to implement the risk management. Traceability is the main feature I expect from this tool.

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    Maryam Tajziehchi
    Germany
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    Original Message


  • 4.  RE: Risk Management Software

    Posted 22-Sep-2020 08:36
    Adam

    Great rant.  I think the best way to approacht risk management is to have a project leader lead the team in a room when doing parts of it.  Even if they are completing the documents at the time, it makes everyone sit down and really think through hazards, hazardous sequences etc.  Without group discussion, just filling out forms is silly.  On the back side, reminding the team risk management is not done  once it is an ongoing lifecycle issue is critical. 

    For those new to.it, i have found it really takes time to embrace the whole process.

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 5.  RE: Risk Management Software

    Posted 22-Sep-2020 08:58

    I loved Adam's reply, he is so on target. Everything he says should be part of your considerations. 

    But one more thing is very important in driving a selection of a software package. That is FIRST develop the requirements of any software system you purchase. Then you can measure the packages you look at against the requirements to see which package best fulfills your your requirements. 

    I will double down with Adam on the requirements, do not expect the software to improve your risk management process. If it does not work now, the use of a tool like software will not improve the risk management process execution. 

    Your team needs to understand that risk management is a crucial part of the ENTIRE lifecycle of your medical device. It needs to be done correctly as if members of your risk management team are going to be the first patient to use the device. Or their spouse or child or mother.  Software is only a tool to document the execution of the risk management process you have put in place. 

    One more thing, make sure your process is in compliance of the most recent edition of ISO 14971:2019 before you develop your requirements. There have been some important updates to strengthen the process. And ISO TR 24971:2020 contains important information for guiding you in updating your process to meet the requirements of the standard. 



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


  • 6.  RE: Risk Management Software

    Posted 22-Sep-2020 09:14
    If you want traceability, it might be worth looking at software programs that are used for developing product trace matrices, that is, connecting user needs to design requirements to specifications, to testing for v&v. The trace process for a risk assessment is very similar-- instead of user needs, you substitute hazards, hazardous situations instead of design requirements, controls for specifications, and testing  for v&v would be the same. Assessment of the risks would be a separate exercise. There are several programs I have used that do a decent job of tracking test verification and validation back to design inputs and user needs to ensure all necessary v&v is completed.
    I have yet to find a software program that is more effective in performing an FMEA for the amount of effort than excel, but I don't like to limit risk assessments to FMEA's. There are a number of good tools for managing risks that make the process work better when done in tandem. The biggest issue I have run into is convincing management that more than a one and done approach is worth the time spent, although inevitably the effort proves itself.

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    Barbara Young
    Bear DE
    United States
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    Original Message


  • 7.  RE: Risk Management Software

    Posted 22-Sep-2020 10:15
    Greenlight Guru is an eQMS (Greenlightguru.com) and it contains an excellent interactive risk management software module compliant with ISO 14971. It also interfaces with the Greenlight Guru design control module. Very user friendly.

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    Penny Northcutt RAC, FRAPS
    REGSolutions, LLC
    President/CEO
    Santa Rosa Beach FL
    United States
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    Original Message


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