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  • asn9 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 8 years, 5 months ago

    Hi All,

    At my company we have a similar setup as was mentioned previously:
    1- Documentation Reviews
    2- Information Gathering Techniques like Brainstorming, Delphi Technique, Interviewing, Root cause analysis
    3- Checklist analysis – previous similar project, lowest level RBS
    4- SWOT Analysis
    5- Expert Judgment.

    However after a SWOT analysis is done, we setup SMART (Specific, Measurable, Achievable, Realistic and Timely) goals. Basically, these are specific goals that we setup to analyze risk and who will evaluate each section of the risk. I have found that this really helps to create realistic goals and responsiblites for each person on the team.

    -Andrew Nashed