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  • lurongyang replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 7 months ago

    To identify and prioritize the risks for a project, you need to start with looking up in the design history files for other similar projects for reference. This will cost less time when you hold meetings to have every member brainstorm the risks within their job duties. However, more effort still needs to be put on the risks related to highly specific details in the project design and manufacture. After all the risks have been enlisted in the documents, then ranking them in the descending order of frequency and severity to prioritize the risks. Also, for each risk, quality members should also evaluate the emergency of addressing that potential risk to make adjustment, then the priority order will be finalized for that development stage.