Update
April 24, 2023
Risk Analysis has been updated based on feedback on our assignment. Specifically, inconsistencies in severity ratings for allergic reactions were adjusted, considerations for an app (not included in final design) were removed, and risk mitigation was made more specific to attempt to reduce user error as much as possible (particularly regarding alerts and design specifications that prevent incorrect setup and use). Fault tree analysis is unchanged from our previous submission.
Revised Risk Analysis
Here is our updated Fault Tree Analysis and our dFEMA. After receiving further instructions on how these documents should appear, we made these edits.
Preliminary Risk Analysis
March 10, 2023
The two docs above contain our Fault Tree Analysis and our dFMEA. We analyzed the risks based on our current design and after figuring out how to mitigate the risks we concluded that we can move forward with the design.