| quote | Originally posted by whadeduck:
It's for school and the text makes a feeble attempt at describing what it is and how to create one.
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I have to do formalized risk assessments all the time.
The FDA requires it with every new medical device submission I send.
If you're looking for help I suggest a Google search for "FDA Guidance Risk Analysis"
It's actually pretty straightforward cause and effect + severity scoring.
Trying to boil it down to it's most basic:
"If X happens then Y failure may result, and that failure on a scale from 0 - 10 of severity goes from minor inconvenience to catastrophic."You can combine all of the risk factors that you have identified and average the severity scoring to come up with the overall risk assessment numeric.
[This message has been edited by randye (edited 06-21-2017).]