For discussion here - I?m discussing with some people (including Covers Mike Schmidt and Grant Ramaley - an thanks Mike for the inputs, and I suggest reading Mike?s article at http://www.mddionline.com/article/reducing-risk-without-wasting-resources-doing-risk-management-right).
I?ve been toying with a more clear and streamlined risks management process to deal with Brazilian problems of having mandatory standards (as you might now, we are revising current regulations right now).
The attached documents are one example procedure, with an example risk management summary (with only some information). Please note that it still fulfills ISO 14971, but in a more generic way (less focus on probability and severity for risk control measures based on standard requirements). Also, for hazards and hazardous situations not addresses in standards, both risk estimations will be necessary.
Please take a look, comments are welcome.
I?ve been toying with a more clear and streamlined risks management process to deal with Brazilian problems of having mandatory standards (as you might now, we are revising current regulations right now).
The attached documents are one example procedure, with an example risk management summary (with only some information). Please note that it still fulfills ISO 14971, but in a more generic way (less focus on probability and severity for risk control measures based on standard requirements). Also, for hazards and hazardous situations not addresses in standards, both risk estimations will be necessary.
Please take a look, comments are welcome.
Attachments
-
877.7 KB Views: 586
-
60.4 KB Views: 758
