Streamlined Risk Management Process - Focus on Compliance with Standards

Marcelo

Inactive Registered Visitor
#1
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.
 

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yodon

Staff member
Super Moderator
#2
I like the approach of integrating the essential requirements and 14971 questions.

May be jumping the gun a little but in the RM Summary spreadsheet, there's a "pre-mitigation side" column for whether or not the risk needs to be reduced. That would seem to be contrary to the harmonized standard.

Anyway, I'll be interested to see how this plays out.
 

Marcelo

Inactive Registered Visitor
#3
Hum, forgot to mention this is not for Europe (although I?ve used the European ERs, should?ve used the GHTF ones probably...but the idea is the same), this is following ISO 14971 directly and not using any deviation.
 
#4
Marcelo,

Could I ask you to post pdf versions of your documents as I cannot access the current versions.

Thanks in anticipation.

Edit:
Managed to open them properly on another computer.
 
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