Risk Management Review

Seekingknowledgee

Starting to get Involved
#1
Hi All,

Should the "Risk Management Report" be changed to "Risk Management Review" in our Risk Management Files? And what about the content under it if it needs to be changed.

Thanks
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
Well words matter.
report is just a thing (noun). it is a record of sorts.
review is an action as in "to review the report". reports that are not reviewed by others are useless.
files are where reports go to disappear

what is your intent?
 

yodon

Staff member
Super Moderator
#3
Not exactly sure where you're headed but, per the standard:

The results of this [risk management] review shall be recorded and maintained as the risk management report and shall be included in the risk management file.

(emphasis added)

So you document the results of the risk management review. You could include them or reference them in the report.
 

Jean_B

Trusted Information Resource
#4
In the update of ISO 14971:2012 to ISO 14971:2019 that section's header changed from "Risk management report" to Risk management review".
That namechange is less important than what changed within that clause, namely it is no longer a review of the risk management process (which could have focused on the 'procedure') but is on the execution of the risk management plan (so a realized part of risk management), as well as that information is no longer only obtained, but instead collected and reviewed. Last (but perhaps more least) assignment of responsibility for the review by way of the risk management plan has been changed from should to shall.
The clause keeps the record of the activity defined as "risk management report" in contrast to the section title's change. Reading between the lines the activity of reviewing actually executed risk management versus planned risk management has been made more important than simply having a report with certain line items, but the report is still an essential output of that activity.
Recommend: don't change the name of the report, do check whether you're now reviewing executed risk management versus plan, instead of procedure versus standard.
In my word for word redline I've seen the update to make many of such nuanced changes, but overall if you had the right spirit you were already doing the right stuff. If you were nitpicking for holes in the standard, then the update closed a lot (But I think there should have been enough grounds to stick it to any true abusers).
 
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