ISO 14971 Risk Management - Questions for Hazard identification

sriramsl

Involved In Discussions
#1
Hi all
I am looking for a standard questions for Hazard identification for Hazards during Production, Testing, Packaging, Transportation.... similar to the ones in Annex C of the ISO 14971:2007 standard.
Can anyone point to a any available documents?
Thanks
Regards
Sriram
 
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yodon

Staff member
Super Moderator
#2
Just to ensure there's no confusion, Annex C is a list of questions to characterize the device and help identify any safety concerns.

Annex E (Table E.1) has example hazards.

Since you're asking about non-use scenarios, are you considering how those operations can affect subsequent device operations (i.e., transportation in temperatures exceeding some threshold could damage the device)? Or are you considering how those operations could harm someone (e.g., testing is done with covers off thereby exposing line voltage to the tester)?

Unfortunately, I don't know of any documents that enumerate either of these. I think most companies do a Process FMEA (PFMEA) to consider how the various processes you identified could cause the device to not meet specification.
 

sriramsl

Involved In Discussions
#3
Dear Yodon
Thank you so much.
Yes, I did the PFMEA, however I was wondering if there are some standard questions like the questions in Annex C that can be straight away applied to these processes that could lead to Risks.
 
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