Risks arising from control measures vs. ineffective control measures

ThatSinc

Involved In Discussions
#11
The NB have no issues with the translations - they never did based on the feedback I've been told, it was that it wasn't explicitly addressed in the risk file, and those being audited couldn't explain how it was captured by the translation process ensuring that translations match the content and intent of the English master when read by clinicians in the appropriate language. (comprehension by typical users is a separate issue).

It was exactly as @indubioush stated, retrospectively updating the risk file to "take credit" for activities currently being performed.


The issue is how the company resolved it, and applying the same logic to every risk where the instructions for use provide mitigation, will result in at least triple the number of lines, and the control measures for some are in effect the verification of effectiveness of others.
 
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indubioush

Quite Involved in Discussions
#12
There is now a line for "inadequate instructions for use provided" with the control measure of "instructions for use provided"
and another line for "user does not understand instructions for use" with the control measure of "instructions for use provided"
This is terrible. I feel your pain. When you retrospectively update the risk file, it has to make sense, and this just doesn't. It sounds like this is an office politics problem. You could provide more training to people to help them understand, or you could refuse to sign the document. Not sure what else you can do.
 
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