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.
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.