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Does anyone here suppose that, for FDA purposes, feedback elicited by
such a form could be regarded as "complaints" and therefore subject to
FDA regulations on complaint handling?
Maybe there's something else for medical devices, but the only FDA
regulations concerning complaint handling that I know of would come
under HACCP/ISO 22000 requirements.
Is the FDA involved directly with anything other than food, cosmetics,
and medical devices? I'm not being facetious, I really don't know and
would like to.
The short answer to your question is "Yes, but don't panic."
The company glossary should contain clear definitions of "feedback" and
"complaint", and point out the differences between the two. "Feedback"
can be positive, neutral, or negative. Negative feedback is a
complaint.
If the feedback contains one or more complaints, the person receiving
and logging the feedback would simply send it on into the complaint
handling process as soon as it's logged. And of course it will be noted
in the log that the feedback contained a complaint, and what action was
taken. And this will be all written up as a procedure/instruction for
employees who receive feedback calls and correspondence.
An immediate response to the customer thanking them for their feedback
and letting them know that their comments have been forwarded would be
courteous (and a good idea). A follow-up with the complaint-handling
department to make sure they've responded to the customer within one
week after forwarding is a good CYA move -- log that action also.
>From the point that the complaint is forwarded, it belongs to the
person(s) who get to play with complaints all day. Of course they have
all of the appropriate policies, procedures/ instructions, forms, etc.
and they have been well-trained in FDA compliance.
Dori Green
Yes there is a lot of passive voice in the above -- I've been working
with old HR docs all day. We'll all live but it's at the "not so
pretty" stage and the tech writer is just about fried.
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