C
Calico
Good Morning,
Question for all you quality folks out there...
I work for a call center (part of a hospital) that does data intake for pharmaceutical companies. We take calls on Adverse Events basically and then process that information and submit Medwatch forms back to the client so that they can send to the FDA.
My question is around one of our clients hiring an auditor to come in and audit our processes. This particular auditor owns his own consulting business. This auditor came in several years ago and there was some conflict of interest involved because he was also the consultant for our competitors. I believe there were some hard feelings involved because my company made him take down a website that was advertising our competition.
Long story short is one of our clients had this same auditor back in a few months ago and we feel that the auditor was NOT impartial in his evaluation. He wrote up findings against many different standards such as the European Union (we do not do anything outside of the US). He also included major findings in his audit report that were not disclosed during the closing meeting.
We feel that this auditor is not in our best interest and would prefer to not allow him back onsite again. Do we have grounds to deny him? What is the best way to document this that would not be specifically aimed at him but that we could use for all client auditors?
Hopefully this makes sense but we really feel that this particular auditor is a detrement to our business.
Thanks much for any help,
Callie
Question for all you quality folks out there...
I work for a call center (part of a hospital) that does data intake for pharmaceutical companies. We take calls on Adverse Events basically and then process that information and submit Medwatch forms back to the client so that they can send to the FDA.
My question is around one of our clients hiring an auditor to come in and audit our processes. This particular auditor owns his own consulting business. This auditor came in several years ago and there was some conflict of interest involved because he was also the consultant for our competitors. I believe there were some hard feelings involved because my company made him take down a website that was advertising our competition.
Long story short is one of our clients had this same auditor back in a few months ago and we feel that the auditor was NOT impartial in his evaluation. He wrote up findings against many different standards such as the European Union (we do not do anything outside of the US). He also included major findings in his audit report that were not disclosed during the closing meeting.
We feel that this auditor is not in our best interest and would prefer to not allow him back onsite again. Do we have grounds to deny him? What is the best way to document this that would not be specifically aimed at him but that we could use for all client auditors?
Hopefully this makes sense but we really feel that this particular auditor is a detrement to our business.
Thanks much for any help,
Callie