Hi all,
Im just posting to discuss a non-conformity that I received that seems pretty dumb to me. We just had an annual surveillance audit, and it went well overall. I think, as a result of finding so little, the auditor started to go fishing. He gave us the following (paraphrased) non-conformity (category 2):
We recently switched our EU Authorized Rep. We did this because the previous Authorized Rep was a distributor, and we just wanted to get in line with a higher level of regulatory standard. So we are now using a respected EU Rep. The non-conformity was that when we changed, we did not put in place a distributor agreement with the previous Authorized Rep (the distributor) that mandated they continue to provide us information on customer complaints. He claimed this under Clause 7.2.3 "The organization shall determine and implement effective arrangements for communicating with customers in relation to: c) customer feedback, including customer complaints, and d) advisory notices."
So, I dont know why I didnt fight this harder at the time (probably because I just thought that I know the distributor well, and it would be pretty easy to establish communication, so it seemed easy to solve). But now that im looking at it and thinking WTF. I'm just going through MEDDEV 2.12-1 rev 8, and it's reasonably clear that the end users and distributors don't have a major role in facilitating customer feedback, and that is the entire purpose of an Authorized Rep. That's why we put their name on the label. Geesh.
And also, now I'm worried that to clear this NCR I may have to go through all my customers and establish separate agreements with them mandating they provide me notice of any complaints and feedback? Again, that's the point of the Authorized Rep, and what's already in the law.
Anyway, Im just posting to rant a little. but any feedback would be appreciated.
Thanks,
Im just posting to discuss a non-conformity that I received that seems pretty dumb to me. We just had an annual surveillance audit, and it went well overall. I think, as a result of finding so little, the auditor started to go fishing. He gave us the following (paraphrased) non-conformity (category 2):
We recently switched our EU Authorized Rep. We did this because the previous Authorized Rep was a distributor, and we just wanted to get in line with a higher level of regulatory standard. So we are now using a respected EU Rep. The non-conformity was that when we changed, we did not put in place a distributor agreement with the previous Authorized Rep (the distributor) that mandated they continue to provide us information on customer complaints. He claimed this under Clause 7.2.3 "The organization shall determine and implement effective arrangements for communicating with customers in relation to: c) customer feedback, including customer complaints, and d) advisory notices."
So, I dont know why I didnt fight this harder at the time (probably because I just thought that I know the distributor well, and it would be pretty easy to establish communication, so it seemed easy to solve). But now that im looking at it and thinking WTF. I'm just going through MEDDEV 2.12-1 rev 8, and it's reasonably clear that the end users and distributors don't have a major role in facilitating customer feedback, and that is the entire purpose of an Authorized Rep. That's why we put their name on the label. Geesh.
And also, now I'm worried that to clear this NCR I may have to go through all my customers and establish separate agreements with them mandating they provide me notice of any complaints and feedback? Again, that's the point of the Authorized Rep, and what's already in the law.
Anyway, Im just posting to rant a little. but any feedback would be appreciated.
Thanks,