Complaints handling and GMP

If anybody out there in medical manufacturing gets landed with the responsibility of dealing with complaints on a regular basis (and experience has taught me here, over the years, that it's best if there is only one person who deals with complaints, if at all possible), here's a little tip: it is a significant part of Good Manufacturing Practice to produce a trending report on a regular basis. It may not be you doing it.

In my case, we have somebody else dealing with the complaints. I just have to produce the trending reports. This means that I need to be able to grab up the complaints folder every six months and find completed reports in it. All neatly filed away.

This is terribly important - regulatory bodies (or, at least, the TGA) absolutely love looking at complaints trending reports, and woe betide the company that doesn't have them. They take complaints very, very seriously.

In my report, I have to identify any trends that might appear. And, if a trend does appear, I make sure that I inform all relevant parties, and get properly documented procedures started to fix the problem that has caused the trend, before I close out the report. I get this done quickly so that I can refer to a Corrective Action in the report. Then, when the TGA sees this Corrective Action in place, they can reassure themselves that we, as QA, are fully aware of the problem and are taking steps to correct the situation.

First hand experience has told me that this is the best process to follow. I have only once found an actual trend in the complaints, and that was the process I thought was a good idea. The TGA auditor later read my report, saw that steps were being taken to correct the problem, and downgraded what would have been a major non-conformance to a simple comment.

Why am I talking about this now? It's for three reasons:

1. We have the TGA coming at the beginning of next month.
   
2. I haven't produced a trending report for the first half of the year yet.
3. I went looking for the complaints paperwork and discovered that none of it was complete. We've got somebody different handling complaints now, and she hadn't been bloody filling out the forms!

I let her that I needed them urgently, and she's promised them to me by the end of the day. When I look at them, we can see what needs to be done. I'm afraid that I may have to have a little chat with Mistress Mouth about this, and make the handling of complaints an issue. Which, frankly, we don't need. We've got too many other things to deal with right now.

Update: Houston, we have a problem. Somebody has been sending outdated complaints forms to the complainants. I'm going to have to have a chat with Mistress Mouth about this. The only positive to the whole thing is that there are only three complaints, one of which was withdrawn. Which means only two complaints, which means that there are no trends which are not related to the handling of complaints.