The reliquary

I've just started working on translating our archives into electronic format. Since the archive system I'm building bears no relation to our current set-up, however, and I have not yet obtained the space and filing cabinets I require to do the job properly, I'm starting in the areas where I don't have to reorganise anything.

To be more specific about it, I'm starting with the superseded master documents. That's right - our old SOPs. And, since the company is about 20 years old and run by people who don't like throwing anything out, there are some very interesting artefacts in the SOP archive.

The one I uncovered this morning was our original staff training record. The one that was written 20-odd years ago, when there were a grand total of two people working in the company. And one of them was part time.

I showed it to Mistress Mouth, who is in the middle of trying not to stress about things here (it's pretty frantic out there, really), so she could have something to smile about. I've showed her a couple of other things from the early days so far, and she's actually quite impressed with our early system. It's small, certainly, but it says everything that needs to be said.

The staff training record, for example, briefly covers the ongoing educational history of the company's only two employees (as it was then). It's two pages long, at 1.5 spacing. It says absolutely everything that needs to be said about the two employees in question. And, at the time, they were the only two employees that mattered in the eyes of the regulators.

Mistress Mouth commented to me that the current, fairly impressive, state of our quality system (yes, there are gaps, but not as many as she was afraid there'd be) makes a lot more sense when viewed in the light of the company's early documented history. She also told me that the documentation I've showed her was exactly right for a very small company, even in today's climate.

It puts things into perspective.

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.

Google Chrome, round 1

I decided to give Google Chrome a go and, with that in mind, I thought I might as well post a preliminary review.

So far, it's not too shabby.  It's simple, and I don't have to look at a whole lot of extra nonsense whilst I'm surfing the net.  That said, it may take me a while to get used to not having a 'home' button, and it will definately take me a while to get used to not having del.icio.us at my beck and call the way I do with Firefox.  

I also rather like the idea of what they do with their tabs.  It's not something I'm likely to use too often, given that I like to have one window open with several tabs in it, rather than more than one browser window.  However, being able to merge two or more windows together when the computer insists on separate windows is a definate plus.

I do have one or two minor concerns - the first concerns their applications.  It seems to me that it is possible to make it too easy to download things onto your computer, and too reliant on anti-malware and anti-spyware software when it comes to preventing silly mistakes.  Sure, there's nothing to stop you ignoring the warning notices that appear when you're about to download something, but you at least have to push a button.  That said, I should add a disclaimer:  I haven't used the applications section yet.

The other concerns my experiences with the way Google software sometimes interacts with computers.  Google's desktop function is, according to those of my acquaintance who use it, a useful piece of software.  However, if your computer is a bit on the elderly side, it slows the system down to an infuriating degree.  My computer is (currently) fast enough to cope with whatever Google throws at it, but I wouldn't like to gamble with their stuff on an older machine.

I shall add more when I've spent more time with this software.  Currently, I rather like it.

There was movement at the station.

Things are getting busy at work for me. At last. We've got a government audit next month, you see, and I was starting to get nightmare visions of half the company arriving on my doorstep with piles of documentation in their hands and pleading looks on their stressed-out faces. I, of course, would have responded to their pleas with a hysterical laugh and an unsympathetic comment about how they should have done this sooner.

So, I had a little chat with the Leprechaun and the Grand Visier this morning. The result of that little chat was that Production have taken their kick up the pants with good grace (of course, I did put it rather more diplomatically than that), and the nomination of Messrs Wang and King (no, not their real names) as the best people to take the job on. That's a weight off my shoulders (and on to my workload, but given that I've spent weeks writing fanfic for want of something better to do, I'm not complaining about that.).

Then, I had a quick chat with Mistress Mouth (well - I call it quick...), and it turned out that she was having the same sort of nightmares that I was having, given that Anarchist Prime is the only person to have got any documents signed off for months now (and three of those were policies.). She'd mentioned those particular woes to Anarchist Prime, too, so I was, in one stroke, able to reassure her that it's all in hand and ensure that I've got some management support into the bargain, if I need it.

Thank God.

Document review in times of stress

Oh dear oh dear oh dear. Why, why, why! do they always have to think that the documentation isn't important to auditors? Maybe I'm missing something, but I just had a brief chat with the Grand Visier that gave me the distinct impression that she didn't think the batch records were important. Well, sorry luvvie, but it doesn't work like that.

The batch records are the very heart of manufacturing. In a regulated environment, that's how it goes. The batch records are the things that spawn standard operating procedures, and it's often in the review of the batch records that deficiencies in the operating procedures come to light.

Plus, I'm going to have to remind her when I talk to her again after lunch that reviewing this little lot is a monster job, and if we leave it too long then it isn't going to get completed to the satisfaction of the auditors. Yes, the Grand Visier has a lot to do, but then, she's the Production Manager. Her responsibilities mean that she has to make decisions relating to the day-to-day running of the place. Decisions involving knowing the nitty-gritty of it all.

Yes, it's a juggling act and yes, she could probably afford to drop a few of the balls. But if she drops the wrong balls, then everything is going to go horribly wrong.