We've recently received a shipment of product information sheets for some of our products, and one of them in particular caught the eye of Little Miss QC. There is a sentence in there saying "Interruption to breast feeding is necessary after the administration of....for a period of less than 12hr." Little Miss QC felt that this ought to read "...for a period of no less than 12hr." She duly wrote this on the documentation that I had to produce, and I duly double checked the information. It wasn't a typo on my behalf at all.
I went and pointed this out to Darth Chaos, just in case that this was, in fact, a very serious mistake. I agreed with Little Miss QC. "Less than 12hr" could, after all, be interpreted as "10 minutes," and an interruption to breast feeding of 10 minutes, after being injected with something radioactive, was surely not the intention of the information.
Darth Chaos looked at it, compared it to a consumer information pamphlet (different from a product information sheet as it is intended for the person injected, not the person doing the injecting), and told me that it was actually quite correct. Needless to say, this prompted a loud and fairly lengthy argument on the subject (we have those from time to time.). The consumer information pamphlet, instead of saying "less than 12hr" said "up to 12hr." The intended implication was that any breast milk expressed in that period between the time of the injection and another point on the clock 12 hours later should be discarded.
I went down and explained this to Little Miss QC. The Grand Visier wandered in at that point as well, so I showed it to her, just in case she should interpret it the same way Darth Chaos did. As it happened, she also agreed with the two of us.
It just goes to show that you should be careful of your wording in documentation, especially when it needs to be approved by the TGA, the way product information sheets are. You see, we can't actually change that wording without submitting a Category 3 application, which is time consuming and expensive. Basically, we are stuck with "less than 12hr," since it will hopefully be years before we need to submit any more Cat3 applications...
Tuesday, 27 November 2007
Is it needed?
An interesting question came up in a Quality meeting yesterday - do we need an Emergency Procedure that covers things like power outages? Sure, we need to know what to do about it (how do we keep refrigerated items cold, is it going to affect incubators, do we need to shut down the server?), but, generally speaking, all these questions come up and are answered adequately without the need for a formal SOP.
Not only that, but we've never yet got it wrong. So, do we need it? I asked Darth Chaos this morning. She paused for a few minutes, and decided that the problem could wait since, as I've already said, we tend to deal with these questions adequately anyway.
Why is the question coming up now? Well, the summary is that we are drawing too much power from the grid (long story.). Actew are coming around sometime in December (I've heard two dates so far) to replace cabling, with a view to preventing us from shutting down the neighbourhood (we've blacked out the area more than once). Since we know in advance, we can do things like borrowing generators to run a couple of fridges.
I have a feeling that we probably should look at the situation, and sort out an SOP to go with it. But, as Darth Chaos has already said, it can wait until after Christmas. If nothing else, it'll give us all time to think about the problem a bit more.
Not only that, but we've never yet got it wrong. So, do we need it? I asked Darth Chaos this morning. She paused for a few minutes, and decided that the problem could wait since, as I've already said, we tend to deal with these questions adequately anyway.
Why is the question coming up now? Well, the summary is that we are drawing too much power from the grid (long story.). Actew are coming around sometime in December (I've heard two dates so far) to replace cabling, with a view to preventing us from shutting down the neighbourhood (we've blacked out the area more than once). Since we know in advance, we can do things like borrowing generators to run a couple of fridges.
I have a feeling that we probably should look at the situation, and sort out an SOP to go with it. But, as Darth Chaos has already said, it can wait until after Christmas. If nothing else, it'll give us all time to think about the problem a bit more.
Friday, 16 November 2007
It's going to be one of those days. I can tell.
It isn't even 9am yet, and I've already been told that I should have had all the documentation for new artwork done ages ago and now have to do it all, right now. Never mind that apparently only Sydney and QA had anything to do with it and left everybody else out of the loop. Never mind that everybody has been running around like headless chooks because of an impending months-long shutdown that now isn't going to happen, meaning that I've been twiddling my thumbs for months now because the first thing that everybody drops as irrelevant once things get a little busy is document review.
And I've also been told by Production that they are now hopelessly confused because suddenly they've got time to think about what's going on - and now they don't know what was going on. Because they can't cope with stress. There's internal production office politics involved in that second one as well, but I'm not going to bother with the details since the only relevant detail is that certain senior members of the production team are having trouble working well with eachother, let alone anybody else. I would love to bash a couple of management heads together.
Sigh. Bring on Christmas.
Edit: It's now 9.20am, and I've just been told by Darth Chaos that it's Slap an Irritating Colleague Day...
And I've also been told by Production that they are now hopelessly confused because suddenly they've got time to think about what's going on - and now they don't know what was going on. Because they can't cope with stress. There's internal production office politics involved in that second one as well, but I'm not going to bother with the details since the only relevant detail is that certain senior members of the production team are having trouble working well with eachother, let alone anybody else. I would love to bash a couple of management heads together.
Sigh. Bring on Christmas.
Edit: It's now 9.20am, and I've just been told by Darth Chaos that it's Slap an Irritating Colleague Day...
Labels:
document review,
office politics
Wednesday, 14 November 2007
Control freak grand central
Quality systems, I have discovered, can get out of hand very easily when under the guidance of somebody who doesn't know when to stop. "Please wash your hands" signs become quality controlled and have to be reviewed every two years. Little white sticky dots purchased by the roll have to be put through the GI system, quarantined, and then released, instead of being classed as 'stationary' and just purchased whenever necessary. Documents wind up five times as long as they need to be.
And that sort of behaviour can spread. One hyperactive control freak in the role of QA manager, and it will be years before the system recovers. You see, people working underneath such an individual can easily fall prey to their certainty and determination. And they will proceed to fight for those excessive controls long after the hyperactive control freak has left the company. It often takes the determined efforts of another, far more experienced control freak to undo the damage.
The first control freak hasn't been here for a couple of years now, and left before I started writing about work in blogs. The second is the lady I refer to as Darth Chaos.
And that sort of behaviour can spread. One hyperactive control freak in the role of QA manager, and it will be years before the system recovers. You see, people working underneath such an individual can easily fall prey to their certainty and determination. And they will proceed to fight for those excessive controls long after the hyperactive control freak has left the company. It often takes the determined efforts of another, far more experienced control freak to undo the damage.
The first control freak hasn't been here for a couple of years now, and left before I started writing about work in blogs. The second is the lady I refer to as Darth Chaos.
Thursday, 1 November 2007
Someone Else's Problem
One of the good things about having management around is that, when problems are brought to them, they are usually the ones who get to sort the mess out. The latest 'crisis' revolves around packaging - an artwork code wasn't changed when it should have been.
As far as responsibility goes, the blame for the mistake can be spread around pretty evenly. As a result, nobody's making a big deal of who's responsible. Which is pretty good. Not that that gets us out of fixing the problem (god knows how - that's Somebody Else's Problem right now, and I feel pretty good about it, to be honest.).
It's my Jedi Master who was presented with the situation, and as a result gets to sort it out. Just as well, really, since I'm the one who usually gets presented with the somewhat dubious pleasure of sorting out this sort of mess.
As problems go, though, it's pretty simple to deal with. Artwork gets rejected and destroyed, more artwork is ordered to replace it, people blush, and wrists get slapped for costing the company valuable time and money. It was suggested that hand-written corrections are made, or that perhaps little stickers could be put over the mistake. Personally, I suspect that it would be simpler in the long run just to organise replacements, especially since I think the TGA would frown on corrections of that nature being made. Sigh.
Still, as I said before, for a change it is Someone Else's Problem.
As far as responsibility goes, the blame for the mistake can be spread around pretty evenly. As a result, nobody's making a big deal of who's responsible. Which is pretty good. Not that that gets us out of fixing the problem (god knows how - that's Somebody Else's Problem right now, and I feel pretty good about it, to be honest.).
It's my Jedi Master who was presented with the situation, and as a result gets to sort it out. Just as well, really, since I'm the one who usually gets presented with the somewhat dubious pleasure of sorting out this sort of mess.
As problems go, though, it's pretty simple to deal with. Artwork gets rejected and destroyed, more artwork is ordered to replace it, people blush, and wrists get slapped for costing the company valuable time and money. It was suggested that hand-written corrections are made, or that perhaps little stickers could be put over the mistake. Personally, I suspect that it would be simpler in the long run just to organise replacements, especially since I think the TGA would frown on corrections of that nature being made. Sigh.
Still, as I said before, for a change it is Someone Else's Problem.
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