Friday, 14 December 2007

Staff changes

Well, here's a turnup for the books - the Empress of Production is resigning. She finishes in February. Which means that her husband, the Consort Royale, is almost certainly also leaving. I most sincerely wish them both the best of luck in their new venture, whatever it turns out to be.

When did she resign? Yesterday. When did I find out? Last night. How did I find out? The Office Gossip was handed that particular piece of news by Mr Big, and as soon as he was out of Mr Big's reach he reacted as he normally does when handed a juicy piece of gossip - he passed it on to Little Miss QC, who dutifully told Magicke, who equally promptly passed it on to me.

The Grand Visier has told me in the past that she doesn't really want the role of Empress, but unless Mr Big and his Heir Apparent (aka his daughter) can find a suitable replacement (not a sure thing - trying to get experienced and qualified people to come to Canberra is incredibly difficult, for all sorts of reasons), then the Grand Visier may find herself as Acting Empress.

Monday, 10 December 2007

New nicknames, god help me.

A couple of the company's very senior members, who only appear here a couple of times a year (on average), have earned themselves their nicknames. Little Miss QC was responsible for these: "They're like Jay and Silent Bob, only it's Silent Jay and Bob." It's a very apt description of the two of them (and no, I'm not saying why). So Silent Jay and Bob they are. God help me.

Friday, 7 December 2007

Industry standards

Now don't get me wrong - I think industry standards have their place. But I also think they are a crutch, something that people lean on even when they don't have a broken leg.

If a company doesn't have staff dedicated to document control, then they need to be applying industry standards to documentation, simply because they haven't got that much time to be worrying about it. But I, as a staff member who is dedicated to document control, I find people insisting mindlessly on applying industry standards to documentation is a pain in the butt.

Our latest Validations Manager keeps telling me about things that he's expecting to see in our documentation - things that I haven't put in because I think they are completely irrelevant to somebody who has two functioning brain cells to rub together. Like a table of contents.

Now, a table of contents is useful in some documents - all of our batch documents have them, as does our documentation for packaging. It would be impossible to find your way around the documents in question without them.

I do not believe, however, that a table of contents is necessary in a three page document which tells you how to clean and mop work areas. It's pointless. The document contains a simple set of instructions. It is not difficult to find your way around the document. You flip one page, and you have found the bit you need. You do not need a table of contents on such a document.

Some of our other documents may well get tables of contents next time they are reviewed. But not all of them. And our esteemed Validations Manager is going to have to stop carrying on about bloody industry standards in documentation if he wants me to cooperate. Honestly, he's like Darth Chaos was when she started here - always carrying on about how he can't cope with things because they aren't exactly the same as they were in his last place of employment. Am I going to have to go through this every single time we get more quality staff?

Thursday, 6 December 2007

At last!

I was starting to wonder if Darth Chaos was feeling alright - it's been weeks and weeks since she last told me off for being messy, or swearing, or anything, even though we've got a couple of very senior types visiting from the USA tomorrow, and my desk has been as messy as anything.

But the situation has been corrected now. I swore at the shredder for being an uncooperative so-and-so, and she told me off for swearing. I, of course, ignored her.

Perhaps it's the rebelliousness I never got the opportunity to express as a teenager coming out, but I feel much better now.

Tuesday, 27 November 2007

Be careful of your wording.

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...

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.

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...

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.

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.

Friday, 26 October 2007

Zen and the Art of Losing Things

Procedures get created for the damndest reasons. But then, the ways in which things can go wrong are really quite amazingly varied.

This morning's panic happened over a batch record that was needed by Production. My personal involvement in the handling of batch records stops once I've issued the thing, and doesn't start up again until my Jedi Master has released the batch and I need to trend the details. I like to get freshly issued batch records out of my hands as quickly as possible - it is far too easy for me to forget something if I don't.

The batch record in question needed some details added by Admin, and QC had passed it on to them to have said details added. QC promptly forgot about it, expecting it to be passed back in the appropriate amount of time.

Unfortunately, the person who usually deals with such things wasn't there, and it wound up on the desk of somebody else entirely, who signed his bit, and left it in his office, fully expecting somebody to come looking for it.

Somebody did come looking for it. This morning, in a blind panic, because it wasn't where it was supposed to be.

This is why procedures are individually tailored, not just to each company, but also to each individual set of employees, and need to be revised periodically. That way, odd-looking procedures can be trimmed when they are no longer required.

Thursday, 25 October 2007

The trouble with archive boxes.

Ah, yes. That's why I don't like cardboard archive boxes. The smeggers aren't strong enough to handle a full load of paper without having them supported by hanging folders, of the sort you use in filing cabinets. The bottoms fall out of them.

We've started storing our batch records in what are quaintly called 'doculopes'. They are plastic envelopes large enough to take A4 sheets of paper, in fairly hefty quantities. They are ideal for our batch records. But, it means that they can't be stored in Lever arch folders anymore. Hence the archive boxes. It also makes storing them later on something of a problem. It's alright if you don't have the pull the archive boxes out very often, but if you do, you'll find yourself picking up folders from all over the place.

Thursday, 11 October 2007

Formatting is your friend.

When it comes to computers, scientists can be a problem. (So can grandparents, but that's another story.) They can often program a bit - but they find it incredibly difficult to format a document in such a way that it is well organised and easy to follow. I've got the results of one such effort sitting on my computer right now, and sorting it out is not proving to be a simple job.

What's wrong with it? Well, he's got some basic idea of document structure, but he doesn't really fully understand the idea of numbering systems. (4. 4.1 4.1.1. etc.) And I haven't figured out how to reorganise it yet. I'll get there, but it's going to be a struggle.

And it's a very long struggle. 25 pages, all up.

Sigh.

Thursday, 4 October 2007

Note to self

Don't close the office door when printing large quantities of quarantine stickers - the fumes that emit from the printer thanks to printer ink on the poor quality sticker sheets are pretty overpowering. They don't even make you happy - just groggy.

Good ventilation is your friend!

Monday, 20 August 2007

Pointy headed complaints trending

Darth Chaos is showing signs of Pointy Headedness. The subject matter? Complaints trending. Trending analyses are one of those things that I generate a couple of times a year - they are a most useful tool for identifying things that might be going wrong on a more serious level than we've really comprehended at any given point in time.

I trend complaints using data gathered from, as you would imagine, the complaints received by the company about our products. These are all about the problems that the customer has experienced whilst using our products. Mostly it's stuff that we can do nothing about, and whilst it would probably warrant a couple of really top notch investigations, such things are beyond the scope available to us. It's more the sort of thing that needs government or university attention.

So, what's the problem? Darth Chaos wants me to relate the complaints directly to the number of batches we have manufactured in the given time period. Unfortunately, the products we have sold in that time period cannot be directly correlated to the batches we have manufactured in that same time period. The data does not work that way. Just because we have manufactured a certain number of batches during that time period does not necessarily mean that all of those batches will be sold, and used, during that self-same time period. It just doesn't work like that.

We argued about this for a while, but ultimately I've given up in frustration, at least for now. She's apparently fallen in love with those manufacture figures, and they simply don't relate. I'm happy to relate the numbers to the sales figures - that is a direct correlation, and it works. It just doesn't work the other way around.

Unfortunately, the conclusion I'm coming to is that Darth Chaos doesn't really understand trending. She can see the point of it, and when it comes to providing what amounts to simple progress reports, then trending is fabulous. But she keeps wanting me to add all sorts of stuff to make it all look good (which is another gripe of mine, but I'm sure I've gone into that before somewhere or other.). Fine - I'll try to make it all positive. But please! Stop trying to make me put irrelevant information into it.

ETA: I went back after lunch for round 2, and I am pleased to report that I won. I managed to convince her that the numbers would be incomplete, and I don't have to put them in any more. I'll still have to do an overall trending report which will include those percentages, but she'll probably have forgotten about it by the end of the year.

Thursday, 9 August 2007

RIP Printer

My poor, poor printer has met its end. It was a valiant piece of machinery, right up until the moment when it met its match. What killed it? A sheet of the sticky paper we printed quarantine stickers on. It was very poor quality paper, and I sincerely hope that the Avery paper which we shall investigate will prove to be of better quality. God knows, it couldn't possibly be worse. She says whilst touching wood.

But my printer, poor thing. It got some sticky paper wrapped around its cylinders. The sticky stuff stayed on its cylinders, and I had to get The Office Gossip to pull it to bits to remove said sticky stuff. Unfortunately, enough of the sticky stuff has remained that the printer will no longer print properly.

I am not pleased by this.

RIP printer. You did a heroic job.

Friday, 3 August 2007

Brilliant work, darling.

Dentarthurdent outsmarted himself today. He was waiting for a piece of equipment to be delivered, and he had anxiously told most of the people in the company that it needed to be delivered to the door leading into the lab.

In fact, about the only person he didn't think it necessary to tell was the person who signs for deliveries when the warehouse officer was away. The person who inhabits the office next door to the warehouse officer. The person who, in fact, signed for the piece of equipment when it arrived, couldn't raise either Dentarthurdent or the Biggest Gossip In Town (aka our Technical Services manager), and told the delivery man to put it in the warehouse.

In other words, me.

My Jedi Master nearly repeated the trick by almost forgetting to let me know that he's going to be away for two weeks, but he caught himself in time.

In any case, Dentarthurdent is now going to have to grab some confederates and haul the thing down to the labs. He is going to have a hard time, since the only place the thing would fit in the warehouse effectively blocked the pallet trolley. They are all going to wind up swearing rather profusely, and I am not going to have a shred of sympathy for them.

That's what he gets for forgetting how things work around here.

Friday, 27 July 2007

Dentarthurdent

Heard issuing from the lips of our resident Arthur Dent: "Where's the tea?" I have to admit, it never occurred to me that he's an Arthur Dent until this morning - but that one overheard comment has just pegged him neatly.

So, why is he Arthur Dent whilst my Jedi Master got the tag he got? I don't know. All I can really say is that he's lucky he hasn't made an appearance in my blog before this - I was going to call him the Chemical Goblin.

Tuesday, 3 July 2007

What's the difference between an argument and a spirited discussion?

Darth Chaos and I have been at it again - this time over the subject of training. To be more specific, familiarising people with our new documentation system. For the record, she thinks that we still haven't got it right, and I'm generally trying to avoid getting her and that particular topic together, since it only leads to frustration on my behalf. Mainly of the 'why didn't you tell me this before, when I was actually designing it? Oh, yes. That's right. You're a self-confessed bad communicator. (aka, I tried, but it's not entirely your fault that you didn't understand)' variety.

Anyway.

Everybody has been getting terribly confused about the new system, at least some of which is mired in office politics. But I won't go into details here.

What I have learned this morning is that Darth Chaos and I have rather different ideas on how people should be trained. She apparently favours the bribery-with-small-prizes approach, which I personally loathe and detest as being an unbelievably patronising way of teaching adults. I suspect she sees it as a way to make the training session more entertaining.

We were just getting into the swing of it (aka, I was running out of countering arguments and getting closer to the truth of the matter, which is simply that I would dearly love her to butt out and let me do it my way) when the conversation was interrupted by Darth Chaos getting a phone call. Once she managed to talk her way through to the end of that, she decided that we should drop the subject until we get closer to the time when we can actually conduct the training session.

I was rather relieved by this, since hopefully next time I can go dancing in there armed with training techniques (gained off the internet, of course) which might silence her complaints and persuade her to let me do it my way. Hopefully.

Friday, 29 June 2007

Lonely hearts column

I'm starting to think that job advertisements for senior management positions in private companies (like the one I work for) should be worded like a lonely hearts column. You know - "Commitment-phobic CEO seeks hard-hitting, problem-solving QA Manager for meaningful long-term professional relationship." It would make it so much easier for people like my Jedi Master to wind up in a job which didn't have them wrestling with bosses they weren't compatible with, thus saving them from being on the receiving end of labels such as 'whinger.' Poor sod.

Cross posted to LiveJournal.

Tuesday, 26 June 2007

Education

One of the major factors in the Australian Code of Good Manufacturing Practice for Medicinal Products is that it is considered vital to train employees on the company's procedures. Now, here we do not have a formal training program, as such, although we have a little bit of framework. Our Human Resources manager (Ms Big, the daughter of Mr Big, the CEO) gets to thinking on that once in a while. Recently, she has decided that it would be a good idea to get some staff member to do some workplace training courses.

I, your humble Evil Paperwork Fairy, have been nominated (apparently by popular acclaim) as the person for the job. Personally speaking, I'm all in favour of it. I'm thinking that if I could do the whole of Certificate IV, it would be a good thing. Good for the company, and especially good for me, since it would give me another nice, solid string to my (admittedly fairly weak) bow.

But it's expensive. And with the current rate of spending at work (we're in the process of upgrading our production equipment, which is a very expensive process), I would not be at all surprised if I only do one unit this year.

I just hope that I remember to push for this again after the company has recovered some of the costs of the upgrade.

Monday, 25 June 2007

If ever...

If they ever make a film of my life, I want to be played by Derek Jacobi.

Heh heh heh.

Thursday, 14 June 2007

They will complain

My immediate superior, identified by me as Darth Chaos, is, I hope, learning all about what happens when you try to change the world that everybody is used to.

The field in question was documentation. She didn't like the way we had our SOPs organised (by subject matter, for the record). She felt that they should be organised by distribution point. It was, she felt, much simpler. So she insisted on changing it. Throwing out the old SOP system in favour of her version. It's now been a good year, and we're still at it. And people are still whingeing.

I have a feeling that office politics, that field of perpetual frustration (for those on the receiving end) and entertainment (for those who are on the outside looking in), is what is driving the latest bout of whingeing.

The major Player and Perpetrator in this field of combat is the Production Director, She Who Must Gain Power. I've also been known to refer to her as the Empress of Production.

She and her consort, Master Spy, have been complaining about Darth Chaos' revised documentation system. Again.

Now, I've been trying to get the documents all changed over for quite some time now, ably hindered by a combination of busy schedules and complete lack of interest in reviewing documents. And people have been confused.

Most of Production have, I suspect, come to terms with the new system. They are getting used to the new numbering (which, yes, is more complicated than the old numbering. I was pushing for something simpler, personally speaking, but Darth Chaos wouldn't hear of it), and only rarely do they call me with the question of 'where is it?' They do not customarily complain to She Who Must Gain Power, or even to her off-sider, the long-suffering and highly stressed Grand Vizier.

She Who Must Gain Power and the Master Spy, however, never miss a chance to show us all up. But QA will get its revenge. Every time she receives a complaint about the new system, Darth Chaos intends to make the entire company sit through another training session on the new index. And she will continue to do so until She Who Must Gain Power and the Master Spy decide they've had enough.

Let's see who quits first.

Tuesday, 12 June 2007

How To Annoy The Evil Paperwork Fairy's Boss

One way guaranteed to annoy my boss is to say that the review of a major document resulted in something that was wrong. Her stress levels immediately shoot up to boiling point, and she starts ranting about how the complainants signed off on the document in question - in fact, the last couple of times it crossed their desks, they just signed it without even looking at it.

I, of course, agree with everything she says during this rant. How can I not? I, personally, do not understand all that much about the functioning of this company, except at a fairly general level, and except what is written in the documentation. All I can do is put the document into review at the appropriate time, and make changes that are requested. The content of the documents are largely the responsibility of others.

It's one of the basic aims of GMP - that the appropriate people take responsibility for the appropriate parts of the manufacturing operation. And that means the paperwork, too.

Thursday, 7 June 2007

I don't love fairies

The times in my working life which I find hardest to deal with are those times when nobody's given me any document-related work to do. The main problem at times like that is that everybody else apparently has better things to do.

This has also been known to crop up for me when I have to give a document to three of the people in the company I consider least likely to return the document to me. I don't much like it when I hand a document over, knowing that there is every chance of that document never being given back. Ever. It makes me feel like I'm handing one of my babies over to be sacrificed.

My personal method of getting over this is to rummage around in my pile of documents that could be profitably reviewed, until I find some that I can give to people who are much more likely to return them to me, properly reviewed.

Summarised, this means that when the Evil Paperwork Fairy is feeling unloved, she's likely to descend on somebody (or several somebodies) with a stack of work for them to do.

Wednesday, 6 June 2007

Busy busy busy

One of the facts of life for an Evil Paperwork Fairy like myself is the fact that, as soon as things get busy, the first thing to fall off the radar of anybody who is not intimately connected with document control is the regular reviewing of paperwork. As a result, the first sign of an overly busy workplace is a large number of documents being overdue for review. The second sign, therefore, is an Evil Paperwork Fairy who has either spaced out in an attempt not to care, or who is stressed beyond belief because people keep losing her documents. Personally, I prefer the first approach. It's easier on the nerves to let it slide and to pretend to be a Flower Fairy for a while - I'd suggest being an Opium Fairy, but for one thing it's illegal and for another it's addictive, so I tend to settle for being a Lavender fairy instead. And, of course, it gives me much more time for surfing the net and blogging about my job. :-)

Tuesday, 5 June 2007

As time goes by

The more time I spend at this desk shuffling paper around, the more I realise the importance of a properly set-up database of metadata about the documents that I control. I am, incidentally, saying this as I finish redesigning my document control database (or, rather, the data entry that tends to follow on from such a redesign.). The number of tables I have got have shrunk to something far less ridiculous, and the number of queries that appear will, equally, explode rather dramatically. Well - more or less.

I think it would be very easy to get out of control with the quantity of metadata one generates and maintains surrounding documents. All I really have to do with them is to make sure that they are all under control and regularly reviewed. Which means that information on such things as document numbers, and dates of last review, are important. Information along the lines of which documents are referred to in other documents (in other words, a cross-referencing system) is relevant for the poor benighted Evil Paperwork Fairy, but only if it's set up properly. Otherwise it is nothing but a waste of space. My first attempt at cross-referencing was a waste of space. Hopefully, future attempts at cross-referencing will be a little less unwieldy. Hopefully.

A part of me would love to have the whole mess taken out of my hands and put into the hands of a computerised document control system - but the rest of me is loving the challenge of bringing sense to it all.

First Post

Well, I've been trying some alternate blogging services to LiveJournal, and so far two have proven themselves to be not really for me. So I'll try Google's in-house version for a while, and see how that goes.

So, who am I? I live behind a desk in Canberra, Australia, and I am responsible for ensuring that the company's documentation is correct. Hence the blog's title. I am the Evil Paperwork Fairy. As for everything else? Well, you'll see. Perhaps.