It's 4.25pm on a Friday Afternoon. Yesterday, the Leprechaun officially became Production Manager, temporarily replacing the Grand Visier, who is on maternity leave. On Monday, we are manufacturing a product of a type we have never made before. The batch record is not ready. It's not ready because the Leprechaun has, apparently, never written a batch document before in his entire life.
Nor have any of the R&D team, who originally wrote the thing. The batch record they originally came up with is shockingly awful. The one that will be issued to Production will also be shockingly awful. It isn't properly numbered. There are a couple of internal references that have been given ####'s. It never occurred to any of the people mentioned above that they had to include any steps in the process that went after formulation-related processing, until I, your humble Oracle, prompted them.
And I'm going to have to get the bloody thing formally authorised before I go home today. Ideally, I should have it issued by the end of the day, too, but I'm just plain not going to have time. First thing Monday morning will be fine.
It's 4.30pm, and I'm highly stressed and in a rush. I hate it when Fridays finish like this.
Friday, 27 February 2009
Tuesday, 3 February 2009
Every Good Oracle's Information Source - the Archive.
As the Document Control Officer in a small company, it is often assumed that I know where all the documents are - not an unreasonable assumption, and more so now that I am formally taking on the role of Archivist as well.
Fortunately, I am still in the very early stages of this role, and haven't yet had the time or opportunity to raid everybody's offices for stray documentation yet, something which I am secretly hopeful I will get the chance to do.
One of the things that people are often asking me to find - in fact, it's second only to batch manufacturing records (BMRs) on the hit parade - are copies of the contracts we have with various other companies. Unlike the BMRs, tracking down the contracts tends to prove challenging. In fact, they often come under the category of "items we hope come out of the woodwork once I've finished with the obvious stuff."
Other items that can be categorised in this way include old validations records and initial Regulatory submissions.
I'm still early on in this effort, and still plotting the areas to search next - we've turned up one or two interesting things already, relics of such filing techniques as "putting everything into a big box under somebody's desk", a technique which one really doesn't expect to find in a modern manufacturer, but does turn up from time to time. (I'm hoping that one will disappear entirely once we've got the official company procedures on the archiving of documents in place.) In fact, it's a filing technique to keep an eye on, given that all sorts of stuff can turn up in them.
I do know of a couple of other boxes of random stuff, but they aren't actually under anybody's desks, so that's okay. In time, once I've worked my way through all the BMRs, and the other QA documentation, and have expanded my collection of modern lockable filing cabinets, I shall have a rummage through those boxes as well to see what I can find.
I'm rather looking forward to it.
Fortunately, I am still in the very early stages of this role, and haven't yet had the time or opportunity to raid everybody's offices for stray documentation yet, something which I am secretly hopeful I will get the chance to do.
One of the things that people are often asking me to find - in fact, it's second only to batch manufacturing records (BMRs) on the hit parade - are copies of the contracts we have with various other companies. Unlike the BMRs, tracking down the contracts tends to prove challenging. In fact, they often come under the category of "items we hope come out of the woodwork once I've finished with the obvious stuff."
Other items that can be categorised in this way include old validations records and initial Regulatory submissions.
I'm still early on in this effort, and still plotting the areas to search next - we've turned up one or two interesting things already, relics of such filing techniques as "putting everything into a big box under somebody's desk", a technique which one really doesn't expect to find in a modern manufacturer, but does turn up from time to time. (I'm hoping that one will disappear entirely once we've got the official company procedures on the archiving of documents in place.) In fact, it's a filing technique to keep an eye on, given that all sorts of stuff can turn up in them.
I do know of a couple of other boxes of random stuff, but they aren't actually under anybody's desks, so that's okay. In time, once I've worked my way through all the BMRs, and the other QA documentation, and have expanded my collection of modern lockable filing cabinets, I shall have a rummage through those boxes as well to see what I can find.
I'm rather looking forward to it.
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