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.
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