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...

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