Log Book for Analytical Balance Calibration Verification

[JodiB]

We verify the calibration of our analytical balances every day but have not been keeping a log of this. We're now going to start keeping a log beside each balance for documenting this activity.

Question: Do we need to use bound log books, or is it acceptable to use a 3 ring binder with printed log sheets? We're trying to establish an ISO 17025 program for accreditation next year and don't want to make a misstep on this.

On one hand, I don't see the big deal in having a binder where pages could be removed, etc. (because these are small labs and there would be no motive for doing that) but on the other I can see where an auditor could get snippy about it and say that it isn't proper doc control of this record.

If we can just use printed sheets, I'll create a standard, numbered, form in our system that we'll use. If we must use a bound log book, commercially sourced, then I'll have to find one that I like.....

Advice please.

[insect warfare]

What you're doing sounds good to me, and as long as you're adhering to the requirements of 4.12 (Control of Records) and 4.3 (Document Control), you shouldn't expect anyone to get snippy.

If you start to experience problems with missing or altered records, etc., then tighter controls will obviously be needed. Just my

Brian

[JodiB]

Thanks Brian! Since nobody has offered a different opinion, it looks like I'll be fine using the loose leaf pages in a binder.

[BradM]

In Reply to Parent Post by JodiB

Thanks Brian! Since nobody has offered a different opinion, it looks like I'll be fine using the loose leaf pages in a binder.

I agree with Brian. Now... is this a regulated environment? Asking, because you may want to control and archive those pages (if your organization has a records retention schedule for other documents).

I don't think it matters whether they are bound/ binder/ etc. The more important is that you actually get the users to consistently enter the information into the logbook.

[JodiB]

Brad,
No we aren't regulated (you mean like FDA, etc.?) , but I'll include the pages in records retention anyway so that we have them for audit purposes.