A labeling question:

I am inspecting labeling on a power cord. The text on the label matches word-for-word to the drawing HOWEVER the layout is different.

Example-----

Label version:
This is an example to
show how the text is
written on the
label.

Drawing version:
This is an example
to show how the text
is written on the label.

Is this a nonconformance? The power cord is part of a medical device. It is a 125VAC cord so it is distributed in the U.S. (FDA regs apply) (Is Canada 115/125VAC? - excuse my ignorance) We don't distribute the product, our customer does.

Our customer's ISO 13485 auditor was in here recently and a problem was found with printing a label's part number horizontally while the drawing called out vertically. (a different label than the power cord one) Since then, I am label paranoid.

Does anyone have any thoughts on this?

I would imagine that an NC would be in the eye of the beholder; i.e., no guarantee you would get one but no guarantee you wouldn't get one, either.

I would at least suggest you be armed. Can you write it up as an acceptable deviation? Can you investigate how it happened? If you specified 10pt font and they used 8 to cram the text together, then maybe they're out of spec. You may want to use it as a lesson learned to either tighten specs on the drawings or allow for such variances.

I do not see this as a Major issue as the text is the same. FDA, is particularly heavily focussed on the text of the labels and the symbols used therin.

But from a quality system point of view, I would recommend you to investigate how this happened in the first place and thereby avoid or be more cautious in future !

I'd query it from a usability point of view. Meaning, having things look the same makes for much faster use/scanning etc by the human eye. So unless there's a really good justification for the difference, I'd prefer them to be the same.

I'd query it from a usability point of view. Meaning, having things look the same makes for much faster use/scanning etc by the human eye. So unless there's a really good justification for the difference, I'd prefer them to be the same.

jane, in a regulated field where FDA is concerned, all changes have to be approved though its for faster use / ease of scan :tg:

jane, in a regulated field where FDA is concerned, all changes have to be approved though its for faster use / ease of scan :tg:

Thanks Ajit! I left that side alone because you'd already addressed it. But you're quite right to clarify. :yes:

I am inspecting labeling on a power cord. The text on the label matches word-for-word to the drawing HOWEVER the layout is different.

I had done some work on power cords before. There are limitations when it comes to printing. It would be good to check with them before you decide on the layout of what to print.

Thanks Ajit! I left that side alone because you'd already addressed it. But you're quite right to clarify. :yes:

Yes Jane - being a Systems guy for Healthcare, I take extra precautions in letting the people do themselves and constantly remind that "change is not permitted" :tg:

Our customer's ISO 13485 auditor was in here recently and a problem was found with printing a label's part number horizontally while the drawing called out vertically. (a different label than the power cord one) Since then, I am label paranoid.While this sounds very trivial, was the NC due to the fact that the label had changed rather than the change itself. The auditor would be concerned with the control of these labels, ensuring that no change can be made without the proper approval.