Calibration and Measuring Device Labeling Requirements

[WilBryan]

Just recently completed an external audit for 9001:2008 / 13485:2003 (dual registrations). During the audit it was discovered we were using a non-calibrated tape measure in our assembly process. We were not written a non-conformance however the auditor (without consulting) mentioned the use of "for reference only" stickers to be applied to devices that were used for non-critical measure of product. So... our performance review team chewed on this a while and everyone is now worried we have to label every ruler in the building (in the admin desk etc...) "for reference" and that we must determine what tolerance constitutes a 'critical measurement'.

So the questions are... Who has experience in this sort of ISO issue? How did you resolve it?
Where / how do we draw the line between guaranteeing quality customer product and maintaining a level of sanity & reason about how we label and define our system and processes?

Im curious (and new to QMS).

many thanks,
w.

 

[Lucasmf]

In my experience a simple way to address this is my labeling and recording the use of calibrated equipment on your device/batch history record. This ensures that only equipment that is controlled can be used to make critical measurements and you don't have to worry about chasing down every ruler and caliper in your building.
The action of recording the equipment used on the traveler prevents the use of uncontrolled measuring devices at those inspection steps.
I only use "reference only" labels on equipment on the production floor that looks like it should be calibrated but we have a valid reason why it is not (e.g. secondary pressure gage, power meter that gets checked with a calibrated multimeter, etc.)

 

[mguilbert]

Do not feel bad we actually got one for that. Breif history it was a timer used in a qualitative bacteria/virus identification test. These timers did not need to be accurate as the result is based on indicators. We tried to explain we could use a wall clock for this but we used these as a vendor supplied them free of charge and they had alarms. Are non-conformance was because the supplier had a calibration sticker on them that had expired. We removed the calibration stickers and wrote in permanent ink "For Reference Only" on the timers. In your case I would ensure that no measuring equipment in the process/critical areas is calibratable. If it is be sure of what it is used for. If it used to make decisions on product or equipment used to make product then calibrate it. If it used for reasons not necessarily tied to the product then you can label it "Reference Only" I would suggest permanent ink not stickers as they fade, tear, and are removeable.

Hope this helps.

 

[Michael T]

W.

I feel your pain... We have long rulers (read that metal yard stick) mounted to a "V" track to measure the length of our hose assemblies. Several times we have had auditors and/or customers tell us that because we are measuring length, which is a critical dimension, the rulers need to be calibrated. My response... Okay, why? Is the ruler going to suddenly grow or shrink more than the shortest length tolerance (+/- 1/4")? The temperatures out on the factory floor are not going to materially change the length of the rulers.

We do keep them in the calibration system for our calibration technician to verify that they have not been worn down from use so they are unusable / unreadable. But they are not calibrated. Neither are the tape measures that almost every Area Leader and Supervisor carries. I wouldn't go off the deep end and label every ruler or tape measure in your place "For Reference Only"... especially in places like administrative offices, etc. That's overkill and a waste of resources.

Good luck!!!!!

Michael

 

[WilBryan]

Thank you all for the great replies, its nice to know we are not alone
I agree, labeling every device is unreasonable and could devolve into a ridiculous situation. Defining the line of where to stop becomes a real challenge as a manager because explaining where and why you put the line where you did is difficult. For example, explaining to a technician or an engineer they have to mark their rulers as 'reference' (because they might use it to verify product) but that the one on my desk doesnt need to be marked because it is used for drawing a straight line seems to make the more sensitive staff feel like you have a double standard. Some times it feels like we split hairs for a living.

thanks again for the feedback. I would be curious to hear more experiences. I am very new to QMS (under a year) and am now the manager for our QMS department and in charge of all things ISO. Its a bit daunting but Im grateful for the challenge and hope I can live up to it.

maybe with a little help from this site I will survive the next year or so