Question on equipment - when to use reference only or research only stickers

duff999

Involved In Discussions
#1
I am looking for some advice on how to determine or when to place "for reference only", or "for research only" stickers/labels on equipment used in the lab. I've always used the rule that if the piece of equipment is used in a "locked in process" or affects product quality I would not label it this way. When would I use these labels?

Any help is appreciated
 
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Miner

Forum Moderator
Staff member
Admin
#2
Better questions: Under what circumstances would I be willing to use a measurement device of unknown accuracy and precision to generate data of unknown quality? What would I do with such data?
 

duff999

Involved In Discussions
#3
Better questions: Under what circumstances would I be willing to use a measurement device of unknown accuracy and precision to generate data of unknown quality? What would I do with such data?
Very good point, thank you. I guess what I was getting at was that we have a stir plate used in the lab, it was mostly used for R&D purposes. We are now transitioning into a locked down process and this piece of equipment could be used in production. We do not calibrate this piece of equipment and I was not clear if these pieces should be labeled reference only.
 

chris1price

Trusted Information Resource
#4
You might want to remind R&D that if their results are going to be used to support a design history file or technical file, then the equipment should be calibrated.
 

duff999

Involved In Discussions
#5
You might want to remind R&D that if their results are going to be used to support a design history file or technical file, then the equipment should be calibrated.
Thanks Chris - the items used that might affect product quality are calibrated at the assigned intervals. I'm trying to wrap my head around the equipment used for "general purpose". Lets take a stir plate for example, we are not using that for any type of final measurement but it does sit in our laboratory, I'm just unclear when equipment needs this "for reference only" label
 

Miner

Forum Moderator
Staff member
Admin
#6
A stir plate would typically have the following controls: Speed, duration, and possibly temperature. Could any of these variables impact the results of any tests that you may perform? If so, calibrate these as process controls. If not, I would label them as "Calibration not required" and document the rationale in a risk assessment because you will probably have to defend it.
 
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