ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

Jim Wynne

Staff member
Admin
#21
Maybe so, but if you're wall clock is off, you're just late for the lunch special. :tg: It won't necessarily affect anything. This temperature device may be important.

Take what Sidney suggested. A decent auditor is not going to write up a wall temperature/ RH device sitting by the water cooler, just because it's not calibrated. However, when you see two devices in a particular process area, it does make one think that temperature is kind of important there. Thus, the need to assure valid readings is applicable.

The first thing is to view what the thermometers are measuring, and when it is important (if it exists) when there is a temperature variance. Here in Texas, it is still 100°F everyday. So if there is a requirement to maintain a certain area, say 70°F +/-10°F, then we would need a thermometer. If you are in Southern CA or an area where the temperature is pretty much the same everyday in that range, then you probably would not need to monitor the temperature.

If you have two devices, what you could do is offset their calibration dates; make it a year or so. That way you always have one of them in use. This is, if you need them at all.
We shouldn't be coming to the conclusion that "...the need to assure valid readings is applicable" when there's nothing solid in evidence at this point to support that contention. If there were 50 thermometers it still wouldn't be evidence in and of itself that calibration would be required or even prudent. I can understand an auditor asking questions about it, but if the OP can demonstrate that calibration isn't necessary "...to ensure valid results..." and the auditor doesn't have evidence to the contrary, there is no nonconformity.
 
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BradM

Staff member
Admin
#22
We shouldn't be coming to the conclusion that "...the need to assure valid readings is applicable" when there's nothing solid in evidence at this point to support that contention. If there were 50 thermometers it still wouldn't be evidence in and of itself that calibration would be required or even prudent. I can understand an auditor asking questions about it, but if the OP can demonstrate that calibration isn't necessary "...to ensure valid results..." and the auditor doesn't have evidence to the contrary, there is no nonconformity.
No strong disagreement with this, which is why I suggested it was important to analyze the process. Just as there is no evidence (as of yet) that it needs to be verified; the discovery process might yield a really good reason why they are there. If patients and FDA are involved, then I suspect there might be a reason.

And.... If calibration isn't necessary, then get rid of them; they're useless. :D

There are two extremes: one involving calibrating everything that doesn't move, and the other is not doing what it takes to assure confidence in equipment; possibly in an effort to save money or whatever. Once the process is studied and the needs are known, it will be clear what should be verified, and what does not.
 
C

Chance

#23
The process does not involve anything related to FDA. The process does NOT require tight/precise readings. We just don't want the room to be so hot like 100 degrees. And if the temperature goes up like 100 degrees,it automatically sends an alarm to our facility guy. So yes, the thermometer is just a fancy thing that we have in there.
 

somashekar

Staff member
Super Moderator
#24
The process does not involve anything related to FDA. The process does NOT require tight/precise readings. We just don't want the room to be so hot like 100 degrees. And if the temperature goes up like 100 degrees,it automatically sends an alarm to our facility guy. So yes, the thermometer is just a fancy thing that we have in there.
I understand you. If you have a measurement system and an alert system for the temperature requirement, whatever be the precision requirement, and that is within your calibration scheme, you may have 100 varities of fancy thermometers there just to see them and around. You need not calibrate any one or all of them.
Is 70 +/- 5 the requirement and does the alarm monitor this ?
What you mention about 100 is perhaps a sort of disaster control and not a process control.
 

BradM

Staff member
Admin
#25
The process does not involve anything related to FDA. The process does NOT require tight/precise readings. We just don't want the room to be so hot like 100 degrees. And if the temperature goes up like 100 degrees,it automatically sends an alarm to our facility guy. So yes, the thermometer is just a fancy thing that we have in there.
What device is generating the alarm? Is it verified? I would have it verified, not because it's mandatory. But because you might start having nuisance alarms (or not alarming when you want) if it gets off to much.

If you have no requirement for the thermometers, then don't get them calibrated and challenge the auditors findings.
 

BradM

Staff member
Admin
#26
Slightly :topic:

So many times people walk into an organization with equipment there. Some of it calibrated, some not. But it seems that everyone's memory is being tested. :D They try to remember if it was bought for a particular project, for a specific requirement, contract obligation, etc. So then someone questions the equipment, and it becomes tedious trying to figure out the best course sometimes.

I recommend creating an instrument record when the instrument is purchased. It will have the requirements (if any) for that device, what its use it, etc. This can be as simple as a spreadsheet, or as detailed as an instrument record (in hard copy). This works well in regulated environments, where one can easily document the initial assessment of the instrument and document what actions (if any) are required.

Then years later, when someone wanders upon an instrument (most of the time when calibration is due), there is a history note of what that instrument was purchased for. It makes it so much easier to determine if it is still required, or if it can be retired/quarantined, etc.

Quarantine is another good option. When in doubt, tape it up in a box and put the date on it. If it's not opened or called upon in a couple of years or so, it's probably not needed and can be discarded.
 
D

Dave Dunn

#27
Re: ISO 9001 Surveillance - Thermometers not calibrated

Finally, I got a good justification! thanks to to big Jim.

The reason why we have to set a certain temperature limit ex: not to exceed 70 degrees +/- something is because if we let these materials set in a very hot temp ex: 100 degrees, over time, it may become worthless...
The question I would have is; what are these materials that you store there used for, and what would be the effect if you tried to use them if they had been degraded by an unacceptable environment that was not detected? You're storing them in a controlled environment, however loosely controlled, and have the knowledge that, while minor variations in temperature won't affect them, long term larger variations may destroy them. Would use of the destroyed materials cause production issues?
 
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Chance

#28
Re: ISO 9001 Surveillance - Thermometers not calibrated

The question I would have is; what are these materials that you store there used for, and what would be the effect if you tried to use them if they had been degraded by an unacceptable environment that was not detected? You're storing them in a controlled environment, however loosely controlled, and have the knowledge that, while minor variations in temperature won't affect them, long term larger variations may destroy them. Would use of the destroyed materials cause production issues?
These materials are used for product development, like used for pilot runs. If these materials are being exposed to temperature outside tolerance, it would still be okay as long as it is not for months time of exposure...
 
C

Chance

#29
What device is generating the alarm? Is it verified? I would have it verified, not because it's mandatory. But because you might start having nuisance alarms (or not alarming when you want) if it gets off to much.

If you have no requirement for the thermometers, then don't get them calibrated and challenge the auditors findings.
We have a building control system which monitors all building operations like lights, temperatures, doors, etc.
It is monitored.
 

Jim Wynne

Staff member
Admin
#30
Let's talk about another measuring device. What if the auditor went into a room and saw a clock on the wall, and clocks on desks. Would the question of calibration be raised? How might the auditor know whether or not keeping track of time is important? Why is a thermometer, or lots of thermometers, any different? The OP has already told us there is no mention of thermometers or temperature control in the company's QMS documentation, and there's nothing in evidence to indicate that the auditor is aware of a situation where calibration might be considered necessary or even helpful.

There's this highly irritating (to me, anyway) idea that's almost canonical in industry that if it's used to measure something (anything) it should/must be calibrated. Baloney, I say. Things should be calibrated when calibration makes sense, not calibrated when it doesn't make sense. The whole calibrate-everything-in-sight thing is used to avoid thinking, and to appease auditors like the one it appears the OP is saddled with.
 
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