ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

C

Chance

#11
Re: ISO 9001 Surveillance - Thermometers not calibrated

If calibration isn't necessary to ensure valid results (for whatever the temperature readings are used for) you don't have to calibrate. I'm wondering, though, why this temperature business is documented as a requirement in your QMS. What happens if the temperature is 75°?
This is not documented in our QMS. THe auditor just all of the sudden wanted to see storage rooms (that has a temperature system). Even if the reading is +/- 5 of 70 is still acceptable. We are not storing food, we are not measuring body temperature of patients, in other words, we don't have any health hazard nor product hazard with this storage rooms. The products inside the room won't go to any of our customers.
 
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C

Chance

#12
Re: ISO 9001 Surveillance - Thermometers not calibrated

:agree1: Or 65[sup]o[/sup]? Instead of simply asking if ISO 9001 requires this or that, we should put our thinking caps on and ..... think!

Currently, there are two non-calibrated gages providing a temperature reading! If I were the auditor, I would be thinking: this must be somewhat important; otherwise, why have a redundant temperature reading system? So, if it is important, the temperature reading should be reliable. In order to be reliable, I should have the thermometer (or gage) calibrated; if not, how can I trust the reading?

But the basic question is what Jim asked. What would be the impact to product conformity (if any) if the temperature was off by 2, 3, 5, 10 degrees? Until THAT question is answered, we are just speculating here.
Currently, we have temperature system bought from a third party which they also monitor our system, if there is something wrong the system gives us an alarm, now when that happens, we contact the manufacturer and they fix it for us. The room temperature precision is not that critical, we don't have food stored in there. The acceptance tolerance is wide +/- 5. If something goes wrong, there is no direct impact to our products, it just needs to be fixed as soon as possible.:thanks:
 
C

Chance

#13
Hi Chance,

This question is separate from your other and is easier.

Yes it is possible, but may require you to get a different temperature gage than what you are using now.
We use a digital temperature gage (cheapie from Cole Parmer) and have it calibrated by the same company that does our mics, calipers, etc. They won't do a glass/mercury or glass/whatever liquid type, but the electronic ones they do.
I am still not convinced of having it calibrated.
 
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harry

Super Moderator
#14
The subject on calibration of thermometers is always contentious. If I am not mistaken, one of our metrologist friend's position is why bother having one if you don't calibrate it. To me, you need to at least verify it (0 C and 100 C).

Specifying requirements such as 75 +/- 5 F or so further weakens ones position. If it is really not critical just mention 'around 75 F'.
 

somashekar

Staff member
Super Moderator
#15
I am still not convinced of having it calibrated.
OK Chance.
So I will say that this is just like the wall clock which shows me the time and I have no any direct evidence of this monitoring and measuring anything to determine conformity of product to determined requirement.
Is this also not on your identified instrument for its calibration status ?
If it is not, then explain your case that this is consciously not a monitoring and measuring device and hence not within your control plan for monitoring and measuring devices.
 
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Jim Wynne

Staff member
Admin
#16
Re: ISO 9001 Surveillance - Thermometers not calibrated

Currently, we have temperature system bought from a third party which they also monitor our system, if there is something wrong the system gives us an alarm, now when that happens, we contact the manufacturer and they fix it for us. The room temperature precision is not that critical, we don't have food stored in there. The acceptance tolerance is wide +/- 5. If something goes wrong, there is no direct impact to our products, it just needs to be fixed as soon as possible.:thanks:
This is not documented in our QMS. THe auditor just all of the sudden wanted to see storage rooms (that has a temperature system). Even if the reading is +/- 5 of 70 is still acceptable. We are not storing food, we are not measuring body temperature of patients, in other words, we don't have any health hazard nor product hazard with this storage rooms. The products inside the room won't go to any of our customers.
If the requirements aren't documented and there is no potential impact on products, services or customers, there is definitely no requirement relative to ISO 9001 that an auditor could rationally cite.

BTW, as far as I can see, you still haven't explained why the temperature in these areas has to be controlled.
 
C

Chance

#17
Re: ISO 9001 Surveillance - Thermometers not calibrated

BTW, as far as I can see, you still haven't explained why the temperature in these areas has to be controlled.
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...It is like if you have a bottle of medicine you want it inside your house, not in your garage...coz its too hot..but its okay to put them inside your medicine cabinet..sometimes your house gets hotter or colder..it does not matter. As long as the house don't stay that hot for months...That is the same situation with our materials. Temperature variations even +/-5 is still okay,that means it does not have to be that critical.
Why we have handheld thermometers? Because we want to double check if the temperature system is working as intended in a specific room. What is the probability that temperature system and the handheld thermometer will breakdown at the same time? Probably not at the same time. If one of them is off, then we can identify which one is not working.
 
C

Chance

#18
OK Chance.
So I will say that this is just like the wall clock which shows me the time and I have no any direct evidence of this monitoring and measuring anything to determine conformity of product to determined requirement.
Is this also not on your identified instrument for its calibration status ?
If it is not, then explain your case that this is consciously not a monitoring and measuring device and hence not within your control plan for monitoring and measuring devices.
Yes, its like a wall clock...

It is not listed in our equipment list with its calibration status.
 

BradM

Staff member
Admin
#19
Hello Chance! :)

Most of the others covered the topic pretty well.

If you removed the thermometers tomorrow, what would happen? Would anyone care? Would anything change?

Does anyone actually read and observe the thermometers? Is it written down, or a checkmark put into place?

You mentioned patients in an earlier thread. You might want to check on patient efficacy and such to see if there is a requirement.

Question the process. You may have a need for the thermometers, and I think you should find it. If you don't, then you can remove them or whatever. But without questioning the process, you might remove something you need to be doing; or leave something that is useless, simply because "that's what we have always done".
 

BradM

Staff member
Admin
#20
Yes, its like a wall clock...

It is not listed in our equipment list with its calibration status.
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.
 
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