ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

Golfman25

Trusted Information Resource
#31
Do you have the room temp. standard documented? Does it say somewhere that the room has to be kept to 70 +/- 5? Are the room temps. documented each day, week, or month? If so, I can see why your auditor might want calibration. Maybe you can change your requirement to reference 70 degrees. Sounds to me like calibration would be overkill, but you might need to pick you battles on this one. Good luck.
 
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BradM

Staff member
Admin
#32
We have a building control system which monitors all building operations like lights, temperatures, doors, etc.
It is monitored.
Like I said Chance, I might have some verification done on it every so often so you can prevent nuisance alarms, or a situation when it should have alarmed but didn't. Other than that, I wouldn't worry about it.
 
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Chance

#33
Do you have the room temp. standard documented? Does it say somewhere that the room has to be kept to 70 +/- 5? Are the room temps. documented each day, week, or month? If so, I can see why your auditor might want calibration. Maybe you can change your requirement to reference 70 degrees. Sounds to me like calibration would be overkill, but you might need to pick you battles on this one. Good luck.
NO. My QMS only say" monitor the XX room storage. Current condition is 70 degrees +/- 5. It does not indicate that it "shall be 70 degrees +/-5".
They are just there so we can visually observe the temperatures in the room. The thermometers are read and observed every time the storage guy enters the room, not recorded however. The thermometers are not used as a definitive measurement, it is used as a check.
Exactly, that is why I bring this up here. I will have my closing meeting with him next week. I need to make sure I pick a good :mad:.
 
#34
Re: ISO 9001 Surveillance - Thermometers not calibrated

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...
So, if your temperature monitoring devices are not accurate you could end up throwing away money.
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...
Product development processes should be controlled according to ISO9001. I have been involved in design projects (plural) where the designers arrived at incorrect conclusions about their verifications due to glue that didn't hold parts together (expiry date passed), potting compounds that didn't set properly (material settling, no barrel rotation as required), and even bad solder joints (tin oxide preventing good joints on lead free bolts not stored in a sealed container as required).

The old Covers know that I'm all about avoiding needless calibration. In this case, though, I think I'd buy one decent digital thermometer and get it validated (just checked for accuracy) or calibrated (physically tweaked to best accuracy and precision) on an annual basis.
 
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Chance

#35
Like I said Chance, I might have some verification done on it every so often so you can prevent nuisance alarms, or a situation when it should have alarmed but didn't. Other than that, I wouldn't worry about it.
We don't take responsibility of verifying false alarms because we contracted that with third party. The facility guy receives alarm everytime that happens. If we do verification, we overkill the process. It's like when you have your car serviced, you don't verify the service guy's process.
 
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Chance

#36
Re: ISO 9001 Surveillance - Thermometers not calibrated

The old Covers know that I'm all about avoiding needless calibration. In this case, though, I think I'd buy one decent digital thermometer and get it validated (just checked for accuracy) or calibrated (physically tweaked to best accuracy and precision) on an annual basis.
So you want me to buy one thermometer that is calibrated even if we don't have that requirement. What is my nonconformity against what if I don't?
 
#37
You have a requirement for Preservation of Product, 7.5.5. Even if said materials are not going to ship to a customer, if you are making decisions based on the performance of those materials as part of Design and Development Verification or Validation, 7.3.5 & 7.3.6, I'd say you have something to address.

Do you not validate your designs with controlled measuring devices?
 

BradM

Staff member
Admin
#38
Re: ISO 9001 Surveillance - Thermometers not calibrated

The old Covers know that I'm all about avoiding needless calibration.
I am too.

And needless instrumentation/equipment. :D

I am continually questioning calibrations before they occur. Hey... where did you find this? Has it been used since your last calibration? Has anyone used it? Is there ever any error when you check it? Blah.. blah blah. There's stuff being removed all the time, put in storage, sold, reassigned, etc. But someone needs to be continuously looking at the process(es) and seeing what is needed. If this is being done, only needed equipment will be there. And that needed equipment, should be verified.

Needless calibrations cause prices to go up, and frankly, isn't much fun. That precious money can be spent elsewhere, like procuring redundant standards and instrumentation to perform in-house verification, when needed.
 

harrysons

Realistic Quality
#39
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.

hi chance,
my undestanding, thermometer is using to read the temperature on your storage room or certainly area. this seem like the control the temperature over the product requirement, Is it your thermometer related to "6.4 Work Environment?" if not related and unnecessary to used and you might be able to remove it. that's only my opinion. :rolleyes:
 

qusys

Trusted Information Resource
#40
Re: ISO 9001 Surveillance - Thermometers not calibrated

So you want me to buy one thermometer that is calibrated even if we don't have that requirement. What is my nonconformity against what if I don't?
Hi Chance,
I read now the post about this argument.
I would like to know what countermeasures you have in place, if any, if the temperature of the room is not what you expect.:bigwave:
 
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