ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

C

Chance

#41
Re: ISO 9001 Surveillance - Thermometers not calibrated

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:
Qusys,

I had a closing meeting with the external auditor last week, all of my justifications were not accepted. He told me to file an appeal instead.

Here is the situation. The temperature of the room is monitored using a sensor that detects the accpetable ranges that we want. If the temperature goes off the limit, the sensor sends an alarm to us, so if this happens, the third party comes and check the sensors, calibrate if necessary.

If the temperature goes beyond limit, the materials are still okay, even if it goes up to more than 3 days of having unacceptable temperature. The very reason we have set the temperature limits is that we don't want to be so hot.
All of the data from those materials does not have any impact to our end products. If the material looses its critical usability, the consequence is that we will have to utilize more, that's it. But the data related to decision making is totally not affected by this.
Now, should I have them calibrated still? Please help. It seems that the battle I have is a loose-loose situation for me though.
The auditor did not even listen to what I am trying to explain to him.
 
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BradM

Staff member
Admin
#42
Re: ISO 9001 Surveillance - Thermometers not calibrated

Qusys,

I had a closing meeting with the external auditor last week, all of my justifications were not accepted. He told me to file an appeal instead.

Here is the situation. The temperature of the room is monitored using a sensor that detects the accpetable ranges that we want. If the temperature goes off the limit, the sensor sends an alarm to us, so if this happens, the third party comes and check the sensors, calibrate if necessary.

If the temperature goes beyond limit, the materials are still okay, even if it goes up to more than 3 days of having unacceptable temperature. The very reason we have set the temperature limits is that we don't want to be so hot.
All of the data from those materials does not have any impact to our end products. If the material looses its critical usability, the consequence is that we will have to utilize more, that's it. But the data related to decision making is totally not affected by this.
Now, should I have them calibrated still? Please help. It seems that the battle I have is a loose-loose situation for me though.
The auditor did not even listen to what I am trying to explain to him.
Then appeal. :cool: It sounds like to me the auditor is trying to bully you a bit, now. Is there any citation the auditor is providing? Anything out of your own procedures or an industry-specific document that states it should be done?

Unless there is a clear compelling reason the instrument should be calibrated, I don't see why the auditor is approaching things this way.
 
C

Chance

#43
Re: ISO 9001 Surveillance - Thermometers not calibrated

Then appeal. :cool: It sounds like to me the auditor is trying to bully you a bit, now. Is there any citation the auditor is providing? Anything out of your own procedures or an industry-specific document that states it should be done?

Unless there is a clear compelling reason the instrument should be calibrated, I don't see why the auditor is approaching things this way.
I am still waiting for the CAR from him..
 

Golfman25

Trusted Information Resource
#44
Boy do you have a problem. Pick you battles wisely. Here is where your system in they eyes of your co-workers can begin to crack and fail.

If you appeal, your auditor will be less than happy -- nobody likes to be challenged. He could hold a grudge and just wait until the next audit.

However, if you do the "easy" thing and get the stupid thermometers "calibrated" just so the auditor is happy -- out go your arguments that you are not working the system just to "pass" an audit, but really to help the company.

With all that has been said, it sounds like your auditor is a real tool. Been there, done that. We had a guy tell us that we had to "calibrate" a metal ruler which we used to check strip width. We checked, not because it was product required (everything was blanked to size) but just to make sure it would fit thru the tools -- even if it didn't it was no big deal. It is an eyeball at best -- no precision needed. Now here is the funny part. Our new auditor comes in a year later and observes our receiving clerk doing the check with his "calibrated" ruler. He proceeds to butt the end of the ruler up against his "fat" fingers and take his "measurement." Auditor comments "a lot of good the "calibration" did us" and smiles. Good luck.
 
C

Chance

#45
Boy do you have a problem. Pick you battles wisely. Here is where your system in they eyes of your co-workers can begin to crack and fail.

If you appeal, your auditor will be less than happy -- nobody likes to be challenged. He could hold a grudge and just wait until the next audit.

However, if you do the "easy" thing and get the stupid thermometers "calibrated" just so the auditor is happy -- out go your arguments that you are not working the system just to "pass" an audit, but really to help the company.

With all that has been said, it sounds like your auditor is a real tool. Been there, done that. We had a guy tell us that we had to "calibrate" a metal ruler which we used to check strip width. We checked, not because it was product required (everything was blanked to size) but just to make sure it would fit thru the tools -- even if it didn't it was no big deal. It is an eyeball at best -- no precision needed. Now here is the funny part. Our new auditor comes in a year later and observes our receiving clerk doing the check with his "calibrated" ruler. He proceeds to butt the end of the ruler up against his "fat" fingers and take his "measurement." Auditor comments "a lot of good the "calibration" did us" and smiles. Good luck.
Thanks!!! It is absolutely nonsense to continue arguing this thing. We won't be filing an appeal. Sometimes you gotta have to loose...as the song goes...
I will have the stupid thermometers calibrated twice a year. I will close my eyes and force to think that this is absolutely necessary to help the company.:agree:
 
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qusys

Trusted Information Resource
#46
Thanks!!! It is absolutely nonsense to continue arguing this thing. We won't be filing an appeal. Sometimes you gotta have to loose...as the song goes...
I will have the stupid thermometers calibrated twice a year. I will close my eyes and force to think that this is absolutely necessary to help the company.:agree:
Hi Chance,
I have understood your reason and I totally agree.
However, my suggestion could be to make a risk analysis ( for instance , using FMEA) for the calibration of your devices, in order to assess which of them require calibration and shall undergome under calibration system and which can be used for reference only.
You can also do a procedure to manage calibration and have all records in place to be in conformance with what your QMS requests for as well as ISO 9001 requirement.
If you can demonstrate with data that calibration is not required for some tools, you shall have helped your QMS to improve and also raised the morale of the in charge personnel , because they will know how their job impact the quality of the product and of the QMS.
Good luck:bigwave:
 

BradM

Staff member
Admin
#47
Thanks!!! It is absolutely nonsense to continue arguing this thing. We won't be filing an appeal. Sometimes you gotta have to loose...as the song goes...
I will have the stupid thermometers calibrated twice a year. I will close my eyes and force to think that this is absolutely necessary to help the company.:agree:
I do understand. But... I would still appeal.

By not appealing, you have now allowed the auditor to bully you; to make you change your process because of their own whims.

Now.... you have to calibrate something that is not needed or required.

What auditor whim will your organization be forced to accept during the next audit? :)
 
C

Chance

#48
I do understand. But... I would still appeal.

By not appealing, you have now allowed the auditor to bully you; to make you change your process because of their own whims.

Now.... you have to calibrate something that is not needed or required.

What auditor whim will your organization be forced to accept during the next audit? :)
The folks from my company told me that its not worth the fight..So I think I won't win on this one. I would think that it would be more difficult next time, since I tried to challenge him during this last audit.
 

Golfman25

Trusted Information Resource
#49
Thanks!!! It is absolutely nonsense to continue arguing this thing. We won't be filing an appeal. Sometimes you gotta have to loose...as the song goes...
I will have the stupid thermometers calibrated twice a year. I will close my eyes and force to think that this is absolutely necessary to help the company.:agree:

I would try extending out the calibration. Go at least 1 year. I would try for 5 years. Good luck.
 
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