ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

Jim Wynne

Staff member
Admin
Respectfully, I think the question has been answered and the discussion is getting into management's thought process. Clearly they have determined the temperature to be an important process variable. The thermometer should be calibrated. Reasons have already been cited.
I'm not so sure that it's clear that temperature has been determined to be an important process variable. I'm not even sure that it is, strictly speaking, a process variable. Regardless, the requirement for calibration, once again, is invoked "When necessary to ensure valid results ..." I've seen nothing in this thread to indicate that calibration would be helpful, or needed to ensure valid results.
 
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BradM

Staff member
Admin
I'm not so sure that it's clear that temperature has been determined to be an important process variable. I'm not even sure that it is, strictly speaking, a process variable. Regardless, the requirement for calibration, once again, is invoked "When necessary to ensure valid results ..." I've seen nothing in this thread to indicate that calibration would be helpful, or needed to ensure valid results.
Maybe so, but here and a few other posts:

http://elsmar.com/Forums/showpost.php?p=451109&postcount=83

The OP states it is a requirement, and there is a temperature specification in their procedures. At some level, that requirement has to be satisfied.
 

Big Jim

Super Moderator
Jim & I stand together on this one. It certainly is not clear, from that post, or any other post by the OP, that calibration is needed.

The ONLY thing i see, is that the OP is not willing to say it isn't needed, rather, he dances around the edges.

Until he quits sitting on the fence, there is nothing more we can do to help.
 

BradM

Staff member
Admin
Jim & I stand together on this one. It certainly is not clear, from that post, or any other post by the OP, that calibration is needed.

The ONLY thing i see, is that the OP is not willing to say it isn't needed, rather, he dances around the edges.

Until he quits sitting on the fence, there is nothing more we can do to help.
I agree, that we still don't know what is required. However, there is a specification in his procedure, which makes me think at some time, there was a need. Just don't know if it is still there. :)
 

Jim Wynne

Staff member
Admin
Maybe so, but here and a few other posts:

http://elsmar.com/Forums/showpost.php?p=451109&postcount=83

The OP states it is a requirement, and there is a temperature specification in their procedures. At some level, that requirement has to be satisfied.
I agree, that we still don't know what is required. However, there is a specification in his procedure, which makes me think at some time, there was a need. Just don't know if it is still there. :)
The existence of a specification is not necessarily an indication that calibration is needed. It could be that whomever it was that put the specification in place did so out of ignorance, or because of a bad experience with an auditor in the past.

What is clear is the OP came here because he thought that the auditor's NC was wrong, and he doesn't see value in calibration. He could be wrong, but I doubt it.
 

BradM

Staff member
Admin
The existence of a specification is not necessarily an indication that calibration is needed. It could be that whomever it was that put the specification in place did so out of ignorance, or because of a bad experience with an auditor in the past.

What is clear is the OP came here because he thought that the auditor's NC was wrong, and he doesn't see value in calibration. He could be wrong, but I doubt it.
:applause::agree1: I agree with that point and I thought I had made that same observation in this thread too.:D

If temperature doesn't matter, the requirement (and all the business of monitoring/calibrating 13 devices) is negated and should be addressed as such.

I don't know, because I don't know the process or the material. But I would be surprised if temperature is not critical at some point, if the material is being stored at 30°F.

But requirements and practices should be constantly evaluated to determine if it is needed, makes sense, is best practice, etc. The materials needing tight temperature requirements may have disappeared years ago.:cool:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
A few minutes ago, I read this article. I think it exemplifies very well how the work environment (humidity in this case) can have a dire impact on the product conformity and safety. Before this incident and probable causation determination, I can guarantee many people would think: calibrated humidity meters? We don't need any stinking calibrated humidity meters....
 

Jim Wynne

Staff member
Admin
A few minutes ago, I read this article. I think it exemplifies very well how the work environment (humidity in this case) can have a dire impact on the product conformity and safety. Before this incident and probable causation determination, I can guarantee many people would think: calibrated humidity meters? We don't need any stinking calibrated humidity meters....
It's very easy to use alarmist, absolute-worst-case, airplanes falling out of the sky examples, but there is no evidence in that article that (a) hygrometers were in use in the plant, and (b) if there were hygrometers in use that they were not calibrated. It's possible to ignore a calibrated instrument. We know only that the FAA determined that the cause of the failure was excessive humidity.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
It's very easy to use alarmist, absolute-worst-case, airplanes falling out of the sky examples, but there is no evidence in that article that (a) hygrometers were in use in the plant, and (b) if there were hygrometers in use that they were not calibrated. It's possible to ignore a calibrated instrument. We know only that the FAA determined that the cause of the failure was excessive humidity.
My point is to show that, UNTIL WE KNOW ALL THE ENVELOPE CONDITIONS of the scenario, we are speculating with a degree of risk. The OP is being deliberately sparse about the details revolving around the finding and the product. Some of the opinions expressed in this thread are full of assumptions.
 

Jim Wynne

Staff member
Admin
My point is to show that, UNTIL WE KNOW ALL THE ENVELOPE CONDITIONS of the scenario, we are speculating with a degree of risk. The OP is being deliberately sparse about the details revolving around the finding and the product. Some of the opinions expressed in this thread are full of assumptions.
I agree that we don't know enough to give advice with certainty, but we run across things like that every day here. No one who isn't there knows for sure, and it sounds like maybe people who are there don't know for sure either, but if the OP's situation involves life-or-death potential, or the risk of significant loss of any kind, we need to be able to assume that we would have been given that information.
 
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