ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

#51
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.
Try to think of it this way...

Without you making a formal issue with your CB, the auditor feels validated with their comment. And so, they bring their biases to the next client and so on. So, it may not be a 'big deal' at an individual client level, but over the course of many audits, these (and similar) biases are manifested time and again. It is the Voice of the Customer on which we rely so heavily to improve the credibility of services. Too many people like to 'bash' CBs and their auditors, or poorly performing supplier who have an ISO certificate, but they are unwilling to give feedback to help be part of the improvement!

Sadly, when -or even if - the auditor is 'witness' audited, their biases may not surface (maybe it's a different industry etc). So, for those of us in the CB services and all those clients and consultants on whom the success of Certification is reliant, I'd ask you to - at least - write and inform your CB management of your dissatisfaction with this particular finding and that you'd like them to inform you how they have identified such biases so that other auditors won't bring them to your audits again!
 
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C

Chance

#52
Try to think of it this way...

Without you making a formal issue with your CB, the auditor feels validated with their comment. And so, they bring their biases to the next client and so on. So, it may not be a 'big deal' at an individual client level, but over the course of many audits, these (and similar) biases are manifested time and again. It is the Voice of the Customer on which we rely so heavily to improve the credibility of services. Too many people like to 'bash' CBs and their auditors, or poorly performing supplier who have an ISO certificate, but they are unwilling to give feedback to help be part of the improvement!

Sadly, when -or even if - the auditor is 'witness' audited, their biases may not surface (maybe it's a different industry etc). So, for those of us in the CB services and all those clients and consultants on whom the success of Certification is reliant, I'd ask you to - at least - write and inform your CB management of your dissatisfaction with this particular finding and that you'd like them to inform you how they have identified such biases so that other auditors won't bring them to your audits again!
I do appreciate your help. I wish I could do that....am too scared...with the fact...that

Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards


This requirement is very flexible, not too stringent but I wonder why CB auditors generalized the meaning of it. To a point where all of our measuring device has to be calibrated.

Now if I will complain to the CB, I won't win.

 

Jim Wynne

Staff member
Admin
#53
I do appreciate your help. I wish I could do that....am too scared...with the fact...that

Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards


This requirement is very flexible, not too stringent but I wonder why CB auditors generalized the meaning of it. To a point where all of our measuring device has to be calibrated.

Now if I will complain to the CB, I won't win.
You highlighted only part of the operative phrase, which is "Where necessary to ensure valid results..." The question for the auditor would be "Where is the evidence that lack of calibration has been an issue, and what are the potential results that are jeopardized by lack of calibration?"
 

BradM

Staff member
Admin
#54
I do appreciate your help. I wish I could do that....am too scared...with the fact...that

Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards


This requirement is very flexible, not too stringent but I wonder why CB auditors generalized the meaning of it. To a point where all of our measuring device has to be calibrated.
You answered your own concern with this: Where necessary. There is no need anywhere that you, the auditor, or anyone else for that matter, can seem to verify why calibration is required or even needed. Point being, you could throw the thermometers away, and nothing really would change. When it was uncomfortably hot, someone will complain. :D

Now if I will complain to the CB, I won't win.
I wouldn't be too sure. Unless the auditor can produce a clear reason they would cite such a thing from your own QMS or otherwise, then the CB should give your objection credence.

Recall... you are paying them. You are not there to serve them. I'm certainly not trying to diss your auditor or anything. But I also don't appreciate people 'pushing' their own agenda, while they are supposed to be performing objective audits. :)
 

BradM

Staff member
Admin
#55
You highlighted only part of the operative phrase, which is "Where necessary to ensure valid results..." The question for the auditor would be "Where is the evidence that lack of calibration has been an issue, and what are the potential results that are jeopardized by lack of calibration?"
You were posting as I was. Pretty good speed for an old man. :tg:
 
C

Chance

#56
You highlighted only part of the operative phrase, which is "Where necessary to ensure valid results..." The question for the auditor would be "Where is the evidence that lack of calibration has been an issue, and what are the potential results that are jeopardized by lack of calibration?"
Oh sorry Jim...Hey, do you think it is a good battle for me to take?
 
#57
Hi Covers,

We had a ISO 9001 surveillance very recently. Everything went very well except that the auditor said that our temperature readings taken from our system is not validated against a certified thermometer.

My question is, is it possible to calibrate a thermometer? If yes, how?

Also, there is no regulatory requirement nor ISO requirement that dictates that we have to do it.

ISO 9001 says that where necessary, to ensure valid results, we have to calibrate equipment.

Should I dispute his finding?
Based on this OP? Yes, indeed, it's one worth taking back to them for clarification. I see nothing here that would indicate (sorry for the partial pun) that the thing is a non-conformity.
 

Jim Wynne

Staff member
Admin
#58
You were posting as I was. Pretty good speed for an old man. :tg:
:topic: I'm reminded of the probably apocryphal story about Ty Cobb, who long after his retirement from baseball was allegedly asked by a writer how he thought he would fare against modern pitching. He said, "Oh, I think I'd probably be lucky to hit .270 against today's pitchers." The writer said, "Why is that? Are today's pitchers really that much better?" "No," said Cobb, "but I'm seventy-five years old."
 

Jim Wynne

Staff member
Admin
#59
Oh sorry Jim...Hey, do you think it is a good battle for me to take?
That's up to you. So long as there's no pressure from above to just let it go, I think it would be a good thing to do. I've had one instance where I was barred by management from appealing a CB audit nonconformity, one where I just didn't think the protest was worthwhile, and another where I was able to show the auditor the error of his ways before he left the building. I've never had occasion to do an actual appeal.
 
#60
Is there any citation the auditor is providing?
Exactly. You must know which section they cite before you can fight/appeal.
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.
That is grounds for having an auditor removed from your case. I've done it, with cause, with DNV. Registrars are especially eager to remove auditors if you win the appeal. You are paying the bill.
I would think that it would be more difficult next time, since I tried to challenge him during this last audit.
Dead wrong. If you think he was bad this time, wait until he thinks he can write up anything and you will accept it. Appeal, and if you win, make sure he isn't there next time.
Where necessary to ensure valid results, measuring equipment shall...
Within some pretty wide limits, you determine what is necessary, not the auditor. Every new auditor that comes in has looked at the 100 foot measuring tape that is sealed to our production floor. Before they can finish asking, "Where is the calibration data?" I reply, "There is none, it is not necessary, move on." If they persist, I say, "If you write this up, I will appeal, I will win, and you will not be invited back. I have the data to back that up." No one has been unwise enough to continue. We make electronics, not wire by the foot. If you found several voltage meters out of calibration, you would have some grounds for a calibration finding.
Oh sorry Jim...Hey, do you think it is a good battle for me to take?
I'm not Jim but I say yes, bounded by my previous advice and pending which section is cited.
 
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