Auditor wants to know where our calibration procedure came from - TS16949

R

RESET

#1
My Manager just found out that an auditor of a sister company said that it is not enough to just create a calibration procedure, it has to be based on an accepted procedure. My company is a TS16949 registered manufacturing compant. Is this auditor correct?
I have read on the forum that you have to reference somethnig that shows where you got your calibration procedure from. What standard do you get this information from? ANSI?
 
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J

jrubio

#2
Auditor stament is correct.

Auditor stament is correct, that is a Calibration plan.

What calibrate what?

The idea is to have treazabilty of the meassurement determinating the real error of the meassurement (Calibration).
 
R

RESET

#3
???

I am not sure I understand. If in deed we have to show that our calibration procedures trace back to an "accepted" method. Where can I find these accepted methods?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Hearsay. Let the Covers figure it out.

People have to learn to ask questions to the auditor. If an auditor tells anybody that something needs correction, the first thing you have to understand what is the REQUIREMENT being cited. It would be much easier to give advice if we understand EXACTLY what the auditor said. Otherwise, the guessing game ensues.

Based on what you described, I suspect that the issue has to do with the last sentence of paragraph 7.6.a). In that requirement, the TS Standard alludes to "physical" standards that are traceable. Standards in that sentence do not mean specifications, procedures, documents, etc...

If this is what the auditor is inferring s/he is dead wrong.
 
R

RESET

#5
Let the covers figure it out?

That is not what I am trying to do. I have stated as much information as I have on the subject. Our auditor, while at a sister company, told them that it was not enought to create a calibration procedure, They had to sight references to where they got the procedure. I.E. He wants them to follow an "accepted" process while calibrating things. Our audit is coming up in the next month and this was dropped on me. I understand that my question may be cryptic. All I really need to know is, Where is the shall? And, if indeed this is a requirement, where do I find "accepted" procedures for calibrations.

edit: I see that there are related threads at the bottom of the page and will read them for reference. please not that I did perform a search prior to beginning this thread. I also used the button to search the thread title.
 
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Howard Atkins

Forum Administrator
Staff member
Admin
#6
Sean,
The problem is that you got the information second hand.
The traceability refers to the equipment for the calibration- the masters etc. The procedure is yours and must be adequate to perform the job.
There is no "accepted procedure" to copy. This is like using a canned Manual and procedures for you company.
Please try and find out what was really said or better still written
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
I agree with Howard Atkins.

If your auditor really was asking about a procedure based on an "accepted" method, maybe s/he meant something like ISO 17025 or ANSI/NCSL Z540-1-1994: Calibration Laboratories and Measuring and Test Equipment - General Requirements.

But TS 16949 does not require a procedure to be based on such a standard, and it doesn't require ISO 17025 registration to do calibration. It requires your calibration standards (like gage blocks) are traceable to NIST and the program adequately covers

7.6.1 Measurement system analysis

7.6.2 Calibration/verification records

7.6.3 Laboratory requirements

I would ask the auditor exactly what s/he is referencing in the TS standard and just what deficiency is causing the problem. It's time for direct communication. If the auditor insists the procedure must be based on something like ANSI so the requirements in 7.6 are met, I see a problem with the auditor.
 

apestate

Quite Involved in Discussions
#8
RESET

I would also agree that without a specific shall to address, it is difficult to formulate a precise response. Perhaps you will find that the auditor's finding was merely a suggestion for improvement, or based on an additional standard that is being followed by the sister factory. Perhaps the factory's quality manual threw this requirement in.

I seem to recall a provision for measurement tools being calibrated to APPROVED procedures, but without something to reference it's not really possible to discuss.

The question you posed originally is interesting. Where do these calibration procedures come from? How do you know what steps and adjustments are necessary? It's a good question.

Apparently there are not tool-specific calibration standards published on national or international levels. I would certainly like to be proven wrong, whether the standard is obsolete or not.

There are standards at this level for the establishment of calibration procedures. Industry practice, manufacturer's instructions or recommendations, past experience and the like are the basis of calibration procedures.

Some manufacturers produce calibration procedures for their products. The military often standardizes calibration of certain tools, but usually these are for large-scale electronic systems or machines out of different fields than dimensional metrology. NIST, NPL, NCSL, etc., have some procedures published as well, but this falls short of our purposes again.

How many different tool families and tool types do you estimate are under calibration at your facility?

The suggestion by the auditor is not really a bad one, despite whether or not it is proven a requirement.

Erik
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
My interpretation of the original question is not unlike what I ask when I assess cal labs.....what is the SOURCE of your internal procedure?

If the source is a NA 17-20 series or a T.O. 33K or a relevent ASTM Standard, no sweat, they are well validated.....however, if it is a lab-developed procedure, then it must be validated.

I suspect that is the question here.....so you should have a validated source like the military procedures and reference that in your internal procedure.

Of course, unless you have calibration professionals performing your internal cal, I always recommend outsourcing to accredited labs.

Hope this helps.

Hershal
 

apestate

Quite Involved in Discussions
#10
Hershal

Of course you are talking about evaluating calibration laboratories. While unpleasant, there are certainly different circumstances in most factories, especially the small and mid-size. And of course we're not talking about specific TS-16949 requirements, but about actual practice in calibration laboratories. Proper calibration.

Could you go into more detail on NA 17-20 and T.O. 33k--or other sources of validated calibration procedures that you referenced in your post?

How would you come up with validated procedures for tools like the following:

Sunnen GR series dial bore gages
Sunnen PR bore gaging stand (looks like a toaster or old time radio)
Mitutoyo twin-beam digital readout height stand
TESA-Hite Plus D 600mm digital height stand

Since we're not eligible for GIDEP participation (bleh), and since I don't see anything at NCSL or anywhere, the plan is to develop a procedure based on MIL-PRF-38793B, Performance Specification, Technical Manuals: Calibration Procedures - Preparation. This standard will be the basis of the procedure.

The procedure itself will come from the manufacturer and any other information I can get. As far as validating... I think we'll work toward that when we have something to work WITH. Of course it'll probably never happen because it'll probably be seen as overkill for a tractor/implement parts factory.

In short, could you go into a little more detail about sources for calibration procedures for this sort of gaging?
 
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