Calibration Certificate "As Found" condition - TS16949 Section 7.6.2

C

cdubisms

#1
It's been mentioned to me by several people that TS16949 Section 7.6.2 requires that the "as found" condition be documented on the calibration certificate. I've read the section several times, and perhaps I'm missing it, but I don't read any language that would require that. I know that external laboratories have to be accredited to ISO 17025, but even that only requires that they record the "as found condition", it doesn't require that they do so on the certification.

Can anyone point me to exactly what part of the section/standard is requiring that the "as found" (sometimes known as the "as received" condition) be documented on the calibration certificate?
 
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dwperron

Trusted Information Resource
#2
I'm not sure about TS16949, but the requirement is there in 17025 - when you add things up. First, you have to report the calibration results:

5.10.2 Test reports and calibration certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so:
i) the test or calibration results with, where appropriate, the units of measurement;

It is assumed that a single set of results are the as found / as left results, assuming that no adjustments have been made. In the case of adjustments 17025 gets specific:

5.10.4.3 When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair, if available, shall be reported.

So the results can be assumed to be the as found condition. There is no specific requirement to label the results as "As Found", it's just that most laboratories do this automatically. It does make the customers happier ( a lot of customers require this), makes the results clearer, and can avoid questions and explanations for all involved.
 
C

cdubisms

#3
Thanks for the reply.

I read both of those passage in 17025, but both of them have "wiggle room" phrases like "where appropriate" and "if available".

Section 5.10.4.2 does require them that they maintain the results for possible future reference.

TS16949 7.6.2 is still baffling me a bit. I just don't see verbiage therein that requires the "as found" condition to be included in calibration/verification records.
 

WCHorn

Rubber, Too Glamorous?
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#4
To me, the key is in 7.6. You are required to assess product that was assessed with equipment that is found out of tolerance. How else can you take that action unless your subcontractor reports the "as found" condition?
 

dwperron

Trusted Information Resource
#5
Those phrases I quoted don't really have wiggle room:

"where appropriate" refers to units of measure, not the results. The results must be reported.

"if available" covers cases like broken instruments where you cannot take "as found" measurements. If you can take "as found" measurements, then they are available and must be taken and reported.

The intent is what WC Horn pointed out - the purpose is to let the customer know the extent of any out of tolerance conditions in their equipment. Otherwise the customer can assume that their equipment was within tolerance and no action is required.
 
C

cdubisms

#6
Thanks guys.

I understand the intent. I explained it to a coworker this way:

Let's say widget X needed to measure between 1-10 and when the calibration house received it, it measured 9.9. Knowing it was close to the danger zone, they adjusted it back to 5. The don't document that it measured 9.9 because it wasn't out of tolerance. The TS standard is arguing it's valuable information to know that it was at 9.9 when calibration came due. Do we need to increase the frequency of calibration? Did we use it more often than usual this time? However, if all the certification tells us is that we're getting back in a conforming state, we can't assess that kind of risk.

I was just trying to find the verbiage that actually required that the as found condition be included because it doesn't state it explicitly. I like WCHorn's take on it. Focus on the portion of 7.6.2 that requires that "an assessment of the impact of out-of-specification condition" be completed. If we do that, than the "as found" data is absolutely necessary.
 

Englishman Abroad

Involved In Discussions
#7
I agree you cannot assess the impact if you do not have the out of specification as received condition.

IMO, the requirement for records is defined in 7.6.2;

"Records of the calibration/verification activity for all gauges,.... shall include...​

any out-of-specification readings as received for calibration/verification."

You are correct however that this data does not need to be shown on the calibration certificate.

Indeed for our internal laboratory, we do not issue an internal "certificate" as the calibration data is a controlled record kept on the metrology database.

So you must keep a record of out of spec as received; (But not necessarily in spec as received); and there is no requirement for this to be shown on a paper certificate.

 

dwperron

Trusted Information Resource
#8
Yes, but what I think what cdubisms is pointing out is that lacking the as-found data in instances where the instrument is in tolerance (no reporting on as-found readings is required) but is actually drifting near its tolerance limit exposes the owner to undisclosed risk.

My experience has always been that a calibration without as-found data is far less useful than with the readings. Another reason is that, typically, when you receive a calibration certificate without as-found data you also do not receive a listing of the tests performed, tolerances, etc. I would require that the as-found readings be supplied, it makes your calibration far more valuable to your organization.
 
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