Customer Audit of Guide 25 Calibration - Full pre and post adjustment data?

[Marc]

A past client of mine (currently ISO9001 registered) e-mailed me the following. I'd like some of your feedback on this. Any takers???

---------snippo-------

We recently had a customer audit and they raised an issue in the cal lab. The auditor did not like that we do not specify any instructions on our purchase orders for outside calibration services. We were wondering if you would offer your opinion about the following two points.

1) He wanted to see a requirement for full pre and post adjustment data. I do not see anywhere in Guide 25 or ANSI Z540 that requires full pre and post adjustment data. Currently we only require that the vendor inform us if the item is was out of specifications.

2) We currently require that the item be calibrated to meet manufacturer's specifications and that it be traceable to a national standard such as NIST. The auditor felt that this does not go far enough and wanted to see a requirement that the calibration is done to a standard such as Guide 25, MIL Std 45662A or ANSI Z540.

I have read through MIL Std 45662A, Guide 25, ANSI/NCSL Z540 (1994), and even ISO/DIS 17025 - they all seem to have the same requirements and it seems to me that we are currently meeting those requirements.

Any help that you can give us to clarify these items would be greatly appreciated.

 

[Marc]

I answerd with the following:

-----------snippo-----------

In my opinion the auditor is assessing you to QS9000 requirements.

--> We recently had a customer audit and they raised an issue in the cal
--> lab. The auditor did not like that we do not specify any
--> instructions on our purchase orders for outside calibration
--> services. We were wondering if you would offer your opinion about
--> the following two points.
-->
--> 1) He wanted to see a requirement for full pre and post adjustment
--> data. I do not see anywhere in Guide 25 or ANSI Z540 that requires
--> full pre and post adjustment data. Currently we only require that
--> the vendor inform us if the item is was out of specifications.

My personal opinion is this data should be required of a calibration supplier - BUT, as far as I know there is no specific requirement for before and after data except in QS9000. If I wanted to hit you on that in ISO the closest I could come would be from 4.11.1 of ISO9001:1994.

However, if you somewhere state that you comply with Guide 25 I will cite 9.2 where it states "... Calibration certificates shall where ever applicable [Marc Note: a limited escape clause] indicate....and shall provide the measurement results and associated uncertainty...." A2LA explanitory note says 'As Found' conditions are to be recorded.

Now comes the question as to whether you can make the jump from ISO9001's requirement in 4.11.1 of knowing measurement uncertainty and such to Guide 25. It should also be noted that paragraph 3 of 4.11.1 requires this if the customer requires it. Which is sorta what appears to happening.

I thought we spoke about this when I was there - maybe not. If you want my opinion, I would do it because it's pretty much derigur - expected as normal - any more. But as an independent auditor I would not be able to cite an ISO requirement other than within the context of 4.11.1. There is the case where a supplier of calibration services assumes the responsibilty for tracking that instrument including recommendations of rebuild because of increased variance and such - there are cal services suppliers which will do this which relieves you of the obligation.

As to whether you state it on the purchase order or not - that goes to communicating requirements. You should be able to make the case that you work closely with the supplier of calibration services - that a written requirement is not neccessary and your evidence is that the cal certs and other cal information you get is what you want.

Remember that many auditors, especially customer auditors, ask to see what they expect to see many times - not always what the requirement. I know of a company locally which just got the 3rd degree from Valeo Engine Cooling - a customer. The auditor was really an ass - he went far beyond requirements into his expectations and interpretations and my friend there is really in fits. I can't remember everywhere Missy said he ventured, but I remember it was kinda funny as Missy is hard to shake - a very strong willed gal - and she was really shaken. Never seen her so mad! Your experience with customer audits may vary.

Bottom line - Guide 25 does require before and after. ISO does not specifically do so, but it is 'somewhat' implied in 4.11.1. ISO does call out 10012 but I have misplaced my copy so I can't comment on it. As I read it, Z540-1-1994 implies it like ISO9001 does.

--> ...2) We currently require that the item be calibrated to meet
--> manufacturer's specifications and that it be traceable to a national
--> standard such as NIST. The auditor felt that this does not go far
--> enough and wanted to see a requirement that the calibration is done
--> to a standard such as Guide 25, MIL Std 45662A or ANSI Z540.

Again, in my opinion, you are being held to the QS requirement. But again, this is becoming the norm. I should point out that QS9000 postponed requirement of QS9000 registered companies to use guide 25 compliant labs as there weren't enough labs out there qualified. No - I don't see where, other than as a customer requirement, this is required.

Remember we walk a thin wire - even ISO auditors sometimes cite in accordance with their interpretation as opposed to a 'Show Me' set of words from the requirement document.

--> I have read through MIL Std 45662A, Guide 25, ANSI/NCSL Z540 (1994),
--> and even ISO/DIS 17025 - they all seem to have the same requirements
--> and it seems to me that we are currently meeting those requirements.
-->
--> Any help that you can give us to clarify these items would be
--> greatly appreciated.

The bottom line on it all is this is 'the future' for calibration services suppliers:
Before and after data
Uncertainty
Guide 25 (or equivalent) supplier