Calibration Purchasing Information - TS 16949 Audit Finding

#1
I have an ISO/TS16949 audit finding regarding the Purchasing Information as regards the purchase of calibration services. I am using an external laboratory to calibrate electronic (e.g. Fluke meters) and mechanical (e.g. torque wrenches). Apparently, my Purchase Orders do not contain enough information to specify this service.

Does anyone out there have some bullet-proof language for purchasing this kind of calibration service in an ISO/TS 16949 system.

Here's my first pass:

  • Calibration or verification to manufacturer's specifications for the attached equipment list, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
  • Supplier shall supply calibration record for each piece of equipment in any form or type of medium;
  • Supplier shall identify the the equipment to allow the calibration status to be determined (e.g. via calibration sticker or reference to Model and Serial Number).
  • Supplier shall apply safeguards to prevent adjustments that would invalidate the measurement results.
  • Supplier shall supply notification of any equipment found out of tolerance and provide as-found as-left data for such equipment.
  • Supplier shall be third party registered as meeting the requirements of ISO 9001:2000 with the scope of calibration, repair, and testing of process instruments and equipment, measuring instruments and equipment, and test equipment.
  • Supplier shall be accredited to ISO / IEC 17025:1999 by A2LA with a scope including the required measurements.
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: Calibration Purchasing Information

Icy Mountain said:
  • Supplier shall be accredited to ISO / IEC 17025:1999 by A2LA with a scope including the required measurements.
Two thoughts here.........

Modify this to ISO/IEC 17025:2005

and modify to read a signatory to the ILAC MRA, rather than just A2LA.....after all, there are five ILAC bodies in the U.S., and three in Canada.....
 
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#4
Re: Calibration Purchasing Information

Modify this to ISO/IEC 17025:2005
Duh!:bonk:
and modify to read a signatory to the ILAC MRA, rather than just A2LA.....after all, there are five ILAC bodies in the U.S., and three in Canada.....
Good idea.
Otherwise, Hershal, does that look good? Would you accept that as an auditor?
Do you use blanket P.O.s?
Not for service type PO's, usually. This is one of those easy findings that I missed because I don't have the NUPIC guys breathing down my back. When you are doing TS PPAP or Calibration, your labs have to be 17025 (or acceptable to the customer, don't get started), so all of this is kind of redundant. We picked up a nit-picky auditor when the lead changed over for our re-cert.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: Calibration Purchasing Information

Maybe you should consider leaving the edition of the standards out of the PO requirements.

I mean, just stipulate ISO/IEC 17025, instead of ISO/IEC 17025:2005. After all, the document will get revised sometime in the future, just like ISO 9001 is being revised this year.

Since you are TS-16949 certified, you are expected to flow down ISO 9001 to your supplier base, but if I were your auditor, I would think that, for a calibration lab service provider, reputable accreditation to ISO/IEC 17025 makes more sense than certification to ISO 9001. Even 17025 states that in it's introduction page. And paragraph 1.6 of 17025 also state that, if a lab complies with 17025, they operate a QMS that also meets the principles of ISO 9001.

You can require accredited certification of the lab to ISO 9001, in addition to the 17025 accreditation, but would you be limiting your choices, then?

And if you are going to impose ILAC to the supplier's 17025 accreditation, you should also impose IAF-signatory accreditation for your suppliers ISO 9001 certification....
 
#6
Re: Calibration Purchasing Information

You can require accredited certification of the lab to ISO 9001, in addition to the 17025 accreditation, but would you be limiting your choices, then?
Good points all, Sidney. I have one calibration supplier and I am aiming this specifically at them so it's not really limiting. However, the more generic the better.
And if you are going to impose ILAC to the supplier's 17025 accreditation, you should also impose IAF-signatory accreditation for your suppliers ISO 9001 certification....
Where I sit now, it may come to that. Fortunately, I have a current waiver from my single TS customer for the ISO9001 supplier requirement.
 
#7
Final Language

This is the text for a standard Purchase Order for calibration of our equipment. This was reviewed and accepted by our external auditor.

Calibration or verification to manufacturer's specifications for the attached equipment list, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
Supplier shall supply calibration record for each piece of equipment in any form or type of medium.
Supplier shall identify the the equipment to allow the calibration status to be determined (e.g. via calibration sticker or reference to Model and Serial Number).
Supplier shall apply safeguards to prevent adjustments that would invalidate the measurement results.
Supplier shall supply notification of any equipment found out of tolerance and provide as-found as-left data for such equipment.
Supplier shall be third party registered as meeting the requirements of ISO 9001 with the scope of calibration, repair, and testing of process instruments and equipment, measuring instruments and equipment, and test equipment.
Supplier shall be accredited to ISO/IEC 17025
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
One or two other thoughts.....

Specify the calibration interval in your P.O.s, as the cal lab can SUGGEST intervals but is not allowed to ESTABLISH intervals except for their own equipment, as specified under Clause 5.10

Also, something I used to build into bid specs which you may not be able to do at this point, is to have the certs available to you within 5 working days (on-line counted as available), or charge them $5 per cert. I only had to use that provision once.

Hope this helps.
 
#9
What is the wording of the nc? Just because you were 'written' up for this, doesn't mean it was valid!

Can you post the content of the nc so we can see what to address in our answers?

Thanks!
 
#10
Andy,
When you have been running a certified system for 3 years, the validity of any finding can be debated vigorously.

7.4.2 Purchasing information
Requirement: Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
Failure: Purchasing information does not always describe the product or service to be purchased.
Evidence:
1) Purchase order 123 to Joe's Electronics for calibration does not include requirements for a calibration record, traceability, label, accuracy, tolerances and notification of out of tolerance conditions.

Previous auditors have come to the conclusion that:
We have contracted a 17025 accredited company
We have complete and correct calibration records for every single serial number
We don't have any customer returns or complaints based on faulty measurements.
Therefore, this kind of finding would be pushing the envelope for validity.

However, I know from long experience that if an auditor is bound and determined to write a certain number of findings, and they are coming up dry, that they will hit three areas, throw sampling out the window, and go through everything until they find something:
Purchasing Information (specifically contracted service POs)
Control of Monitoring and Measuring Devices
Control of Documents

I count myself lucky that my Document Control system passed the scrutiny without a finding.
 
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