TS 16949 - A2LA or ISO/IEC 17025 required for material testing?

[QMMike]

Hello Cover's

I'm having some of our materials tested and had this thought....

Normally I send raw materials from our suppliers to an outside lab (Smither's or ARDL - both A2LA or ISO/IEC 17025 accredited) which costs us a substantial amount of money when having all our compounds tested - I know we should look into charging this back to our supplier but bear with me........

Here is my thought -

We are a TS16949:2009 registered company and have been registered to TS almost since the standard was published. In regards to laboratories, all outside labs are required to be ISO/IEC 17025 registered or national equivalent. However, I have a temperature controller that we use internally to calibrate thermo-couples. This temperature controller I send back to the manufacturer for calibration of the unit. The manufacturer does not have a registered lab but since they are the OEM of the unit, their certifying it was enough evidence to satisfy our requirement. I think it is mainly accepted because of 7.6.3.1 of TS16949:2009 - "NOTE - Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory to conformity to this requirement but is not mandatory". Since they are qualifying their own equipment in their own internal lab - it's allowed.

Which made me think -
Only one of our material suppliers have an A2LA lab, theirs is a no brainer. I could call them up and have them test their own materials and supply a cert. What about our other material suppliers? Since they are the OEM of the material, as is the case with my temperature controller, would this be evidence enough?

 

[George Weiss]

Re: A2LA or ISO/IEC 17025 required or not in this case

There was a time, (pre-2005),when the original manufacturer was the best place to take your equipment. It was the first course suggested. Then 17025 became required in some situations. If there was no source for 17025 then the original manufacturer was accepted by A2LA for their Z540 etc. calibration. Today A2LA has pressed for any source for 17025 over the original manufacturer of equipment, if said manufacturer could not produce 17025 level calibration. This has had the effect of some late increases to 17025 by some manufacturers in some areas of scope. In short, I would ask A2LA for your specific issue, but generally you are expected to get the equipment calibrated to 17025, and that would mean not your original equipment source.
A temperature controller calibration is generally a DCmV stimulus calibration, with various calibrator manufacturer sources. Having an onsite service by a local facility would be an easy effort. A service for such an item would range from $200-$400 depending on number of channels, recording features and etc. Specifying your calibration requirements sometimes develops a more effective calibration. There is a large window of acceptable 17025 calibration specifics, subject to customer/cal-lab agreement.
Limited scope 17025 Calibrations: Are process lean/cost-effective. If you only need the temperature feature 17025 calibrated, for use in your process, then the humidity feature can be Z540 w/o data, and be acceptable.
Demonstrating conformity means having it done 17025 or doing it 17025. The manner can be add-hock, but add up to 17025.
17025 is flexable to actual needs, in this case being TS 16949.
You have options.

 

[QMMike]

Re: A2LA or ISO/IEC 17025 required or not in this case

Thanks for the response George. I'm good with the temperature controller, but my question concerns the testing of my raw materials to an ASTM standard (my thoughts in my head were clear - how they translated onto the post was clear.... as mud )....

I was thinking that since sending my temperature controller back to the OEM was acceptable - under that same principle, sending raw material back to the OEM be just as acceptable?

 

[George Weiss]

Re: A2LA or ISO/IEC 17025 required or not in this case

You are in the FDA kingdom I believe.
I offer:
I am in the same posture with either case. outside support is 17025.
I would view the following as direction also:
referenced @
http://www.askartsolutions.com/ts16949/Control-Of-MMD.html
7.6.3.2 External/commercial/independent Labs (raw material suppliers/testing labs also)
Where you use an external, commercial or independent laboratory for inspection, test or calibration services, it shall have a defined laboratory scope that includes its capability to perform the inspection, test or calibration services you require.
The costs of an FDA "FIX" are always higher than prudent process course.

 

[bazboy]

Re: A2LA or ISO/IEC 17025 required or not in this case

You could conduct an audit on the supplier to ensure they are complying with your agreement/contract.

 

[howste]

Re: A2LA or ISO/IEC 17025 required or not in this case

<snip> The manufacturer does not have a registered lab but since they are the OEM of the unit, their certifying it was enough evidence to satisfy our requirement. I think it is mainly accepted because of 7.6.3.1 of TS16949:2009 - "NOTE - Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory to conformity to this requirement but is not mandatory". Since they are qualifying their own equipment in their own internal lab - it's allowed.

Which made me think -
Only one of our material suppliers have an A2LA lab, theirs is a no brainer. I could call them up and have them test their own materials and supply a cert. What about our other material suppliers? Since they are the OEM of the material, as is the case with my temperature controller, would this be evidence enough?

Hi Mike. Sorry for the late response, but I just ran across this thread today. I have to disagree with your argument above. The relevant requirement in the standard is 7.6.3.2, not 7.6.3.1. It states:

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either
- there shall be evidence that the external laboratory is acceptable to the customer, or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.

Note 2 only applies to calibration, and there is no equivalent statement for material testing. Also the use of an unaccredited OEM is only allowed when an ISO 17025 accredited lab isn't available or the customer(s) approve the lab.

 

[Ron Rompen]

An interesting thread to come across, since I just completed an audit where something touching on this was the subject of an OFI.

We require our suppliers (eg steel coil) to PPAP their products to us, and then use that supplier certification in our PPAP submission to our customer. The supplier is registered to TS 16949.

Our auditor questioned whether or not we had a copy of the suppliers lab scope which included the testing performed. I had never been asked this before, but it did raise the thought within our group.

If a supplier is TS registered, AND includes the testing in their lab scope, this would qualify them under 7.6.3.1, and there would be no reason to go to an external lab at all. The TS registration document would serve as evidence that (at some point) their lab scope had been assessed (by the registrars auditors) and found to be compliant.

Anyone else have any thoughts on this?