7.6.3.2 External Lab - HELP!!

D

davidsb

New to TS; received third party non-conformance during surveillance audit because Lab we used to calibrate and did not have ISO17025 accreditation. As I dug into answering NC, I determined the following facts:

- External lab was the OEM of the equipment;
- No other lab could be found to do same calibration;
- Receive approval from all customers to use lab for calibration;
- External lab does not have a lab scope;
- All information required in a lab scope was found on calibration report

Short term, root cause, long term was approved by third party but rejected my objective evidence because they the calibration report I submitted in lieu of a lab scope was not a "controlled lab scope".

I really have no idea what to do next. The essence of what is required has been answered and put into place. Any suggestions on a direction would be most appreciated.

Thanks, Dave
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome to the Cove, congratulations on your first post!

Note 2 of TS 16949:2009, 7.6.3.2 says calibration services "may be" performed by OEM when no other accredited lab is able to do the work. The sub element goes on to say the 7.6.3.1 requirements "should" be met in this case.

Have you asked the OEM for documentation that would support this issue? I wonder if they have confronted such a request before.
 

Chennaiite

Never-say-die
Trusted Information Resource
New to TS; received third party non-conformance during surveillance audit because Lab we used to calibrate and did not have ISO17025 accreditation. As I dug into answering NC, I determined the following facts:

- External lab was the OEM of the equipment;
- No other lab could be found to do same calibration;
- Receive approval from all customers to use lab for calibration;
- External lab does not have a lab scope;
- All information required in a lab scope was found on calibration report

Short term, root cause, long term was approved by third party but rejected my objective evidence because they the calibration report I submitted in lieu of a lab scope was not a "controlled lab scope".

I really have no idea what to do next. The essence of what is required has been answered and put into place. Any suggestions on a direction would be most appreciated.

Thanks, Dave

I would suggest to make a visit to this Laboratory and audit them as per 7.6.3.1 and keep your records. Monopolies generally do not offer so much liberty to their Clients and therefore it might require quite an effort to make a visit or even to get them submit their documents. Also, I think your idea of receiving approvals from all Customers goes down well with ISO/TS requirement. If that be the case, I think the Auditor shall be contented with the evidence of approvals from Customer.
 
D

davidsb

Welcome to the Cove, congratulations on your first post!

Note 2 of TS 16949:2009, 7.6.3.2 says calibration services "may be" performed by OEM when no other accredited lab is able to do the work. The sub element goes on to say the 7.6.3.1 requirements "should" be met in this case.

Have you asked the OEM for documentation that would support this issue? I wonder if they have confronted such a request before.

Thank you for your response. I have been lurking on here for years and it only took me eight years to post. :D

I have asked the OEM, both by phone and e-mail and acted as if they had no clue was a Lab Scope was.
 
D

davidsb

I would suggest to make a visit to this Laboratory and audit them as per 7.6.3.1 and keep your records. Monopolies generally do not offer so much liberty to their Clients and therefore it might require quite an effort to make a visit or even to get them submit their documents. Also, I think your idea of receiving approvals from all Customers goes down well with ISO/TS requirement. If that be the case, I think the Auditor shall be contented with the evidence of approvals from Customer.

Thank you for your input, it is appreciated.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Thank you for your response. I have been lurking on here for years and it only took me eight years to post. :D

I have asked the OEM, both by phone and e-mail and acted as if they had no clue was a Lab Scope was.
You are so welcome.

I wonder if the person you talked to knows what this means? Examples include:

Salflex

Champion

(broken link removed)

I am not affiliated with any of the above.
 
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