Should we immediately have recalibrated our Digital Torque Gauge?

[Izoyd]

Our Lab Technician sent out a Digital Torque Gauge to an ISO 17025 accredited Lab to be calibrated. That lab then outsourced the calibration (without giving written notice to us per ISO 17025) to a secondary vendor, who it turns out was not ISO 17025 accredited. However, the secondary vendor was actually the manufacturer of the gauge.

The Lab Technician who received back the calibration results thought that since the OEM performed the calibration, that it shouldn't be a problem even if they were not ISO 17025 certified. The Lab Tech did not realize that per TS 16949, the OEM should only be used if an ISO 17025 lab could not be found.

We then received a finding at our last External TS 16949 Audit for not using an ISO 17025 lab for the calibration.

However, my question now, is should we have immediately re-calibrated the gauge by an ISO 17025 lab?

Our thinking is that in moving forward, we will most certainly ensure gauges (outsourced or not) will be calibrated by an ISO 17025 lab. However, we did not have additional money in the budget for the re-calibration right then, and since the manufacturer actually calibrated the gauge, it's not like the calibration results were invalid.

What are your thoughts? I would appreciate the help!

 

[AndyN]

Re: Should we immediately have recalibrated our gauge?

Is this a Torque Gauge or a torque wrench? If it's a setting master gauge, then it's a simple finding to fix, "don't do it next time" - BTW, I thought an accredited lab was supposed to tell you if it was sub-contracted...

If the results came back from the OEM and have all the information you need to decide if the item is within spec, I wouldn't worry. It's only the same as if it was a new item anyways.

 

[rsimano]

Re: Should we immediately have recalibrated our gauge?

We then received a finding at our last External TS 16949 Audit for not using an ISO 17025 lab for the calibration.

Has a response been issued to the audit finding? Or is the response still pending?
If response was done and accepted. Did the response indicate you sending the item back out for recalibration? Or issue a PCAR to your vendor?
Accepted response to the audit findings may indicate what needs to be done now or in the future to resolve the issue.

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: If you have not done yet. You could issue a CAR to your calibration vendor and see if they request you send the Digital Torque Gauge back to them for recalibration.
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[Ninja]

Re: Should we immediately have recalibrated our gauge?

... That lab then outsourced the calibration (without giving written notice to us per ISO 17025) to a secondary vendor, who it turns out was not ISO 17025 accredited.

Have you pushed back on the lab yet? There are a couple breakdowns here. Thiers for dropping the ball, yours for not catching it.

My first look would not be at my budget to see if I could pay for it again...it would be at the lab for not doing what I paid them for.

I can't comment on 17025 at all, I don't live in that world. But it looks to me like they didn't fill your order with acceptable goods or services yet.

 

[Kales Veggie]

Re: Should we immediately have recalibrated our gauge?

Our Lab Technician sent out a Digital Torque Gauge to an ISO 17025 accredited Lab to be calibrated. That lab then outsourced the calibration (without giving written notice to us per ISO 17025) to a secondary vendor, who it turns out was not ISO 17025 accredited. However, the secondary vendor was actually the manufacturer of the gauge <snip>

To answer your question: your ISO 17025 lab should pay for recalibration. They made the mistake of not telling you what they did.

Lets take a step back:

Note 2 under 7.6.3.2 states that a manufacturer may calibrate a piece a equipment if they meet 7.6.3.1 (internal lab. requirements) if a qualified lab. is not available.

So, the 1st question: if a qualified lab available for this equipment? So, if your and the 17025 lab research shows there is not, it is OK to use the manufacturer. The 17025 lab and you must then determine if the manufacturer meets 7.6.3.1 requirement (such as scope, procedures, traceable). If the manufacturer meets this requirement, there is no problem.

My conclusion is that you CAN use manufacturers to calibrate equipment, but you have to do your homework before you do.

Another item you should look at: when equipment is sent out for calibration, make sure the calibration of that equipment falls inside the scope of the 17025 lab.

 

[qusys]

Our Lab Technician sent out a Digital Torque Gauge to an ISO 17025 accredited Lab to be calibrated. That lab then outsourced the calibration (without giving written notice to us per ISO 17025) to a secondary vendor, who it turns out was not ISO 17025 accredited. However, the secondary vendor was actually the manufacturer of the gauge.

The Lab Technician who received back the calibration results thought that since the OEM performed the calibration, that it shouldn't be a problem even if they were not ISO 17025 certified. The Lab Tech did not realize that per TS 16949, the OEM should only be used if an ISO 17025 lab could not be found.

We then received a finding at our last External TS 16949 Audit for not using an ISO 17025 lab for the calibration.

However, my question now, is should we have immediately re-calibrated the gauge by an ISO 17025 lab?

Our thinking is that in moving forward, we will most certainly ensure gauges (outsourced or not) will be calibrated by an ISO 17025 lab. However, we did not have additional money in the budget for the re-calibration right then, and since the manufacturer actually calibrated the gauge, it's not like the calibration results were invalid.

What are your thoughts? I would appreciate the help!

Hope that you have disqualify this ISO 17025 Lan due to not having met your requirements too.
Besides, from your side , it seems strange to me that you have paid a service to a 17025 Lab that in reality it has been done by another Lab ( even though vendor). What was the stamp on the certificate of calibratrion? The one of 17025 one or the one of vendor Lab? Were the acceptance criteria in incoming the gauge, that you have externally calibrated , met? How do you proceed for this? I think that the issue is very tricky and complex, given that it could put in jeopardy also the other calibrations that the 17025 has done for you. I am very cuirious which kind of corrective action you have put in place here, if possible.