Calibration System was In-House now Outside (External Service Provider)

D

D.Scott

#11
Sorry to jump in late on this but I am a little confused.

You say your internal calibrations are being done by this "new business" but they are using your procedures and won't accept responsibility for their work because they aren't certified yet.

I understand they are no longer employees but are they doing the work in your building? Are they using your standards? Are they maintaining the calibration records of your company? If they are not taking the work off site and they are not providing certificates of calibration, are they not just contract workers in your facility?

Do you still send your standards to an accredited lab for calibration and maintain records of traceability to NIST?

My point here is to suggest that even though the personnel performing the calibrations are contracted, you are still complying with the calibration and internal lab requirements of the standard (both ISO 9001 and TS 16949).

You would, of course, need to demonstrate the competence of the contract workers. Presumably the use of temporary contract workers is already covered somewhere in a procedure or policy.

Just a thought.

Dave
 
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S

StanH - 2009

#12
They are not doing work in our building, they actually have building next door. They are using our standards updating our cal cert records (word doc form) & forwarding them to us for entry in our system.

They send gold standard equipment out for calibration to keep traceability to NIST standards.

I think as long as our procedure states an ourside source is doing calibration in some wording will cover us. I am just trying to figure out now what to remove and update in the procedure relating to in-house calibration, which has decreased drasticly.

Everyone has given me some great advice I think I know which way to head now.
 
#13
It appears to be a very informal situation that your management have caused to happen. As such, until they fully understand the risk (not simply of another 'major') of not having confidence in what this supplier is doing (it even applies when they were in-house, of course) they are unlikely to allow you or anyone to change much. I'd be finding the data to identify the risks ($$$ or your local currency) that are faced by doing calibrations like this. The accreditation is a nice to have, but management who make these types of decisions are clearly not worried by a certificate.

But then, they may not see much of a risk in their decisions, either...........
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#14
StanH,

You have several potential solutions to your challenges......

First, keep them as an external provider and treat them as such. Have them sign a contract so if they use your procedures and records, they "rent" them (likely just give a discount, but works out the same). Otherwise, since you mentioned FCC, have them join GIDEP to obtain procedures.

Second, call it an internal "contract staffed" lab, which means you still own the space, standards, procedures and so on, but they provide the people and experience.

In the contract you have them sign, make sure you put in a requirement that they obtain accreditation from an ILAC signatory body (don't just say something like "A2LA or NVLAP") and then even help them shop all five ABs here in the U.S. prior to selecting one.

WATCH TRACEABILITY!!!!!!! That is a hang-up.....for the calibrations they provide, they must provide you or have quickly available the measurement uncertainty of that calibration or type of calibration. If you do not have uncertainty available you do NOT have traceability! Also, the traceability chain requires documentation showing the next link up. In other words, an unbroken chain of comparisons to National or international standards with stated uncertainties at each step. Oh, and the traceability chain (not knowing your equipment) may/may not run through NIST; perhaps someone like NRC (Canada).

Validation of procedures could be an issue, if they wrote the procedures. Validate them, don't wait and see, get the evidence of validation on file so you have it before you need it.

Records are always an issue, so check the records yourself and have your internal auditor check them since they are basically running your lab, in spite of the terms considered thus far.

Hope this helps.
 

Helmut Jilling

Auditor / Consultant
#15
They are not doing work in our building, they actually have building next door. They are using our standards updating our cal cert records (word doc form) & forwarding them to us for entry in our system.

They send gold standard equipment out for calibration to keep traceability to NIST standards.

I think as long as our procedure states an ourside source is doing calibration in some wording will cover us. I am just trying to figure out now what to remove and update in the procedure relating to in-house calibration, which has decreased drasticly.

Everyone has given me some great advice I think I know which way to head now.
If they were former employees, and were competent to do this work, and continue to use your standards and such, it might make sense to class them as contract employees and seek a solution in that fashion. Nowadays, employees, temps, independent employees...there are all sorts of payroll approaches. Who knows, pretty soon GM might have just independent assembly contractors working onsite.
 
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