I am updating our calibration procedure and I am trying to find proper way to label our responsible calibration person. Procedure currently refers to "outside vendor" and and "in house calibration test technician". That was fine when we had an outside vendor and cal test tech. What we have transformed to is we have all of our calibrations done by a former employee that works for a former owner of the company. The person performing the calibration is certified but not in an accredited lab. He has been performing duties basically as a outside/inside contractor. I want to change wording to say something like "our calibrations are done by a certified calibration technician" and thats all. Nothing is done in-house just by him in building next door. He does update our databases and certificates and uses our calibration standards under our quality policy. Is that vague enough to get us by and also not lead to any further questions?

I am updating our calibration procedure and I am trying to find proper way to label our responsible calibration person. Procedure currently refers to "outside vendor" and and "in house calibration test technician". That was fine when we had an outside vendor and cal test tech. What we have transformed to is we have all of our calibrations done by a former employee that works for a former owner of the company. The person performing the calibration is certified but not in an accredited lab. He has been performing duties basically as a outside/inside contractor. I want to change wording to say something like "our calibrations are done by a certified calibration technician" and thats all. Nothing is done in-house just by him in building next door. He does update our databases and certificates and uses our calibration standards under our quality policy. Is that vague enough to get us by and also not lead to any further questions?

Stan,

"Designated Calibration Technician" should do the trick. Maintain evidence of this person's competence.

John

Hello Stan!:bigwave:

The thing is.. what is "certified"? Could you possibly get yourself in another trouble-spot by having such specificity?:D

What about if in your procedures you state something like "performed by a qualified calibration technician, as specified byXXXX"

Then, you can have one procedure/form (XXXX) that specifies the qualifications that you desire at the time. For your current situation, you could specify a qualified source as an accredited lab, ASQ certified technician, a calibration technician with X years of experience, etc. You might could define your required experience levels for each category of instruments.

I'm just getting old and somewhat lazy.:tg::lol: I like my procedures to be just what is needed to get the task done, with no more specificity that is needed. If there is something specific and likely to change over time for the entire set of calibration procedures, I like putting that in one document, where I am only revising one instead of 80 for just one change.:2cents:

Do you think we need to keep copy of his certification on file? My concern is that we might get questioned about someone that is not an employee doing calibrations using our procedure/work instructions as a psuedo employee.

Hello, John. :bigwave:Glad to see you drop by.

Stan,

"Designated Calibration Technician" should do the trick. Maintain evidence of this person's competence.

John

Agreed. :yes: I like having a general phrase like this in all the procedures, and then in one place, defining (and maintaining evidence) of the qualifications.

(I was preparing my post while you posted).:tg:

Do you think we need to keep copy of his certification on file? My concern is that we might get questioned about someone that is not an employee doing calibrations using our procedure/work instructions as a psuedo employee.

Stan,

Yes, that certification if current would be contributory evidence of competence. I see no requirement for the Designated Calibration Technician to be an employee.

John

Do you think we need to keep copy of his certification on file? My concern is that we might get questioned about someone that is not an employee doing calibrations using our procedure/work instructions as a psuedo employee.

I would. As John mentioned, you want evidence of their qualifications. As to who is doing the work, to me it does not matter if they are an employee, contractor, big firm, etc.; you want to assure they are competent in doing their job.

Also, maintain evidence of this individual training on your procedures.

Just be able to show that the person is trained and competent.:)

:lol::lmao:

Ok, John... that's two for you and me! You're just a little quicker draw today than I!!:tg:

The problem previously was management felt we could leave procedure as is and kind of make believe this person still worked here. My thinking was we need to remove the "in-house" part and change to as you suggested "designated cal tech" so it would be catch all no matter who did the calibration and where. My thinking as well is less is better say what you need to say and let it be. Of course my former manager felt differently and it never got changed now there is new management I moved to new department and now we have recert audit in 1 week and I am only one left after layoffs with prior ISO audit experience and have been recruited to straighten everything out in a week.

The problem previously was management felt we could leave procedure as is and kind of make believe this person still worked here. My thinking was we need to remove the "in-house" part and change to as you suggested "designated cal tech" so it would be catch all no matter who did the calibration and where. My thinking as well is less is better say what you need to say and let it be. Of course my former manager felt differently and it never got changed now there is new management I moved to new department and now we have recert audit in 1 week and I am only one left after layoffs with prior ISO audit experience and have been recruited to straighten everything out in a week.

Stan,

It is good to read that you will be doing the right thing instead of glossing over the truth.

Good luck my friend,

John

Stan,

"Designated Calibration Technician" should do the trick. Maintain evidence of this person's competence.

John

For 9K that should be fine. Stay AWAY from calling him "Certified" unless he has CCT.

Hope this helps.

StanH, as for your last post...

Under 9K, you get quite a bit of flexibility in management of your calibration system, so some of what you have suggested should work. Keep it as outsourced and put his gentleman on your approved supplier list, and do NOT call him anything that may suggest internal or former employee or any of that.

9K does not require an accreditation fortunately for your situation.

That should allow some room to deflect auditor questions.

Hope this helps.

Hi Stan
In regulated industries (FDA & FAA), the regulators are not interested in who the calibrator works for, however they are extremely interested in what training and qualification they have.
In these industries you must have on file the training records for all personnel that carry out such tasks.
On regulatory inspections the inspectors will often ask for calibration certificates for critical instruments. Once they have the certificates they usually follow on and ask for the training records for the certificate signatories.
So it is mandatory throughout the industry that that you hold on file an up to date CV for all your contractors (and your own staff) involved in product related work.


Alex Kennedy
Validation Online

Thanks for the insight once again everyone has been very helpful. I need to check on approved vendor list and make sure his certificate is on file now since I just got it. We have full blown re-cert audit next week starting Monday and the newly appointed "Quality Manager" has been giving me a procedure to review almost hourly because he doesnt know what to do. We'll see how the priot week goes, wish I was on vacation next week.

PC Load letter? What the....

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