Internal Calibration Process Suggestions

AmandaMusser

Quality Rules!
#1
Hello Covers!
I am in need of some suggestions regarding our internal calibration process.
We are an AS9100, ISO 9001, ISO 13485 & FDA certified/registered contract manufacturer of circuit board assemblies. For our calibration process, the majority of our eqpt is sent to an outside vendor for calibration. However, some eqpt is calibrated in-house by our Maintenance Technician.

1. We received the following finding from our Internal Audit "In review of the training record database for Vanguards Calibration Technician, Maint Tech has no record of any basic training associated with ISO 17025 or other calibration standards. Technical training for the oven calibration and pick/place equipment was listed as ?On the Job Training? only. Calibration records and certificates signed off by Mr. Tech cannot be accepted as authentic calibrations conducted by a calibration technician". In order to meet requirements, does our Maintenance Tech need to have training/certification in metrology or does OTJ experience meet this?

2. Calibration/validation/verification... our 1 tech is getting buried with all the eqpt that he calibrates, validates, verifies &/or performs PM on. Is it acceptable for him to train eqpt users to perform the validations &/or verifications and if a calibration is required, it is moved to him & he performs that part?

Thank you in advance!
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Re: Internal Calibration Process - Suggestions needed

I note you do not mention being accredited. However, the other standard most likely require that personnel be appropriately trained. In such instance, the internal audit finding is valid on its surface. At the very least, I would suggest acquiring a copy of The Metrology Handbook, available from ASQ. Then look to somewhere such as Workplace Training for distance learning in Metrology theory and basics.

Verification between calibrations can be done by users, but calibration truly should be by a trained and experienced professional. Two things to make sure of. The traceability must be documented establishing the link to your measurement standards. Additionally, uncertainty must be estimated. The metrological definition of traceability requires both of these, for traceability. Watch the so-called NIST number as generally it is NOT valid for traceability, as it is a work order number.

Training in ISO/IEC 17025 is desirable but for internal cal may not be needed. However, you should have the "Trilogy" documents there: ISO/IEC 17025, Guide to the Expression of Uncertainty in Measurement (GUM), and the international vocabulary of metrology (VIM) and you want the most recent edition. I think it is now designated JLDG200 but I don't have my copy in front of me.

Hope this helps.
 
Q

QualityEMW

#3
Re: Internal Calibration Process - Suggestions needed

we have had the same issue arise here, the solution for us was a documented procedure for calibrating an item with calibrated (by a lab) referenced in the Calibration record.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: Internal Calibration Process - Suggestions needed

I agree it is important to have these procedures, but I also favor the Handbook that Hershal recommends because it talks to technique, which is critically important to achieve consistent calibration results.
 

somashekar

Staff member
Super Moderator
#5
Re: Internal Calibration Process - Suggestions needed

I am not sure about the AS specific requirement, however following is important.
1. The documented procedure
2. The basis used for the calibration or verification.

Whoever is responsible for the in-house calibration must be competent by way of education / skill / experience which can be evident in the determined competency / training record.
There is no requirement of ISO 17025 or other calibration standards. This for me is just the auditor's own interpretation.
The need here is about the competency in knowing and performing per calibration procedures from the manufacturer of those specific equipment OR Basis used for verification, and availability of necessary infrastructure.
 
Last edited:

AmandaMusser

Quality Rules!
#6
Re: Internal Calibration Process - Suggestions needed

Thanks everyone!
I have now scheduled training for our technician. Better to be safe than sorry :)

I'm now looking at re-vamping our process to allow users to validate/verify equipment based on work instructions created by the technician. If needed, they would submit equipment to the technician for adjustments/calibration.
 

Mikishots

Trusted Information Resource
#7
Re: Internal Calibration Process - Suggestions needed

I am not sure about the AS specific requirement, however following is important.
1. The documented procedure
2. The basis used for the calibration or verification.

Whoever is responsible for the in-house calibration must be competent by way of education / skill / experience which can be evident in the determined competency / training record.
There is no requirement of ISO 17025 or other calibration standards. This for me is just the auditor's own interpretation.
The need here is about the competency in knowing and performing per calibration procedures from the manufacturer of those specific equipment OR Basis used for verification, and availability of necessary infrastructure.

I can help with the AS standard, if it helps others here. In additional to ISO 9001:2008, it requires:

1. A register of M&M equipment and a defined process for calibrating/verifying, including details of equipment type, unique ID, location, frequency of checks, check method and pass/fail criteria.

2. Environmental conditions must be suitable for the calibration, inspection, measurement and testing you do.

3. There must be a method (established, implemented, maintained) of notifying people to send in the devices that are due for calibration or verification (or at a minimum, a method of recall, irrespective of how you do it).

There is also a note added, which states that M&M equipment includes (but is not limited to) test hardware, test software, automated test equipment and plotters used to create inspection data. It also includes personally owned/customer supplied M&M equipment, if present.
 
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