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Calibration Procedures - ISO/IEC 17025, Clause 5.5.9 - Outsourced Calibration

T

Tom from Clayton

#1
Requires that both the function and calibration status of equipment sent out for calibration be checked per a defined procedure and the results be recorded.

Considering we just sent sent out various types of instruments and equipment out to have that very thing done for us, by an A2LA accredited company, by the way, what does the group think this requirement means? I'm thinking I would rather not do a mini calibration on every pipette and timer we have calibrated.

Tom from Clayton
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
You don't 'recheck' them when they come back, and the calibration laboratory is supposed to have procedures applicable to the instrument/device they are calibrating. You have to tell the laboratory what you want. For example, some laboratories charge more if you want a copy of the pre- and post- data, for example.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Yes, the laboratory must record results and per the requirements of Clause 4.13.2 (and sub-Clauses) must be applicable to specific tests or calibrations.

However, if you need the results and you should get the uncertainty, you may well have to pay extra for it.
 
T

Tom from Clayton

#4
In A2LA's November newsletter the question presented was "Does the requirement in Section 5.5.9 of ISO 17025 apply to equipment that has been sent out for calibration?"

The response from A2LA was: "Yes. When equipment is returned from being calibrated, the lab is responsible for performing a check per a defined procedure and recording the results of that check...."

Section 5.5.9 requires the function and calibration status of the equpment be checked. My calibration person is going beserk and if i knew how to spell apolpletic I would also use that word to describe how she feels.

This is a case of checking the checker but the checker is an accredited calibration lab and I am not.

Tom from Clayton
 

BradM

Staff member
Admin
#5
Hello, Tom!

In essence, you are correct about the perceived approach and your frustration within. :D

Remember, the procedures are about establishing policies and processes; not about dictating specific steps to take.

I have spent many an hour with the technicians I work with on this, getting them to understand the value for this check.

IMHO, the clause is less about checking the checker. Pipettes are sent off for calibration, pistons changed, etc. The check you are being asked to do is less about checking the calibration performed, and more about verifying that nothing has changed with the device during the time it was calibrated and the pipette ending back on the bench.

First, I would suggest you develop procedures for establishing a process that is in control. Check several pipettes first, then back off on the number of verifications and the number of test points. E1154 and the ISO spec both cover this concept.

Next, I would think you would want to check pipettes every now and then anyway, especially with repeatibility/reliability checks between operators; a huge source of error.

My interpretation of that clause in 17025 is more about mitigating risks involved with standards; equipment sent out for calibration to be used for calibration. One does not want to get back a standard thermometer, check 200 instruments, then discover something strange happened when it was first sent back to you.:)

I would start with developing processes that even though you send them out for calibration, that the devices still produce reliable, consistent readings with the different environments/ operators that are present.
 
T

Tom from Clayton

#6
Thanks, Brad. Our processes include checks to ensure everything is in control and if out of control although they would not specifically point to pipettors, they would indicate a problem that would have to be corrected.

Our issue was.... well it really doesn't matter because you have cleared things up nicely. We currently examine returned items fairly thoroughly to ensure they have been calibrated correctly but our written procedure was a little weak. We consider this correction to be an opportunity for improvement.

Thanks again all.

Tom from Clayton
 
S

stenna10

#7
Hi,
it is recommended that they be calibrated at both a low point and a higher reference point. For convenience, most manufacturers have selected 75% and 33% RH as the default calibration standards. So, to calibrate your instruments, you need to be able to place the device in our own custom "humidity chamber".
Always give an instrument some time to stabilize, after moving it from one humidity chamber to another. This is the most accurate way for you to calibrate an instrument, if it can be done this way. The readings stay more stable than they do when a plastic bag is used: If a bag is inadvertently compressed or the contents shifted, which is likely to happen if you have to calibrate the instrument instead of merely viewing it, stability of the humidity chamber is affected and that can result in calibration errors. As a result, that process must be performed cautiously and double-checked.
 
S

stenna10

#8
HI,
You need not to. Nowadays manufacturers will often use a thermostat bath or solid block where the temperature is held constant relative to a calibrated instrument. Other instruments to be calibrated are put into the same bath or block and allowed to come to equilibrium, then the scale marked, or any deviation from the instrument scale recorded. For many modern devices calibration will be stating some value to be used in processing an electronic signal to convert it to a temperature.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
Given the information subsequent to my last note, this is an easy fix.

Pipeetes: Are they cracked? Do they leak? Do you have a cert with the A2LA logo and uncertainty? Document that the returns were checked, make sure the record is controlled per Clause 4.13. Process under Clause 5.5.9 complete.

For other things, take similar simple approaches. Put that into the procedure, train your folks and document it.

That should be all you need to do.

Hope this helps.
 
D

dv8shane

#10
Tom,

I operate a laboratory under an ISO17025 and AS9100B QMS. From my interpretation both quality systems require that I record at least the functionality for items I can not calibrate that need to be sent out and when standards are sent out, a series of readings are to be taken for outgoing and incoming within the capabilities of the organization. These provide a chance to view if any major changes have occurred during shipping or service. In fact everytime I take a unit out for a field calibration it must tested before and after to ensure that nothing has shifted, as part of the AS9100 control of service provision and to fulfill the requirements of 17025 5.5.9

Shane
 
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