ISO 9001 vs Procedure

[Big Jim]

This is a very good point and I agree with this.

In a different circumstance, we as a calibration team, provide a master list of all the instruments being calibrated internally/externally and are stable.
However, with a particular customer, they pull-out their own instrument and replace it with other spare instruments which messes up the Master list. They do this in a very frequent manner (almost 10-15 instruments per week are replaced) and there is no assurance that the instrument they pulled out will ever be returned.

I am looking for a way to exclude them in our Master list since our Test Engineers with direct contact with that customer have their very own Master list of instruments for that account and the control of calibrating the instrument already belongs to the Customer even in their financial budgets for calibration. Would this still satisfy 7.1.5? Provided that the Test Engineers have the Calibration Certificates.

List them separately and REQUIRE that your customer provide a record of the calibration along with the tool.

 

[Calibrationian]

List them separately and REQUIRE that your customer provide a record of the calibration along with the tool.

I guess there's no other way around...
This has been very helpful. Thanks!

 

[ChrisM]

For your own protection you should surely be keeping a list of instrument serial numbers and dates in and out of your company. Supposing there were an allegation of theft, for example, wouldn't you want records to show that the instrument was not on your premises when it went missing? This is over and above and quality-related issues that you may need to keep records for, eg instrument fails calibration, which pieces of equipment did you measure with it? (I hope you are recording serial numbers when you set up/calibrate assemblies/complete devices using these items of equipment.....)

 

[Calibrationian]

For your own protection you should surely be keeping a list of instrument serial numbers and dates in and out of your company. Supposing there were an allegation of theft, for example, wouldn't you want records to show that the instrument was not on your premises when it went missing? This is over and above and quality-related issues that you may need to keep records for, eg instrument fails calibration, which pieces of equipment did you measure with it? (I hope you are recording serial numbers when you set up/calibrate assemblies/complete devices using these items of equipment.....)

Our test support group handles the records and all instruments going in and out by the customer are documented via e-mail, and as I have mentioned before, we do not conduct the calibration. We are also included in the loop when exchanging instruments.

Anyway, appreciate the response and concern Sir.

 

[dwperron]

Our test support group handles the records and all instruments going in and out by the customer are documented via e-mail, and as I have mentioned before, we do not conduct the calibration. We are also included in the loop when exchanging instruments.

Anyway, appreciate the response and concern Sir.

What we do here in similar cases is to consider your customer to be just another third party calibration source. That way you can treat those instruments just like all the others that get sent out for calibration. Your recall database will show what instruments left your facility, when they left, when they got back, calibration results, etc. They will look like your other tools in the recall system.

It will be a pain in dealing with instruments that leave but do not come back as far as traceability goes (did your customer's calibration find Out of Tolerance results that need to be investigated for impact?). I would try to have them provide calibration results for everything they take from you to close that gap.

 

[Calibrationian]

What we do here in similar cases is to consider your customer to be just another third party calibration source. That way you can treat those instruments just like all the others that get sent out for calibration. Your recall database will show what instruments left your facility, when they left, when they got back, calibration results, etc. They will look like your other tools in the recall system.

It will be a pain in dealing with instruments that leave but do not come back as far as traceability goes (did your customer's calibration find Out of Tolerance results that need to be investigated for impact?). I would try to have them provide calibration results for everything they take from you to close that gap.

Our customer sometimes do not simply return the instruments. They just replace them with other instruments. As for their unreturned instrument status, we are not notified if they are out of tolerance. They are also endorsed to their other "assembly" companies to use.

 

[Big Jim]

You have a problem. A legitimate nonconformance could be written by your registrar against your organization for not being able to determine if the equipment is out of tolerance. You need a serious conversation with your customer and come to workable terms before that happens.

 

[dwperron]

You have a problem. A legitimate nonconformance could be written by your registrar against your organization for not being able to determine if the equipment is out of tolerance. You need a serious conversation with your customer and come to workable terms before that happens.

Big Jim is absolutely right.
If you don't know the equipment is out of tolerance when you are done using it then you have no clue how that could impact your products and processes.
This is like people who buy replacement equipment instead of getting it calibrated.
You might as well just stop calibrating your stuff, you end up with the same result: you don't know if you are using good, accurate equipment.

 

[Calibrationian]

You have a problem. A legitimate nonconformance could be written by your registrar against your organization for not being able to determine if the equipment is out of tolerance. You need a serious conversation with your customer and come to workable terms before that happens.

Big Jim is absolutely right.
If you don't know the equipment is out of tolerance when you are done using it then you have no clue how that could impact your products and processes.
This is like people who buy replacement equipment instead of getting it calibrated.
You might as well just stop calibrating your stuff, you end up with the same result: you don't know if you are using good, accurate equipment.

As much as this are true, I may have caused a misunderstanding. Out of tolerance equipment are not coordinated with us but directly to the Test Engineers and the Production personnels, but simply not coordinated with us since we are not exactly the user of the instruments.

In this matter i agree with Sir dwperron to treat them as third party calibration partners, which endorses the calibration certificate along with the calibrated instrument.
After endorsing their expiring instruments, they are calibrated at their (Customer's) own facility but are endorsed totheir other departments/branches... That is why they are not exactly expected to return.