W
Question?
Our Third party registrar LRQA has stated that we (my company) must define
the acceptance criteria for all equipment, in other words, define the actual
criteria for the standards to be used to such as the tolerance on the gauge
blocks that is to be used to calibrate a micrometer.
4.11.2 Control procedures
The supplier shall: c) define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are
unsatisfactory;
We use an outside certified laboratory to perform our calibrations on items
such as scales, surface tables, and measuring instruments.
How are other companies doing this? I've never had to do this with DnV or ABS, is this just a LRQA requirement? I've always used a certified laboratory and placed their internal procedure on the purchase order, and
required that the out-of-tolerance be no more than 50% of the accuracy of the instrument without adjustment, (which is in our procedures and on the PO) and if out more than allowed by the instrument measuring accuracy the sub-contractor is required to report and state any adjustment they took and we will do all necessary corrective action inside to prevent our customers from receiving nonconforming
product. For those that want the response from LRQA let me know, "oh" Heck, I'll place it with this.
Regards
Wendell Goodson
LRQA's Response:
I have received your Email of today concerning LRQA's interpretation of
calibration controls.
I have not seen any paperwork from a visit to know the specifics but I can give
general comments, using a micrometer as an example.
1. You must define the acceptance criteria for the devices. We have seen
companies state the tolerances and method of calibrating, specifically call for
a specification (example ASTM) which gives method and tolerances or call for
another specification (such as your calibration lab's procedure which gives
method and tolerances).
2. If you accept a calibration lab's procedure and tolerances, you should have
a copy of it available to you to know what you are accepting. The tolerance
must be known as you accept the results of the external laboratory. You can
accept the work of the lab not subcontract the acceptance of the results.
3. When found to be out of your defined tolerance, a documented assessment of
the validity of previous inspection and test results must be performed
(4.11.2.f).
I hope this helps a bit. I can not give consultancy but you will have my email
address on receipt of this message and with more information, I can possibly
clarify some issues. The phone number is 281-398-7370 ext 211.
Richard Gensmer
Operations Manager.
Our Third party registrar LRQA has stated that we (my company) must define
the acceptance criteria for all equipment, in other words, define the actual
criteria for the standards to be used to such as the tolerance on the gauge
blocks that is to be used to calibrate a micrometer.
4.11.2 Control procedures
The supplier shall: c) define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are
unsatisfactory;
We use an outside certified laboratory to perform our calibrations on items
such as scales, surface tables, and measuring instruments.
How are other companies doing this? I've never had to do this with DnV or ABS, is this just a LRQA requirement? I've always used a certified laboratory and placed their internal procedure on the purchase order, and
required that the out-of-tolerance be no more than 50% of the accuracy of the instrument without adjustment, (which is in our procedures and on the PO) and if out more than allowed by the instrument measuring accuracy the sub-contractor is required to report and state any adjustment they took and we will do all necessary corrective action inside to prevent our customers from receiving nonconforming
product. For those that want the response from LRQA let me know, "oh" Heck, I'll place it with this.
Regards
Wendell Goodson
LRQA's Response:
I have received your Email of today concerning LRQA's interpretation of
calibration controls.
I have not seen any paperwork from a visit to know the specifics but I can give
general comments, using a micrometer as an example.
1. You must define the acceptance criteria for the devices. We have seen
companies state the tolerances and method of calibrating, specifically call for
a specification (example ASTM) which gives method and tolerances or call for
another specification (such as your calibration lab's procedure which gives
method and tolerances).
2. If you accept a calibration lab's procedure and tolerances, you should have
a copy of it available to you to know what you are accepting. The tolerance
must be known as you accept the results of the external laboratory. You can
accept the work of the lab not subcontract the acceptance of the results.
3. When found to be out of your defined tolerance, a documented assessment of
the validity of previous inspection and test results must be performed
(4.11.2.f).
I hope this helps a bit. I can not give consultancy but you will have my email
address on receipt of this message and with more information, I can possibly
clarify some issues. The phone number is 281-398-7370 ext 211.
Richard Gensmer
Operations Manager.