Can I Claim That Periodic Calibration is Not Required?

[Bob Sutton]

I've spent the last hour reviewing multiple threads related to calibration and am very impressed with the knowledge that is out there. This is my first posting. I have recently taken on the managing responsibilities for our company’s calibration program. We are a medical company. My question relates to the designation of "Periodic Calibration Not Required". If the device in question cannot be calibrated, would you designate it as PCNR or would it not be in the calibration system at all. I realize that basic tools don't go into the calibration system however, we make fixtures that are used during the process yet no aspect of the fixture can be calibrated. The previous mind set was that all fixtures should either be calibrated (if possible) or have a PCNR label. The justification is written up as: "No aspect of fixture can be calibrated".
In my opinion the first decision to be made is to determine if the device is truly Inspection, monitoring & measuring equipment. If answer is no, then device is not part of calibration program. Your thoughts on this would be greatly appreciated.

[Jim Wynne]

I'm having a hard time trying to imagine any sort of measurement device that can't be calibrated, unless you're saying that the things you're referring to can't be adjusted. "Calibration" is comparison of a device to a controlled standard, and may or may not involve adjustment. If you could give more information about the types of devices you're referring to, it would help.

[Bob Sutton]

Here is what was given to me.
Equip Description is:
"Delphin display Test Fixture for a Quantum Test Stand."

Justification for designation of Calibration Not Required is:
"The purpose of the Delphin Display test Ficture is to exercise a device under test against a variety of functional requirements. The active element of the fixture (power supply) is routinely cross-checked as part of the functional test process, but it cannot be individually calibrated. A failure of the test fixture would result in a functional test during routing production testing, which would identify the fixture as in need of repair".

Hope this helps. If there is something else you need to know or need clarified just let me know.

[Jim Wynne]

Originally Posted by Bob Sutton

Here is what was given to me.
Equip Description is:
"Delphin display Test Fixture for a Quantum Test Stand."

Justification for designation of Calibration Not Required is:
"The purpose of the Delphin Display test Ficture is to exercise a device under test against a variety of functional requirements. The active element of the fixture (power supply) is routinely cross-checked as part of the functional test process, but it cannot be individually calibrated. A failure of the test fixture would result in a functional test during routing production testing, which would identify the fixture as in need of repair".

Hope this helps. If there is something else you need to know or need clarified just let me know.

I don't know what the "Quantum Test Stand" is measuring or checking, other than "a variety of functional requirements." Perhaps someone else here might have some experience with this sort of thing that I lack, but given the information available I can't say whether there's anything that should be calibrated or not.

[Bob Sutton]

Jim,
I went to our manf floor and watched the fixture in use. First let me explain that a Quantum Test Stand is a functional test stand that we designed and built which is loaded with validated software. This is really a functional test stand used to test different components of the heart lung machine we build.
The Delphin display fixture is a fixture that was designed to hold a PC Band and digital display (PC board and digital display go together as one unti. The fixture is connected to the Quantum (functional) test stand and different test are run to ensure the display functions properly. The fixture itself consists of some electrical connectors, wires and an internal PC board.

[bobdoering]

Simple question: How do you know that the test stand is accurately passing good parts and failing bad parts?

Is it attribute pass/fail? Can you verify it with certified boundary samples?

Most important: is there any adjustment whatsoever on the device? If so, calibration (assuring the adjustments have not altered the ability of the device to correctly pass or fail product) would be necessary.

[Hershal]

Originally Posted by azaplas

Hi everyone,

I have a quick question about calibration labels.

In our surveillance audit, we received a "Sensitive Point" indicating:
"Some test equipments are not calibrated and not identified as 'calibration not required'".

Are there any standard/official formats for the "Calibration Not Required" labels? Must I purchase these labels from a company who makes them or may I use say a standard white mailing label and print out my own "Calibration Not Required" label?

Thanks!

You can make them yourself. Of greater significance is that you have a good reason to give Management and your auditor(s) regarding why it is CNR.