Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed?

[duff999]

Does every piece of equipment used in the lab need to have an IQ (installation qualification) protocol written and executed? Would this include hand tools such as micrometers, calipers, etc. Can recent calibration services performed cover the IQ portion. Also, if no IQ was every performed on any of the equipment do you suggest performing the IQ.

thanks

 

[yodon]

All equipment should be appropriately qualified. It's your responsibility to define (and defend) what's appropriate.

Calibration is not qualification. Calibration is about accuracy; qualification is about appropriateness. Part of qualification may be calibration but not all.

 

[duff999]

All equipment should be appropriately qualified. It's your responsibility to define (and defend) what's appropriate.

Calibration is not qualification. Calibration is about accuracy; qualification is about appropriateness. Part of qualification may be calibration but not all.

Thanks of always being a wealth of knowledge in answering my questions. I am circling back with calibration and qualification, for pipettes specifically. I understand that calibration can be part of the qualification process, do you have any experience with what other than calibration can satisfy IQ, OQ of a pipette. During calibration they measure accuracy, and perform operational tests. Would I need any more than that to defend that things are installed and operational. Thanks

 

[yodon]

I don't have any experience with pipettes. Maybe someone can chime in here?

 

[Tidge]

I am circling back with calibration and qualification, for pipettes specifically. I understand that calibration can be part of the qualification process, do you have any experience with what other than calibration can satisfy IQ, OQ of a pipette. During calibration they measure accuracy, and perform operational tests. Would I need any more than that to defend that things are installed and operational. Thanks

Consumable lab tools like pipettes shouldn't need much more in an "IQ" other than identification of the specific type pipette used, and storage conditions established.

I would totally pass on an individualized OQ, assuming that you implement a standard method of reading the measurements of specific pipettes you use. ASTM may have such a standard, or there may be another recognized technical society.

As far as "PQ", I can foresee two possible approaches:

1. A typical "run through the standard process with standard variation from raw materials, operators." using your manufacturing/test procedures
2. Some sort of round-robin testing of pipette usage against the (ASTM?) standard

My first PQ suggestion is IMO more valuable, as you can leverage/inform control charts for your standard process. The second is only recommended if there is some variability (attributed specifically to the use of the pipettes) that you want to analyze, or are otherwise required to monitor/control.

 

[ntecwood0215]

If you have an IQ OQ PQ based process already then the IQ on these hand tools could simply be a check for suitability. E.g. Range, calibration status, damage and included in the lab asset register with recal dates. If you don’t have a prescriptive process you can do the same and call it a “hand tool introduction process” and include some of the PQ suggestions above

 

[Mhalik]

Hello, in the last company I worked in, I defined a differently approach depending if it was an equipment or measuring device.
For what we called equipment, we automatically performed IQ and OQ of the equipment, and then if it was a special process we would add OQ and PQ of the process.
In another hand, for the measuring devices we only performed verification/calibration and metrology follow up (life sheet, identification, planning) .
Note that complex test benches were part of "equipment" : we had the IQ/OQ of the equipment + PQ (Gage R&R)

Our notified body was OK with this approach for ISO 13485 and CE mark, but it was never submitted for FDA audit

I never had pipette in our production area but I think I would have treated them following our "measuring device" approach