IQ/OQ/PQ of CNC Milling Machine

#1
Hi guys,

I'm trying to validate a CNC Milling Machine to make custom titanium implants. I just wanted to get some second opinions/constructive criticism on whether i'm on the right direction for each of the qualification processes since i've never really done one before.

IQ:
- Verify that we got all the documents from the manufacturer: Operating manual, Maintenance and calibration schedule, machine drawings
- Verify that the whole unit is installed according to the drawings or obtain a installation certificate
- Verify that subsystems and utilities are met
- Verify that environmental conditions are met

OQ:
- Verify that each components of the machine work: so verify that the control panel works, the tool bits can be change and spin
- Verify that safety doors, switch, alarm works
- Verify that SOPs and WIs are made for operating the machine so at least the drafts are completed.
- Verify that Maintenance and calibration of the machine has been in-cooperated into the company's calibration and maintenance program.
- Because the machine is designed to mill out custom product each time would i just verify that the machine can mill out a part as part of the OQ?
- Verify that the equipment used to measure the part made is calibrated. E.g a calibre

PQ:
- Verify that the equipment used to measure the part made is calibrated. E.g a calibre
- Verify that for each type (family) of custom implant, the machine can mill out parts to correct thickness and dimensions
- Do a repeatability test to confirm that the machine can reproduce the same thickness and dimension all the time
- I was thinking of a sample size of 40 per implant type since that is one month worth of production.

Because the dimension of the product changes every time i was thinking of just verifying the part each time a part is made and in cooperate the verification into the part inspection process. Providing that I do this along with the ensuring that calibration and maintenance are carried out at appropriate time would that be sufficient?

The reason i'm doing the IQ/OQ/PQ even though i plan on inspecting all the parts is because i assume auditors are used to seeing IQ/OQ/PQ carried out on most manufacturing machine and it add a level of security that the machine is working right.
 
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chris1price

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#3
This seems like a good starting point. I am not an expert on milling machines, but here are a few suggestions:
In the OQ, test the limits of the machine, is it consistent over the whole bed, check the largest and smallest parts that will be milled. Also review tool wear and the effect of wear on the parts
In the PQ test the consistency of operators setup/loading of the machine
Validate the computer interfaces, and if it has not been done, the CADCAM software itself.

There may be more, but you need to examine your risk assessments to establish what to check
 
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