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IQ, OQ & PQ (Installation, Operation, and Performance Qualifications) on a CMM

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BradM

Staff member
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#2
Hello there! We are sure glad you dropped by!

well, the first thing that came to mind was the below thread:

Validation documentation

In it, Ajit and some others provide steps/guidelines to developing the program.

1. Do you already have a validation plan for your facility?

2. Is this your first validation to perform?

3. Are you going to have to validate other equipment?

4. Have you already written the operating procedure?

Also, I know we have several attachments relating to validation. You might want to view those and see if there is something of interest.

The instruction manual/ mfg. information is a great start for the IQ/OQ. Hopefully your management has some plan/functional specification for the equipment. That will also be a great start.

The mfg. of the equipment may have something (usually for sale:)) that you might can use. Also, if you are so inclined, it might be worth it to find a contractor that is qualified for this project to help you out.

Just some thoughts.
 
G

Gert Sorensen

#3
I am not quite certain as to why you want to validate a CMM machine? But assuming that you have good reason to do it here is my ideas:

1. Use a dedicated computer - subject to change management.
2. Make sure that the computer is accepted by your IT department
3. The computer should be a standard of the shelf machine
4. Only the minimal software should be installed on the computer.
5. Evaluate it for Part 11 compliance - if applicable
6. Make sure that it is being set up with users, passwords and restricted network access.

As far as IQ goes it is fairly simple:
Verify that the CMM is installed according to specs. Is it level? Controlled lighting? Temperature of the room? Humidity? Some of this you will need to define depending on your products.
That cabling is done in an orderly manner.
That the software is installed correctly

OQ:
SOP's need to be in place
Calibration need to be done
Test all relevant functionalities of the program

PQ:
I wouldn't go there, I would make sure that OQ testing were comprehensive.

Hope this helps:bigwave:
 
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