How should I make an installation and operational qualification protocol for equipment with no available drawings, specifications, and operation manual. I can visually inspect the parts of the equipment and see that they are acceptable(visually), and operate each function and record it to use as future reference. I feel I don’t have enough to work with. Has anyone gone through a situation like this before?
Is this equipment you made or purchased?
What is the risk if the equipment fails? That will probably drive the level of detail you need to consider.
If you really have nothing, you can probably document how it’s installed and provide some justification around that to qualify. For example, if process air is hooked up, you may be able to see how it’s used and make an assertion based on that to justify how you have it hooked up. You can probably also point to any use studies (e.g., a run over a typical production cycle) to confirm stability (thus some clue as to proper installation). I’d suggest to document as much as you can find out (input power, hookups to other utilities) to form a basis for any equipment move / re-validation.
I’m not sure a visual inspection would count much in terms of qualifying the equipment.
To show operational qualification, you’ll need to establish what the system should do - that would be in your user-defined specs anyway so not having anything provided may be ok. Do what you can to document equipment expectations (stated as “requirements”) and don’t just focus on the ‘happy path’ - especially if there’s no automated quality assessment. You might consider doing FMEAs or FTAs to help define these type events.
Don’t know if that helps but maybe it gets the ball rolling.