Let's see if I can help... Note that this response in in the context of medical device manufacturing process validation, and NOT pharmaceutical manufacturing process validation, nor product design validation.
When authoring your qualification documents (IQ/OQ/PQ), wouldn't it be necessary to have some User Requirement document to test against to see if the equipment meets pre-defined requirements such as:
Ease of Use
Environmental Conditions
Foot print requirements
Or can those pre-defined requirements be specified in our Manufacturing Process documents or specifications/release criteria?
One approach to validation documentation is to view the protocols as the mechanism by which a manufacturer establishes belief that the process is established as intended, and when executed the protocols contain the objective evidence that the process is working as intended. If you approach process validation in this way, you will likely consider certain things in the appropriate protocol. For example:
IQ (Installation Qualifications) should reference everything necessary to install (and maintain) the equipment at a given spot on the shop floor, such that if the time ever comes to move it... or duplicate it, at the same or other spot (could be in a different country) all of the information exists, along with a checklist of the necessary items to verify. This could be the footprint (for fixed or otherwise immobile EQ), the utility connections (e.g. electricity, compressed air, de-ionized water) as well as plans for waste disposal (old solder, noxious gasses). Consideration of environmental conditions are most likely part of the IQ, with some exceptions such as those related to product sterility requirements (which will get formally challenged in OQ and PQ). A good IQ is one that could be sent along with the equipment to a building on the other side of the planet and be executed in such a way that a person would have confidence that the EQ was installed correctly. If these things are done, a medical device manufacturer will have addressed the necessary elements of 21 CFR 820.70 (g). The IQ should also cover the elements of 820.72 for test and measurement equipment that is part of a process.
It would be unusual for an auditor to question a thorough IQ, but experience among auditors varies and manufacturers should be prepared for 'red-face' questions. For example, an auditor might ask if a PC system has a AC line conditioner, and if it does, where is it specified and documented? If you walk onto the floor and have a hard time maneuvering around a piece of equipment, the auditor might ask about floor space considerations. I can't think of an audit (involving manufacturing) where calibration records were not requested.
While there can be stumbles with the elements of 820.70 (often around "low hanging fruit" like change control and contamination control), it is more typical that manufacturers struggle with are the elements of 820.75 Process Validation. Process Validation requires critical thinking in the areas of process requirements and methods to challenge the process. My personal experience is that it is very rare for an auditor to examine an OQ or PQ with anything but a cursory examination. I can politely ascribe this behavior to the idea that a poorly validated manufacturing process will reveal itself through nonconformances and corrective actions.
I can impolitely ascribe such behavior to thoughts like "it's hard, and do I really want to have a shop manager try to explain his vision of both Ohm's law and Study Designs to me?"
The manufacturing process parameters will be established as part of the product development process.
The most effective product launches consider manufacturing early in the product development life-cycle, but many manufacturers delay consideration to a specific "design transfer" phase that fits between design validation and product manufacturing. The process parameters are established, and then the OQ and PQ protocols for the manufacturing processes are developed from the established process parameters. The
bolded text above is the direct mention in 820.75 (b) and by choosing equipment for your process you end up with some specific equipment parameters in 820.70 (g).
I'll stop here, because you haven't asked any questions about OQ/PQ.