Hi

Once again Production Vs Services related query from my side

Are production equipment, tools and programs validated prior to use and maintained and inspected periodically according to documented procedures?

We use only workstation loaded with software to carry out the task. So what kind of validation required?

Does validation prior to production use include verification of the first article produced to the design data/specification?

Is it something like doing one pilot work in the workstation before we do the actual work from customer?

Are storage requirements, including periodic preservation/condition checks, established for production equipment or tooling in storage?

Is it periodic maintenance schedule for malware and computer worms etc?

To your 2nd question:
Yes. Our company also perform 1st-piece inspection to check whether the NC program can produce the correct configuration to the print. This is done after the program is designed and also before the beginning of each discontinuous lot to prevent problem due to unauthorized change to the computer program.

To your 3rd question:
I think it include PM and the preservation of machines and equipment when they are not in use, eg. protection against rust.