Do your device specifications conform to user needs and intended uses?
Performance Qualification Can you demonstrate, with a high degree of assurance, that your process consistently produces a result that meets predetermined requirements?
Do your tools, equipment, systems, and people work together as a system, and are they capable of consistently meeting
process requirements? Have you established process control limits and action levels which result in product that meets all predetermined requirements?
Did you order the right equipment and ancillary system for your process?
Did you receive exactly what you ordered?
Was it properly installed per manufacturer's approved specification?
Did you consider supplier recommendations?
Do your facilities adequately and reliably provide the utilities and environment the process requires?