Taking the ISO names for these processes: IQ, OQ, PQ, let’s look at some devices and summarize what kinds of tests or data you would want to collect to complete each of them. In other words, for each process below, what would the IQ testing look like? What would the OQ and PQ testing look like?

Syringe Filling Process – filling syringes with an injectible bone void filler

Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft

Antibiotic releasing hip stem manufacturing line – creating an artificial hip with an antibiotic coating on the surface

Wound Healing Growth Factor and delivery device manufacturing line – creating a liquid growth factor that sits in a bottle and gets added to a wound dressing when ready to apply to the wound