Related to IQ OQ PQ process, my company has an sop that states when equipment is used to assemble or test product IQ Oq Pq process is required.
An engineer designed, built and released a device (let's call it that for now) that consists of a nest, pneumatics, and a switch. The device punches a hole in a small part with a needle.
The engineer is stating it's not equipment but it's a fixture. And that fixtures do not need to go thru that process.
How would you define equipment vs. fixture?
An engineer designed, built and released a device (let's call it that for now) that consists of a nest, pneumatics, and a switch. The device punches a hole in a small part with a needle.
The engineer is stating it's not equipment but it's a fixture. And that fixtures do not need to go thru that process.
How would you define equipment vs. fixture?