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What is 'equipment'?


Starting to get Involved
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?

Ronen E

Problem Solver
Staff member
Super Moderator
Fixture in the manufacturing context is something that is fixed (not moving) or is used solely for fixing some other object in place. Self-explanatory IMO.

What you describe sounds like simple machinery.

Besides, who said fixtures are categorically exempt from qualification?... IMO fixtures are a subset of equipment.


Staff member
Super Moderator
@Ronen E is spot on again. Just one additional thing to consider. Why do you force IQ/OQ/PQ on everything? You need to qualify equipment (methods / approaches are not prescribed) and validate processes (again, methods not prescribed). The extent to which these activities are carried out should be risk driven. So if your needle-punching fixture has little bearing on quality or functionality, the effort can possibly be reduced.

(And, to your engineer, a reminder that there are scads of test fixtures that get qualified / methods validated!)
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