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Mobile equipment qualification?

W

WisdomseekerSC

#1
We perform IQ/OQ/PQ (Equipment Qualification) on New Equipment. The company once "grandfathered" the legacy equipment, now new products are being produced on the legacy equipment so no more "grandfathering". Documentation on legacy equipment is sparse if available at all. Protocols for qualifying these pre-existing pieces of manufacturing equipment are being written. Any advise? :cool:

We have a good idea what constitutes requalification of equipment, however, what is considered "relocated" (e.g, moved from one facility to another vs across the room)? :read:

We also have a unique situation in which we have interchangable pieces of equipment that are mobile (on wheels). They are moved into place when needed (e.g. godets, CAT pullers, spoolers), they are not in motion when in use. How are these frequently moved manufacturing equipment qualified? :confused:
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
I am in the exact same boat as you and recently re-wrote our validation master plan to take this sort of thing into consideration.

A lot of it has to do with the type of equipment - how sensitive it is.

What I did was break it down into "levels" of validation based on various criteria - distance of moves, scale of repairs, scale and impact of upgrades, etc.
As far as moves - these levels could be from a full IQ/OQ/PQ (like a move of a piece of equipment out of the building to another plant) down a a simple challenge for something moved in a straight line on a level surface.

Items that are meant to be moved are, by nature, exempt from movement based revalidation. If it's a refurb or major repair that's another story.
Of course, all new equipment gets a full IQ/OQ/PQ.

You have to also ask yourself - does this need to be validated? Is the output sufficiently checked by measurement and monitoring? If so, then it may not need validation at all.

If I get some time I'll add more detail to what I proceduralized.
 
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