Operation.
Now there is an operative word.
Plant is done, but somehow something was built correctly, or some inspection wasn't completed, or some, anything, keeps it from being allowed to operate. Gee, management PR'ed blah, blah, blah, etc., etc., etc., but failed to pay attention to detail. It's all the consultants fault. No it's all the contractors fault. No it's all the FDA's fault for not telling us this or that or this and that. It can't be managements fault at the lab has to be ripped half way out and redone.
I call this management risk and think that it is the biggest risk associated with NNVC. Management has a history of failing to effectively execute effectively.
Again, hold onto your enthusiasm.