out of specifications- Could cause an Unplanned deviation.
Ex: Tablet weight should be between W1=350 and 400mg, during the run the average weight of 10 tablets was 349 or 401mg, this will be recorded as an oos…which leads unplanned deviation, and therefore you will initiate an UDR, report to have proper CAPA;
unplanned deviation is an “Event which went Out of control during a process”
Incident- is not accident, but something unusual that accidently occurred…
“Remember you never plan for an incident BUT you do for an Accident”