Can anyone clarify for differences in the following terms:
-Out of specifications
-Unplanned Deviations
-Incidences
Thanks in advance!!!
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”
“Bilal”
[quote=sims]Can anyone clarify for differences in the following terms:
-Out of specifications
-Unplanned Deviations
-Incidences
Thanks in advance!!![/quote]
OOS = Analytical test failure (requires extensive investigation as to why you received the OOS results)
Unplanned Deviation = I don’t get the “unplanned” portion, a “planned” deviation would be a change control. Deviation is not following the written procedure in a protocol or SOP. (steps out of order) If you plan not to follow one or the other you have large GMP issues. I would actually say that a deviation could cause an OOS and not the other way around.
Incident - Random Act that you have no control over…i.e. power outage.