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what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
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Answer Posted / santhosh matam
Deviation: Departure from the approved manufacturing
process/SOP/Systems shall be considered as a deviation
management system. This is an unexpected event occurring
which is out of control. The concept of Planned deviation
is wiped out long back. There is no planned deviation as
such. As planned deviation is a non compliance to the
approved process/SOP/Systems.
Change control System: Any change in the process/SOP/Systems
shall be changed from approved Change Control Procedure.
Change control procedure denotes permanent change and
temporary changes. After getting assessment from CFTs & QA,
change can be implemented by validating the procedures. If
there are any discrepancies identified at the
initial(Validation stage), immediately this can be revert
back to the original state by closing the change control and
stated as not approved. If found no discrepancy this
temporary change control shall be approved and converted
into a permanent change. Some change controls can be made
permanent when we know the
| Is This Answer Correct ? | 46 Yes | 5 No |
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