Deviation and change control


#1

Can any deviation be changed into the change control?


(prajacta) #2

Yes, any major deviation should leads to a change control.


(ussidaho) #3

I personally regard them as all elements within a total ‘Process’ for the effective management of any Change and its consequences. Whether that Change is Planned Change (what is normally called Change Control) or Unplanned Change (often called Deviation of which OOS is, in my view, a specialised sub-set), the actions are remarkably similar. The main difference in my experience between Planned and Unplanned Change (also known as Deviation) is the concept of CAPA which is partly the ‘…catch up…’ on the actions you should have done prospectively had the Change been done under control, though it often includes additional actions created by the lack of control.
Hope it helps.
Reagrds,


(gaikwadabhi.pharma) #4

Yes. After repetitive deviation it can be changed into change control, and also deviation leads to change control.


(Meenakshi Gupta) #5

Usually after three deviations change control is taken.


(Md.Asif Hussain) #6

Yes basically preventive action give rise to Change request.


(Md.Asif Hussain) #7

Devaition can be considered as Temporary Change Control.
Change control is permanent Change control.


(mohammed mahmoud ahmed) #8

YES IF THE DEVIATION IS PLANNED