Deviation closure procedure


(Ravi) #1

What is the proper procedure to close a deviation.
For e.g. - A deviation occurred due to breakdown of any leakage checking machine, and due to market urgency a unplanned deviation is taken and leakage checking is done manually in random order. Leakage checking machine is get corrected (come into work) after 2 days, then in this condition when we will close the deviation and how ?


(lalpratap) #2

identify the root cause , then write down the corrective actions taken
for preventive actions sort out all the possibilities that such kind of incident doesn’t happen in future

the proper flow of deviation is :

Incident description
scope
immediate actions taken
potential causes
root cause – (using tools like fish bone, DMAIC etc)
CAPA
Effectiveness check


(Ajay S) #3

Before taking an unplanned deviation make sure that you have a proper trained staff who will perform the activity.
take an WORK ORDER and try to start the machine as soon as possible.
unplanned deviation can only be taken or applicable for the current running batch not for next batch.
close the unplanned deviation with proper investigation and CAPA with the help of fish bone diagram.

make sure without a proper trained staff you cannot perform unplanned deviation.preserve the training documents for the further investigation and attach one copy to the the unplanned deviation.


(Ravi) #4

Dear Sir,
My one query is that when we will close the deviation (timeline to close the deviation).


(Ajay S) #5

within 30 days of initiation