Reference SOP No.
: QA-XXX/NN
Company Name Deviation Investigation Report Company Logo
Note: Put a dash (-) in the column whichever is not applicable.
Assigned Deviation No.: DEV-XXX-NNN/YY *
Product : Date :
Nature of Deviation :
___________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Batches Affected:
Reasons For Deviation (If Identified) :
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Immediate Corrective Action: (If Any)
_________________________________________________________________________________
_________________________________________________________________________________
_______________________________________________________________________________
Originating Department Observed by : Checked by :
Sign & Date Sign & Date
(Department Head)
Review/ Comments By Quality Assurance:
Prepared By Checked By Approved By
Name
Designation
Signature
Date
Issued by : Copy No. :
(Sign/date )
Page 1 of 3 F1/QA-XXX/NN
Reference SOP No. : QA-XXX/NN
Company Name Deviation Investigation Report Company Logo
Critical Major Minor
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Sing / Date :
Investigation : (If given space is not sufficient then attach a additional sheet as annexure)
__________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Signature & Date of Investigation Team:
Name : Name : Name :
Department : Department : Department :
Sign / Date : Sign / Date : Sign / Date :
Root Cause Determination :
__________________________________________________________________________________
__________________________________________________________________________________
_________________________________________________________________________________
Risk Assessment/ Impact Assessment :
__________________________________________________________________________________
__________________________________________________________________________________
________________________________________________________________________________
Conclusion :
___________________________________________________________________________________
___________________________________________________________________________________
Prepared By Checked By Approved By
Name
Designation
Signature
Date
Issued by : Copy No. :
(Sign/date )
Page 2 of 3 F1/QA-XXX/NN
Reference SOP No. : QA-XXX/NN
Company Name Deviation Investigation Report Company Logo
___________________________________________________________________________________
___________________________________________________________________________________
__________________________________________________________________________________
Recommended CAPA :
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
__________________________________________________________________________________
Closure of Deviation :
Sign : ________________ Name : Date :
(Head - Quality)
* Where UPD stands for Unplanned Deviation & PD stands for Planned Deviation,
XXX stands for Dept. Code, for ex. QA, QC, PRD, ADM, WH etc.
NNN stands for sequential no. of change control
YY stands for last two digits for the current year, for ex. 19 for 2019
Prepared By Checked By Approved By
Name
Designation
Signature
Date
Issued by : Copy No. :
(Sign/date )
Page 3 of 3 F1/QA-XXX/NN
