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Deviation Form

This document is a deviation investigation report template for a company. It contains sections to document an assigned deviation number, affected product and batches, nature of deviation, corrective actions taken, an investigation with signatures, root cause determination, risk assessment, conclusions, recommended corrective and preventative actions, and final closure of the deviation by quality management. The template provides guidance on how to document a deviation from standard processes or results and the subsequent investigation and corrective actions.

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samia khan
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4K views3 pages

Deviation Form

This document is a deviation investigation report template for a company. It contains sections to document an assigned deviation number, affected product and batches, nature of deviation, corrective actions taken, an investigation with signatures, root cause determination, risk assessment, conclusions, recommended corrective and preventative actions, and final closure of the deviation by quality management. The template provides guidance on how to document a deviation from standard processes or results and the subsequent investigation and corrective actions.

Uploaded by

samia khan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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

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