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Deviation Approval Form

This document is a deviation approval form used to document any deviations that occur from standard processes. It contains 14 sections to document the deviation details, investigation conducted, root cause analysis, corrective and preventive actions, evaluation, and final approval or disposition. Key information includes the deviation number, date of occurrence, product/material involved, description of the deviation, immediate actions taken, risk assessment, categorization as minor, major or critical, and approval by quality management.

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Mv Patel
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929 views

Deviation Approval Form

This document is a deviation approval form used to document any deviations that occur from standard processes. It contains 14 sections to document the deviation details, investigation conducted, root cause analysis, corrective and preventive actions, evaluation, and final approval or disposition. Key information includes the deviation number, date of occurrence, product/material involved, description of the deviation, immediate actions taken, risk assessment, categorization as minor, major or critical, and approval by quality management.

Uploaded by

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

Deviation No.
Note: Attach additional sheets if required
Initiator Location/site

Date of reporting Department

Product / Material

Scope / Market Customer

Batch No./ Lot No.

Date of discovery Time of discovery


Stage of processing
of product
1. Description of Deviation : ( To be filled by initiator)

Initiator sign Date

2. Immediate action taken: (To be filled by responsible department )

3. Risk & impact assessment for deviation (To be filled by responsible department )

Responsible person sign Date

Head of Responsible dept. sign Date

4. Similar type of deviation repeated in the past one year (To be filled by QA) Yes No

If yes Specify Deviation No. :

Categorization of deviation  Minor  Major  Critical


QA sign and date

Requirement of Investigation Yes No

Head QA/Designee Comments

Approval of Head QA / Designee (Sign / Date)

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DEVIATION APPROVAL FORM
Deviation No.
Note: Attach additional sheets if required
5. Investigation (To be filled by responsible department ):
Reference investigation Number (if applicable) :

6. Identified root cause (To be filled by responsible department)

7. Comments by other departments:

Name Dept.

Sign Date

8. Corrective Actions and Preventive actions (To be filled by responsible department ):


Sr. No. CAPA details CAPA number Responsibility TCD

Responsible person sign Date

9. Final Evaluation and Conclusion by Head QA or Designee :

Sign Date

10. Comments By Regulatory Affairs :( if necessary)

Sign Date

11. Comments and approval By customer / QP / MA Holder:

Sign Date

12. Disposition of deviation impacted materials/products by Head QA or Designee :

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DEVIATION APPROVAL FORM
Deviation No.
Note: Attach additional sheets if required
Impacted batches to be released  Yes  No  NA

Sign Date

13. Comments and approval By CQA: ( if necessary)

Sign Date

14. Closure:
All actions related to investigation are complete:  Yes  No
Remark:

Head of Responsible dept. sign Date

Review by QA:

All CAPA logged into the CAPA log book :  Yes  No


Remark:

Deviation closed on

Closed within the timeframe  Yes  No

Extension form filed-1  Yes  No  NA

Extension form filed-2  Yes  No  NA

Head- QA/ designee sign Date

Annexure no. List of Annexure Number of pages

Total No. of pages.

Page 3 of 3

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