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Deviation Form

The Deviation Form is a structured document used to record and evaluate deviations in manufacturing processes. It includes sections for product details, deviation specifics, root cause analysis, proposed corrective actions, and impact evaluations on quality and safety. The form requires signatures from various responsible parties to ensure accountability and communication across departments.

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27 views2 pages

Deviation Form

The Deviation Form is a structured document used to record and evaluate deviations in manufacturing processes. It includes sections for product details, deviation specifics, root cause analysis, proposed corrective actions, and impact evaluations on quality and safety. The form requires signatures from various responsible parties to ensure accountability and communication across departments.

Uploaded by

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

Deviation Form No. Date


Name of the Product Batch No.
Batch Size (in Nos.) Mfg. Date Exp. Date
Deviation Initiated by Deviation Observed Section/Stage

Sign/Date

 Process Parameters  Yield  Equipment  Facility  BMR/BPR


Deviation In
 Procedure  Document  Material  Other_______________

Type of Deviation Planned / Unplanned Category Critical / Major / Minor

Deviation Received by Root Cause of Deviation

Sign/Date

Affecting other
Documents
(filled by QA)

If yes, QA, Asst.


Previous Batch
(Yes/No) Manager,
Affecting Batch No. (Sign/Date)
Proposed Corrective Action Taken (By Receiving Department):

(Sign/Date)

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DEVIATION FORM

Evaluation of Deviation Impact (Filled by QA):


a. Does it have any impact on process? {Yes / No}
b. Does it have any impact on quality? {Yes / No}
c. Training required? {Yes / No}
d. Does it have any impact on safety, environmental and health? {Yes / No}
e. Does it have impact on regulatory filing? {Yes / No}
f. Any other impact. Please specify

Comments by (Asst. Manager / Designee):

(Sign/Date)
Relevant Department / s (comment on this deviation):

(Sign/Date)
Final Conclusion of received Department Head (Preventive and Reoccurrence of such incident):

(Sign/Date)
Comment (QA, Head)

Approved / Not Approved (Sign/Date)


To be circulated to the following departments (Xerox copy):
 QC  PD  ST  EM  HR  FD
 Any other department, Specify _________________________________
Note: Attach separate sheet if required…….

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