Doc. Name Form Doc. No.

XMT-QA-SOP-
TITLE CAPA Form
Doc. Issue Date: 01-06-2024 Doc. Rev. Date: 01-06-2024 Doc. Rev. No.: 00
Format Rev. No.: 01 Format Rev. Date: 28-08-2019 Page 1 of 5

CAPA Form CAPA NO.: ____/ CAPA/_____

Criticality of the CAPA Form: □ Major □ Minor □ Observation □ Improvement

PART – A (To be filled by Initiator):
Date/Time of Name of Department
Request Initiator Name

CAPA generated from: (Reference document no.): (Note: ‘✔’ in the box wherever applicable, Attach
additional sheet, if writing space is not sufficient)
OOS (Out of
Change Control □ Specification) □
Internal Feedback □
Customer Complaint □
OOT(Out Of
Deviation □ trend) □
Customer Feedback Calibration □ □
Product/Batch
Investigation □ Audit □
Failure
Qualification □ □
Risk Management □ APQR □ Product Return □ Malfunction □
Training Deficiency □ Validation □ Product Recall □ Any other □
Any Other (Mention details):

PART A: To be filled by Initiator:

Description of Quality Issue / Non conformity / Problem (Attach copy of reference document from CAPA
to be generated, if required Doc No.___________):________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

Name & sign of Initiator:

-------------------------------------------------------------------------------------------------------------------------------------_
Date:
Immediate Action/Correction Description: __________________________
 Doc. Name Form Doc. No. XMT-QA-SOP-
TITLE CAPA Form
Doc. Issue Date: 01-06-2024 Doc. Rev. Date: 01-06-2024 Doc. Rev. No.: 00
Format Rev. No.: 01 Format Rev. Date: 28-08-2019 Page 2 of 5

__________________________________________________________________________________________
__________________________________________________________________________________________
Root Cause Analysis :
__________________________________________________________________________________________
Method used for Root Cause Analysis: ________________________________________________________

Corrective Action Description (if any):_________________________________________________________

Corrective Action done By:

Name & sign:
Date:

Proposed Preventive action (if any):

Preventive Action done By:

Name & sign:
Date:

List of affected documents / system / process / procedure:

(If list is more than the allotted rows, kindly attach the attachment and referenced below.)
Sr. No. Title (Reference) Existing Ref. No. Brief description of changes
 Doc. Name Form Doc. No. XMT-QA-SOP-
TITLE CAPA Form
Doc. Issue Date: 01-06-2024 Doc. Rev. Date: 01-06-2024 Doc. Rev. No.: 00
Format Rev. No.: 01 Format Rev. Date: 28-08-2019 Page 3 of 5

Training Required: - Yes No (If yes mention department/Personnel)

Criteria for measurement of CAPA Plan (Qualitative / Quantitative) if any:

__________________________________________________________________________________________
__________________________________________________________________________________________

CAPA Implementation Team and Initiation Date:

Sr. No. Name Dept. Name Designation Sign with date

Part B:
CAPA Review & approved by QARA Department
1. QARA review comments (justify the rejection of CAPA, if required):
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
Name: ____________________ Designation: ______________ Sign with date: _______

Part – C:
QARA approval for implementation:
QARA Manager review comments and approval:
___________________________________________________________________________________
___________________________________________________________________________________
Name: ____________________ Designation: ______________ Sign with date: _______
 Doc. Name Form Doc. No. XMT-QA-SOP-
TITLE CAPA Form
Doc. Issue Date: 01-06-2024 Doc. Rev. Date: 01-06-2024 Doc. Rev. No.: 00
Format Rev. No.: 01 Format Rev. Date: 28-08-2019 Page 4 of 5
PART – D (Implemented CAPA Verification Details):
To be filled by Initiator To be filled by QARA
Physical verification/
Sr.
Responsible Target Actual Date Document
No. Action Details
Department Date of completion verification*
Action verified by

* If list is more than the allotted rows, kindly attach the attachment and referenced above,
* Document photocopy shall be attached for reference ( if required).

PART – E: Comments on implemented CAPA (By QARA) (if applicable):

_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

CAPA Effectiveness Verification (Post Implementation) required; Yes / No.

If yes, mention period / no. of batches

____________________________________________________________________________________
____________________________________________________________________________________

** Related document evidence/photocopy/summary report shall be attached for CAPA effectiveness

verification.

PART – F: CAPA Effectiveness Verification Comments (By QARA/ MR):

_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_________________________________________________________________________

Name: __________________ Designation: ______________ Sign with date: _____________

# of Extension taken for CAPA:

Justification for extension of CAPA timeline (to be filled by initiator/related department HOD):
 Doc. Name Form Doc. No. XMT-QA-SOP-
TITLE CAPA Form
Doc. Issue Date: 01-06-2024 Doc. Rev. Date: 01-06-2024 Doc. Rev. No.: 00
Format Rev. No.: 01 Format Rev. Date: 28-08-2019 Page 5 of 5
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

PART – G: Closing comments (QARA Manager/ designee):

_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Name: __________________ Designation: ______________ Sign with date: _____________