STANDARD OPERATING PROCEDURE

TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.

DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 1 of 11

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 2 of 11

1. PURPOSE:

To lay down the procedure for taking corrective action and applying of controls to ensure that they are effective as well as to
identify potential causes of quality problems and to prevent them.

2. SCOPE:

This procedure applies for all corrective and preventive actions taken for the non-conformities occurred in the site at Hermes
Laboratories Pvt. Ltd.

3. RESPONSIBILITY:
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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 3 of 11

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 4 of 11

5.1.1.8 Deviation investigation report shall be reviewed and necessary corrective action shall be taken
for non-conformance.

5.1.1.9 Customer complaints received shall be handled and root cause of the complaint to be
investigated.

5.1.1.10 Corrective actions on the non-conformances pointed out during internal quality audits are taken
up as appropriate.

5.1.2 Changes to procedures initiated through change control system. For any changes done to the
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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 5 of 11

5.2.1.4 Results of self-assessment.

5.2.1.5 The causes for the potential non-conformities shall be determined and the need for action to
prevent occurrence of such non-conformities shall be evaluated.

5.2.1.6 Records of all preventive actions shall be maintained and the effects shall be reviewed

5.3 CAPA CLOSURE

5.3.1 On Completion of actions, the department head shall certify that the proposed CAPA is completed and
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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 6 of 11

implemented along with associated actions.

5.3.2 QA shall verify the implementation and completion of CAPA with respective ANNEXURES.

5.3.3 Timeline for CAPA closure is 30 days.

5.3.4 If the timeline is not sufficient to close the CAPA then target date will be given.

5.3.5 Within the target date the CAPA should be closed and all the annexures should be submitted.

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 7 of 11

6. RELATED DOCUMENTS:

6.1 Failure investigation sop.

6.2 Handling of non-confirming product sop.

6.3 Handling of customer complaints sop.

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 8 of 11

7. ANNEXURES:

Annexure No. Annexure Title

Annexure-1 Corrective Action / Preventive Action form

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 9 of 11

8. REVISION RECORD:

Revision No. Effective Date Details of Revision Remarks

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 10 of 11

00 06.-May-2010 First issue --

01 06-May-2013 Periodic Review --

No revision in document
because no changes in
01 06-May-2016 Periodic Review procedure.
Document sealed as
“Review found ok”

02 06-May-2019 Periodic Review --

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 STANDARD OPERATING PROCEDURE
TITLE: PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION.
DEPARTMENT : QUALITY ASSURANCE SOP NO : HER/SOP/QA/017
EFFECTIVE DATE : 06-Oct-2021 NEXT REVIEW : 06-Oct-2024
REVISION NO : 03 PAGE NO : Page 11 of 11

Timeline for CAPA closure is mentioned

03 06-Oct-2021 Audit observation
in the SOP

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