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    Procedure For Corrective Action and Preventive Action

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    sohankumar.mahale
    The document outlines a standard operating procedure for corrective and preventive actions. It details the purpose, scope, responsibilities, methodology, related documents, annexures, and revision record. The procedure applies to non-conformities at Hermes Laboratories and aims to identify quality issues and prevent recurrence.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Procedure For Corrective Action and Preventive Action

    Uploaded by

    sohankumar.mahale
    97 views11 pages
    The document outlines a standard operating procedure for corrective and preventive actions. It details the purpose, scope, responsibilities, methodology, related documents, annexures, and revision record. The procedure applies to non-conformities at Hermes Laboratories and aims to identify quality issues and prevent recurrence.

    Original Title

    PROCEDURE FOR CORRECTIVE ACTION AND PREVENTIVE ACTION

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    The document outlines a standard operating procedure for corrective and preventive actions. It details the purpose, scope, responsibilities, methodology, related documents, annexures, and revision record. The procedure applies to non-conformities at Hermes Laboratories and aims to identify quality issues and prevent recurrence.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    97 views11 pages

    Procedure For Corrective Action and Preventive Action

    Uploaded by

    sohankumar.mahale
    The document outlines a standard operating procedure for corrective and preventive actions. It details the purpose, scope, responsibilities, methodology, related documents, annexures, and revision record. The procedure applies to non-conformities at Hermes Laboratories and aims to identify quality issues and prevent recurrence.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 11

    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

    Prepared by Checked by Approved by


    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:
    Prepared by Checked by Approved by
    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

    Prepared by Checked by Approved by


    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
    Prepared by Checked by Approved by
    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
    Prepared by Checked by Approved by
    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.

    Prepared by Checked by Approved by


    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.

    Prepared by Checked by Approved by


    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

    Prepared by Checked by Approved by


    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

    Prepared by Checked by Approved by


    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 --

    Prepared by Checked by Approved by


    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

    Prepared by Checked by Approved by

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