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    Rework Procedure

    Uploaded by

    Tushar Wagh
    1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

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    Rework Procedure

    Uploaded by

    Tushar Wagh
    30 views1 page
    1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

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    1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    30 views1 page

    Rework Procedure

    Uploaded by

    Tushar Wagh
    1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

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    of 1

    QMS-065 Manufacturing Rework Procedure

    Flowchart – Rework Process Flow

    Process deviation or quality


    concern raised

    DR raised

    Rework required?
    QA to assess

    QA approve for rework to go Critical product defect? Only QAM approve for
    ahead rework to go ahead

    Production planner is to
    schedule a rework

    In-Process Manufactured Manufactured Finished


    Goods (IPMG) Goods (MFG)

    Planner to create rework


    QA to raise a rework
    RBPN
    protocol, TEM-125

    QA to raise a rework
    Protocol approved and protocol, TEM-115
    signed off

    Protocol approved and


    signed off
    Rework done

    Production to request goods


    Completed Rework Protocol to transfer from warehouse.
    included in the batch Use ‘Goods Return for
    documents Rework Form’

    Warehouse picks and send


    goods/material as requested

    Rework done. Retention


    sample kept.

    Completed Rework Protocol


    included in the batch
    documents

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