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    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    This standard operating procedure outlines the production process for abdominal pads with x-ray detectable thread. The procedure involves cutting materials to size, forming multiple plies, placing the thread in the pad, stitching to secure it, and finally packing the finished pads into pouches and shippers for distribution. Quality checks are performed during cutting to ensure materials meet specifications. The procedure is approved by the CEO and subject to the company's quality management system and responsibilities outlined elsewhere.

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    © All Rights Reserved
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    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    62 views2 pages
    This standard operating procedure outlines the production process for abdominal pads with x-ray detectable thread. The procedure involves cutting materials to size, forming multiple plies, placing the thread in the pad, stitching to secure it, and finally packing the finished pads into pouches and shippers for distribution. Quality checks are performed during cutting to ensure materials meet specifications. The procedure is approved by the CEO and subject to the company's quality management system and responsibilities outlined elsewhere.

    Original Description:

    SOP

    Original Title

    S 12

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    This standard operating procedure outlines the production process for abdominal pads with x-ray detectable thread. The procedure involves cutting materials to size, forming multiple plies, placing the thread in the pad, stitching to secure it, and finally packing the finished pads into pouches and shippers for distribution. Quality checks are performed during cutting to ensure materials meet specifications. The procedure is approved by the CEO and subject to the company's quality management system and responsibilities outlined elsewhere.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    62 views2 pages

    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    This standard operating procedure outlines the production process for abdominal pads with x-ray detectable thread. The procedure involves cutting materials to size, forming multiple plies, placing the thread in the pad, stitching to secure it, and finally packing the finished pads into pouches and shippers for distribution. Quality checks are performed during cutting to ensure materials meet specifications. The procedure is approved by the CEO and subject to the company's quality management system and responsibilities outlined elsewhere.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 2

    NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/12

    QUALITY STANDARD OPERATING PROCEDURE- ISSUE NO: 01


    MANAGEMENT
    SYSTEM PRODUCTION ISSUE DATE:-15/07/10
    ABDOMINAL PAD B.P
    PAGE 1 OF 2
    WITH X RAY DETECTABLE THREAD

    1.0 PURPOSE:
    The purpose of this procedure is to define and control critical activities in production as per the
    requirement of ISO 13485: 2003.

    2.0 SCOPE:
    This procedure covers standard operating procedure of the concerned area in production.

    3.0 RESPONSIBILITY:
    Refer Responsibility & authority chart NO/QSM/AX04.

    4.0 APPROVAL:
    This procedure is approved by CEO and can be amended only by him.

    5.0 DEFINITIONS: Nil

    6.0 PROCEDURE:

    Cutting &spooling
    1.0 Ensure cleaning of working tables, Equipments along with room.
    2.0 All materials used for should be issued by stores. And ensuring that the materials
    released by Q.C.
    3.0 The cotton gauze type 1 is allowed to Slit exactly to the required width and form to
    slitted rolls. instructed

    Instruction:
    Visual inspection by supervisor/ skilled work mens shall be carried for any types of
    weaving defect, crease, loose threads, any marking of shade etc.

    4.0 Then slitted rolls are allowed to folding machine for forming ply and wind into a roll.
    After repetition of the folding and winding up to the required ply and form in roll.
    5.0 Place the pre cut x-ray detectable thread straight in corner to corner
    6.0 Stitch the thread as well as pad in such away that no loose threads shall expose to out
    side.
    7.0 Then stitch the tape at the corne of the pad just in the direction in which x-ray thread
    stitched.
    8.0 Packing:

    PREPARED APPROVED ISSUED


    REVISION HISTORY
    BY BY BY
    REV.NO
    ISO 13485:2003
    DATE
    PM CEO MR
    NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/12
    QUALITY STANDARD OPERATING PROCEDURE- ISSUE NO: 01
    MANAGEMENT
    SYSTEM PRODUCTION ISSUE DATE:-15/07/10
    ABDOMINAL PAD B.P
    PAGE 2 OF 2
    WITH X RAY DETECTABLE THREAD

    1. Insert the pad into previously coded glass in poly pouch and allow to seal.
    2. Arrange 20 such pouch into a inner. And 10such inner packed into the shipper.

    PREPARED APPROVED ISSUED


    REVISION HISTORY
    BY BY BY
    REV.NO
    ISO 13485:2003
    DATE
    PM CEO MR

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