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    Neptune Orthopaedics Standard Operating Procedure-Production

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    dhir.ankur
    This document outlines the standard operating procedure for producing cotton crepe bandages according to ISO 13485:2003. It details the cutting and spooling process which includes ensuring clean working areas, visual inspections for defects, and cutting the cloth in half-length increments. It also describes the packing process of wrapping rolled bandages, placing them in plastic jars, inserting jars into shrink wrap tubes, and packing tubes into shippers for shipping. The purpose is to define and control critical production activities, and the CEO approves and amends this procedure.

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    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    85 views2 pages
    This document outlines the standard operating procedure for producing cotton crepe bandages according to ISO 13485:2003. It details the cutting and spooling process which includes ensuring clean working areas, visual inspections for defects, and cutting the cloth in half-length increments. It also describes the packing process of wrapping rolled bandages, placing them in plastic jars, inserting jars into shrink wrap tubes, and packing tubes into shippers for shipping. The purpose is to define and control critical production activities, and the CEO approves and amends this procedure.

    Original Description:

    sop qms

    Original Title

    S 1

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    This document outlines the standard operating procedure for producing cotton crepe bandages according to ISO 13485:2003. It details the cutting and spooling process which includes ensuring clean working areas, visual inspections for defects, and cutting the cloth in half-length increments. It also describes the packing process of wrapping rolled bandages, placing them in plastic jars, inserting jars into shrink wrap tubes, and packing tubes into shippers for shipping. The purpose is to define and control critical production activities, and the CEO approves and amends this procedure.

    Copyright:

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

    Neptune Orthopaedics Standard Operating Procedure-Production

    Uploaded by

    dhir.ankur
    This document outlines the standard operating procedure for producing cotton crepe bandages according to ISO 13485:2003. It details the cutting and spooling process which includes ensuring clean working areas, visual inspections for defects, and cutting the cloth in half-length increments. It also describes the packing process of wrapping rolled bandages, placing them in plastic jars, inserting jars into shrink wrap tubes, and packing tubes into shippers for shipping. The purpose is to define and control critical production activities, and the CEO approves and amends this procedure.

    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/01

    QUALITY
    MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
    SYSTEM
    PRODUCTION ISSUE DATE:-15/07/10
    COTTON CREPE BANDAGE B.P PAGE 1 OF 2

    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 QA.
    3.0 The crepe cloth is allowed to fold exactly of the cutting length instructed by QA
    Instruction:
    Crepes quality varies lot to lot hence the cutting length may vary hence QA should puts
    remarks for cutting length in BMR Sheet.
    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 cut straight one after one at folding. Incase of any defects the bandage shall be
    discard
    5.0 Move the whole folded & cut cloth to spooling assembly. And spool concentrically and
    folded about 4-8 cm towards inside. for clipping with elastic metal clip. Allow 1 for
    6cm, 2 for 8cm and 10cm, 3 for 15cm bandages.
    Packing:

    6.0 Wrap the rolled and locked bandages in printed label having batch data over printed on
    it. Insert it into plastic jar with PVC Lid.

    PREPARED APPROVED ISSUED


    REVISION HISTORY
    BY BY BY
    REV.NO
    ISO 13485:2003
    DATE
    PM CEO MR
    NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/01
    QUALITY
    MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
    SYSTEM
    PRODUCTION ISSUE DATE:-15/07/10
    COTTON CREPE BANDAGE B.P PAGE 2 OF 2

    7.0 Insert 10 of the filled jar into pvc shrink warp tube and shrink it either by gun/shrink
    machine by maintaining temp about 130-1350C.
    8.0 Insert such 6/9 unit of 10jars into a shipper. And close the shipper with BOPP tape, and
    strap the box at two places length wise.

    PREPARED APPROVED ISSUED


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

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