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    QSP-03 Control Documents

    Uploaded by

    l20me011

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    © All Rights Reserved
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    QSP-03 Control Documents

    Uploaded by

    l20me011
    6 views5 pages

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    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    6 views5 pages

    QSP-03 Control Documents

    Uploaded by

    l20me011

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    DOC No: XXXX/QSP/03

    LOGO NAME Issue No:01


    Date: DD/MM/YYYY
    LOGO Revision No:00
    CONTROL OF DOCUMENTS Date: DD/MM/YYYY
    Page 1 of 5

    1. PURPOSE
    To ensure that all QMS documents are controlled by

    a. Issuing them when authorized and ensuring their adequacy before approval
    b. Reviewing, updating when necessary and re approving them
    c. Changing in an authorized manner
    d. Making available at the correct place of use
    e. Ensuring their Legibility, identification, indexing & codification
    f. Listing and preserving documents of external origin
    g. Preventing unintended use of obsolete documents

    2. SCOPE
    This procedure covers approval, issue and change of the following documents and
    Data:

    - Quality Manual
    - Quality System Procedure
    - Formats

    3. RESPONSIBILITIES
    The responsibility for maintaining this procedure is as detailed in table 1:

    4. PROCEDURE
    All levels of documents under the ‘QMS’ controlled to ensure satisfactory
    performance and operation. All level 4 documents generated during the course of
    the operation of the QMS written legibly and properly filed. All these files numbered.

    Prepared By Approved By Control Status


    DOC No: XXXX/QSP/03

    LOGO NAME Issue No:01


    Date: DD/MM/YYYY
    LOGO Revision No:00
    CONTROL OF DOCUMENTS Date: DD/MM/YYYY
    Page 2 of 5

    a) Issue and Approval:


    The MR ensure that only approved documents are issued to the user as “control
    Copies” as per the ‘Distribution List’. This formal issue to the specified individuals or
    location done to ensure availability of relevant documents at the respective places
    of use. All issues recorded in the document issue record and acknowledgement
    taken. The ‘QMS’ manual issued in full to all personnel listed in the distribution list,
    but ht procedures and instructions issued, based on whether the particular
    procedures or instructions are applicable to the concerned personnel’s area of work.
    All approved formats available for use but not issue.

    The manual, procedures, work instructions, inspection instructions, maintenance


    instruction, calibration instructions, specifications and lists issued in separate files
    have “Contents pages” at the ginning, listing all the documents of the type available
    and also indicate which of documents have been issued to the control copy holder
    and hence available in the control copy file issued.

    b) Review, Update & Re-approval:


    The first three levels of documents are signatures for ‘Prepared by’ and ‘Approved
    by’ on all control copies but in the fourth level documents, only master copies signed
    for ‘Prepared by’ and ‘Approve by’. After any updating, the documents once again
    reviewed and reapproved by the same authority, which had reviewed and approved
    the earlier document. All four levels of ‘QMS’ documents reviewed and approved by
    the following authorities at XXXX

    Prepared By Approved By Control Status


    DOC No: XXXX/QSP/03

    LOGO NAME Issue No:01


    Date: DD/MM/YYYY
    LOGO Revision No:00
    CONTROL OF DOCUMENTS Date: DD/MM/YYYY
    Page 3 of 5

    Level Prepared by Approved by

    1 Management Representative CEO / MD

    2 Management Representative CEO / MD

    3 Management Representative CEO / MD

    4 Management Representative CEO / MD

    c) Changes and revision status identification:


    Any person at XXXX can initiate change in any level of document. By requesting the
    change, the change suggested and its justification. This forwarded to the MR
    through the concerned area head or process owner. The MR will discuss the
    change suggested and if found appropriate, modify the document incorporating the
    change. After this the changed document reapproved by the same authority, which
    had reviewed and approved the earlier documents. The changes could initiate
    based on difficulties encountered; possibility often or improved practices, internal
    audits, external audits, etc.

    d) Revision status:
    Only those pages, which are amended or revised, replaced and corresponding
    obsolete pages withdrawn. The nature of change recorded in the amendment
    data record. The modified document issued and recorded in the document issue
    record.

    After changes have been made, obsolete document and if the changes have
    been initiated by an observation / Non Conformance Report NCR then this also,

    Prepared By Approved By Control Status


    DOC No: XXXX/QSP/03

    LOGO NAME Issue No:01


    Date: DD/MM/YYYY
    LOGO Revision No:00
    CONTROL OF DOCUMENTS Date: DD/MM/YYYY
    Page 4 of 5

    marked with a common number at the top right corner to inter-relate the
    documents.

    e) Documents of external origin:


    The documents of external origin taken under control entered in the list of
    external origin documents, which include ‘National & International Standards’,
    ‘Customer Drawings’ and ‘Operation & Maintenance Manuals of Equipment’
    (retained for reference only). The national & international standards verified for
    amendments or revision at-least once every year for ensuring availability of latest
    amendments and revisions.

    f) Obsolete:
    Whenever revised documents are formally issued to users, the corresponding
    obsolete documents withdrawn and destroyed. The formal handling over of the
    current issue recorded in the same format as for document issue. One copy of
    all withdrawn documents retained for knowledge purpose. For this purpose the
    ‘MASTER COPY’ of the documents that came obsolete extracted from the
    master file and after striking off with pen across the master copy stamp, and
    stamping them ‘SUPERSEDED COPY’, shifted to the obsolete documents file

    5. RECORDS
    SL.NO. DOC NO DOCUMENT/RECORD MAINTAINED BY

    1. MLD Master list for Issue of MR


    Documents

    2. MLED Master list of External origin MR

    Documents

    Prepared By Approved By Control Status


    DOC No: XXXX/QSP/03

    LOGO NAME Issue No:01


    Date: DD/MM/YYYY
    LOGO Revision No:00
    CONTROL OF DOCUMENTS Date: DD/MM/YYYY
    Page 5 of 5

    Table1

    Sl. No Document Preparation Approval Issuing authority

    1 Quality Policy CEO / MD CEO MD CEO / MD

    2 Quality manual MR CEO / MD MR

    3 Quality system Procedure MR CEO / MD MR

    4 Format MR CEO / MD MR

    Prepared By Approved By Control Status

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