Friday, February 28, 2014

SOP: Control of Documents


1.0 GENERAL
 

Scope:

2.0 DEFINITION 
  • Document: information and its supporting medium (refer to section 3.5 of this standard)
  • SOP: A Standard Operating Procedure. A document specified a way to carry out an activity or a process (refer to section 3.19 of this standard).
  • WI: A Work Instruction. A document specified an extent requirement addressed in SOP: Operational Control. It is another way to carry out an activity or a process (refer to section 3.19 of this standard).
  • DCN: Document used to propose a new creation of document or needs of document revision for controlled document.
  • Controlled Document: All document listed in the Document Master List


3.0 RESPONSIBILITY AND AUTHORITY

      Safety Manager:
      • Responsibility: <define the function>
      • Authority: <define the function>
      OSHMR:
      • Responsibility: <define the function>
      • Authority: <define the function>
      SHO
      • Responsibility
      • Authority
      4.0 CONTROL PROCEDURE 
      • New Document
        • Any new document proposal must use DCN.
        • It is however the use of DCN only applicable after the OHSMS has been fully implemented.
        • Any new proposal of document other than OH&S Manual, Procedure and Work Instruction, no DCN issued but QMR need to state evidence of document being reviewed and approval. (Need to confirm the applicability)
        • DCN after filled-in by initiator and submit to MR for review. MR has to review the DCN. Generate a unique reference number if the proposal is accepted.
        • DCN to be forwarded to <MD> for approval.
        • Issue to the respective section.
        • Revision history is placed in the front page of Quality Manual and Procedures to track the changes record.
      • Generation of document numbering.
        • The Quality Manual is to be numbered as follows;  SM – 001.
        • The OH&S System procedures are to be numbered as follows: - SOP  - Sequential Number (001-999).
        • The Work Instruction are to be numbered as follows: WI  - Sequential Number (001-999).
        • The form type code shall be as follows; FM – Sequential Number (001-999)
        • The flow chart or flow process type code shall be as follows; FC – Sequential Number (001-999).
        • The other type of document than above the code shall be as follows; DOC – Sequential Number (001-999)
        • If there any document without the document number, the document is classified as an old document generated before the establishment of company QMS. The QMR will decide the generation of numbering depends on it impact to QMS implementation.
      • Revise Document
        • Any proposal of revision to the existing document must use DCN.
        • Any proposal of changes the existing document other than Quality Manual and Procedure, no DCN issued but need to be reviewed and approved by the MR.
        • The DCN need to be filled-up by issuer and submit to MR for review.
        • MR has to review the DCN. Generate a revision number based from running order if the changes are accepted.
        • DCN to be forwarded to <MD> for approval.
        • If use of DCN is not applicable, old version of document need to be cleared first before use of revised document. Where applicable, MR has authorized to stop usage of old document if reflected to the document control conformity.
      • Additional control required for revision of OH&S Manual and procedure;
        • Changed item will over write the old version of document.
      • Integrity of document
        • Master Copy shall be in PDF file and stored in <web-based system>.
        • Copy of document is allowed but shall obtain approval from MR before issuance.
        • Original soft copy only kept by the MR for reference or to be used upon requires for changed.
        • Maintenance of soft copy should be in appropriate manner and back-up system should be activated.
        • If requires an extra hard copy, MR will justify the method of distribution and <DRL> will be update
        • Distributed copies shall be indicated with CONTROLLED in red on the first page of Revision History. MASTER indication shall be remained but font to be set in black color.
        • Distribution of document should be completed by filling the <DRL>.
        • Any content printed onto hard copy format will be deemed 'uncontrolled' & will not maintained as part of the OH&S management system.
      • Control of External Document
        • External document can be described as any document originated by the external parties which may reflected to the product conformity and/or QMS implementation effectiveness.
        • Following is the list of external document kept by company;
          • Document A
          • Document B
          • Document C
          • Document D
        • Control of the external document shall be in accordance to Integrity of Document subject.
      • Control of Obsolete Document
        • After approval process of DCN is completed or any existing document is no longer to be used, the superseded document should be returned to <MR> to prevent unintended of use.
        • No obsolete copy is applicable for Master Copy of OH&S Manual and SOP as changes being made is done through over-writing the valid document.
        • Obsolete document should be crossed and can be used as a recycled paper.
        • Master copy of obsolete document (if applicable) can be retained as for reference and indicated by OBSOLETE at each pages for identification.
        • The soft copy of obsolete document must be kept by MR only, if necessary.
      • Document should remain legible and readily identifiable.
        • All documents must be readable and given the clear direction in meeting the intent of its establishment.
        • No any duplication of document prior approval as procedure is described for new creation document and amendment of document as above.
        • Any establishment or re-establishment of document which are not following with procedure for document creation or revision of document process, the document is consider invalid.
        • If distributed document found damaged or unable to be read due to circumstances, <process owner> should ask <document controller > to provide new legible document. jihiuhui
      • Maintenance of document
        • MR shall ensure the controlled document shall be preserved though periodical backup process.  
      5.0 CROSSED REFERRENCE SECTION
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      6.0 RECORDS
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