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STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT

1.0 OBJECTIVES To define the controls needed

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1.1 To approve documents for adequacy prior to issue, 1.2 To review and update as necessary and re-approve documents, 1.3 To ensure that changes and the current revision status of documents are identified, 1.4 To ensure that relevant versions of applicable documents are available at points of use, 1.5 To ensure that documents remain legible and readily identifiable, 1.6 To ensure that documents of external original are identified and their distribution controlled, and 1.7 To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purposes. 2.0 SCOPE Applicable to all documents established for the Quality Management System of ABC International Berhad as follows. 2.1 Quality Manual 2.2 Standard Operating Procedures 2.3 Work Instructions, and 2.4 Forms / Records 3.0 RESPONSIBILITIES The Quality Management Representative is responsible to establish, document, implement and maintain this procedure. 4.0 REFERENCES 4.1 ISO 9001:2000 / 4.2.3 4.2 Quality Manual of ABC International Berhad 5.0 ACRONYM 5.1 Quality Management System 5.2 Quality Management Representative 5.3 Quality Manual 5.4 Standard Operating Procedure 5.5 Work Instruction 5.6 Job Description 5.7 Head Of Department - QMS - QMR - QM - SOP - WI - JD - HOD 1st level document 2nd level documents - 3rd level documents 4th level documents

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT


6.0 PROCEDURE 6.1 Preparation and validation of New Document 6.1.1 6.1.2 6.1.3 6.1.4

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The Originator to prepare the draft of the document with white A4 papers and provide an appropriate document name. Submit the draft of the document to the respective Head Of Department for review and approval. Forward this approved draft to the QMR to prepare for an Official Draft. QMR to prepare the Official Draft and indicate all the relevant approval parties needed on the front page of draft using the DRAFT COPY APPROVAL format as shown in the sample below. DRAFT COPY APPROVAL

Position Name Signature Date

CEO AS Tan

GM

Engineering

Quality

HOD

HOD of Doc. Owner.

Originator

6.1.5 6.1.6 6.1.7

6.1.8

QMR to return the prepared Official Draft to the originator for review and approval prior to obtain the approval of HOD of document owner. QMR will then forward this approved and duly signed Official Draft to the HOD of other department affected for review and approval. All the parties concerned to review the completeness and adequacy of the Official Draft document and its compliance with the requirements of ISO 9001:2000 Standard and Quality Manual. Any amendment or disagreement made shall be referred back to the originator and the draft approval process is then repeated. The QMR shall forward the HODs approved Official Draft pertaining any of the following matters to the CEO for his final mandatory approval. 6.1.8.1 Policy change 6.1.8.2 Process change 6.1.8.3 System change and 6.1.8.4 Quality standard change Similarly, any amendment or disagreement made by the CEO shall be referred back to the originator to be rectified and the draft approval process is to be repeated.

6.1.9

After obtaining the approval of CEO, the QMR will prepare the Master Copy of document and its History Page using white A4 papers.

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT

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6.1.10 QMR to sign on this History Page and forward to the Executive Director for approval. 6.1.11 The approved Master Copy of document shall be safeguarded and its distribution controlled by QMR. 6.2 Format Of Document 6.2.1 Letterhead of the Master Copy of document shall contain the following informations. 6.2.1.1 Name of the company ABC INTERNATIONAL BERHAD 6.2.1.2 Type of document - e.g. QUALITY MANUAL, STANDARD OPERATING PROCEDURE, WORK INSTRUCTION or FORM. 6.2.1.3 Name of document - e.g. CONTROL OF DOCUMENT 6.2.1.4 Document number - e.g. SOP-12 (refer 6.3 ) 6.2.1.5 Revision number - e.g. 05 (Two-digit number) 6.2.1.6 Effective date - e.g. 08/02/2007 6.2.1.7 Page - e.g. 3 of 48 6.2.1.8 Section - e.g. EHF (if necessary) 6.2.1.9 Line - e.g. Face Line (if necessary) Letterhead sample for Standard Operating Procedure ABC STANDARD OPERATING INTERNATIONAL PROCEDURE BERHAD CONTROL OF DOCUMENT
Doc. No. Revision Date Page : SOP-12 : 05 : 08/02/2007 : 3 OF 48

Letterhead sample for Work Instruction WORK ABC INSTRUCTION INTERNATIONAL BERHAD QC FACE LINE Letterhead sample for Form ABC INTERNATIONAL BERHAD FORM DOCUMENT MASTER LIST

Doc. No. Section Line Revision Date Page Doc. No. Revision Date Page

: WI-QC-01 : : : 05 : 08/02/2007 : 3 OF 48 : F-SOP12-01 : 00 : 08/02/2007 : 3 OF 48

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT


6.2.2

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The content of the document shall follow the sample format given below as a guide. 1.0 OBJECTIVE:

2.0 SCOPE:

3.0 RESPONSIBILITY:

4.0 REFERENCE:

5.0 DEFINITION: (If necessary)

6.0 ACRONYM: (If necessary)

7.0 PROCEDURE or INSTRUCTION: 7.1 7.2 7.2.1 7.2.2 a)

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT

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8.0 APPENDIX: (If necessary) 8.1 8.2 9.0 RECORD: (If necessary)

10.0

CHART:

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT


6.3 Document Number

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All documents shall be categorized and shall be assigned a document number according to type, section / department and content. The method of categorization of document is as follows. a) Quality Manual: QM Where QM is the acronym for Quality Manual. b) Standard Operating Procedure: SOP-XX Where SOP is the acronym for Standard Operating Procedure and XX is the serial number of the Standard Operating Procedure. c) Work Instruction: WI YY XX Where WI is the acronym for Work Instruction, YY is the type of Work Instruction and XX is the serial number of the Work Instruction. d) Form / Record: F ZZZZ XX Where F is the acronym for Form / Record, ZZZZ is the type of reference document and XX is the serial number of the Form / Record.

STANDARD OPERATING PROCEDURE CONTROL OF DOCUMENT


6.4 Review And Approval Of Document

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Head Of Department is responsible and empowered to review and up-date the documents of his respective department for adequacy and suitability. All documents shall also subject to the approval of HOD of any other relevant department, section or individual having concern / interest in that document. 6.5 Final Endorsement Of Approved Document