01 QA-P01 Control of Documents Rev C
01 QA-P01 Control of Documents Rev C
DOCUMENTS
ST/QA/P01
Revision No: C
APPROVAL
REVISION HISTORY
1.0 PURPOSE
The purpose of this procedure is to define the Document Control System for the approval, distribution
and revisions of all documents within the scope of the QMS.
2.0 SCOPE
This procedure covers the control of documents and data which form part of the Quality Management
System.
5.0 PROCEDURE
3.1. GENERAL
3.1.1. The QA Manager shall be the Overall responsible person for this procedure. The Department
HOD’s shall be the Functional responsible persons for this procedure.
3.1.2. The Management Representative shall be responsible for ensuring that the procedure, work
instructions and all other Quality System documents comply with the requirements.
3.1.3. This includes the review and approval for adequacy prior to issue of new as well as revised
procedures, work instruction and forms, making the relevant issue of documents available at all
appropriate locations and promptly removing obsolete documents, ensure documents remain
legible and readily identifiable.
3.2.1. When a department / employee of ST wants to create or amend any procedure / work
instruction, they can initiate the Document Approval Request process.
3.2.2. The originator shall fill in the Document Change Notice and submit to their departmental HOD.
3.2.3. The departmental HOD shall review the necessity, usefulness and the technical correctness
and completeness of the document, including meeting relevant legislative and other
requirements.
3.2.4. If he / she satisfied with the necessity of the DAR, shall submit the document to QA
department.
3.2.5. Quality Document Controller shall assign the record number as per Appendix A – Document
Coding and Numbering System of this procedure.
3.2.6. MR shall review the document for the adequacy to but not limited to the following;
3.2.7. If the above criteria are met, MR shall complete the Document Change Notice and forward to
QMR for approval.
3.2.8. QMR shall approve all the QMS document originated from QA and MR.
SWASTIKAA TECH (M) SDN BHD CONTROL OF DOCUMENTS
3.2.9. Quality Document Controller shall update the Documents Master list and distributed
accordingly.
3.3.1. Prior to issue and release, the documents are reviewed for adequacy, correctness, and
conformity to the established quality policy. A document is considered to be formal when it is
authorized and approved for release by the issuing authority.
3.3.2. The review and approval authority for all new / revise QMS documents is as per APPENDIX B -
Documents and Approval Authorities of this procedure.
3.4.1. The Document Approval Request shall be initiated for any revision or amendments of any level
of QMS documentations.
3.4.2. For any amendment(s) in any of the QMS documents, the same steps mentioned above in
Section 5.2 shall be followed.
3.4.3. All the revisions, additions, changes and deletions, will be documented in the Revision History
page.
3.4.4. Changes to the documents shall be reviewed and approved by the same functions or
authorities that performed the original review and approval and refer to the Appendix B -
Documents and Approval Authorities.
3.4.5. Once approved, Quality Documents Controller shall update the revision of the document.
3.4.6. Document Master List will be updated with the new revision number by the Quality Documents
Controller.
3.5.1. Since the documents are converted into PDF format and generated from the system itself “NO
SIGNATURE IS REQUIRED” in the documents.
3.5.2. All the persons having access to the computer will have the “relevant” access to the
documents.
3.5.3. The printed hard copies other than ‘Controlled’ and ‘For Reference’ kept by QA department are
considered to be uncontrolled.
SWASTIKAA TECH (M) SDN BHD CONTROL OF DOCUMENTS
3.6.1. Hard copy of the QMS Documents will not be distributed to any departments instead they can
print out the uncontrolled copy from the common drive.
3.6.2. Master copy water marked with ‘Controlled’ is kept by the QA Department.
3.6.3. All the obsolete QMS documents hard copies will be destroyed and no obsolete hard copy will
be maintained. If needed QA ONLY can keep the obsolete documents by stamping as
“Obsolete” for future references.
3.6.4. Each department is responsible for ensuring the QMS documents under their possession are
correct, legible and easily retrievable.
3.6.5. The respective HOD is responsible for the internal communication / training of such
documents / information to their department employees.
3.7.1. Copies of the documents issued to external agencies, such as potential customers at technical
proposal stage, or to suppliers for order shall be water marked with “CONTROLLED”.
3.7.3. QMS documents to external parties shall be given ONLY by the QA department.
3.8.2. Respective Department in charge shall submit the external document that need to register and
control to DCC Supplier procedures and other quality related records when required to be
maintained for future references or use, the same shall be maintained.
3.8.3. Legislations, legal requirements and other documents originated by external sources shall be
controlled by QA.
SWASTIKAA TECH (M) SDN BHD CONTROL OF DOCUMENTS
4.0 RECORDS
Document Master List
Document Distribution Record
Document Change Notice
5.0 ANNEXURES
Appendix A - Documents and Approval Authority
SWASTIKAA TECH (M) SDN BHD CONTROL OF DOCUMENTS
QMS Documents
Review
SN* Type of Document Originator Approval Authority
Authority
Engineering /
05 Work instructions Any Employee Concerned HOD
Production / QA
Standard Operation
06 Any Employee - Concerned HOD
Procedure
07