Document Control Stamp - ARABI ENERTECH K.S.C



Document Control Stamp

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1. Objectives: Description of the methods used to ensure the review, authorization, issue, amendments, distribution and control of all quality system documentation and the control of reference documents.

2. Resources: None

3. Scope of Application:

This procedure applies to the quality management manual, quality management procedures, standard operating procedures, work instructions, and reference documents.

4. Normative References-Definitions:

1. Reference Documents - Any document used as a reference apart from the quality procedures e.g. product specifications, National and International standards and codes, and spare parts catalogue.

5. Responsibilities

1. Management Representative is responsible for the issue, distribution, amendments, and control of the documentation system.

2. Quality Steering Committee is responsible for the reviewing the quality system periodically to assure adequacy periodically as specified in this procedure.

3. Each designated holder of quality system documents is responsible of them and has to deal with as described within the document control procedures.

6. Process

1. Quality System Document Control

1. The Quality Manual and Quality Procedures shall be subject to review and authorization by the Management Representative prior to issue or amendment. The review shall include a consultation process in which those affected by any changes have the opportunity to comment.

2. Quality Management System (Quality Manual, Quality Procedures and Work Instructions) will be reviewed annually by Quality Steering Committee and the review result will be documented on Quality Management System Review Form (qf-doc-01-06)

3. Changes to quality system documentation may be proposed as a result of audits, or because personnel operating the procedure identify a way in which it can be improved. Proposed changes to quality system documentation shall be recorded on a Issue, Change Document request (qf–doc-01-1), which shall be subject to authorization by the Management Representative. The master copy of each Issue, Change Document request (qf–doc-01-1) shall be retained on file by the Management Representative.

4. Documentation process and procedures formats are discussed in Procedures Documentation Procedure (QP-doc-02).

2. Issue Control

1. Copies of the Quality Manual, Quality Procedures and Work Instructions shall be issued under a control system which ensures that all personnel have available to them an up-to-date copy of all relevant documents. Controlled copies shall be stamped with “Controlled Copy” and numbered, and may not be photocopied. Issue of new or amended quality system documents shall be controlled by the Management Representative, who shall maintain a register of all controlled copies in controlled document Document Distribution List (qf–doc-01-02), and shall record that all copies have been updated and all personnel notified of the changes.

2. The issue number is simply a one number figure pointing to the level that the quality system is at, starting from number 0 (Zero) which indicates that the overall system is draft. When the issue number is increased to 1 (one) that means that the system is at the first official and final status. When major changes on the system take place, like most of the quality manual most of the quality procedures and work instructions have been amended 6 times, the issue number may be increased.

3. The revision number is simply a one number figure, starting from number 1, which indicates the first revision of a certain revision. When any document within the quality system is amended or changed, fully or partially, the index number has to be increased by one. The index number is reset to one each time the issue number is increased. All the changes will be identified by being underlined writing.

Example 1: If the document control procedure is at issue no. 1 and revision no. 2, and some changes were introduced to paragraph 5.1. Then the revision number should be increased to 3, were the issue number will stay at 1.

Example 2: If the document control procedure is at issue no. 2 and revision no. 6, and the system had major changes, then the revision number will be reset to 1 while the issue number will be increased to 3.

4. Master copies of those documents shall be held by the Management Representative, who shall ensure that the amendment history is updated at each change in controlled Document Distribution List (qf–doc-01-2).

5. Uncontrolled copies of Quality System documentation may be made available only by the Management Representative, who shall ensure that they are clearly identified and stamped as “Uncontrolled Copies” and that the recipient understands that they will not be updated.

6. Old issues of the quality manual, quality procedures, and work instructions have to be withdrawn by the Management Representative upon providing the concerned staff member with the new issue. Those old copies are stamped with “Cancelled” stamp and disposed, keeping one copy for record in a specified file.

3. Issue Control

1. Record Forms and Cards

1. Forms are subject to issue control also. The issue status for a form is shown in one starting from 0 to show that a form is draft and not in the system yet, and the issue number is raised to (a) once the form is used officially. Then the issue letter is raised to the following letter with each amendment and changes applied to the form.

Example: If the Purchase Order is at issue b, and some changes were introduced to the contents of the order, then the new issue number should be changed to c.

2. Amendment of record forms used within the company, and referenced in the Quality Procedures, shall be subject to the authorization of the Management Representative, as described for Quality Procedures in 6.1 above. Form format shall be reviewed annually, or when forms are due for reprinting, at the discretion of the Management Representative. The authorization for any changes shall be recorded on a Issue, Change Document request (qf–doc-01-1).

3. The Management Representative shall ensure the disposal of any old forms remaining when revised forms are introduced.

4. Reference Documents

1. Various documents, including product specifications, and national and international standards and codes, shall be held for reference. These shall be listed in a Reference Index (qf–doc-01-3) which shall contain details of the documents held, their location and their revision status. Documents retained for reference are not regularly updated by the company, shall be marked "Reference Document".

2. When a new specification, or a new edition of an existing specification, is added to the Reference Index, the Management Representative shall ensure that it is reviewed to identify any changes which have significant implications, such changes shall be notified to the personnel affected.

3. The Reference Index (qf–doc-01-3) shall be updated whenever reference documents are updated, added, replaced or removed.

5. Documentation Master List

1. The Management Representative creates a Documentation Master List (qf–doc-01-4) for all controlled documentation.

2. The Documentation Master List is on-line and available throughout the office

3. At the start of each work order, new task, etc., the documentation user is required to access the Documentation Master List (qf–doc-01-4) and validate the revision and issue level of the documentation intended for use.

4. Work must not commence if there is a difference between the Master List and the available documentation at the work site.

5. The user will report the difference to his department supervisor.

6. The supervisor will procure the correct documentation and determine why the normal distribution of documentation did not occur.

7. Persistent occurrence of delayed distribution of documentation will be submitted to the Continual Improvement Procedure (QP-ci-01).

6. Control of Electronic Data

1. Electronic data will be controlled by having a certain password at each computer to assure that there isn’t any unauthorized use. Also there will be a virus detector on each computer, and there will be a back up performed on a weekly basis

2. Back up shall be performed all departments on weekly basis using the Back-up Follow Up Sheet (qf-doc-01-05).

7. Related Documents:

1. Procedures Documentation Procedure (QP-doc-02)

8. Records

The following documents are defined as quality records for the purpose of section 4-2-4 BS EN ISO 9001: 2000

1. Issue, Change Document request (qf–doc-01-1)

2. Controlled Document Distribution List (qf-doc-01-2)

3. Reference Index (qf-doc-01-3)

4. Documentation Master List (qf-doc-01-4)

5. Back-up Follow Up Sheet (qf-doc-01-5)

6. Quality Management System Review Form (qf-doc-01-06)

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