CM-MA-100 Procedure for The Preparation of Quality System Documents

Table of Contents

1. Purpose
2. General
3. Responsibilities
4. Procedure
5. Flowchart
6. References
7. Attachments

1. Purpose

This procedure describes the preparation and administration of all Company Quality System Documents. The preparation and control of Company’s Q.A. Manual is covered in section 10.6.3 of Company’s Q.A. Manual.

This procedure will not further address the Q.A. Manual.

This procedure shall also be used as an example of how a "procedure" shall be formulated and presented.

2. General

This procedure shall apply to all procedures that identify the activities and functions of departments or groups and shall be observed by all Company departments and groups.

1. Procedures describing a flow of activities and also ‘who’ is responsible for 'what' activities.
2. Work instructions giving details on 'how' activities are completed. Work instructions are written if activities need to be standardized or if the absence would adversely effect "Quality".
3. A guide is a reference document that is intended to assist the responsible persons to carry out activities. The guide may give additional details and/or include a checklist of the activity. Details may also refer to relevant standards.
4. A standard is a specific piece of information, detail or form that, in whole or in part, may be incorporated in a product.

For the preparation of project specific procedures refer to 6.5.

2.1 Company Documented Quality System

This system is composed of Company standard documents divided into the following levels.

2.2 Quality Assurance Manual

This Quality Assurance Manual contains the objects, tasks and measures, general responsibilities of Company's department and project activities compiled as a corporate Quality Assurance Program.

2.3 Company Procedures Manual

The Company Procedures Manual is a collection of Company's inter-departmental and administrative procedures.

2.4 Departmental Procedures Manual

This level of procedures covers the activities within and limited to each department.

2.5 Work Instructions

Work instructions that are referred to in procedures.

2.6 Guides and Standards

In addition to the mandatory documented Quality System, departments may establish documents for easy reference. Information for the implementation of operations can be taken from:

• (General/engineering/design) standards
• (General/engineering/design) guides
• (Standard) specifications
• (Standard) requisitions
• Standard forms

3. Responsibilities

The Manager of Quality Assurance (Q.A.) or his delegate shall administer all Quality System documents on behalf of all Company departments, including filing of originals, retention of records of approvals, signatories, distribution and revisions, together with the coordination of Quality System document production and maintenance.

Departmental Managers or their delegates shall initiate preparation of the Quality System documents as required, assign authors for new documents, review applicable documents in conjunction with other responsible personnel, review inter-departmental procedures and ensure the implementation of those applicable within their own departments.

The Author shall prepare and develop a quality system document in accordance with the requirements of this procedure including coordination of checking and approval activities.

The Printroom Supervisor is responsible for the filing of originals of a selected number of standard forms.

4. Procedure

4.1 Authorization to Proceed

Anybody may identify the possible requirement for a new, additional or updated quality system document.

The appropriated departmental manager shall be responsible for the authorization to proceed with the development of such a document.

Such authorization shall be confirmed with the Manager of Q.A., prior to proceeding, so as to ensure the coordination and integration of all similar activities.

Once the authorization has been confirmed, an author shall be assigned. The Author shall obtain a definitive quality system document number from the Manager of Q.A. (refer to 6.6).

In the event that the decision to proceed with the document is withdrawn the Manager of Q.A. shall be advised to allow the register to be amended accordingly.

4.2 Preparation

Procedures are to be prepared in accordance with (ref. 6.8).

Work Instructions are to be prepared similarly to procedures (ref. 6.8), although a flowchart is not required and the topics of the index may vary.

Guides and Standards text is prepared similarly to work instructions.

Standard drawings shall have the layout as per (ref. 6.9).

Standard forms are to be prepared in accordance with (ref. 6.10).

4.3 Authorization

The Q.A. Manual is:

• "Checked" and "Approved" by the Manager of Quality Assurance.
• "Certified" if appropriate, by the General Manager and the Manager of Quality Assurance.

Other quality system documents are:

• "Checked" by a supervisor of the appropriate department.
• "Approved" by the Departmental Manager/Manager of Q.A.
• "Certified" if appropriate by the Departmental Manager and Manager of Q.A.

Once a standard form has been prepared/revised, the author shall submit the draft to the Form Administrator. The final version shall be returned to the originator to obtain authorization from his departmental manager. After receipt of the approved form, the form will be released on the network

4.4 Issue

Once a Quality System Document has been developed and authorized in accordance with para.4.3, the document shall be issued by the Manager of Q.A. to the relevant personnel for comments.

"Comments" are to be submitted to the Author.

If recipients do not submit comments within a stated period then their agreement with the document as presented, will be assumed. The allocated period for such comments to be submitted, shall be based on approximately one sheet per working day (i.e. 7 sheets in 7 days), however with a maximum of 14 days.

The Author shall expedite and receive all comments back for review. If comments have been agreed by the Author with the responsible managers and incorporated into the document, the document shall be re-issued "certified" similarly as in 4.3 and 4.4.

The certification signatures on the front sheet shall be deemed to certify the complete document and (if applicable) its attachments. Subsequently revisions shall be considered "certified", if initialed as "approved" on the front sheet revision.

The Manager of Q.A. shall establish and maintain a record and examples of signatures and initials of personnel authorized to approve and/or certify Quality System Documents.

4.5 Revision

Requests for revisions to Quality System Documents shall be submitted to the Manager of Q.A., for review with applicable parties and confirmation for action if agreed.

Revisions to Quality System Documents shall be identified by the issue code, issue date and triangles to the left of the test in a similar manner as described in ref. 6.7.

Signatures for revised issues shall be as described in 4.4.

Each issue cancels and replaces all previous issues.

4.6 Document Control

The original document, it's attachments and all comment prints shall be passed to the Manager of Q.A. once the procedure is ready for issue.

The Manager of Q.A. shall update the Quality System Document control index.

The control index summary of level 1 through to 5 shall be regularly distributed by the Manager of Q.A.

The Manager of Q.A. shall establish and maintain files for the Quality System Documents containing:

• the document original;
• previous issues and superseded documents (ref. 6.3);
• records of departmental manager's comments, that will be kept for one month after the document's re-issue;
• distribution list or coding.

The Printroom supervisor shall establish and maintain files for the originals of selected standard forms. The majority of the forms is available on the network: L:\STD\REC.

Standard forms are not distributed. The originals, if filed by the print room, and copies thereof may be requested by means of the reproduction form ref. 6.11.

4.7 Distribution

Certified Company Quality System Documents and subsequent revisions shall be distributed by the Manager of Q.A., (or designate) in accordance with distribution lists approved by the relevant managers (ref. 6.1).

Recipients of Quality System Documents shall be responsible for the disposal of superseded documents in their possession.

5. Flowchart

Development of Procedures

6. References

7. Attachments

None.