Documentation relating to all project activity is prepared and maintained by
each organizational element. Such documentation will provide accurate and
current information on all project activities and for all information which contributes to the understanding of the project. Records are reviewed by appropriate personnel and provided to all concerned organizational elements. Procedure for documentation and record maintenance and retention are given as below:
1.1. This procedure defines the requirements for the creation, review, approval, distribution, use and revision of quality management system documents.
1.2. This procedure applies only to documents which instruct office/site staff on how to carry out activities and tasks; this includes manuals, procedures, forms and instructional sheets or posters.
2.1. Creation of Documents
2.1.1. Documents are created by an appropriate subject matter expert.
2.1.2. All internal documents are created as soft files (MS Word®, etc.); it is recommended that files of a similar type follow the format of other documents in that type.
2.1.3. Draft versions must then be sent to the appropriate approver(s) for review and approval.
2.1.4. Original releases of documents are given a revision indicator of “0”.
2.2. Review and Approval
2.2.1. The Quality Manual may only be approved by the senior Management. Other documents are to be approved by the original author, or a company executive.
2.2.2. Draft files may be sent to the approver(s) via hard copy or e-mail.
2.2.3. The reviewer will resolve any issues with the original author to achieve a satisfactory document.
2.2.4. The reviewer will indicate approval of the document by e-mail.
2.2.5. The approved document shall then be forwarded to the Document Controller .
2.2.6. If hard copy binder will be used , document Controller , will maintain a binder of most current hard copy versions of documents.
2.2.7. The Document Controller will maintain a computer folder, on the company server, for the latest soft copy versions of document with backup facility. The Document Controller Title will place new or revised documents into that folder, Any previous soft versions are then moved to a separate folder identified for obsolete documents which are kept for historical purposes.
2.2.8. The directory of official released documents shall act as a “master list” of documents, indicating the setting each file’s permission to READ ONLY, or converting the released versions to a non-editable file format.
2.2.9. current versions of all documents. No other master list is required.
2.3. Distribution of Documents
2.3.1. If intranet is used, Controlled documents will be available via the intranet for all employees.
2.3.2. If hardcopy document distribution is used, the Document Controller will maintain a list of where controlled hardcopy documents are to be distributed. The Document Controller will be responsible for distributing updated copies of such controlled hardcopies to proper locations. Controlled hardcopies shall be marked with stamp in color ink on the first page as CONTROLLED, to distinguish them from uncontrolled documents or photocopies.
2.3.3. Controlled hardcopies may not be altered or modified by users, and must remain legible and readily identifiable. This includes hand mark-ups by unauthorized personnel. Controlled hardcopies may not be photocopied, unless for the purposes of sending to a recipient who is authorized to receive uncontrolled versions of Project documents (i.e., a vendor or customer).
2.4.1. Documents must be reviewed by the original author or another subject matter expert or top manager as required.
2.4.2. The Document Controller will ensure re-evaluation is conducted and that documents are updated if required. The Document Controller will maintain a record of document re-evaluations of any process, to identify when documents are due for re-evaluation.
2.4.3. If a document is determined to require updating, the changes shall be made and a new version issued per the rules below.
2.4.4. If a document is determined not to require updating, no action on the document is necessary.
2.5. Revising Documents
2.5.1. Changes to documents go through the same steps as original issue, except that their revision level is advanced upon approval.
2.5.2. Only authorized personnel may change documents, although any employee can request a change to their Manager, or other document change request form. All the revised document shall include a change history table within its text.
2.5.3. Any changes to documents require authority review and approval shall be submitted accordingly, and not implemented until such approval is obtained.
2.5.4. If document changes require regulatory approval prior to implementation, this will be obtained in writing & reflect the reason for the change.
2.5.5. Re-evaluation, inspection (where applicable) and internal auditing will confirm the effectiveness of changes.
2.6. Controlling Documents of External Origin
2.6.1. For external documents such as standards or third party specifications which are referenced in a customer purchase order or contract, these documents may be maintained without control.
2.6.2. For external documents such as standards or third party specifications which are not referenced in a customer purchase order or contract, these must be controlled. Such control requires that the Document Controller or responsible manager obtain the latest version of the document, and maintain it on the company server (for electronic versions) or in a binder of controlled external documents (for hardcopies). Like other controlled documents, these may not be edited or copied.
2.6.3. Third party specifications and prints, including those of the customer, are controlled per the configuration management requirements set forth in the Quality Manual .
2.6.4. External documents for non-critical use, such as user manuals, reference books, marketing materials, and supplier directories are not controlled.
2.7.1. Forms are a special kind of document that may be photocopied as needed. A softcopy of each approved form should be sent to document controller for his record for inclusion in the Document Master List .