Control of Documents Procedure

1.      PROCEDURE

1. Creation of Documents

1.1.1.        Documents are created by an appropriate subject matter expert.

1.1.2.        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.

1.1.3.        Draft versions must then be sent to the appropriate approver(s) for review and approval.

1.1.4.        Original releases of documents are given a revision indicator of “0”.

1.2.  Review and Approval

1.2.1.        The Quality Manual may only be approved by the Managing Director.  Other documents are to be approved by the original author, an appropriate area manager or a company executive.

1.2.2.        Draft files may be sent to the approver(s) via hardcopy or e-mail.

1.2.3.        The reviewer will resolve any issues with the original author to achieve a satisfactory document.

1.2.4.        The reviewer will indicate approval of the document by signing on the first page of the document with date.

1.2.5.        The approved document shall then be forwarded to the Management Representative.

1.2.6.        The Management Representative will maintain a binder of most current hardcopy versions of documents. Any previous hardcopies in this binder are to be discarded or filed in an obsolete document file.

1.2.7.        The Management Representative will maintain a computer folder, on the company server, for the latest soft copy versions of document. This file set must be on a server subject to data backup.

1.2.8.        The Management Representative will place new or revised documents into that folder, setting each file’s permission to READ ONLY, or converting the released versions to a non-editable file format.

1.2.9.        Any previous soft versions are then moved to a separate folder identified for obsolete documents which are kept for historical purposes.

1.2.10.    The directory of official released documents shall act as a “Master List” of documents, indicating the current versions of all documents. No other master list is required.

1.3.  Distribution of Documents

1.3.1.        Internet: Controlled documents will be also available via the internet for authorized employees. Authorized Employees receive training on how to access current documents.

1.3.2.        Hardcopy: Where hardcopy document distribution required the Management Representative will maintain a list of where controlled hardcopy documents are to be distributed. The Management Representative will be responsible for distributing updated copies of such controlled hardcopies to proper locations. Controlled hardcopies shall be stamped CONTROLLED in red ink on the first page, to distinguish them from uncontrolled documents or photocopies.

1.3.3.        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. The only exception to this rule is for Forms (see below.)

1.3.4.        Controlled hardcopies may not be photocopied, unless for the purposes of sending to a recipient who is authorized to receive uncontrolled versions of Lyra (Pvt) Ltd documents (i.e., a vendor or customer). The only exception to this rule is for Forms (see below.)

1.4.  Re-Evaluation

1.4.1.        Documents must be reviewed by the original author or another subject matter expert or top manager regularly.

1.4.2.        The Management Representative will ensure re-evaluation is conducted and that documents are updated if required. The Management Representative will maintain a record of document re-evaluations, to identify when documents are due for re-evaluation.

1.4.3.        If a document is determined to require updating, the changes shall be made and a new revison number issued per the rules below.

1.4.4.        If a document is determined not to require updating, no action on the document is necessary.

1.5.  Revising Documents

1.5.1.        Changes to documents go through the same steps as original issue, except that their revision level is advanced upon approval. 

1.5.1.1.              Only authorized personnel may change documents, although any employee can request a change to their Manager, or by filing a Change Request Form.  Wherever possible, the document shall include a change history table within its text. Forms do not require a revision history table.

1.5.1.2.              All documents created and distributed via internet at http://www.companycertification.com/lyra are full revision controlled with complete change history record readily available online. Only current and approved documents are available to the users and change history table is available under revisions tab of each document node.

1.5.2.        Any changes to documents that require customer or regulatory authority review and approval shall be submitted accordingly, and not implemented until such approval is obtained. 

1.5.3.        If document changes require customer or regulatory approval prior to implementation, this will be obtained in writing.  When processes are changed, the appropriate documentation shall be updated, with a change history updated to reflect the reason for the change. 

1.5.4.        Re-evaluation, inspection (where applicable) and internal auditing will confirm the effectiveness of changes.

1.6.  Controlling Documents of External Origin

1.6.1.        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, provided that the revision of the document on file matches the revision indicated by the customer. Where the customer provides no revision number, the latest (most recent) revision shall be assumed.

1.6.2.        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 Management Representative 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.

1.6.3.        Third party specifications and prints, including those of the customer, are controlled per the configuration management requirements set forth in the Lyra (Pvt) Ltd. Quality Manual. 

1.6.4.        External documents for non-critical use, such as user manuals, reference books, marketing materials, and supplier directories are not controlled.

1.7.  Forms

1.7.1.        Forms are a special kind of document that may be photocopied as needed.  Furthermore, forms do not require an approval signature; department managers are responsible for creating and using forms in their areas.

1.7.2.         A softcopy of each approved form must be sent to the Management Representative for inclusion in the document control area on the intranet/internet, and for inclusion in the Document Master List.

1.8.    Distribution of Printed Documents

1.8.1. Whenever necessary to distribute printed controlled copies or external documents, the Management Representative will do it, according the Printed Document Distribution Record.

Note:

Optionally following records are maintained online at www.companycertification.com

• Document Master List
• Change Reqeust Form & Log
• Printed Document Distribution Record