[Company Name]
[Company Group, Division, Location]
Document Title: Released Document Control
Document Number: [Document Number]
Document Filename: [Document Filename]
CONTROLLED COPY/ MASTER COPYSTAMP HERE
OTHER
STAMP HERE
Revision Level / Revision Date / DCO/ECO
Number / Description of Revision / Revision
Author
DRAFT / DD/MM/YY / YY-00000 / Draft / Author Name
1.00 / DD/MM/YY / YY-00000 / Initial Release / Author Name
COMPANY PROPRIETARY AND CONFIDENTIAL
[Company Name] Released Document Control
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY
Table of Contents
1.0 Purpose 2
2.0 Scope 2
3.0 Definition of Terms 2
3.1 [Company Name] Documentation System 2
3.2 Document 2
3.2.1 Organizational Document 2
3.2.2 Production Document 2
3.3 Controlled Document 2
3.3.1 Controlled Copy 2
3.3.2 Uncontrolled Copy 2
3.4 Librarians 2
3.5 Library 2
4.0 References 3
5.0 Responsibilities and Requirements 3
5.1 Technical Support Services 3
5.2 MIS 3
6.0 Procedure 3
6.1 Overview of the Document Retention System 3
6.2 Library 3
6.2.1 Library Structure 3
6.2.2 Library Access 3
6.2.3 Checking Documents into Documentation System 4
6.2.4 Viewing Documents 4
6.2.5 Printing Documents 4
6.2.6 Modifying Documents 4
6.2.7 Controlled Hard Copies 4
6.2.8 Library Backup and Security 4
1.0 Purpose
This procedure describes the methods used by [Company Name]. to distribute and maintain released documents. It also describes the methods used in order to ensure that released documents are secured and protected from uncontrolled and accidental modification.
2.0 Scope
This procedure applies to all documents released under [Company Name]'s procedures for production document release and change control at the facilities of [Company Name].
3.0 Definition of Terms
3.1 [Company Name] Documentation System
The [Company Name] Documentation System is a methodical process through which documents are created, approved, revised, and released. It is used to ensure control, uniformity, and quality of daytoday operations by maintaining a traceable record of document creation and revision.
3.2 Document
A document is any written, printed, or electronic record. Documents include, but are not limited to the following examples: drawings, specifications, blueprints, procedures, and work instructions.
3.2.1 Organizational Document
An organizational document is a general business document, either interdepartmental or intradepartmental, which defines organizational operations not directly related to product manufacture.
3.2.2 Production Document
A production document is a document directly related to the manufacturing process that describes either the product itself or processes directly related to the manufacture of the product. Production documents include design documents and process documents and follow a very structured system of revision control.
3.3 Controlled Document
A controlled document is the original document that must be maintained for uniformity, process control, and tracking. There is only one original for each document, instruction, procedure, standard, or form. It may be maintained on paper, as an electronic file, or in another medium. The master copy of any procedure is the electronic file available for viewing on the network. Controlled documents are maintained by Technical Support Services.
3.3.1 Controlled Copy
A controlled copy is an exact copy of the original controlled document that must be maintained for uniformity, process control, and tracking. It has limited and specific distribution, and each page is marked in red with "Controlled Copy." The Vice President, Quality Systems determines if a controlled copy is necessary. Technical Support Services must issue any controlled copies.
3.3.2 Uncontrolled Copy
Any copy of a document that is not controlled is an uncontrolled copy.
3.4 Librarians
Librarians are those individuals who are granted full access to the library in order to maintain it.
3.5 Library
The library is the controlled access area on the network in which all released documents are stored.
4.0 References
Production Document Release and Change Control
5.0 Responsibilities and Requirements
5.1 Technical Support Services
Technical Support Services is responsible for developing, implementing, and maintaining procedures to maintain and secure copies of released documents, as well as systems and procedures to control the distribution and revision of those documents.
5.2 MIS
MIS will assist in the maintenance of electronic document security by limiting access to the library to designated librarians and by structuring the library as outlined in this document. MIS also is responsible for a system setup that ensures that periodic backups of the library take place.
6.0 Procedure
6.1 Overview of the Document Retention System
The document retention system is an electronicallybased archive with several security levels and a system of backups to ensure that documents cannot be deleted or modified, except under a controlled system. The system will prevent a document, once released, from ever being lost or modified. The modification process will create a new document with a different filename.
6.2 Library
The library is an electronic partition of the network storage system that has controlled access and has been designated as the repository for released documentation. Access to the library is controlled by designating it as a "read only" area in which only select and specific individuals have the capability to write files.
Information in the library will be secured against loss of information through periodic backup of the network files. Additional copies of backups shall be secured in offsite storage location that will protect the information from damage to the basic building structure.
6.2.1 Library Structure
The library will have a structure that will allow easy retrieval and backup of information.
The exact structure of the library is not a controlled feature and will be changed as the number and type of documents retained changes.
6.2.2 Library Access
Any user with basic password access to the computer network will have access to the library. Levels of access to the library are determined by Technical Support Services.
6.2.2.1 General Access
Basic access to the network is controlled at the workstation level through passwords. Any user attached to the network shall have readonly access to the library and may read files and copy files from the library into their own network areas. However, once copied from the library, users will not be able to copy these files back to the library.
6.2.2.2 Restricted Access
To prevent accidental modification of any existing files, only the system manager and selected individuals in Technical Support Services will have the ability to place files in the library. These individuals will be the system librarians. Determination of personnel as system librarians will be made by the Technical Support Services manager.
To prevent other individuals from using a librarian's workstation with its greater network access, librarians will secure their workstations whenever access to the library is not required. This security will be implemented at all times that the librarians are not physically present at their workstations.
6.2.3 Checking Documents into Documentation System
The submission of a new or modified document for release shall be done according to the procedures defined for production document release and production document change control.
Documents submitted to librarians for release shall be placed in a secure area of the library, distinct and separate from released documents, until such time as approval for formal release is verified. Upon approval for release by necessary personnel, the librarians shall move it into the released area of the library.
6.2.4 Viewing Documents
Documents may be viewed at any time by anyone with appropriate software and general access to the network.
6.2.5 Printing Documents
Copies of document in the library may be printed by anyone with appropriate software and general access to the network. Any printed copies of the electronic files are considered to be uncontrolled.
6.2.6 Modifying Documents
Any user with basic password access to the network will have the ability to copy documents onto their own working directories, but they will not be able to copy them back to the library's released directory.
When a working copy of a controlled document is copied by a user with the intent of modifying it, the document should be immediately modified so as to make it obvious that it is no longer the original document.
6.2.7 Controlled Hard Copies
When deemed necessary by Vice President, Quality Systems, Technical Support Services will issue controlled copies of released documents. These controlled hard copies will be clearly marked as such, and Technical Support Services will establish sufficient record keeping procedures to ensure that holders of controlled copies can be identified and that the hard copies themselves may be retrieved.
6.2.8 Library Backup and Security
Local network backups will be performed daily. Offsite backups also will be periodically performed. MIS will do these.
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