[Company Name]

[Company Group, Division, Location]

Document Title: Released Document Control

Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision

Level Date Number Description of 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

Table of Contents....................................................................................................................................................1

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

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[Company Name] Released Document Control
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

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
day-to-day 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.

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[Company Name] Released Document Control
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

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 electronically-based 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 off-site 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 read-only 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

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[Company Name] Released Document Control
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

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. Off-site backups also will be
periodically performed. MIS will do these.

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