QUALITY SYSTEM PROCEDURE

Document and Data Control

Procedure No.: QSP-05

Copy No.:

Original Issue: December 19, 1997 Page No.: 1 of 5

Revision Level: 12 Revision Date: December 27, 2012
Issued by: Approved by:

Controlled copies of this procedure are printed on tan paper.

Uncontrolled copies are stamped in red “Uncontrolled Document” on each page. Uncontrolled copies of the
Quality Manual, Quality System Procedures and Work Instructions are released upon the authority of the
Management Representative for commercial and training purposes only.
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QUALITY SYSTEM PROCEDURE Revision: 12
TITLE: Document and Data Control Revision Date: December 27, 2012

1.0 PURPOSE

This Quality System Procedure describes methods of working, individual

responsibilities, standards of workmanship, retained records, and arrangements for
corrective and preventive action used to control quality system documentation and
data approval, revision, and issue.

2.0 RESPONSIBILITIES

The Management Representative ensures documents and data are properly

identified and controlled, ensures all documents and data have been approved for
completeness and adequacy by authorized personnel prior to use, prevents the use
of outdated or obsolete quality system documents or data, and ensures revisions
are properly made and re-issued to the appropriate locations.

The Document Control Coordinator (DCC) is responsible for creating the master
document, maintaining the master list of holders of Quality Management System
(QMS) documents, controlling and logging requests for changes in various
documents, issuing (QMS) documents and changes to holders, maintaining revision
history of documents, and administration of this procedure to assure holders of
(QMS) documents have received new or revised documents and have, in turn,
disposed of old (QMS) documents.

Vice Presidents, Managers or Technical Services Department are responsible for

controlling relevant customer documentation, drawings, specifications, engineering
standards, external standards, and other QMS documentation, and providing the
Document Control Coordinator with a list of these controlled copies.

Vice Presidents, Managers or Technical Services Department controls specific

quality records and data for their area of responsibility.

3.0 PROCEDURE

3.1 Quality Management System documents are reviewed and approved by the
appropriate Vice Presidents, Managers or Technical Services Department. The
documents are then issued by the Management Representative and distributed by
the Document Control Coordinator to the appropriate departments and locations.
The Document Control Coordinator maintains the Master Copy of each document.

3.2 All requests for revisions to the Quality Management System (QMS) must be
submitted on FQS-03 Document Change Request (DCR) form. The Requester
completes the top part of the form identifying document title and section and a brief
description of the change requested. The form is then forwarded to the appropriate
Vice President, Manger or Technical Services Department.
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TITLE: Document and Data Control Revision Date: December 27, 2012

3.3 The Vice President, Managers or Technical Services Department reviews the
document and either approves or denies the request for change. If the request is
denied, a brief explanation is provided and the form is returned to the requester. If
approved, the Department Vice President, Technical Services Department prepares
the document revision in accordance with QSP-02 Writing Quality System
Documents. Then signs and dates the (DCR) and forwards with the document
revision to the Document Control Coordinator.

3.4 The Document Control Coordinator assigns a control number using the
applicable document and the next available revision level. The master copy of the
revision is prepared and forwarded with a signed and dated (DCR) form to the
Management Representative.

3.5 The Management Representative reviews the document and either approves or
denies the request for change. If the request is denied, a brief explanation is
provided and the form is returned to the requester. The Management
Representative reviews the request for content, format and if approved the master
copy of the revision is signed and forwarded with a signed and dated (DCR) form to
the Department Vice President, Managers or Technical Services Department.

3.6 The Vice President, Managers or Technical Services Department signs and
dates both the master copy of the revision and the (DCR) and forwards to the
Document Control Coordinator.

3.7 The Revision History section of the documents shows the changes made to the
documents and/or refer to the (DCR). The approved (DCR) is attached to the
original copy of the obsolete document and kept by the Document Control
Coordinator for an appropriate amount of time.

3.8 The Document Control Coordinator distributes copies of the revisions to holders
of the documents. The Document Change Notice (FQS-01) is distributed with the
copies of the revision identifying the nature of the change. Any obsolete document
that is maintained for historical purposes is marked by the Document Control
Coordinator.

3.9 “Uncontrolled” copies of (QMS) documents are issued on request by the

Document Control Coordinator on the authority of the Management Representative.
Uncontrolled copies are stamped as such on each page and will not be updated.

3.10 Forms which affect quality are given a unique number and are given a revision
date. The master copy of each form is kept by the Document Control Coordinator.
Any revisions to such a form are to be handled through the Document Change
Request Form (DCR). Management Representative approval is not required for
changes to a form. The Vice President, Managers or Technical Services
Department are responsible for removing obsolete forms.
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3.11 Master copies of standards and/or specifications are retained and controlled
by the appropriate department. Log sheets are used to track distributed copies,
location and latest revision levels. The Document Control Coordinator periodically
verifies the revision status of all standards by use of published up dates and/or
inquiries to the publishers or originators. A master list of national standards and
specifications is maintained by the Document Control Coordinator on form FQS-13.

3.12 When immediate changes are necessary and approved by the Management
Representative, the document changes are marked in red and then sent through
the established Document Change Request process.

3.13 The I.T. Director is responsible for maintaining a tape backup of “Mission
Critical” information after the end of every business day. The tape is stored off the
premises. “Mission Critical” information includes, but is not limited to, operating
system files, accounting system program, and data files, manufacturing supporting
files, which include bill of materials and engineering drawings, sales support files,
and quality system documents.

3.14 Prints which are received from the customer through the Sales Department,
they are stamped as “APPROVED”, dated, and initialed by the appropriate
Technical Services Department personnel. Prints are controlled and issued by the
Technical Services Department. Prints stamped as “APPROVED” are considered
controlled documents. The Technical Services Department maintains an electronic
log identifying customer prints by number, revision level, and revision date.

4.0 CORRECTIVE AND PREVENTIVE ACTION

Any nonconformity or potential nonconformity to the product, the process or the

procedure must be handled through a corrective/preventive action document.
Corrective/Preventive action may be initiated by any employee when confronted
with such nonconformity. Employees must follow corrective/preventive action
procedures.

5.0 REFERENCES

The following documents should be referenced, as necessary to ensure complete

understanding of the quality system requirements:

ISO 9001–2008 Standard-Section 4.2.3, Control of Documents

Quality Manual – Sec. 5.0 – Document and Data Control
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6.0 RELATED FORMS & DOCUMENTS

FQS-01 Document Change Notice

FQS-03 Document Change Request
FQS-13 Master List of National Standards and Specifications

7.0 REVISION HISTORY

The following revisions have been approved as issued:

Ref: DCR Page No.: Revision Details Revision Date

Level
CAR-0012 2, 3, 4 Sect. 3.1, 3.2, 3.11, 3.12 paragraphs 01 3/3/98
completely changed. Section 2.0, 3.3, 3.4,
3.5, 3.6, 3.7, 3.8, 3.9, 3.10 wording
changed.
DCR-002 4 Section 3.15 added 02 3/18/98
DCR-013 4 Section 3.15 modified 03 4/29/98
DCR-074 2, 3, 4 Added “Qual. Assur. Mgr.” title to sect 2.0 04 7/6/98
para. 3 & 4, sect. 3.1, 3.2, 3.3, 3.5, 3.6, &
3.10. Added “DCC” title to sect. 3.1, 2nd
sent. Changed storage location for tapes
in sect. 3.13. Deleted original sect. 3.14
DCR-279 5 Section 5.0 updated to reference ISO 05 6/7/01
9001-2000
DCR-343 2.0, 3.1, Eliminated reference to Directors and 06 12/13/02
3.3, 3.5, replaced with Managers
3.6, 3.10
DCR-441 6.0, 3.11 Added reference to FQS-13, Master List of 07 5/31/05
National Standards and Specifications.
Updated Section 3.11 adding reference to
FQS-13
DCR-468 3.2 & 3.13 Eliminated director title from section 3.2 08 6/19/06
and changed MIS Manager to IT Manager
DCR-476 5.0, 6.0 & Error in section numbers corrected 09 10/30/06
7.0
DCR-524 5 Updated to ISO 9001-2008 10 12/9/08
DCR-541 4 Section 3.13 Changed IT Manager to IT 11 4/15/10
Director
DCR-584 2-4 Updated reference Technical Services 12 12/27/12
Department