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Document Control2

This document outlines the procedures for controlling quality system documentation at a manufacturing plant. It describes the responsibilities for document creation, approval, distribution and revision. The quality assurance manager oversees the overall quality system and document control. The ISO coordinator is responsible for administering and maintaining the document control system, including reviewing, formatting, and distributing all documents. It also provides details on how to handle revisions, withdrawals of documents, and record retention requirements.

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0% found this document useful (0 votes)
18 views

Document Control2

This document outlines the procedures for controlling quality system documentation at a manufacturing plant. It describes the responsibilities for document creation, approval, distribution and revision. The quality assurance manager oversees the overall quality system and document control. The ISO coordinator is responsible for administering and maintaining the document control system, including reviewing, formatting, and distributing all documents. It also provides details on how to handle revisions, withdrawals of documents, and record retention requirements.

Uploaded by

vishal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 6

NUMBER :

REVISION : F
DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
PAGE : 1 of 6
QUALITY SYSTEM DOCUMENT
TITLE: QUALITY SYSTEM DOCUMENTATION CONTROL
1.0 PURPOSE

1.1 This document is to ensure that quality system procedure; work instructions,
SOPs, reference documents, forms, etc. have an easy to use and consistent format.

1.2 This document will outline the issuance control, define responsibilities for their
maintenance and use, and correctly represent the quality system for all internal
and external concerns.

2.0 REFERENCES

2.1 PRC--0001 Quality System Documentation Format


2.2 PRC--0002 Document Change Request (DCR)
2.3 PRC--0003 Document Distribution Form (DDF)
2.4 PRC--0004 Use of SOP’s and Posted Materials
2.5 PRC--0005 Master Document Control List (MDCL)
2.6 CWI-16-QAD-0001 Quality Record Retention

3.0 RESPONSIBILITIES

3.1 The Plant Manager has responsibility for the overall site Quality System, to be
overseen by the Quality Assurance Manager.

3.2 The ISO Coordinator has responsibility for the administration and maintenance of
the site document control system.

3.3 Others as defined throughout this work procedure.

4.0 DOCUMENT CREATION, APPROVAL, AND CONTROL

4.1 All new or revised documents must pass through the document approval process
known as the Document Change Request (DCR), PRC--0002.

4.2 The ISO Coordinator shall review all submitted documents for compliance to ISO
standards, this procedure, PRC--0002, and PRC--0001, the Quality System
Documentation Format.
4.3 Final approved documents shall be formatted and assigned a number or revision
per PRC--0001.
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REVISION : F
DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
PAGE : 2 of 6
QUALITY SYSTEM DOCUMENT
4.4 Original copies are to be retained in a master file by the ISO Coordinator.

4.5 Originals from the master file shall be used to make controlled copies for use by
all GNB Columbus personnel.

5.0 WORK INSTRUCTION MANUALS

5.1 Reference manuals (relevant to specific department) will contain:


5.1.1 Corporate Specification
5.1.2 Plant Work Instructions

5.2 The Department Manager/Engineer will be considered the Manual Holder and be
responsible for the maintenance of manuals in their area.

5.3 The ISO Coordinator shall maintain a current manual distribution list.

5.4 Each manual will be numbered for reference and include an index of all
documents contained in it.

5.5 Manuals that require multiple binders to hold the contents of the manual are to be
labeled “Book # of #”. For example, if Manual 8.01 requires two binders; the
binders are labeled 8.01 Book 1 of 2 and 8.02 Book 2 of 2.

6.0 DOCUMENT ISSUE

6.1 Controlled copies of Quality System documents are issued to Department


Engineers, by referencing the Master Document Control List (MSDL), ensuring
that each user has the latest of the document.

6.2 Distribution lists for official controlled copies of Quality System documents shall
be determined by the Quality Assurance Manager and/or the ISO Coordinator.

6.3 These distribution lists shall be maintained using a document control database
system so all relevant personnel can be properly notified of new or revised
documents.

6.4 Distribution of controlled copies shall be by the ISO Coordinator and shall follow
the Quality System Documentation Distribution, PRC--0003.

7.0 CONTROLLED COPIES

7.1 Manual holders shall be responsible for incorporating new or revised documents,
and keeping their manuals updated and accessible.
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REVISION : F
DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
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QUALITY SYSTEM DOCUMENT
7.2 Manual holders shall ensure that all obsolete and uncontrolled documents are
removed from points of use.

7.3 The ISO Coordinator may update any department manual in lieu of the
department Engineer.

8.0 UNCONTROLLED COPIES

8.1 Company personnel may make uncontrolled copies of documents for training,
short-term use (less than 30 days), audits, or proposed revisions.

8.2 These copies are to be discarded after use.

8.3 Uncontrolled copies of Quality System documents, including the Work


Instruction Manuals, may be issued to organizations, customers, consultants, and
suppliers at the discretion of the Plant Manager or Quality Assurance Manager.
8.3.1 These copies are to be stamped "UNCONTROLLED COPY, CURRENT
WHEN ISSUED". The recipient shall not receive subsequent revisions.

9.0 REVISIONS TO DOCUMENTS

9.1 All personnel are responsible for notifying the Supervisor, Engineer or Manager
for their area if there is a need to update procedures whenever actual practices are
permanently changed from documented procedures.
9.1.1 The primary responsible Supervisor/Engineer or Manager for the
department affected is responsible for initiating a document change
request (DCR), in accordance with PRC--0002, to ensure document
changes are made.

9.2 The ISO Coordinator shall be responsible for issuing a CF-Q-27, Document
Distribution Form (DDF), in accordance with PRC--0003.

9.3 The nature of changes within revised documents shall be clearly indicated in the
last section “REVISION CONTROL” of each Work Instruction.
9.3.1 Details of the three latest revisions will be maintained in the current
document.

9.4 Actual documents shall be maintained by retaining electronic copies of all old
revisions.

10.0 WITHDRAWAL OF DOCUMENTS

10.1 It is the responsibility of all employees to destroy obsolete documents found in


their work areas.
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DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
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QUALITY SYSTEM DOCUMENT

10.2 Current and approved documents shall appear by number on the index found in
the front of each Manual and on the Master Document Control List (MDCL).

10.3 Removal of a document from the MDCL shall constitute permanent withdrawal
of that document.

10.4 These documents shall be considered obsolete and removed from all work areas.
Any obsolete document not destroyed shall be clearly stamped in red,
"OBSOLETE DOCUMENT".

11.0 MASTER DOCUMENT CONTROL LIST

11.1 Follow procedure outlined in PRC--0005 to assist in the control and identification
of current Columbus Quality System documents.

12.0 RECORD RETENTION

12.1 The Plant shall retain quality records for an appropriate time as determined by the
QA Manager.

12.2 Record retention schedules and procedures are documented in the Record
Retention Procedure, CWI-16-QAD-0001.

13.0 BACK UP OF ELECTRONICALLY STORED DOCUMENTATION

13.1 Documentation electronically stored by the Network Management Group shall be


backed up using a tape backup process.

13.2 The monthly tape drive back-up shall be retained for 3 years.
NUMBER :
REVISION : F
DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
PAGE : 5 of 6
QUALITY SYSTEM DOCUMENT
14.0 USE OF SOP’s and REFERENCE MATERIALS

14.1 SOP’s are controlled summaries or highlights of work instructions, procedures,


drawings, product specifications, or best process parameters.

14.2 The use of SOP’s as posted material is authorized in accordance with PRC--0004.

14.3 A SOP log shall be maintained to assist in the control of all posted materials.

14.4 This log shall contain a document number, revision level, reference to parent
document, and department location of document.

15.0 USE OF FORMS

15.1 Forms referencing or recording product data or process specifications, work


practices, SOP’s, etc…are to be controlled as part of the document control
system.

15.2 The ISO Coordinator will maintain a form log assist in the control of forms
requiring document control.

15.3 The form log shall consist of a form number, form title/description, revision level
and revision date.

15.4 Supervisor/Engineer is responsible for reviewing forms when adding, removing


or modifying process equipment.
15.4.1 As part of the PM system, a semi-annual review is required.

15.5 Initiating or revision forms shall be done by:


15.5.1 Drafting or marking up current revision and turning it in to the ISO
Coordinator
15.5.2 ISO Coordinator will create/edit the file and issues the form.

16.0 REVISION CONTROL

16.1 Revision C – Format changes. Redefine responsibilities and all sections of this
work instruction.

16.2 Revision D – Remove sections 5.1.3 Plant SOPs, 5.1.4 Plant Forms and 5.1.5
Labels. Remove “and revision” from section 10.2. Clarify section 15.4

16.3 Revision E – remove “and initialed by the authorizing manager, the Plant
Manager, or the QA Manager” from 4.3. Delete 4.4 “The authorizing manager is
the manager of the department responsible for the procedure, see PRC--0001.”
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REVISION : F
DATE : 11/28/00
EDITOR :
APPROVAL : DCR #
PAGE : 6 of 6
QUALITY SYSTEM DOCUMENT
And 4.7 “The QA Manager and the ISO Coordinator are the only personnel
authorized to store the controlled copy paper.”

16.4 Revision F – Changed 1.1 from “This document is to ensure that quality system
procedure documents, forms, etc. have an easy to use and consistent format.”
Removed section 4.7. Changed 6.1 was “Controlled copies of Quality System
documents are issued to Department Engineers, by referencing the Master
Document Control List (MSDL), as required to maintain the standards of quality,
ensuring that each user has the latest issue and has received adequate training for
use of the document.”. Added 7.3 “The ISO Coordinator may update any
department manual in lieu of the department Engineer.” Added “(less than 30
days),” to 8.1. Added 9.1.1. Add new sections 15.4 and 15.4.1.

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