Document Control Procedure
Document Control Procedure
REVISION HISTORY
Revision Section ACTION Description
Rev. B ALL Initial Issue Issued for Review/Comments
Rev. 0 Issued for Use Issued for Use
Table of Contents
Page
1 PURPOSE 4
2 SCOPE 4
3 POLICY STATEMENT 4
4 RESPONSIBILITIES 4-5
5 DEFINITIONS/REFERENCES 4-5
6 PROCEDURE 5-9
7 APENDICES 10-11
1. PURPOSE
To define the methods and responsibilities for controlling documents used to provide
work direction or set policy and to define methods for document revision, approval, and
distribution.
2. SCOPE
This procedure applies to all documents required by the QMS. Documents of internal or
external origin are included.
3. POLICY
IRON OX will control Quality Management System (QMS) documents to ensure that
everyone is working according to current – and identical – procedures and guidelines
4. RESPONSIBILITIES
b) Department Managers and Supervisors are responsible for ensuring that the
latest versions of relevant documents are available at the point(s) of use, that these
documents are legible, and that they are understood and followed. They are also
responsible for reviewing and responding to document change requests in a timely
manner.
c) Engineering is responsible for control of external and internal drawings (e.g.,
blueprints, schematics, technical drawings), bills of material (BOM), and customer
specifications and requirements documentation.
d) Quality Management is responsible for ensuring that documents conform to
applicable standards.
5. DEFINITIONS / REFERENCES
Definitions:
a) Controlled Document: Document that provides information or direction for
performance of work within the scope of the QMS. Characteristics of control include
such things as revision number (letter), signatures indicating review and approval,
and controlled distribution.
b) Document: Information and its supporting medium. The medium may be paper,
magnetic, electronic, optical, photograph, or sample product.
c) External Document: Document originating outside the Company (e.g., customer
drawings, industry and/or international standards, suppliers’ equipment maintenance
manuals, or references) that provides information or direction for performing activities
within the scope of the QMS.
d) Form: Printed, typed, or electronic document with blank spaces for insertion of
required or requested information (e.g., tax form, order form).
e) Internal Document: Document of internal origin (developed entirely by or completed
by the Company) that provides information or direction for the performance of
activities within the scope of the Quality Management System. Examples include,
but are not limited to, the procedures contained in the Company’s QMS manual.
f) Master List: List of all parts, materials, supplies, manufacturing aids, etc., used in
manufacture of a product.
g) Procedure: Process or series of acts involved in a particular form of work; detailed
elements of a process used to produce a specified result.
h) Quality Management System (QMS): Ordered, well-documented system of policies,
processes, and procedures, designed to assure product quality and customer
satisfaction and promote continual improvement of products and processes.
i) Quality Manual: Formal, authorized document setting out the quality policies,
systems, procedures, and practices of an organization.
j) Uncontrolled Document: Document that is not a part of the controlled document
system. Uncontrolled documents may not be used to provide work direction or
information necessary for the performance of work.
Work Instruction: Description of how to perform a process in steps;
sufficiently detailed to allow an inexperienced person to perform the
work.
References:
a) ISO 9001:2008, “Quality Management Systems
b) IOX Quality Procedures
6. PROCEDURE
6.1 Procedure Format
a) Procedures should reasonably follow the “Plan-Do-Check-Act” (Deming Cycle)
format. Quality procedures may use this document as a template; however, if any
heading in this procedure format is not applicable to the situation requiring a
procedure, it may be changed or deleted.
b) All procedures must:
Be legible and identifiable;
Have a procedure name;
Have a current revision number and revision history;
Show an “effective date”;
Have a page number on each page of the document;
Show cross-references to other procedures, forms, etc., where applicable; and
Show Top Management approval (i.e., a signature) prior to use.
c) All procedures must show approvals on the first, or cover, page of the hardcopy form
of the document. Electronic versions of procedures may show approving parties’
names typed. Electronic signatures may also be allowed, provided they meet
customer and/or regulatory requirements.
d) Document Control shall keep the original signed, paper (“master”) copy of all required
documents. Alternately, Document Control shall be responsible for the Company’s
electronic document management system.
e) Electronic files shall be named using the document number, title, and revision
number.
6.2 Work Instructions (WI)
a) Work instructions (WI’s) can vary greatly in appearance from one department to
another. Due to this variation, there are no specific format requirements.
b) Work instructions, by definition, must be specific as to the work that is performed.
c) Work instructions may take the form of text, drawings, diagrams, charts,
photographs, video, or any combination of these or other forms not mentioned here.
d) Work instructions must have:
A unique identifier (name and/or ID);
A revision number;
An effective date; and
d) Temporary change documents shall include the range of dates in which the changes
are valid and the scope of applicability. Temporary documents may not be used for
more than two (2) business days without being superseded, terminated, or made
permanent.
e) Department management shall submit temporary changes to Quality, whose
designated representative shall review changes for conformance to the Standard.
The Quality Manager or the designated representative shall initial and date the
temporary (or temporarily changed) document.
f) If temporary changes bypass any part of the QMS, Quality shall submit the changes
to Top Management, who shall review the changes and indicate approval by initialing
and dating the document before the temporary change is implemented.
7. APENDICES
Apendix 1
IOX-DRF-DCC-0003
Date: Request #
Originator:
Existing New document
Internal External document
Document title / publication date:
Page / chapter / paragraph number:
Description of problem, opportunity, or reason for request (define in detail):
Comments:
Apendix 2
Document Number Document Title Rev. Num. Rev Date Effective Distribution2
Date
3 QUALITY QAC 3
4 SAFETY/SECURITY S 4
5 CONSTRUCTION/FABRICATION FAB 5
6 LOGISTICS/FACILITY L 6
7 TENDERING MGT 7
9 HR HR 9
10 ACCOUNT AC 10