Change Control
Changes to documents shall be reviewed and
approved by the same organizations that performed
the original review and approval unless specified
otherwise. The designated organizations shall have
access to pertinent background information upon
which to base their review and approval.
5
Change Control
Where does it say that you have to change, review, approve, and
follow engineering procedures? Well, if you are or want to be in compliance
with ISO 9000 regulations then the following will apply to you.
ISO 9000 Sec. 4.5, Document Control; Subsection 4.5.2,
Document Changes/Modifications:
Changes to documents shall be reviewed and
approved by the same organizations that performed
the original review and approval unless specified
otherwise. The designated organizations shall have
access to pertinent background information upon
which to base their review and approval.
Where practicable, the nature of the change shall be
identified in the document or appropriate
attachments.
A master list or equivalent document control
procedure shall be established to identify the current
revision of documents in order to preclude the use
of non-applicable documents.
Documents shall be re-issued after a practical number
of changes have been made.
80
Change Control 81
This chapter covers the method used for document review and
approval, how to request changes to released documentation, how the
document review board operates, and how to record the revision history of
changes to all of the documentation.
5.1.0 DOCUMENT REVIEW AND APPROVAL
Now that documentation has been written, it is time for review and
approval by qualified individuals. Your document must be reviewed by the
engineering department and then by outside departments, if required.
Review and approval will be required for each of the following engineering
documents: policies, departmental instructions and engineering procedures
and all changes to these documents. All of these documents will need to go
through the Document Review Board for review and approval. The
Document Review Board is explained later on in this chapter. Figure 5.1
illustrates the flow of all documents for review and approval.
N ew
D oc u m en t
R eview F low
E n g in eerin g O u tsid e
D ep artm en t D ep artm en t
R eview R eview
D raft 1 D raft 2 D ocu m en t
R eview B oard
R evis e D ocu m en t D ocu m en t
R eview F orm R eview F orm
an d D raft 1 an d D raft 2
E n g in eerin g R evis e
D ep artm en t
A p p roval
O u tsid e
D ep artm en t
A p p roval
Figure 5.1. New document review flow.
82 Developing and Managing Engineering Procedures
5.1.1 Engineering Department Review
After you have finished writing your documents, you will need to
distribute them for review and approval by the engineering department. You
do not need the Document Review form for this step. Your documents will
go through several iterations (as shown above) within the engineering
department. Stamp the first review copy ‘”Draft 1;” this way the review-
ers will know from the front of the document what part of the review cycle
the document is in. When your documents come in from review, you can
tell at a glance the state of the document. When the document returns with
the reviewers comments marked up in red, incorporate the changes and
distribute “Draft 2,” and so forth until there are no more changes required.
This allows you to have all of your ducks in a row before distributing your
work to outside departments. Do not sign the document at this time
because this is just a draft copy, not the final.
5.1.2 Outside Department Review and Approval
Next, you will prepare a document review form (see below) and
attach a copy of the document to be reviewed (Fig. 5.1), and then distribute
the document review form and document simultaneously to the Document
Review Board members for review or approval. Give the reviewers a week
or two to review the document, depending on the magnitude of the
document. Inform the reviewers that they can return their comments to
you or bring them to the next Document Review Board meeting. You will
go through the same iterations with the outside departments as you did with
your own. Call the first distribution copy “Draft 1.” When you get the
document back marked up in red, incorporate the changes and distribute
“Draft 2” and so forth until there are no more changes required.
After you receive the marked-up copies from each reviewer the
Document Review Form will be marked with either:
“Approved.” The document is ready for use.
“Conditionally Approved.” You will need to show
that the conditions have been met.
Change Control 83
“Not approved.” You will need to call a Document
Review Board meeting to resolve any issues. Also,
when you get different department inputs that conflict
with each other, you will need to call a Document
Review Board meeting to resolve those issues.
After all concerns have been addressed and changes incorporated,
have your own department verify that you have incorporated all of the
changes correctly. Next, sign and date the document, then have your
manager sign and date the document and bring it to the next Document
Review Board meeting. There, all board members will sign the document.
After approval the document will be released into engineering document
control where it will be readied for distribution to manuals.
5.1.3 Document Review Form
With this form you will be answering the following questions:
Who was the originator of the form and when did
they check out the number?
What is the document review form number?
What is the document number and title?
Which type of document is being reviewed?
What was the reviewer’s response?
Who was the reviewer?
Who were copies distributed to?
84 Developing and Managing Engineering Procedures
Document Review Form
Originator: Date: DRF No.:
Document Number: Title:
Documentation Types:
Policy Departmental Instruction
Engineering Procedure
Reviewer Response:
Mark your comments directly on the document.
After your review is complete, either hold on to
your mark-ups for the next Document Review
Board meeting or return them to Engineering.
Engineering will bring all marked-up copies to
the next meeting for discussion and agreement.
Your comments are due by: _____________. If more time is
needed, contact engineering for an extension.
Approved
Conditionally Approved (See attached comments.)
Not Approved, explain.
Reviewer Signature: Date:
Distribution:
Engineering:
Manufacturing:
Quality:
Form E001 (Procedure EP-1-5) 7/12/01
Example-Document Review Form.
Change Control 85
Document Review Form Preparation. Each circled number
below corresponds to the circled number in the example document review
form.
Originator: Enter your name and date when the form
is initiated.
DRF No.: Enter the document approval form number.
(See Ch. 6 under Document Review Form Numbers.)
Document Number: Enter the document number and
title.
Documentation Types: Mark the appropriate box for
the document that is being reviewed and approved.
Reviewer Response: Mark the appropriate response
after your review.
Reviewer Signature: Sign and date when your review
is complete.
Distribution: Enter distribution names. This is a
standard distribution for all documents.
86 Developing and Managing Engineering Procedures
5.1.4 Example Document Review Form
Document Review Form
Originator: Date: 6/1/01 DRF No.: 015
Document Number: DI-01 Title: Where-Used Input
Documentation Types:
Policy • Departmental Instruction
Engineering Procedure
Reviewer Response:
Mark your comments directly on the document.
After your review is complete, either hold on to
your mark-ups for the next Document Review
Board meeting or return them to Engineering.
Engineering will bring all marked-up copies to
the next meeting for discussion and agreement.
Your comments are due by: 06/12/01 . If more time is
needed, contact engineering for an extension.
Approved
• Conditionally Approved (See attached comments.)
Not Approved, explain.
Reviewer Signature: Date:
Distribution:
Engineering:
Manufacturing:
Quality:
Form E001 (Procedure EP-1-5) 7/12/01
Change Control 87
5.2.0 CHANGE CONTROL METHODS
The change control process starts with a request to make changes
to released documents. (See Fig. 5.2.) Anyone can request a change by
preparing a Document Change Request form and attaching a marked up
copy of the document that needs changing. The Document Change Request
form will be distributed to the Document Review Board members for
review. At the next Document Review Board meeting the decision will be
made to reject or accept the change request.
D ocu m en t
C h an g e R eq u est
an d M arked -u p
D ocu m en t
D ocu m en t
R eview B oard
R eview
A ccep t R eject
M ake C h an g es R etu rn to
O rig in ator
W ith E xp lan ation
Figure 5.2. Document change request method.
88 Developing and Managing Engineering Procedures
5.2.1 Document Change Request Form
This section will show you how to complete a document change
request form. The method of preparation is the same for all departments.
Document change requests will be reviewed and approved by the Docu-
ment Review Board. With the document change request form you will be
answering the following questions:
• Who was the originator of the form and when was
it originated?
• What is the document change request form
number?
• What type of document is being changed?
• What is the document’s disposition?
• What is the priority of the change request?
• What are the document’s number, revision, and
title?
• What is the reason for the change?
• What is the justification for the change?
• Who reviewed and approved the change request?
Change Control 89
Document Change Request Form
Originator: Date: DCRF No.:
Document Type: Disposition:
Policy Change
Departmental Instruction Obsolete
Engineering Procedure Priority:
Form Routine Urgent
Document Affected:
Document Number Revision Title
Reason for change:
Justification:
Approved By:
Engineering Manager: Date:
Manufacturing Manager: Date:
Quality Manager: Date:
Form E002 (Procedure EP-6-3) 8/19/01
Example–Document Change Request Form
90 Developing and Managing Engineering Procedures
Document Change Request Form Preparation. Each circled
number below corresponds to the circled number in the example document
change request form.
Originator: Enter your name and date when the form
is initiated.
DCRF No.: Enter the document change request
number. (See Ch. 6 under Document Change Request
Form Numbers.)
Document Type: Mark the appropriate box for the
document that is affected.
Disposition: Mark the appropriate box depending on
the document’s disposition.
Priority: Mark the appropriate box depending on the
priority of the change.
Document Number, Revision, and Title: Enter the
document’s number, revision, and title.
Reason for Change: Enter the reason and description
of the change or attach marked up documents.
Justification: Enter the justification for the change.
Approved By: Enter your name and date when the
change request form is complete and ready for
processing.
Change Control 91
5.2.2 Example—Document Change Request Form
Document Change Request Form
Originator: Date: DCRF No.: 003
Document Type: Disposition:
Policy • Change
Departmental Instruction Obsolete
• Engineering Procedure Priority:
Form • Routine Urgent
Document Affected:
Document Number Revision Title
Ep-02-05 B Part Numbering System
Reason for change:
The form number E044 on page 6 should be E023.
Justification:
There would be lost time and money after finding out that you
have the wrong form.
Approved By:
Engineering Manager: Date:
Manufacturing Manager: Date:
Quality Manager: Date:
Form E002 (Procedure EP-6-3) 8/19/01
Example–Document Change Request Form (with sample entries)
92 Developing and Managing Engineering Procedures
5.3.0 DOCUMENT REVIEW BOARD
Establish a review board with representation from key personnel
(Fig. 5.3). A good change control system is necessary to make sure that
previous documentation efforts have not been lost. Change control starts
when policies, departmental instructions, and engineering procedures have
been approved and released into engineering document control. From this
time on every change to any of the documents must go through the
Document Review Board for review and approval.
D ocu m en t
R eview
B oard
M em b ers
E n g in eerin g M an u factu rin g Q u ality
Figure 5.3 Document review board.
The Document Review Board is responsible for the review and
approval of all policies, departmental instructions, engineering procedures,
and forms. The Document Review Board will receive documents from
engineering procedure writers, and are required to be accurate and effi-
cient in their reviews. A specific length of time and completion date will be
assigned to each document.
Change Control 93
The Document Review Board:
Ø Convenes once a week or sooner as required.
Ø Reviews and either accepts or rejects each proposed
new, revised, or obsoleted policy, departmental
instruction, engineering procedure, or form.
Ø Determines if a document is a policy, departmental
instruction, or engineering procedure.
Ø Reviews documents line-for-line and reaches an
agreement on which changes need to be incorporated.
Ø Establishes an effectivity date for when the changes
will be incorporated into the system.
After the Document Review Board has been operating, you can
create a memo (Fig. 5.4) that notifies the members about which document
is going to be reviewed and approved at the next Document Review Board
meeting.
5.4.0 REVISION HISTORY SHEET
There will need to be a revision history sheet created for each
policy, departmental instruction, and engineering procedure. The revision
history sheet starts when a document is released for use. This method
keeps a running history of the changes to each document. There will be lots
of times where you will be referring back to when a certain change took place.
The initial release will be ‘A’ and the second ‘B’ and so-forth. Some
companies start with the revision system as ‘No Change’ or the revision
box is left blank. All of these will work but you have to agree on one
method or later on you will be sorry. With this sheet you will be answering
the following questions:
• What is the document’s number?
• Where is the revision letter?
• What is the document’s title?
• Who filled out the sheet?
• What was the date that the sheet was filled out?
94 Developing and Managing Engineering Procedures
Up-Coming Document Review Board Meeting Memo
MEMO
To:
From:
Subject: Document Review Board
The next Document Review Board meeting will
be 3/10/01. If you are unable to attend send
someone in your place who can speak and sign
for you.
The agenda for the meeting will be as follows.
Bring your marked up documents to the meeting
for discussion.
• Documents to be discussed and approved this meeting:
EP-02-02 Document Numbering System
EP-03-04 Engineering Logbooks
• Distribution of first drafts for your review.
EP-02-03 Bill of Material
Distribution:
Figure 5.4. Document review board meeting memo.
Change Control 95
Revision History Sheet
Document Rev. Title Initials Date
Number
Example–Revision History Sheet
96 Developing and Managing Engineering Procedures
Revision History Sheet - Preparation
Each of the following circled numbers corresponds to the circled
numbers on the example revision history sheet.
Document Number: Enter the document number.
Rev.: Enter the revision letter of the document.
Title: Enter the document’s title.
Initials: Enter your initials after logging in the
information.
Date: Enter the date after the information is loaded
onto the sheet.
5.5.0 REVISION HISTORY LIST
There will need to be a revision history list to keep a running
history of all of the changes to each policy, departmental instruction, and
engineering procedure. With this list you will be answering the following
questions:
• What is the document’s number?
• Where is the revision letter?
• What is the document’s title?
• Who filled out the list?
• How many pages are there?
• What is the document change request form
number?
• Who logged in the information?
• When was the information entered?
Change Control 97
Revision History Sheet
Document Rev. Title Initials Date
Number
EP-02-05 A Initial release
The form number E044
EP-02-05 B on page 6 was changed
to E023
etc.
Example–Revision History Sheet (with sample entries)
98 Developing and Managing Engineering Procedures
Revision History List
Document Rev. Title # of DCRF Initials Date
Number Pages No.
Example–Revision History List
Change Control 99
Revision History List - Preparation
Each of the following circled numbers corresponds to the circled
numbers on the example Revision History List.
Document Number: Enter the document number.
Rev.: Enter the revision letter of the document.
Title: Enter the document’s title.
# of Pages: Enter the total number of pages.
DCRF No.: Enter the associated DCRF Number.
Initials: Enter your initials after the information is
logged.
Date: Enter the date after the information is logged.
5.5.1 Example—Revision History List
Following is a completed example of a Revision History List.
