Document

Control

Basics of Good
Documentation
and
Document Control Systems
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 Annual Quality Survey
Report
 Identifies Document Control as the
most difficult clause to
implement...

 And the most difficult clause to

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Step One in Building
an Effective System
Is:

To Have Good
Documentation!

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Good Documentation is:
 Clear
 Concise
 User friendly

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 Avoid Drowning in
Detail…..
 “The purpose of this procedure is to
document the aforementioned
activities, herin after referred to as the
prescribed tasks in terms that
preclude their execution in an
inconsistent manner, wherin such
inconsistency may potentially result in
the prescribed tasks delivering a result
that is not repeatable or reproducible”
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 And poorly written
procedures
 Why use ten words when one will do?
– “The items hereinunder referenced in
some cases fell excessively outside
normal parameters.”


“The procedures contained herin
are applicable to all operations in
the following departments within
their functional ambit”
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 Make procedures user
friendly
 Use short sentences starting with a
verb.
 Avoid using the passive voice.
Make it clear who is performing the
task.
 Use white space for easy reading.

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Step Two: Have the
Right Amount of
Documentation

But how much

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 Or too little:
 Lack of work instructions where
the process affects the quality of
the product.
 Employees have their own way of
performing processes
 There is variation in the process
because it is not well documented

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 Documentation:
The right amount
 Remember that the goal here is
consistency for your processes.
 If two trained employees were to
perform this task, would they do it
the same way?
 If the answer to this is “Maybe not”
a work instruction is appropriate.

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Step 3: Outline Your
Document Control
System
Manual

Procedures

Work Instructions

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Clarify Your Terminology:
 Procedure
Procedure: Describes
 Work Instruction the process.
 Attachments Work Instructions: Tells
how to perform the
 Forms process.
Attachment: Information
attached to the
procedure to help clarify
the procedure.
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 What Will You Control?
 Procedures  External Docs:
 Work Instructions Customer
 Forms Drawings
 Attachments
 Prints
 Drawings
 Routers/Traveler

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 Step 4:
Where will
you keep
your
documents?

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 Planning Your
Infrastructure
 ISO gives you the specs
 You prepare your own blue print
 You may choose:
– A simple word processing program.
For example, Word.
– An existing database program
– A packaged document control
software.
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What Will be Best for Your
Company?
 Choose a system for your company
based on:
– Company size
– Computer set-up and availability
– Number of different processes
performed
– Rate of change for your processes or
documents
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Your company may need
more than one type of
system.
 For example:
– One for quality system documents,
and
– One for engineering documents

 These documents may be different

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Simple Hardcopy System
 The master electronic documents
are stored in “Word”.
 A Master list is prepared and kept
in “Excel”.
 Hard copies are copied on to paper
that is marked “CONTROLLED”.

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Simple Hardcopy System
 The hardcopies are distributed to 3-
ring notebooks throughout the
facility.
– The master list indicates what
procedures and work instructions need
to be in each book.
– Copies are kept to a minimum by only
distributing relevant documents to
each area.
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Simple Hardcopy System
 One person is designated as the
Document Control Coordinator.
 This person
– keeps the master list up-to-date
– Makes revisions to documents
– Distributes revised documents
– Collects the outdated documents

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Simple Hardcopy System
 A “Change Request Form” is
available for employees to initiate
revisions to documents.
– Changes must be approved before
they are made.
– Changes are indicated by using the
revision tool in word.
– Staff must be aware of revisions.
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 Online System
 A Database is set-up to hold
procedures and work instructions.
– Lotus Notes
– Packaged System
 This may be organized into a
“Chapter System” with a chapter
for each clause of the standard.

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 Online System
 Procedures and Work Instructions are
written in or loaded into the system.
 Employees are given “Rights”
– System Administrator
– Author
– Editor
– Approver
– Read Only
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 Online System
 Authors write the procedures or work
instructions.
 The document is sent to the editor
and approver for approval.
 When it is approved it is
automatically moved into the
“Quality Documents” and becomes
available to all those with read rights.
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 Online System
 The documents may be viewed on
the screen or printed.
 Printed documents are controlled
by a “sunset clause”
– The date printed appears on all
printed documents. Documents are
valid only for the day they are
printed.
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 Online System
 Some hardcopy distribution may be
necessary.
 A master list must be kept for
distributed documents.
 Controlled hardcopies need to be
identified.

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 Online System
 Revisions are made by the author,
and must be reviewed and approved
by the editor and approver.
 The author must determine if the
changes affect any process that is
being performed that day.

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 Engineering Prints
 A master list indicating the current
revision of each print is maintained.
– This is usually in the manufacturing
software.

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 Engineering Prints
 A master file of the current print
revisions is maintained.
– Simple file cabinet system
– An electronic CAD system

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 Engineering Prints
 If prints are distributed to each
operation they must be controlled.
– Operators verify against electronic
master list.
– Prints are copied and labeled with a
job number.
– The copy is good only
for the job number.

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Documents of External
Origin
 These documents must be
included in your document control
system. For example:
– Customer Prints
– Industry Regulations
– ISO 9000 Standards
– References used for your
documentation.
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Documents of External
Origin
 Control these by having a section
on your master list for documents
of external origin. Include:
– Document Name
– Current Revision
– Document Location(s)
– Document number
 assigned by your company.
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Common Problems with
Document Control

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 Common Problems
 Employees writing documents do not
understand the difference between a
Procedure and a Work Instruction.
 Terminology has not been defined,
and is not used in a consistent
manner.
 Revisions take too long, documents
are not kept current.
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 Common Problems
 There is no process for tracking
changes or training on changes
 Inconsistent use of other
documents such as:
– forms
– attachments
– drawings
– documents of external origin
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 Common Problems
 Approval
 Distribution
 Keeping distribution current

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 Common Problems
 Too many documents are
distributed. The system cannot be
maintained.
 Lack of control of documents of
External Origin.
 Avoid these problems by planning
ahead..…...

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And All the pieces will fall
in place.

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 THANK YOU
ADEL SAYED ALI

QUALITY MANAGER

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