Document Control

u

M

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Annual Quality Survey Report

¦ entifies Document Control as the
most ifficult clause to implement...
An the most ifficult clause to

maintain.
YYY
Step One in Buil ing an

Effective System ¦s:
w

YYY
oo Documentation is:

Clear
Concise
User frien ly
YYY
Avoi Drowning in DetailƦ..

he purpose of this proce ure is to
ocument the aforementione activities,
herin after referre to as the prescribe
tasks in terms that preclu e their
execution in an inconsistent manner,
wherin such inconsistency may
potentially result in the prescribe tasks
elivering a result that is not repeatable
or reproYYYucibleơ

An poorly written proce ures

hy use ten wor s when one will o?
ƛ he items hereinun er reference in some
cases fell excessively outsi e normal
parameters.ơ
he proce ures containe herin

are applicable to all operations in
the following epartments within
their functional ambitơ
YYY
Gake proce ures user frien ly

Use short sentences starting with a
verb.
Avoi using the passive voice. Gake it
clear who is performing the task.
Use white space for easy rea ing.
YYY
Step wo: Have the

Right Amount of
Documentation
M

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Avoi Creating too Guch:

ork instructions written for virtually
everything
Overlap an repetition - ¦nclu ing a
process in more than one work
instruction.
YYY
Or too little:
xack of work instructions where the
process affects the quality of the
pro uct.
Employees have their own way of
performing processes
here is variation in the process
because it is not well ocumente
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Documentation:
he right amount
Remember that the goal here is
consistency for your processes.
¦f two traine employees were to
perform this task, woul they o it the
same way?
¦f the answer to this is Gaybe notơ a
work instruction is appropriate.
YYY
Step 3: Outline Your

Document Control
System
G

YYY
Clarify Your erminology:

Ñroce ure

ork ¦nstruction
Attachments

w

Forms

YYY
hat ill You Control?

Ñroce ures External Docs:
ork ¦nstructions Customer Drawings
Forms Ñrints
Attachments Drawings
Routers/ raveler
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Step 4:
here will
you keep your
ocuments?
YYY
Ñlanning Your ¦nfrastructure

¦SO gives you the specs
You prepare your own blue print
You may choose:
ƛ A simple wor processing program. For
example, or .
ƛ An existing atabase program
ƛ A package ocument control software.
YYY
hat ill be Best for Your

Company?
Choose a system for your company
base on:
ƛ Company size
ƛ Computer set-up an availability
ƛ Number of ifferent processes performe
ƛ Rate of change for your processes or
ocuments
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Your company may nee more

than one type of system.
For example:
ƛ One for quality system ocuments, an
ƛ One for engineering ocuments
hese ocuments may be ifferent enough to

make it best to have two istinct systems.
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Example Systems
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Simple Har copy System

he master electronic ocuments are
store in or ơ.
A Gaster list is prepare an kept in
Excelơ.
Har copies are copie on to paper that
is marke CON ROxxEDơ.
YYY

he har copies are istribute to 3-ring
notebooks throughout the facility.
ƛ he master list in icates what proce ures
an work instructions nee to be in each
book.
ƛ Copies are kept to a minimum by only
istributing relevant ocuments to each
area.
YYY

One person is esignate as the
Document Control Coor inator.
his person
ƛ keeps the master list up-to- ate
ƛ Gakes revisions to ocuments
ƛ Distributes revise ocuments
ƛ Collects the out ate ocuments
YYY

A Change Request Formơ is available
for employees to initiate revisions to
ocuments.
ƛ Changes must be approve before they are
ma e.
ƛ Changes are in icate by using the revision
tool in wor .
ƛ Staff must be aware of revisions.
YYY
Online System
A Database is set-up to hol proce ures
an work instructions.
ƛ xotus Notes
ƛ Ñackage System
his may be organize into a Chapter
Systemơ with a chapter for each clause
of the stan ar .
YYY
Online System
Ñroce ures an ork ¦nstructions are
written in or loa e into the system.
Employees are given Rightsơ
ƛ System A ministrator
ƛ Author
ƛ E itor
ƛ Approver
ƛ Rea Only
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Online System
Authors write the proce ures or work
instructions.
he ocument is sent to the e itor an
approver for approval.
hen it is approve it is automatically
move into the Quality Documentsơ
an becomes available to all those with
rea rights.
YYY
Online System
he ocuments may be viewe on the
screen or printe .
Ñrinte ocuments are controlle by a
sunset clauseơ
ƛ he ate printe appears on all printe
ocuments. Documents are vali only for
the ay they are printe .
YYY
Online System
Some har copy istribution may be
necessary.
A master list must be kept for istribute
ocuments.
Controlle har copies nee to be
i entifie .
YYY
Online System
Revisions are ma e by the author, an
must be reviewe an approve by the
e itor an approver.
he author must etermine if the changes
affect any process that is being performe
that ay.
YYY
Engineering Ñrints
A master list in icating the current
revision of each print is maintaine .
ƛ his is usually in the manufacturing
software.
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Engineering Ñrints
A master file of the current print
revisions is maintaine .
ƛ Simple file cabinet system
ƛ An electronic CAD system
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Engineering Ñrints
¦f prints are istribute to each
operation they must be controlle .
ƛ Operators verify against electronic master
list.
ƛ Ñrints are copie an labele with a job
number.
ƛ he copy is goo only
for the job number.
YYY
Documents of External Origin

hese ocuments must be inclu e in
your ocument control system. For
example:
ƛ Customer Ñrints
ƛ ¦n ustry Regulations
ƛ ¦SO 9000 Stan ar s
ƛ References use for your
ocumentation.
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Documents of External Origin

Control these by having a section on
your master list for ocuments of
external origin. ¦nclu e:
ƛ Document Name
ƛ Current Revision
ƛ Document xocation(s)
ƛ Document number
assigne by your company.
YYY
Common Ñroblems with

Document Control
YYY
Common Ñroblems
Employees writing ocuments o not
un erstan the ifference between a
Ñroce ure an a ork ¦nstruction.
erminology has not been efine , an
is not use in a consistent manner.
Revisions take too long, ocuments are
not kept current.
YYY
Common Ñroblems
here is no process for tracking
changes or training on changes
¦nconsistent use of other ocuments
such as:
ƛ forms
ƛ attachments
ƛ rawings
ƛ ocuments of external origin
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Common Ñroblems
Approval
Distribution
Keeping istribution current
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Common Ñroblems
oo many ocuments are istribute .
he system cannot be maintaine .
xack of control of ocuments of External
Origin.
Avoi these problems by planning
ahea ..Ʀ...
YYY

YYY

Document Control

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u 

Annual Quality Survey Report

 An the most ifficult clause to

Step One in Buil ing an

oo Documentation is:

Avoi Drowning in DetailƦ..

An poorly written proce ures

 he proce ures containe herin

Gake proce ures user frien ly

Step wo: Have the

Avoi Creating too Guch:

Step 3: Outline Your

Clarify Your erminology:

hat ill You Control?

Ñlanning Your ¦nfrastructure

hat ill be Best for Your

Your company may nee more

 hese ocuments may be ifferent enough to

Simple Har copy System

Simple Har copy System

Simple Har copy System

Simple Har copy System

Documents of External Origin

Documents of External Origin

Common Ñroblems with

    

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An the most ifficult clause to

oo Documentation is:

he proce ures containe herin

hese ocuments may be ifferent enough to