u


 

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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.

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Step One in Buil ing an

Effective System ¦s:

w 

   

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 ’oo Documentation is:

 Clear
 Concise
 User frien ly

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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
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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.

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Step wo: Have the

Right Amount of
Documentation

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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.

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 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.

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Step 3: Outline Your

Document Control
System
G
 

 

 



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 Clarify Your erminology:

 Ñroce ure
  


 ork ¦nstruction 


 Attachments  



 w


 Forms



 
    
 

 


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 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?

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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.

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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.

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 Simple Har copy System

 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.

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 Simple Har copy System

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

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 Simple Har copy System

 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.
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 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 .

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 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.
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 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 .

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 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 .

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 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.

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 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.

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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.
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Common Ñroblems with

Document Control

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 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.

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 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...

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