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Document Control

The document discusses planning and implementing an effective document control system. It identifies some key steps as defining terminology, determining what documents to control, choosing storage locations, outlining approval and distribution processes, and avoiding common problems like inconsistent use of terms or revisions taking too long. The right system depends on a company's size, resources, and document change frequency. Examples of simple paper-based and online systems are provided.

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kensei1219
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
580 views

Document Control

The document discusses planning and implementing an effective document control system. It identifies some key steps as defining terminology, determining what documents to control, choosing storage locations, outlining approval and distribution processes, and avoiding common problems like inconsistent use of terms or revisions taking too long. The right system depends on a company's size, resources, and document change frequency. Examples of simple paper-based and online systems are provided.

Uploaded by

kensei1219
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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u 

 

M  
 


  
YYY  

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



  

YYY  

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

YYY  

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

YYY  

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

YYY  

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.

YYY  

Example Systems

YYY  

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  

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.

YYY  

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

YYY  

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.
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
YYY  

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.

YYY  

Engineering Ñrints
 A master file of the current print
revisions is maintaine .
ƛ Simple file cabinet system
ƛ An electronic CAD system

YYY  

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.
YYY  

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
YYY  

Common Ñroblems
 Approval
 Distribution
 Keeping istribution current

YYY  

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  

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