Anda di halaman 1dari 40

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