DocumentControl
Basics of Good Documentation
and
Document Control Systems
Annual Quality Survey Report
nIdentifies Document Control as themost difficult clause to implement...
nAnd the most difficult clause tomaintain.
Step One in Building anEffective System Is:
To Have GoodDocumentation!To Have GoodDocumentation!
Good Documentation is:
nClear
nConcise
nUser friendly
Avoid Drowning in Detail…..
n“The purpose of this procedure is todocument the aforementioned activities,herin after referred to as the prescribedtasks in terms that preclude theirexecution in an inconsistent manner,wherin such inconsistency maypotentially result in the prescribed tasksdelivering a result that is not repeatableor reproducible”
And poorly written procedures
nWhy use ten words when one will do?
–“The items hereinunder referenced in somecases fell excessively outside normalparameters.”
n“The procedures contained herinare applicable to all operations inthe following departments withintheir functional ambit”
Make procedures user friendly
nUse short sentences starting with averb.
nAvoid using the passive voice. Make itclear who is performing the task.
nUse white space for easy reading.
Step Two: Have theRight Amount ofDocumentation
But how muchdocumentation do Ineed?
Avoid Creating too Much:
nWork instructions written for virtuallyeverything
nOverlap and repetition - Including aprocess in more than one workinstruction.
Or too little:
nLack of work instructions where theprocess affects the quality of theproduct.
nEmployees have their own way ofperforming processes
nThere is variation in the processbecause it is not well documented
Documentation:The right amount
nRemember that the goal here isconsistency for your processes.
nIf two trained employees were toperform this task, would they do it thesame way?
nIf the answer to this is “Maybe not” awork instruction is appropriate.
Step 3: Outline YourDocument ControlSystem
Manual
Procedures
Work Instructions
Clarify Your Terminology:
nProcedure
nWork Instruction
nAttachments
nForms
Procedure: Describes theprocess.
Work Instructions: Tellshow to perform theprocess.
Attachment: Informationattached to the procedureto help clarify theprocedure.
What Will You Control?
nProcedures
nWork Instructions
nForms
nAttachments
nExternal Docs:Customer Drawings
nPrints
nDrawings
nRouters/Traveler
Step 4:Where willyou keep yourdocuments?
Planning Your Infrastructure
nISO gives you the specs
nYou prepare your own blue print
nYou may choose:
–A simple word processing program. Forexample, Word.
–An existing database program
–A packaged document control software.
What Will be Best for YourCompany?
nChoose a system for your companybased on:
–Company size
–Computer set-up and availability
–Number of different processes performed
–Rate of change for your processes ordocuments
Your company may need morethan one type of system.
nFor example:
–One for quality system documents, and
–One for engineering documents
nThese documents may be different enough tomake it best to have two distinct systems.
Example Systems
Simple Hardcopy System
nThe master electronic documents arestored in “Word”.
nA Master list is prepared and kept in“Excel”.
nHard copies are copied on to paper thatis marked “CONTROLLED”.
Simple Hardcopy System
nThe hardcopies are distributed to 3-ringnotebooks throughout the facility.
–The master list indicates what proceduresand work instructions need to be in eachbook.
–Copies are kept to a minimum by onlydistributing relevant documents to eacharea.
Simple Hardcopy System
nOne person is designated as theDocument Control Coordinator.
nThis person
–keeps the master list up-to-date
–Makes revisions to documents
–Distributes revised documents
–Collects the outdated documents
Simple Hardcopy System
nA “Change Request Form” is availablefor employees to initiate revisions todocuments.
–Changes must be approved before they aremade.
–Changes are indicated by using the revisiontool in word.
–Staff must be aware of revisions.
Online System
nA Database is set-up to hold proceduresand work instructions.
–Lotus Notes
–Packaged System
nThis may be organized into a “ChapterSystem” with a chapter for each clauseof the standard.
Online System
nProcedures and Work Instructions arewritten in or loaded into the system.
nEmployees are given “Rights”
–System Administrator
–Author
–Editor
–Approver
–Read Only
Online System
nAuthors write the procedures or workinstructions.
nThe document is sent to the editor andapprover for approval.
nWhen it is approved it is automaticallymoved into the “Quality Documents”and becomes available to all those withread rights.
Online System
nThe documents may be viewed on thescreen or printed.
nPrinted documents are controlled by a“sunset clause”
–The date printed appears on all printeddocuments. Documents are valid only forthe day they are printed.
Online System
nSome hardcopy distribution may benecessary.
nA master list must be kept for distributeddocuments.
nControlled hardcopies need to beidentified.
Online System
nRevisions are made by the author, andmust be reviewed and approved by theeditor and approver.
nThe author must determine if the changesaffect any process that is being performedthat day.
Engineering Prints
nA master list indicating the currentrevision of each print is maintained.
–This is usually in the manufacturingsoftware.
Engineering Prints
nA master file of the current printrevisions is maintained.
–Simple file cabinet system
–An electronic CAD system
Engineering Prints
nIf prints are distributed to eachoperation they must be controlled.
–Operators verify against electronic masterlist.
–Prints are copied and labeled with a jobnumber.
–The copy is good onlyfor the job number.
Documents of External Origin
nThese documents must be included inyour document control system. Forexample:
–Customer Prints
–Industry Regulations
–ISO 9000 Standards
–References used for yourdocumentation.
Documents of External Origin
nControl these by having a section onyour master list for documents ofexternal origin. Include:
–Document Name
–Current Revision
–Document Location(s)
–Document number
n assigned by your company.
Common Problems withDocument Control
Common Problems
nEmployees writing documents do notunderstand the difference between aProcedure and a Work Instruction.
nTerminology has not been defined, andis not used in a consistent manner.
nRevisions take too long, documents arenot kept current.
Common Problems
nThere is no process for trackingchanges or training on changes
nInconsistent use of other documentssuch as:
–forms
–attachments
–drawings
–documents of external origin
Common Problems
nApproval
nDistribution
nKeeping distribution current
Common Problems
nToo many documents are distributed.The system cannot be maintained.
nLack of control of documents of ExternalOrigin.
nAvoid these problems by planningahead..…...
And All the pieces will fallin place.