ISO9001DocumentControl(4.2.3) MarkA.Randig SomethingIruninto,withseeminglyalarmingregularity,aredocumentcontrolsystemsthatareoverly conceived,ridiculouslycomplexandunnecessarilyconstrictive.Thisissomewhatofamysterytome,as withsomuchemphasisplacedonthisarea,itneverthelessseemstoalsobeoneoftheareasthatmost organizationsstrugglewith.ItsnotthattherequirementsoftheISO9001standardaredifficulttomeet itsthefactthatmanyorganizationsseemcompelledtogoaboveandbeyondtherequirementsofthe standard,implementingpracticesthatmakesthemanagementofthisfunctionharderthanitshouldbe. Clause4.2.3oftheISO9001standardrequiresthatdocumentsusedbyanorganizationsQMSbe controlled.ThisisoneofonlysixclauseswithintheISO9001standardwhereawrittenprocedureis required,andit'sprettyclearonwhatcontrolsneedtobeaddressed.Ifwereviewtheactualrequirements ofthestandard,wecanseewhatsreallyneeded Approvedocumentspriortoissue; Letsbepracticalforamoment.Howmanysignaturesdoyouactuallyneed?Manyorganizationsrequire thesignatureofthePresident,ManagementRepresentative,QualityManager,etal.

etal.Thispracticeisfine, providedtheresareasonforit.Requiringsignaturesforthesakeofhavingsignaturesdoesntaddanyreal value,particularlyifit'sonlyarubberstampor"CYA"typeofexerciseisthePresident,CEO,CFO,etc. ofthecompanyreallygoingtoread(anddotheyreallyneedtoread)allofthesedocuments? Whiletheactualapprovalswillneedtobedefinedbytheorganization,documentapprovalshouldbeleft totheresponsibleparty(e.g.,processowner)andotherappropriatestakeholders.TopManagement doesntneedtosigneverypieceofpaperandjustanotefromexperiencetheytypicallydontwantto.If adocumentcanbeadequatelyreviewedandapprovedbyjustoneortwofunctionswithinanorganization, thatsalltheapprovalsthatadocumentreallyneeds. Reviewandupdateasnecessaryandreapprovedocuments; Therequirementhereisfor"asnecessary".Thiscanbeaperiodic/scheduledreview,oritcanbeareview performedonanasneededbasisinordertoaddressadeficiencyornegativetrendthathasbeen identified.Youalreadyperformamanagementreview,sothismayserveastheperfectopportunityto reviewthedocumentationthatmakesupyoursystemaswell.Youwillneedsomemethodofrecording thisreview,howeverthiscanbeaccomplishedinanymannerthatsuitstheorganization. Updatesandthesubsequentreapprovalofdocumentsshouldonlybeperformedasneededandshould notbeusedmerelytosatisfytherequirementfortheabovereviewit'sanunnecessaryandwasteful practice.Shouldadocumentrequireupdatingandreapproval,thisresponsibilitywouldtypicallyremain withthesameapprovalauthorityastheoriginalversion. Noteherealso,thatmanycodes,standardsand/orspecificationsareonlyupdatedonaperiodicbasis(not annually),sothereisntmuchreasontoreviewand/orupdaterelatedinternaldocumentsmorefrequently, unlesstherewasacausetodoso.
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Ensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified; Thestandardrequiresthatdocumentschangesbeidentifiedandtherevisionstatusnoted.Inmostcases, thiscanbeaccomplishedbyarevisionhistorythatsincludedaspartofthedocument,withchangesnoted inthedocument'smargins(blackline),bynotesintherevisionhistory,orbyreferencetoachange record(inmanycases,aChangeRequest).Revisionscanthenbeidentifiedbynumbers(1,2,3...),letters (A,B,C)orsomecombinationthereof.Theorganizationshouldmaintainsomeformofmasterlistor registeridentifyingwhichdocumentsareusedbythesystemandeachdocumentscurrentrevisionstatus. Ensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse; Itsbecomingrarerinthisdayandagetocomeacrosscompaniesthatdontmaintainanetworkserver.By virtueofhavingthesedocumentsinadedicatedfolder(ornetworkdrive)thisrequirementissatisfied, providedaccessisallowedtothosepersonnelthatrequireit.Itshouldbecommunicatedhoweverthatall printedversionofsuchdocumentsareuncontrolledandthattheusershouldrefertotheserverforthe mostrecentversion.Limitingaccesstotheprintingofdocumentscanbehelpful;althoughitisnot essentialtocontrol,providedthatanyprintedcopiesofdocumentsaredestroyedimmediatelyafteruse. Ifpapercopiesofdocumentsareused,thisactivityshouldbelimitedtothosecaseswhereabsolutely necessary.Thecontrolofsuchcopiescanrequireaconsiderableamountofadministration,oftenrequiring resourcesdedicatedtothisactivity.Asthespanofsuchcontrol(e.g.,thenumberofdocumentrecipients) isincreased,considerationshouldalsobegiventothemanagementofrevisionsandthetiming/scheduling oftheirrelease,asperpetualupdatingandreupdatingofpapercopiesnotonlycreatesalotofwork,but canalsocauseconsiderableconfusionincommunicatingnecessaryinformationtoaffectedparties. Inmanycases,functionsutilizingpapercopiescanbenefitfromaplannedrevisionandreleaseschedule (e.g.,monthly,quarterly,annually,etc.)asopposedtoissuingareviseddocumenteachtimethattheneed foraminorcorrectionoreditorialchangeisidentified.ThisapproachwouldnotapplytoMajorissues whichaffectprocessperformanceand/orproductconformancehowever,astheseissueswouldrequirean immediateupdatewhenidentified. Ensurethatdocumentsremainlegibleandreadilyidentifiable; Incaseswheredocumentsmaintainedinanelectronicformat,legibilityreallyisntanissue.Inthecaseof papercopies,ensuringthatdocumentremaininauseableconditionistypicallyaresponsibilityofthe documentrecipient.Asfarasidentificationisconcerned,eachdocumentshouldbeassignedsomeformof identifier(number,lettersorcombinationthereofevenjustatitleisfine)whichallowsthedocumentto bereferencedwithinthesystemandidentifiedaspartofthedocumentationthatmakesupthesystem. Ensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled;and Makealistofthedocumentsthatyouuse.Thiscanincludeapplicablecodes,standardsandspecifications (yesincludingISO9001:2008),aswellasanycustomerspecificationsorinstructions.Customerdesigns arealsoconsidereddocuments,soifyoumaintainthese,thanthisrequirementwouldapplyaswell.In suchcases,youwouldn'tberesponsiblefortheapprovalorupdatingofthesedocuments(theyrenot yours)howeveryouarestillrequiredtoensurethatyouhavethemostrecentversionsandthattheyare madeavailabletoaffectedpersonnelatpointsofuse.
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 Preventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyare retainedforanypurpose. Thisrequirementprettymuchspeaksforitself.Thesimplestapproachtocomplyingwiththisrequirement istoensurethattherearentdocumentslyingaround.Useofelectronicsystemsmakesthistaskeasier,as thecopymaintainedonthenetworkorserveristhecurrentversionandallothersareconsidered obsolete;howeverifpaperbasedcopiesareused,instructionsshouldbegivenwithanydocument updatesforthedispositionofthedocumentsbeingsuperseded.Supersededand/orobsoletedocuments shouldeitherbedestroyedorifretained,markedasobsolete,supersededorinasimilarmanner. Whileacopyofeachsupersededdocumentshouldberetained,itshouldbemaintainedasafilecopyand controlledinanareawhereitwouldnotbeaccessibleforuse. Idliketomakeafinalnotethatnowherewithinthestandardisthereanyreferencemadetocomplex numberingschemes,theuseofcontrol,uncontrolled,obsoleteorotherstamps,coloredpaper, revisionchecklists,transmittallettersorreceipts.Whilesomeoftheserequirementsmayhelpthe organizationensurecompliancewiththeclauseofthestandard,theyaresupplementalcontrolsthathave beendefinedbytheorganization,notprescribedbythestandard. Ifyouhavingproblemskeepingyourdocumentcontrolfunctioninline,perhapsyouneedtoactuallyre readthestandard.Theproblemsthatyouaresufferingthroughmaybeproblemsthatyouarecreatingfor yourself.Yourcontrolsshouldaddtotheeffectivenessofthefunction,andnotjustcreateadditional bureaucracyandadministration.Aproperlydevelopedandimplementeddocumentcontrolfunction shouldbeaneffective,sustainable,efficientaidinhelpinganorganizationcommunicatednecessary informationtoaffectedparties. Isthishowyourdocumentcontrolsystemworks? MarkRandigisthePresidentandFounderofMASSolutionsLLC.,aHoustonTexasbasedconsultingfirm thatspecializesinhelpingcompaniesachievebreakthroughperformancebyfocusingonQuality EnhancementandProductivityImprovement.TogetyourFREEcopyofMarksnewsletter"TheQuality Specialist",gotohttp://www.masquality.com. 2009MASSolutionsLLC.AllRightsReserved.

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