21/10/2016
TraceabilityMatrixforProcessValidation|IVTDocumentation
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TraceabilityMatrixforProcessValidation|IVT
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Soyouvefollowedyourvalidationplan,qualifiedalltheappropriate
equipment,anddeveloped,challenged,andplacedcontrolsonyourprocess.
Installationqualification(IQ),operationalqualification(OQ),and
performancequalification(PQ)iscomplete.Drawings,procedureshavebeenapproved.Trainingiscompleteandwell
documented.Thesummaryreportindicatesthatalltheexpectedactivitiesandtestswerecompletedsuccessfullyand
anyexceptionshavebeenappropriatelyresolved.
Youregoodtogo!
Sometimelater,maybeyearslater,anauditorshowsup.Thequestionsstart.Allhandsondeck!
Notsurprisingly,bynow,manyoftheoriginalteammembershavemovedontootherpositions.Mostoftheleaders
whoapprovedtheprotocolsandreportshavetransitionedtootherresponsibilities.Thedocumentationmuststandon
itsown.
Maybetherearecertainlinksbetweendocuments(typicallyonchangehistorypages),butovertimetheyusually
becomedifficulttofollowespeciallyifyourenotoneofthedocumentcontrolspecialists.So,ifprobingquestionsarise,
wouldntitbegreattohaveawaytofindaccurateandcompleteanswersquickly?Notareplacementforyourtechnical
file,butonedocumentthatwillbringtogetheralltheprocessdevelopment,specifications,testing,etc.thatsaligned
withyourvalidationreport.
HereiswhereIseeanopportunitytoimprovemanyprocessvalidationsystems.Takealessonfromthecomputer
systemsvalidation(CSV)group.Addatraceabilitymatrixtoyourdocumentation.
BasicallyarequirementforCSV,traceabilitymatrixesclearlyindicatetherelationshipsbetweenuserrequirements,
developmentspecifications,tests,andprocedures.Atraceabilitymatrixprovidesameansoflinkingrelevant
specificationstotestingmustbeestablishedandmaintained.Thematrixtraceseachrequirementthroughdesign,
implementationinthecode,andevaluationduringtesting.Traceabilityensuresthatrequirementsaremetandcanbe
tracedtotheappropriateconfiguration/designelements.
Andthatalltherequirementsareverifiedandcanbetracedtotestingorverificationactivitytheshowsthatthe
requirementhasbeenmet.
Thisconceptcaneasilybeadoptedtoshowtherelationshipsbetweenproductionspecifications,riskanalysis,IQ,OQ,
PQtests,andtheproceduresestablishedtomaintainthevalidatedstateofyourprocess.Bestofall,itcanbenavigated
bypeoplenotintimatelyfamiliarwiththeprocesstofindallthedocumentationassociatedwithanyspecificelementof
thatprocess.
Ofcourse,inpractice,eachcellinthisgenericexamplewouldbepopulatedwiththeappropriatedocument
identificationnumber.Besuretoincludetheversionnumber.Manyofthedocumentswillchangeovertime,andyou
wanttorefertotheversionthatwasineffectatthetimeofthevalidation.
Product
Specification
DOE
Critical
Input
SealIntegrity
Specification
CriticalInputs Heat
Process
Parameters
Controllers
Challenges,Checks,andBalances
Heating
Element
IQ
PM
Temperature IQ/OQ
Controller
Calibration
Temperature DOE
Setttings
DOE
Setup Operating Training
Sheets Procedures
Whileyoucouldstartfurtherbackinthedevelopmentprocess,itseemstomakesensetostartwithyourfinalproduct
specificationsthatwillbeusedformanufacturing.Thencreateamapfromeachspecificationthroughdesignof
experiment(DOE),equipmentqualifications,challengetesting,andrundocumentation.
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21/10/2016
TraceabilityMatrixforProcessValidation|IVTDocumentation
Atsomepoint,youwillbeabletocreateastandardtemplateforthematrix.Thenyoucanusethematrixintwoways.
Thefirstwouldbetoshowwhereorhoweachprocesselementwasdeveloped,tested,andcontrolled.Secondly,itcould
alsobeusedasanaudittooltoclearlyshowthateachelementwasfullyvalidated.
PRINTERFRIENDLYVERSION
Tags:Documentation,ProcessValidation
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