INSIGHTS

Akeyactivityinoptimizingproductqualityiscriticallyassessingyourqualitysystemsagainstprovenqualitymaturitymodels–suchasthosedescribedinQualityisFree,byPhillipCrosby.WetookCrosby’squalitymanagementmodelandenhanced itbasedonourexperienceinthelifesciencesindustry.Usingthismodel,ourinitialfocuswasonhoworganizationscanensureproductqualitybyoptimizingtheperformanceof theirqualitysystems.

InrevisitingtheQualityMaturityModel,ourfocusisshifting toakeychallengefacingpharmaceutical,biotechnology,andmedicaldevicemanufacturerstoday–achievingqualityinaglobalmarketthatisconstantlyunderthescrutinyofvariousregulatoryagencies.

Inanattempttoeliminatetheseregulatoryhurdles,anetwork ofscientificorganizationslaunchedaglobalinitiativetoharmonizeregulationsandlegislation.Theobjectiveistoencourageconvergenceamongregulatorysystemsatthegloballevel,facilitatingtradewhilepreservingtherightofparticipatingmemberstoaddresstheprotectionofpublichealthusingregulatorymeansconsideredsuitablefortheirnation.Intheory,thiswillresultinareductionofregulatorydifferencesinsubmissions/approvals,auditsandenforcement.

Inordertoachieveglobalharmonization,companiesandregulatoryauthoritiesneedtoreceiveandreacttoinformationconsistently,somethingthatinthepasthasprovendifficult.Sothebigquestionis:howdoesyourcompanymaintainamaturequalitysystemthatisstillflexibleandadaptableenoughtomeetmultiplemarketneedsandregulatorystandards?

‘‘ A key activity in optimizing product quality

is critically assessing your quality systems

against proven quality maturity models.’’

One More Look at Quality Systems MaturityAchieving Quality Maturity in a Global Marketplace

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Looking Back at Looking Ahead…In2011,wepublished“LookingAheadwithQualitySystems; The importance of knowing where you are–and where you need to go...” The paper focused on the FDA’s goals and strategic priorities, and how organizations could improve their product quality efforts. Despite the increased complex-ity surrounding quality systems and global harmonization, our approach is still the same. To identify the strengths and weaknesses of your quality systems, and to develop a plan for moving forward, use our assessment method below.

1. Determine your organization’s current quality manage-ment maturity.

2. Go through the assessment process to analyze your organization’s quality systems in detail, identifying opportunities, and developing an optimization plan to address the opportunities identified.

3. Create a plan for implementing the changes identified in the assessment.

For more information, visit http://www.clarkstonconsulting.com/publication/looking-ahead-with-quality-systems.

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Clarkston’sQualityMaturityModelidentifieseffectiveness,efficiency,andsustainabilityaskeycomponentsofamaturequalitysystem.

• Effectivenessisthecapabilityofproducingadesiredresult.Whensomethingisdeemedeffective,itmeansithasanintendedorexpectedoutcome.

• Efficiencydescribestheextenttowhichtime,effort,orcostiswellusedfortheintendedtaskorpurpose.

• Sustainabilityisthecapacitytoenduresocial,environmental,economic,andresourcechanges.

Quality Systems MaturityINSIGHTS

Summary

Qualityisameasureofaproduct'sabilitytosatisfythepatient'sstatedorimpliedneeds.Qualitysystemsareacompany’sformalizedbusinesspracticesthatdefinemanagementresponsi-bilitiesfororganizationalstructure,processes,procedures,andresourcesneededtofulfillproductqualityrequirements,customersatisfaction,andcontinualqualityimprovement.Amaturequalitysystemhasquality,safety,andeffectivenessdesignedintothesystemandbuiltintotheproduct.Qualityisnottestedintothefinishedproduct,noristheproducttestedintocomplianceinamaturequalitysystem.Eachstepintheprocessiscontrolledtomaximizetheprobabilitythatyourproductmeetsallpre-estab-lishedqualityanddesignspecificationlimits.AmaturequalitysystemisdesignedtoassureoverallcompliancewithcGxPs,internalprocedures,andspecifications.

Inamaturequalitysystem,yourcompany’sQualityControlUnit(QCU)willreviewandapproveallcriticalstepsinyourproduct’sprocess,includingallproductdefectevaluations,returnedproductevaluationsandsalvagedproducts.TheQCUmustassurethatallerrorshavebeenfullyinvestigated,approvechangesbeforetheyareimplemented,andprovidefeedbackregardingtheappropri-atenessofthosechanges.Essentially,amaturequalitysystem:

• Willimprovecustomerloyalty,leadingtorepeatbusiness;enhancecustomersatisfaction;andincreaseyourcompany’sspeedandagilityintakingadvantageofmarketopportunities.

• Ensuresyourproductdoesnotadverselyimpactpatient/usersafety.

• Hastheresourcesandflexibilitytoadapttoglobalregula-torychanges.

• Isharmonizedtoglobalregulatorystandardsbecause itisefficient,effective,andsustainable.

‘‘ A mature quality system has quality,

safety, and effectiveness designed into

the system and built into the product.’’

Effectiveness

SustainabilityEfficiency

A mature quality system is harmonized to global regulatory standards because it is efficient, effective, and sustainable.

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arecaptured.Itisalsoimportanttodocumentactionstaken,whichensureschangesdidnotintroducenewhazards.

• Understandyourproductandprocessrisks,whichbetterprepareyourqualitysystemsforregulatorycompliancewithoutcompromisingtheabilityofyoursystemtomeetfuturerequirements.

Does your quality system track your product through commercial distribution?

• Definemetrics,establishatrackingsystemandriskassessmenttools,andintegratespeedandagilitytochangewithnewrequirements.

• Trackoperationalandqualitydataandevaluatekeyoperationalmetrics;thiscanbeausefulmethodto determineifyourqualitysystemiseffective.

Does your quality system trend quality incidents across time, product lines, and batches?

• Reviewcomplaintsatoccurrenceandreexaminethemovertimetoseeifapatternortrendispresent,whichmayresult inescalatingtheassociatedseriesofcomplaintstoaCAPA.

• Includetrackingandtrendingstrategiesthataretriggeredbyprocessmonitoring,riskassessments,rework/reprocessing,deviations,complaints,audits,andnewequipmentqualifica-tions.Thetrackingandtrendingstrategiesassociatedwiththesetriggersshouldhaveanextensivepost-implementationfollow-upduration.Post-implementationfollow-upshouldincludesimilarproductlines.

Are you conducting thorough root cause investigations and determining causal relationships?

• Ensurethatyourcompany’sdesign,R&Dandqualityteamsmeetroutinelytodiscussrootcausesandassociatedcausalrelationshipsdeterminedduringqualityinvestigations,andjointlycommunicateissuestomanagement.Design/R&Ddepartmentshaveimportantproductknowledgeandexperi-encethatcanincreasetheeffectivenessofrootcausedeterminationsandformulationofpreventiveactions.

• Establishastrongmanagementteamthatcandeterminecausalrelationshipswithspeed,implementnecessarychangestopreventrecurrenceofqualityincidents,anddriveinformationbacktoR&Dandthesuppliertoimprovetheirprocesses.

• Evaluateyourrootcauseinvestigations,whichwillidentifyqualitysystemgapsandcontributetoaroadmapforimprovements.

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Considerations and Impact

Whileregulatorystandardsmayvary,whatisconsistentacrossallregulatoryagenciesispublichealthandsafetymonitoring.Todetermineifyourqualitysystemiseffective,efficient,sustainableandharmonizedtoglobalmarkets,youmustconsiderthefollowingquestions:

Does your quality system have the ability to respond to quality incidents with speed and agility?

• Reviewtheaveragecompletiontimefortheseeventsandstrivetocontinuouslyimprovecompletiontimeandeffectiveness:– CAPA– Complaintinvestigation– ProductRecall– ProductMarketWithdrawal

• EstablishaSpeed&AgilityIndex(SAI)withspecificmetrics.

• Benchmarkhowyourcompanycomparesagainstpeercompaniesandexamineindustrybestpractices.

Is your quality system proactive?

• Establishatrackingandtrendingprogramtoensureconsis- tent,repeatablequalityresults,reducemistakes,improvecustomersatisfaction,andmovetowardsqualitysustainability.

• Measureandtrackyourcompany’sorganizationaleffective-ness,orhoweffectiveyourorganizationisinachievingintendedoutcomesandsuccessfullyexecutingstrategies.

Do all of your quality subsystems use risk assessments as an evaluation tool?

• Makesurethatyourriskassessmentsincludetheprobability ofoccurrenceofharmandtheconsequenceofthatharm (i.e.,howsevereitmightbe).Amaturequalitysystemhasariskassessmentprogramthatincludesriskanalysis,riskevaluation,riskcontrol,andproductionandpost-productioninformation.

• Establishariskmanagementfilethatassessesriskinterms ofpatient/user,risktoemployees,propertyandenvironment.Documenttheestimationofrisksforeachhazardoussituationintheriskmanagementfileandprioritizeinorderofinherentsafetybydesign,protectivemeasuresinthemanufacturingprocess,andsafetyinformation.

• Verifyeachriskcontrolmeasureandevaluateanyresidualrisk.

• Reduceanyunacceptablerisktoacceptablelevels.Defineanddocumentacceptableandunacceptablerisklevels,ensuringthatchangesmadetoeliminateorminimizehazards

Quality Systems MaturityINSIGHTS

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Is your supply chain aligned with your quality system standards?

• Compareyourvendorselectionprocessagainstpeercompaniesandindustrybestpractices.

• Increasethefrequencyorintensityofsupplieraudits whensupplierissuesaredeterminedtobetherootcause.

• Haveastrategyfordisqualifyinganapprovedsupplierthat istiedtoseverityofriskandfrequencyofqualityincidents.

• Establishasupplierrequalificationprocessthatincludesassessingriskofrecurrenceofsimilarqualityincidents.

Do you have computer systems in place that can customize your technical and regulatory information for each nation’s format?

• Audityourcomputersystemstoensurecompliance withcurrentregulatorystandards.

• Hirethenecessaryexpertisetoaddressanygaps discoveredduringtheaudit.

Can your quality system withstand resource, organizational and economic changes without becoming fragmented and ineffective?

• Makesurethatyourqualitysystemisaninteractive processbetweenmanagement,quality,andproduction,andthatitallowsemployeestonavigateandrespond tochangeappropriately.

• Measureandtrackyourcompany’sorganizational effectiveness.

Ifyourqualitysystemconfidentlyensuresyourproductissafe,effective,andfulfillsitsintendeduse,thenglobalharmonizationhasbecomeanadministrativeissueforyourcompany,notaqualitysystemissue.Globalharmonizationasanadministrativeissuecanbeaddressedbydedicatingresourcestocreatingadaptable,flexiblecomputersoftwaresystemsthatcanaccommodateeachnation’sregulatoryformat.Thekeyis thatsafety,technical,andqualityinformationwillbeaccuratelycaptured,electronicallystoredandaccessedacrossnations.Oncetheseelementsareestablished,yourcompanycanreportglobally–achievingqualitymaturityinaglobalmarketplace.

About the Author

MelanieDraytonisaSeniorConsultantwithClarkstonConsult-ing.Shehas20yearsofLifeSciencesindustryandlabexperi-ence.AsaninvestigatorfortheFDA,sheledinvestigationsandauditsacrossthepharmaceutical,biotech,medicaldevice,andfoodmanufacturingverticals.

About Clarkston Consulting

Clarkston Consulting is a different kind of management and technology consulting firm. We deliver a unique experience for market leaders within the Consumer Products and Life Sciences industries. Considering professionalism, expertise, and value as prerequisites, we take service a step further through our unyielding commitment to the success of people as individuals, both our clients and our employees. By combining integrity, adaptability, and a whatever-it-takes attitude, we have achieved an extremely high rate of referral and repeat business and a 10-year average client satisfaction rating of 97%.

Quality Systems MaturityINSIGHTS

Formoreinformationonhowyourcompanycanevaluateandimproveyourqualitysystems,orestablishadaptablequali-tysystemsthatadheretoglobalstandards,pleasecontactMelanie Drayton / mdrayton@clarkstonconsulting.com.