质量体系的分析研究ppt课件

1、Implementing aHolistic Approach to yourQuality Management SystemSteven R. CagleV.P. of Marketing & Product DevelopmentSparta Systems, Inc.AgendaSession ObjectivesQuality Management System OverviewTraditional ChallengesRe-defining CAPAImplementing a Quality Management Software SolutionConclusionQ&A2.

2、Session ObjectiveDiscuss critical components of an effective Quality Management System (QMS), challenges with current systems, and solutions to overcome these challenges by implementing a holistic Quality Management Software solution.3.General IntroductionDefining CAPA ISO 13485:20038.5.2 Corrective

3、 Action Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements forreviewing nonconformities (including customer complaints)determining the cause of nonconformitiesevaluating the need for action to

4、ensure that nonconformities to not recurdetermining and implementing action needed, including, if appropriate, updating documentationrecording of the results of any investigation and of action taken, andreviewing the corrective action taken and its effectiveness5.Defining CAPA ISO 13485:20038.5.3 Pr

5、eventive action The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.It is also determine potential nonconformities and their causesevaluatin

6、g the need for action to prevent occurrence of nonconformitiesdetermining and implementing action neededrecording of the results of any investigations and of action taken, andreviewing preventive action taken and its effectiveness6.Quality Regulation 21 CFR 820.100U.S. Food and Drug Administrations

7、regulation governing medical device manufacturers quality systems:(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action:analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, re

8、turned products, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problemsinvestigating the cause of nonconformities relating to product, processes, and the quality systemidentifying the actions needed to correct and prevent recur

9、rence of nonconforming product and other quality problemsverifying or validating the corrective and preventive actionImplementing and recording changes in methods and procedures needed to correct and prevent identified quality problems Ensuring that information related to quality problems or nonconf

10、orming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; andSubmitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review7.Quality Regulation 21 CFR

11、211.22Very similar is the U.S. FDAs regulation for pharmaceutical manufacturers 21 CFR Part 211.22 (Quality Control Unit)responsibilities of a quality control unit.to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.The quality control unit shal

12、l have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, an purity of the drug productand in Part 211.92 (Production Record Review)Any unexplained discrepancyor the failure of a batch or any of its components to meet any of i

13、ts specifications shall be thoroughly investigatedThe investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclus

14、ions and follow-up. 8.Quotes from Current FDA WarningLettersEach manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality sy

15、stem . Quality audits shall be conducted by individuals who do not have direct responsibility for the matters and shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibi

16、lity for the matters audited. The dates and results of quality audits and reaudits shall be documented as required by 21 CFR 820.22 . internal quality audits conducted by your firm failed to verify that the quality system was effective in fulfilling quality system objectives (FDA 483, Item #2).9.Quo

17、tes from Current FDA Warning LettersYour firm fails to implement and maintain corrective and preventive action (CAPA) procedures that include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and

18、 other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR 820.1 00(a)(1). Your firm fails to establish and implement corrective and preventive action (CAPA) procedures that include requirements for identifying t

19、he action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3) All activities required by 21 CFR 820.100 must be verified or validated to ensure that such action is effective and does not adversely affect finished device

20、s, and the results of these activities shall be documented as required by 21 CFR 820.100(a)(4) and (b). Your firms CAPA procedures fail to document how analysis is done and fails to require verification/validation that CAPA does not adversely affect finished devices (FDA 483, Item #8). 10.Commission

21、 Directive 2003/94/ECPreambleHaving regard to the Treaty establishing the European Community, All manufacturers should operate an effective quality management system of their manufacturing operations, which requires the implementation of a pharmaceutical quality assurance system.Article 13 - Complai

22、ntsAny complaint concerning a defect shall be recorded and investigated by the manufacturerArticle 14 - InspectionsThe manufacturer shall conduct repeated self-inspectionsin order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measure

23、s. Records shall be maintained of such self-inspections and any corrective action subsequently taken.11.More than just corrective actionsCAPA is much more than just “corrective actions and “preventive actions.Any opportunity to improve quality in your organization is a CAPA!12.Holistic QMS Defines C

24、APA SourcesComplaintsInternal InspectionsSupplier AuditsRegulatory AuditsNon-conformanceDeviationsOut of SpecificationOut of SpecificationAdverse TrendsAdverse EventsIncoming InspectionsAnd moreNumerous source areas for CAPA Scope of “problems that drive CAPAs go beyond nonconforming productAny proc

25、ess that affects product quality is included13.CAPA Process best practicesVerify EffectivenessImplement ActionsReview & Approve PlanInvestigate, Root Cause, Action PlanIdentify & TriageRegardless of where the problem originates, or what type it is, it must follow a processIdentify problemAssess impa

26、ctQuality / Regulatory / Management NotificationInvestigation Process?Complete InvestigationDetermine Root CauseProposed Corrective / Preventive ActionsPlan effectivenessAssess changesEnsure no impact to product qualityConsensus from SMEsApprovalImplement ActionsVerify completedInform stakeholdersMe

27、asure to ensure problem has been resolvedMonitor to ensure it is not re-occurringChange ControlMetrics and Reporting14.Addressing QMS ChallengesTypical QMS ChallengesChallenges in Problem IdentificationMissing view of the big pictureLack of ownership and accountabilityInability to link related probl

28、emsInsufficient tools for trending and analysisChallenges in InvestigationQuality of investigations is poorMissing & incomplete informationInability to easily review similar past investigationsInconsistent investigation process & Root CauseNot determining root causePast due investigations, not being

29、 closed, get lostProblem IdentificationIdentify & Investigate Root CauseCreate Action PlanChallenges in PlanningVague root cause analysisConfusion over what is “corrective and what is “preventive actionInability to relate corrective actions to source problemsLack of integration to Change Control Sys

30、tem16.Typical QMS Challenges (cont.)Verify EffectivenessImplement ActionsChallenges in ImplementationNo way to track issues through workflowLack of visibility to open itemsLack of visibility to related itemsChanges to plan mid-streamCompliance riskChallenges in EffectivenessEasy to “forget to measur

31、e effectivenessDifficult to gather necessary metricsNo means to generate metricsInability to measure effectiveness does not give us any assurance if we are addressing the root cause of the problemsReview & Approve PlanChallenges in Review & ApprovalNot sure who needs to approveApprovals in serial, n

32、ot parallelApproval process takes long timeLack of key stakeholder input17.SolutionHolistic Approach to Quality ManagementGlobalize (harmonize) around a common philosophy and approach to CAPA and source EventsObtain full compliance with cGxPs, as well as regulatory & customer expectationsUse quality

33、 metrics as a basis for continuous improvementsTrending Problem AnalysisThorough Investigations and Root Cause AnalysisEnsuring CAPA effectivenessBring attention to risk areas to prevent problemsImplement a centralized Quality Management System: Manages all inputs and outputs as well as the actual a

34、ctionsScalable to be deployed on a global basisFunctionality / Flexibility to meet business requirements18.Re-defining CAPARe-defining CAPADefinitionsStandardize definitions across the organizationTerms like “ “deviation, “event, “nonconformance, correction, “corrective action, “preventive action, “

35、discrepancy must be consistent for each operating unitThe same term should have the same meaning everywhere, and drive the same processCAPA sources include: Complaints, Audits Observations, Trends can feed CAPADetermine, scope identification & impact of new systemWhere does the process need to chang

36、e?Who will the system affect?What existing policies may change?Understand the difference between the “what and the “who20.Define the Inputs & ProcessRecord the EventCapture all related data of any event regardless of the type SourceDate & Time of EventTypeDescriptionDepartmentFor issues surrounding

37、Events, utilize a quality evaluation:Quality Event onlyQuality Event + CAPAQuality Event + Investigation + CAPA + Change ControlLog observations / trends to implement pro-active changes22.Perform Assessment & InvestigationAssign InvestigatorUse “Push or “Pull conceptAssess impact, consider decision

38、tree approachCreate Investigation PlanUse Parent-Child concepts track each investigation “taskUse Investigation TemplatesTrack & Complete InvestigationsUse workflow, due dates and remindersEscalation of past due investigationsSearch & ReportingUser DashboardsAnalyze Root CauseStructure Root cause An

39、alysis TreeUse Root Cause to Drive CAPA process23.CAPA Plan & ApprovalReview currently in progress CAPAsCreate CAPAs and link to root causeIf multiple CAPAs identify which ones resolve which root cause?Which actions must be closed to close the deviation?Create an Effectiveness Plan at this timeDeter

40、mine ApproversUse pre-set approver functions if possibleRoute Investigation & CAPA plan for approval alerts, remindersDashboardsObtain ApprovalAbility to reject to various previous workflow states24.Implementing CAPA & EffectivenessEach CAPA record should have its own record and workflowUse Parent-c

41、hild relationships to break up the process into “smaller bitesAction Item TrackingTrack completion and verification of each CAPAUse workflow, due dates and remindersEscalation of past due investigationsSearch & ReportingUser DashboardsMeasure effectiveness according to the plan - evidence that root

42、cause has been eliminated25.Important QMS RequirementsHigh Level Requirements Centralized database Handles all process areas - modular Workflow driven Proactive user notification and escalationAction items managementQuerying & ReportingElaborate security by user-groupDefining the RequirementsManagem

43、ent reportsPerformance Metrics & TrendingPart 11 Compliance27.Management of all DataModular approach to handling all source areas but maintains individual requirementMultiple “Record Types to handle all process areasAbility to create user defined fieldsConfigurable data entry formsValidation and bus

44、iness rulesIntegration to external systemsE.g., Create deviations automatically from ERPE.g., Create OOS Investigation from LIMSMaster data (customer, product/item, etc.)External SystemsData Management28.Workflow ManagementConfigurable workflow Automate review and approval process based on meta data

45、Business-rule based workflowsParallel ApprovalsProcess changing activity notificationsIntegrated source areas process to Corrective Action processParent child relationshipsCross referencingWorkflowExternal SystemsData Management29.Escalations and Business RulesBusiness rules enforcementDate Due, Mil

46、estone DatesAutomatically assigning investigators, reviewers, approversAutomatically scheduling tasks based on type of RecordEscalation“Reminders of tasks reaching expected completion dateEscalation of CAPA past dueWorkflowExternal SystemsData ManagementBusiness Rules & Escalation30.Query, Reporting

47、, TrendingWorkflowExternal SystemsData ManagementBusiness Rules & EscalationSearch, Report, TrendQueryingAbility to query on all fieldsFull text / search engine functionalityAbility to save searchesReportingCustomizable report formatOn screen view, print, , saveStatus reportingTrendingAcross all sit

48、esAcross all source areasRoot cause analysisIdentify occurrence rate decrease / increaseAbility to detect trends automatically31.Compliance with Part 11Does the system conform with your firms Part 11 requirements?Has the software “passed the test, I.e., has it gone through FDA audits at another firm

49、?Can it be validated?How confident are you in the above assessment?Full audit trailReporting featuresConfigurable security groupsComplete record of created and modified dataEnforced workflow sequencingPassword composition rulesElectronic Signatures made up of two unique componentsPassword aging/expi

50、rationCannot re-use previous passwordAccount Locking and Admin Notification after failed log-in AttemptsSession time-outRequirement of “reason for data modificationAdministrator / Configuration Audit Trail32.Implement SolutionQuality, Operations, ITStructured Project OrganizationCustomer System Admi

51、nistratorImplementation ConsultantProject ManagementCustomer Executive SponsorSr. Mgmt. SupportBusiness & IT Project Mgr.Vendor Project ManagerProject TeamChange ManagementValidation PartnersOperations managementVendor SMEsQA & Customer SatisfactionTechnical Support LAN/WANDBAServersCustomer IT Spon

52、sorMedtronic Leads:Medtronic Leads:Customer. Owner TeamCAPAComplaintsAuditsRMAsOthersSteering CommitteeInternal Computer Systems ValidationVendor3rd Party (recommended)Validation TeamVendor Administrative Resources34.Rapid ROI - Phased ApproachCritical Systems PrioritizationPhase-1: FIRST QMS Configure, Prototype, TrainValidationPhase-2: Additional QS Implementation,Configure, Prototype, TrainDATA Migration & Systems IntegrationReduced Validation via Migration toolFully integrated CAPAInitial ROI / Business and compliance BenefitsRoll out Production