The document discusses best practices for establishing effective Corrective and Preventive Action (CAPA) programs, highlighting the importance of risk assessment and compliance with regulatory requirements from entities like the FDA and ISO. It outlines seven essential habits of effective CAPA systems, including problem identification, root cause analysis, and action plan implementation, while also addressing common causes of CAPA program failures and strategies for continuous improvement. Additionally, the document emphasizes the need for collaboration and proper documentation within an integrated system to enhance overall quality management.

1. CAPA Best Practices:7 Habits of Highly Effective ProgramsValarie King-Bailey, M.B.A.VP Sales & MarketingApril 7, 2011

2. Today’s TopicsCAPA Challenges & OpportunitiesEstablishing An Effective CAPA Program Framework7 Habits of Highly Effective CAPA SystemsSummary

3. Polling QuestionDoes Your CAPA Program Include Risk Assessment?YesNo

4. Why CAPA?Regulatory RequirementsBoth FDA And ISO Require An Active CAPA Program As An Essential Element Of A Quality System.Customer SatisfactionThe Ability To Correct Existing Problems Or Implement Controls To Prevent Potential Problems Is Essential For Continued Customer Satisfaction Good Business PracticeQuality Problems Can Have A Significant Financial Impact On A Company.

5. Advantages of a CAPA Risk-Based ApproachEffective Management Of Problems, Events, Resources, And TimePrioritization Of Problems According To Degree Of Severity And RiskDefines Process, Test Methods, And/Or Product Improvements

6. The Problem With CAPA…“It only makes sense that CAPA system compliance issues show up in almost every Warning Letter, because each time we inspect a firm now, we look to see that a CAPA system is in place and operating effectively, Welch told AAMI News.”“FDA investigators cited problems with corrective and preventive action (CAPA) systems in 88% of the Warning Letters issued to medical device firms last year, according to FDA quality system expert Jan Welch .”Jan WelchJan Welch

7. Principles of Compliance ExcellenceCompliance-Focused OrganizationTop-Down Compliance LeadershipCollaborationCompliance Process ControlEffective Management ControlsContinuous ImprovementActionable Compliance IntelligenceDedication To Quality

8. “Though the vast majority of firms we inspect have effective CAPA systems in place, a few companies actually have no system set up at all. Others may have just a small, specific problem such as lack of documentation for a procedure,” Welch says.”The CAPA Problem…Jan Welch“Firms need to have a mindset that appreciates the importance of having an operational CAPA procedure in place. This isn’t just a regulatory issue, this is a business issue.”

9. The Cost of Non-ComplianceTop 10 FDA 483 Items

10. Why Do CAPA Programs Fail?Typical Causes Of Failed CAPA Programs Include Inadequate “Buy-in” From Key Stakeholders:Over-ambitious Custom CAPA System Development Insufficient Labor Resources Or Delegation Of ResponsibilityPoor CommunicationFaulty Or Missing ProceduresLack Of Closed Loop SystemFailure To Enforce ProceduresSystem Or Equipment Malfunction Due To Lack Of Monitoring Or MaintenanceInadequate TrainingInadequate Compliance Awareness

11. Establishing An Effective CAPA Program Framework

12. CAPA [21CFR 820.100] Includes Actions Needed To: Correct (“Correction”) Nonconforming Product And Other Quality ProblemsPrevent Recurrence (“Corrective Action”) Of Nonconforming Product And Other Quality ProblemsEliminate The Cause Of Potential (“Preventive Action”) Nonconforming Product And Other Quality Problems

13. Corrective Action Action Taken To Eliminate The Causes Of An Existing Non-conformity, Defect Or Other Undesirable Situation In Order To Prevent Recurrence. [ISO 8402]

14. Preventive Action Action Taken To Eliminate The Cause Of A Potential Non-conformity, Defect, Or Other Undesirable Situation In Order To Prevent Occurrence [ISO 8402]

15. Closed-Loop Corrective Action ProcessCA ReviewReportPreventive ActionCorrective ActionInvestigateSubmitExport .HTML.TXTCA Review

16. Effective CAPA FrameworkManagementDesign ControlsElectronicSubmissionsCorrective &PreventiveActionsEquipment & Facility ControlsMaterialControlsRecords, Documents, &Change ControlsControlsSource: Quality System Inspection Techniques, U.S. FDA

17. The Importance of RiskProvides Clear Guidance To Help:Manage Problems, Events, Resources And TimePrioritize Issues/ProblemsManage Product/Process Design

18. CAPA & RiskImportant DefinitionsRisk – Combination Of The Probability Of Harm And The Severity Of That HarmSeverity – The Degree Of Patient Harm Or The Loss Of Efficacy Caused By FailureProbability Of Harm– The Probability Of Physical Injury Or Damage Degree Of Remedial Action Taken Must Be Appropriate And Commensurate With The Risks.Risk Assessment Is An Important Element of A CAPA Program

19. CAPA Risk Management ProgramTop Level Risk ManagementProvide Guidance Regarding The Risk Management Lifecycle Quality System Risk AnalysisHelps Identify The Impact Of An Event Prior To InvestigationImplementation Of Corrective And Preventive ActionsCompletion Of Effectiveness Checks

20. Assessment“Top Down” - ImplementedID Existing Problems (Corrective Actions)Quality Data Sources Are IdentifiedData From Sources Are AnalyzedID Potential Problems (Preventive Actions)Quality Data Sources Are IdentifiedData From Sources Are Analyzed

21. Assessment“Top Down” - ImplementedStatistical And Non-statistical TechniquesDetect Recurring Quality ProblemsResults Of AnalysesCompared Across Different Data SourcesIdentify And Develop Extent Of Problems

22. Assessment“Top Down” - ImplementedStatistical And Non-statistical TechniquesDetect Recurring Quality ProblemsResults Of AnalysesCompared Across Different Data SourcesIdentify And Develop Extent Of Problems

23. 7 Habits of Highly Effective CAPA Systems

24. CAPA ProceduresSeven StepsIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

25. CAPA ProceduresSeven StepsIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

26. IdentificationDevelop Comprehensive Corrective Action Report (CAR)Initial Step Of The CAPA ProcessCAR Includes:Problem SourceTime, Date, Person Reporting ProblemDetailed Explanation Of The Problem Link To Supporting Documentation Supporting The Nature of Problem

28. IdentificationSource of the InformationDocument Specific Source Of Information. Sources Include:Information Used To Investigate & Develop CAPUseful For Effective Evaluation & Communication of Problem Resolution

30. Identification Detailed Problem ExplanationCAPA System Should Facilitate The Ability To Record Written Detailed ProblemEffective Descriptions Should Be:ConciseDetail-OrientedAccurateFactual

31. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

32. EvaluationCarefully Study Problem To Determine The Need For Action & The Level Of Action RequiredEvaluation Should Include:Potential Impact Of The ProblemRisk To The Company Or Its CustomersRemedial Action That May Be Required

33. EvaluationPotential ImpactEvaluation Should HighlightNature of the ProblemWhy The Problem Is A Concern Impact To The Organization/CustomersOther Considerations:CostsFunctionProduct QualitySafetyReliabilityCustomer Satisfaction.

34. EvaluationRisk & Remedial ActionEvaluate Level of RiskProblem SeverityProblem PriorityMay Influence Recommendations In The CAP Stage Potential Impact & Risk Assessment May Indicate A Need Immediate Action Until A Permanent Solution Can Be ImplementedRemedial Action May Be Adequate

35. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

36. InvestigationDevelop Written ProcedureProcedure Should Include: Objectives For The Action Investigation StrategyAssignment Of Responsibility & Required Resources

37. InvestigationStrategyStrategy Includes:Set Of Specific Instructions For Determining Root Cause & Contributing FactorsComprehensive Review Of All Circumstances Related To The Problem Considering:

38. InvestigationAssign Responsibility and ResourcesAssign Responsibility For Each Aspect Of The InvestigationIdentify Any Additional Resources (Financial, Equipment, etc.) Required

39. The Workflow Can Be Routed Based On User Entry. Checking The “Investigation Required” Will Automatically Launch An Investigation

40. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

41. AnalysisPrimary Goal is Determination of Root CauseRecord Problem Investigation and AnalysisEvery Possible Cause Is Identified And Appropriate Data Collected.Document Results Of Investigation

42. AnalysisRoot Cause AnalysisRoot Cause Analysis Includes:Determination of The Actual Cause Of The Problem Establish Primary Cause - Essential For Determining Appropriate Corrective And/Or Preventive Actions.

43. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

44. Corrective Action Plan (CAP)CAP Includes:The Best Method(s) For Correcting The Situation (Or Preventing A Future Occurrence)All Tasks Required To Correct The Problem And Prevent A Recurrence Are Identified Summary Of Required ChangesAssignment Of Task Responsibility

45. Corrective Action PlanChangesCAP Should Also Include:Required Changes To DocumentsProcesses & ProceduresOther System Modifications Must Be Detailed To Ensure Clear Understanding of Tasks And Desired Outcome Of Changes

46. Corrective Action PlanTrainingEmployee Training Is Essential Effective CAPA Systems Should Facilitate:Communication Of All Modifications And Changes To All Persons, Departments, Suppliers, and Other Affected Stakeholders

47. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

48. Action Implementation!The Action Plan That Has Been Developed Is Executed And All Identified Tasks And Activities Completed.The Actions That Were Taken Are Summarized And All Modifications To Documents, Processes, etc. Are Listed.

49. The CAPA leader can also create action plans with multiple tasks, setting notifications, due dates, and priorities. The action plans can be created ad-hoc or can be copied from action plan templates in the library to expedite the creation process.

50. CAPA ProceduresIdentification – Clearly Define The Problem (CAR)Access – Access Problem Magnitude And ImpactInvestigation – Investigate Facts and CauseAnalysis – Analyze & Determine Root CauseAction Plan – Develop Corrective Action Plan (CAP)Implementation – Execute Corrective Action PlanFollow Up – Verify And Assess The Effectiveness Summarize & Close The Event

51. Follow Up – CLOSE THE LOOP!Fundamental Step In The CAPA Process Is Completing Summary ReportEvaluation Of The Actions TakenConfirmation of Successful Completion of All TasksAssessment Of The Appropriateness And Effectiveness Of The Actions Taken

52. Follow upKey QuestionsHave All Of The Objectives Been Met? (Did The Actions Correct Or Prevent The Problem With Assurances That The Same Situation Will Not Happen Again?)Have All Recommended Changes Been Completed And Verified?Has Training And Appropriate Communications Been Implemented To Assure That All Relevant Employees Understand The Situation And The Changes That Have Been Made?Has An Investigation Demonstrated That That The Actions Taken Have Not Had Any Additional Adverse Effect On The Product Or Service?

53. Follow upVerification ResultsMake Sure That Appropriate Information Has Been Recorded That Provides Proof That All Actions Have Been Completed Successfully.

54. Enterprise Compliance Collaboration

55. Integrated Content ManagementIntegrated With Documentum® Enterprise Content Management

56. eQCM Competency Manager™Training is an essential part of any compliance program

57. Corrective Action ReportingSimple list reports are available quickly for the manager to determine the status of all actions

58. Follow upValidation ResultsValidation and Summary Report.Summary Report Highlights:Root Cause Of The Problem Summary of Secondary Problems CorrectedConfirmation of Established Proper Controls To Prevent A Future OccurrenceConfirmation That Actions Taken Had No Other Adverse EffectsMonitoring For Continuous Improvement

59. CAPA ProceduresCompletionWhen The Follow Up Has Been Finished, The CAPA Is Complete.System Should Facilitate Signing and Date Stamp By Appropriate, Authorized Personnel.

60. Key MessageDON’T JUST BUY A “CAPA” SYSTEM – LOOK FOR AN INTEGRATED SYSTEM

61. 7 Habits of Effective CAPA ProgramsProcess Focused, Closed LoopOnline CollaborationComprehensive WorkflowElectronic SignaturesNotification & Problem EscalationStatistical AnalysisIntegrated Content Management

62. Questions?

63. THANK YOU FOR ATTENDING!Valarie King-Bailey, M.B.A.VP Sales & Marketing vkbailey@xybion.comKevin MillerInside Sales Managerkmiller@xybion.com