Implementing an Effective CAPA System

Definition of CAPA Elements of an effective CAPA processData analysisGetting to probable causeCAPA Timeliness For CAPAEffectiveness checks*

CAPA is a concept within good manufacturing practice, and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).*

Documented procedure(s)Defined CAPA inputsRisk assessment and prioritizationInvestigation disciplinesVerification / validationWell defined action planCirculation of informationDocumentation rulesEffectiveness checks Complete? Effective? TimelyDefined criteria for Management ReviewManagement escalationMetrics - ability to monitor progress *

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*Define the ProblemInitiate CAPAInvestigate CauseSolution(Action Plan)Verify / ValidateConductEffectiveness CheckImplementClose CAPA

*EvaluateInitiateCAPAThreshold met?CAPA already exists?Risk?Collect more data?

Can issue be resolved through: Containment? Correction? Remediation?

*DesignProduct & ProcessesProductionProcess ControlsIncld. Supply ChainPost-marketMonitoringComplaints DefineMonitor

Analyze Processes, Work OperationsConsider what is relevant to your businessProduct complexityProcess complexity Risk associated with failureLeverage Design Control to drive CAPAIntended use, essential outputsManufacturing process designIdentification of hazards, estimation of riskRisk control decisions*

Monitor data directly linked to decisions implemented to reduce (control) riskDesign FMEAProcess FMEAApplication FMEAHazards and risk mitigation implemented*

ConcessionsUse as is, deviations, temporary changesAudit ResultsRecurring audit observations, internal audits and external auditsQuality RecordsEvidence of compliance to your quality systemDistribution, Change Control, SPC, PARETO ANALYSISPost Market dataFrequency and occurrence as expected? Service RecordsComplaintsReturned Products*

Establish a prioritization methodIdentifying risk involved in the processUse the method of monitoring tools consistently across the quality management systemComplaint HandlingNonconforming ProductSupplier PerformanceChange ControlTrend MonitoringProcess Controls Audits

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NOT REQUIREDFREQUENCYIMPACTOPTIONALRECOMMENDEDMANDATORYRoot Cause Requirement?

Ultimate goal - determine WHY the problem occurredPhases of Investigation Probable Cause apparent during early investigation, suggestions that may explain the effect but needs validationContributing Causesecondary and possible causesRoot Causeprimary reason for the problem which if corrected will prevent recurrence*

A clear problem statement will establish investigation boundariesThe problem statement is the difference between what is and what should be Focus on facts not emotionswhat is wrong, not why its wrong*

Implement a solution to address the cause not the symptomImplementation of a solution that does not address the cause of the problem is costly *

Define method of investigationInclude quality tools usedIs/Is Not, Cause and Effect, 5 Whys, etc.Document Dates of investigation Data reviewed (data sources, records, dates)Corrections or Containment measuresResults: Statement of Cause

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EFFECT

PEOPLE

MATERIAL

METHODS

MEASUREMENT

MACHINE

ENVIRONMENT

Cause

Why

State the problem in measurable termshow often, how much, when, and whereEmphasize the effects (risk)Rejection, rework, cost etc. Avoid negative descriptors, inflammatory statements words that are broad and do not describe the conditions or behavior such as careless, complacency, neglect, oversight*

*DetectAnalyzeTrendInvestigateIdentify SolutionsCommunicateVerify/ValidateMonitor EffectivenessInputsOutputsMany Sources of Quality DataInternalExternalImplement changes for correction/preventionTake global actionsDisseminate informationApply learningMeasure effectiveness Management reviewApply risk managementRecordsInvolvement of PeopleRecords

*Production & ProcessControlsCAPACAPANowProcess monitoringPREVENTIVE ACTIONSCAPAThe CAPA System Quality ImprovementCorrective Actions Corrections MANAGEMENT CONTROLS Risk ManagementOversightManagement ReviewAnalysisTake actionAssure effectiveness

*ExternalDataInternalData

DesignControl, etc.Inputs Into CAPA SystemEvaluationCorrectionInvestigationCauseCorrective & Preventive ActionEffectiveness CheckTracking And TrendingFlow Chart of CAPA

CORRECTION is any action that is taken to eliminate a nonconformity. Correction is like first-aid, its the instant action that is taken to correct the nonconformity or to reduce the impact of nonconformity that has occurred.

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CORRECTIVE ACTIONS is an action to eliminate the cause of nonconformities which have occurred, to prevent their recurrence. Corrective action will target the root cause so that the non-conformity or undesirable situation do not re-occur. Corrective Action can be considered as a Problem Solving.

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PREVENTIVE ACTIONS is an action to eliminate the causes of potential nonconformities which have not occurred, to prevent their occurrence. Preventive action can be called as proactive approach.

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Not all CAPAs are created equalCAPAs age for a reasonUtilize a risk based approach to monitor key steps in the processInitiationInvestigationImplementationClosure

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*OpenCAPACloseCAPAInvestigationImplementationEffectiveness Check

Effectiveness ChecksAvoid applying the same criteria to all CAPAs Plan the effectiveness check specific to the CAPAIdentify early detection points to monitor for recurrence/occurrence

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*Was the Problem Statement well defined?

Investigate CauseRe-assess Risk

Proposed Solution

Verify/Validate

?

Implement

Action Plan Complete

Effectiveness Check

NO

YES

Data Source indicates problem still exists.

Determine Additional Action

NO

?

Recurring issues Inability to manage the many sources of quality data to understand early trends and issuesMore reaction than preventionResources ($$$) are spent on handling failure rather than learning from it and preventing more of the sameField issues*

What to do when a effectiveness check fails, and what are the consequences?Close the CAPA and open a new one Leave the CAPA open and investigate why?Focus on execution*

The challenges of implementing and sustaining an effective CAPA processMany sources of Quality DataSpreading of informationConnecting the links of causesDriving global actionsDemonstrating Effectiveness AND EfficiencyApplying Risk Management principles*

The right people: training, qualifications, accountability, communication.Follow basic good quality and business practices PDCA : Plan-Do-Check-Act. DMAIC : Define-Measure-Analyze-Improve-Control. ROI : Return-On-Investment. Team has to work as a closed loop systemScale the system to fit the business requirement.Keep it simple and straight forward !Continuous improvement should be the goal*Some points to consider

A reduction in quality issuesA reduction in the severity of issuesMore preventive actions over timeBetter designed products/processesImproved customer satisfactionBetter business results *

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Implementing an Effective CAPA System

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