Implementing an Effective CAPA Process · Implementing an Effective CAPA Process Sue Jacobs...
Transcript of Implementing an Effective CAPA Process · Implementing an Effective CAPA Process Sue Jacobs...
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Implementing an Effective CAPA Process
Sue JacobsPresidentQMS Consulting, Inc.Hoffman Estates, [email protected]
Cecilia Kimberlin, PhDMedical Products Group VPAbbott LaboratoriesAbbott Park, [email protected]
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Topics
Elements of an effective CAPA processData analysisGetting to probable causeCAPA timelinessEffectiveness checksLearning from experience
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Elements of an Effective CAPA Process
Documented procedure(s)Defined CAPA inputsRisk assessment and prioritizationInvestigation disciplinesVerification / validationWell defined action planDisseminate information
Documentation rulesEffectiveness checksComplete? Effective? Timely
Defined criteria for Management ReviewManagement escalationMetrics - ability to monitor progress
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CAPA Simplified
Define the Problem
Initiate CAPA
Investigate Cause
Solution(Action Plan)
Verify / Validate
ConductEffectiveness Check
Implement
Close CAPA
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Evaluate InitiateCAPA
Complaints Quality Records Servicing
NonconformingProduct
Supply Chain
ProcessMonitoring
Audits Concessions(Deviations)
Threshold met?CAPA already exists?Isolated occurrence?Risk?Collect more data?
Can issue be resolved through:Containment?
Correction?Remediation?
CAPA Inputs
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CAPA Data Analysis
Analyze Processes, Work OperationsConsider what is relevant to your business
Product complexityProcess complexity Risk associated with failure
Leverage Design Control to drive CAPAIntended use, essential outputsManufacturing process designIdentification of hazards, estimation of riskRisk control decisions
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CAPA Data Analysis
Monitor data directly linked to decisions implemented to reduce (control) risk
Design FMEAProcess FMEAApplication FMEA
Hazards and risk mitigation implemented
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Data Analysis
DesignProduct & Processes
ProductionProcess Controls
Incld. Supply Chain
Post-marketMonitoringComplaints
Define
Monitor
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CAPA Data Analysis (cont.)
ConcessionsUse as is, deviations, temporary changes
Audit ResultsRecurring audit observations, internal audits and external audits
Quality RecordsEvidence of compliance to your quality systemInstallation, Distribution, Change Control,
Post Market dataFrequency and occurrence as expected?
Service RecordsComplaintsReturned Products
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Risk & Prioritization
Establish a prioritization methodUse the method consistently across the quality management system
Complaint HandlingNonconforming ProductSupplier PerformanceChange ControlEnvironmental MonitoringProcess Controls ServicingAudits
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Investigating Cause
Ultimate goal - determine WHY the problem occurredPhases of Investigation
Presumptive Cause apparent during early investigation, hypotheses that may explain the effect but needs validation
Contributing Causesecondary and possible causes
Root Causeprimary reason for the problem which if corrected will prevent recurrence
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A clear problem statement will establish investigation boundariesThe problem statement is the difference between what isis and what should beshould be
Focus on facts – not emotionswhatwhat is wrong, not whywhy it’s wrong
Investigating Cause
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Problem Definition
State the problem in measurable termshow often, how much, when, and where
Emphasize the effects (risk)safety, death, injury, 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
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Plan the Investigation
Define method of investigation
Include quality tools usedIs/Is Not, Cause and Effect, 5 Why’s, etc.
DocumentDates of investigation Data reviewed (data sources, records, dates)Corrections or Containment measuresResults: Statement of Cause
Is / Is Not Diagram
WHAT
WHEN
WHERE
EXTENT
IS IS NOT
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Investigating Cause
Implement a solution to address the causecause …… not the not the symptomsymptom
Implementation of a solution that does not address the cause of the problem is costly
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Effectiveness Checks
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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Effectiveness Checks
What to do when a effectiveness check fails, and what are the consequences?
Close the CAPA and open a new one?Get an extension?Leave the CAPA open and investigate why?
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Was the Problem
Statement well defined?
Effectiveness Checks
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Timeliness
Not all CAPAs are created equalCAPAs age for a reason
Utilize a risk based approach to monitor key steps in the process
InitiationInvestigationImplementationClosure
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Timeliness
OpenCAPA
CloseCAPA
InvestigationVerification/ Validation
SolutionImplementation
- Major- Moderate- Minor
- Aging Investigations
- Implementation Overdue
- Failed Effectiveness Checks- Overdue Effectiveness Checks
Effectiveness Check
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CAPA SystemEffectiveness
Learning from experience
Cecilia Kimberlin, PhDGroup VP QA/RA/MA/Compliance
Abbott Medical Products
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A focus on execution
The challenges of implementing and sustaining an effective CAPA process
Many sources of Quality DataDissemination of informationConnecting the dotsDriving global actionsDemonstrating Effectiveness AND EfficiencyApplying Risk Management principles
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What should management do?
Evaluate the CAPA system and ability to meet business needs and be in compliance
HOW ?
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What should we expect over time ?
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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What are the symptoms of a less than effective CAPA system?
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 same”Field issues
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What’s so hard about the CAPA Process?
Detect
Analyze
Trend
Investigate
Identify Solutions
Communicate
Verify/Validate
Monitor Effectiveness
Inputs
Outputs
Many Sources of Quality Data•Internal•External Implement changes for
correction/preventionTake global actionsDisseminate informationApply learningMeasure effectiveness Management review
Apply risk management
RecordsPeople
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20071997/8
Learning/ ImplementationReactive
Refining/improving
Proactive
CAPA
RiskManagement
Human Factors
ManagementResponsibility
Regulatory requirements business requirements
TotalQS
Performance
DesignControls
How well have our systems evolved over the last 10 years?
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Design Control Products/Processes
Production & ProcessControls
Post-market monitoring
CAPA
CAPA
Now
Process monitoring
PREVENTIVE ACTIONS
CAPA
The CAPA System Quality Improvement
Corrective Actions
Corrections
MANAGEMENT CONTROLS
Ris
k M
ana g
e men
t
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Business with low complexity
Functions
Sites
Medical Device Company
Fewer products, similar in type, fewer people, limited locations, etc.
Analysis & ACTION
•Products
•Parts
•Processes
•Performance
•Systems
Connect the dots ……………….
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ExternalData
InternalData
DesignControl, etc.
•Oversight•Management Review•Analysis•Take action•Assure effectiveness
Inputs Into CAPA System
Evaluation
Correction Investigation
Cause
Corrective & Preventive Action
Effectiveness Check Trac
king
And
Tre
ndin
g
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More Complexity?
R&D OPS QAFunctions
Sites
DIV DIV DIV DIV DIV DIV
Headquarters
Now connect the dots ……………….
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Some points to considerThe right people: training,qualifications, recognition, accountability, communicationIT system – can really help but is not the only answerBasic good quality and business practices –PDCA, DMAIC, ROI, etc. Has to work as a closed loop systemScale the system to fit the businessKeep it simple and straightforward !Continuous improvement is the goal
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Thank-You !Questions? Thoughts? Ideas?
Sue JacobsQMS Consulting, Inc. 847 359 [email protected]
Cecilia KimberlinAbbott Laboratories 847 937 [email protected]