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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 process Data analysis Getting to probable cause CAPA timeliness Effectiveness checks Learning from experience
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Elements of an Effective CAPA Process Documented procedure(s) Defined CAPA inputs Risk assessment and
prioritization Investigation disciplines Verification / validation Well defined action plan Disseminate information
Documentation rules Effectiveness checks
Complete? Effective? Timely Defined criteria for
Management Review Management escalation Metrics - 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 Operations
Consider what is relevant to your business Product complexity Process complexity Risk associated with failure
Leverage Design Control to drive CAPA Intended use, essential outputs Manufacturing process design Identification of hazards, estimation of risk Risk control decisions
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CAPA Data Analysis Monitor data directly linked to
decisions implemented to reduce (control) risk Design FMEA Process FMEA Application 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.)
Concessions Use as is, deviations,
temporary changes
Audit Results Recurring audit
observations, internal audits and external audits
Quality Records Evidence of compliance
to your quality system Installation, Distribution,
Change Control,
Post Market data Frequency and
occurrence as expected? Service Records Complaints Returned Products
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Risk & Prioritization Establish a
prioritization method Use the method
consistently across the quality management system
Complaint Handling Nonconforming Product Supplier Performance Change Control Environmental
Monitoring Process Controls Servicing Audits
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Investigating Cause Ultimate goal - determine WHY the problem
occurred Phases of Investigation
Presumptive Cause apparent during early investigation, hypotheses that may
explain the effect but needs validation Contributing Cause
secondary and possible causes Root Cause
primary reason for the problem which if corrected will prevent recurrence
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A clear problem statement will establish investigation boundaries
The problem statement is the difference between what isis and what should beshould be Focus on
facts – not emotions whatwhat is wrong, not whywhy it’s wrong
Investigating Cause
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Problem Definition State the problem in measurable terms
how 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 used
Is/Is Not, Cause and Effect, 5 Why’s, etc.
Document Dates of investigation Data reviewed (data
sources, records, dates) Corrections or Containment
measures Results: Statement of
Cause
Is / Is Not Diagram
WHAT
WHEN
WHERE
EXTENT
IS IS NOT
EFFECT
PEOPLE MATERIAL
METHODS MEASUREMENT
MACHINE
ENVIRONMENT
Cause
Why
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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 Checks
Avoid applying the same criteria to all CAPAs
Plan the effectiveness check specific to the CAPA
Identify 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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Investigate CauseRe-assess Risk
Proposed Solution
Verify/Validate
Implement
EffectivenessCheck
NO
YES
Data Sourceindicates
problem stillexists.
DetermineAdditional
Action
NO
Action Plan Complete
?
?
Was the Problem
Statement well defined?
Effectiveness Checks
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Timeliness Not all CAPAs are
created equal CAPAs age for a
reason
Utilize a risk based approach to monitor key steps in the process Initiation Investigation Implementation Closure
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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 Data Dissemination of information Connecting the dots Driving global actions Demonstrating Effectiveness AND Efficiency Applying 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 issues A reduction in the severity of issues More preventive actions over time Better designed products/processes Improved customer satisfaction Better 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 issues
More reaction than prevention Resources ($$$) 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/prevention
Take global actions
Disseminate information
Apply learning
Measure effectiveness
Management review
Apply risk management
RecordsPeople
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20071997/8Learning/
Implementation Reactive
Refining/improvin
g 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
anag
emen
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 consider The right people: training,qualifications,
recognition, accountability, communication IT system – can really help but is not the only
answer Basic good quality and business practices –
PDCA, DMAIC, ROI, etc. Has to work as a closed loop system Scale the system to fit the business Keep 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]
