Transcript CAPA - Xavier University Health

Total Product Life Cycle
An Example
Agenda
Post Market Surveillance
Total Product Life Cycle and Product Design
Systematic Collection of Data
Risk Assessments and Investigations (CAPA)
Final Thoughts
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Post Market Surveillance...
 Activities carried out to gain information about the quality, safety, or
performance of products placed in the market
 Proactive collection of information
 Distinct from enforcement
 Review of post-market studies
 Clinical trials required as a condition of market approval
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Total Product Life Cycle and Design
Identification of Risks Begins at
Design
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Factors Important to Risk Assessment
 Device design and manufacture
 Materials
 Device users
 Human Factors
 Medical device systems
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Design Records
 Input Requirements
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Ability to deploy the implant
Ability to access the intended location
Deliver stent to lesion
 Output Requirements
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Materials
Stent Retention
Balloon Burst Pressure (Balloon Rupture)
Test Methods
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Design Records
 Design Verification
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Balloon deployment and retraction
Balloon inflation and deflation time
Deliver stent to lesion
Deploy stent at lesion
Stent dislodgment
Balloon rupture
Tensile strength
 Design Validation
 Risk Assessment
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Use FMEA
Design FMEA
Component FMEA
Process FMEA
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Design Transfer
 Manufacturing Procedures
 Bill of Materials
 Manufacturing Process
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Crimping Process
Extrusion
 Test Methods
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Incoming Materials
In-process
Finished product
 Training
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Production and Process Controls
 Manufacturing processes procedures
 Validated processes
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Crimping
Extrusion
 Process Monitoring
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Crimping (force, mandrel diameter)
Split mold (pressure/temperature/split mold diameter)
Press parameters (force, press sheath ID)
Extrusion
 Temperature
 Pressure
 Drying of polymer granules
 Rotational speed of the screw
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Monitoring and Analysis
Internal
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External
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Complaints &
MDRs
Service
NONCONFORMING
PRODUCT
Evaluate
Investigate
Monitor
Trend
Management
Review
Audits
Nonconforming
Product
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Returned
Product
Supplier
Performance
CAPA
Analyze
Investigate
Identify
Verify or Validate
Implement
Disseminate
Submit to
Management Review
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Process
Monitoring
Inspection
Monitor
Trend
COMPLAINTS
Evaluate
Investigate
Data Sources
 Complaints Types
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Difficult to deploy
Failure to deploy
Loose
Unstable
Inflation issue
Leak
Deflation time
Dislodged/Dislocated
Balloon Rupture
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Data Sources
 Medical Device Reports
 Nonconformances
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Process Parameters
Incoming acceptance testing
In-process testing
Finished product testing
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Post Launch Reviews
 Premarket Clinical Trials
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Comparison
 Product Launch Learnings
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Marketing and Sales
Complaints
 Postmarket Clinical Trials
 Product Performance
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Investigated Concerns
MDRs
Complaints
Design Changes
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Interlocked Concepts
CAPA and Risk Management are central to the implementation of
an effective, closed loop, continuous improvement process that
focuses on prevention and quality
Document
Control
Training
Deviations
Analysis &
Trending
Facilities &
Equipment
Audits
CAPA
Complaints
Reports
NonConformances
OOS Results
Mgmt
Review
Systems
Integration
Risk Management
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21 CFR Part 11
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Closed-loop process control
Interdependency of Post Market Surveillance, Risk and CAPA
PMS
DATA
Ris
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CAPA
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Final Thoughts
• Begins at design and development
• Establish a risk management process
• Identify risks early, mitigate, and monitor
• Engage in postmarket surveillance monitoring as required by
regulations
• Collect and analyze internal and external data sources
• Use leading indicators to prevent product issues
• Act on lagging indicators such as complaints, product failures, and
adverse events associated with product use
• Establish a PMS program that meets your needs
• Use a total product life cycle
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Questions
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Contact Information:
Monica J. Wilkins
Divisional Vice President Quality
Abbott Laboratories
(847) 937-9255
[email protected]
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