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  • A lot of things have to come together…each of these steps are important and need skills, subsystems, etc. – some thoughts on most challenging…..Investigations ( to root cause ) and good verification and validation- People need the skills..but most importantly they need good judgment Finally – it is only as good as the records reflect . . .
  • One perspective is …. Industry struggled with adapting to the new QS as a system … came at it in parts…some with parallel implementation…more recently getting better at connecting the dots in the system…in the next slides…talk about some possible reasons
  • Is it easier for a smaller firm? …they face limited expert resources…people wear many hats… Larger firms … the complexity is multiplied by the number of products, locations, divisions, etc.
  • Transcript

    • 1. Implementing an Effective CAPA Process
      • Sue Jacobs
        • President
        • QMS Consulting, Inc.
        • Hoffman Estates, IL
        • [email_address]
        • 847.359.4456
      • Cecilia Kimberlin, PhD
        • Medical Products Group VP
        • Abbott Laboratories
        • Abbott Park, IL
        • [email_address]
        • 847.937.7933
    • 2. Topics
      • Elements of an effective CAPA process
      • Data analysis
      • Getting to probable cause
      • CAPA timeliness
      • Effectiveness checks
      • Learning from experience
    • 3. 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
    • 4. CAPA Simplified Define the Problem Initiate CAPA Investigate Cause Solution (Action Plan) Verify / Validate Conduct Effectiveness Check Implement Close CAPA
    • 5. CAPA Inputs Evaluate Initiate CAPA Threshold met? CAPA already exists? Isolated occurrence? Risk? Collect more data? Can issue be resolved through: Containment? Correction? Remediation? Complaints Quality Records Servicing Nonconforming Product Supply Chain Process Monitoring Audits Concessions (Deviations)
    • 6. 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
    • 7. 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
    • 8. Data Analysis Design Product & Processes Production Process Controls Incld. Supply Chain Post-market Monitoring Complaints Define Monitor
    • 9. 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
    • 10. 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
    • 11. 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
    • 12.
      • A clear problem statement will establish investigation boundaries
      • The problem statement is the difference between what is and what should be
        • Focus on
          • facts – not emotions
          • what is wrong, not why it’s wrong
      Investigating Cause
    • 13. 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
    • 14. 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
    • 15. Investigating Cause
      • Implement a solution to address the cause … not the symptom
      • Implementation of a solution that does not address the cause of the problem is costly
    • 16. 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
    • 17. 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?
    • 18. Was the Problem Statement well defined? Effectiveness Checks
    • 19. 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
    • 20. Timeliness Open CAPA Close CAPA Investigation Implementation Effectiveness Check Verification/ Validation Solution - Major - Moderate - Minor - Aging Investigations - Implementation Overdue - Failed Effectiveness Checks - Overdue Effectiveness Checks
    • 21. CAPA System Effectiveness Learning from experience Cecilia Kimberlin, PhD Group VP QA/RA/MA/Compliance Abbott Medical Products
    • 22. 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
    • 23. What should management do?
      • Evaluate the CAPA system and ability to meet business needs and be in compliance
      HOW ?
    • 24. 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
    • 25. 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
    • 26. 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 Records People
    • 27. 2007 1997/8 Learning/ Implementation Reactive Refining/improving Proactive CAPA Risk Management Human Factors Management Responsibility Regulatory requirements business requirements Total QS Performance Design Controls How well have our systems evolved over the last 10 years?
    • 28. Production & Process Controls CAPA CAPA Now Process monitoring PREVENTIVE ACTIONS CAPA The CAPA System Quality Improvement Corrective Actions Corrections MANAGEMENT CONTROLS Risk Management Design Control Products/Processes Post-market monitoring
    • 29. 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 ……………….
    • 30. External Data Internal Data Design Control, etc.
      • Oversight
      • Management Review
      • Analysis
      • Take action
      • Assure effectiveness
      Inputs Into CAPA System Evaluation Correction Investigation Cause Corrective & Preventive Action Effectiveness Check Tracking And Trending
    • 31. More Complexity? R&D OPS QA Functions Sites DIV DIV DIV DIV DIV DIV Headquarters Now connect the dots ……………….
    • 32.
        • 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
      Some points to consider
    • 33. Thank-You ! Questions? Thoughts? Ideas?
      • Sue Jacobs
      • QMS Consulting, Inc.
      • 847 359 4456
      • [email_address]
      Cecilia Kimberlin Abbott Laboratories 847 937 7933 [email_address]