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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.

Capa Presentation 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
    Is / Is Not Diagram WHAT WHEN WHERE EXTENT IS IS NOT
  • 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]