Revised Quality Management Basics Texas Histology Society
Capa
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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)
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8. Data Analysis Design Product & Processes Production Process Controls Incld. Supply Chain Post-market Monitoring Complaints Define Monitor
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18. Was the Problem Statement well defined? Effectiveness Checks
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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
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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
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31. More Complexity? R&D OPS QA Functions Sites DIV DIV DIV DIV DIV DIV Headquarters Now connect the dots ……………….
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Editor's Notes
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.
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