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.
What are the symptoms of a less than effective CAPA system?
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”
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
Implement changes for correction/prevention Take global actions Disseminate information Apply learning Measure effectiveness Management review Apply risk management Records People
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?
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
Business with low complexity Functions Sites Medical Device Company Fewer products, similar in type, fewer people, limited locations, etc.
Analysis & ACTION
Connect the dots ……………….
External Data Internal Data Design Control, etc.
Inputs Into CAPA System Evaluation Correction Investigation Cause Corrective & Preventive Action Effectiveness Check Tracking And Trending
More Complexity? R&D OPS QA Functions Sites DIV DIV DIV DIV DIV DIV Headquarters Now connect the dots ……………….