IMDA QA/RA Forum 2012 Discussion Forum 1: CAPA’s

1. IMDA QA/RA Forum 2012Discussion Forum 1: CAPA’s 25th October 2012 Clarion Hotel, Dublin Airport. Define ● Deliver ●Sustain

2. The CAPA Dichotomy • Desired Vision • Incremental process to reduce/prevent Non-Conformities. • Proactive, not just reactive. • Pro-Patient: • Safer, more reliable products • Better information • Pro-Business: • Safer, more reliable processes & products • Personnel more aware, engaged. • Continuous Competitive Improvement Define ● Deliver ● Sustain

3. The CAPA Dichotomy • Practice (for many) • Reactive Snagging Process • Low Cost-Benefit • Time consuming; Over conservative; Under resourced • Anti-Business • High Cost/Low Benefit without CI • Roadmap to failure • Consistently High Trendsetter on FDA/ISO audits. Why? Define ● Deliver ● Sustain

4. CAPA’s – Natural Trendsetters • Human Intensive Process • Crisis Mode, Fatigue, Uncertainty, Approach. • Quality Critical • Draws Enquiry, Fire. • Requires coherent QMS & Management Review • Instruction & Standardisation • 820.100 & ISO-13485 (8.5) is extent, MDD states expectation • Uncertain rules of Engagement • Drives conservatism • How bad is ‘bad’? What does moderate risk mean? • Over responsive, difficult to verify. Define ● Deliver ● Sustain

5. What Can We Do? Speak to Each Other! Why do this in Silo? Establish, Agree & Benchmark Good Practice Similar method to Standards Development Harmonise Our Response to expectations Control the Conversation Empowered understanding of own practice. Rise the Tide With benefit to all, not anti-competitive!

6. Session Objectives • Create neutral discussion environment • Provide practical discussion provoking scenarios • Participants • Describe their firm’s approach to scenario • Listen to the approach of their peers • Discuss/Debate/Agree optimal approach • Outcomes • Member practices are informally peer benchmarked • Valdiation, Confidence, or Direction. • Members have greater appreciation for industry practice • Lines of future collaboration, cooperation opened. Define ● Deliver ● Sustain

7. Session Targets • Key Uncertainties • When should a CAPA be raised? • How can/should CAPA interact with other processes? • What constitutes ‘verification’ of effectivenes? Pre/Post. • Secondary Target • True expectations? • Structured Control • Integrated Approach • Feedback Systems • Business Alignment (or at least Support) Define ● Deliver ● Sustain

8. Discussion Outline Structure • Handout – ‘CAPA Scenarios’ • Non-specific circumstances, to frame discussion • Review & Discuss • Consider suggested discussion points. • Use required Outputs as structure • Develop & Handle Failure (General Case) • Establish Problem Statement • Propose Actions, Resolutions & Plans • Discuss, Agree, Document • Report to Floor • Handout – ‘CAPA Session Notes’ Define ● Deliver ● Sustain

9. Scenario Outputs • Problem Statement • What is the actual non-conformance? • Investigations • Identify potential steps & systems for investigation. • Actions • Summarise likely CA’s and PA’s. • Verification • Summarise Pre/Post Implementation Verification • Regulatory Stance • Comment on any weakness in Approach • Potential Observation? Define ● Deliver ● Sustain

10. Thank You Alan Barry Principal Consultant, MD, SysComm alan.barry@syscomm.ie Define ● Deliver ●Sustain

11. Open Forum • Key Points • When should a CAPA be raised? • When can/should CAPA interact with other processes? • When can it hand over control? • When can it close? • What constitutes ‘verification’ of effectiveness? Pre/Post. • When can we implement without pre-verification? • What practices exist in terms of limits of verification? Define ● Deliver ● Sustain

12. Resources

13. Sample Relationship Diagram Define ● Deliver ● Sustain