Implementing an Effective CAPA Process

1. Implementing an Effective CAPA Process Sue Jacobs President QMS Consulting, Inc. Hoffman Estates, IL sue@QMSconsultant.com 847.359.4456 • Cecilia Kimberlin, PhD • Medical Products Group VP • Abbott Laboratories • Abbott Park, IL • cecilia.kimberlin@abbott.com • 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. Documented procedure(s) Defined CAPA inputs Risk assessment and prioritization Investigation disciplines Verification / validation Well defined action plan Disseminate information Documentation rules Effectiveness checksComplete? Effective? Timely Defined criteria for Management Review Management escalation Metrics - ability to monitor progress Elements of an Effective CAPA Process

4. CAPA Simplified Initiate CAPA Verify / Validate Define the Problem Implement Investigate Cause Conduct Effectiveness Check Solution (Action Plan) Close CAPA

5. Complaints Quality Records Servicing Nonconforming Product Supply Chain Process Monitoring Audits Concessions(Deviations) CAPA Inputs Threshold met? CAPA already exists? Isolated occurrence? Risk? Collect more data? Can issue be resolved through: Containment? Correction? Remediation? Evaluate Initiate CAPA

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 Monitor Design Product & Processes Production Process Controls Incld. Supply Chain Post-market Monitoring Complaints Define

9. 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 CAPA Data Analysis (cont.)

10. 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 Risk & Prioritization

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. Investigating Cause • 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

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. 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 WHAT WHEN WHERE EXTENT Is / Is Not Diagram Plan the Investigation

15. 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 Investigating Cause

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. Effectiveness Checks Was the Problem Statement well defined?

19. 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 Timeliness

20. - Major - Moderate - Minor - Implementation Overdue Solution Verification/ Validation - Aging Investigations - Failed Effectiveness Checks - Overdue Effectiveness Checks Timeliness Open CAPA Close CAPA Investigation Implementation Effectiveness Check

21. CAPA SystemEffectiveness 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? Inputs Detect Analyze Trend Investigate Identify Solutions Communicate Verify/Validate Monitor Effectiveness • Many Sources of Quality Data • Internal • External Outputs Implement changes for correction/prevention Take global actions Disseminate information Apply learning Measure effectiveness Management review Apply risk management People Records

27. How well have our systems evolved over the last 10 years? Risk Management Total QS Performance Design Controls CAPA Human Factors Management Responsibility 2007 1997/8 Refining/improving Learning/ Implementation Reactive Proactive Regulatory requirements business requirements

28. Design Control Products/Processes Post-market monitoring The CAPA System Quality Improvement CorrectiveActions PREVENTIVE ACTIONS Corrections CAPA Production & Process Controls Risk Management CAPA Now CAPA Process monitoring MANAGEMENT CONTROLS

29. Business with low complexity • Analysis & ACTION • Products • Parts • Processes • Performance • Systems Medical Device Company Sites Functions Fewer products, similar in type, fewer people, limited locations, etc. Connect the dots ……………….

30. Oversight • Management Review • Analysis • Take action • Assure effectiveness Internal Data External Data Inputs Into CAPA System Evaluation Design Control, etc. Correction Investigation Cause Tracking And Trending Corrective & Preventive Action Effectiveness Check

31. More Complexity? Headquarters DIV DIV DIV DIV DIV DIV Sites R&D OPS QA Functions Now connect the dots ……………….

32. Some points to consider • 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

33. Thank-You !Questions? Thoughts? Ideas? Sue Jacobs QMS Consulting, Inc. 847 359 4456 sue@qmsconsultant.com Cecilia Kimberlin Abbott Laboratories 847 937 7933 cecilia.kimberlan@abbott.com