Implementing an Effective CAPA Process Sue Jacobs President

Implementing an Effective CAPA Process Sue Jacobs President QMS Consulting, Inc. Hoffman Estates, IL sue@QMSconsultant. com 847. 359. 4456 Cecilia Kimberlin, Ph. D Medical Products Group VP Abbott Laboratories Abbott Park, IL cecilia. kimberlin@abbott. com 847. 937. 7933 1

Topics § Elements of an effective CAPA process § Data analysis § Getting to probable cause § CAPA timeliness § Effectiveness checks § Learning from experience 2

Elements of an Effective CAPA Process § Documented procedure(s) § Documentation rules § Defined CAPA inputs § Effectiveness checks § Risk assessment and § § prioritization Investigation disciplines Verification / validation Well defined action plan Disseminate information Complete? Effective? Timely § Defined criteria for Management Review § Management escalation § Metrics - ability to monitor progress 3

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

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

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 6

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 7

Data Analysis Design Product & Processes Production Monitor Post-market Process Controls Monitoring Incld. Supply Chain Complaints Define 8

CAPA Data Analysis § Concessions (cont. ) § Quality Records § Use as is, deviations, § Evidence of compliance temporary changes to your quality system § Installation, Distribution, Change Control, § Audit Results § Recurring audit observations, internal audits and external audits § Post Market data § Frequency and occurrence as expected? § Service Records § Complaints § Returned Products 9

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 10

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 11

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 12

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 13

Plan the Investigation § Define method of investigation § Include quality tools used § Is/Is Not, § Cause and Effect, § 5 Why’s, etc. IS § Document § Dates of investigation § Data reviewed (data sources, records, dates) § Corrections or Containment measures § Results: Statement of Cause IS NOT WHAT WHEN WHERE EXTENT Is / Is Not Diagram 14

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 15

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 16

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? 17

Effectiveness Checks Was the Problem Statement well defined? 18

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 19

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

CAPA System Effectiveness Learning from experience Cecilia Kimberlin, Ph. D Group VP QA/RA/MA/Compliance Abbott Medical Products 21

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 22

What should management do? § Evaluate the CAPA system and ability to meet business needs and be in compliance HOW ? 23

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 24

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 25

What’s so hard about the CAPA Process? Inputs Many Sources of Quality Data • Internal • External Detect Analyze Trend Investigate Identify Solutions Apply risk management Communicate Verify/Validate People Monitor Effectiveness Outputs Implement changes for correction/prevention Take global actions Disseminate information Apply learning Records Measure effectiveness Management review 26

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

The CAPA System Quality Improvement Corrective Actions ow Risk NManagement PREVENTIVE ACTIONS Corrections P CA A Design Control Products/Proces ses P CA A Production & Process Controls Process monitoring MANAGEMENT CONTROLS Postmarket monitorin g 28

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

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

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

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 32

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 33