CAPA Simplified Define the Problem Initiate CAPA Investigate Cause Solution (Action Plan) Verify / Validate Conduct Effectiveness Check Implement Close CAPA
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)
CAPA Data Analysis
Analyze Processes, Work Operations
Consider what is relevant to your business
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
CAPA Data Analysis
Monitor data directly linked to decisions implemented to reduce (control) risk
Hazards and risk mitigation implemented
Data Analysis Design Product & Processes Production Process Controls Incld. Supply Chain Post-market Monitoring Complaints Define Monitor
CAPA Data Analysis (cont.)
Use as is, deviations, temporary changes
Recurring audit observations, internal audits and external audits
Evidence of compliance to your quality system
Installation, Distribution, Change Control,
Post Market data
Frequency and occurrence as expected?
Risk & Prioritization
Establish a prioritization method
Use the method consistently across the quality management system
Ultimate goal - determine WHY the problem occurred
Phases of Investigation
apparent during early investigation, hypotheses that may explain the effect but needs validation
secondary and possible causes
primary reason for the problem which if corrected will prevent recurrence
A clear problem statement will establish investigation boundaries
The problem statement is the difference between what is and what should be
facts – not emotions
what is wrong, not why it’s wrong
State the problem in measurable terms
how often, how much, when, and where
Emphasize the effects (risk)
safety, death, injury, rework, cost, etc.
negative descriptors, inflammatory statements
words that are broad and do not describe the conditions or behavior such as careless, complacency, neglect, oversight
Plan the Investigation
Define method of investigation
Include quality tools used
Cause and Effect,
5 Why’s, etc.
Dates of investigation
Data reviewed (data sources, records, dates)
Corrections or Containment measures
Results: Statement of Cause
Is / Is Not Diagram WHAT WHEN WHERE EXTENT IS IS NOT
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
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
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?
Was the Problem Statement well defined? Effectiveness Checks
Not all CAPAs are created equal
CAPAs age for a reason
Utilize a risk based approach to monitor key steps in the process
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
CAPA System Effectiveness Learning from experience Cecilia Kimberlin, PhD Group VP QA/RA/MA/Compliance Abbott Medical Products
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
What should management do?
Evaluate the CAPA system and ability to meet business needs and be in compliance
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
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 ……………….
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.