1. business and industrial
2. business operations
3. business plans

Implementing an
Effective CAPA Process
Sue Jacobs
Cecilia Kimberlin, PhD
President
QMS Consulting, Inc.
Hoffman Estates, IL
Medical Products Group VP
Abbott Laboratories
Abbott Park, IL
sue@QMSconsultant.com
847.359.4456
cecilia.kimberlin@abbott.com
847.937.7933
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Topics
 Elements of an effective CAPA process
 Data analysis
 Getting to probable cause
 CAPA timeliness
 Effectiveness checks
 Learning from experience
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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
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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
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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
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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
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Data Analysis
Design
Product &
Processes
Monitor
Production
Post-market
Process Controls
Monitoring
Incld. Supply Chain
Complaints
Define
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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
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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
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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
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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
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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
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Plan the Investigation
 Define method of
 Document
investigation
 Dates of investigation

 Data reviewed (data
Include quality tools used
 Is/Is Not,
 Cause and Effect,
 5 Why’s, etc.
IS
WHAT
WHEN
sources, records, dates)
 Corrections or Containment
measures
 Results: Statement of
Cause
IS
NOT
PEOPLE
MATERIAL
MACHINE
Cause
Why
WHERE
EFFECT
EXTENT
Is / Is Not Diagram
ENVIRONMENT
METHODS
MEASUREMENT
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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
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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
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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?
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Effectiveness Checks
Investigate Cause
Re-assess Risk
Was the
Problem
Statement well
defined?
Proposed Solution
NO
Data Source
indicates
problem still
exists.
?
Verify/Validate
Determine
Additional
Action
YES
Implement
?
Action Plan Complete
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NO
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
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Timeliness
- Major
- Moderate
- Minor
Open
CAPA
- Implementation Overdue
Solution
Investigation
- Aging Investigations
Implementation
Verification/
Validation
Effectiveness
Check
Close
CAPA
- Failed Effectiveness Checks
- Overdue Effectiveness Checks
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CAPA System
Effectiveness
Learning from experience
Cecilia Kimberlin, PhD
Group VP QA/RA/MA/Compliance
Abbott Medical Products
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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
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What should management do?
 Evaluate the CAPA system and
ability to meet business needs and
be in compliance
HOW ?
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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
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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
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What’s so hard about the CAPA Process?
Inputs
Detect
Many Sources of
Quality Data
Analyze
•Internal
Trend
•External
Investigate
Identify Solutions
Apply risk
management
People
Outputs
Implement changes for
correction/prevention
Take global actions
Communicate
Disseminate information
Verify/Validate
Apply learning
Monitor Effectiveness
Measure effectiveness
Records
Management review
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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
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The CAPA System
Quality Improvement
Corrective Actions
PREVENTIVE ACTIONS
Corrections
Design Control
Products/Processes
Production &
Process
Controls
Post-market
monitoring
Process
monitoring
MANAGEMENT CONTROLS
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Business with
low complexity
Medical Device Company
Analysis &
ACTION
•Products
•Parts
Sites
•Processes
•Performance
Functions
•Systems
Fewer products, similar in type, fewer people,
limited locations, etc.
Connect the dots
……………….
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•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.
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More Complexity?
Headquarters
DIV
DIV
DIV
DIV
DIV
DIV
Sites
Functions
R&D
OPS
Now connect the dots
QA
……………….
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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
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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
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