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Definition
of CAPA
Elements
of an effective CAPA process
Data
analysis
Getting
to probable cause
CAPA
Timeliness
For CAPA
Effectiveness
checks
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CAPA
is a concept within good
manufacturing practice, and numerous
ISO business standards. It focuses on
the systematic investigation of the root
causes of identified problems or
identified risks in an attempt to prevent
their recurrence (for corrective action)
or to prevent occurrence (for
preventive action).
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Documented procedure(s)
Defined CAPA inputs
Risk assessment and
prioritization
Investigation disciplines
Verification / validation
Well defined action plan
Circulation of information
Documentation rules
Effectiveness checks
Complete? Effective? Timely
Defined criteria for
Management Review
Management escalation
Metrics - ability to monitor
progress
Initiate CAPA
Verify / Validate
Define the Problem
Implement
Investigate Cause
Conduct
Effectiveness Check
Solution
Close CAPA
(Action Plan)
Complaints
Nonconforming
Product
Audits
Quality
Records
Supply
Chain
Servicing
Process
Monitoring
Concessions
(Deviations)
Threshold met?
CAPA already exists?
Risk?
Collect more data?
Can issue be resolved through:
Containment?
Correction?
Remediation?
Evaluate
Initiate
CAPA
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Monitor
Design
Product &
Processes
Production
Post-market
Process Controls
Monitoring
Incld. Supply Chain
Complaints
Define
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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
Monitor data directly linked to
decisions implemented to reduce
(control) risk
Design FMEA
Process FMEA
Application FMEA
Hazards and risk mitigation implemented
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
Distribution, Change
Control, SPC, PARETO
ANALYSIS
Post Market data
Frequency and occurrence
as expected?
Service Records
Complaints
Returned Products
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Establish a prioritization method
Identifying risk involved in the process
Use the method of monitoring tools
consistently across the quality
management system
Complaint Handling
Nonconforming
Product
Supplier Performance
Change Control
Trend Monitoring
Process Controls
Audits
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IMPACT
Root Cause Requirement?
RE
CO
M
M
NO
T
OP
TI
ON
AL
M
AN
DA
TO
RY
EN
DE
D
RE
QU
IR
ED
5 WHYs
OBSERVATION
FREQUENCY
MINOR
MAJOR
Ultimate goal - determine WHY the problem
occurred
Phases of Investigation
Probable Cause
Contributing Cause
apparent during early investigation, suggestions that
may explain the effect but needs validation
secondary and possible causes
Root Cause
primary reason for the problem which if corrected will
prevent recurrence
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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 its wrong
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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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Define method of
investigation
Include quality tools used
Is/Is Not,
Cause and Effect,
5 Whys, 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
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State the problem in measurable terms
Emphasize the effects (risk)
how often, how much, when, and where
Rejection, 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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Records
Inputs
Many Sources of
Quality Data
Internal
External
Apply risk
management
Involvement of People
Detect
Analyze
Trend
Investigate
Identify Solutions
Communicate
Verify/Validate
Monitor Effectiveness
Outputs
Implement changes for
correction/prevention
Take global actions
Disseminate information
Apply learning
Measure effectiveness
Records
Management review
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The CAPA System
Quality Improvement
Corrections
Corrective Actions
PA
A
C
PA
CA
No
Risk Management
PREVENTIVE ACTIONS
Design Control
Products/Processes
PA
CA
Production &
Process
Controls
Process
monitoring
Post-market
monitoring
Oversight
Management
Review
Analysis
MANAGEMENT CONTROLS
Take
action
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Assure effectiveness
Flow Chart of CAPA
Internal
Data
External
Data
Inputs Into CAPA System
Correction
Investigation
Cause
Corrective & Preventive Action
Tracking And Trending
Evaluation
Design
Control, etc.
Effectiveness Check
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CORRECTION
is any action that is
taken to eliminate a nonconformity.
Correction is like first-aid, its the instant
action that is taken to correct the
nonconformity or to reduce the impact
of nonconformity that has occurred.
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CORRECTIVE
ACTIONS is an action to
eliminate the cause of nonconformities
which have occurred, to prevent their
recurrence. Corrective action will target
the root cause so that the nonconformity or undesirable situation do
not re-occur. Corrective Action can be
considered as a Problem Solving.
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PREVENTIVE
ACTIONS is an action to
eliminate the causes of potential
nonconformities which have not
occurred, to prevent their occurrence.
Preventive action can be called as
proactive approach.
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Not all CAPAs are created equal
CAPAs age for a reason
Utilize a risk based approach to monitor
key steps in the process
i.
ii.
iii.
Initiation
Investigation
Implementation
Closure
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- Major
- Moderate
- Minor
Open
CAPA
- Implementation Overdue
Solution
Investigation
- Aging Investigations
Verification/
Validation
Implementation
Effectiveness
Check
Close
CAPA
- Failed Effectiveness Checks
- Overdue Effectiveness Checks
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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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Was the
Problem
Statement well
defined?
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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 to do when a effectiveness check
fails, and what are the consequences?
Close the CAPA and open a new one
Leave the CAPA open and investigate why?
Focus on execution
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The challenges of implementing and
sustaining an effective CAPA process
Many sources of Quality Data
Spreading of information
Connecting the links of causes
Driving global actions
Demonstrating Effectiveness AND Efficiency
Applying Risk Management principles
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Some points to consider
The right people: training, qualifications,
accountability, communication.
Follow basic good quality and business practices
PDCA :
Plan-Do-Check-Act.
DMAIC :
Define-Measure-Analyze-Improve-Control.
ROI :
Return-On-Investment.
Team has to work as a closed loop system
Scale the system to fit the business requirement.
Keep it simple and straight forward !
Continuous improvement should be the goal
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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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