1

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

10

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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