Training Program on

CORRECTIVE ACTION
AND
PREVENTIVE ACTION
 THE QUALITY SYSTEM

Quality System

Has six subsystems held together

11 by management controls

MANAGEMENT CONTROLS

1. It is interactive
2 2. Monitored through
Management review

PURPOSE OF YOUR QUALITY SYSTEM

To produce products and services

3 that meet requirements of your
internal and external customers
THE QUALITY SYSTEM
THE QUALITY SYSTEM

• Each subsystem has a defined function

• CAPA is one of the subsystems
• The function of a CAPA system is to improve
product and processes in the Quality system
• CAPA is a continuous improvement Quality
subsystem
• CAPA is Facts and data driven: risk assessment
and impact assessment.
THE QUALITY SYSTEM
WHAT IS THE ROLE OF CAPA IN
THE QUALITY SYSTEM ?

THE ROLE OF CAPA

THE ROLE OF CAPA IN THE QUALITY
SYSTEM

CAPA defined:

• CAPA is an acronym
for CORRECTIVE
ACTION and
PREVENTIVE ACTION
THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)

CORRECTIVE LOOP: CA PREVENTIVE LOOP: PA

11 Corrective Action: 2 Preventive Action:

t

•Action taken to •Action taken to

Prevent recurrence
of a
nonconformance.
Action taken after the
fact
prevent occurrence of
a nonconformance.
Action taken before
the fact
THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)

CAPA SYSTEM

PREVENTIVE LOOP AND CORRECTIVE LOOP

THE ROLE OF CAPA IN THE QUALITY SYSTEM

The role of a CAPA system is to continuously improve product

and processes in the Quality system
•CAPA is a continuous Quality improvement subsystem
•CAPA is Facts and data driven
•CAPA decision making is based on risk assessment and
impact assessment
•Risk assessment is performed on three levels:
End-user, compliance ,and business
THE ROLE OF CAPA IN THE QUALITY SYSTEM

The CAPA system receives information from two

Quality management loops:
•The internal feedback-loop: Quality data from within
the organization
•The external feedback-loop: Quality data from
outside the organization
THE CAPA LANGUAGE
THE CAPA LANGUAGE

A nonconformance:
•Not meeting
specifications, or
requirements
THE CAPA LANGUAGE: LEXICON (Cont.)

A deviation:
•Not following specified
instructions
THE CAPA LANGUAGE: LEXICON (Cont.)

Containment:
•Action taken to arrest the
effects of nonconformance
THE CAPA LANGUAGE: LEXICON (Cont.)

A variance:
•A one time waver to
perform a task through a
planned deviation
THE CAPA LANGUAGE: LEXICON (Cont.)

A Correction:
•Action taken to rework, or
repair product to meet
specifications
THE CAPA LANGUAGE: LEXICON (Cont.)

Risk assessment:
•Action taken to estimate
the likelihood and
consequence of a potential
failure, and failure
happening again
THE CAPA LANGUAGE: LEXICON (Cont.)

Preventive loop:
•Information fed into the
CAPA system about
potential (future)
nonconformities
THE CAPA LANGUAGE: LEXICON (Cont.)

Corrective loop:
•Information fed into the
CAPA system about
nonconformities
THE CAPA LANGUAGE: LEXICON (Cont.)

Closed loop:
•CAPA Information flow
from initiation in the CAPA
system to management
review and back to the
CAPA system for closure
CAPA SYSTEM REQUIREMENTS
KNOW CAPA REQUIREMENTS: PHARMACEUTICALS

ICHQ10 :

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KNOW CAPA REQUIREMENTS: PHARMACEUTICALS

ICHQ10 :
1.You must have a CAPA system for product and process improvement
2.Suppliers to your CAPA should be:
•The complaint system
•Process reject data
•Nonconformities
•Deviations
•Audit findings
•Regulatory inspections
•Adverse trends from KPIs
3.Your effort and level of investigation should be risk-based
 CAPA REQUIREMENTS

ICHQ10
The decision as to whether to open a CAPA
or not after reviewing data from data
sources is based on:
•Risk assessment
•Impact assessment
•Trend analysis
 CAPA SYSTEM REQUIREMENTS

The two Quality feedback loops feed two

CAPA loops with information:
•The reactive loop: After the fact (CAR)
•The pro-active loop: Before the fact (PAR)
CARs are initiated based on a
nonconformance.
PARs are initiated based on risk and
adverse trends
THE SEVEN PHASES

CAPA LIFE CYCLE

 THE CAPA LIFE CYCLE

CAPA is definitive:

•It has a beginning and it has an end

•CAPA workflows in six phases
•Each phase accomplishes a task
THE CAPA LIFE CYCLE
 THE CAPA LIFE CYCLE

Quality issues are discovered through the following

discovery vehicles:
1.DISCOVERY

Internal loop: Primary inputs for this loop includes

1.Internal audit findings

2.CONTAINMENT
2.Batch record review and batch release
3.Trend analysis / Annual product review
4.Process control indices (Yield, CCP etc)
5.Cost to quality (Re-processing, Re-working etc)
6.Quality control Test reports (OOS, Lab Deviations)
7.Calibration records
8.Equipment maintenance records
9.Facilities environment control records
10.Management review feedback
11.Risk analysis data
 THE CAPA LIFE CYCLE

Quality issues are discovered through the following

discovery vehicles:
1.DISCOVERY
External loop:

1.Customer complaint
2.Customer returns
3.Customer audit findings
4.Regulatory audit findings : FDA 483s, warning letters,
ISO audit findings
5.Product recall
6.Supplier (Vendor) audits
 THE CAPA LIFE CYCLE

The decision on whether to open a CAPA ,or

1.DISCOVERY not is based on:

1.The risk assosiated with the finding:

•Regulatory risk
2.CONTAINMENT

•Business risk

•Risk to the end user of your product

2.An adverse trend exists

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 THE CAPA LIFE CYCLE

3.Impact assessment data

DISCOVERY
•Implications

•Cost
2.CONTAINMENT

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RISK ASSESSMENT

TWO RISK FACTORS

FIVE EVALUATION
LEVELS:

1.LIKELYHOOD
•Almost certain
•Likely
•Moderate
•Unlikely
•Rare
2. CONSEQUENCES
•Catastrophic
•Major
•Moderate
•Minor
•Insignificant
RISK ASSESSMENT

1.EXTREME
CA: NOW
Containment ASSESSMENT KEY
required !

4.LOW
TRENDABLE EVENT:
MONITOR
2.CONTAINMENT Containment reffers to arresting the implications
or impact of the problem,or potential problem so it
doesn’t spread
The question that drive this phase are
5.MONITOR FOR
EFFECTIVENESS 1.What is the problem or potential problem?
2.Is it important?
3.What should we do to correct it while we look
for long term solution?
6.CLOSURE 4.Does it affect our mission?
5.What is the risk inolved?
6.What is its effect on product, process and
quality management system?
 Containment may involve the following:

2.CONTAINMENT 1.Stopping production

2.Recalls
3.Stop ship
4.Quarantine
5. Reprocess / Re-work

The level or degree of containment taken should

be appropriate to the risk possed by the
problem,or potential problem.
6.CLOSURE
 Quality system problems and potential
3.INVESTIGATION

problems are classified in three categories:

1.Product: Specification related

5.MONITOR FOR
EFFECTIVENESS 2.Process

3.System
• During investigation the right tool for the right job
6.CLOSURE should be be used

• The analysis to find the underlying cause of the

problem: Root Cause analysis should be performed
 1.CHOOSE BEST SOLUTION: Through
4.IMPLEMENTATION
validation , or verification
2.DEFINE THE CRITERIA FOR SUCCESS C

3.DEVELOP IMPLEMENTATION PLAN

5.MONITOR FOR
4. DEFINE WHAT DATA TO COLLECT AND
EFFECTIVENESS
WHEN TO COLLECT IT

This is an example text. Go ahead and replace it

6.CLOSURE with your own text. tThis is an example text. Go
ahead and replace it with your own text. This is
an example text. Go ahead and replace it with
your own text.

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5.ASSESSMENT 1.CHOOSE STATISTICAL TOOLS FOR DATA
MANIPULATION

5.MONITOR FOR 2.DECIDE HOW YOU WANT TO PRESENT

EFFECTIVENESS YOU’RE YOUR DATA TO
EFFECTIVENESS

3.REVIEW YOUR MEASURE OF

6.CLOSURE
SUCCESS
4.COMPARE AND DRAFT REPORT
 7.CLOSURE
1.DEFINE ELEMENTS OF THE CAPA FILE

5.MONITOR FOR
EFFECTIVENESS 22.AUDITED CAPA FILE ACCURACY

6.CLOSURE
3.3.FILE THE CONTENT

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 1.A DEFINED CRITERIA
ESCALATI FOR ESCALATION
ON

5.MONIT 2.22.DEFINED COMPOSITION OF THE

OR FOR CAPA REVIEW BOARD
EFFECTI
VENESS
3.DEFINED FREQUENCY
6.CLOSU
RE