CAPA

CAPA Overview Training
CAPA Overview Training
In today’s CAPA Overview training, we will discuss information broken

into the following learning segments:
 Segment #1: CAPA General Information
 Segment #2: Identification of the Problem
 Segment #3: Evaluation, Investigation and Analysis of the Problem
 Segment #4: Development of an Action Plan
 Segment #5: Implementation of the Action Plan and Follow-up
slide 2
1
Learning Segment #1
CAPA General Information

WHAT is CAPA?
 CAPA refers to corrective and preventative actions.
 CAPA is a concept within Good Manufacturing Practices (GMP).
 CAPA focuses on the systematic investigation of discrepancies (failures

and/or deviations) in an attempt to prevent their recurrence.
 CAPA is part of the overall quality management system (QMS)
slide 4
WHAT is the Difference Between Corrective
Actions and Preventive Actions?
A corrective action is a term that encompasses the process of reacting to

product problems, customer complaints or other nonconformities and fixing
them.
The process includes:
 Reviewing and defining the problem or nonconformity

 Finding the cause of the problem
Developing an action plan to correct the problem and prevent a
recurrence
 Implementing the plan
 Evaluating the effectiveness of the correction
slide 5
WHAT is the Difference Between Corrective
Actions and Preventive Actions?
A preventive action is a process for detecting potential problems or

nonconformance’s and eliminating them.
The process includes:
 Identify the potential problem or nonconformance

 Find the cause of the potential problem
 Develop a plan to prevent the occurrence.
 Implement the plan
 Review the actions taken and the effectiveness in preventing the
problem.
slide 6
WHAT is the Objective of CAPA?
 The CAPA process ensures that corrective and preventive actions are
effective and that systematic investigation of the failure incidence is
pivotal in identifying the corrective and preventive actions undertaken.
 CAPA must be part of an integrated Quality Management system that

collects data on existing and potential problems, investigates and
analyzes the data, digs down to the root cause, addresses the issue,
institutes specific procedures to avoid similar problems in the future and
documents the entire process.
 CAPA is most effective when it is part of the culture of a company,

pervading every organizational level and department.
slide 7
WHY do we need a CAPA Process?
Effective CAPA (correction action, preventive action) management is

more than just an important regulatory requirement. It is a good business
practice that brings many benefits.
A strong CAPA program can:
 reduce liability
 improve customer satisfaction
 prevent major financial losses
 strengthen a company’s reputation
slide 8
WHY do we need a CAPA Process?
Additionally, a strong CAPA program can:
 quickly identify and address deficiencies and zero in on the

sources of potential problems and prevent them
 drive a company’s continual improvement efforts
 help achieve operational excellence both in product and

process which translates to increased performance and
greater revenue.
slide 9
WHO Participates in the CAPA process?
 Quality Assurance and Quality Control

 Manufacturing
 Packaging
 IT
 Facilities
 External Consultants
slide 10
WHAT are the Major Components of a
CAPA system?
 The Identification of the problem, nonconformity, or incident or the potential problem,
nonconformity, or incident.
 An Evaluation of the magnitude of the problem and potential impact on the

company.
 The development of an Investigation procedure with assignments of responsibility.
 Performing a thorough Analysis of the problem with appropriate documentation.
 Creating an Action Plan listing all the tasks that must be completed to correct and/or
prevent the problem.
 The Implementation the plan.
 A thorough Follow up with verification of the completion of all tasks, and an

assessment of the appropriateness and effectiveness of the actions taken.
slide 11
1
2
Evaluation,
Identification Investigation,
and Analysis
Implementation of
Action Plan the
Development Action Plan and
Follow-up
Learning Segment #2
Identification of the Problem

Reporting the Source of the Problem
The specific origin of the information

that initiated this action is recorded.
Documenting the source of the

information can be very useful when
conducting an investigation into the
problem and implementing the action
plan that is created.
Documentation also provides data for

evaluating the effectiveness of the quality
system and facilitate communicating the
completion of the action to the
appropriate individuals or departments.
slide 13
Reporting the Source of the Problem
(cont’d)
Examples of possible sources might include:
 Service Request  Failure Mode Analysis
 Internal Quality Audit  Risk Assessment
 Customer Complaint /  Process Performance

Concern
 Monitoring
 Quality Management Review
Assurance
Inspection
 Staff Observation
 Trending Data
slide 14
Explaining the Problem
 A complete description of the

problem is written.
 The description should be

concise but must contain
sufficient information to
assure that the problem can be
easily understood from
reading the explanation.
slide 15
Determining and Preparing Evidence
 List the specific information available that demonstrates that the

problem does exist.
 An example might be:
 The evidence for a product defect may be a high percentage

of service requests or product returns.
 The evidence for a potential equipment problem may be
steadily increasing downtime.
slide 16

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CAPA Overview Training

CAPA Overview Training

In today’s CAPA Overview training, we will discuss information broken

 Segment #1: CAPA General Information

 Segment #2: Identification of the Problem

 Segment #3: Evaluation, Investigation and Analysis of the Problem

 Segment #4: Development of an Action Plan

 Segment #5: Implementation of the Action Plan and Follow-up

CAPA General Information

 CAPA is a concept within Good Manufacturing Practices (GMP).

 CAPA focuses on the systematic investigation of discrepancies (failures

 CAPA is part of the overall quality management system (QMS)

A corrective action is a term that encompasses the process of reacting to

The process includes:

 Reviewing and defining the problem or nonconformity

Developing an action plan to correct the problem and prevent a

 Evaluating the effectiveness of the correction

A preventive action is a process for detecting potential problems or

The process includes:

 Identify the potential problem or nonconformance

 CAPA must be part of an integrated Quality Management system that

 CAPA is most effective when it is part of the culture of a company,

Effective CAPA (correction action, preventive action) management is

A strong CAPA program can:

Additionally, a strong CAPA program can:

 quickly identify and address deficiencies and zero in on the

 drive a company’s continual improvement efforts

 help achieve operational excellence both in product and

 Quality Assurance and Quality Control

 An Evaluation of the magnitude of the problem and potential impact on the

 The development of an Investigation procedure with assignments of responsibility.

 Performing a thorough Analysis of the problem with appropriate documentation.

 The Implementation the plan.

 A thorough Follow up with verification of the completion of all tasks, and an

Identification of the Problem

The specific origin of the information

Documenting the source of the

Documentation also provides data for

 Service Request  Failure Mode Analysis

 Internal Quality Audit  Risk Assessment

 Customer Complaint /  Process Performance

 A complete description of the

 The description should be

 List the specific information available that demonstrates that the

 An example might be:

 The evidence for a product defect may be a high percentage

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