This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.

1. CORRECTIVE & PREVENTIVE
ACTIONS (CAPA)
(QUALITY MANAGEMENT SYSTEM)
PRESENTED BY : YASH R.MENGHANI
M.PHARM 1st YEAR (QA)
SMT.KISHORITAI BHOYAR COLLEGE OF
PHARMACY,KAMPTEE
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2. DEFINITION :
Corrective and Preventative Action (CAPA) is a
system of quality procedures required to eliminate
the causes of an existing nonconformity and to
prevent recurrence of nonconforming product,
processes, and other quality problems.
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WHAT IS CAPA ?

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CAPA IS PART OF THE OF
SEVEN QUALITY SUBSYSTEMS :

4. Nonconforming Material or Process (Discrepancy) - Any
material or process that does not meet its required specifications or
documented procedure.
Correction – Refers to repair, rework, or adjustment and relates to the
disposition of an existing nonconformity.
Corrective Action - To identify and eliminate the causes of existing
nonconforming product and other quality problems.
Preventive Action - To identify and eliminate the causes of potential
nonconforming product and other quality problems.
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TERMINOLOGY :

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NONCONFORMANCE CONTROL STEPS :

6. Collect and analyze data to identify nonconforming product,
incidents, concerns or other quality problems that would be
worth the effort to correct.
Investigate and identify root cause.
Implement the correct solution.
Verify or validate effectiveness.
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COMPONENTS OF CORRECTIVE ACTION :

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CORRECTIVE ACTION (CA) STEPS :

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CORRECTIVE VS PREVENTIVE :

9.  Corrective action is aiming to correct an existing non-conformity and
to avoid reoccurrence of the same non-conformity.
 Corrective action may arise e.g. from manufacturing deviations,
complaints, audit findings, recalls.
 A systematic investigation should be performed to determine the
reason(s) for the non-conformities and to agree upon appropriate
corrective action.
 Agreed corrective actions should be closely followed-up and
monitored until their completion.
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CORRECTIVE ACTION

10.  Preventive action is aiming to avoid the initial occurrence of a non-
conformity by proactively implementing improvements.
 Similar to corrective actions, agreed preventive actions should be
closely followed-up and monitored until their completion. Effectiveness
of preventive actions should be reviewed regularly, i.e. as part of the
product quality review (annual product review).
 Information regarding preventive actions including costs and cost
savings should be regularly subject to management review in support
of maintaining and improving the effectiveness of the Quality
Management System.
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PREVENTIVE ACTION

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13.  To enable an efficient root cause investigation, the
problem has to be clearly defined.
 Collect all available information, ask questions: Who,
when, what, why, how
 Summarize the problem in a detailed and concise
description.
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IDENTIFICATION

14.  The problem must be evaluated to determine the need for
immediate, corrective and preventive actions and the level of
action required, based on the impact and risk of the problem.
 The evaluation should include:
◦ Potential Impact of the problem.
◦ Risk to its customers and/or the company (i.e. risk to the patient
related to the quality, efficacy or safety of the product; risk for the
reputation of the company; risk of adverse regulatory actions;
financial risk)
◦ Immediate action that may be required Drug Regulations
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IMPACT / RISK ASSESMENT

15.  Immediate action is necessary, when the quality, efficacy or
safety may be compromised by the problem.
 Examples for immediate action:•
◦ Product recall
◦ Blockage of the stock of a product
◦ Rejection of a batch
◦ Interruption of the production (i.e. until problem is assessed
and fixed)
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IMMEDIATE ACTION

16.  A systematic approach should be applied to ensure that no
potential root cause is lost through focusing only on a few
assumed root causes.
 Tools can be applied to facilitate the investigation, i.e. ◦ Start
with a brainstorming,I.e. using an Ishikawa diagram (fishbone or
cause and effect diagram)
 List all potential root causes and evaluate their likelihood
◦ Likely–
◦ Possible (but less likely)–
◦ Remote, unlikely 16
ROOT CAUSE INVESTIGATION

17.  If more than one root cause is likely, a simulation of the
potential root cause can help to prove the root cause.
 Finding the primary root cause is essential for determining
appropriate corrective and/or preventive actions.
 These “root causes” suggest that the failure investigation
did not go far enough–
◦ Training, operator error or similar „obvious“ root causes
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ROOT CAUSE INVESTIGATION

18.  Summarize the identified root cause(s).
 Summarize the impact and the risk for the customer and/or
company.
 Document the quality decision, i.e.–
◦ No impact of the deviation on the product quality, efficacy or
safety – product can be released.–
◦ Product is rejected due to major impact of the failure on
product quality.–
◦ Product is recalled
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CONCLUSION AND QUALITY DECISION

19.  Based on the result of the root cause analysis, all tasks
required to correct the problem and prevent a reoccurrence
are identified and included in an action plan.
 The plan assigns responsibilities and due dates for
implementation.
 Enough detail must be included regarding the required
action and the expected outcome.
 Pay attention on correct order of activities
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ACTION PLAN

20.  The Action Plan is executed and all tasks are completed.
 The actions that were taken are documented.
 The appropriateness and effectiveness of the actions taken
is evaluated:–
◦ Have all recommended changes been completed and verified?–
◦ Have all objectives been met?–
◦ Has training been performed to ensure that all affected employees
understand the changes that have been made?–
◦ Was an assessment made that the actions taken have not had an
adverse effect on other properties or aspects of a product or process.
Closure of CAPA after successful implementation
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IMPLEMENTATION AND FOLLOW-UP

21.  CAPA is a “pulse check” for FDA on how well a firm’s Quality
System is operating – Strong CAPA systems are usually indicative of
strong Quality Systems
 CAPA Subsystem is all about identifying and resolving problems that
can or have resulted in nonconforming product.
 CAPA is much more than just “corrective actions” and “preventive
actions”.
Any opportunity to improve quality in your organization is a CAPA!
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IMPORTANCE OF CAPA

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Quality is never an accident; it is always the result of high
intention, sincere effort, intelligent direction and skillful
execution; it represents the wise choice of many
alternatives.”
- William A. Foster
THANK YOU !