This document discusses corrective and preventive action (CAPA) processes. It defines CAPA and outlines the typical steps, including identifying issues, investigating root causes, taking action, verifying effectiveness and monitoring. Corrective action addresses existing problems, while preventive action aims to prevent potential future problems. The document provides examples and definitions of key CAPA terms and principles. It emphasizes that CAPA is an important part of a quality management system and helps ensure continuous quality improvement.

1. NAME : PAVAN V. KHODKE
CLASS : M. PHARM. FIRST YEAR (Q.A.)
SUBJECT : QUALITY MANAGEMENT SYSTEM
COLLEGE NAME : SMT. KISHORITAI BHOYAR
COLLAGE OF PHARMACY KAMPTEE
CORRECTIVE AND PREVENTIVE
ACTION

2. 1.Identifying: Recognizing a problem or
potential issue.
2.Investigating: Analyzing the root cause
of the problem.
3.Taking Action: Implementing CA or PA
measures.
4.Verifying: Confirming that the actions
taken have been effective.
5.Monitoring: Keeping track of the
situation to ensure the problem remains
resolved.

3. Corrective Action (CA):
• Reactive: Focuses on fixing problems after they occur.
• Goal: Eliminate the root cause of a problem to prevent its recurrence.
• Example: A software update introduces bugs. CA involves identifying
and fixing those bugs to restore normal functionality and prevent
similar issues in future updates.
Preventive Action (PA):
• Proactive: Identifies and addresses potential problems before they
happen.
• Goal: Minimize the risk of problems occurring in the first place.
• Example: Regular equipment maintenance helps prevent unexpected
breakdowns and production halts.

4. DEFINATION:
• Corrective and Preventative Action (CAPA) is a system of quality
procedure required to eliminate the causes of an existing
nonconforming product, processes, and other quality problems.

5. CAPA IS PART OF
SEVEN QUALITY SUBSYSTEMS:
Corrective
&
Preventive
Actions
Equipment
& Facility
Controls
Production &
Process Control
Records,
Documents
, & Change
Controls
Material
Controls
Design
Control
Management

7. TERMINOLOGY:
• 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.

8. NONCONFORMANCE CONTROL STEPS:
4.Take remedial
action.
3. Decide what
should be
done.
2.Move items
away from
work area.
1.Identify
nonconforming
items.

9. COMPONENTS OF CORRECTIVE ACTION:
• 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.

10. CORRECTIVE ACTION (CA) STEPS
4.See if it
worked
3. Change
the system.
2. Identify
root cause.
1. Would the
correction
be worth the
effort.

11. CORRECTIVE VS PREVENTIVE :
Root cause Problem
Quality
Improvement
Potential
Cause
Potential
Problem
Quality
Improvement
Corrective Action
Preventive Action

12. CORRECTIVE ACTION
• 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.

13. PREVENTIVE ACTION
• 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 manager review in support of
maintaining and improving the effectiveness of the Quality
Management System.

14. CAPA Process
Immediate Action
Protect the customer from the problem.
Impact / Risk Assessment
Initial assessment of the impact and the magnitude of the problem.
Identification
Define the Problem

15. CAPA Process
Action Plan
Define corrective and preventive actions
Conclusion and Quality Decision
Final through conclusion on the impact and magnitude of the problem, decision regarding the use of
the product, etc .
Root Cause Investigation:
Identify the root cause of the problem by using a systematic approach.

16. IDENTIFICATION
• 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.

17. IMPACT/RISK ASSESMENT
• 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 (ie 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

18. IMMEDIATE ACTION
• 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)

19. ROOT CAUSE INVESTIGATION
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

20. ROOT CAUSE INVESTIGATION
• 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

21. CONCLUSION AND QUALITY DECISION
• 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 onproduct
quality.-
• Product is recalled

22. ACTION PLAN
• Based on the result of the root cause analysis, all tasks required to
correct the problem and prevent a reoccurrenceare 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

23. IMPLEMENTATION AND FOLLOW-UP
• The Action Plan is executed and all tasks are completed.
• The actions that were taken are documented.
• The appropriateness and effectiveness of the actions takenis 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

24. IMPORTANCE OF CAPA
• 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!

25. 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!