SUBJECT : QUALITY MANAGEMENT SYSTEM

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 !