Available online on www.ijpqa.

com
International Journal of Pharmaceutical Quality Assurance 2016; 7(1); 1-6

ISSN 0975 9506

Review Article

Corrective Action and Preventive Actions and its Importance in

Quality Management System: A Review
Tenzin Tashi2, Vitalis B Mbuya2, H V Gangadharappa1*
Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeswara Nagara, Mysuru
570015, Karnataka, India

Available Online: 1st January, 2016

ABSTRACT
Every organization should have a written standard operating procedure (SOP) establishing the provisions for corrective
and preventive actions. Instructions for how they should be handled within the organization in case of potential product
problems, customer complaints or action to eliminate the cause of a detected Nonconformities or incident. Effective
corrective action and preventive action (CAPA) systems are a key component to continuous improvement. This review
provides a comprehensive view on steps involved in corrective action and preventive action, mechanism of taking CAPA
enabling to improve the system of quality management and Application of CAPA System throughout the Product Lifecycle
in pharmaceutical industry, and it is importance to establish change management system after CAPA which provide a high
degree of assurance there are no unintended consequences of the change.

Keywords: corrective action, preventive action, Quality management system, Change management system.

INTRODUCTION
It is assumed that the medicinal product manufacturer has improvement efforts may not improve customer
a QMS which requires the manufacturer to have satisfaction.
documentation processes, to ensure that medicinal Why CAPA?
products placed on the market are safe and effective. For Regulatory requirement
this purpose, the manufacturer will establish processes and Both FDA and ISO require an active CAPA program as an
define appropriate controls for measurement and analysis essential element of quality system
to identify nonconformities and potential nonconformities. Customer satisfaction: ability to correct existing problem
Also, the manufacturer should establish processes, or implement control to prevent potential problem which
defining when and how corrections, corrective actions, or is essential for continuous customer satisfaction
preventive actions should be undertaken. The ability to Good business practice: quality problem can have
correct existing problems or implementing controls to significant financial impact on company1
prevent potential problems is essential for continued Definition
customer satisfaction and efficient business practice. Correction: A correction is any action that is taken to
Effective corrective action and preventive action (CAPA) eliminate nonconformity. However, corrections do not
systems are a key component to continuous improvement. address causes.
Their risk-based CAPA requirements demand a well- Corrective action: Corrective actions are steps that are
documented system that determines the root cause of taken to remove the causes of an existing nonconformity
nonconformance’s, system failures, or process problems, or undesirable situation. The corrective action process is
corrects the problems, and prevents them from recurring. designed to prevent the recurrence of nonconformities or
The documentation must identify why something went (or undesirable situations. It tries to make sure that existing
may go) wrong and what has been done to make sure it nonconformities and situations don’t happen again. It tries
does not happen again. to prevent recurrence by eliminating causes. Corrective
CAPA is a fundamental management tool that should be actions address actual problems.
used in every quality system. This program provides a Preventive action: Preventive actions are steps that are
simple step-by-step process for completing and taken to remove the causes of potential nonconformities or
documenting corrective or preventive actions. The result potential situations that are undesirable. The preventive
will be a complete, well-documented investigation and action process is designed to prevent the occurrence of
solution that will satisfy regulatory requirements and form nonconformities or situations that do not yet exist. It tries
the basis for an effective continuous improvement plan for to prevent occurrence by eliminating causes.
any Company1.
Without a CAPA process, focusing on quality

*Author for Correspondence

 Tenzin et al. / Corrective Action and…

Note: While corrective actions prevent recurrence, information to assure that the problem can be easily
preventive actions prevent occurrence. Both types of understood from reading the explanation1.
actions are intended to prevent nonconformities. Evidence
Preventive actions address potential problem. In general, List the specific information available that demonstrates
the preventive action process can be thought of as a risk that the problem does exist
analysis process. Evaluation
CAPA Procedures The situation that has been described and documented in
Implementing an effective corrective or preventive action the “Identification” section should now be evaluated to
capable of satisfying quality assurance and regulatory determine first, the need for action and then the level of
documentation requirements is accomplished in seven action required. The potential impact of the problem and
basic steps: the actual risks to the company and/or customers must be
The Identification of the problem, nonconformity, or determined. Essentially, the reasons that this problem is a
incident or the potential problem, nonconformity, or concern must be documented1.
incident. Potential Impact
An Evaluation of the magnitude of the problem and Part of the evaluation is a specific explanation of
potential impact on the company. specifically why the problem is a concern. This may
The development of an Investigation procedure with include the possible impact that the problem may have in
assignments of responsibility. terms of costs, function, product quality, safety, reliability,
Performing a thorough Analysis of the problem with and customer satisfaction1.
appropriate documentation. Assessment of Risk
Creating an Action Plan listing all the tasks that must be Using the result of the impact evaluation, the seriousness
completed to correct and/or prevent the problem. of the problem is assessed. The level of risk that is
The Implementation the plan. associated with the problem may affect the actions that are
A thorough Follow up with verification of the completion taken1.
of all tasks, and an assessment of the appropriateness and Remedial Action
effectiveness of the actions taken1. Based on the outcome of the impact and risk evaluations
Identification above, it may be determined that immediate remedial
The initial step in the process is to clearly define the action is required to remedy the situation until a thorough
problem. It is important to accurately and completely investigation and a permanent solution is implemented.
describe the situation as it exists now. This should include The actions that are taken are documented. This
the source of the information, a detailed explanation of the documentation will become part of the ‘Action
problem, the available evidence that a problem exists 1. Implementation’ and ‘Follow Up’ sections of the CAPA
Report Source action1.
Documenting the source of the information can be very Remedial Action form
useful when conducting an investigation into the problem A sample “Remedial Action” form is included. This form
and implementing the action plan that is created. It will should be used to explain the steps that must be taken to
also provide data for evaluating the effectiveness of the avoid any further adverse effects1.
quality system and facilitate communicating the Investigation
completion of the action to the appropriate individuals or In this step of the process a procedure is written for
departments1. conducting an investigation into the problem. A written
Corrections/Corrective and preventive actions for Quality plan helps assure that the investigation is complete and
issues, risks and nonconformity should be identified from nothing is missed. The procedure should include: an
the following: objective for the actions that will be taken, the procedure
Customer Audits and regulatory inspections to be followed, the personnel that will be responsible, and
Internal Audits any other anticipated resources needed1.
Customer complaints Objective of the investigation
Customer returns The first step in the investigation is to state an objective for
Product recalls the action. In the “Identification” section the problem was
Deviations defined and the current situation stated. The objective is a
Out of specification statement of the desired outcome of the corrective or
Out of calibration preventive action. State what the situation will be when the
Batch Failures / Rejected batches action is complete. This may be a statement in the form of:
Out of Trends “the problem will be corrected, all effects of the problem
Annual product reviews identified and rectified, and controls will be in place to
Output of management reviews prevent the situation from happening again1.
Any other GMP issues / observations and non- Investigation Procedure
conformances2 A set of specific instructions is created that outline what
Explanation of the Problem must be done to determine the contributing and root cause
A complete description of the problem is written. The of the problem. The investigation procedure will vary
description should be concise but must contain sufficient depending on the circumstances1.

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Responsibilities / Resources expected completion date should also be entered1.

An important part of the investigation procedure is to
assign responsibility for conducting each aspect of the ANALYSIS
investigation. Any additional resources that may be The investigation procedure that was created is now used
required is also identified and documented. For example, to investigate the cause of the problem. The goal of this
specific testing equipment or external analysis may be analysis is primarily to determine the root cause of the
required1. problem described, but any contributing causes are also
Investigation procedure form identified. This process involves collecting relevant data,
A sample “Investigation Procedure” forms is included. investigating all possible causes, and using the information
This is a written plan of action for the investigation into the available to determine the cause of the problem. It is very
problem. It should include the overall objective and the important to distinguish between the observed symptoms
instructions for conducting the investigation. The person of a problem and the fundamental (root) cause of the
or persons responsible for the investigation and an problem1.

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Possible Causes / Data Collection systematic way of looking at effects and the causes that
A list of all possible causes is created. This will form the create or contribute to those effects. Because of the
basis for collecting relevant information, test data etc. function of the Fishbone diagram, it may be referred to as
a cause-and-effect diagram. Some of the benefits of
RESULTS AND DATA constructing a Fishbone diagram are that it helps determine
The results of the data collection are documented and the root causes of a problem or quality characteristic using
organized. This may include a combination of testing a structured approach, encourages group participation and
results and/or a review of records, processes, service utilizes group knowledge of the process, identifies areas
information, design controls, operations, and any other where data should be collected for further study4.
data that may lead to a determination of the fundamental Problem Analysis form
cause of the problem. The resulting documentation should A sample “Problem Analysis” form is included. This form
be complete and address all of the possible causes that is optional but is intended to be used for recording
were previously determined. This information is used to information related to the analysis of the problem. The
determine the root cause of the problem1. form can be used as a collection point for the information
Root Cause Analysis discovered during the analysis and any supporting data or
Determining the root cause often requires answering a documentation could be attached1.
series of ‘why?’ questions and digging deep into the Action plan
situation until the fundamental reason for the problem is By using the results from the Analysis, the optimum
found. Root cause analysis is basic link to corrective method for correcting the situation (or preventing a future
action, without an effective Root Cause analysis, it is occurrence) is determined and an action plan developed1.
impossible to come up with good corrective action1. Actions to be completed
List all of the activities and tasks that must be
METHODS accomplished to either correct the existing problem or
For the analysis of nonconformity, appropriate statistical eliminate a potential problem. For a CAPA program to be
and non-statistical techniques can be applied. effective, it is very important to take a very global
Examples for statistical techniques are: approach. Make sure to identify all actions that will be
Statistical Process Control (SPC) charts required to address everything related to the situation1.
Pareto analysis Document or Specification changes
Data trending List any documents that will be modified and describe in
Linear and non-linear regression analysis general terms what the modifications will be1.
Experimental design (DOE – Design of Experiments) and Process, Procedure, or System changes
analysis of variance If any changes to processes, procedures, or systems must
Graphical methods (histograms, scatter plots, etc.) be made they are described. Enough detail should be
Non-statistical techniques are for example: included so that it is clearly understood what must be done.
Management reviews The expected outcome of these changes should also be
Results from quality meetings explained1.
Safety committees (internal/external) Employee Training
Failure Mode and Effect Analysis (FMEA) Employee training is an essential part of any change that is
Fault Tree Analysis (FTA)2 made and should be part of the action plan1.
Failure Mode Effects Analysis (FMEA) Action Plan form
FMEA depends on product and process understanding. It A sample “Action Plan” form is included. This should
methodically breaks down the analysis of complex provide a set of written procedures that detail all of the
processes into manageable steps. It provides evaluation of actions that must be done to resolve the problem and
potential failure modes for processes and their likely effect prevent it from recurring. This includes corrective and
on product performance. It can be applied to equipment preventive activities, document changes, training, etc. The
and facilities and might be used to analyses a person or persons responsible and an expected completion
manufacturing operation and its effect on product or date should also be entered on the form1.
process. Action implementation
Fault tree analysis (FTA) Proposed corrections / corrective and preventive actions
This tool assumes failure of the functionality of a product that require changes to process, ways of working,
or process. The results are represented pictorially in the procedures or equipment must be implemented using the
form of a tree of fault modes. This can be used to approved change control system.
investigate complaints or deviation in order to fully The corrective / preventive action plan that has been
understand their root cause and ensure that intended created is now implemented. All of the required tasks listed
improvement will resolve the issues and not cause any and described in the action plan are initiated, completed,
other different problem3. and documented1.
Ishikawa Implementation Summary
The Ishikawa diagram (also called the Fishbone diagram) All of the activities that have been completed as required
is a tool for identifying the root causes of quality problems. in the “Action Plan” should be listed and summarized. This
The Fishbone diagram is an analysis tool that provides a section should contain a complete record of the actions that

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were taken to correct the problem and assure that it will not the effectiveness of the actions should be evaluated.
recur. This includes changes, preventive measures, process Product discontinuation: CAPA should continue after the
controls, training, etc1. product is discontinued. The impact on product remaining
Documentation on the market should be considered, as well as other
All documents or other specifications that have been products that might be affected5.
modified are listed. Typically, the documentation would be Change Management System
attached to a final printed report of this CAPA action. This Corrective action and preventive, to evaluate, approve, and
will facilitate verification of the changes for the follow up1. implement these changes properly; a company should have
Follow up an effective change management system.
One of the most fundamental steps in the CAPA process is The change management system ensures continual
an evaluation of the actions that were taken. Several key improvement is undertaken in a timely and effective
questions must be answered: manner. It should provide a high degree of assurance there
Have all of the objectives of this CAPA been met? (Did the are no unintended consequences of the change.
actions correct or prevent the problem and are there The change management system should include the
assurances that the same situation will not happen again?) following, as appropriate for the stage of the lifecycle:
Have all recommended changes been completed and Quality risk management should be utilized to evaluate
verified. proposed changes. The level of effort and formality of the
Has appropriate communications and training been evaluation should be commensurate with the level of risk.
implemented to assure that all relevant employees Proposed changes should be evaluated relative to the
understand the situation and the changes that have been marketing authorization; there should be an assessment to
made? determine whether a change to the regulatory filing is
Is there any chance that the actions taken may have had required under regional requirements. However, from a
any additional adverse effect on the product or service? pharmaceutical quality system standpoint, all changes
Verification Results should be evaluated by a company’s change management
The implementation and completion of all changes, system.
controls, training, etc. must be verified. The evidence that Proposed change should be evaluated by expert teams
this has been done must be recorded. Appropriate contributing the appropriate expertise and knowledge from
information should have been entered to document that all relevant areas (e.g., Pharmaceutical Development,
actions have been completed successfully1. Manufacturing, Quality, Regulatory Affairs, and Medical)
Results / Effectiveness of the Actions to ensure the change is technically justified5.
Another important aspect of any CAPA action is to make CAPA Quality System – More than Just Corrective Action
sure that the actions taken were effective. A thorough A CAPA Quality System is absolutely essential in some
evaluation must be done to make sure that the root cause format for a complete quality management program.
of the problem has been solved, that any resulting The corrective action, preventive action program is the
secondary situations have been corrected, that proper means by which unforeseen issues are addressed,
controls have been established, and that adequate remedied, and eliminated from ever happening again. A
monitoring of the situation is in place. This evaluation CAPA quality system is a required part of ISO compliance,
must also include an investigation to determine if the and is a vital part of TQM practices if a company ever
actions taken could result in any other adverse effects. This expects to reach its goal of zero defects.
investigation and the results should be documented. Preventive Actions can be anything, but some typical ones
Documenting the complete process involved in a are: Write a new procedure and train everyone on it,
corrective or preventive action from identifying the documenting the training, inspect every other machine that
problem to a successful completion is important for all performs a similar function at the facility to ensure it does
companies, but absolutely essential for meeting current not have a similar issue, Perform periodic maintenance
regulatory requirements. Following the steps outlined in inspections etc.
this document will provide a complete, well documented In a true CAPA system, there is a formalized process to
CAPA action that will meet regulatory requirements and “close the loop” to make sure all of the corrective and
can significantly improve the quality process in an preventive actions were completed, that they perform as
organization1. they were intended to perform, and the organization can be
Application of Corrective Action and Preventive Action assured that it will never have to deal with this same issue
System Throughout the Product Lifecycle again.
Pharmaceutical Developments: Product or process The CAPA system is one of the best ways to find, fix, and
variability is explored. CAPA methodology is useful eliminate defects from the process. Fixing it once and
where corrective actions and preventive actions are ignoring the root cause guarantees that the issue will
incorporated into the iterative design and development return. And every time it comes back, it will be as costly
process. as it was the first time to fix6.
Technology Transfer: CAPA can be used as an effective
system for feedback, feed-forward, and continual List of Abbreviation
improvement. SOP, CAPA, QMS
Commercial Manufacturing: CAPA should be used, and

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REFERENCE 1 2
4. Gheorghe ILIE , Carmen Nadia CIOCOIU
1. R.M Baldwin,Inc.’ Preventive / Corrective Actions Application of fishbone diagram to determine the risk
(CAPA) Guidelines of an event with multiple causes. 2010
2. Dr. Larry Kelly, GHTF Chair, Quality management
5. Guidance for Industry Q10 Pharmaceutical Quality
system –Medical Devices – Guidance on corrective
System, April 2009
action and preventive action and related QMS
6. CAPA Quality System – More than Just Corrective
processes, 4 November 2010] Action (Quality Management System Education and
3. Quality Risk Management – A Tool to minimize the Resources)
Risks

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