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Corrective Actions Preventive Actions

The document outlines the processes of corrective actions and preventive actions, and explains the seven step CAPA (Corrective and Preventive Action) procedure. The seven steps are: 1) identification of the problem, 2) evaluation of its impact and risks, 3) developing an investigation plan, 4) performing a root cause analysis, 5) creating an action plan, 6) implementing the plan, and 7) follow up to verify effectiveness. The CAPA process is important for regulatory compliance, customer satisfaction, and good business practices by addressing quality problems.

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128 views33 pages

Corrective Actions Preventive Actions

The document outlines the processes of corrective actions and preventive actions, and explains the seven step CAPA (Corrective and Preventive Action) procedure. The seven steps are: 1) identification of the problem, 2) evaluation of its impact and risks, 3) developing an investigation plan, 4) performing a root cause analysis, 5) creating an action plan, 6) implementing the plan, and 7) follow up to verify effectiveness. The CAPA process is important for regulatory compliance, customer satisfaction, and good business practices by addressing quality problems.

Uploaded by

Vidya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Corrective Actions

&
Preventive Actions
Corrective Actions :

The process of reacting to an


existing product problem,
customer complaint or other
non conformances and fixing
it.
Preventive Actions :

The process of detecting


potential problems or
nonconformance's and
eliminating them.
Why CAPA ?

 Regulatory Requirements
Both FDA and ISO require an action CAPA
program as an essential element of a quality system.

 Customer Satisfaction
The ability to correct existing problem or implement
control to prevent potential problems is essential for
continuous customer satisfaction.

 Good Business Practice


Quality problems can have significant financial impact
on company.
CAPA Procedures

Implementing a fully Corrective / Preventive


action program is a seven step process :
Each step must be thoroughly documented.
Properly documented action provides important
historical data for continuous quality
improvement plan and are essential for any
product that must meet regulatory requirements
demanded by FDA & ISO
CAPA Procedures :

1) Identification : Clearly define the problem


2) Evaluation : Appraise the magnitude and
impact
3) Investigation : Make a plan to reach the
root cause of the problem
4) Analysis : Perform a thorough
assessment
5) Action plan : Create a list of required tasks
6) Implementation : Execute the action plan
7) Follow up : Verify and assess the
effectiveness
1) Identification : Clearly define the problem

# The initial step in the process is to clearly


define the problem or potential problems

# This should include


* The source of information
* A detailed explanation of Problem
* Document of the available evidence
that a problem exists.
The source of information ( Identification )

The specific source of information is documented.


There are many possible sources :
 Market Complaint / Customer complaint / Recall.
 Self inspection / Quality Audit.
 Annual Product Review.
 Deviation / Incidence.
 OOS Results investigation.
 Output of Quality System Review Meeting.
 Arising out of other needs.
 Risk analysis.

This information is important for investigation and action


plan and also useful for communicating the resolution of
the problem.
A detailed explanation of problem
( Identification )

* A description of problem should be


noted concisely but completely

* The description must contain enough


information so that the specific
problem can be easily understood.
Evidence : ( Identification )

* List the specific information,


documents or data available that
demonstrate that the problem does
exist.

* The information will be very


important during the investigation
into the problem.
2) Evaluation : Appraise the magnitude
and impact

The situation must be evaluated to determine both


the need for action and the level of action
required.

An evaluation should include :

* Potential impact of the problem.


* Risk to the company or its customers.
* Remedial action that may be required.
Potential impact of the problem. ( Evaluation )

* Determine and document specifically about


the concern of the problem and the impact
to the company and/or customers.

* Function may include product


quality, safety, reliability, cost and/or
customer satisfaction.
Risks (Evaluation)

* Based on result of impact


evaluation, the seriousness of the
problem is assessed.

* The level of risks that is associated


with the problem will affect the
actions that are taken and the
priority assigned to the situation.
Remedial actions : ( Evaluation )

* The potential impact and risk


assessment may indicate a need for
some immediate actions to remedy
the situation until a permanent
solution can be implemented.

* In some cases, remedial actions may


be adequate. If so, CAPA can then
be closed, after documenting a
rational for this decision and
completing appropriate follow up.
3) Investigation : Make a plan to
reach the problem

A written procedure for investigation into


the problem should be created.

This procedure should include:

* The objectives of the action


* An investigation strategy
* Assignment of responsibility and required
resources.
Investigation - Objective

 The objective is a statement of the


desired outcome of the corrective
and preventive action

 The action will be complete when


all aspects of the objective have
been met and verified
Investigation - Strategy
Specific instructions for determining the root causes
of the problem is written.

This procedure directs a comprehensive review of all


circumstances related to the problem and must
consider following.
 Equipment
 Materials
 Personnel
 Procedures
 Design
 Training
 Software
 External factors
 FISH BONE DIAGRAM

Equipment Materials Personnel

Cause Cause

Cause Cause

Cause
Cause
Cause

Problem

Cause
Cause Cause

Cause
Cause

Measurem
Procedures
ent
Design software
Investigation – Assign Responsibility
and Resources

* It is important to assign the responsibility


for each aspect of the investigation

* Any additional resources (financial


equipment etc.) should be identified and
documented.
4) Analysis : Perform a thorough
assessment

The investigation procedure is used to conduct


investigation in to the root cause of the problem.

* Every possible cause is defined and appropriate


data collected.
* The result of the data collection are
documented and organized.
* Every cause related to the problem must be
identified but the primary goal should be to
find the root cause.
Possible cause and Data collection
( Analysis )

* A list of all possible causes should be


collected which then shall form the basis
for collecting the relevant information, test
data etc.

* The necessary data and other


information should be collected that will be
used to determine the primary cause of
the problem.
Results ( Analysis )

* Data may come from a variety of sources e.g testing results


and or a review of records, procedures, services, information,
design control, operation and other information that may lead
to a determination of the fundamental cause of the problem.

* The data collected should be organized into a usable form.

* The resulting documentation should address all of the possible


causes previously determined. This information is used
determine the root causes of the problem. The effectiveness of
the analysis will depend on the quality and thoroughness of
the information available.
Root cause analysis (Analysis)

* Use the data to complete a root cause analysis


This involves finding the actual cause of the
problem rather than simply dealing with the
symptoms.

* Finding the primary cause is essential for


determining appropriate corrective and
preventive actions.
6) Action plan :
Create a list of required tasks.

* Using the results from analysis, the best methods


for correcting the situation (or preventing future
reoccurrence) is determined.

* All of the tasks required to correct the problem


and prevent a re-occurrence are identified and
incorporated into an action plan.

* The plan includes changes that must be made and


assigning of responsibility for the tasks.
Action to be completed ( Action Plan )

* List all activities and tasks that must be


accomplished to correct the existing
problem or eliminate a potential problem
and prevent a re-occurrence.

* It is very important to identify all actions


necessary to address everything that
contributed to or resulted from the situation.
Changes ( Action Plan )

* Needed changes to documents,


processes, procedures or other system
modification should be described.

* Enough details must be included to


understand clearly the action plan and
the result of the outcome.
Training ( Action Plan )

* Employee training is an essential part of


any change that is made and should be
made part of the action plan.

* To be effective, all modifications and


changes must be communicated to
all concerned [persons, departments,
suppliers etc.,].
Execute the action plan ( Action Plan )

* The action plan that has been developed


should be executed and all identified
tasks and activities completed.

* The actions that were taken should be


summarized and all modification to
documents, processes etc. should be
listed.
FOLLOW UP

* Verify and assess the effectiveness.

* One of the most fundamental steps in the CAPA


process is completing an evaluation of the
actions that were taken.

* This evaluation must not only verify the


successful completion of the identified tasks, but
also assess the appropriateness and effectiveness
of the actions taken.
Follow up KEY QUESTIONS?

* Have all of the objectives been met? (Did the actions


correct or prevent the problem with assurances that the
same situation will not happen again?

* Have all recommended changes been completed and


verified ?

* Has training and appropriate communications been


implemented to assure that all relevant employees
understand the situation and the changes that have been
made?

* Has an investigation demonstrated that the action taken


have not had any additional adverse effect on the product
or services?
Validation results
* Make sure that appropriate information has been recorded
that provide proof that all action have been completed
successfully.

* A validation of the action is done. This must document


that
# The root cause of the problem has been solved
# Any resulting secondary situations have been corrected.
# Proper control have been established to prevent a future
occurrence.
# The action taken had no other adverse effects.
# Adequate monitoring of the situation is in place.
Completion

 When the Follow up has been


finished, the CAPA is
complete.

 It should be dated and signed


by appropriate, authorized
personnel.
THANK YOU

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