Corrective and Preventive Actions

The CAPA Process
Correcting and Preventing
Problems
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The Thought Leadership
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Corrective Actions
• The process of reacting to an
existing product problem,
customer complaint or other
nonconformity and fixing it.

Preventive Actions
• A process for detecting
potential problems or
nonconformance’s and
eliminating them.

Why CAPA?
• Regulatory Requirements
– Both FDA and ISO require an active CAPA program
as an essential element of a quality system.
• Customer Satisfaction
– The ability to correct existing problems or implement
controls to prevent potential problems is essential for
continued customer satisfaction
• Good Business Practice
– Quality problems can have a significant financial
impact on a company.

CAPA Procedures
• Implementing an effective and
fully compliant Corrective /
Preventive action program is a
seven step process.
• Each step must be thoroughly
documented!
– Properly documented actions
provide important historical
data for a continuous quality
improvement plan and are
essential for any product that
must meet the regulatory
requirements demanded by
FDA and ISO.

CAPA Procedures
Seven Steps
1. Identification – clearly define
the problem
2. Evaluation – appraise the
magnitude and impact
3. Investigation – make a plan to
research 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
• The initial step in the
process is to clearly
define the problem or
potential problem.
• This should include:
– the source of the
information,
– a detailed explanation
of the problem,
– Documentation of the
available evidence that
a problem exists.

1. Identification
Source of the Information
• The specific source of the information is
documented. There are many possible sources:
• This information is important for the investigation
and action plan, but also useful for effectiveness
evaluation and communicating the resolution of
the problem.
Service requests Customer complaints
Internal quality audits Staff observations
Trend data QA inspections
Process monitoring Risk analysis

1. Identification
Explanation of the Problem
• A description of the
problem is written that
is concise - but
complete.
• The description must
contain enough
information so that the
specific problem can be
easily understood.

1. Identification
Evidence
• List the specific
information,
documents, or data
available that
demonstrates that the
problem does exist.
– This information will
be very important
during the
investigation into the
problem.

2. Evaluation
• The situation must be
evaluated to determine both
the need for action and then,
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

2. Evaluation
Potential Impact
• Determine and document
specifically why the
problem is a concern and
what the impact to the
company and/or
customers may be.
– Concerns may include
costs, function,
product quality, safety,
reliability, and/or
customer satisfaction.

2. Evaluation
Risk
• Based on the result of
the impact evaluation,
the seriousness of the
problem is assessed.
• The level of risk that is
associated with the
problem will affect the
actions that are taken
and the priority
assigned to the
situation.

2. Evaluation
Remedial Action
• The potential impact and risk
assessment may indicate a
need for some immediate
action to remedy the
situation until a permanent
solution can be
implemented.
• In some cases the remedial
action may be adequate. If
so, the CAPA can then be
closed, after documenting
the rationale for this decision
and completing appropriate
follow up.

CAPA Procedures
1. Identification – clearly define the problem
2. Evaluation – appraise the magnitude and impact
3. Investigation – make a plan to research 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

3. Investigation
• A written procedure for
doing an investigation into
the problem is created.
• This procedure should
include:
– The objectives for the
action
– An investigation strategy
– Assignment of
responsibility and
required resources

3. Investigation
Objective
• The objective is a
statement of the
desired outcome(s) of
the corrective or
preventive action.
• The action will be
complete when all
aspects of the objective
have been met and
verified.

3. Investigation
Strategy
• A set of specific instructions for determining
the contributing and root causes of the
problem is written.
• This procedure directs a comprehensive
review of all circumstances related to the
problem and must consider:
- equipment - materials
- personnel - procedures
- design - training
- software - external factors

3. Investigation
Assign Responsibility and Resources
• It is important to assign
someone the
responsibility for each
aspect of the
investigation.
• Any additional
resources (financial,
equipment, etc) should
be identified and
documented.

CAPA Procedures
problem

4. Analysis
• The investigation procedure is
used to conduct the
investigation into the cause of
the problem.
• Every possible cause is
identified and appropriate
data collected.
• The results of the data
collection are documented
and organized.
• Everything related to the
problem must be identified,
but the primary goal must be
to find the root cause.

4. Analysis
Possible Causes / Data Collection
• A list of all possible
causes is created which
then form the basis for
collecting relevant
information, test data, etc.
• The necessary data and
other information is
collected that will be used
to determine the primary
cause of the problem.

Analysis
Results
• Data may come from a variety of
sources: testing results and/or a
review of records, processes,
service information, design controls,
operations, and any other
information that may lead to a
determination of the fundamental
cause of the problem.
• The data collected is organized into
a useable form.
• The resulting documentation should
address all of the possible causes
previously determined. This
information is used to determine the
root cause of the problem. The
effectiveness of the analysis will
depend on the quality and
thoroughness of the information
available.

4. Analysis
Root Cause 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/or
preventive actions.

CAPA Procedures
problem

5. Action Plan
• Using the results from the
analysis, the best method(s)
for correcting the situation (or
preventing a future
occurrence) is determined.
• All of the tasks required to
correct the problem and
prevent a recurrence are
identified and incorporated
into an action plan.
• The plan includes changes
that must be made and
assigns responsibility for the
tasks.

5. Action Plan
Actions to be Completed
• List all activities and tasks
that must be accomplished
to correct the existing
problem or eliminate a
potential problem, and
prevent a recurrence.
• It is very important identify
all actions necessary to
address everything that
contributed to or resulted
from the situation.

5. Action Plan
Changes
• Needed changes to
documents, processes,
procedures, or other
system modifications
should be described.
• Enough detail must be
included so it is clearly
understood what must
be done and what the
outcome of the
changes should be.

5. Action Plan
Training
• 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 made must be
communicated to all
persons, departments,
suppliers, etc. that were
or will be affected.

CAPA Procedures
problem

6. Action Implementation!
• The Action Plan that
has been developed is
executed and all
identified tasks and
activities completed.
• The actions that were
taken are summarized
and all modifications to
documents, processes,
etc. are listed.

CAPA Procedures
problem

7. Follow up
• 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.

7. 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 that the
actions taken have not had any additional adverse
effect on the product or service?

7. Follow up
Verification Results
• Make sure that
appropriate
information has
been recorded that
provides proof that
all actions have
been completed
successfully.

7. Follow up
Validation Results
• 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 controls have been
established to prevent a
future occurrence,
– The actions taken had no
other adverse effects.
– Adequate monitoring of the
situation is in place.

CAPA Procedures
Completion
• When the Follow Up has been
finished, the CAPA is complete.
• It should be dated, and signed
by appropriate, authorized
personnel.

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