UNDERSTANDING

Corrective and
Preventive Actions
(CAPA)
 Objective
1. To understand the importance of CAPA
2. To be able to know how to create CAPA
Plan
3. To be able to identify the root cause and
its corrective action
4. To be able to identify the different forms
of CAPA
DEFINITION OF TERMS
Correction Actions
Immediate actions taken to
address the cause of a
detected non-conformity.
Also termed as containment
action.
 Corrective Actions
A reactive process used to
address an existing product
problem, customer complaint
or other nonconformity and
fixing it to prevent recurrence.
Preventive Actions
A proactive process
intended to prevent
occurrences of potential
problems or to prevent to
become more severe.
 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:
 Service requests Recalls
 Risk analysis Management Reviews
Staff observations Warning Letters
 Out of Trend Regulatory Audits
 Process monitoring Out of Specs
Customer Complaints Supplier/customer Audit
Internal Audits Yield data

 This information is important for the investigation and

action plan, but also useful for effectiveness evaluation
and communicating the resolution of the problem.
 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.
Examples: pictures, analysis or
examination results, records of deviation,
interviews, specimen samples
 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
 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 is 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
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
 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.
 4. 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
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
 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 to 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 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
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
 NCR FORM
 SAMPLE NCR FORM
 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
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
 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 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.
 NOW LET’S
LEARN FROM

EXAMPLES
 EXAMPLE 1 Nobody accomplished
Nobody thought that
cleaning it is
a cleaning procedure
necessary
No cleaning
procedure Nobody thought
that it is necessary
to document
METHOD
Nobody thought Nobody thought
that it is necessary that cleaning it is
to include in SSOP necessary
Not included in
SSOP
Neglected to
Brush include in SSOP
holders
at Bldg.6
are dirty Personnel did not
thought
and slimy that cleaning it is
necessary
Sanitation Personnel
unable to clean Nobody thought that
Nobody instructed
cleaning it is
to clean
necessary
MANPOWER
Nobody thought that
Nobody instructed / cleaning it is
reminded to clean necessary
Sanitation Personnel
unaware that it Personnel did not
should be cleaned thought
that cleaning it is
necessary
Non-Conformity Brush holders at Bldg.6 are dirty and slimy based on IQA last June 10,
2016
Root Cause Nobody thought that cleaning it is necessary.

Correction Action Immediately clean the brush holders noted at Bldg.6

Target Date Responsible

Identify and clean other brush holders Until End of Sanitation

installed within the plant. June 2016 Personnel
Corrective
Action Establish and document a cleaning 15th of July QA Personnel/
procedure and include in SSOP. 2016 Sanitation
Supervisor
Orient sanitation personnel on cleaning 20th of July QA Personnel/
procedure and frequency. 2016 Sanitation
Supervisor

Target Date Responsible

Inclusion of brush holder in daily GMP 15th of June QC Personnel

audit. 2016

Preventive Include future brush holders in cleaning Upon arrival Sanitation

Action schedule. Personnel

Check if other cleaning implements are 15th of June

2016
QA/Sanitation
Supervisor
being cleaned depending on applicability.
EXAMPLE 2

Identification and Evaluation

Detail of Non-conformity Degree

Actual frying temperature is MAJOR
different from the standard as
stated in the product SOP
 Investigation
 The product SOP is outdated (dated July 26,
2011
 Personnel are aware of outdated SOP and
deviation is allowed as long as QC parameters
are passed
 Verification of forms is being done by
Supervisors
 Deviation found started since April 2016 (scope
of audit)
 Root Cause Analysis Supervisor do not
have Lack of manpower
enough time to
verify
Supervisors verify the the standards
monitoring records but
failed to compare the
standards
Supervisor thinks
Insufficient system
that there is no
MANPOWER on review
need to compare
of records
with the standards

Actual
frying
temperature Supervisors verify the Insufficient system
(OOR) monitoring records but on review of
is different do not relay the data records
from standard Insufficient system
as stated in the on review
product SOP Frequency of of records
MATERIAL Product SOP is outdated document review is
deviated

Lack of manpower
Lack of manpower

Frequency of document
METHOD review is deviated
Insufficient system
on review
of records
Non- Actual frying temperature is different from standard as stated in the
Conformity product SOP
Root Insufficient system on review of records.
Cause
Correction Not applicable
Action
Review and revise the Control of Records Procedure according to
Corrective the need of the system
Action Revise the product SOP for frying section (OOR)
Issue updated product SOP and Control of Records Procedure to
concerned department
Re-orientation of the updated system
Review Supervisor’s responsibilities and allocation
Timeline June 2016
Person QA Officer/ R&D/ QC Supervisor/ Production Supervisor
Responsible
Preventive Review the product SOP for all products
Action Conduct internal quality audit quarterly
Orientation of newly hired or transferred employees (Supervisor)
 IQA CAPA
 SAMPLE FILLED UP CAPA
EXAMINATION
TIME!!!
(30 minutes)
 INSTRUCTIONS:
 Fill up the CCAF form issued by
QA department (except the
verification section)
 Accomplish a Root Cause
Analysis at the back of the Form.