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Background
Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and
procedure in place to deal with such situations. When an unplanned event arises it must be handled accordingly.
FDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 clearly emphasise the increasing relevance of a
proper deviation management and CAPAs. ICH Q9 on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems
empower us to handle issues that arise in our daily work on the basis of risk analysis.
In any case a sound failure investigation is the key. Here it is also important to know how to deal with human error based and non
human error based non-conformances.
Effective root cause analysis is the key to identifying appropriate CAPAs.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve
processes and avoid future failures. All personnel involved in the management of deviations and in CAPAs should aim to identify
opportunities for further improvement.
CAPA within the Pharmaceutical Quality System:-
What is CAPA as per ICH Q10? (Corrective And Preventive Actions) CAPA
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH
Q9. CAPA methodology should result in product and process improvements and enhanced product and process understanding.
Q10 Definition for Corrective Action
  Corrective Action:Action to eliminate the cause of a detected nonconformity or other undesirable situation.
NOTE: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
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Q10 Definition for Preventive Action
  Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
CAPA - Corrective and Preventive Actions

 Corrective Action • Eliminate detected nonconformity
 Preventive Action Prevent nonconformity occurrence
CAPA Process Map

1. Deviations/OOS/Failure Problem Occurs
2. Determine Root Cause
3. Determine Corrective Action
4. Initiate CAR (corrective action request)
5. CAR Respondent(s) and Approver(s) Determined
6. Respondent(s) Provides Corrective Responses, Root Cause Verification, and Implement Due Dates
7. Response(s) Summarized
8. Response(s) Approved
9. Corrective Action Implementation begins Respondent(s) review similar systems for Preventive Action Opportunities
Effectiveness review date set
10. Respondent(s) sign-off when implementation is complete
11. Effectiveness is reviewed and signed-off
12. CAR Closed

CAPA - Corrective and Preventive Actions
 Corrective Action – Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented
procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints)

b) determining the cause of nonconformities
c) evaluating the need for action to ensure that nonconformities to not recur
d) determining and implementing action needed, including, if appropriate, updating documentation
e) recording of the results of any investigation and of action taken, and
f) reviewing the corrective action taken and its effectiveness
 Preventive action – The organization shall determine action to eliminate the causes of potential nonconformities in order to
prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
 It is also determine potential nonconformities and their causes

a) evaluating the need for action to prevent occurrence of nonconformities
b) determining and implementing action needed
c) recording of the results of any investigations and of action taken, and
d) reviewing preventive action taken and its effectiveness

CAPA Process – Best practices
 Regardless of where the problem originates, or what type it is, it must follow a process
Metrics and Reporting Change Control
Identify & Triage Investigate, Review & Approve Implement Verify

Root Cause, Plan Actions Effectiveness
Action Plan
 Identify  Complete  Assess changes  Implement  Measure to

problem Investigation Actions ensure problem
 Assess impact  Determine Root  Ensure no has been
 Quality / Cause impact to  Verify resolved
Regulatory /  Proposed product quality completed
Management Corrective /  Monitor to
Notification Preventive ensure it is not
 Investigation Actions  Consensus from  Inform re-occurring
Process?  Plan SMEs stakeholders
effectiveness  Approval

Re-defining CAPA
 Definitions
Standardize definitions across the organization
Terms like ― ―deviation‖, ―event‖, ―nonconformance‖, correction‖, ―corrective action‖, ―preventive action‖,
―discrepancy‖ must be consistent for each operating unit
The same term should have the same meaning everywhere, and drive the same process
CAPA sources include: Complaints, Audits Observations, Trends can feed CAPA
 Determine, scope identification & impact of new system
Where does the process need to change?
Who will the system affect?
What existing policies may change?
Understand the difference between the ―what‖ and the ―who‖

FDA-Corrective and Preventive Action –Background

& Examples
Purpose of the CAPA Subsystem
•Collect and Analyze Information based on appropriate Statistical Methodology as necessary to detect recurring quality problems
•Identify and Investigate Existing and Potential Product and Quality Problems
•Take Appropriate, Effective, and Comprehensive Corrective and/or Preventive Actions
When Does FDA Review CAPA?
• Inspections
– Quality System Inspection Technique (QSIT) – Corrective and Preventive Action (CAPA) Subsystem
– Compliance Program (7382.845) – Inspection of Medical Device Manufacturers
–
• Premarket Approval Applications (PMAs)
– Original PMAs
– Some PMA supplements (Site changes, 30-Day Notices)
• CAPA is NOT Reviewed in 510(k) applications
• Recalls (corrections and removals)

Why is CAPA Important?
• Linked to many other requirements.
– 820.198 Complaint Files
– 820.90 Nonconforming Product
– 820.80 Acceptance Activities
– 820.200 Servicing
– 820.22 Audits
– 803 Medical Device Reporting (MDR)
– 806 Reports of Corrections and Removals (―Recalls‖)

– ... And many more
•Ensures problems are detected AND resolved.
Definitions
• Correction: repair, rework, or adjustment and relates to the disposition of an existing nonconformity.
• Corrective Action: the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation
in order to prevent recurrence.
• Preventive Action: action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in
order to prevent occurrence.

• Nonconformity: non-fulfillment of a specified requirement.
Correction, Corrective Action, or Preventive Action?
• Replacing the label on a device that had the wrong label applied?
• Revising process parameters in response to complaints?
• Rewelding a contact that does not meet visual inspection requirements?
• Auditing all vendors of a key component after quality issues with only one vendor are identified?
• Revising equipment maintenance procedures to reduce drift in process specifications?
CAPA Procedures –21 CFR 820.100(a)
Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.
 Procedures must ensure all requirements of CAPA subsystem are met
Establish: define, document (in writing or electronically), and implement.
Number and complexity of procedures vary based on the organization
The CAPA Process

INPUTS ELEMENTS OUTPUTS
DATA Sources FOR CAPA •Analyze Data, 820.100(a)(1)  Implement Changes, 820.100(a)(5)
•Investigate Cause, 820.100(a)(2)  Disseminating Information,
Internal Sources :- •Identify Action, 820.100(a)(3) 820.100(a)(6)
& •Verify/Validate Effectiveness,  Submit for Management Review,
External Sources 820.100(a)(4) 820.100(a)(7)
 Document, 820.100(b)

Internal Sources :- External Sources
•Inspection/Test Data
•Nonconforming Material Reports
•Equipment Data
CAPA •Complaints
•Field Service Reports
•Legal Claims
•Scrap/Yield Data
•Rework Data
•Returned Product
•Internal Audits
SOURCES •Warranty Claims
•External Audits
•Medical Device Reports (MDRs)
•Process Control Data

•Acceptance Activities
CAPA and Statistical Analysis

―FDA emphasizes that the appropriate statistical tools must be employed when it is necessary to utilize statistical methodology.
FDA has seen far too often the misuse of statistics by manufacturers in an effort to minimize instead of address the problem. Such
misuse of statistics would be a violation of this section.‖
Common Statistical Techniques
• Pareto charts
• Run charts
• Control charts
• Mean and standard deviation
• T tests for comparisons
• Experimental design (DOE)
• Graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.)

Other Analysis Techniques
• Management reviews
• Quality review boards
• Material review boards
• Other internal reviews
CAPA Data Analysis – 21 CFR 820.100(a)(1)

• Ensure all quality data sources are defined and analyzed to identify existing product and quality problems
• How is the data is captured and maintained?
• How does your firm categorize and group data and perform the analysis?
– Expect FDA to verify your firm is using appropriate analysis techniques
– Analysis of data should also include a comparison of the same problem type across different data sources
• Is the data received by the CAPA system is complete, accurate, and timely?
• Trend analysis is one type of data analysis
CAPA Investigation – 21 CFR 820.100(a)(2)

Investigating the cause of nonconformities relating to product, process, and the quality system.
21 CFR 820.198, Complaint Handling, also requires investigations for the device involved, but the CAPA requirement is broader to
cover the process and the quality system
Typical Investigation Steps

• Identify problem and characterize.
• Determine scope and impact.
• Investigate data, process, operations and other sources of information.
• Determine root cause, if possible.

Possible Root Causes
• Training • Purchasing/Supplier Quality

• Design • Testing
• Manufacturing • Documentation
• Management • Maintenance
• Change Control
Many manufacturers tend to overuse training as a corrective action and do not adequately address the systemic corrective action.
Root cause analysis tools
• Commonly used tools

– Fishbone diagrams
– 5 ―whys‖
– Fault-tree analysis
– Among others
CAPA Investigation – 21 CFR 820.100(a)(2)

• Is the depth of the investigation sufficient?
• Expect FDA to evaluate the adequacy of your firm’s rationale for determining if a corrective or preventive action is necessary
– Decision process may be linked to risk analysis
• What controls does your firm have over devices suspected of having potential nonconformities?
– Justification for concessions should be well documented and appropriate to the product risk
Identify Required Actions – 21 CFR 820.100(a)(3)

Identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems.
Beware of terminology!
A Preventive Action is NOT required for all situations; however, a Corrective Action to prevent recurrence is required.
Taking Action
• Identify solutions.
• Develop action plan for corrective action and/or preventive action.
• Should consider the risk posed by the problem.
– Not all problems require the same level of investigation and action.
– It is appropriate to ―elevate‖ some issues at the expense of others
CAPA and Risk Management

―FDA agrees that the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities
must be appropriate to the magnitude of the problem and commensurate with the risks encountered…FDA does expect the
manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to
correct or prevent the problem from recurring, depending on that risk assessment.‖
• Risk analysis allows a manufacturer to:

– Determine priorities
– Assign resources
– Determine the severity of impact
– Determine the depth of investigation
• Common tools
– Hazard analysis
• Used early for potential problems
– Failure Mode Effects Analysis (FMEA)
• Bottom up
– Fault Tree Analysis (FTA)
• Top down

Identify Required Actions – 21 CFR 820.100(a)(3)
• Expect FDA to review the actions taken
• Be prepared to discuss the appropriateness of the action taken
– Why was corrective action taken?
– Does the corrective action extend to include any additional actions (component suppliers, training, acceptance
activities, field actions) if necessary?
Verify and Validate – 21 CFR 820.100(a)(4)

Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the
finished device.
Effectiveness:
Did my solution work?
Did it create other potential non-conformances?
• Verify that verification/validation protocols were established

• Review data associated with verification or validation activities
• Review the effectiveness of the corrective and preventive actions by reviewing data to determine if similar quality problems exist
after implementation

CAPA is a fundamental management tool that should be used in
every quality system.
Corrective Actions
A corrective action is a term that encompasses the process of reacting to product problems, customer complaints or other
nonconformities and fixing them. The process includes:
 Reviewing and defining the problem or nonconformity.

 Finding the cause of the problem.
 Developing an action plan to correct the problem and prevent a recurrence.
 Implementing the plan.
 Evaluating the effectiveness of the correction.
Preventive Actions
A preventive action is a process for detecting potential problems or nonconformance’s and eliminating them. The process includes:
 Identify the potential problem or nonconformance

 Find the cause of the potential problem
 Develop a plan to prevent the occurrence.
 Implement the plan
 Review the actions taken and the effectiveness in preventing the problem.
Differences between Corrective and Preventive Actions

The process used for corrective actions and preventive actions is very similar and the steps outlined in this document can be used for
either. However, it is important to understand the differences and also be aware of the implications involved in performing and
documenting each.
Corrective Action

A corrective action is a reaction to a problem that has already occurred. It assumes that a nonconformance or problem exists and has
been reported by either internal or external sources. The actions initiated are intended to: a) fix the problem and b) modify the quality
system so that the process that caused it is monitored to prevent a reoccurrence. The documentation for a corrective action provides
evidence that the problem was recognized, corrected, and proper controls installed to make sure that it does not happen again.
To address the Corrective Action clause you should be identifying the root cause of non-conformances that have already taken place
and implementing immediate corrective actions to contain the situation and long term corrective actions to prevent their re-occurrence.
Preventive Action
A preventive action is initiated to stop a potential problem from occurring. It assumes that adequate monitoring and controls are in
place in the quality system to assure that potential problems are identified and eliminated before they happen. If something in the
quality system indicates that a possible problem is or may develop, a preventive action must be implemented to avert and then
eliminate the potential situation. The documentation for a preventive action provides evidence that an effective quality system has
been implemented that is able to anticipate, identify and eliminate potential problems.
7 Steps of CAPA for Pharmaceutical Industry

Implementing an effective corrective or preventive action capable of satisfying quality assurance and regulatory documentation
requirements is accomplished in seven basic steps:
1. Identification - Clearly define the problem

2. Evaluation - Appraise the magnitude and potensial impact
3. Investigation - Make a plan to research the problem
4. Analysis - Perform a thorough assessment with documentation
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. It is important to accurately and completely describe the situation as it
exists now. This should include the source of the information, a detailed explanation of the problem, the available evidence that a
problem exists.

This should include:
 The source of the information

 The specific source of the information is documented. There are many possible sources: Service requests, Internal Quality
Audit, Customer complaints, Internal quality audits, Staff observations, Trend data, QA inspections, Process monitoring, Risk
analysis, Process performance monitoring, Management review, and Failure mode analysis. This information is important for
the investigation and action plan, but also useful for effectiveness evaluation and communicating the resolution of the problem.
 Detailed 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.
 Documentation of the available evidence that a problem exists.
 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. For example, the evidence for a product defect may be a high
percentage of service requests or product returns. The evidence for a potential equipment problem may be steadily increasing
downtime.
 Corrective/Preventive Action Request form
 A sample form is provided ―Corrective/Preventive Action Request that can be used to
 initiate a CAPA action and collect the initial information.
2 - Evaluation - Appraise the magnitude and impact

The situation must be evaluated to determine both the need for action and then, the level of action required. The potential impact of
the problem and the actual risks to the company and/or customers must be determined. Essentially, the reasons that this problem is a
concern must be documented.
An evaluation should include:
 Potential Impact of the problem

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.
 Assessment of Risk
Using the result of the impact evaluation, the seriousness of the problem is assessed. The level of risk that is associated with
the problem may affect the actions that are taken. For example, a problem that presents a serious risk to the function or safety
of a product may be assigned a high priority and require immediate remedial action. On the other hand, an observation that a
particular machine is experiencing an increasing level of downtime each month may have a lower priority.
 Remedial Action that may be required
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.
 Remedial Action form
A sample ―Remedial Action‖ form is included. This form should be used to explain the steps that must be taken to avoid any
further adverse effects.
3 - Investigation - Make a plan to research the problem

A written procedure for doing an investigation into the problem is created. A written plan helps assure that the investigation is
complete and nothing is missed.
This procedure should include:
 The objectives for the action

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.
 An 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.
 Assignment of responsibility and required resources
An important part of the investigation procedure is to assign responsibility for conducting each aspect of the investigation. Any
additional resources that may be required is also identified and documented. For example, specific testing equipment or
external analysis may be required.
 Investigation Procedure form
A sample ―Investigation Procedure‖ form is included. This is a written plan of action for the investigation into the problem. It
should include the overall objective and the instructions for conducting the investigation. The person or persons responsible for
the investigation and an expected completion date should also be entered.
4 - Analysis - Perform a thorough assessment

The investigation procedure is used to conduct the investigation into the cause of the problem. The goal of this analysis is primarily to
determine the root cause of the problem described, but any contributing causes are also identified.
 Every possible cause is identified and appropriate data collected.

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.
 The results of the data collection are documented and organized.
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.
 Everything related to the problem must be identified, but the primary goal must be to find the root cause.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.
 Problem Analysis form
A sample ―Problem Analysis‖ form is included. This form is optional but is intended to be used for recording information
related to the analysis of the problem. The form can be used as a collection point for the information discovered during the
analysis and any supporting data or documentation can be attached.
5 - Action Plan - Create a list of required tasks

Using the results from the analysis, the best method(s) for correcting the situation (or preventing a future occurrence) is determined
and act ion plan developed. 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. The action plan should also identify the person
or persons responsible for completing each task.
 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.
 Document or Specification 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.
 Process, Procedure, or System changes

If any changes to processes, procedures, or systems must be made they are described. Enough detail should be included so that
it is clearly understood what must be done. The expected outcome of these changes should also be explained.
 Employee 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.
 Action Plan form
A sample ―Action Plan‖ form is included. This should provide a set of written procedures that detail all of the actions that must
be done to resolve the problem and prevent it from recurring. This includes corrective and preventive activities, document
changes, training, etc. The person or persons responsible and an expected completion date should also be entered on the form.
6 - Implementation - Execute the action plan
 The corrective / preventive action plan that has been created is now implemented. All of the required tasks listed and described
in the action plan are initiated, completed, and documented.
 Implementation Summary

All of the activities that have been completed as required in the ―Action Plan‖ should be listed and summarized. This section
should contain a complete record of the actions thatwere taken to correct the problem and assure that it will not recur. This
includes changes, preventive measures, process controls, training, etc.
 Documentation
All documents or other specifications that have been modified are listed. Typically the documentation would be attached to a
final printed report of this CAPA action. This will facilitate verification of the changes for the follow up.
7 - 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.
 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?
 Verification results
Make sure that appropriate information has been recorded that provides proof that all actions have been completed
successfully.
 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.
Completion
 When the Follow Up has been finished, the CAPA is complete. It should be dated, and signed by appropriate, authorized
personnel.
Essential Elements of Effective CAPA Systems

From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action
(CAPA) is viewed as the central component that affects all control points including design controls, production and process controls,
records and documents change controls, material controls, and facility and equipment controls. Because more than half of Form 483
observations and warning letters cite CAPA deficiencies, it’s evident that FDA investigators are likely to look first at a company’s
CAPA system during their inspections. In recent years, the FDA has been promoting the adoption of closed-loop CAPA systems
where CAPA is the tool that drives reports and keeps management informed.
The objective of CAPA is a solution to the issue from which the CAPA was generated. If it isn’t driving toward a solution, a CAPA is
a waste of time and resources. For organizations in regulatory environments, all control points flow through to the CAPA system.
Some organizations are suffering from ―death by CAPA‖—too many elements are included in their CAPA systems. In its most basic
form, there are just two fundamental sets of ingredients in a CAPA system. The first set is the experience, expertise, and wisdom of
the personnel involved with conducting CAPA processes. If personnel don’t have a prior track record with CAPA, this may be an area
where an organization has less control over CAPA activities. The second core element of CAPA, one where more organizational
control can be demonstrated, is process. The CAPA process requires critical thinking and an effective determination of the exact
questions that need to be asked to come up with proper solutions.
CAPA Essential:-
Most companies doing business in regulatory environments could improve their CAPA processes by implementing better
methodologies and applying effective risk-based filters. At a minimum, a good closed-loop CAPA system comprises the following
elements:
 Identification
 Prioritization
 Assignment or acknowledgment
 Investigation

 Correction
 Implementation
 Verification
 Close
The first element of a CAPA is the input that opens the CAPA—a customer complaint, a nonconformity report, an out-of-spec finding,
an internal audit finding, and so forth. There are four core modules of an open CAPA: issue review, investigation (or failure analysis),
effectiveness checks for verification, and preventive action.
Issue review is the evaluation phase, a scoping process where a determination is first made whether or not an investigation is
warranted. The three main components of issue review are commonly called CSG: concern, specifics, and gateway.
Issue-review specifics are defined by asking five ―W‖ questions:
 What
 Where
 When
 Weight (magnitude)
 Who
An organization’s ability to close a CAPA successfully is directly related to how capably it’s able to narrow down these five
dimensions and arrive at a defensible decision.
Designing and utilizing an issue-review worksheet can facilitate CAPA investigations and streamline gathering information on these
specifics.
The ―gateway‖ component of CAPA revolves around the effect (safety, hazard, severity, visibility, etc.) and magnitude (i.e., frequency
and/or size) of the situation. A gateway score chart can home in on magnitude specifics based on qualitative or likelihood compared
with descriptions of the input-event occurrence (continually, frequently, occasionally, rarely, etc.). Likewise, an effect chart can
provide a gateway scorecard for the severity of the event: critical, important, minor, or negligible. Most issues will likely be important
or minor events. Specific scores can be assigned according to effect and magnitude scales to determine if the event is acceptable (no
action required), undesirable (may or may not be put in the formal CAPA system), or unacceptable (CAPA opened and a resolution is
required).
Taking action
Once CAPA specifics have been defined, and effect and magnitude scores have been determined, it’s time to take action. Possible
actions include:

 Adaptive action: Actions that allow the organization to live with or adapt to the issue and continue to operate according to
organizational objectives.
 Interim/correction actions: ―Band-aid‖ or containment actions that alleviate the effects of the issue and buy time before a
corrective action is implemented. Containment is a backup plan if a problem cannot be resolved.
 Corrective actions: Problem prevention and containment actions that permanently eliminate the issue.
 Preventive actions: Actions that anticipate potential problems and eliminate the most likely causes of the problem so they are
less likely to occur again.
Approaches to investigations
As in any problem solving situation, there are three basic approaches to the investigation component of a CAPA:
 Trial and error: This is a risky method that may work for some companies but it also has the potential to exacerbate the
problem. You may get lucky, but you also may complicate the problem.
 Fishboning, design of experiments, and brainstorming: These quality tools are usually better solutions than trial and error, but
they are also dependent on past experience and potentially useless if the root cause lies outside the realm of personnel
expertise. Scrap and downtime are potential complications.
 Comparative approach: A deductive thinking approach is the ideal method in that it provides understanding of what the
problem is not. Investigators can use a comparative approach to discover what sets the problem apart. A fact-based, objective
comparative approach investigation should yield clues that identify the problem’s root cause which will then require a
corrective action.
PICCC
One valuable investigative tactic is sometimes referred to as the PICCC or PI-cubed methodology: Problem, Investigate, Clues,
Compare, and Cause.
 Problem:The first step in the PICCC method is to determine and understand exactly what’s gone wrong.
 Investigate:Once the problem has been defined, investigators can gather data that can be used in comparisons and
determinations of what the problem is not.
 Comparison:Asking ―is not‖ questions (comparing time periods, locations, types of defects, etc.) furthers refine the
investigation.
 Clues:The clues uncovered during the investigation are inferences of the facts. At this stage of the investigation, the
organization is finally formulating some answers as to why the problem has occurred.
 Cause: Investigators can now take the clues and build a cause that can explain the problem or deviation. An assessment can be
made regarding the impact of the event and preventive measures, if necessary, can be identified and implemented.

At this stage, the problem-prevention-analysis model (a modified FMEA tool) can be useful for developing mitigation strategies. The
model consists of four basic components:
 Result
 Problem
 Prevent
 Contain
CAPA verification and documentation
Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system is
working. Data tracking is a mandatory component of CAPA so that the organization can ensure that all CAPA-related information can
be confirmed, monitored, measured, and, if necessary, corrected.
Documenting CAPAs according to regulatory requirements is another vital CAPA factor to take into account. Because CAPA data
must be easy to access and analyze, every phase of a CAPA investigation is forms based. Automating forms-based processes such as
CAPA can facilitate regulatory compliance, and save a company time and resources.
Commercial off-the-shelf (COTS) software solutions are available that can comprehensively document CAPA investigations and
integrate the CAPA process with other processes critical to regulatory compliance such as change control, customer complaints, and
audits. An effective CAPA software solution should be configurable and user-friendly and should include features such as:
 Automated routing, notification, delivery, escalation, and approval of CAPAs and all related documentation
 Secure, centralized, and web-based repository for all CAPA documents
 System oversight of quality incidents that escalate to CAPAs (i.e., customer complaints, audit findings, etc.)
 Efficient reporting and advanced analytics
 Form-to-form launching capabilities
 Revision and approval history features
Best-practice electronic forms and workflow routes that can be used as is out-of-the-box or customized based on company
requirements.

CAPA FORMAT





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CAPA DOCUMENTS

MADE FROM SO MANY SOURCES

A small work on CAPA document How to

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CAPA within the Pharmaceutical Quality System:-

Q10 Definition for Corrective Action

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CAPA - Corrective and Preventive Actions

CAPA Process Map

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a) reviewing nonconformities (including customer complaints)

 It is also determine potential nonconformities and their causes

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Metrics and Reporting Change Control

Identify & Triage Investigate, Review & Approve Implement Verify

 Identify  Complete  Assess changes  Implement  Measure to

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FDA-Corrective and Preventive Action –Background

•Take Appropriate, Effective, and Comprehensive Corrective and/or Preventive Actions

When Does FDA Review CAPA?

• Recalls (corrections and removals)

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• Linked to many other requirements.

– 820.198 Complaint Files

– 820.90 Nonconforming Product

– 820.80 Acceptance Activities

– 803 Medical Device Reporting (MDR)

– 806 Reports of Corrections and Removals (―Recalls‖)

•Ensures problems are detected AND resolved.

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CAPA Procedures –21 CFR 820.100(a)

The CAPA Process

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•Process Control Data

CAPA and Statistical Analysis

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CAPA Data Analysis – 21 CFR 820.100(a)(1)

CAPA Investigation – 21 CFR 820.100(a)(2)

Typical Investigation Steps

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• Training • Purchasing/Supplier Quality

Root cause analysis tools

• Commonly used tools

CAPA Investigation – 21 CFR 820.100(a)(2)

Identify Required Actions – 21 CFR 820.100(a)(3)

CAPA and Risk Management

• Risk analysis allows a manufacturer to:

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Verify and Validate – 21 CFR 820.100(a)(4)

• Verify that verification/validation protocols were established

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 Reviewing and defining the problem or nonconformity.

 Identify the potential problem or nonconformance

Differences between Corrective and Preventive Actions

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7 Steps of CAPA for Pharmaceutical Industry

1. Identification - Clearly define the problem

1 - Identification - Clearly define the problem

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 The source of the information

2 - Evaluation - Appraise the magnitude and impact