In any industry, ensuring product quality and safety is always a top priority. CAPA (Corrective and Preventive Action) plays a crucial role in achieving this goal, providing an effective system to address current issues and prevent potential problems in the future.

This article, GOL will delve into CAPA, including its definition, significance, and the steps for effective implementation.

What is CAPA?

CAPA stands for Corrective Action Preventive Action, which means actions taken to correct and prevent issues. CAPA is a requirement by the US Food and Drug Administration (FDA), a branch of the Department of Health and Human Services in the United States. Accordingly, food, drug, or medical device products intended for shipment to the US must have FDA certification and undergo stringent inspections.

Among these requirements, CAPA is one of the mandatory ones. CAPA consists of two parts: CA – Corrective Action and PA – Preventive Action. In standards such as ISO 9000 and FDA 21 CFR 820, these two actions are often mentioned together, with CA preceding PA. This has led to confusion that these two processes must always follow each other in sequence. However, in reality, these two actions are separate, and PA may even precede CA to prevent or mitigate the need for corrective actions. This means that preventing errors or incidents beforehand is preferable to waiting for them to occur before taking corrective measures.

 

 

The parts included in CAPA

The CAPA process consists of two essential components: Corrective Actions (CA) and Preventive Actions (PA), each serving distinct yet complementary purposes in ensuring product quality and compliance.

Corrective Actions (CA)

Corrective Actions (CA) involve a comprehensive response to product issues, customer complaints, or other discrepancies, aimed at addressing and rectifying these issues at their root causes to prevent recurrence. This process typically includes:

• Review and identification of the encountered issue: This step involves thoroughly examining and defining the problem at hand, ensuring a clear understanding of its scope and impact.
• Root cause analysis: Identifying the underlying causes of the problem is crucial for effective corrective action. This often involves investigating processes, procedures, or systems to pinpoint the root cause(s) of the non-conformance.
• Development of an action plan: Based on the root cause analysis, a detailed plan of action is formulated to address the identified issues and prevent their recurrence. This plan may include specific tasks, timelines, and responsibilities to ensure accountability and effectiveness.
• Implementation of the plan: Executing the action plan involves putting the proposed solutions into practice, making necessary adjustments or improvements as needed to address the identified issues comprehensively.
• Evaluation of effectiveness: Once the corrective measures have been implemented, their effectiveness is assessed through follow-up evaluations. This step helps determine whether the implemented solutions have successfully resolved the identified issues and prevented their recurrence, or if further adjustments are necessary.

Preventive Actions (PA)

Preventive Actions (PA), on the other hand, focus on proactively identifying and addressing potential issues or non-conformities before they occur, thereby minimizing the likelihood of future problems. The PA process typically involves:

1. Identification of potential issues or non-conformities: This step entails actively seeking out and identifying areas within processes, procedures, or systems that may be susceptible to issues or non-compliance.
2. Root cause analysis of potential issues: Similar to CA, understanding the root causes of potential issues is critical for effective preventive action. This may involve analyzing historical data, conducting risk assessments, or utilizing other tools to identify underlying vulnerabilities.
3. Development of a preventive action plan: Based on the identified potential issues and their root causes, a proactive plan of action is developed to mitigate or eliminate these risks before they manifest as problems. This plan may involve implementing process improvements, training initiatives, or other proactive measures.
4. Implementation of the preventive plan: Once developed, the preventive action plan is put into action, with measures implemented to address the identified risks and strengthen processes or systems to prevent future issues.
5. Review of implemented actions and effectiveness: Periodic review and assessment of the implemented preventive measures are essential to ensure their ongoing effectiveness. This may involve monitoring key performance indicators, conducting audits, or soliciting feedback from stakeholders to gauge the success of the preventive actions and make any necessary adjustments.

By integrating both corrective and preventive actions into the CAPA process, organizations can establish a robust quality management system that not only addresses existing issues but also proactively identifies and mitigates potential risks, ultimately enhancing product quality, compliance, and customer satisfaction.

 

 

The differences between CA and PA

The differences between Corrective Action (CA) and Preventive Action (PA) lie in their focus and timing within the quality management process, despite their similar procedures. While the steps outlined in the previous explanation can be applied to both, understanding the nuances and the impact of each is crucial.

Corrective Action (CA):

Corrective action is a response to an issue that has already occurred. It assumes that a non-conformance or problem exists and has been reported by internal or external sources.
The actions undertaken aim to: a) rectify the incident, and b) modify the quality system to better monitor the process that caused it, thereby preventing recurrence. Documentation for a corrective action provides evidence that the issue has been identified, rectified, and appropriate control measures have been implemented to ensure it doesn’t recur.
To address corrective action, you should identify the root cause of the non-conformance and implement immediate corrective actions to prevent the situation, along with long-term corrective actions to prevent their recurrence.

Preventive Action (PA):

Preventive actions (PA within CAPA) are implemented to prevent a potential issue from occurring. It assumes that thorough monitoring and control are applied within the quality system to ensure that potential issues are identified and eliminated before they arise. If something within the quality system indicates that an issue may be occurring or developing, a preventive action must be taken to forestall and subsequently eliminate the potential situation. Documentation for preventive actions provides evidence that an effective quality system has been implemented, capable of predicting, identifying, and eliminating potential issues.

In summary, corrective actions address existing issues to prevent their recurrence, while preventive actions proactively identify and eliminate potential issues before they occur. Both are essential components of a comprehensive CAPA system, ensuring continuous improvement and compliance within the pharmaceutical industry.

 

 

The importance of CAPA in the pharmaceutical industry

CAPA stands for Corrective and Preventive Action, and it plays a crucial role in the pharmaceutical industry for maintaining product quality, ensuring compliance with regulatory standards, and continually improving processes. Here’s why it’s so important:

• Quality Assurance: CAPA processes help ensure that pharmaceutical products meet the required quality standards. When deviations, errors, or non-conformances occur, CAPA helps identify the root causes and take corrective actions to prevent recurrence.
• Compliance: Regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) require pharmaceutical companies to have robust CAPA systems in place. Adhering to CAPA guidelines ensures compliance with regulatory requirements, avoiding penalties, recalls, or other regulatory actions.
• Risk Management: CAPA helps in identifying potential risks to product quality and patient safety. By addressing these risks promptly, pharmaceutical companies can mitigate the likelihood of adverse events or product failures, thus safeguarding public health.
• Continuous Improvement: CAPA is not just about fixing problems; it’s also about preventing them from happening in the future. Through the analysis of root causes and implementation of preventive actions, CAPA fosters a culture of continuous improvement within pharmaceutical companies, leading to enhanced efficiency, reliability, and innovation.
• Customer Confidence: Maintaining a strong CAPA system enhances customer confidence in pharmaceutical products. When customers trust that a company is capable of addressing and preventing quality issues, they are more likely to choose and remain loyal to that brand.
• Cost Reduction: While investing in CAPA processes may require resources upfront, it can lead to significant cost savings in the long run. By identifying and rectifying quality issues early, companies can avoid costly recalls, product rejections, and regulatory fines.
• Documentation and Traceability: CAPA requires thorough documentation of all corrective and preventive actions taken. This documentation ensures traceability and accountability, providing a clear record of how quality issues were addressed and prevented.

Overall, CAPA is indispensable in the pharmaceutical industry for ensuring product quality, regulatory compliance, risk management, and continuous improvement. Companies that prioritize CAPA are better equipped to deliver safe, effective, and reliable pharmaceutical products to patients worldwide.

 

 

Where To Utilise CAPA Principles?

The CAPA principles can be applied across various industries and disciplines where quality management and continuous improvement are critical. Here’s where CAPA principles are commonly utilized:

• Manufacturing: In manufacturing, CAPA principles are essential for identifying and addressing deviations or non-conformities in the production process. This ensures that products meet quality standards and specifications.
• Product Design: CAPA principles can be applied during the product design phase to anticipate and mitigate potential issues that may arise during manufacturing or use. This proactive approach helps in designing products that are reliable and meet customer requirements.
• Testing Verification and Validation: CAPA principles are integral to testing, verification, and validation processes to ensure that products meet performance and safety criteria. Any issues identified during these processes can trigger corrective or preventive actions to improve product quality.
• Distribution, Shipping, Transport, and Packaging: CAPA principles are relevant throughout the supply chain, including distribution, shipping, transport, and packaging stages. Any deviations or failures in these processes can lead to product damage or quality issues, requiring CAPA measures to address and prevent recurrence.
• Food Processing: In the food processing industry, CAPA principles are vital for ensuring food safety and quality. Any deviations from food safety standards or incidents of contamination require immediate corrective actions to prevent harm to consumers and maintain regulatory compliance.
• Medical Device Development: In the medical device industry, CAPA principles are crucial for ensuring the safety and efficacy of medical devices. Any design flaws, manufacturing defects, or adverse events need to be addressed promptly through CAPA processes to protect patient safety.
• Pharmaceutical Industry: As mentioned earlier, the pharmaceutical industry relies heavily on CAPA principles to maintain product quality, comply with regulatory requirements, and ensure patient safety. Any deviations in manufacturing processes, quality control, or adverse events related to drug efficacy or safety require CAPA actions to mitigate risks.
• Quality Management: CAPA principles are at the core of quality management systems across industries. ISO standards such as ISO 9001 emphasize the importance of CAPA processes for continuous improvement and customer satisfaction. Meticulous documentation of CAPA processes is often a requirement for compliance with quality standards and regulations.

In essence, CAPA principles are versatile and can be applied wherever quality management, risk mitigation, and continuous improvement are essential, spanning across various industries and disciplines.

 

 

7 key phases in CAPA process

To execute an effective CAPA process capable of meeting quality assurance requirements and regulatory documentation, it is carried out through seven fundamental steps:

1. Identification – Clearly defining the issue.
2. Assessment – Evaluating the extent and potential impact.
3. Investigation – Planning the investigation of the problem.
4. Analysis – Conducting thorough analysis with documentation.
5. Action Plan – Creating a list of required tasks.
6. Implementation – Executing the action plan.
7. Follow-up – Verifying and evaluating effectiveness.

 

 

1. Identification – Clearly defining the issue

The first step of the process is to identify the issue clearly. It is crucial to describe the current situation accurately and comprehensively. This should include the source of information, detailed explanation of the problem, and available evidence demonstrating the existence of the issue.

Source of information

Specific sources of information are recorded. There can be multiple sources: Service requests, Internal quality assessments, Customer complaints, Internal quality evaluations, Employee observations, Trend data, Quality checks, Process monitoring, Risk analysis, Process performance monitoring, Management review, and Failure mode analysis. This information is crucial for the investigation and action plan, but also useful for evaluating effectiveness and communicating problem resolution approaches.

Detailed description of the issue

The problem description should be concise yet comprehensive. The description must contain enough information to easily understand the specific issue.

Documentation of existing evidence of the problem

List specific information, documents, or data available to demonstrate the existence of the issue. This information will be crucial in the process of investigating the problem. For example, evidence of product defects could be a high rate of customer requests for handling or returning products. Evidence of potential equipment failure could be increasing downtime.

Corrective/Preventive Action Request Form:

A provided “Corrective/Preventive Action Request Form” can be used to initiate CAPA actions and collect initial information

2. Assessment – Evaluating the extent and potential impact

In the second step of CAPA in pharmaceutical plants, the situation must be assessed to determine both the need for action and then the level of action required. The potential impact of the issue and actual risks to the company or customers must be identified. Essentially, the reasons why this issue is a concern must be documented.

Potential impact of the issue

Identify and specifically document the reasons why the issue is a concern and what its impact on the company or customers could be. Concerns may include cost, functionality, product quality, safety, reliability, and/or customer satisfaction.

Risk assessment

Using the results of the impact assessment, the severity of the issue needs to be evaluated. The level of risk associated with the issue may affect the actions taken. For example, an issue posing a serious risk to product functionality or safety may be assigned a high priority level and require immediate corrective action. On the other hand, an observation indicating a specific device experiencing increasing downtime each month may warrant a lower priority level.

Corrective consequence actions may be required

Assessing the impact and potential risks may indicate the need for some immediate actions to mitigate the situation until a long-term solution can be implemented. In some cases, corrective consequence actions may be appropriate. If so, CAPA can then be closed out after documenting the rationale for this decision and completing proper follow-up.

Corrective consequence action form

A “Corrective Consequence Action Form” is necessary. This form should be used to explain the steps to be taken to avoid any future adverse effects

3. Investigation – Planning the investigation of the problem

A written procedure to conduct an investigation into the issue is generated. And a written plan will also help ensure that the investigation is completed and nothing is overlooked.

This procedure should include:

Objectives for the action

Objectives are statements of the desired outcomes of corrective or preventive actions.

Actions will be considered complete when all aspects of the objectives have been met and verified.

An investigation strategy

A set of specific guidelines to identify contributing causes and root causes of the problem is written out.

This process aims to comprehensively review all situations related to the issue and must consider: equipment, materials, personnel, processes, design, training, software, external factors.

Assignment of responsibilities and necessary resources

An important part of the investigation procedure is assigning responsibility for conducting each aspect of the investigation. Any additional resources that may be required are also identified and documented. For example, specific testing equipment or external analysis may be required.

Investigation procedure template

At this stage, we need an “Investigation Procedure Template”. This is a written action plan to investigate the issue. It should include overall objectives and guidelines for conducting the investigation. The person or persons responsible for the investigation and the expected completion date must also be entered

4. Analysis – Conducting thorough analysis with documentation

The investigation procedure is utilized to conduct an inquiry into the causes of the problem. The aim of this analysis is primarily to identify the root cause of the described issue, but any contributing causes are also identified.

All causes can be identified and appropriate data collected.

A list of all possible causes is generated, followed by establishing a basis for collecting relevant information, test data, etc.

The necessary data and other information collected will be used to identify the primary cause of the issue.

The results of data collection are documented and organized.

Data can come from various sources: test results and/or record reviews, processes, service information, design controls, operations, and any other information that may lead to identifying the underlying causes of the issue are organized into a usable form. The resulting documentation must address all previously identified causes. 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 available information.

Everything related to the issue must be identified, but the main objective must be to identify the root cause. Use the data to complete the root cause analysis. It involves finding the actual cause of the problem rather than simply addressing the symptoms. Identifying the root cause is necessary to determine appropriate corrective and/or preventive actions.

Problem analysis form

At this stage, we will need a “Problem Analysis Form”. This form is optional but is used to record information related to problem analysis. The form can be used as a point of data collection identified during the analysis process, and any supporting data or documentation can be attached

5. Action Plan – Creating a list of required tasks

In step 5 of conducting CAPA, we will utilize the results of the analysis, identify the best methods to address the situation (or prevent future occurrences), and devise an action plan. All necessary tasks to rectify the current issue or mitigate potential issues and prevent recurrence are identified and incorporated into an action plan.

The plan includes changes that must be implemented and assigns responsibility for each task. The action plan also needs to identify the person or persons responsible for completing each task.

Actions to be completed

List all activities and tasks that must be completed to rectify the existing issue or eliminate potential problems and prevent recurrence. It is crucial to identify all necessary actions to address everything that contributed to or led to the situation.

Changes to documents or technical specifications

Necessary changes to documents, processes, procedures, or other system modifications must be outlined. Sufficient detail should be included to ensure clear understanding of what needs to be done and the outcomes of these changes.

Changes to Processes, Procedures, or Systems

Any changes to processes, procedures, or systems must be described. Sufficient detail should be provided to ensure clear understanding of what needs to be done. The expected outcomes of these changes should also be explained.

Employee Training

Employee training is an essential part of any changes implemented and should be included as part of the action plan. For effectiveness, all modifications and changes made must be communicated to all affected individuals, departments, suppliers, etc.

Action Plan Form

Step 5 of the CAPA process will require an “Action Plan Form.” The form will provide a set of written procedures detailing all actions that must be taken to address the issue and prevent its recurrence. This includes corrective and preventive actions, document changes, training, etc. The person or persons responsible and the expected completion date must also be filled in on the form.

6. Implementation – Executing the action plan

The corrective/preventive action plan has been created and is now being implemented. All mandatory tasks listed and described in the action plan have been initiated, completed, and documented.

Deployment Summary

All activities completed as per the requirements in the “Action Plan” must be listed and summarized. This section should contain a comprehensive record of the actions taken to rectify the issue and ensure its non-recurrence. This includes changes, preventive measures, process controls, training, etc.

Documentation

All other documents or technical specifications that have been modified are listed. Typically, these documents will be attached to the final report of this CAPA action. This facilitates verification of the changes for monitoring purposes.

7. Follow-up – Verifying and evaluating effectiveness

One of the most fundamental steps in the CAPA process is completing the evaluation of the actions taken.

This evaluation must not only verify the excellent completion of identified tasks but also assess the appropriateness and effectiveness of the actions taken.

Key Questions:

Have all objectives been met? (Have the actions corrected or prevented the issue, ensuring that similar situations will not occur again?)

Have all proposed changes been completed and verified?

Was proper training and communication conducted to ensure that all relevant personnel understand the situation and the changes made?

Has an investigation proven that the actions taken have not resulted in any additional adverse effects on products or services?

Verification Results:

Ensure that proper documentation has been recorded to provide evidence that all actions have been successfully completed.

Verification Outcome:

• Confirmation of actions taken. This must document that:
• The root cause of the issue has been addressed,
• Any resulting secondary situations have been remedied,
• Appropriate control measures have been established to prevent recurrence in the future,
• The actions taken have had no additional adverse effects.
• Full monitoring of the situation is established.
• Completion

What is a CAPA Report?

A CAPA (Corrective and Preventive Action) Report is a tool used in identifying, addressing, and preventing regulatory and organizational non-conformance. Compliance officers record the details of an issue or incident on a CAPA Report form, which primarily includes a summary of the event, date of occurence, items and people involved, corrective actions taken, and preventive action established to avoid future recurrence.

When to Write a Report?

A CAPA report is versatile and can be employed for various types of issues and incidents. However, not every event necessitates a CAPA report. Quality teams need to use risk management techniques to assess the severity of an incident and determine whether a CAPA report is required.

Here are some situations where a CAPA report is advantageous:

If the Issue is Severe/Urgent

Issues or events that have long-term negative impacts on the business, employees, and/or customers can be classified as severe or urgent. Examples include the risk of severe injury, the risk of significant financial loss, and non-conformance with regulatory and organizational standards.

If the Issue is Recurring

A recurring issue often cannot be resolved with quick fixes. An investigation must be conducted to identify its root cause so that the CAPA report can provide a permanent solution. An example would be persistent complaints from customers regarding the functionality of a laptop’s keyboard.

If the Issue is Systemic

In some cases, a recurring issue exists because of an inherent system or design flaw rather than an isolated error. Understanding the root cause before writing a CAPA report is crucial to properly address the issue. An example would be the recall of all units of a smartphone model due to exploding batteries.

 

 

Corrective Action and Preventive Action (CAPA) Plan

The following form is used to document a single or a series of related deficiencies and the corresponding CAPA plan. The fields included in this form may be modified or deleted based on the organization’s specific needs. 

 

Protocol Title / Code
Qualified / Principal Investigator

ISSUE
Date Occurred1	Click here to enter a date.	Date Identified1	Click here to enter a date.
Description	Describe the deviation / deficiency / non-compliance.
Impact	Describe the impact of the issue on participant safety, rights, and well-being, as well as data integrity. Include a list of affected participants, if applicable.
References	List any regulation, policy, procedure, or section of the protocol that the issue deviated from.
Root Cause	Outline the root cause to the issue.

 

CORRECTIVE ACTION
Date Implemented2	Click here to enter a date.	Date Completed2	Click here to enter a date.
Description	Describe the corrective action plan in detail.
Attachments	List documents attached that help support the corrective action.
Person(s) Responsible	List names of individuals who are responsible for carrying out the corrective action.
N/A	In the event there can be no corrective action, specify the reason.

 

PREVENTIVE ACTION
Date Implemented2	Click here to enter a date.	Date Completed2	Click here to enter a date.
Description	Describe the preventive action plan in detail.
Attachments	List documents attached that help support the preventive action.
Person(s) Responsible	List names of individuals who are responsible for carrying out the corrective action.
N/A	In the event there can be no preventive action, specify the reason.

 

ADDITIONAL COMMENTS

Include any additional comments or information not noted above. If applicable, outline any plan / procedure to evaluate the effectiveness of the CAPA.

1.   If a distinct date is not available, a rough range of dates may be entered.
2.   Date may be a projected date if the plan is written prior to implementation / completion. Write “N/A” if not applicable.

CAPA Written By (Print Name & Title)		CAPA Written By (Signature)		Date (dd-MMM-yyyy)

 

CAPA Approved By (Print Name & Title)		CAPA Approved By (Signature)		Date (dd-MMM-yyyy)

 

We hope that this article has provided you with sufficient information about CAPA (Corrective and Preventive Action) and its importance in ensuring product quality and safety across various industries. By understanding the significance of CAPA and the steps involved in its implementation, businesses can better address current issues and prevent future problems, ultimately enhancing their overall quality management practices.

For further insights and assistance in implementing CAPA effectively within your organization, feel free to explore more on GOL. Let’s strive together for excellence in quality and safety standards.