Corrective Action and Preventive Action (CAPA)

Corrective Action and Preventive Action (CAPA) is a systematic approach designed to identify, resolve, and prevent recorded issues such as deviations, nonconformities, audit findings, or complaints.

Corrective Action (CA) is taken to eliminate the root cause of a detected issue and prevent its recurrence. Preventive Action (PA) is taken to identify and eliminate potential issues before they occur. The key difference between corrective action and preventive action is based on timing and intent. Corrective action is implemented after an issue has occurred to address the root cause. Preventive action is taken beforehand to mitigate potential risks based on risk assessments.

The CAPA management process begins with the identification of the issue, followed by an evaluation of its impact and urgency. The process is followed by Root Cause Analysis (RCA) to determine underlying causes, guiding the development and implementation of corrective and preventive actions. After this, CAPA effectiveness verification leads to formal CAPA closure. Proper CAPA report writing and documentation are maintained for trend analysis, quality improvements, and compliance.

CAPA is significant within a quality management system (QMS) because it drives systematic problem resolution, ensures regulatory compliance, and fosters a culture of continuous improvement. 

CAPA process requirements vary across industries. In pharmaceuticals, regulations and internationally recognized requirements like 21 CFR Part 211, ICH Q10, PIC/S, and EU GMP. In the medical device sector, 21 CFR Part 820, ISO 13485, and EU MDR require robust CAPA systems to manage recorded issues.

SimplerQMS is a comprehensive QMS software with an integrated CAPA management module that streamlines corrective and preventive action workflows. To learn more about how SimplerQMS can help you streamline your CAPA management and other QMS processes, book a personalized demo today!

What Is CAPA (Corrective Action and Preventive Action)?

CAPA, which stands for Corrective Action and Preventive Action is a structured process to identify, address, and prevent the recurrence or occurrence of quality and compliance issues. CAPA involves detecting issues such as deviations, nonconformities, audit findings, complaints, or potential issues. CAPA carries out a thorough root cause analysis to understand the underlying problem and implement targeted measures to correct existing issues (Corrective Action) or avert potential ones (Preventive Action). 

Corrective Action (CA) is an action to eliminate the cause of a detected nonconformity or other undesirable situation. Preventive Action (PA) is the action to eliminate the cause of a potential nonconformity or other undesirable situation.

What Is the Purpose of CAPA?

The primary purpose of the CAPA system is to resolve the current occurrence of a recorded issue (e.g. defects, deviations, or nonconformities) and prevent the issue from recurrence.

CAPA helps to analyze information, find and investigate problems, and take effective actions to stop product or quality issues from recurring. CAPA ensures compliance with customer and regulatory requirements, improves product safety, and strengthens overall QMS.

What Is the Difference Between Corrective Action and Preventive Action?

The key difference between Corrective Action (CA) and Preventive Action (PA) is that corrective action is reactive and preventive action is proactive.

Corrective action is taken to address issues after they arise by identifying root causes and implementing steps to eliminate recurrence, whereas Preventive action is designed to recognize and remove potential causes of issues before they materialize.

Both corrective and preventive actions are essential in quality management systems, with corrective action focusing on resolving existing issues and preventive action focusing on anticipating and avoiding similar issues in the future.

When Is CAPA Required?

CAPA is necessary whenever there are issues related to product quality, nonconformity, or failures that require investigation and corrective or preventive actions.

The core principles of CAPA management include problem identification, root cause analysis, corrective and preventive actions, effectiveness checks, and documentation. These principles apply consistently across different life science companies.

However, the variations in depth, strictness, and procedures of CAPA implementation depend on a company’s internal quality practices and the regulatory requirements specific to its industry. Highly regulated sectors like medical devices and pharmaceuticals implement documentation-intensive CAPA processes with strict regulatory oversight.

It is important to tailor CAPA procedures to align with regulatory requirements and quality goals.

What Are the Steps in the CAPA Management Process?

The steps of a typical CAPA management process are outlined below. The complexity of the CAPA procedure depends on the company’s internal procedure.

• 1. Identify the Issue: Recognize and define the nonconformity or defect in the process, product, or system.
• 2. Evaluate and Prioritize: Identify the issue and assess its impact and urgency to set the right priority. Once initial evaluation is taken, make corrections or immediate action to stop the issue or apply a quick fix if the issue is urgent.
• 3. Plan Initial CAPA and Approval: Outlines all actions in the CAPA process including the scope, objectives, responsibilities, timelines, and approach and approval for addressing the issue.
• 4. Investigate and Determine Root Cause: Conduct a thorough analysis to pinpoint underlying causes.
• 5. Develop Corrective and/or Preventive Actions: Formulate solutions to resolve current issues and prevent recurrence with the approval of key personnel.
• 6. Implement the CAPA Action Plan: Execute corrective and preventive measures.
• 7. Measure the CAPA Effectiveness: Check that actions effectively resolve the problem.
• 8. Document and Close the CAPA: Maintain records, completely accomplish CAPA form/report, and formally close successful CAPAs in a timely manner.
• 9. Perform Trending and Continuous Review: Monitor trends to ensure overall continuous improvement.

The process flow for the CAPA management is shown in the image below.

1. Identify the Issue

The first step in the CAPA management process is to identify the issue. This step involves recognizing issues or undesirable situations.

Several recorded issues or undesirable situations are listed below.

• Deviations: General deviation from a process or specifications.
• Nonconformities: Clear failure to meet a specific requirement.
• Audit Findings: Identified nonconformity with established requirements (e.g., regulations, standards, internal procedures) in an audit.
• Complaints: Any written, electronic, or oral communication that contends deficiencies (e.g. identity, quality, safety, effectiveness) related to a product or service.
• Supplier Issue: Noncompliance with agreed specifications for raw material or service.

At this stage, document the issue using a CAPA form, which standardizes the recording of key details such as the issue’s source, date of identification, and a brief description. The use of the CAPA form ensures a traceable and organized CAPA initiation process. This structured form makes it easier for the CAPA process to move smoothly to the next steps.

Although a full CAPA risk assessment is not typically conducted at this phase, an initial risk evaluation helps determine the severity of the issue (e.g., critical, major, or minor). This aids in prioritizing the issue for further action in the CAPA process.

For urgent or critical issues, such as life-threatening conditions or death, immediate action is taken to contain the problem. This immediate action prevents further risks before proceeding with the next extensive CAPA steps.

2. Evaluate and Prioritize

The next step in the CAPA management process is evaluating and prioritizing the identified issue. It is essential to assess its potential impact on product quality, patient safety, and compliance.

During this evaluation, factors such as severity, frequency, and potential impact are analyzed to determine if immediate action is needed. Risk assessment is used to classify and prioritize the issue at this stage. CAPA risk assessment helps rank issues based on their effect on patient safety, regulatory compliance, and overall quality. Higher-risk issues require immediate action to reduce potential harm.

Not all issues require a CAPA. This decision depends on an evaluation of the issue of whether it is low-risk or does not have any potential to recur. In this instance, this can be recorded in an issue log or recorded issue log and then be resolved based on priority.

All details are recorded in the CAPA form to explain why some issues need urgent attention. This step ensures that resources are allocated effectively and that CAPA actions are taken based on risk priority.

3. Plan Initial CAPA and Approval

After evaluation and prioritization, the next step is to plan and approve the CAPA. This stage clearly defines the problem and outlines the necessary corrective and preventive actions. The CAPA team is selected at this point.

A key task in CAPA planning is assigning responsibility for implementation. This includes selecting a team with members from departments such as quality assurance, operations, and engineering.

Setting timelines is an essential part of the initial planning phase. Clear deadlines help track progress and ensure timely resolution of the issue.

The CAPA strategy outlines the corrective and preventive actions needed to fix the problem and prevent future occurrences. Stakeholders must review and approve the strategy to ensure it aligns with organizational goals and regulatory requirements.

In cases where similar issues arise in multiple areas, it may be efficient to create a central “mother” CAPA to address the root cause of all related problems. This approach streamlines the process and ensures consistency. Addressing the most critical issues first is always a priority.

4. Investigate and Determine the Root Cause

The third step in the CAPA management process involves investigating and determining the root cause. This step requires a detailed analysis to uncover reasons for the identified issue. Accurate root cause identification directly affects the effectiveness of the CAPA.

The use of structured problem-solving tools is commonly employed during this phase. These tools help the investigation to systematically break down the issue to reveal its root cause.

Common tools used in CAPA investigations are listed below.

• Root Cause Analysis (RCA) Tools: 5 Whys, Fishbone Diagram (Ishikawa), Fault Tree Analysis (FTA), Pareto Analysis
• Data Collection and Analysis Tools: Control charts, histograms, scatter diagrams
• Process Review and Improvement Tools: Process mapping (flowcharts), Gemba walks.

Clear instructions on how to carry out CAPA investigations are provided by the CAPA procedure. The CAPA procedure outlines the responsibilities of each team member, sets timelines for task completion, and specifies acceptable methods for conducting the investigation.

The CAPA form is typically shared with cross-functional teams, including members from quality assurance (QA), manufacturing, engineering, and other relevant departments. This collaboration ensures a well-rounded investigation. It further helps to acquire evidence to support the findings of the investigation.

A thorough root cause investigation by the departments involved ensures a deeper understanding of the issue. All findings and necessary details are documented in the CAPA form. This form ensures that every part of the investigation is traceable and that the data collected is organized and accessible for review.

Prioritization of actions based on risk levels is necessary to ensure that the most critical issues are addressed first. The CAPA risk assessment needs to be revisited or refined if multiple root causes are identified upon review. This helps in understanding the impact of each cause and aids in prioritizing resources effectively to address the most critical issues first.

5. Develop Corrective and/or Preventive Actions

CAPA management requires developing corrective and preventive actions based on investigation findings and root cause analysis.

The CAPA procedure outlines how to design effective measures including the items listed below.

• Correction: Action to eliminate detected nonconformity.
• Corrective Action (CA): Action to eliminate the cause of a nonconformity and to prevent recurrence.
• Preventive Action (PA): Action to eliminate the cause of a potential nonconformity or undesirable potential situation, preventing future issues.

In developing the CAPA action plan, risk assessment is conducted using tools like Failure Mode and Effects Analysis (FMEA) to evaluate potential risks in processes, products, or systems.

The level of risk dictates the complexity of the proposed actions. For instance, high-risk issues require immediate containment measures. Lower-risk issues can be addressed with long-term preventive strategies.

Additionally, the action plan outlines each corrective or preventive measure for an identified issue. This plan indicates responsible individuals and sets due dates to ensure accountability and timely completion. Corrective and preventive actions are registered in CAPA form.

6. Implement the CAPA Action Plan

Once the CAPA action plan is reviewed and approved, implementation begins. This stage involves executing each action within the assigned timelines to address the identified issues.

The CAPA procedure ensures execution follows consistent practices by providing clear guidelines on expectations across departments. It includes communication protocols to ensure successful implementation. Following the guidelines, teams proceed with executing the correction, corrective action, and preventive action in alignment with established practices.

Tracking progress and documentation of any changes to the plan are captured in a CAPA form. Any revisions must be justified within the form to maintain a clear audit trail, ensuring transparency and accountability.

CAPA tracking and monitoring help manage the status of each action item, due dates, and responsible individuals. It also involves identifying potential delays to keep actions on schedule. Tools like a CAPA log, spreadsheet, or electronic Quality Management System (eQMS), such as SimplerQMS, help streamline this process.

7. Measure the CAPA Effectiveness

Measuring CAPA effectiveness is crucial for confirming the effectiveness of the actions taken. CAPA effectiveness check ensures that corrective and preventive actions have successfully addressed the issue and reduced the risk of recurrence.

One way to assess effectiveness is by revisiting the risk assessment. Successful or effective corrective actions indicate root cause elimination and a low likelihood of recurrence. This evaluation helps determine whether the actions taken are acceptable.

Another way is through follow-up checks or audits to confirm that the implemented actions have resolved the problem and prevent recurrence. Desired performance goals or quality metrics, such as the number of complaints, production rejections, or other performance indicators, help assess CAPA effectiveness.

8. Document and Close the CAPA

Documenting and closing the CAPA involves preparing a final summary that captures the issue, the root cause, the actions taken, and the verification results. CAPA documentation ensures that all aspects of the CAPA process are accurately recorded for future reference and compliance.

The CAPA form is finalized as part of the process for closing the CAPA, ensuring all actions, findings, and outcomes are documented and reviewed for completeness. Supporting documents and evidence are referenced or attached to provide a full record of the actions taken and their outcomes.

Different options are available during the closing stage of CAPA handling. Based on the effectiveness check and risk assessment, a CAPA can be closed if the corrective action has successfully eliminated the issue.

The CAPA may need to be reopened for further investigation if the corrective actions are not effective. Alternatively, if the issue was handled incorrectly, creating a new CAPA might be necessary. In cases involving vigilance reporting, CAPA is communicated to authorities.

Whatever the option chosen, approval from the QMS key personnel is required to officially move the CAPA. This approval confirms that the CAPA was executed according to CAPA procedure and requirements and that the issue has been fully addressed.

A CAPA report is generated as a formal summary of the entire CAPA lifecycle, from issue identification to closure. This report serves as an audit trail, documenting decisions, approvals, and verification activities. Depending on internal organizational CAPA procedure, the completed CAPA form can serve as the CAPA report.

CAPA documentation ensures compliance with regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485. ISO 13485 Clauses 8.5.2 and 8.5.3 require CAPA activities to be documented, while FDA 21 CFR 820.100(b) mandates that all CAPA-related activities and their results must be thoroughly documented.

Furthermore, to ensure compliance with FDA (21 CFR 820.100), ISO 13485:2016, and other regulations, a timely manner or reasonable timeframe in CAPA implementation and closing is required. This timely manner or reasonable timeframe refers to executing and completing CAPA based on the level of risk.

High-risk issues require immediate action, typically within days to weeks, while medium and low-risk issues may take 30 to 90 days (as the industry benchmark). Delays must be justified, documented, and reviewed during audits or management reviews.

9. Perform Trending and Continuous Review

Trending of CAPA data and continuous review are the last steps for the CAPA management process. This step reviews CAPA data to identify patterns, systemic issues, or areas for improvement.

The CAPA procedure typically includes regular trending and periodic reviews of CAPA metrics to ensure actions remain effective and prevent the recurrence of similar issues. In some cases, the CAPA procedure is revised to incorporate new tools or process changes for the improvement of CAPA implementation.

Individual CAPA reports contribute a comprehensive overview if enough data is gathered over time. This data helps organizations identify long-term trends for process improvement and necessary adjustments. Additionally, organizations use this data for insights to enhance staff training and prevent future issues or undesirable situations.

Scheduled management reviews are a key part of continuous review, with CAPA review as a part of the main agenda. The management review ensures lessons learned are integrated into quality strategies which drive improvement and are sustained over time as part of the QMS.

What Does a CAPA Form Look Like?

A CAPA form is a structured document used to record all relevant details about the identification, evaluation, and resolution of issues. The CAPA form typically includes sections for issue description, investigation and RCA, action plan, outcomes, and effectiveness checks.

The image below shows a blank CAPA form template.

A free CAPA form template can be downloaded here.

How Is a CAPA Report Different from a CAPA Form?

A CAPA report is a detailed document that provides a comprehensive analysis of an issue, including investigation and RCA, actions taken, and effectiveness.

A CAPA form, however, is a tracking tool used to capture initial information about an issue and monitor CAPA progress. It includes fields for issue description, planned actions, completed actions, and approval signatures.

In some organizations, the CAPA form and CAPA report are combined into a single document. Initially, personnel complete the CAPA form by entering relevant details, and once authorized personnel review and approve it, the form transitions into the CAPA report.

SimplerQMS streamlines CAPA documentation by using a single, centralized document that functions as both the CAPA form and the CAPA report. This document records issue descriptions, RCA, corrective and preventive actions, implementation steps, and effectiveness checks. Using one document simplifies the process and improves CAPA management efficiency.

What Are CAPA Investigation Tools?

CAPA investigation tools include root cause analysis methods, data collection and analysis tools, and process review tools. Root Cause Analysis (RCA) methods include 5 Whys and Fishbone Diagram. Data collection and analysis tools like control charts, histograms, and scatter diagrams help detect patterns. Process review tools like process mapping and Gemba walks optimize workflows and prevent recurrence.

Root cause analysis (RCA) tools include systematic approaches to identifying the underlying causes of issues to prevent recurrence.

Various root cause analysis (RCA) tools used in CAPA investigations are listed below.

• 5 Whys: A CAPA tool technique that repeatedly asks “why” to trace an issue back to its root cause.
• Fishbone Diagram (Ishikawa): A visual CAPA tool (like a fishbone) that categorizes potential causes of a problem to aid in brainstorming.
• Fault Tree Analysis (FTA): A systematic CAPA tool that maps out failure events to identify the root cause of process disruptions.
• Pareto Analysis: A CAPA-based prioritization tool using the 80/20 rule to focus efforts on the most significant contributing factors to process failures.

Another tool used in CAPA investigations is data collection and analysis. Data collection and analysis tools work by gathering quantitative data and analyzing trends to identify patterns that possibly signal problems. One example of data collection and analysis tools is control charts.

Control charts track process performance over time, helping to identify deviations and emerging problems. An example of a control chart is a histogram that serves as graphical tools that visualize data distribution, making it easier to detect variations in performance. Another example is scatter diagrams, which illustrate relationships between different variables, allowing investigators to uncover potential correlations that may contribute to root causes.

Process review and improvement tools are essential in CAPA investigations for analyzing workflows and identifying areas where issues may arise. Process mapping (or flowcharts) is a widely used tool that visually represents workflows, helping to uncover inefficiencies and pinpoint potential problem areas. Another effective tool is Gemba walks, where leaders or quality professionals observe processes directly at the source, gaining firsthand insights into operational challenges and identifying opportunities for improvement.

What Is the Significance of CAPA Within the Quality Management System (QMS)?

CAPA is essential to QMS because it provides a systematic approach to problem resolution, ensures compliance with regulatory requirements, and prevents issue recurrence.

The listed below are the benefits of CAPA within the QMS.

• Systematic Problem Resolution: Identifies and eliminates root causes of the issue.
• Regulatory Compliance: Ensures adherence to requirements like 21 CFR 820, ISO 13485, and EU MDR.
• Risk Mitigation: Prevents recurrence and occurrence of issues.
• Product and Patient Safety: Reduces defects and enhances safety for end users.
• Process Efficiency: Improves operational workflows within the organization.
• Continuous Improvement: Drives ongoing enhancements in the process and/or product.
• Organizational Accountability: Fosters a culture of compliance and proactive quality management.

What Are the CAPA Process Requirements?

CAPA is a fundamental requirement across different frameworks, including USFDA, ISO 13485, and MDR.

The CAPA process requirements relevant to the pharmaceutical industry are listed below.

• 21 CFR Part 211: US FDA regulations for current Good Manufacturing Practices (cGMP) in pharmaceutical manufacturing.
• ICH Q10: International guideline for a Pharmaceutical Quality System (PQS) ensuring continuous improvement and regulatory compliance.
• PIC/S (Pharmaceutical Inspection Co-operation Scheme): Global framework for harmonizing GMP standards in the pharmaceutical industry.
• EU GMP (EudraLex Volume 4): European Good Manufacturing Practice (GMP) guidelines ensuring pharmaceutical quality and patient safety.
• ISO 9001:2015: Internationally recognized quality management standard that promotes continuous improvement and risk-based thinking across various industries, including pharmaceuticals.

The following are CAPA process requirements relevant to the medical devices industry.

• 21 CFR Part 820: US FDA Quality System Regulation (QSR) for medical device manufacturing.
• ISO 13485:2016: International QMS standard for medical devices.
• MDR (EU Regulation 2017/745): European Medical Device Regulation (MDR) governing device safety, performance, and post-market surveillance.

CAPA Requirements in the Pharmaceutical Industry

The requirements in CAPA management in the pharmaceutical industry are outlined in regulations and guidelines such as 21 CFR Part 211, ICH Q10, PIC/S, and EU GMP.

21 CFR Part 211

21 CFR Part 211 or the Current Good Manufacturing Practice for Finished Pharmaceuticals is a set of US FDA regulations that establish the cGMP for the manufacture, processing, packing, and storage of pharmaceutical products.

21 CFR Part 211 or the Current Good Manufacturing Practice for Finished Pharmaceuticals does not explicitly mention CAPA. Key CAPA principles such as identifying nonconformities, implementing CAPA, and verifying their effectiveness are integrated into this regulation.

The various CAPA-related requirements that are reflected in 21 CFR Part 211 are listed below.

• 21 CFR 211.22(d) – Responsibilities of Quality Control Unit: Requires a quality control unit to oversee drug production, investigate deviations, and implement CAPA
• 21 CFR 211.192 – Production Record Review: Mandates batch record reviews, with CAPA required if discrepancies or deviations are found to correct issues and prevent recurrence.
• 21 CFR 211.100(a) – Control of Drug Product Containers and Closures: Investigations and CAPA must be applied to resolve defects or contamination issues
• 21 CFR 211.180(e) – General Requirements for Records and Reports: Requires documentation of CAPA taken related to failures or deviations
• 21 CFR 211.192(b) – Deviations: Demands investigations into procedural deviations, with CAPA implemented to correct root causes and prevent future occurrences.

ICH Q10

ICH Q10 is an international guideline developed by the International Council for Harmonization (ICH) that establishes a comprehensive Pharmaceutical Quality System (PQS). ICH Q10 is designed to complement GMPs, such as 21 CFR Part 211 and EU GMP by enhancing quality management.

ICH Q10 Section 3.2.2 mandates that pharmaceutical companies establish a CAPA system to address complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory findings, and process trends.

As outlined in ICH Q9, the investigation process follows a structured, root cause-focused approach, with the level of effort, formality, and documentation aligned with risk levels.

The CAPA system should drive product and process improvements while enhancing the overall process.

PIC/S (Pharmaceutical Inspection Co-operation Scheme)

The PIC/S Guidelines are a set of harmonized Good Manufacturing Practice (GMP) standards developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S guidelines standardize regulatory requirements for pharmaceutical manufacturing. The guidelines are based on requirements such as EU GMP and US FDA 21 CFR Part 211.

PIC/S Chapter 8 Complaints and Product Recall includes RCA and corrective and preventative actions. Chapter 8 requires that a structured root cause analysis should be conducted for quality defects.

Moreover, human errors must be formally justified, ensuring that process, procedural, or system-based issues are not overlooked. Appropriate CAPAs should be implemented, monitored, and assessed for effectiveness.

Lastly, quality defect records should undergo regular trend analysis to detect and address recurring issues.

EU GMP (EudraLex Volume 4)

EU GMP (EudraLex Volume 4) is a European Good Manufacturing Practice (GMP) guideline ensuring pharmaceutical quality and patient safety.

EU GMP requires CAPA once issues arise under Chapter 1 Pharmaceutical Quality System (Clause 1.4xiv). Organizations must establish a documented CAPA system to address deviations, complaints, audit findings, and quality defects. CAPA must follow a scientific and risk-based root cause analysis (RCA) approach, with effectiveness checks to ensure issues do not recur.

Chapter 8 Complaints and Product Recall (Clause 8.16) requires CAPA must address trending complaints, adverse events, and product defects. Manufacturers must determine whether an issue is isolated or systemic and implement preventive measures. CAPA effectiveness must be continuously monitored.

ISO 9001:2015

ISO 9001:2015 is an internationally recognized quality management standard that promotes continuous improvement and risk-based thinking across various industries, including pharmaceuticals.

ISO 9001:2015 does not explicitly define CAPA as a standalone process, its nonconformity and risk management requirements align closely with CAPA principles.

Section 10.2 Nonconformity and Corrective Action points out that organizations must establish a corrective action process to address issues.

The methods mentioned in ISO 9001:2015 needed to address issues are listed below.

• Identifying and correcting nonconformities to prevent recurrence.
• Conducting root cause analysis to determine underlying causes.
• Assessing the need for corrective actions based on impact and risk.
• Implementing corrective actions and verifying their effectiveness.
• Documenting and reviewing corrective actions as part of the QMS.

CAPA Requirements in the Medical Device Industry

The requirements in CAPA management in the medical device industry are outlined in regulations and guidelines such as 21 CFR Part 820, ISO 13485, and EU MDR.

21 CFR Part 820

21 CFR Part 820 is the US FDA’s Quality System Regulation (QSR) that defines requirements for medical device manufacturers.

21 CFR 820.100 mandates Corrective and Preventive Action (CAPA) requirements for medical device manufacturers under the U.S. FDA’s Quality System Regulation (QSR) in 21 CFR Part 820.

21 CFR 820.100 requires that each manufacturer establish and maintain procedures for implementing CAPA. This CAPA procedure must include specific requirements to ensure systematic identification, investigation, and resolution of issues.

The requirements of 21 CFR 820.100 typically cover methods investigating the root cause, the development and implementation of appropriate CAPAs, and the verification of their effectiveness. Additionally, the regulation requires proper documentation of all CAPA activities to demonstrate compliance with regulatory requirements and support ongoing quality improvements.

ISO 13485:2016

ISO 13485:2016 specifies Quality Management System (QMS) requirements for medical device manufacturers to ensure compliance with regulatory requirements, safety standards, and customer expectations. ISO 13485:2016 requires that organizations establish CAPA processes.

ISO 13485 requirements for corrective action and preventive action are listed below.

• Clause 8.5.2 Corrective Action: ISO 13485 requires organizations to establish a documented process for corrective action. This involves identifying issues, conducting RCA, implementing corrective measures, and verifying their effectiveness. Additionally, ISO 13485 mandates management reviews to ensure continuous improvement in quality management systems.
• Clause 8.5.3 Preventive Action: ISO 13485 outlines the need for a proactive, documented process for preventive action. This includes identifying potential risks, assessing their significance, and implementing preventive measures. Monitoring outcomes is essential, along with management oversight, to prevent nonconformities and promote ongoing process improvement.

MDR (EU Regulation 2017/745)

The Medical Device Regulation (MDR) of the European Union or EU MDR 2017/745 governs the safety, performance, and market approval of medical devices in the European Union (EU) and European Economic Area (EEA). EU MDR replaces the Medical Device Directive (MDD), imposing stricter requirements on manufacturers, suppliers, and distributors.

The EU MDR requires manufacturers to establish a robust CAPA system to address product issues and ensure ongoing compliance.

Article 10 (General obligations of manufacturers) under 10(9) emphasizes that manufacturers must have systems in place to handle product nonconformities, complaints, and product recalls, with corrective and preventive actions taken as necessary.

Article 83 Postmarket Surveillance (PMS) requires the implementation of PMS including the identification and investigation of safety issues, followed by CAPA, when necessary.

What Are CAPA Management Best Practices?

To ensure an effective CAPA system, CAPA management best practices include proactive identification, comprehensive documentation, and root cause analysis, among others.

Listed below are the CAPA best practices.

• Proactive Identification: Identify risks and nonconformities before they escalate to prevent issues proactively.
• Comprehensive Documentation: Maintain detailed records of all CAPA activities to ensure traceability, compliance, and audit readiness.
• Root Cause Analysis: Use structured techniques like Five Whys or Fishbone Diagrams to accurately determine the cause of issues.
• Employee Training and Involvement: Train and involve staff in CAPA processes for better issue identification and resolution.
• Regular Reviews and Updates: Update CAPA procedures to align performance data, feedback, and regulatory changes regularly or periodically.
• Timely Execution of Actions: Implement corrective and preventive actions promptly and verify their effectiveness.
• System Integration: Align CAPA with other quality systems to enhance consistency and overall compliance.
• CAPA Process Improvements: Optimize CAPA using feedback, technological advancements, and industry best practices.

What Is the Role of CAPA Management Software?

CAPA management software offers key features to streamline CAPA management processes such as workflow automation, RCA, and trending analysis.

CAPA software has automated workflows with reminders and notifications to ensure the timely completion of actions. Data integration allows organizations to track and analyze quality issues across multiple sources. Additionally, reporting and analytics capabilities generate detailed dashboards, enabling management to monitor CAPA performance and make informed decisions.

CAPA management software is often integrated into QMS software, such as SimplerQMS. Integrated CAPA management software module ensures CAPA processes align with other quality processes, improving efficiency in the organization.

CAPA management workflow in SimplerQMS begins with recording the issue and ensuring accurate documentation of nonconformities or potential risks. Next, the team proceeds with RCA and drafting and planning the necessary CAPA. The process is followed by the execution of CAPA actions to address the root cause. The effectiveness assessment phase is next to verify that corrective and preventive measures are successful. CAPA is then routed for review and approval before the final release and a secure archiving in compliance with regulatory requirements.

Apart from CAPA management, SimplerQMS offers a comprehensive QMS module that covers document control, training management, change control, audit management, supplier management, complaint handling, and more.

Robust QMS process support and predefined workflows enable life science companies to adhere to requirements such as FDA 21 CFR Part 820, ISO 13485, EU MDR, and EU GMP, among others.

If you are interested in automating and improving your CAPA management process, book a personalized product demo and talk to our experts.