CAPA (Corrective and Preventive Action) Form: Format, How to Write, Example, Template

CAPA, or Corrective Action and Preventive Action, is a systematic approach to identify, resolve, and prevent issues. A CAPA form serves as a structured tool to document and implement CAPAs when a recorded issue or nonconformance is detected. A CAPA form typically includes key elements such as a problem description, root cause analysis, data collection, corrective and preventive actions, as well as timelines and milestones.

A CAPA form template provides a standardized model for creating CAPA form. CAPA form serves as a quality document adopted by the organization. CAPA forms can be maintained in various formats, including Microsoft Word, Excel, PDF, Google Docs, Google Sheets, or as a form built in CAPA management software.

A CAPA report is a formal document summarizing the entire CAPA process that has been successfully implemented. The main difference between a CAPA report and CAPA form is that CAPA report is a full documentation of the completed CAPA management process while CAPA form is a working file to document the CAPA management process.

CAPA management software, often integrated within a QMS software, streamlines CAPA processes by automating data collection, root cause analysis, and CAPA implementation. CAPA form is electronically stored in CAPA management software for ease of streamlining the workflows.

SimplerQMS is a QMS software that has CAPA management module that automates CAPA workflows, helping ensure compliance with regulatory requirements and standards such as US FDA 21 CFR 820, ISO 13485:2016, and EU MDR 2017/745.

Life sciences organizations aiming to improve CAPA efficiency can explore SimplerQMS solution. Book a demo to learn more of SimplerQMS’ robust CAPA management and other QMS processes such as document control, training, change control, and more.

What Is a CAPA Form?

A CAPA form is a tool to initiate the corrective and preventive action process in response to nonconformance or undesirable events. CAPA form can be based on different templates but with the goal of collecting information throughout the CAPA handling process.

The CAPA form records activities during the CAPA handling. The CAPA form includes sections to describe the issue, investigate the root cause, and outline actions to fix detected issues such as deviations, audit findings, complaints, or potential issues.

Additionally, the CAPA form provides a structured approach to documenting the requirements mentioned in FDA 21 CFR Part 820.100 and ISO 13485:2016 Clause 8.5. For example, these requirements mandate documenting root cause analysis, corrective and preventive actions, and effectiveness verification. The CAPA form is a way to track actions and verify outcomes as it records all data regarding the initial CAPA plan, CAPA implementation and effectiveness checks.

Depending on the organization’s internal CAPA procedure, CAPA form and CAPA report may exist as one single document or as two separate documents. For instance, a CAPA form transitions into a CAPA report once personnel complete it with relevant information and approved. Some organizations treat CAPA forms and CAPA reports as different documents, using a specific CAPA report format when reporting to authorities.

What Does a CAPA Form Include?

A typical CAPA form includes the following elements as listed below.

1. Problem Description: A clear explanation of the issue should include context and impact to ensure accurate problem definition. Determining whether a problem is legitimate is essential before proceeding. A problem statement must use simple and clear language for effective communication. Assessing the scope of the problem helps in understanding its impact.
2. Immediate Actions Taken: An organization can implement temporary measures to contain the issue or problem. Immediate actions minimize disruption to the operation and create a stable environment before formal problem analysis.
3. Root Cause Analysis: Root Cause Analysis or RCA identifies the underlying cause of a problem to ensure effective CAPAs. There are common tools used in RCA including 5 Whys and the Fishbone Method. The 5 Whys technique traces issues by repeatedly asking “Why?” to reach the root cause, while the Fishbone Diagram categorizes potential causes into factors like people, process, equipment, materials, environment, and measurement.
4. Data Collection and Evidence: Relevant records, observations, and supporting data are gathered to strengthen the investigation and findings. These data include training records, risk assessments, and any other valuable documentation related to the identified problem. By compiling comprehensive evidence, the investigation ensures accuracy and enhances the effectiveness of CAPAs.
5. Corrective Actions: Corrective actions are measures to fix the current problem. Each corrective action should be assigned to a responsible party. Any supporting documentation (such as training records) must be included to demonstrate compliance with the corrective plan.
6. Preventive Actions: Preventive actions stop similar issues from occurring. A company implements preventive actions after completing corrective actions. These actions, such as changing suppliers or retraining employees, are carried out, to make sure the similar issues don’t happen again.
7. Timeline and Milestones: A timeline establishes the deadline for implementing CAPA to ensure timely resolution, while milestones mark significant progress points. To effectively set timelines and milestones, the CAPA plan should be divided into distinct phases, with estimated completion times for each milestone. Utilizing project timeline software helps track progress, identify potential delays, and enable timely execution of CAPA initiatives.
8. Responsibilities and Roles: Responsibilities must be clearly assigned to relevant personnel to ensure accountability and efficiency in CAPA implementation. Each aspect of the CAPA process, including investigation, corrective actions, and effectiveness verification, is handled by designated team members.
9. Effectiveness Checks: Effectiveness checks verify whether CAPAs address the root cause and prevent recurrence. Inspections, data analysis, or feedback loops assess whether implemented actions achieve the desired outcomes.
10. Review and Monitoring: Ongoing review and monitoring assess corrective action effectiveness and identify emerging issues. Continuous tracking allows strategy adjustments to prevent recurrence.
11. Sign-offs and Approvals: Sign-offs and approvals confirm key CAPA stages are properly completed, including corrective actions and closure.
12. Record-Keeping Requirements: Record-keeping requirements aredocumentation rules for storing CAPA records and ensuring compliance.

How to Format a CAPA Plan?

To format a CAPA plan, include all necessary data, verify tables for accuracy, and ensure a clear structure. Proper formatting of the CAPA form enhances readability and supports efficient documentation of corrective and preventive actions.

Effective methods and best practices for organizing and documenting a CAPA plan are listed below.

• Structured Layout: Segments the document into logical parts (header, body, closure) for readability.
• Consistent Style Guidelines: Uses uniform fonts, headings, spacing, and branding to maintain clarity.
• Tables and Checklists: Organizes action items, tasks, and deadlines in accessible formats for quick reference.
• Flowcharts and Diagrams: Illustrates analysis steps or processes in a visual way to simplify understanding.
• Section Headings and Subheadings: Guides readers through each phase of the CAPA process. In writing, ensure that the typical CAPA form contents are considered.
• Bullet Points and Numbering: Break down complex information into concise, trackable points.
• Alignment with Requirements: Ensures formats meet FDA, ISO, GMP, or internal standards.
• Document Control Practices: Maintains version history, document number, change logs, and audit trails for transparency.
• Electronic Templates vs. Paper Forms: Electronic templates have greater flexibility for customization and updates. For instance, modifications of electronic templates support real time updates. Paper forms, on the other hand, require reprinting and manual updates.
• Interactivity and Automation: Enables fillable fields, digital signatures, and automated workflows.

What Is a CAPA Form Example?

The image below shows a blank CAPA form.

What Is a CAPA Form Template?

A CAPA form template provides a model document for creating CAPA. CAPA form template is available in various formats like Microsoft (MS) Word, MS Excel, PDF, Google Docs, Google Sheets, or other digital formats such as a form built in CAPA management software.

The main difference between a CAPA form template and a CAPA form is that a CAPA form template is essentially a model or a framework for a CAPA form. Once the CAPA form template is approved and officially adopted by the organization for consistent use, it becomes a CAPA form. The CAPA form officially becomes a quality document.

Furthermore, the CAPA form template becomes a CAPA form when you start to use and fill in the fields.

You can download the CAPA form template example here.

What Is the Difference Between CAPA Form and CAPA Report?

CAPA form is the initial document that initiates and tracks CAPAs for a recorded issue. CAPA form collects data on the problem, root cause analysis, and planned actions. Regulatory requirements like the ones stated by the FDA, in ISO standards, and in GMP require clear CAPA records to demonstrate compliance.

CAPA report, on the other hand, is the finalized document that confirms completion of the actions and includes effectiveness checks. CAPA report shows whether the chosen measures solved or prevented the problem from recurring. This final document meets the requirements for closure and sign-off.

CAPA form and CAPA report may exist as one continuous record or as two separate documents, depending on organizational CAPA procedures.

How to Write a CAPA Report?

The recommended steps to write an effective CAPA report are listed below.

1. Assign a CAPA Number: A unique identifier ensures traceability and easy tagging of the CAPA report.
2. Identify the Recorded Issue: Clearly define the problem, assess the issue’s impact, noting what happened, when, where, how it was identified, and which product, process, or system is affected.
3. Gather Relevant Data: Collect supporting records like audit findings, complaints, inspection reports, and test results to strengthen the investigation.
4. Analyze the Root Cause: Use tools like the 5 Whys and Fishbone Diagram to determine the underlying cause and focus on fixing the root issue rather than symptoms.
5. Outline Corrective Actions: Define steps to eliminate the root cause and mitigate immediate risks, tailoring actions based on issue severity.
6. Develop Preventive Measures: Propose long-term strategies like process improvements, SOP updates, employee training, and monitoring enhancements to prevent similar issues from occurring.
7. Assign Responsibilities: Designate qualified personnel for each action and document assignments in the CAPA report to ensure accountability.
8. Set Timelines and Milestones: Establish deadlines to maintain efficiency and ensure timely CAPA execution.
9. Describe the Implementation of the CAPA Plan: Execute corrective and preventive measures per the plan, documenting findings, actions, and any necessary adjustments.
10. Evaluate the Effectiveness of Actions: Verify resolution using audits, performance data, or follow-up checks, before proceeding to CAPA closure.
11. Review and Validate the Report: Ensure completeness, accuracy, and compliance by reviewing the CAPA report with key stakeholders.
12. Approve and Finalize the Report: Obtain final approval, formally close the CAPA, and archive documentation for future reference and audits.

How Does CAPA Management Software Enhance the CAPA Process?

CAPA management software improves the CAPA process by centralizing documentation, automating workflows, and ensuring timely corrective actions. CAPA software streamlines root cause analysis, offers real-time reporting and analytics, and helps ensure regulatory compliance.

CAPA management software module, often part of a QMS software offers greater efficiency, compliance, and collaboration compared to traditional paper-based CAPA systems, which are prone to manual errors and slower documentation workflows.

SimplerQMS offers QMS software with a built-in CAPA management module, designed specifically for life science companies. In addition to CAPA management, SimplerQMS provides comprehensive QMS process support, including document control, complaint management, audit management, and more. It supports compliance with requirements such as 21 CFR Part 210/211/820, ISO 13485:2016, EU MDR, and others.

Book a free demo to learn how SimplerQMS can help your organization streamline your CAPA processes and other QMS processes including document control, training, change control, audits, supplier management, and more.