CAPA Procedure: Definition, Example, Process Steps

Corrective and Preventive Action (CAPA) is a critical process within Quality Management Systems (QMS), ensuring organizations identify, investigate, and resolve quality issues while maintaining regulatory compliance. A well-structured CAPA procedure helps detect problems, conduct root cause analysis, implement corrective and preventive actions, and verify their effectiveness to prevent recurrence.

Various regulations, standards, and guidelines, including FDA 21 CFR Part 820 and 211, ISO 13485, ICH Q10, and GMP guidelines, mandate CAPA to ensure product safety and continuous improvement across life science industries. While the core CAPA principles remain consistent, their focus differs across industries. Medical device companies focus on post-market surveillance and performance monitoring, whereas pharmaceutical manufacturers prioritize batch consistency and process validation.

Managing CAPA manually can be overwhelming, leading to compliance risks, inefficiencies, and increased audit challenges. CAPA management solutions, often integrated into a comprehensive QMS, help streamline the CAPA management process.

SimplerQMS offers a QMS software with built-in CAPA management capabilities, enabling organizations to efficiently manage corrective and preventive actions. Life science companies trust SimplerQMS to simplify CAPA management among other QMS processes, maintain quality, and meet regulatory standards effortlessly.

What Is a CAPA Procedure?

A Corrective and Preventive Action (CAPA) procedure is a documented procedure within Quality Management Systems (QMS) that outlines the process for managing corrective and preventive actions. A CAPA procedure outlines the step-by-step approach an organization follows to manage corrective and preventive actions in response to identified recorded issues.

CAPA procedure is designed to identify, analyze, and resolve recorded issues by systematically investigating root causes and implementing corrective and preventive measures.

Recorded issues include deviations, complaints, audit findings, non-conformities, and process failures. These issues are identified through audits, inspections, customer feedback, internal reviews, supplier evaluations, or trend analysis.

The purpose of the CAPA procedure is to ensure regulatory alignment, product integrity, and operational efficiency by addressing quality issues at their source. Effective corrective actions (CA) eliminate defects, inconsistencies, and process failures. Preventive actions (PA) proactively address potential risks, ensuring that issues are avoided before they arise.

Regulations, standards, and guidelines including FDA 21 CFR Part 820 and Part 211, ICH Q10, ISO 13485, ISO 9001, GMP, and EU MDR require CAPA procedures to ensure product conformity across industries. These frameworks integrate CAPA into risk-based quality management systems to drive quality assurance, continuous improvement, and compliance in medical devices, pharmaceuticals, and manufacturing.

What Is a CAPA Procedure Example?

Listed below is an overview of the main sections of the CAPA procedure.

• Purpose and Scope: Defines the objective and coverage of the CAPA process. The purpose explains how CAPA identifies, corrects, and prevents quality issues, ensuring continuous improvement. The scope specifies the processes, departments, and products involved in CAPA activities.
• Definitions and Acronyms: Provides standardized definitions of terms and abbreviations used within the CAPA procedure.
• Responsibilities: Assign roles and responsibilities to individuals involved in the CAPA process.
• References: Lists external standards, regulations, and guidelines used in the development of the CAPA procedure.
• Procedure for Identifying Issues (Nonconformances): Specifies the methods used to detect quality issues that require CAPA. Organizations identify non-conformances through customer complaints, internal audits, external audits, product inspections, and process deviations.
• Root Cause Investigation: Details the process for identifying the root cause of an issue. Different root cause investigation tools are used to identify issues in processes, products, or systems, such as the 5 Whys Analysis and the Fishbone Diagram. The 5 Whys Analysis identifies the root cause by asking “why” multiple times. The Fishbone Diagram (Ishikawa) categorizes potential causes based on factors such as materials, methods, machines, and people.
• Corrective Actions: Lists the immediate steps taken to correct the identified issue  followed by the long-term corrective actions implemented after determining the root cause. Organizations develop action plans, assign responsibilities and timelines, and use verification methods to confirm corrective action effectiveness.
• Preventive Actions: Defines measures to prevent the occurrence of issues. Organizations implement process modifications, policy updates, training programs, and risk assessments to proactively address potential risks.
• Implementation and Verification: Details the steps taken to implement the corrective and preventive actions and verify their effectiveness. Organizations assign action items with deadlines, conduct follow-up audits or inspections, and evaluate whether the corrective and preventive measures resolve the issue.
• Reporting to Authorities: Specifies the requirement to report CAPA findings and corrective actions to regulatory authorities when necessary. Organizations ensure compliance with regulatory reporting obligations, document reporting activities, and provide transparency in addressing quality and safety issues.
• Documentation and Record-Keeping: The CAPA procedure specifies documentation requirements for compliance. Organizations must maintain CAPA reports and investigation records, provide evidence supporting findings and decisions, and ensure verification results and closure approvals are properly documented.
• Review and Closeout: Defines the final review process before closing a CAPA case. The quality management team evaluates corrective actions, ensures compliance with approval requirements, and determines if additional actions are necessary before closure.
• Training and Awareness: The CAPA procedure outlines the approach for training employees on CAPA processes. Organizations conduct initial and periodic CAPA training, maintain training records for compliance, and assess employee competency in CAPA-related tasks.
• Monitoring and Continuous Improvement: Focuses on monitoring CAPA effectiveness and ensuring continuous improvement. Organizations track performance using CAPA metrics, analyze trends for recurring issues, and implement process enhancements based on findings.

What Are the CAPA Process Steps?

The key CAPA process steps are listed below.

1. Identify the Issue: Clearly define the problem, deviation, or non-conformance. Identify the source, which may include customer complaints, audits, or production issues, and document supporting evidence.
2. Evaluate and Prioritize: Assess the severity, frequency, and impact of the issue to determine its priority level. Categorize issues based on urgency, distinguishing between those requiring immediate corrective action and those suitable for preventive measures.
3. Plan Initial CAPA and Approval: Define all essential steps in the CAPA process, including the scope, objectives, responsibilities, timelines, methodology, and necessary approvals for addressing the issue.
4. Investigate and Determine Root Cause: Perform a root cause analysis (RCA) using tools such as the 5 Whys and Fishbone Diagram. Identify the underlying cause to prevent recurrence.
5. Develop Corrective and/or Preventive Actions: Based on the root cause analysis, create an action plan to correct the issue (CA) or prevent its recurrence (PA). Ensure the plan addresses the root cause rather than just the symptoms.
6. Implement the CAPA Action Plan: Execute corrective or preventive actions within the established timeline. Assign responsibilities, allocate resources, and communicate action plans to relevant stakeholders.
7. Measure the CAPA Effectiveness: Verify and validate that the implemented actions have resolved the issue effectively. Use follow-up audits, key performance indicators (KPIs), and testing to confirm the CAPA’s success.
8. Document and Close the CAPA: Maintain detailed records of all CAPA activities, including investigation reports, action plans, implementation status, and effectiveness checks. Formally close the CAPA once it meets the necessary criteria.
9. Perform Trending and Continuous Review: Regularly analyze CAPA data to identify recurring issues and improvement opportunities. Use trend analysis to enhance long-term process stability and compliance with quality standards.

What Are CAPA Management Requirements?

Listed below are the key CAPA management requirements.

• Identification & Documentation: Detect and record quality issues or deviations for future investigation.
• Root Cause Analysis: Investigate and determine the underlying causes of nonconformities.
• Risk Assessment: Evaluate the potential impact on product quality and safety.
• Action Plan Development: Create clear corrective and preventive strategies with defined timelines and responsibilities.
• Implementation and Monitoring: Execute and oversee action plans to ensure effective resolution.
• Verification and Validation: Test and review the actions to confirm that issues have been resolved.
• Documentation & Record Keeping: Maintain detailed records of the CAPA process for continuous improvement and regulatory audits.

Requirements outlining CAPA management processes include key regulations, standards, and guidelines listed below.

• The International Council for Harmonisation (ICH) Guideline Q10: ICH Q10 is a Pharmaceutical Quality System (PQS) standard that ensures consistent product quality through effective risk management systems. CAPA within ICH Q10 (Section 3.2.2) requires organizations to detect, investigate, and resolve quality issues through action plans and monitoring to prevent recurrence.
• FDA 21 CFR Part 820: 21 CFR Part 820 is a U.S. Food and Drug Administration (FDA) Quality System Regulation (QSR) for medical device manufacturers. CAPA in this regulation (Subpart J, Section 820.100) mandates the identification, documentation, and investigation of nonconformities, along with the implementation of corrective and preventive actions to drive continuous improvement.
• FDA 21 CFR Part 211: 21 CFR Part 211 is a U.S. FDA regulation outlining current Good Manufacturing Practices (cGMP) for pharmaceuticals, ensuring product quality and safety. CAPA in this context (Subpart J, Section 211.192) focuses on the documentation of nonconformities, root cause investigation, and process validation for maintaining compliance.
• ISO 13485:2016: ISO 13485 is an international standard for medical device quality management systems. CAPA in ISO 13485 (Clause 8.5.2 and 8.5.3) requires organizations to establish early warning systems and feedback mechanisms, conduct product quality monitoring and risk-based corrective actions, perform data analysis, and notify regulators about adverse events to ensure compliance.
• EU GMP: EU GMP guidelines define pharmaceutical manufacturing quality standards to ensure product safety and efficacy. CAPA under EU GMP (Chapter 1, Section 1.4.xi and Chapter 8 (Section 8.16 to 8.19) requires organizations to document and regularly review preventive actions, conduct root cause investigations to enhance product safety, and optimize manufacturing processes for ongoing regulatory compliance.
• WHO GMP: WHO GMP sets global standards for pharmaceutical and healthcare product manufacturing. CAPA in WHO GMP (Annex 3, Section 14.2) requires companies to establish clear procedures, conduct root cause analysis, implement corrective and preventive actions, and monitor their effectiveness to maintain high-quality standards.
• European Union Medical Device Regulation (EU MDR): The EU MDR sets requirements for the safety and performance of medical devices within the European Union. CAPA in the MDR (Chapter I, Article 2(68)) focuses on identifying and addressing nonconformities to ensure product safety and regulatory compliance.
• European Union In Vitro Diagnostic Regulation (EU IVDR): The EU IVDR establishes requirements for the safety, performance, and regulatory compliance of in vitro diagnostic medical devices within the European Union. CAPA under IVDR (Chapter I, Article 2(70)) focuses on identifying, investigating, and addressing nonconformities by implementing actions to eliminate the cause of a potential or actual nonconformity or other undesirable situation.
• ISO 9001:2015: ISO 9001 is an international standard for Quality Management Systems (QMS), applicable across industries to ensure consistent product and service quality. CAPA in ISO 9001:2015 (Clause 10.2) emphasizes the correction of nonconformities and the prevention of future issues through risk-based approaches.

What Is the CAPA Approach Across the Life Science Industries?

The CAPA approach across the life sciences industry ensures product quality, regulatory compliance, and patient safety. CAPA approach identifies root causes of deviations, implements corrective actions, and establishes preventive measures to mitigate risks.

The medical device and pharmaceutical sectors rely on CAPA to maintain high product quality, process integrity, and regulatory compliance. Although the core principles remain consistent, regulatory standards and operational focuses differ slightly to address each sector’s specific challenges and risks. These distinctions ensure that each industry meets its specific safety and efficacy requirements while maintaining a consistent CAPA framework.

CAPA in the medical device industry is governed by FDA 21 CFR Part 820 and standards such as ISO 13485, which require companies to monitor device performance and conduct post-market surveillance. This approach ensures that any design or performance issues receive correction and that improvements occur to prevent future problems.

CAPA in the pharmaceutical industry is regulated under FDA 21 CFR Part 211, GMP, and ICH Q10. These regulations, standards, and guidelines ensure consistent manufacturing processes and batch quality. This approach addresses production deviations and ensures that every batch of product meets strict quality standards.

CAPA ensures product quality and safety in both medical device and pharmaceutical industries. It mandates Vigilance Reporting, Pharmacovigilance, and Medical Device Reporting (EU/FDA) to monitor performance, address deviations, and ensure compliance with authorities like FDA and EMA. Organizations must document CAPA findings, report corrective actions, and maintain transparency to drive continuous improvement.

How Does CAPA Software Streamline CAPA Process?

CAPA software is a powerful digital solution designed to help companies systematically identify, address, and prevent quality issues by streamlining corrective and preventive action processes. CAPA management software centralizes documentation, automates workflows, and ensures compliance with rigorous industry standards.

CAPA management capabilities are an integral part of QMS software. Centralized data management stores all CAPA-related information in a single system, making it easier to monitor progress, track documentation, and generate audit-ready reports. Integrated tools for risk management and root cause analysis help identify underlying issues and assess potential risks, leading to more targeted corrective actions. This digital solution reduces compliance gaps and promotes continuous quality improvement across the organization.

SimplerQMS is a fully validated QMS software specifically designed for life science companies. SimplerQMS seamlessly incorporates CAPA management capabilities to enhance compliance and overall quality management.

SimplerQMS provides CAPA management solutions and extensive support for other QMS processes. SimplerQMS supports broader QMS processes, including document control, change management, audit management, training management, complaint handling, supplier management, risk management, and more. The SimplerQMS platform is built to meet key regulatory requirements for life science companies, including ICH Q10, FDA 21 CFR Part 820, FDA 21 CFR Part 211, ISO 13485:2016, EU GMP, WHO GMP, EU MDR, and ISO 9001:2015.

Managing CAPA manually is time-consuming and prone to errors, leading to compliance risks and operational inefficiencies. By adopting SimplerQMS QMS software and its CAPA management module, companies can enhance traceability, automate issue tracking, streamline root cause analysis, and resolve issues as they arise, ensuring the timely implementation of CA and PA.