1. What is CAPA?
CAPA (Corrective Action and Preventive Action) is a fundamental quality management system that forms the backbone of quality control. As the name suggests, CAPA consists of two complementary components: corrective actions (addressing problems that have occurred) and preventive actions (proactively preventing similar problems from occurring). The characteristic feature is a process that distinguishes between “responding to what has happened” and “preparing for what might happen,” while ensuring both elements work together synergistically.
It is crucial to understand that Corrective Action and simple Correction must be clearly distinguished. Correction refers to immediate measures taken to eliminate a detected nonconformity, whereas Corrective Action represents a systematic approach to eliminate the root cause of nonconformity and prevent recurrence. Similarly, Preventive Action is a proactive activity aimed at eliminating the causes of potential nonconformities before they occur.
2. Why the FDA and International Regulatory Authorities Focus on CAPA
The CAPA system is one of the most critical elements in the quality system regulations established by the U.S. Food and Drug Administration (FDA). Traditionally regulated under 21 CFR Part 820 (Quality System Regulation: QSR), the FDA published a final rule on February 2, 2024, transitioning to the Quality Management System Regulation (QMSR), which will be implemented on February 2, 2026. The QMSR achieves international harmonization by referencing the international standard ISO 13485:2016.
The FDA’s strong interest in CAPA stems from its role as a criterion for evaluating not merely defect correction, but whether an organization’s product and process quality assurance systems possess the capability to prevent problem recurrence and achieve continuous improvement. In fact, according to FDA inspection data from 2008 to 2025, CAPA-related citations have consistently ranked among the top three violations, with CAPA deficiencies appearing in over 60% of warning letters.
When CAPA functions effectively, the risk of quality problem recurrence can be significantly reduced. Conversely, if CAPA activities are inadequate, organizations may face serious consequences during FDA inspections, including warning letters, product seizures, or market exclusion.
3. CAPA Requirements in International Standards
3.1 ISO 13485:2016 Requirements
ISO 13485:2016 clearly distinguishes between corrective action and preventive action, specifying each in separate clauses.
Clause 8.5.2 Corrective Action requires organizations to:
- Review nonconformities and identify their causes
- Determine the need for corrective action
- Plan, document, and implement necessary actions
- Appropriately update documentation
- Verify that actions do not adversely affect regulatory requirements or device safety and performance
- Review the effectiveness of implemented corrective actions
Clause 8.5.3 Preventive Action requires the identification and elimination of causes of potential nonconformities before they occur. This includes analysis of multiple information sources such as processes, operations, quality audit reports, quality records, service records, complaints, and returned product data.
3.2 FDA 21 CFR Part 820.100 (Current QSR) and New QMSR
The current 21 CFR Part 820.100 requires each manufacturer to establish and maintain procedures for implementing CAPA. This includes:
- Analysis of processes, operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data
- Identification of existing and potential causes of nonconforming product or other quality problems
- Identification and implementation of corrective actions needed
- Documentation of implemented changes in methods and procedures
- Dissemination of information to those responsible for quality
- Submission of relevant information to management review
The QMSR, which will take effect on February 2, 2026, achieves international harmonization by referencing ISO 13485:2016 requirements while maintaining U.S.-specific requirements. Manufacturers should note that certification to ISO 13485:2016 alone is insufficient; they must also satisfy additional QMSR requirements.
4. Basic Concepts and Implementation Flow
The CAPA system fundamentally comprises the following steps:
Step 1: Problem Identification Systematically identify problems from diverse “signals” including product anomalies, customer complaints, internal audit findings, nonconformity data, service reports, returned products, and process monitoring data. The key is to systematically collect and analyze these data to identify trends and patterns.
Step 2: Root Cause Analysis Rather than merely applying superficial symptomatic treatments, conduct root cause analysis to understand “why the problem occurred in the first place.” The use of systematic analytical methods such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA) is recommended. Inadequate root cause identification results in ineffective measures and high probability of problem recurrence.
Step 3: Planning and Implementation of Corrective and Preventive Actions Based on root causes, plan and implement appropriate corrective actions (addressing problems that have occurred) and preventive actions (preventing recurrence or similar incidents). It is crucial to verify that measures do not adversely affect product safety, performance, or regulatory requirements. When necessary, update risk management files (based on ISO 14971) and ensure consistency with design control documentation.
Step 4: Effectiveness Verification Verify that implemented measures are “truly effective.” This goes beyond merely confirming that measures have been completed; it includes monitoring over a period of time to ensure that similar problems have not recurred and that preventive actions are functioning. Inadequate effectiveness verification results in CAPA becoming a formality, causing the continuous improvement cycle to cease functioning.
Step 5: Documentation and Continuous Improvement All CAPA activities must be documented in detail and maintained as audit trails. This includes problem identification, root cause analysis, planning and implementation of actions, effectiveness verification results, and reporting to management review. Furthermore, knowledge gained from CAPA activities should be shared throughout the organization and utilized for continuous improvement of the quality management system.
5. Design Philosophy Supporting Professionalism
CAPA systems require systems thinking rather than mere checklist-based operations. Beyond correcting individual mistakes and nonconformities, they must address the organizational fabric itself, including structural vulnerabilities in overall processes, deficiencies in information sharing, inadequacies in personnel training, thoroughness of standardization, and effectiveness of supplier management.
5.1 Integration of Risk-Based Approach
ISO 13485:2016 introduces a risk-based quality management system (QMS). In CAPA activities, this means prioritizing problems based on severity and probability of occurrence and appropriately allocating resources. Not all nonconformities require CAPA initiation; focus should be placed on systemic and recurring problems.
5.2 Cross-Functional Collaboration
CAPA reviews and follow-ups require involvement of experts from multiple departments including quality assurance, regulatory affairs, design and development, manufacturing, service, and purchasing. Particularly for product-related CAPAs, involvement of the regulatory affairs department is essential to assess impact on regulatory requirements.
5.3 Documentation and Traceability
All CAPA activities must be documented with complete traceability using electronic quality management systems (eQMS) or similar tools. This includes time-stamped audit trails, electronic signatures, and version control. Maintaining closed-loop traceability to track all quality activities from raw materials to final products and post-market surveillance is critical.
6. Key Points for Beginners
A common pitfall for beginners in CAPA is limiting “corrective action” to “makeshift repairs or responses.” The essence of CAPA lies in addressing root causes and elevating this knowledge into organization-wide preventive actions.
6.1 Basic Approach
- Systematic Recording of Problems: Centrally record and manage all nonconformities, complaints, and audit findings
- Utilization of Root Cause Analysis Methods: Use methods such as 5 Whys, Fishbone Diagrams, and FMEA to identify true causes
- Verification of Action Effectiveness: Verify over a period of time whether implemented measures are actually functioning
- Organization-Wide Learning: Horizontally deploy lessons learned from CAPA activities to other product lines and processes
6.2 Common Misconceptions and Points of Caution
Misconception 1: All nonconformities require CAPA In reality, isolated and one-time problems can be addressed with simple corrections. CAPA should be implemented for systemic, recurring problems or issues with potential for significant impact.
Misconception 2: Confusing corrective and preventive actions Corrective action addresses problems that have already occurred, while preventive action addresses potential problems. Both must be clearly distinguished with independent evaluation and documentation.
Misconception 3: Timing of effectiveness verification Directly applying the Eight Disciplines (8D) problem-solving methodology to the medical device industry can result in reversed order of verification and implementation. Regulatory requirements mandate verification of effectiveness after implementing actions.
Point of Caution: Unrealistic timelines Short, arbitrary deadline settings may be used to create superficial compliance appearances but actually hinder quality improvement. CAPA timelines should be set realistically, considering problem complexity, required resources, and time needed for effectiveness verification.
7. Latest Regulatory Trends and Industry Best Practices
7.1 Preparation for QMSR Implementation
In preparation for QMSR implementation on February 2, 2026, medical device manufacturers need to:
- Ensure conformity with ISO 13485:2016 requirements
- Conduct comparative analysis of existing QSR procedures with QMSR requirements
- Perform comparative analysis demonstrating that records created before February 2, 2026 meet QMSR requirements
- Recognize FDA access to management reviews, quality audits, and supplier audit reports (exceptions that existed in the former QSR have been removed in QMSR)
7.2 Data Integrity and Digitalization
Recent regulatory trends place important focus on data integrity. Data management based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) is required. Implementation of electronic quality management systems (eQMS) enables time-stamped audit trails, electronic signatures, automated workflows, and real-time monitoring, achieving improved compliance and efficiency.
7.3 Integration with Post-Market Surveillance
The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) require close integration of post-market surveillance data with CAPA. Manufacturers must continuously analyze post-market data (complaints, adverse events, clinical data, etc.) and initiate CAPA as necessary. Field Safety Corrective Actions (FSCA) must be reported to regulatory authorities.
7.4 Utilization of Artificial Intelligence (AI) and Machine Learning
Some advanced companies are using AI and machine learning to automatically detect trends and patterns from vast amounts of quality data, enabling early identification of potential problems. This significantly enhances the effectiveness of preventive actions, allowing problems to be addressed before they become apparent.
8. Conclusion
The CAPA system is not merely a “problem response manual” but an important framework that reflects the culture of quality assurance itself. The fact that the FDA and international regulatory authorities place the highest importance on this quality system element means that CAPA serves as an indicator clearly demonstrating a company’s quality level and organizational capability.
With the implementation of QMSR in February 2026, international harmonization will further progress, while companies need to continuously strengthen their CAPA capabilities and adapt to evolving regulatory requirements. Even beginners, by being conscious of the distinction between corrective and preventive actions and practicing systematic and reproducible operations, can contribute to achieving a high-quality culture.
An effective CAPA system not only achieves regulatory compliance but also enhances organizational learning capacity, promotes continuous improvement of products and processes, and ultimately leads to improved patient safety and satisfaction. This is the true value of the CAPA system and the goal that all medical device manufacturers should strive for.
Table 1: Comparison of Corrective and Preventive Actions
| Item | Corrective Action | Preventive Action |
|---|---|---|
| Purpose | Eliminate causes of occurred nonconformities and prevent recurrence | Identify causes of potential nonconformities and prevent occurrence |
| Trigger | Problems that have already occurred (complaints, nonconformities, audit findings, etc.) | Trend analysis, risk assessment, process monitoring data, etc. |
| Focus | Past problems | Future problems |
| Analysis | Root Cause Analysis (RCA) | Risk analysis, trend analysis |
| Regulatory Requirements | ISO 13485:2016 8.5.2, FDA 21 CFR 820.100 | ISO 13485:2016 8.5.3, FDA 21 CFR 820.100 |
| Implementation Timing | After problem occurrence, without delay | Before problem occurrence, proactively |
Table 2: Comparison of Major Regulatory Requirements
| Regulation/Standard | CAPA Clause | Key Requirements | Implementation Status |
|---|---|---|---|
| FDA 21 CFR Part 820.100 (QSR) | Subpart J | Establishment and maintenance of CAPA procedures, root cause analysis, effectiveness verification, documentation | Valid until February 1, 2026 |
| FDA QMSR (New Rule) | ISO 13485:2016 reference + additional requirements | ISO 13485:2016 requirements + U.S.-specific requirements | Effective from February 2, 2026 |
| ISO 13485:2016 | 8.5.2 (Corrective Action), 8.5.3 (Preventive Action) | Review of nonconformities, cause identification, implementation of actions, effectiveness verification, regulatory impact verification | Widely applied internationally |
| EU MDR 2017/745 | Article 10, Annex IX | CAPA within QMS, integration with post-market data, FSCA reporting | Effective from May 2021 |
| EU IVDR 2017/746 | Article 10, Annex IX | CAPA within QMS, integration with post-market data, FSCA reporting | Effective from May 2022 (with transition period) |
Table 3: Major Violations in FDA Inspections (Medical Devices)
| Violation | CFR Reference | Cumulative Citations 2008-2025 (Approximate) | Description |
|---|---|---|---|
| Design Controls (especially Design Validation) | 21 CFR 820.30(g) | Over 1,855 | Most citations for design validation deficiencies |
| CAPA | 21 CFR 820.100 | Consistently in Top 3 | Deficiencies in root cause analysis, effectiveness verification |
| Complaint Handling | 21 CFR 820.198 | Consistently in Top 3 | Uninvestigated complaints, delayed responses |
| Document Control | 21 CFR 820.40 | Numerous | Version control, approval procedure deficiencies |
| Process Control | 21 CFR 820.70 | Numerous | Process validation, equipment management deficiencies |
Note: According to 2024 data, over 60% of warning letters issued to medical device companies include CAPA deficiencies.
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