The commercialization of medical devices and drugs depends on a single aspect – patient safety. Patients must know that the device or drug does what it is supposed to do and won’t unintentionally harm them. Enter, quality management. Quality management is how you ensure safe and efficient production processes and adequate control measures for your devices and drugs.
One of the more important control measures is Corrective and Preventive Actions, a.k.a. CAPAs. They represent structured responses to any issues that appear in product development, manufacturing, or post-market stages. The main purpose of CAPAs is to help identify root causes and implement solutions to prevent recurrence.
Regulatory bodies such as the US Food and Drug Administration, FDA, the European Medicines Agency, (EMA), and standard organizations, such as ISO, frequently highlight CAPA deficiencies in their standards. Likewise, anyone who has been part of a notified body audit or ISO 13485 certification process knows how much time is spent on CAPA procedures, underscoring their importance in ensuring high product quality and safety standards. From contamination issues in production to unexpected failures, CAPAs are a key part of maintaining regulatory compliance and fostering continuous improvement.
In this article, we’ll discuss why a well-structured CAPA process is essential, break down the ten fundamental phases of an effective CAPA, and share some industry tips, including how an eQMS and, by extension, CAPA management software can improve efficiency and consistency in CAPA processes.
CAPA Requirements
Let’s break down the primary regulations and standards that govern CAPA processes for medical devices and the pharmaceutical industry.
ISO 13485:2016 - Medical Devices Quality Management Systems
ISO 13485:2016 is one of the most critical standards for medical devices, specifically tailored to quality management within the industry. It emphasizes CAPA as an integral part of the quality management system (QMS), requiring manufacturers to document and implement CAPA procedures that include identification of nonconformities, investigation, and root cause analysis, corrective and preventive action implementation, and documentation and reporting, among others.
21 CFR Part 820 - FDA’s Quality System Regulation (QSR)
In the United States, the FDA’s Quality System Regulation (QSR), codified in 21 CFR Part 820, outlines CAPA requirements specifically for medical device manufacturers. The regulation requires companies to establish and maintain CAPA processes as part of their quality systems.
Key CAPA-related requirements under QSR include data collection and analysis, investigation of nonconformities, verification and validation of CAPA, and procedural documentation.
ICH Q10 Pharmaceutical Quality System (PQS)
ICH Q10 is the International Council for Harmonization’s guideline for a Pharmaceutical Quality System (PQS) designed to enhance quality management throughout a product’s lifecycle. While it primarily focuses on pharmaceuticals, its framework also supports CAPA processes within quality systems, making it useful across industries involved in regulated product development and manufacturing, including medical devices.
ISO 9001:2015 Quality Management Systems
In ISO 9001, Corrective and Preventive Actions (CAPA) are integral components of the Quality Management System (QMS), aimed at ensuring issues are effectively addressed and future nonconformities are prevented. CAPA is essential for achieving ISO 9001's focus on continuous improvement, customer satisfaction, and maintaining a structured approach to managing quality issues.
Under ISO 9001, CAPA consists of processes that address both corrective actions and preventive actions to support the overall QMS.
Key elements include identification of nonconformities, corrective and preventive action procedures, effectiveness review, and documentation and record keeping.
CAPA Phases
An effective CAPA process is generally composed of a series of carefully structured phases, each designed to build upon the previous steps to address and prevent quality issues comprehensively.
While CAPA processes can vary slightly, a 10-phase approach is widely accepted as a best practice.
Here’s a closer look at each phase:
1) Problem Identification
The CAPA process begins with problem identification, where a quality issue is flagged for further analysis. This can be a result of customer complaints, non-conformances, audit findings, or adverse events.
Effective problem identification requires detailed documentation that captures the nature of the issue, its scope, and its potential impact on quality, safety, and regulatory compliance.
2) Immediate Action
Once the problem is identified, immediate actions are taken to contain the issue and prevent further impact. These actions may include halting a production line, quarantining affected products, or notifying internal stakeholders.
Immediate action is an essential risk management step, ensuring that issues do not worsen or spread while the root cause analysis is underway.
3) Problem Description
After containment, the next step is to thoroughly describe the problem, providing a detailed overview of the issue’s history, symptoms, and any relevant background information. This problem description forms the foundation for the investigation and should be easily understandable, clear, concise, and supported by data to ensure all stakeholders have a shared understanding of the issue.
4) Investigation and Root Cause Analysis
Next up is root cause analysis, focusing on identifying the fundamental causes of the issue. Commonly used tools in this phase include the 5 Whys method, Fishbone diagrams, and Failure Mode and Effects Analysis (FMEA). Each tool serves a specific purpose in drilling down to the core reasons behind the problem, enabling the CAPA team to identify and formulate targeted corrective actions that address the true root causes rather than mere symptoms.
Note that human error is not a good root cause. Human mistakes happen all the time, and they always have a deeper root cause. It could be a lack of training, unclear instructions, lack of resources causing personnel to rush through tasks, or sub-optimal working conditions, among others.
5) Corrective Action Plan
With the root cause identified, the next step is to develop a corrective action plan to address it. This plan should specify clear, actionable steps for mitigating the issue and include details on resources, timelines, and responsibilities.
For example, if the root cause was found to be a procedural lapse, the corrective action plan might involve revising SOPs and providing additional training.
6) Implementation of Corrective Actions
Once the corrective action plan is in place, it is time for execution. Corrective actions are implemented according to the defined plan, and each step is documented carefully to provide an audit trail.
This phase requires a coordinated effort across departments, as multiple functions—such as quality assurance, operations, and engineering—may need to collaborate to fully resolve the issue.
7) Verification of Corrective Actions
Verification ensures that the corrective actions have effectively resolved the issue. This involves testing, monitoring, and evaluating outcomes to confirm that the problem no longer exists. Verification also helps identify any residual risks and provides confidence that the corrective actions were successful in addressing the issue’s root cause.
8) Preventive Action Plan
To further reinforce quality and prevent similar issues from arising, a preventive action plan is then developed. This phase looks beyond the specific problem to identify potential vulnerabilities within the process. For instance, if the initial issue was due to a lack of knowledge or training of the involved personnel, preventive actions might include enhancing training programs to reduce future risk.
9) Implementation of Preventive Actions
Just as with corrective actions, preventive actions must be implemented in a structured manner. Preventive actions are designed to protect the process from future issues by addressing weaknesses or gaps that were uncovered during the investigation.
These actions might include regular monitoring, process improvements, or implementing additional quality checks, among others.
10) Effectiveness Review and Closeout
The final phase involves reviewing the entire CAPA process to ensure all steps were followed and that both corrective and preventive actions effectively resolved the issue and reduced future risk.
The CAPA process is formally closed out with documentation that includes the findings, actions taken, and evidence of effectiveness, ensuring compliance with regulatory requirements and creating a record for future reference.
Recommended learning: Add new tools to your quality toolbox! Discover the best tools for data acquisition and analysis for robust risk assessment.
Scilife tips and tricks
Managing CAPAs efficiently can be complex and time-consuming, especially as regulatory scrutiny and documentation requirements grow.
One of the best ways to streamline CAPA processes is by investing in an electronic Quality Management System, or eQMS.
Here, we’d be remiss not to mention Scilife’s eQMS which offers specialized CAPA management features that support each phase, from problem identification to effectiveness review. Additionally, Scilife’s eQMS integrates with other quality management tools, which helps life sciences companies establish a seamless workflow across CAPA, audit management, document control, and training.
With tools to automate task assignments, track deadlines, and centralize documentation, eQMS and CAPA management software can improve CAPA efficiency, maintain comprehensive audit trails, reduce administrative overheads, reduce errors, speed up response times, free up resources to be used elsewhere, and ensure compliance by keeping everything in one place. Not to mention, CAPA software gives you the ability to quickly dig up any CAPAs your auditor might randomly pick out during yearly surveillance audits or ISO inspections.
Conclusion
The CAPA process is more than a regulatory requirement; it is a critical component of quality assurance in life sciences. By following a structured, 10-phase CAPA process, you can address immediate issues effectively, prevent recurrence, and continuously improve your medical device’s or drug’s quality and safety. CAPAs enable companies to identify not only what went wrong but also why, leading to targeted actions that strengthen processes and mitigate future risk.
Remember, CAPA management is as much about efficiency, as it is about compliance.
A well-documented, comprehensive CAPA process can reduce the likelihood of regulatory findings, strengthen customer confidence, and ensure that quality remains at the forefront of operations. Investing in CAPA management software, like Scilife’s eQMS, can further enhance these efforts by providing a centralized, digital platform that supports every phase of CAPA management and aligns with industry standards.
Discover how to control CAPAs in the most effective way possible with Scilife’s CAPA Management Software here.
