Understanding CAPA for medical devices: key concepts and requirements


    CAPA for medical devices is the reason that the medical device products we use every day can be trusted and relied upon to do their jobs. Corrective and preventive action (CAPA) quality processes consist of the critical activities medical device organizations must activate to eliminate nonconformities, defects and process deviations.

    For start-ups and scale-ups in a highly regulated industry, building a high-value CAPA quality process is critical for maximizing your product and process quality.

    Let's take a look at the CAPA process for medical devices.


    What is CAPA for medical devices?


    CAPA, which stands for corrective and preventive action, is a critical aspect of quality management in the medical device industry.

    It's designed to identify, rectify and prevent issues related to device quality and compliance. CAPA for medical devices involves a systematic approach to identify root causes of device non-conformances or defects, then implement corrective actions to eliminate the causes, and establish preventive measures to avoid recurrence.

    A CAPA system in medical devices ensures continuous improvement and compliance with regulatory standards, like FDA 21 CFR 820 and ISO 13485.

    This system includes several steps: data collection and analysis, identification of root causes, implementation of the corrective and preventive actions themselves, verification of their effectiveness, and documentation of the entire process.


    CAPA example in medical devices


    Imagine a recurring defect is reported for a breast implant product.

    The CAPA system in this medical device context would begin with a thorough investigation to pinpoint the root cause, such as a flaw in the manufacturing process, or an issue with the raw materials used in manufacture.

    Once identified, corrective actions, such as revising the manufacturing process or switching supplier, would be implemented.

    Preventive measures might include additional quality assurance training for staff, or more stringent supply chain control and supplier onboarding checks.

    The overall objective? For the CAPA implementation in the medical device company to permanently end the reported defect. Customers have no reason to take their business elsewhere, patient trust remains strong, and the medical device company can continue to market its product.


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    5 major CAPA requirements for medical device start-ups


    To get CAPA for medical devices in place, you'll need to build a robust and effective quality management system (QMS)

    Your QMS should combine processes for document, training, supplier and CAPA management together, allowing device problems to be proactively spotted and stamped out.

    To streamline and maximize your CAPA implementation in the medical device world, we recommend following these five key CAPA medical device requirements.


    1. Automate with CAPA software


    Traditionally, CAPA procedures include a considerable volume of manual processes, spreadsheets, and data entry. 

    So proactive, quality-centric medical device start-ups are turning to CAPA and nonconformance management software to automate and accelerate their CAPA processes. While core features vary across each eQMS platform, most systems are built around these five core themes:

    1. Integrated processes
    2. System flexibility
    3. Monitoring and management
    4. Regulatory compliance
    5. Promoting a culture of quality


    As your organization measures the effectiveness of a QMS, consider asking potential vendors how the system integrates with core CAPA best practices and requirements.


    RELATED READING: CAPA management software: benefits, top features and how to select the best



    2. Use data to identify root causes


    Today, current medical device regulations require careful analysis of process data, work operations data, and quality data. Many growing medical device companies place a strong focus on inbound consumer complaints. 

    Typically, consumer complaints are one of the biggest indicators of problems with distributed products, and as a result, CAPA processes. The U.S. Food and Drug Administration (FDA) has underlined this point, stating that it views complaints as a more important CAPA data source.


    3. Follow a root cause analysis process


    By adopting a regimented approach to root cause analysis, CAPA investigators can quickly and accurately identify issues of nonconformance and/or product deviations. The CAPA procedure for your medical device company should reflect this.

    Many medical device start-ups use cause mapping to identify root issues. To analyze the cause-and-effect relationship of quality issues, we recommend asking these questions:

    • Why did this problem occur?
    • What caused this problem to occur?
    • Why would that problem occur?
    • When would that problem occur?


    4. Verify and validate CAPA effectiveness


    We recommend verifying and validating CAPA process effectiveness both during and after activation. ASA Training & Quality Consulting recommends asking the following question to determine the most effective CAPA process verification measures:

    • Who will measure it?
    • What will be measured?
    • Where will it be measured?
    • How will it be measured?
    • How will measurements be analyzed and communicated?

    In most cases, conducting a simple internal audit is one of the most effective methods to analyze the effectiveness of your medical device CAPA system. By doing so, your team can pinpoint core issues affecting product quality assurance and institute company-wide activities to eliminate or reduce issues of nonconformity. 

    By building a culture of quality, every team member (executive leadership included) is held accountable for her/his actions related to product design and development. As a result, the company is equipped to deliver a quality product and/or service that complies with applicable regulations.


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    5. Document changes to CAPA processes


    After measuring CAPA process effectiveness, document any changes in procedures, and share these changes with executive and other quality assurance personnel. 

    In the Guide to Inspections of Quality Systems, the FDA underscores the importance of frequent management reviews by stating that “if you find that there are quality issues that do not seem to be known to executive-level management, then the reviews may not be occurring with sufficient frequency.”

    However, simply conducting more frequent reviews with upper management is not enough. To ensure that management is involved, information related to CAPA findings must be clearly communicated and disseminated across the entire organization.


    How effective is your organization’s medical devices CAPA system?


    Unfortunately, failure to address quality issues will have an immediate impact on your growing medical device start-up. And failure to identify and address the root cause of compliance failures may result in serious regulatory infractions.

    As such, timely investment in your medical device CAPA processes is critical. 

    Qualio’s cloud-based CAPA software is designed specifically for medical device start-ups and scale-ups. Our software empowers your quality and compliance teams to implement and manage world-class CAPA processes and procedures with document control, training, design controls, complaint handling, management reviews, and more.