5 Major CAPA Medical Device Requirements


    The corrective and preventive action (CAPA) quality processes consist of the critical activities life sciences organizations must activate to eliminate nonconformity and/or product deviation instances.

    For start-ups and scale-ups in highly regulated industries, building a high-value CAPA quality process enables teams to produce enterprise-grade products and services.

    However, when you consider the total volume of CAPA resources available, it can be difficult to determine which CAPA medical device requirements translate to the most significant improvements in quality processes.

    5 Major CAPA Medical Device Requirements for Startups

    To solve these and other CAPA-related challenges, many industry-leading medical device startups and scale-ups invest in a quality management system (QMS). Most systems apply CAPA best practices to product design and development automatically. In doing so, quality and compliance teams can take the guesswork out of CAPA-related quality issues — including complaint handling, supplier management, and regulatory audit.

    To streamline and maximize CAPA quality process activation and effectiveness, we recommend following these five CAPA medical device requirements.

    1. Automate with a QMS

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

    Many industry-leading medical device startups leverage emerging technology such as enterprise quality management software to automate and improve CAPA-related systems. While core features vary across each QMS solution partner, 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 the vendor how the system integrates with core CAPA best practices and requirements.

    2. Use Data to Identify Root Causes of Quality Problems

    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.

    According to the Association of Public Health Laboratories (APHL), a root cause analysis and investigation is a “type of problem-solving method aimed at identifying the root causes(s) of a problem (nonconformance) with the goal to prevent recurrence.”

    Many medical device startups use cause mapping to identify root issues. To analyze the cause-and-effect relationship of quality issues, APHL recommends 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 CAPA systems. By doing so, teams can align around 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.

    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 CAPA Process?

    Unfortunately, failure to address quality issues will have an immediate impact on your growing medical device startup. Moreover, failure to identify and address the root cause of compliance failures may result in serious regulatory infractions. As such, an investment in CAPA processes is critical. In this pursuit, many industry-leading life science organizations make significant investments in quality management systems.

    Qualio’s cloud-based QMS is designed specifically for life sciences startups and scale-ups. Our software enables quality and compliance teams to implement and manage CAPA processes and procedures via document control, training, design controls, complaint handling, management reviews, and more.

    How effective are your organization’s quality management and compliance systems? Take our interactive self-assessment to discover the steps that your organization can take to improve overall quality management and compliance effectiveness.