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Corrective and Preventive Actions (CAPA)

    What Is CAPA?

    A CAPA is an action taken to correct and protect the quality management system, product, or system involving a medical device product.

    What Is Corrective Action?

    A corrective action is fixing a current process that creates an issue or a nonconforming product.

    What Is Preventive Action?

    Preventive action is correcting the process that could cause a nonconformance or issue with the medical device process.

    Common Misconceptions Around CAPA

    CAPAS are only for Corrective actions

    CAPAS are solely for compliance

    CAPAS are only for major issues

    CAPAS are a one time activity

    CAPAS are primarily the quality department’s responsibility

    CAPAS must always result in change

    1. Treating CAPA as A One-Time Event

    CAPAs should be viewed as a continuous process rather than a one-time activity. Implementing a CAPA does not signify the end of the issue; it requires ongoing monitoring and verification to ensure sustained effectiveness. Additionally, CAPAs should be reviewed periodically to assess their efficacy and make necessary adjustments.

    2. Neglecting Preventive Actions

    CAPAS are meant to be done frequently to find preventive actions.

    CAPA Reports

    CAPA Reports are intended to show that the project of analysis and investigation has been implemented and complete.

    What is included in a CAPA Report?

    • Affected Product
    • Cause for initiation
    • Failure investigation and risk analysis results
    • Correction, root cause, and proposed solution
    • Implementation description
    • Verification of implementation
    • Effectiveness assignment
    • Verification of effectiveness

    Identify what’s causing the issue

    • Customer complaints
    • Internal audits
    • Process deviations
    • Root Cause Analysis
    • Fishbone Diagrams
    • 5 Whys
    • Pareto Analysis
    • Fault Tree Analysis
    • Customer satisfaction
    • Data Analysis
    • Stakeholder Input
    • Regulatory Compliance
    • Previous CAPA Review

    Corrective actions to be taken

    Results of actions

    • Problem resolution
    • Prevention of recurrence
    • Improved quality
    • Enhanced compliance
    • Cost reduction
    • Enhanced reputation
    • Risk mitigation
    • Increased efficiency

    How Rook can help with CAPA Reporting

    Rook can help with internal audits that expose reasons for CAPAS. Rook can also help with a gap analysis which could trigger a CAPA creation. Rook can also create CAPAS and complete it for CAPA support for your medical device company. We have years of experience we can support and give recommendations when handling CAPAS for your quality management system.

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