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    Quality & RiskQuality SystemCAPA

    Corrective and Preventive Action

    Systematic process to investigate and resolve quality issues and prevent recurrence.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    CAPA is a quality system process for identifying, investigating, and addressing the root causes of nonconformities, complaints, and other quality events, and for preventing their recurrence.
    What the regulation says
    FDA lists inadequate CAPA procedures and inadequate investigations among the most frequent Form 483 observations year after year. Under QSMR (which incorporates ISO 13485:2016), CAPA obligations are effectively unchanged from 21 CFR 820.100.

    What this means in practice

    CAPA is one of the most frequently cited subsystems in FDA inspections and forms one of the four Quality System subsystems FDA reviews under QSIT. Regulators expect a documented procedure covering identification of quality data sources, investigation, root cause analysis, action planning, implementation, verification of effectiveness, and communication of information to management review.

    Examples

    • A complaint trend showing repeated battery under-performance triggering a CAPA that redesigns the charge circuit and updates the risk file.
    • An internal audit finding on inconsistent supplier evaluation records leading to a preventive action that revises the supplier control procedure.

    Use cases

    1 scenario
    1

    Pattern of pump occlusion complaints

    QA / Complaint handling

    Trending shows occlusion complaints rising 30% quarter over quarter. A CAPA is opened: root cause traced to a tubing supplier change, corrective action requalifies the prior supplier, preventive action adds incoming inspection criteria for tubing durometer.

    OutcomeComplaint rate returns to baseline; the CAPA closes after effectiveness checks across three production lots.
    Common pitfalls
    • •Treating CAPA as a paperwork exercise without verification of effectiveness (VoE). VoE is what regulators look for first when reviewing closed CAPAs.
    • •Jumping to a corrective action without a documented root cause analysis (5 Whys, fishbone, fault tree).
    • •Opening a CAPA for every nonconformance. CAPA should be reserved for systemic issues; individual NCRs are handled through the nonconformance process.
    • •Not feeding CAPA outputs into management review, risk management, and design controls.

    Frequently asked questions

    Corrective action addresses the root cause of an existing nonconformity to prevent recurrence. Preventive action addresses the root cause of a potential nonconformity (identified from trends, risk analysis, or audits) to prevent occurrence.

    Cross-references

    Part of

    Precedes

    Follows

    Related terms

    Shared paths + category
    Quality & Risk
    Complaint Handling

    Process for receiving, evaluating, and responding to device complaints.

    QMS Foundations · adjacentPost-Market Mastery · adjacent
    Quality & Risk
    Quality Management System Regulation(QMSR)

    FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.

    QMS Foundations
    Quality & Risk
    Quality System Regulation(QSR / 21 CFR 820)

    FDA's current good manufacturing practice (cGMP) requirements for medical devices.

    QMS Foundations
    Standards
    ISO 13485

    International standard for medical device quality management systems.

    QMS Foundations
    Quality & Risk
    Management Review

    Top-management evaluation of QMS performance at planned intervals.

    Same category
    Quality & Risk
    Nonconformance (NCR)(NCR)

    Failure of a product, process, or system to meet specified requirements.

    Same category

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    Primary references

    3 sources
    Link health: 1 verified 2 unchecked· last checked 2026-06-20
    eCFR·1FDA·1MDIC·1
    1. 1
      21 CFR 820.100 (CAPA)
      Unchecked
      eCFRecfr.gov
    2. 2
      FDA Inspections Observations Data
      Unchecked
      FDAfda.gov
    3. 3
      MDIC Case for Quality
      Verified
      MDICmdic.org

    Inline markers like [1] jump to the matching reference above.