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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 this means in practice

    CAPA is one of the most frequently cited subsystems in FDA inspections. Inadequate root cause analysis and verification of effectiveness are common findings.

    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.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Precedes

    Comes before in a typical workflow or lifecycle.

    Follows

    Comes after in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1MDIC·1FDA·1
    1. 1
      21 CFR 820.100
      Needs review
      eCFRecfr.gov
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

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