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    CAPA Effectiveness Check

    Verification step confirming a corrective or preventive action actually fixed the problem.

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

    Definition

    An effectiveness check is a planned, objective evaluation performed after a CAPA action is implemented to confirm the action eliminated the root cause and the issue does not recur. Acceptance criteria and a defined timeframe are set in advance.

    What this means in practice

    Closing CAPAs without an effectiveness check is one of the most common QSR/ISO 13485 audit findings. Effectiveness data should be quantitative wherever possible.

    Cross-references

    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
    FDA·2ISO·1
    1. 1
      FDA CAPA Inspection Guide
      Needs review
      FDAfda.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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