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    Quality & RiskQuality SystemNCR

    Nonconformance (NCR)

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

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

    Definition

    A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA.

    What this means in practice

    Trend analysis of NCRs is a key feedback loop into design and process improvements.

    Cross-references

    Precedes

    Comes before in a typical workflow or lifecycle.

    Mentioned in recent activity

    3 entries

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.90
      Needs review
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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