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    Scrap Rate and Yield

    Production metrics tracking material loss (scrap) and the proportion of acceptable output (yield).

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

    Definition

    Scrap rate and first-pass yield are core operations KPIs that also signal process drift. Spikes feed CAPA, supplier-quality investigations, and process-validation re-evaluation triggers.
    What the regulation says
    Regulators view scrap rate and yield as critical indicators of a manufacturer's quality management system effectiveness, as outlined in FDA 21 CFR Part 820, Quality System Regulation, and EU MDR Annex I, General Safety and Performance Requirements. Sustained deviations in these metrics can prompt regulatory scrutiny regarding process control, design transfer, and overall product quality, potentially leading to findings during inspections.

    What this means in practice

    Quality teams should treat sustained yield decline as a leading indicator of nonconformance trends, not just a financial issue.

    Examples

    • A manufacturer observes a sudden increase in the scrap rate for a specific component, triggering an investigation into the supplier's most recent batch of raw materials.
    • Monthly review of production data reveals a gradual decline in the first-pass yield for an assembly line over three consecutive months, prompting a re-evaluation of the process validation.
    • A company uses statistical process control charts to monitor the yield of a sterilization process, identifying a subtle but consistent downward trend that leads to recalibration of the sterilizer.
    Common pitfalls
    • •Treating scrap rate and yield solely as financial metrics overlooks their significance as quality indicators.
    • •Failing to initiate appropriate corrective and preventive actions (CAPAs) when scrap rate or yield consistently fall outside established limits is a common oversight.
    • •Not adequately linking scrap rate and yield data to process validation re-evaluation criteria can lead to undetected process drift.
    • •Ignoring the potential impact of supplier quality on scrap rate and yield can result in ineffective root cause analysis.
    • •Failing to trend and analyze scrap rate and yield data over time can mask gradual but significant process degradation.

    Frequently asked questions

    Scrap rate and yield are key indicators of effective design transfer, demonstrating that the manufacturing process can consistently produce the device as designed. Poor yield post-transfer may indicate design for manufacturability issues or inadequate process development, as per FDA guidance on Design Control for Medical Device Manufacturers.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    ASQ·1ISO·1IMDRF/GHTF·1
    1. 1
      ASQ Yield Definitions
      Verified
      ASQasq.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

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