--- title: "Scrap Rate and Yield, Definition | MedTech Terms" description: "Production metrics tracking material loss (scrap) and the proportion of acceptable output (yield). Plain-English Manufacturing definition for MedTech teams, wit" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/scrap-yield#term", "name": "Scrap Rate and Yield", "description": "Scrap rate and first-pass yield are core operations KPIs that also signal process drift. 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By identifying trends and out-of-control conditions early, SPC helps prevent process drift and reduces the likelihood of producing nonconforming products, aligning with guidelines in ISO 13485:2016 clause 7.5.2, Control of production and service provision." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Scrap Rate and Yield [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply) # Scrap Rate and Yield Production metrics tracking material loss (scrap) and the proportion of acceptable output (yield). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Scrap rate and first-pass yield are core operations KPIs that also signal process drift. Spikes feed [CAPA](/terms/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](/terms/qsr), and EU [MDR](/terms/mdr-reporting) Annex I, [General Safety and Performance Requirements](/terms/gspr). Sustained deviations in these metrics can prompt regulatory scrutiny regarding process control, [design transfer](/terms/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 How do scrap rate and yield relate to design transfer? Scrap rate and yield are key indicators of effective [design transfer](/terms/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. Can high scrap rates trigger a recall? What is the role of statistical process control (SPC) in managing scrap rate and yield? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Nonconformance (NCR)(NCR) Failure of a product, process, or system to meet specified requirements. ](/terms/nonconformance) ### More in Manufacturing · Same category [ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom)[ Manufacturing Bioburden Quantification of viable microorganisms on or in a product before sterilization. ](/terms/bioburden)[ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644)[ Manufacturing Container Closure Integrity(CCI) Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life. ](/terms/container-closure) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ASQ· 1 ISO· 1 IMDRF/GHTF· 1 1. [1 ASQ Yield Definitions Verified ASQ · asq.org ](https://asq.org/quality-resources/) 2. [2 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) 3. [3 GHTF/IMDRF Process Validation Guidance Verified IMDRF/GHTF · imdrf.org ](https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Manufacturing Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=scrap-yield) Learn in 60 seconds Card Lesson Quiz Production metrics tracking material loss (scrap) and the proportion of acceptable output (yield). - · Quality teams should treat sustained yield decline as a leading indicator of nonconformance trends, not just a financial issue. - · Spikes feed CAPA, supplier-quality investigations, and process-validation re-evaluation triggers. Remember this Watch out: Treating scrap rate and yield solely as financial metrics overlooks their significance as quality indicators. Related terms - [Nonconformance (NCR)(NCR) ](/terms/nonconformance) You may also need Auto-suggested from Manufacturing and shared keywords. - [MRP and ERP Systems(MRP / ERP) ](/terms/mrp-erp) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Device History Record(DHR) ](/terms/dhr) - [Device Master Record(DMR) ](/terms/dmr) - [Process Capability (Cp/Cpk) and SPC ](/terms/spc-cpk) - [Process Capability and Cpk ](/terms/process-capability-cpk) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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