MedTech manufactured Class II medical devices under strict FDA regulations. Manual quality inspection was slow and subjective with paper records. Spreadsheet-based SPC couldn't detect real-time trends. 4.2% defect rate was unacceptable for medical devices.
Built custom platform (React + Node.js + TimescaleDB) integrated with inspection equipment. Dashboard showed real-time SPC charts for 250+ quality parameters. ML models detected anomalies and predicted out-of-spec conditions.
Quality dashboard transformed manufacturing from reactive to predictive. Real-time SPC detected process drift before defects occurred, reducing scrap from 4.2% to 0.67%. Automated documentation ensured FDA traceability. Root cause analysis cut MTTR from 18 hours to 2.5 hours. Achieved Six Sigma certification.
Automated data from measurement equipment updated SPC charts every 30 seconds. ±3 sigma control limits detected approaching out-of-control conditions. Western Electric rules identified patterns indicating process drift. Operators received instant alerts for adjustments before producing defects. First-pass yield improved from 95.8% to 99.33%.
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