Sigma Mixer / Kneader – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 The Sigma Mixer must achieve a blade speed of 100-300 RPM. M DQ-001 IQ-001 OQ-001 PQ-001 Blade Speed Calibration Record
URS-002 The mixer must maintain a temperature range of 20-80°C during operation. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Monitoring Log
URS-003 The vacuum must be maintained at a minimum of 500 mbar. M DQ-003 IQ-003 OQ-003 PQ-003 Vacuum Pressure Record
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