Ribbon Blender – 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 Ribbon Blender must blend powders uniformly. M DQ-001 IQ-001 OQ-001 PQ-001 Blend uniformity report
URS-002 The equipment must operate at specified RPM for optimal blending. H DQ-002 IQ-002 OQ-002 PQ-002 RPM calibration records
URS-003 The mixing time must be adjustable and validated. M DQ-003 IQ-003 OQ-003 PQ-003 Mixing time validation report
URS-004 The equipment must have safety features to prevent over-mixing. L DQ-004 IQ-004 OQ-004 PQ-004 Safety feature inspection report
URS-005 The Ribbon Blender must be easy to clean and maintain. L DQ-005 IQ-005 OQ-005 PQ-005 Cleaning validation report
See also  Serialization & Aggregation System – Equipment Validation SOP