Crimping Machine (Pump Fixing) – 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 Ensure the crimping machine applies the correct crimp force for pump fixing. H DQ-001 IQ-001 OQ-001 PQ-001 Crimp Force Audit Log
URS-002 Verify the torque applied during the crimping process is within specified limits. H DQ-002 IQ-002 OQ-002 PQ-002 Torque Audit Trail Log
URS-003 Document all audit trail logs for crimping operations. M DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Record
URS-004 Ensure the machine is calibrated and maintained according to the schedule. M DQ-004 IQ-004 OQ-004 PQ-004 Calibration Certificate
URS-005 Confirm that the machine operates without errors during production runs. L DQ-005 IQ-005 OQ-005 PQ-005 Error Logs
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