Tube Sealing Machine (Hot Air/Ultrasonic) – 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 machine shall maintain the seal temperature within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log
URS-002 The machine shall apply the correct pressure during sealing. H DQ-002 IQ-002 OQ-002 PQ-002 Pressure Log
URS-003 The machine shall maintain the specified dwell time for sealing. M DQ-003 IQ-003 OQ-003 PQ-003 Dwell Time Log
URS-004 The machine shall have a reject mechanism for non-conforming seals. M DQ-004 IQ-004 OQ-004 PQ-004 Reject Log
URS-005 The machine shall maintain an audit trail of all operations. L DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Report
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