Patch Leak Test Machine – 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 Verify that the Patch Leak Test Machine can detect leaks at specified sensitivity levels. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail Log [Result Placeholder]
URS-002 Ensure the machine maintains an audit trail for all leak tests performed. M DQ-002 IQ-002 OQ-002 PQ-002 Audit Trail Record [Result Placeholder]
URS-003 Confirm that the machine operates within the specified leak rate parameters. H DQ-003 IQ-003 OQ-003 PQ-003 Test Results [Result Placeholder]
URS-004 Validate that the machine’s performance is consistent across multiple test runs. M DQ-004 IQ-004 OQ-004 PQ-004 Performance Data [Result Placeholder]
URS-005 Ensure that the machine is calibrated according to specified intervals. L DQ-005 IQ-005 OQ-005 PQ-005 Calibration Records [Result Placeholder]
See also  Vision Inspection System – PQ Protocol