Cartridge Crimping 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 ID] The machine must effectively crimp cartridge seals to ensure product integrity. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] Crimp force must be adjustable within specified limits to accommodate various cartridge types. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] The machine must maintain an audit trail of crimping operations for compliance. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] Diameter of the crimp must be within specified tolerance levels to ensure seal effectiveness. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
See also  Jet Mill / Micronizer – PQ Protocol