PROCESS INFORMATION. Process information is traced to all levels of Manufacture. At a minimum, this includes operator performing the operation and date performed, shift (as applicable), Manufacturing instructions used, use of Validated equipment and identification of equipment used, BOM/design revision and configuration, resolution of any discrepancies, and Record of any rework performed.
Appears in 2 contracts
Sources: Exclusive Lead Sharing and Distribution Agreement (Mazor Robotics Ltd.), Exclusive Lead Sharing and Distribution Agreement (Mazor Robotics Ltd.)
PROCESS INFORMATION. Process information is traced to all levels of Manufacturethe Supplier’s assembly. At a minimum, this This includes identification of the operator performing the operation and operation, date identifying shift or time performed, shift manufacturing instructions (as applicable), Manufacturing instructions including revision level) used, use of Validated equipment and identification of relevant equipment usedused with traceability to equipment validation and calibration status, BOM/design revision and configuration, identification and resolution of any discrepancies, and Record record of any rework performed.
Appears in 1 contract
Sources: Supplier Quality Agreement