TGFR Consulting LLC System Realization begins following the deployment of the design inputs to the subsystems. The following table describes the inputs and outputs of the realization process
| Inputs | Key Activities | Outputs |
|---|---|---|
| System Transfer Functions The details of the interrelationships between requirements, the transfer functions. Workflow Diagrams The details of the workflow and subsystem interactions. Design Worksheet The details of how the system design inputs and subsystem requirements interrelate N2 Chart The details of the subsystem interactions Subsystem Requirements The subsystem requirements System Use Cases Workflows, both primary and secondary System Requirements The Design Inputs | Subsystem Development The development of the design, manufacturing and service procedures Subsystem Integration The planning and execution of the integration between subsystems Subsystem Integration The planning and execution of the integration between subsystems Manufacturing and Service Design The processes used to manufacture and service the product Process Characterization The characterization of the manufacturing and service procedures System Verification The verification that the design inputs meet the design outputs. Regression Development Response to the issues uncovered in verification | System Design The design (including software) for the system Manufacturing Design Manufacturing Procedures and test methods. Service Design Service Procedures and test methods. Verification Results The objective evidence that the system design meets the Design Inputs Process Characterization Results The objective evidence that the process can produce the finished device |
The following summarizes the activities involved in system realization
- Subsystem Development – this involves the development of the subsystem and the associated test methods.
- Subsystem Integration – the focus here is on the piecewise integration of the system, relying on the worksheet and transfer functions to dictate the staging and integration steps
- Manufacturing and Service Design – the interaction with the Development through test methods and the system design
- Process Characterization – this identifies which processes require verification and which require validation (this will help considerably during the process qualification)
- Verification – the final confirmation of requirements and use cases. This is closely linked to the subsystem deployment (section 4.1)
- Regression Development – the incremental adjustments conducted as a result of verification. Again, the subsystem deployment (section 4.1) is critical to the effective execution of regression and associated development
The following figure shows the relationship of these activities
