Category	Subcategory	BioMRL1	BioMRL2	BioMRL3	BioMRL4	BioMRL5	BioMRL6	BioMRL7	BioMRL8	BioMRL9	BioMRL10
TRL		TRL1	TRL2	TRL3	TRL4	TRL5	TRL6	TRL7	TRL7/8	TRL8/9	TRL9
F. Process Capability and Control	F.1–Modeling and Simulation	Scale-down models and simulation approaches and tools identified to support manufacturing and quality activities. Relevant mass and energy balances identified.	Scale-down models and simulation in development initiated. Detailed mass and energy balance equations developed.	Manufacturing and quality gaps for system concepts identified using simulation and laboratory experiments utilizing scale-down models.	Scale-down models and simulation tools utilized to define manufacturing and quality requirements for preferred materiel solution. Laboratory experiments and simulation results considered in the AoA.	Initial scale-down models and simulations (product or process) developed for each unit operation and used to determine constraints. First systems implemented to facilitate routine monitoring of mass and energy balances.	Revised scale-down models and simulations developed for each unit operation and used to refine system constraints. Initial scale-down data review and release processes utilizing control charts are formalized.	Simulations and laboratory experiments utilizing scale-down models used to determine system constraints and identify improvement opportunities.	Scale-down models and simulations verified by production line build. Results used to improve process and determine that LRIP requirements can be met.	Scale-down models and simulation verified by LRIP build, assists in management of LRIP, and determines that FRP requirements can be met.	Scale-down models and simulation verified by FRP build. Production simulation models used as a tool to assist in management of FRP.
	F.2–Manufacturing Process Maturity	Hypotheses developed regarding cause–effect relationships between process variables and process stability and repeatability. Failure Modes and Effects Analysis (FMEA) conducted to estimate Risk Priority Numbers (RPNs)	Studies performed to test high-RPN hypotheses regarding cause–effect relationships. Initial process approaches identified.	Cause–effect relationships between process control variables and process stability and repeatability validated through laboratory experiments. Critical process control variables identified.	Maturity of critical processes for preferred materiel solution assessed. Process capability requirements and improvement plans developed and documented in the SEP.	Process Maturity assessed on similar processes in production. Process capability requirements identified for production line, LRIP and FRP. FMEA revisited and RPNs revised.	Manufacturing processes demo'd in production relevant environment. Collection or estimation of process capability data from prototype build and refinement of process capability requirements initiated. Work to mitigate high-RPN failure modes ongoing.	Manufacturing processes demonstrated in a production representative environment. Collection and/or estimation of process capability data and refinement of process capability requirements ongoing. Work to mitigate high-RPN failure modes concluded.	Manufacturing processes for LRIP verified on a production line. Process Capability data from production line meets target. Process capability requirements for LRIP and FRP refined based upon production line data.	Manufacturing processes are stable, adequately controlled, capable, and have achieved program LRIP objectives. Variability experiments conducted to show FRP impact and potential for continuous improvement.	Manufacturing processes are stable, adequately controlled, capable, and have achieved program FRP objectives.