category,engineering_question,required_input,unit_or_format,evidence_class,acceptance_test
process_basis,What is the released batch and campaign basis?,batch size; recipe; yield; campaign count,declared basis,approved process record,Every quantity resolves to one batch and annual horizon
equipment,Does each step fit the available train?,working volume; minimum fill; pressure; temperature; materials,SI units,current equipment data sheet,All operating points remain inside qualified limits
occupancy,When is each asset unavailable?,setup; processing; hold; cleaning; changeover; maintenance,hours,site schedule or time study,No overlapping allocation of the same finite resource
rooms,Which rooms or suites constrain concurrency?,room class; occupancy window; segregation rule,time interval,site layout and operating procedure,Every operation has a feasible room assignment
utilities,Do peak demands fit the utility system?,steam; cooling; WFI; gases; power; waste,time series and SI units,meter data or approved design basis,Peak and recovery constraints pass with declared margin
materials,Can materials arrive and be stored when needed?,lot size; lead time; shelf life; storage volume,quantity and time,supplier and warehouse records,No stockout or storage overflow in the simulated horizon
labor,Are qualified roles available at critical steps?,role; shift calendar; task duration; concurrency,person-hours,staffing plan,Required skills are available without double booking
quality,Do sampling and release activities fit the plan?,sample point; assay time; release gate; failure path,hours,quality procedure,Holds and release dependencies are explicit
cleaning,Are CIP and SIP resources modelled as shared assets?,recipe; skid; return path; turnaround; verification,hours and utility profile,site procedure,Cleaning and production demands do not conflict
maintenance,Are planned and credible unplanned outages represented?,asset; interval; duration; recovery action,hours,maintenance history,Base and stressed schedules remain interpretable
capacity,What is the binding bottleneck?,throughput; utilization; queue; lateness; WIP,annual and time-series result,calculated model output,Bottleneck and lost-capacity mechanism are named
evidence,Can a reviewer reproduce the decision?,source; owner; date; version; assumption class,reference fields,controlled project record,Every material input has provenance and review status