Phase 1 Exit Study Guide

What is the purpose of Phase 1 Exit?

To determine whether a project is ready to move from evaluation and refinement into committed development and Design Control.

What is the central Phase 1 Exit decision?

Whether the project is ready for committed development, extended team resources, budget, and entry into Design Control.

What are the four Phase 1 Exit pillars?

Desirability, feasibility, viability, and the project plan.

What does desirability assess?

Whether the proposed solution addresses high-priority customer needs and is expected to create high customer impact.

What does feasibility assess?

Whether the proposed product, architecture, and core and secondary requirements can be successfully developed.

What does viability assess?

Whether the project offers sufficient return on investment, strategic alignment, or business value.

What does the project plan assess?

Whether the organization has credible objectives, schedule, resources, budget, ownership, and risk controls for the remaining development work.

What is the overall Phase 1 Exit confidence standard?

Good confidence in desirability, feasibility, and viability, with a credible development plan and no known outstanding showstoppers.

What is required to demonstrate desirability?

Thorough customer and user research showing that the proposed solution addresses high-priority needs and is expected to create meaningful impact.

What document is initially released to support market needs?

The Market Requirements Document, or MRD.

What should the desirability case identify?

The intended customers and users, their priority needs, desired outcomes, and the expected impact of the proposed solution.

What is the recommended desirability traceability chain?

Customer problem to proposed solution to expected impact to customer or business value.

What evidence may support desirability?

Customer interviews, workflow observations, jobs-to-be-done analysis, prototype evaluations, formative studies, modeling, and relevant field experience.

What should be understood about each customer need?

Who experiences it, what the problem is, its importance and frequency, and the outcome the customer wants.

What is MoSCoW prioritization?

A method for classifying scope as Must Have, Should Have, Could Have, or Won't Have.

What is a Must Have?

A capability required for the minimum credible product, launch proposition, or expected customer value.

What is a Should Have?

An important capability that provides meaningful value but may be treated as a secondary priority or fast follow.

What is a Could Have?

A lower-priority capability that is not required for the minimum product or launch.

What is a Won't Have?

A capability explicitly excluded from the active project scope.

What is required to demonstrate feasibility?

Good confidence based on prototype testing, evaluations, analysis, or other relevant technical evidence.

What areas must the feasibility case address?

Core requirements, secondary requirements, COGS, product architecture, draft Product Requirements, and showstoppers.

What evidence may support technical feasibility?

Prototypes, bench tests, simulations, analyses, user evaluations, system testing, and early reliability testing.

Does feasibility require a production-ready design?

No. It requires enough evidence to justify committing resources to the proposed technical direction.

What are core requirements?

Essential functions or characteristics needed to deliver the minimum acceptable product proposition.

What requirements document is expected at Phase 1 Exit?

Draft Product Requirements.

What is the purpose of draft Product Requirements?

To translate market needs into product-level capabilities and performance expectations.

What is the difference between the MRD and Product Requirements?

The MRD describes market needs and desired outcomes, while Product Requirements translate them into product-level expectations.

What should draft Product Requirements address?

Core and secondary requirements, interfaces, compatibility, safety, performance, and known areas of uncertainty.

What is a showstopper?

An unresolved issue that could invalidate the product concept, critical customer value, technical approach, business case, regulatory path, manufacturing approach, or development plan.

What should be recorded for each major risk?

Risk level, category, description, potential impact, mitigation or resolution, accountable owner, and relevant checkpoint.

Why are integration risks important?

Individually feasible subsystems may fail when their physical, electrical, software, or user interfaces are combined.

What should an integration strategy identify?

Major interfaces, cross-workstream dependencies, integration sequence, early prototypes, system testing, owners, and decision checkpoints.

What is the key principle of system feasibility?

Subsystem feasibility alone does not demonstrate system-level feasibility.

What is required to demonstrate viability?

Good confidence in sufficient return on investment, strategic alignment, business value, or an appropriate combination of these.

What should the business case address?

Market opportunity, pricing, revenue, product cost, margin, development expense, resources, cash flow, return, break-even, and strategic value as applicable.

Why must business-case assumptions be identified?

To distinguish supporting evidence from estimates, targets, sensitivities, and unresolved uncertainty.

What is sensitivity analysis?

Evaluation of how changes in assumptions such as price, volume, cost, or schedule affect the business case.

Why is COGS evaluated during Phase 1?

A technically feasible product may still be commercially impractical without a credible path to an acceptable cost and margin.

What should the Phase 1 COGS assessment include?

Preliminary targets, current estimates, major cost drivers, gaps, assumptions, and plans for reaching the business-case targets.

What manufacturing evidence is expected?

An initial NPI and manufacturing strategy covering process feasibility, DFM, DFA, DFT, tooling, testing, facilities, suppliers, scale-up, and major risks.

Why should NPI participate early?

Early involvement helps ensure that designs account for manufacturing, assembly, testing, tooling, scale-up, and production risks.

What supply-chain risks should be assessed?

Long-lead components, sole sources, limited supplier capacity, prototype-only processes, and non-scalable materials or manufacturing methods.

What should a Phase 1 reliability strategy include?

A current baseline, launch and long-term targets, relevant metrics, known failure modes, improvement projects, owners, and milestones.

What preliminary regulatory work is expected?

Identification of the likely pathway, intended markets, evidence needs, major uncertainties, evolving requirements, and planned regulatory interactions.

What human factors evidence may support Phase 1 Exit?

Early concepts, prototype evaluations, formative studies, workflow analysis, interaction assessments, and identification of usability risks.

What must the Phase 1 project plan include?

Objectives, schedule, resources, development-cost estimates, accountable leadership, workstreams, dependencies, development builds, and major risks for the remaining phases.

What is the overall standard for Phase 1 Exit approval?

Evidence-supported confidence that the project addresses important customer needs, is technically and economically achievable without known showstoppers, and has a credible plan for committed development and Design Control.