Front-end planning

The investment thesis, product and capacity requirements, and the first regulatory strategy. Decisions here — modality, make-vs-buy, target markets — set the compliance burden for everything downstream.

Purpose

Decide whether and why to build, and frame the regulatory and quality strategy before any money is committed to design.

Work performed

• Build the business case, capacity model, and target-market analysis
• Frame the regulatory strategy and applicable frameworks per market
• Set the make-vs-buy and technology/modality direction
• Define the high-level quality criteria the project will be judged against

Who is involved

• Executive sponsor and corporate development
• Regulatory affairs and the quality unit
• Technical operations and engineering leadership

What quality owns

• Regulatory-strategy input and the first quality criteria
• A veto on modality/market choices that cannot be qualified or inspected

What engineering owns

• Feasibility of the technology and capacity concept
• Rough order-of-magnitude cost and schedule for the technical scope

What operations owns

• The demand, capacity, and reliability assumptions the case rests on
• Input on operability of the proposed modality

Management decisions

• Go/no-go on funding the next phase
• Target markets, modality, and make-vs-buy

Deliverables

• Business case & project charter
• Regulatory strategy memo
• Quality project plan (first issue)

Evidence to retain

• The approved business case and charter
• The regulatory strategy of record

Common risks

• A modality or market chosen without regulatory input
• Optimistic capacity/demand assumptions never revisited

Gate criteria to advance

• An approved business case with a defined product, capacity, and target markets
• A first regulatory strategy naming the applicable frameworks and markets
• Quality represented in the decision, not consulted after it

Expensive if deferred

• Regulatory strategy — deciding markets late forces redesign
• Quality involvement — its absence here is the costliest gap of all

Business effect

The single highest-leverage phase: a modality or market choice made without quality in the room can make the whole asset expensive or impossible to qualify.

Greenfield vs brownfield

Greenfield frames a whole facility and site; brownfield frames a change to a licensed operation, so the case must weigh disruption to current supply.

Front-end loading (FEL/FEP): the basis of design, user requirements outline, cost and schedule ranges, and the contracting model. The project is shaped here before design detail is committed.

Purpose

Define the basis of design and the delivery model so design proceeds against agreed requirements rather than discovering them.

Work performed

• Develop the basis of design from the business case — capacity, product mix, and the quality target the facility must meet
• Draft the first user-requirements outline and the regulatory expectations design must satisfy
• Set the contracting and delivery model (design-bid-build, EPCM, integrated, or modular) and the vendor-documentation requirements
• Produce a class-appropriate cost and schedule range with the quality and verification scope included, not bolted on

Who is involved

• Project sponsor, project director, and front-end/FEL engineering lead
• Quality unit and regulatory affairs shaping the requirements basis
• Procurement and contracts defining the delivery and vendor model

What quality owns

• The regulatory and quality requirements the basis of design is built to
• Confirmation that the contracting model keeps vendor documentation usable as verification evidence

What engineering owns

• The basis of design and the technical assumptions behind the cost/schedule range
• Constructability and delivery-model feasibility for the technical scope

What operations owns

• Operability, maintainability, and capacity inputs to the basis of design
• The throughput and staffing assumptions the schedule rests on

Management decisions

• Approval of the basis of design and the funding class it supports
• The contracting and delivery model, and the risk allocation it carries

Deliverables

• Basis-of-design document
• User-requirements outline (first issue)
• Class cost estimate and project execution plan
• Contracting/procurement strategy

Evidence to retain

• The approved basis of design and execution plan
• The requirements outline of record and its regulatory basis

Common risks

• A basis of design frozen before quality has shaped the requirements
• A low-bid contracting model that omits documentation, FAT, and access rights
• Cost and schedule ranges that quietly exclude the C&Q and validation scope

Gate criteria to advance

• A basis-of-design document and initial user-requirements outline
• A contracting/delivery model that keeps vendor documentation usable for verification
• A defensible cost and schedule range with the quality scope included

Expensive if deferred

• Requirements definition — a requirement found in construction is the costliest change a project makes
• Documentation and FAT rights in the contract — impossible to add back once the deal is signed

Business effect

Front-end loading is where cost and schedule certainty are bought cheaply; requirements found late are the most expensive change a project makes.

Greenfield vs brownfield

A greenfield basis of design starts from the process and market; a brownfield one starts from the constraints of the existing facility and must protect its validated state and supply while the project is delivered.