Design & engineering

Requirements become a concept and then a basic design: process flows, room and pressure schemes, major equipment, and the first quality-risk assessments that identify what is critical to product quality.

Purpose

Turn user requirements into a design concept whose critical aspects are identified by quality risk before detail locks in.

Work performed

• Finalise the user-requirements specification (URS) as the design’s controlling document
• Develop process flows, room and pressure-cascade schemes, material and personnel flows, and major-equipment concepts
• Run the initial quality-risk assessment to identify critical aspects and critical quality attributes (ASTM E2500 / ICH Q9 thinking)
• Establish the contamination-control strategy concept and the classification scheme

Who is involved

• Process, facility, and automation design engineers
• Quality and the SMEs owning the critical-aspects risk assessment
• Operations providing flow, ergonomics, and operability input

What quality owns

• Approval of the URS and the risk-based identification of critical aspects
• The contamination-control strategy concept and the acceptability of the flow/segregation scheme

What engineering owns

• The concept and basic design — process flows, layouts, and major-equipment selection
• Translation of the URS into a technically coherent design concept

What operations owns

• Operability, material and personnel flow, and maintainability review of the concept
• The staffing and throughput model the layout must serve

Management decisions

• Approval of the concept/basic design and the capital it commits
• Trade-offs between capital cost and the flexibility or compliance margin of the design

Deliverables

• Approved user-requirements specification
• Concept / basic design package (flows, layouts, classification scheme)
• Initial quality-risk assessment and critical-aspects register

Evidence to retain

• The approved URS and its revision history
• The critical-aspects risk assessment that scopes later verification

Common risks

• Flow and segregation decisions that permanently cap contamination control
• Critical aspects not identified early, so verification is later mis-scoped
• A URS that is vague or unmaintained, breaking downstream traceability

Gate criteria to advance

• An approved user-requirements specification (URS)
• Concept/basic design with process, flow, and classification schemes
• Initial quality-risk assessment identifying critical aspects (ASTM E2500 thinking)

Expensive if deferred

• Flow, segregation, and classification decisions — fixed at concept and unaffordable to reverse later
• Critical-aspects identification — its absence mis-scopes every downstream qualification

Business effect

Concept decisions on flows and segregation set the contamination-control ceiling for the life of the facility; they cannot be cheaply undone later.

Greenfield vs brownfield

Greenfield concept design has full freedom over flows and classification; a brownfield concept must fit new flows into an existing shell and prove they do not compromise the segregation the facility already relies on.

Detailed design and specifications, with design review and design qualification confirming the design meets the URS and the critical design elements are addressed before construction commits.

Purpose

Complete and verify the design against the URS so that what is built is what qualification will be able to accept.

Work performed

• Produce functional specifications and detailed design (P&IDs, layouts, equipment/automation specifications)
• Hold formal design reviews and perform design qualification (DQ) confirming the design meets the URS
• Trace critical design elements back to the critical aspects identified at concept
• Freeze the design and place it under change control before construction commits

Who is involved

• Detailed-design engineering and specialist discipline engineers
• Quality performing/approving the design qualification and design reviews
• Operations and maintenance reviewing the detailed design for use

What quality owns

• The design-qualification decision — that the design satisfies the URS and its critical aspects
• Approval to freeze the design and the change control that governs it afterwards

What engineering owns

• The complete, coordinated detailed design and its specifications
• Resolution of design-review comments and closure of the DQ actions

What operations owns

• Confirmation the detailed design is operable and maintainable as drawn
• Sign-off on ergonomics, access, and maintenance provisions

Management decisions

• Approval of the frozen design and release for construction/procurement
• Any value-engineering changes and the re-verification they trigger

Deliverables

• Functional and detailed design specifications
• Design-review records and the design-qualification report
• Design traceability from URS → critical aspects → design elements

Evidence to retain

• The approved design-qualification record
• The design-basis documents and the traceability that supports qualification

Common risks

• A design frozen without design qualification, exporting gaps downstream
• Critical design elements not traced to critical aspects, so verification misses them
• Uncontrolled late design changes that break the as-designed baseline

Gate criteria to advance

• Functional and detailed design specifications complete
• Design review and design qualification records against the URS
• Critical design elements traced to the critical aspects from concept

Expensive if deferred

• Design qualification — a gap left in the design surfaces in C&Q at an order-of-magnitude cost
• Design freeze and change control — without them, construction chases a moving target

Business effect

A design frozen without design qualification exports its gaps into construction and C&Q, where they cost an order of magnitude more to fix.

Greenfield vs brownfield

Brownfield detailed design adds tie-in design and shutdown planning against live systems, and every design element is assessed for its impact on the existing validated state — a constraint greenfield does not carry.