Abbott Project Management Playbook

DEFINITION: What is Detailed Design? Detailed Design typically occurs after FEP concept design (10%) and preliminary design phases (30%), at the conclusion of FEP and following RCE approval. This phase includes 60% and 90% design reviews, and final design approval. This is a critically important phase of the project as approval of final design solidifies design requirements and specifications, which will drive acceptance criteria. Elements/Process/Details

Deliverables/Output/Next Steps 60% Design Review During this review, drafts of the following items should be covered in detail:

• Basis of Design Elements: Process Flow Diagrams, P&IDs, Equipment Layouts, Equipment Utility Demands, Utility Tie-in Points, GMP Zoning Map with Room Class, HVAC Design Parameters, Mass Balance and Capacity Calculations, DOH • Integrated Schedule Review • Design Qualification Deliverables o User Requirements Specification (URS)

o Functional Requirements Specification (FRS) o Failure Modes and Effects Analysis (FMEA) o Project Validation Plan (PVP) o Basis of design (BOD)

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