What usually happens after starting up a new plant?

• New facility has been delivered on time.

• The risk of not reaching 100% throughput and planned yield is high due to lag phase.

• Losses in process/technical excellence and GMP Compliance must be recovered later at high cost.

As-Is Situation 

• CAPEX team (inhouse/contractor) is fully focused on its targets to deliver a working facility with finished OQ/PQ on time, and leaves when they are reached
• OPS, QC/QA, technical services and automation are faced with multiple challenges e.g. parallel workstreams with minor coordination
• Lack of communication leads to losses in data, know how and expertise
• Lag phase and delays in reaching 100% throughput and planned yield is often standard
• Losses in process/technical excellence and MP Compliance must be recovered later at high cost

Elements

• Oversight and gap analysis of transition elements e.g. facility ops, validation, automation, maintenance, logistics, regulatory affairs, personnel, OPEX
• As-is analysis and to-be set-up of the transition planning, tracking, and monitoring system (transition framework)

• As-is analysis and to-be set-up of necessary modus operandi including communication/governance/decision-making between triangle Engineering, OPS and Quality (transition framework)

• Tactical implementation plan including tracking and automated monitoring system

Goals & impact

• Friction free hand-over from CAPEX to OPS team – seamless interfaces and information flow

• Clear roles & responsibilities and transparent decision-making

• Improvement of communication between Engineering, OPS and Quality – key factor to success
• Faster to continuous production at planned vields
• Reduction of total cost of ownership