Overview of the Outsourced Manufacturing Workflow

This chapter summarizes the staged flow of work activities from the decision to outsource manufacturing activities to the conclusion of the outsourcing relationship. The activities focus primarily on managing process safety hazards and risks, with limited discussion of managing other HSE disciplines. The chapter summarizes a typical workflow for an OMP, including typical recycle paths. The steps for an OMP includes: develop and validate the business case for outsourcing, complete applicable R&D, perform initial screening of CMs and brokers, select broker and CM, perform technology transfer, perform final assessment and implement manufacturing contract, pre-startup activities and first run, and managing process safety in contract operations. The underlying principle of RBPS is that the manufacturer manages its process safety risk to meet risk tolerance criteria that have been developed and approved by company leadership.