Guidelines for Process Safety in Outsourced Manufacturing, 2nd Edition

This book explores the various forms of outsourced manufacturing—including custom manufacturing, toll manufacturing, and process development—where clients contract with CMOs (Contract Manufacturing Organizations) to produce products or intermediates. Sometimes, brokers act as intermediaries between clients and CMOs. A central theme is the importance of understanding the relationships among clients, brokers, and CMOs to assign and execute hazard recognition, risk analysis, and mitigation responsibilities. The process begins with a client-driven need, followed by identifying process safety information and screening potential partners to ensure safety and business requirements are met. A key tool is the technology transfer package, which outlines hazards, risks, and stakeholder responsibilities.

The book emphasizes the importance of clearly defined roles and ongoing management throughout the manufacturing lifecycle to prevent safety incidents. It uses the CCPS Risk Based Process Safety (RBPS) framework—comprising 20 elements—as a structured method for safely managing outsourced manufacturing. Case studies, examples, checklists, and references are included to guide stakeholders in fulfilling their roles effectively.

Note: Prior to the publication of the book, CCPS will issue a monograph (Book Summary) that will be accessible to all, serving as a complement to the book. Please check back for more information.