Guidelines for Process Safety in Outsourced Manufacturing, 2nd Edition

Outsourced manufacturing strategies can take many forms.  In simple terms, the outsourcing organization, or client, contracts with the contract manufacturing organization (CMO) to provide a product or an intermediate on their behalf.  In some cases, a contract organization may also develop the manufacturing process. Outsourced manufacturing can include custom and contract manufacturing, the development of processes, and toll manufacturing.  In some cases, brokers are used as intermediaries that connect clients with CMOs.  In all cases the potential relationships between clients, brokers and the various types of CMOs must be understood so that hazard recognition and risk analysis, and mitigation roles are assigned and executed to manage risk throughout the outsourced manufacturing process.  This book focuses on the outsourced manufacturing process and the roles the affected parties assume, and applies the elements of Risk Based Process Safety to minimize the potential of process safety events.

           Typically, the decision to outsource surfaces from a client need.  If a business case is made to outsource, steps are made to identify process safety information to clearly and concisely identify the potential hazards that CMOs must address in the process.  Affected parties in the process, such as brokers and CMOs are screened to ensure that the business and process safety needs defined by the client can be addressed and hazards managed.  A pivotal element is the technology transfer package which describes the hazards identified and risks assessed with outsourced manufacturing.  Identification of the roles and responsibilities for each stakeholder to address risk are clearly defined for a final assessment and contracts completion.  In addition, ten case studies are provided detailing how breakdowns in the transfer of information in the various outsourced manufacturing process steps and failure for affected parties to understand their role in the process have led to process safety incidents.” The process continues with first manufacturing runs followed by ongoing management of the manufacturing.  Clear definition and follow up on all aspects of Risk Based process for all affected parties are key to the success of the venture.  This book details each step of this process and the role of each affected party.

            In addition, this book illustrates how the twenty Elements of the CCPS Risk Based Process Safety (RBPS) management approach can be used as the framework for a consistent, structured method to safely execute outsourced manufacturing.  Case studies, examples, checklists and guides are provided. Complete references to additional CCPS risk based process safety materials are given to aid all stakeholders in understanding and executing their roles in the process.  (Note: Instructions on how to access the complimentary resources are provided in the book)

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.