Business Situation
A major device manufacturer had committed to a major MES project in conjunction with a new proprietary manufacturing process to be deployed in a new plant. This MES design would be a using a common best practice "Manufacturing Compliance Platform".
Program Description
The client recognized to need to employ key stakeholders and process owners from the engineering, operations, and IT portions of the business to develop a comprehensive set of user requirements. These requirements would represent the key capabilities and functions desired by the chosen software vendor to enable key strategic improvements in the process and allow for an Electronic Batch Record (EBR) solution.
Endeavor Involvement
Endeavor was retained to drive and manage the Blueprinting process by which the requirements would be developed. Through facilitating comprehensive interviews, and consensus-building workshops with cross-functional stakeholder representation, Endeavor developed key deliverables which served as a strong foundation for the design phase of the project. In addition to a validation level URS, several deliverables were developed including a dependencies and assumptions list, an ISA-95 analysis , and updated process maps which represented the new manufacturing process.
Business Benefit
The blueprinting deliverables and requirements provided an excellent detailed foundation of the capabilities required for the design and prototype phases of the project. With over 400 requirements which used the MES software package-specific terminology, and organization by manufacturing stage and function, the requirements were well structured to provide an solid input to the system's functional design. The key assumptions and dependencies underscored and formalized key points to either finalize open issues, or drive open action items required by other functions and initiatives.
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