Project Profile
Strategic Enterprise Asset Management Implementation for Bulk Cell Manufacturing Sites
#1
Perform detailed Enterprise Asset Management (EAM) assessments of the maintenance and reliability practices of multiple bulk cell culture manufacturing sites
#2
Develop and implement maintenance best practices
Project Overview
Over the years, GenesisSolutions (Genesis) has developed a longstanding relationship with a global biotechnology company. Through collaboration, Genesis has become a trusted advisor to this company's leadership and management teams within the manufacturing network.
Genesis was selected to be the implementation partner for the client's World Class Maintenance initiative, designed to implement maintenance best practices, including:
- Reliability-Centered Maintenance (RCM)
- MRO Inventory Optimization
- Preventive Maintenance (PM) Optimization
- Planning and scheduling
- Job plan task development and best-practice utilization of their current Computerized Maintenance Management System (CMMS) Infor10 (now HXGN)
Client Needs
- Assess maintenance and reliability posture
- Determine the manufacturing site's top vulnerabilities
- Create a roadmap to address identified vulnerabilities
Our Solution
Conduct Enterprise Asset Management (EAM) Assessments
Genesis performed detailed EAM assessments of the maintenance and reliability practices of bulk cell culture manufacturing sites located in Raleigh, North Carolina, Boston, Massachusetts and Hillerod, Denmark. The detailed assessments were based on our proven methodologies, which provided this company with a detailed gap assessment and cGMP compliance risk level ranking of their global and site-specific Maintenance and Reliability Engineering Programs. The outcomes of the assessments were compiled into a finalized report inclusive of a detailed heat map that revealed the strengths and opportunities within the global manufacturing network.
Develop an Implementation Roadmap
Detailed implementation plans were developed with the leaders of Maintenance and Reliability engineering for the global network to address immediate risks and long-term improvement needs. We facilitated the development of the cost justification, rationale and benefits realization plan that was presented to the officers of the company to secure funding for global improvements and risk mitigation.
Additionally, during the assessment process for the bulk cell culture manufacturing plants, our client purchased an Oral Solid Dose (OSD) facility and requested that this site be assessed as well. During the assessment process, it became apparent that the OSD Site needed immediate attention to bring it up to speed to ensure the facility's licensure met its target date. We created a critical path implementation plan that addressed this facility’s Maximo and CMMS data migration into our client's Info10 CMMS System, along with performing Asset Criticality Ranking of all Systems, Equipment and Instrumentation, and the development of their MRO Spares Program, Storeroom Buildout, Critical Spares identification and PM Optimization.
As an outcome of these efforts, our client successfully integrated the OSD facility into their manufacturing network and met the requirements for facility licensure without observations from the regulatory auditors.
Value Delivered
Overall, throughout our engagement with this major biotechnology company, GenesisSolutions provided the client with a better understanding of their strengths and opportunities within the global manufacturing network and developed detailed multi-year improvement plans to reduce the levels of risk to acceptable thresholds and improve upon the network’s maintenance and reliability programs effectiveness.