The manufacturing industry continues to evolve toward the fourth generation of the industrial revolution. Industry 4.0 has arrived for those at the leading edge of manufacturing, as terms such as “Integration, Automation, Real-Time Data, Smart Factories, AI, and Digital Enterprise,” are becoming commonplace in manufacturing articles, websites, and boardrooms throughout the globe.
As this revolution continues to evolve (a Revolution Evolution, if you will), it is expected that Medical Device Manufacturers will be a highly involved force for change. For any medical device organization still manufacturing and processing with paper, it may be time (actually it IS time) to consider jumping into the wave of digital transformation.
Paper deserves credit for modernizing the sharing of information throughout the ages. Paper in the modern factory, however, is quickly becoming obsolete. If an organization still utilizes paper as the primary driver of their processes, they have certainly experienced several pain points, including security issues, labor inefficiencies, regulatory challenges, and the extreme cost of paper purchase, use, and storage. On the digital side of manufacturing, paperless environments created through the implementation of a Manufacturing Execution System (MES) realize a high level of return on investment (ROI) through improved regulatory compliance, better agility and time to market, improved supply chain visibility, reduced manufacturing cycle time, elimination of paperwork and manual data-entry processes, reduced order lead time, lowered labor costs, reduced work-in-progress (WIP) inventory, and increased machine utilization. All of these factors lead to greater revenues.
According to a Patricia Panchak, MESA1 contributing writer and independent tech journalist, “As real-time data collection, integration, and analysis continue to become more critical to manufacturing business success, MES continues to evolve to address the challenge – and to become more integral to an overall smart manufacturing transformation. Put simply: MES has become a foundational element of smart manufacturing, [and] any company cannot create its digital thread or complete its smart manufacturing transformation without it.”2.
As MES (Manufacturing Execution System) implementation is the foundational element to smart factory transition, it’s important to look at the four stages of system implementation. Before we do so, however, it is important to note that Seabrook Technology Group looks holistically at the digital manufacturing enterprise, regardless of the phase of the MES transformation journey. We believe that people, processes and technology formulate the tenets of any digital transformation. We focus on the continuous coordination and alignment of these tenets to ensure the enablement of operations excellence and strategic transformation for our manufacturing partners (in other words, without the proper processes and people in place, the technology alone will not provide the solution sought by the manufacturer).
FOUR STEPS TO MES TRANSITION
MES IDEATION. In this phase, the MES vision formation occurs. The transforming organization must answer the following questions: “Is MES right for us? Is our business ready? Are our people ready? Where do we start?” This phase is critical to the long-term success of any MES transformation, and includes:
- Business Process Review and Readiness Analysis
- People Readiness (executive approval, stakeholders, etc.)
- Technology Readiness (IT landscape and system review)
- Transformation Readiness (business case, ROI analysis, manufacturing mapping)
MES DEFINITION. In this phase, the MES begins to be realized. An organization has formulated it’s MES transformation strategy and has the desire and goal of implementing the MES. Key elements to a successful implementation include:
- Alignment of manufacturing and supply chain processes
- Information flow definition
- Manufacturing KPIs
- Applications requirements (blueprint creation), evaluation and selection of the correct MES (we recommend Siemens Opcenter Execution Medical Device & DiagnosticsTM – formerly Camstar Medical Device Suite)
- MES Readiness preparation
MES DELIVERY. In this phase, the MES will be implemented, and the organization will begin to realize the benefits of MES. Specific steps include:
- Implementation and rollout strategy for product lines, areas, and factories
- Design, configuration, development, and deployment of MES
- Change management and training
- Validation methodology
Additionally, during the MES DELIVERY, solution tools can include: Business Process Analysis, People Process Analysis, Technology Analysis, and Transformation Analysis
MES OPERATION. In this phase, the MES has been implemented and is in “maintenance” mode. Don’t be fooled, however, as “maintenance” is an active term when used here. MES transition can never be implemented as “status quo.” It is important to understand that complete MES transformation and utilization is never fully complete, as it is not a project with a fixed project timeline, discrete set of deliverables and ultimate completion. MES transition and operation is a constantly-evolving, ongoing journey that includes:
- Building and improving governance and organization best practices
- Performance monitoring
- Maintenance support
- KPI monitoring and refinement
- Continuous improvements
As with the MES Delivery phase, solution tools can include Operations Management in the areas of Business, People, Technology, and Transformation. Examples of these tools would be continuous improvement analysis, future site readiness, managed services, KPI reporting and monitoring, and system roadmap reviews.
MES Implementation is an exciting process for the transforming factory that embraces the future of manufacturing. Transition – as with any change – can also cause feelings of anxiety and trepidation. However, our experience has been that companies utilizing MES quickly realize that the benefits outweigh the potential challenges. As it can be daunting to undertake such a transformation, it is recommended that any manufacturing entity considering such transition find a caring and dedicated solution provider to solve pain points and assist with MES implementation. For more information on MES Implementation Strategy and Solutions, please visit the “Services” tab at www.seabrookglobal.com. Best of luck to those who are beginning this MES journey – welcome to the evolution!
Questions about transforming your manufacturing to a digital environment? Let Seabrook help! Seabrook Technology Group celebrates its 30th year in 2019! Consisting of a team of global experts and industry thought leaders, Seabrook brings end-to-end manufacturing solutions (people, processes, technology) together in a harmonized fashion to enable operational excellence for medical device manufacturers. Our team consists of MESA Certified Consultants, a CamstarTM Certified Team, APICS, CPIM Certified Consultants, PMP Certified Consultants, and FDA Regulation Experts. Our entire team brings their passion for Integration, Manufacturing Intelligence and DHR Requirements skillsets to their work. Seabrook Technology Group is a global, privately held company which was founded in 1989.
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References and Resources:
- MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders, and solution providers who are focused on driving business results from manufacturing information.
- The State of MES in the Age of Smart Manufacturing. MES is Now (or Should Be) Viewed as a Foundational Enabler of Manufacturing’s Digital Transformation.” Patricia Panchak. In-Tech Magazine. www.isa.org/intech/20180805. July-Aug 2018.