In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. That’s why meeting FDA requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical.
The Digital Thread integrates design, engineering, manufacturing and MRO (maintenance, repair and overhaul) systems, establishing a seamless flow of information. This type of integration employs data and analytics across the complete product life cycle, optimizing efficiency, from design to manufacturing, operations and maintenance to service in a closed loop.
Operational challenges include disparate systems and data sources, ineffective measurement of quality metrics, and the departmentalization of quality (i.e., quality understood as a department, not an organizational responsibility).
Leveraging a framework for the Digital Thread allows you to streamline shop floor and supplier operations with existing machine communication technology. This Industry 4.0 Framework is the answer to controlling and optimizing your Complex Discrete Manufacturing Environment.
Over the past few years, customers across all industries have demanded higher quality from manufacturers. Couple that with the evolving quality standards and your company’s task to uphold quality products becomes an ongoing challenge.
As such, MES is not a casualty of the advent and development of smart manufacturing, but rather one of its most essential enablers, a stepping stone on the path that all manufacturers must go down to succeed in today’s marketplace.
“We selected iBASEt because of their experience in managing the complex processes involved in manufacturing highly engineered products,” says Todd Kackley, Vice President and Chief Information Officer at Textron Systems.
With over three days of keynote presentations from international industry experts, networking opportunities and an immersive “Innovation Pavilion,” this conference will enable attendees to discover new and innovative ways to work smarter.
Overall, the aerospace manufacturing industry is beginning to ramp up in 2016. In last year's Roundup of Aerospace Forecasts and Predictions, 2015, the experts were more optimistic about the aerospace growth, but in reality, the growth has been slow. It seems we are in the midst of a transition phase and will see significant growth starting late this year or next year.
iBASEt, the creators of Solumina, a fully integrated software suite for manufacturing process planning, execution and enterprise quality management, announced today their continued contribution to the manufacturing industry’s Smart Manufacturing initiative.
Kicking off the first session in MESA’s Smart Manufacturing track at the Manufacturing & Technology Conference, iBASEt lead an interactive presentation explaining the current landscape of Smart Manufacturing, and the barriers businesses face to achieve this type of connected environment.
Much has been talked about regarding the concept of “Smart Manufacturing,” however this concept was in full display at Hannover as much of the integration was complete with data analysis and the digital thread.
The worst part of a software roll-out is documenting what you did. In this process-centric manufacturing world, documentation is something you have to do, your last resort, your anything-but-go-to source.
Your Bill of Materials (BOM) and process plans are fully developed, and now your team of experts are able to get to work, and bring your design to life. Unfortunately, as your project grows, so does the amount of paperwork necessary to get the job done and ensure quality and compliance.
The 2016 Manufacturing & Technology conference and Expo will be co-located with the MESA International Conference at the Donald E. Stephens Convention Center. With over three days of keynote presentations and networking opportunities, these conferences will focus on uncovering the latest transformative technologies enhancing best practices in Lean, quality management and continuous improvement.
In today’s highly competitive, fast-paced medical and diagnostic device industry, manufacturer’s often struggle to find the right time to shift away from their costly, inefficient and error-prone processes, such as assembling a DHR (Device History Record) from multiple paper and spreadsheet sources.
Selecting a Manufacturing Execution System (MES) is an intimidating task, especially if it means your reputation is on the line. With impending project proposals and a need to compete in today’s competitive manufacturing industry, your company can’t afford to make the wrong decision.
Most of our process planning authors have never taken a course or have read information about writing work instructions. Technical writing is a very different type and style of writing. More specifically, it is an abbreviated type of writing.
iBASEt announced today that they will host an educational webinar on March 8, 2016, to help complex discrete manufacturers navigate through their Manufacturing Execution System (MES) selection process.
Manufacturing Execution Systems automation software helps manufacturing industries to improve operational performance by automating, executing, and managing various processes. The rising demand for mass production in various industries in the EMEA region has led to the surge in adoption of Manufacturing Execution Systems software.
In order to stay competitive in today’s fast paced manufacturing industry, manufacturers must evolve beyond simply tracking defects, failures and corrections, and start integrating quality management practices that prevent errors.
Manufacturers have the unrelenting need to innovate and create products faster with higher levels of quality. A major problem that stands in the way of accomplishing these goals are the preexisting silos throughout the product lifecycle value chain.
Last week, we had the opportunity to exhibit at AeroDef 2016 Manufacturing Expo and Conference in Long Beach, California. Exhibitors and attendees arrived to AeroDef from across the country, some even traveling from overseas seeking aerospace and defense visions and innovations.
Recently, I was involved in a sales call with a major medical device manufacturer. While exchanging goodbyes, the EVP said, “This implementation has to work.” For prospective buyers those words seem to be all too common.
Earlier in the implementation, BAE Systems initiated a project to harmonize operations process management across its Electronic Systems’ manufacturing facilities, utilizing Solumina’s process planning, manufacturing execution, and enterprise quality management tools.
On September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.
Taking the time to do proper risk management, identifying and mitigating risks, can protect the organization from unnecessary costs and heartache. In this post, you will find key risk factors that you must understand in both approaches to ensure a smooth path to implementation.
“For aerospace and defense manufacturers to stay competitive in the 21st century, the urgency of enabling the digital thread, incorporating new processes, consolidating disparate systems and technologies are critical to their continued growth and scalability,” said Vic Sial, President, iBASEt.
January 19, 2016
iBASEt Discusses Digital Thread to Manufacturing at AeroDef 2016
iBASEt Discusses Digital Thread to Manufacturing at AeroDef 2016