Standardizing Best Industry Practices
Medical device companies require highly visible, timely and accurate manufacturing and quality management systems to maintain high-quality standards and meet rigid requirements. Effectively meeting ISO 13485, ISO 9001, FDA 21 CFR Part 11 and 21 CFR 820 compliance standards, and efficiently documenting Device Master Records (DMR) and Electronic Device History Records (eDHR) are imperative conditions for the success of manufacturing businesses and the continued prosperity of medical device manufacturers. Additionally, medical device companies must maintain Good Manufacturing Practices (GMP) through consistent training and con-tinuous quality improvements. Compliance should not be an afterthought for the quality department, but an integrated part of all business processes for internal op-erations and supplier management.
Electronic Record Collection
eDHR technology has long been predicted in the medi-cal device industry. FDA regulations encourage medimedi-cal device companies to harness the latest auto ID and data collection technologies to improve their delivery systems. Specifically, FDA regulations address electronic process-ing of printed materials used in production, product com-ponents, quality assurance, packaging, labeling, instal-lation, maintenance and services. These procedures are targeted because manual processes lead to endless paper trails. Not only does the continued use of paper require larger physical storage space, it also complicates data retrieval, creating a labor intensive and extensive system.
Make it Lean
It is necessary for medical device companies to apply lean concepts to their production cycles as well. With an emphasis on product lead-time reduction, com-panies must establish a real-time visibility system of their production shop floor. This new visibility reveals waste quickly and gives companies the opportunity to redesign the production flow. A lean manufacturing system will also help companies detect and address quality trends and other product issues promptly, which, in turn, will improve products’ time to market.
Ready for the New Workforce?
In preparation for the retirement of its most expe-rienced workers, medical device manufacturing facilities must leverage new technology to educate and assist new talent quickly. Facility managers also need to modernize shop floor practices, such as incorporating visual-training aids and best practices into intuitive work instructions. Technology alone won’t solve all of the workforce problems though. Companies need to capture the expertise and lessons learned from their most experienced employees to pass along to the new workers.
MEDICAL
DEVICES
Current market conditions have
created a highly competitive and
challenging environment for the
medical device industry. With
stricter FDA regulatory oversight,
increasing material costs and
rising off-shore competition, the
need to innovate, produce
high-quality devices and reduce the
time to market has never been
greater. Both medical device
and bioscience companies are
also looking for ways to improve
efficiency in their processes, and
remain competitive and compliant
with the various regulatory bodies
that govern the world’s markets.
In addition, like many American
industries, the medical device
industry is struggling to prepare for
the upcoming workforce turnover
as experienced workers retire.
Collecting All Available History
Solumina collects all eDHR as devices go through the production cycle, accu-mulating the device’s process and consumption history, including the materials, components and subassemblies used for each unit. A device’s eDHR is assembled in real time, which virtually eliminates
companies’ indirect cost of accumulat-ing and validataccumulat-ing this important data. Solumina’s strict adherence to data col-lection ensures that each device meets the highest quality standards and compliance regulations. Non-acceptable data, such as out-of-limit data collections or duplicate serial numbers, are immediately identified and resolved. The parts cannot be moved into finished goods inventory until all of the collected data are validated.
Implementing High-Quality Standards
Solumina’s robust Corrective Action and Preventive Action (CAPA) system allows companies to defend against regulatory scrutiny and avoid FDA warning letters. Solumina addresses the critical activities in CAPA, such as verifying or validating corrective and preventive actions, commu-nicating within the organization, provid-ing relevant information for management review, and documenting the activities essential to effectively manage product and quality problems.
Figure 1: Solumina excels in manufacturing complex, discrete medical devices.
SOLUMINA CAN HELP
Solumina’s ability to promote collaboration among engineering, quality and operations, integrate engineering data, and facilitate
lean manufacturing makes it an invaluable tool for medical device production. Constraints related to paper-based processes are
eliminated. Solumina provides real-time visibility to the shop floor and a real-time problem resolution system that extends into the
supplier network.
Ensuring Compliance throughout the Manufacturing Process
Solumina provides a complete work process and inspection management system that standardizes best-in-class quality management processes. These processes are tightly integrated with the production system to ensure the delivery of qual-ity products consistently and with confidence. Solumina’s process control and enforcement mechanisms also ensure full compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 11 and 21 CFR 820 regulations. Specifically, Solumina contains the required technical elements to comply with FDA 21 CFR Part 11 standards – a must for all software used to produce and manufacture quality medical devices.
Easy-to-Use Interface
Another benefit of using Solumina to manufacture medical devices is its ease of use on the shop floor. The software’s user interface includes all of the required information at the operator’s fingertips. Work instructions can be as simple as text or as sophisticated as 3D-model animations, videos and dynamic slide shows with built-in data collections and signature prompts. Additionally, the user interface is configured to display only the options required for the current job and provide speed buttons for the most-used commands. These are just a few of Solumina’s advanced features that reduce errors and create a lean environment.
Figure 2: Solumina is uniquely designed to manage the product lifecycle, beginning with a product’s design and process quality specifications into the supply chain, continuing with the manufacture of component parts, the assembly of the product, and the aftermarket service of each product unit until retirement.
Reduce Scrap and Rework
By identifying quality issues in real time, Solumina reduces scrap and rework. Solumina provides complete visibility into quality processes, storing all of the his-tory on each unit to be accessed at any time. The complete product genealogy ensures that each unit meets quality standards throughout the production cycle. Solumina also reduces process and product variability with its sophisticated sta-tistical process control (SPC) and CAPA features that alert operators of inconsis-tencies. Solumina’s true closed-loop system also provides real-time feedback to monitor a unit’s production.
Increase Time Operators Work with Tools
Solumina radically improves the efficiency of facilities’ shop floor. Operators spend more time doing the job they were trained to do, and less time looking for documents or waiting for corrections or repair instructions. Solumina’s enhanced work instructions greatly reduce learning curves and the potential for mistakes. Managers can also make quicker decisions and assignments using Solumina’s graphical view of the work schedule, resources and constraints. Additionally, all of the information required to do a job is displayed for the operator, including the latest version of drawings, specifications and parts. Operators are automatically alerted to conditions holding up a job with time-delay tracking.
Reduce Cost of Regulatory Compliance
Solumina provides a full audit trail of the work process from design to execu-tion and inspecexecu-tion, including unit history for the entire tree of subassemblies and components. By collecting these careful records, Solumina is able to meet the strictest process management and integrity requirements for the medical de-vice industry, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, 21 CFR 820 and 2011/65/EU standards.
ROI
iBASEt’s Solumina software substantially improves medical device facilities’ manufacturing environment in measurable ways. Facilities
can expect to see returns on their investments in a few months in multiple areas on the shop floor – from reducing scrap and rework
to shortening cycle times, while maintaining quality standards.
Figure 3: Orthopaedic production is an ideal avenue for Solumina because of its ability to manage thousands of product variations.
Faster Training for New and Current Employees
In Solumina’s paperless system, new and current employees are introduced to intuitive software that displays everything that they need to perform a job. Additionally, Solumina complements and easily integrates with engineering (CAD, PLM) and enterprise software systems (ERP), so administrative tasks are performed and submitted online, leaving operators with more time to perform and perfect the job they were trained to do.
Improve Quality
Quality issues impact the ability to meet schedule and cost objectives. Solumina provides reports and charts to view quality metrics and drill down into problem areas for more details. Solumina has also incorporated Six-Sigma process control and oversight into its software. Solumina identifies and removes the causes of defects, and minimizes manufacturing and product variability.
Shorten Cycle Times
Solumina harmonizes with CAD, PLM and ERP systems. This straightforward integration creates seamless coordination among all of the software systems and results in better coordination in the production flow. Companies will no lon-ger have to rely on a patchwork of legacy systems that involves countless hours of reconciling to make sure the correct data were used. To maintain constant visibility of the shop floor, Solumina also manages work in process through its production control information board. Shop supervisors and production schedulers will be able to take advantage of this board to view valuable informa-tion – such as order statuses, scheduled start and stop times and crews assigned – to make the most efficient use of production cycles. Minor adjustments to sched-ules can quickly and easily be made in real time from the screens, keeping the shop floor engaged and on schedule.
Figure 5: Solumina supports easy, online illustrated work instructions.
Figure 4: Solumina provides seamless control over manufacturing processes, your supplier network and full compliance.
Reduce Process and Product Variability
Solumina’s sophisticated CAPA system addresses key quality areas, including event management, risk assessment, root cause analysis, implementation and checking. All of the data and documentation tied to a product are tracked through-out the manufacturing process, making it easy to determine where a component was used and if that component met quality specifications. Solumina also moni-tors processes to identify the areas where enhanced work instructions are needed. Solumina also provides consistent process control by guaranteeing each operator meets certification qualifications, each tool used is properly calibrated, the lat-est process documentation is used, and the proper change procedures for process instructions are utilized.
Improve Product Warranty Recall
Solumina captures lots and serial numbers throughout the manufacturing process in case of a warranty recall. Effected products can be identified quickly by lot or impacted serials, greatly reducing the cost and time involved in a paper process.
Reduce Indirect Labor Costs
Solumina removes waste in the information flow throughout operations and the supply chain by eliminating procedures that are based on routing paper docu-ments. Solumina’s effective use of eDHRs streamlines both validation and col-laboration among the engineering, quality and operations departments. Because data are validated in real time, all of the wasteful hours collating and verify-ing DHRs are eliminated. With Solumina, changes in the work instructions are deployed to the shop floor in real time, ensuring the latest versions are used.
Figure 6: Solumina collects eDHR as devices go through the production cycle in real time, eliminating paper-related costs and dramatically reducing production times.
27442 Portola Pkwy Suite 300
Foothill Ranch, CA 92610
P: 877.422.7381 • F: 949.598.2600
www.solumina.com
Solumina is a revolutionary Operations Process Management (OPM) software suite that is uniquely designed to manage the product lifecycle for companies specializing in discrete, complex manufacturing. Solumina can function as a standalone solution or can be seamlessly integrated into Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) solutions, allowing users to capitalize on shop floor efficiency without sacrificing enterprise planning and execution capabilities.
Solumina also streamlines procedures essential to comply with process and quality management requirements in highly regulated industries, including medical devices, aerospace and defense, nuclear, industrial equipment and high-tech electronics.
