Standardizing Best Industry Practices

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2 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 highquality 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. 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 continuous quality improvements. Compliance should not be an afterthought for the quality department, but an integrated part of all business processes for internal operations and supplier management. Electronic Record Collection edhr technology has long been predicted in the medical device industry. FDA regulations encourage medical device companies to harness the latest auto ID and data collection technologies to improve their delivery systems. Specifically, FDA regulations address electronic processing of printed materials used in production, product components, quality assurance, packaging, labeling, installation, 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, companies 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 experienced 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. 1

3 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. Collecting All Available History Solumina collects all edhr as devices go through the production cycle, accumulating 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 accumulating and validating this important data. Solumina s strict adherence to data collection 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, communicating within the organization, providing 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. 2

4 Ensuring Compliance throughout the Manufacturing Process Easy-to-Use Interface Solumina provides a complete work process and inspection management system Another benefit of using Solumina to manufacture medical devices is its ease of that standardizes best-in-class quality management processes. These processes use on the shop floor. The software s user interface includes all of the required are tightly integrated with the production system to ensure the delivery of qual- information at the operator s fingertips. Work instructions can be as simple as text ity products consistently and with confidence. Solumina s process control and or as sophisticated as 3D-model animations, videos and dynamic slide shows with enforcement mechanisms also ensure full compliance with ISO 13485, ISO 9001, built-in data collections and signature prompts. Additionally, the user interface FDA 21 CFR Part 11 and 21 CFR 820 regulations. Specifically, Solumina contains is configured to display only the options required for the current job and provide the required technical elements to comply with FDA 21 CFR Part 11 standards a speed buttons for the most-used commands. These are just a few of Solumina s must for all software used to produce and manufacture quality medical devices. 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. 3

5 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. 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 history 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 statistical process control (SPC) and CAPA features that alert operators of inconsistencies. Solumina s true closed-loop system also provides real-time feedback to monitor a unit s production. Reduce Cost of Regulatory Compliance Solumina provides a full audit trail of the work process from design to execution and inspection, 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 device industry, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, 21 CFR 820 and 2011/65/EU standards. 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. Figure 3: Orthopaedic production is an ideal avenue for Solumina because of its ability to manage thousands of product variations. 4

6 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. Figure 5: Solumina supports easy, online illustrated work instructions. Shorten Cycle Times Figure 4: Solumina provides seamless control over manufacturing processes, your supplier network and full compliance. 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 longer 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 information such as order statuses, scheduled start and stop times and crews assigned to make the most efficient use of production cycles. Minor adjustments to schedules can quickly and easily be made in real time from the screens, keeping the shop floor engaged and on schedule. 5

7 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 throughout the manufacturing process, making it easy to determine where a component was used and if that component met quality specifications. Solumina also monitors 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 latest 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 documents. Solumina s effective use of edhrs streamlines both validation and collaboration among the engineering, quality and operations departments. Because data are validated in real time, all of the wasteful hours collating and verifying 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. 6

8 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. More papers and resources available for download at the Library section of our website: Portola Pkwy Suite 300 Foothill Ranch, CA P: F: Copyright 2013 ibaset. All Rights Reserved.

The transition to a complete paperless system for operations process management will yield the following immediate benefits:

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