Quality teams often think of their role as different and separate from product development. However, in today’s increasingly complex medical device market, a product-centric approach to quality management is fundamental to delivering high-quality devices.
Next-level proactive quality management processes requires a closer connection between product development and quality teams to address potential quality issues and develop compliant processes. This connection improves collaboration, while fostering a smooth and innovative product development process between teams to ensure that safer and more reliable devices get to market on time.
Here, we highlight keys to success to help quality teams escape the siloed mentality and better adhere to compliance standards.
Complex products require connected quality management processes
Medical device companies that make products comprised of a variety of electrical, mechanical, and software components must align quality system records with the complete product record throughout the new product development and introduction (NPDI) process. To prevent siloed designs and interoperability problems, each engineering team must bring the various aspects of design together so devices work as designed. Having a single, controlled system for quality and product development helps all key stakeholders collaborate more effectively and transparently.
Connected quality management not only provides a more comprehensive picture of the product design and related quality issues, it creates a traceable audit history of each revision in context with direct links to quality records. This is especially important as complex medical device manufacturers must manage many internally designed assemblies to function with externally supplied parts. Managing quality issues for multiple product lines, versions of the same product, and suppliers is simpler when you have a product foundation based on the bill of materials (BOM). This allows every impacted team optimal visibility and access to information to help engineering, purchasing, quality, and manufacturing teams introduce products and enhance regulatory compliance.
Ultimately, a product-centric approach recognizes that quality is important beyond just compliance. Connecting quality with product design and development history helps promote continuous improvement. Additionally, a single system captures key decisions by all impacted teams, making it much easier to design new products while responding to audits with confidence.
Quality management depends on accurate, comprehensive data
To improve visibility of quality issues and streamline investigation of root causes, medical device companies need a persistent product record linked to nonconformances and other audit findings. If data is stored in static paper-based or document-centric quality systems that are siloed from product design and development, it’s much harder to find and correlate which designconfiguration relates to each quality record or issue.
Linking product development to key quality processes like corrective and preventive action (CAPA) reduces resolution cycle time, while allowing disparate teams to work more efficiently with a single source of truth. Furthermore, by managing the product development process in context with quality, teams have more information to gain insights to analytics throughout the product lifecycle.
Superior Quality management processes require cross-functional collaboration
Quality teams cannot work in a vacuum when dealing with complex medical devices—they must interact with many internal departments and external teams. With globalization on the rise, these teams are also comprised of supply chains that include contract manufacturers, component suppliers, and more. With the increased complexity of both medical devices and their product teams, effective communication and teamwork is imperative for compliance and innovation.
Despite industry and technological advancements, many companies continue to rely on a variety of point solutions like shared drives, spreadsheets, and email to manage quality and product records, as well as tribal knowledge to transmit information. These manual and outdated approaches not only reinforce the inherently siloed nature of product and quality teams, but are also dangerously disconnected from the product record.
Removing old-school paradigms in which quality teams use manual systems disconnected from product development is the best method for creating transparent and traceable processes. When quality records are connected to the product record, the result is a shared, controlled, and unified view throughout the NPDI process. This fosters effective collaboration and faster iterations to deliver high-quality products on time and under budget.
How Arena helps unite product and quality
Arena QMS is built on the principle that product and quality management should go hand-in-hand to speed product development and streamline regulatory compliance. To do this, Arena provides a single product-centric QMS solution to connect all quality processes with direct links to the affected aspects of the product record and multi-level BOM. This approach makes it easier for medical device manufacturers to collaborate quickly and effectively with everyone in the supply chain from early development through to product launch.
Are you interested in learning more about the role a product-centric approach plays in quality management? Download our 7 Principles of Product-Centric Quality Management eBook today.