Quality 4.0 is reshaping product development

Manufacturers need to stay ahead of the competition and leverage artificial intelligence (AI), machine learning (ML), augmented reality (AR), the Internet of Things (IoT), robotics, and other technologies aimed at improving how people, data, and devices interact. Quality 4.0 arises from Industry 4.0, also known as the fourth industrial revolution. Today’s fourth industrial revolutionary change is driving new quality paradigms, processes, and technologies.

Digital transformation

Industry 4.0 represents the dawn of digital transformation. The impact of digital data, analytics, connectivity, scalability, and collaboration are the drivers empowering this fourth industrial revolution and informing Quality 4.0 strategies. As we connect to people, devices, and data, the democratization of technologies is introducing transformative capabilities in analytics, material science, and computer science.

For highly regulated companies in high tech, consumer electronics, and medical device industries, such technologies empower a quality transformation of culture, leadership, collaboration, and standards. Quality 4.0 is reshaping device designs, functionality, manufacturing processes, supply chain strategy, customer service, and the methods of maintaining quality systems that are compliant with regulatory bodies like the FDA and ISO. Intelligent and connected technologies are rapidly becoming more widely used as manufacturers seek an advantage to introduce inventive products to market and leapfrog existing competitors.

Digital transformation trends have helped define Quality 4.0 strategies to eliminate reliance on disparate paper-based quality management systems and processes. The move away from manual systems reduces errors, silos, collaboration barriers, and traceability issues. Furthermore, the digitization and automation of design and production processes enables small and global companies to scale their design and supply chain processes quickly. In one example, RefleXion Medical, which provides biology-guided radiotherapy systems for cancer treatment, knew they needed to implement a completely connected QMS that could scale to support their path to digital transformation and improved compliance. They required a flexible platform that could grow with their team, products, and path throughout the quality compliance process.

Manufacturers’ ability to leverage Quality 4.0 technologies will be key to market success in the years ahead. LNS Research sees Quality 4.0 — the application of Industry 4.0 technologies to quality initiatives — as following in IoT’s path. And industry experts are seeing a huge drive in quality improvements coming from digital transformation. These same technologies are being used to design and deliver products. What does this mean for the manufacturing community?

Development gets more complex

Modern manufacturers rely on distributed teams and supply chains, including design partners, contract manufacturers, and tiered component suppliers to speed product development and launches. Companies that have embraced new technologies and cloud-based systems understand the unique benefits that digital transformation technologies can bring to a device manufacturer’s product requirements, product capabilities, and regulatory compliance objectives.

In the life sciences realm, digital therapeutics, medical diagnostic equipment, implantable devices and disposable devices are just a few of the wide array of devices that strive to be problem-free while delivering higher throughput and maintaining compliance.

Consumer electronic, medical device, and equipment manufacturers must overcome many challenges as they move from early concept and design through commercialization. Taking advantage of Quality 4.0 technologies can help at every stage of the new product development (NPD) and new introduction (NPI) process to deliver high-quality, safe devices and equipment. However, manufacturers are finding that Quality 4.0-influenced designs and quality processes can only be achieved by adopting a newer and higher standard for quality that is driven from leadership and embraced by everyone involved during the product realization journey.

Connected quality

To meet the demands created by Quality 4.0 trends, companies should adopt a more connected, or product-centric quality management system (QMS) approach. As complexity of products increases with AI, IoT, robotics, and related 4.0 technologies, quality teams must have a unified system to identify issues, address audits, and resolve quality incidents.

Older, antiquated document-centric QMS approaches create too many blind spots. Product-centric QMS is founded on maintaining the full, complex product design comprised of electrical, mechanical, and software components in a single system. This foundation allows for complete, connected quality and corrective action records with direct linkage to every aspect of the underlying product design. This connected methodology provides increased visibility and transparency as teams collaborate through each phase of NPD and NPI. Benefits from a product-centric QMS can be realized in areas such as audit readiness, requirements, design controls, training, supplier quality, and integration to upstream and downstream systems (e.g., CAD, ERP, CRM).

Furthermore, companies will gain competitive advantages by having more intelligence-driven product and quality process insights. This, in turn, will lead to better data-driven decisions and cross-functional visibility with quality, engineering, operations, and supply chain teams. These Quality 4.0 transformational technologies add complexity in meeting strict requirements.

To ensure compliance, a product-centric QMS solution makes it possible to:

• Create a completely connected quality and product process.
• Establish quality product processes to avoid audit issues.
• Ensure traceable design and change controls.
• Manage product bills of materials (BOMs) linked directly to quality records.
• Drive closed-loop quality and CAPA processes to faster resolution.
• Improve quality compliance and supplier management processes.

The last point about supplier management process is essential because the right QMS solution can unify quality and product record management to provide complete control and traceability, simplify audits, and decrease risks.

Product-centric QMS

In the case of satellite and communications provider Kymeta, they were able to improve their product quality with a connected quality system. Their complex products bring connectivity to cars, planes, boats, and much more–requiring multivariable analysis of product change processes across the global supply chain. Kymeta placed a priority on visibility of processes to better measure progress against company priorities. The ability to connect product and quality processes laid the foundation for further analysis. Using the Analytics capabilities, the team gained enhanced insights of all their quality and corrective action preventive action (CAPA) activities, particularly product change analysis during the critical new product introduction timeframe. With those added metrics and analysis, Kymeta has been able to drive continuous improvement during their new product introduction processes and reduce the time to launch new products.

And Swan Valley Medical, manufacturer of surgical instruments and accessories for application in the field of urology, implemented a product-centric QMS solution because they were burdened with inefficient paper-based manual processes that resulted in potential compliance exposure due to misplacing critical documentation. During audits, when missing or inaccurate information was found, it was difficult to recover and could take a couple hundred hours or even several months.

With a cloud-based product-centric QMS solution, accelerated root-cause analysis and risk management observation processes were implemented. This enabled different processes to call the other ones by having linked product and quality records to support audits with cross-linked evidence chains.

Innovation requires quality

As organizations embrace newer technologies like IoT, AR, and robotics, technology for product development and quality strategies needs to keep pace. Both large, established organizations and smaller innovators are racing to improve functionality by connecting people and data to deliver better-performing products around the globe.

The advances made with Industry 4.0 have helped drive Quality 4.0 technologies and strategies to improve quality compliance. The ability to align complex product development and quality processes is critical to compete in today’s global economy.

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