“If you build it, he will come.”
The immortal words uttered by actor Kevin Costner in the 1989 baseball drama “Field of Dreams” also ring true in the manufacturing world. The “it” in this case is the limitless forms of advanced technology (AI, blockchain, the internet of things and the cloud, just to name a few) that are rapidly changing the way companies do business and manufacture products. The “he” is the digital transformation, the global movement toward leveraging these new technologies for more efficient, seamless and data-driven production operations.
Fast-forward to 2020, and the “it” has been built, the fourth industrial revolution (Industry 4.0) is here, and the “he” — digital transformation — is no longer just a trade buzzword. Manufacturers, including life sciences companies, are embracing the new normal of using tech to achieve greater data-driven operational efficiencies and speed to market. Quality 4.0, which aligns quality management with Industry 4.0, should be a high priority for quality leaders. Connected systems and advanced technology solutions provide life sciences companies with the digital tools they need to conduct in-line quality assurance for closed-loop, proactive quality management.
However, an LNS Research report indicates that while 38% of life sciences companies have started the Quality 4.0 journey, nearly 84% are still in the pilot phase.(1) That’s a higher percentage than the market at large. A successful strategy and implementation of Quality 4.0 requires total buy-in from leadership across the company from the C-suite and IT to operations and sales and marketing as well as quality professionals. Improved quality efficiencies enable companies can get their product to market faster.
An e-book by LNS Research, “Quality 4.0 Impact and Strategy: Getting Digitally Connected to Transform Quality Management” can help quality leaders keep pace with the digital transformation and adopt and incorporate the tenets of this approach to quality. This article gives an overview of the some of the basic concepts of Quality 4.0 outlined in the e-book and provides actionable recommendations for quality managers of how to successfully implement it within their companies.
LNS Research has identified 11 components or “axes” of Quality 4.0. Some of these concepts are very familiar (e.g., compliance, management systems), but some reflect the changing nature of technology brought about by Industry 4.0 and might be new to you or your company’s quality division (e.g., app development, connectivity, scalability). Understanding these axes will help you take the first step in adopting a Quality 4.0 approach.
Data – Data has always driven quality, and many updated regulations and standards highlight the importance of data-driven decision-making. But most of the market lags in its adoption of real-time metrics, with only 22% of typical companies using real-time visibility of quality metrics in customer service, supplier performance, engineering and manufacturing. Companies must seek ways to combine data from various systems to ensure accuracy and transparency.
Analytics – More than one-third of the market identifies poor metrics as the primary barrier to accomplishing quality objectives. Traditional quality metrics typically describe what happened, why it happened and what might happen next, but they fail to prescribe what actions to take, an insight only available with the help of big data, machine learning (ML) and AI. Companies are well-served to develop an analytics strategy after or concurrently with a data strategy, otherwise the insights will be of little value.
Connectivity – Connecting IT systems, such as a digital quality management system (QMS), with operational technology (OT) (e.g., technology used in laboratories, manufacturing and service) is a longstanding challenge. Of those that have invested in an electronic QMS, only 16% are connected to manufacturing operations. Industry 4.0 enables greater connectivity with inexpensive sensors that connect and provide feedback from people, products and processes. Leaders should work to bridge the IT/OT divide, not only with technology, but by enabling data, processes and people to work together.
Collaboration – Only 21% of the market has adopted an automated QMS, forcing quality to execute its (often collaborative) processes with the help of email, automated workflows, portals and even outdated manual paper systems. Tech trends such as social listening and blockchain have transformed collaboration in recent years, and leaders should look to leverage the transformative powers of connectivity, data and analytics.
App development – Apps are becoming more versatile, customizable and mobile. Recently, companies have created “mashup” apps that combine content from multiple sources into a single interface, a meaningful trend for quality with its involvement in all facets of operations and management. Leaders should consider the full potential of interactive apps available today, including wearables, augmented reality and virtual reality.
Scalability – More than one-third of companies cite fragmented data sources and systems as a top challenge in achieving quality objectives. Without global scale, traditional quality and Quality 4.0 alike are unable to reconcile processes, best practices, competencies and lessons learned throughout the company. Cloud computing is of particular importance to scalability, along with data lake technologies. Start by assessing the current scalability – or the ability to support data volume, users, devices and analytics on a global scale – of your in-house systems.
Management systems – Only 21% of the market has adopted a digital QMS solution and of those, 41% have adopted a standalone, unintegrated solution. Due to fragmented core processes, companies often find it unrealistic to adopt quality technology. But harmonizing and automating processes and systems can allow quality staff to shift their focus from simply executing quality to innovating and improving it.
Compliance – Over a third of of respondents in the life sciences reported ensuring compliance was their top strategic objective for quality management, followed by reducing the total cost of quality. Quality 4.0 provides many opportunities to automate compliance. Today’s tech providers deliver highly configurable, automated and connected QMS solutions, and even offer tools to automate validation. Companies should assess their current compliance systems and strategies to identify where improvements can be made.
Culture – At times, quality can seem to exist in a vacuum, despite its corporatewide reach and importance. In fact, only 13% of cross-functional teams clearly understand how quality contributes to strategic success. The improved connectivity, visibility, insights and collaboration offered by Quality 4.0 make a culture of quality attainable.
Leadership – Despite a widespread interest in quality improvement and the tendency to include quality as a corporate value, only 13% of companies say that quality is a priority for top management. To address this issue, quality teams must realign their objectives to clearly link to the organization’s strategic objectives, and quality leaders should advocate and lead quality across the organization, including at the executive level, to encourage buy-in and instill ownership.
Competency – Quality 4.0 can also facilitate a movement toward improved baseline competency of workers and better scaling of specialized knowledge. Technologies such as social media, ML and AI, mashup apps, wearables and VR should be leveraged to improve training and knowledge sharing.
Industry 4.0 and its technologies provide new ways for people, machines and data to connect, and makes powerful technology an accessible commodity. With that said, one of the main assertions of the e-book is that Quality 4.0 is not about technology, but about the people who use the technology and their processes; another is that Quality 4.0 does not replace traditional quality, but builds and improves on it. For quality, these technologies are most significant because they allow for a meaningful transformation of culture, leadership, collaboration and compliance.
Like the first, second and third industrial revolutions before it, Industry 4.0 represents major changes in the way products are manufactured. But it also signals an important shift in quality processes, systems and methods of collaboration from isolated to integrated. With the technology and connectivity available today, quality teams are poised to solve the long-standing quality challenges that have prevented them from innovating and improving quality.
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