"Beyond Quality: Leveraging Technology to Build a Quality Culture, Part 2"

The first article in this two-part blog series examined the impact of technology on quality initiatives in the life sciences and the pivotal roles that quality and quality experts play in the increasingly automated modern world. The conclusion addresses Quality 4.0 technologies and their meaning and future impact on the life sciences.

If, as it’s been established, quality experts are ideally positioned to be the vanguard of modernization initiatives, what tools are available to help them turn their organizations’ Industrial Transformation (IX) dreams into reality? The answer to that question lies in the innovative technologies emerging in the Quality 4.0 wave.

Defining Quality 4.0 Technology

Many life sciences professionals have heard the term Quality 4.0, but to some, it is an ambiguous buzzword. LNS Research, a leading manufacturing research and advisory firm, coined the term to underscore the connection between technology and quality. The firm defines Quality 4.0 as the merging of traditional quality approaches with innovative technologies for the purpose of achieving unprecedented levels of operational excellence and performance. Robust technologies can bolster quality as an enterprise-wide strategy, according to the firm’s research, and performance will be improved when the executives at the helm of life sciences organizations embrace the vision of Quality 4.0 and its potential.

Quality 4.0 goes hand in hand with the central objective of IX, which is the proactive and coordinated leveraging of digital technologies to create step-change improvements. The technologies at the core of Quality 4.0 and IX initiatives include:

• Cloud systems.
• Big data and data “lakes” that store vast amounts of raw data in native formats within a flat architecture until it is needed.
• Connected devices and “edge” devices (e.g., routers that provide an entry point into enterprise or service providers’ core networks).
• Blockchain.
• Artificial intelligence (AI) and machine learning (ML).
• Mobile, augmented reality (AR) and virtual reality (VR) devices.
• Social media.

How Will Quality 4.0 Technology Impact the Life Sciences?

In a webinar on June 27, 2019, LNS Research co-founder and president Matthew Littlefield will join MasterControl executive vice president Matt Lowe to examine the increasing significance of these technologies as quality’s role expands in life sciences manufacturing environments. The “Enabling Transformation in Life Sciences: Delivering Near- and Long-Term Success with Quality 4.0” webinar will review LNS Research’s latest industry analysis and outline the essential building blocks of successful IX programs.

The webinar’s aim is to help attendees get answers to their questions about IX and understand the vital connection points between Quality 4.0 and Industry 4.0. So named because it represents manufacturing’s fourth revolution, Industry 4.0 is the augmentation of the computers and automated tools of the third industrial revolution with smart and autonomous systems powered by data and machine learning. Building on the Quality 4.0 theme, the presenters will explore the main use cases for which vendors are developing new Industry 4.0 innovations that enhance quality and connectedness. The presenters will discuss the areas that will be significantly affected by IX and Quality 4.0 technologies, including manufacturing operations, supply chains, customer experiences, workers, products, and robotic process automation (RPA).

Developing an IX Strategy with a Business-First Approach

In the life sciences, technology is primarily used as a means of increasing efficiency and streamlining processes. As such, most companies choose which technologies to implement based on the most urgent problems that need to be resolved. Purpose-built technology should be implemented strategically, however, and not as an extinguisher for the latest fire that has erupted. But for life sciences organizations engaged in transformation initiatives, backsliding into a technology-first mentality is an ongoing challenge.

As Littlefield and Lowe will highlight in their upcoming webinar, a business-first focus is one of the primary characteristics shared by the pioneers who have successfully adopted Quality 4.0 technologies and developed IX programs. IX leaders have discovered that a technology-first approach doesn’t take broader implications into consideration and can even contradict organizational objectives at times. As LNS Research’s latest reports indicate, companies that lead with technology are far less likely to succeed than those who use the modern manufacturing world’s unique convergence of quality and technology as an opportunity to break down traditional barriers to success.

The benefits of a business-first approach and other fundamental IX components, such as cross-functional development, the importance of establishing an enterprise-wide view of operations, and the implications of IX funding strategies, will be covered in the June 27 webinar. The presentation will also examine ways companies can reduce risks by following in the footsteps of successful early innovators and provide recommendations for accelerating the adoption of IX programs.

Building a Compelling Business Case for IX

Every forward-thinking company craves solutions that improve quality, efficiency and performance. Life sciences executives, however, are notorious for rejecting any piece of technology that doesn’t have decades of demonstrable use throughout the slow-to-change industry. As pointed out in the executive brief “The War on Paper: A Corrective Action Plan for Going Paperless,” the industry’s overreliance on paper processes has derailed far too many organizations’ dreams of fully connecting and digitizing their systems. And as an added setback, regulatory requirements often prevent life sciences companies from undertaking IX initiatives at the same rate as counterparts in other industries. The result of these combined factors is that it takes a great deal of convincing to get decision-makers in life sciences organizations to invest in IX technologies — even in solutions with proven track records.

To help life sciences organizations strengthen their IX positioning and planning, Littlefield and Lowe will take time in their webinar to examine the following four pillars that any IX business case must be founded upon.

1. A compelling event (i.e., an event with a defined date and business impact, as well as an owner in top management).
2. Strategic, peer and quality objectives.
3. Operational and financial key performance indicators (KPIs).
4. An emphasis on the IX journey, as opposed to viewing the transformation in terms of a one-time investment.

To learn how these foundational elements can help your organization develop successful IX initiatives, sign up for the June 27 webinar. See the evidence of the benefits of IX firsthand and get answers to your pressing questions about the future of Quality 4.0.