GxP Lifeline
"Beyond Quality: Leveraging Technology to Build a Quality Culture, Part 1"
The implications of quality go far beyond just the quality department, especially in the life sciences world. In every life sciences company, quality has a direct and substantive impact on each role within operations, engineering, R&D, marketing, IT and regulatory compliance teams. That being the case, in the increasingly more automated manufacturing environments found in life sciences organizations, why aren’t quality professionals at the forefront of modernization initiatives?
The answer: they should be. And they can be, with the right mindset shift.
Combining People and Tech to Empower a Culture of Quality
Quality professionals in the life sciences are the ideal experts to be leading their companies’ digital transformation initiatives because nobody has a better understanding of the challenges that have long been hallmarks of the industry (i.e., highly fragmented data, outdated technology, poor support for classic quality metrics and similar inefficiencies that drag down manufacturing processes). They understand that a product’s value is ultimately determined by customers’ judgments of the product’s quality and that quality excellence can’t be achieved without the right tools and processes.
So, in an industry that is frantically trying to catch up to other modernized business sectors, why don’t life sciences companies turn first to their resident experts who understand the criticality of quality optimization? Furthermore, how can companies overcome persistent, industry-wide obstacles to quality monitoring and analytics to drive improvements to their manufacturing operations?
The answer to these questions lies in the intersection of quality, manufacturing and what LNS Research has termed Industrial Transformation (IX). According to the research firm, IX is the “proactive and coordinated approach to leverage digital technologies to create step-change improvement in industrial operations.” It is different than, yet overlapping and tightly integrated with, Quality 4.0, which is the blending of traditional quality approaches with innovative technologies to achieve new levels of operational excellence and performance.
In a June 27, 2019, webinar, MasterControl executive vice president Matt Lowe will join LNS Research co-founder and president Matthew Littlefield to discuss quality’s critically important role in IX and Quality 4.0 initiatives, the dire need for cross-functional engagement in all quality endeavors, and the substantial benefits life sciences companies can realize through modernization. Titled “Enabling Transformation in Life Sciences: Delivering Near- and Long-Term Success with Quality 4.0,” the webinar will examine the latest industry analysis from LNS Research. In addition, it will explore strategies life sciences companies can employ to reduce risks in their quality initiatives and increase the speed of IX adoption.
Leveraging Technology to Redefine Quality
As technology continues to revolutionize the responsibilities of life sciences professionals of all stripes, there is a growing need to instill quality into every function throughout the industry. And although manufacturing and quality are now at the forefront for life science organizations, most of them struggle with where to begin with IX. Quality 4.0 is a leading use case for IX, but it is disproportionally in pilot mode in the life sciences in comparison with other manufacturing sectors. This critical juncture of IX and Quality 4.0 is where proven technology has become the difference-maker for life sciences companies that truly want to foster a culture of quality throughout the enterprise.
In the June 27 webinar, Lowe and Littlefield will explore some of the mature tech vetted by innovators in their quest for quality and manufacturing transformation, and they’ll discuss some of the lessons learned by Quality 4.0 pioneers. They will also explain how the convergence of quality and technology represents the greatest opportunity for cross-functional collaboration and awareness in life sciences companies, since quality activities impact every aspect of an organization, from operational efficiency and rework to throughput and on-time delivery.
Quality is at the core of supplier and connected-worker initiatives, making modern technology’s ability to connect workers and integrate the processes they work with even more essential. To this end, Lowe and Littlefield will examine some of the technologies available for IX initiatives. They’ll demonstrate how technology can serve as the critical hub in an organization’s mission to spread a culture of quality beyond the quality department, which is a monumental challenge shared by most life sciences companies due to the organizational, competency and collaboration constraints so commonly found in the industry.
They’ll also explain why, in order to plan and execute IX successfully, a life sciences company must first determine its strategy and define the guiding data and IX framework that will be needed by manufacturing, IT and quality teams. Their research also indicates that organizations must ensure that all quality initiatives will be implemented across all functions throughout an enterprise and not regarded as standalone activities.
Laying the Groundwork for IX
Although other organizations have already begun blazing the IX trail, it’s still an intimidating prospect for the decision-makers in life sciences organizations who understand the inevitability of modernization and are still in planning stages.
To prepare for your company’s IX journey — and for the upcoming webinar — start by asking the following questions about your organization and its outlook:
- How do we pull all of our technology initiatives into a cohesive strategy?
- How can we ensure that our quality experts have a say in the conversation?
- How have other organizations approached IX, and what can we glean from their experience to deliver more value sooner?
- How do we reconcile the ways we vary from other companies in terms of our legacy systems, management, competencies and attitude toward change?
- How can digital technology enhance our compliance endeavors?
The June 27 webinar will examine these questions and explore paths that your company might choose to follow while finding the solutions that work best for your organization.
Ask questions. Get the research firsthand. Sign up for the webinar on June 27.
Stay tuned for the second part of this blog series that will examine the business case for IX by exploring what new technology trends mean to life sciences professionals, how those trends will impact their roles, and what they need to be doing about them today.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
