This year marked Sparta’s 15th annual user conference, and a lot has changed within that relatively short period of time. From 2002 and throughout most of the proceeding decade, most quality teams we worked with focused on regulatory compliance. But then a few years ago, we noticed more quality teams making noise around the financial impact of quality management. This year, that noise became a loud and unmistakable rumble heard throughout the conference.
If your quality department is on the leading edge of this change, you already know the drivers full and well. But if your team is focused solely on compliance, it’s worth watching Sparta CEO, Eileen Martinson’s keynote on Quality and the Digital Revolution.
In short, the digital revolution has forever changed the way that companies approach quality. Beyond compliance, quality teams have the unprecedented opportunity to influence product design, user satisfaction, operational performance, and more.
In fact, at the 4:44 mark of the video, Eileen makes note of a recent study coauthored by Forbes and ASQ showing that 47% of respondents felt that quality affects a company’s bottom line. Yet in a later slide, we see that 64% of organizations have no formal quality initiatives, are struggling with quality efforts, or are still developing their quality programs.
Why the disconnect? The short answer is, it depends on where the focus has been historically.
Most life sciences companies have regulatory compliance down to a science because, well, they’ve had little choice in the matter. But in truth, few have ventured far enough beyond compliance and into performance. This is an area where manufacturers in non-regulated industries excel not because they’re forced to, but because it simply makes good business sense.
And just as the needs of quality teams have evolved, so too have the quality management platforms that support them. Where users previously relied on siloed point solutions to manage singular processes, now companies are turning to platforms that manage every process in one place.
Moreover, these platforms can be integrated with other core systems (like your CRM, ERP, LIMS, or MES) for a more complete view of the organization. You can even extend your QMS to your supply chain, ensuring greater visibility and consistency throughout product life cycles. From a technological perspective, there’s never been a better time to evolve your quality objectives to focus on performance.
The real challenge comes with realigning the people and processes that underlie your quality management system. But make no mistake: quality can no longer afford to be a checkbox under regulatory compliance and the time to make that shift is now.
Learn more about current Tech Approaches to Quality Management.