Roxane Napoli, Associate Director – Product Marketing, IQVIA Quality Compliance
Life Sciences industry regulations are evolving rapidly, and many business leaders see these regulatory changes as a threat to growth. The pressure weighs most heavily on organizational quality compliance. But it is possible to lessen the load and address growth challenges by ascending the Quality Maturity ladder.
At any given time, a company’s maturity level falls within a range that scales from development (low quality maturity) to leadership (high maturity). The higher the stage of maturity, the quicker the realization of benefits: higher product quality, improved compliance and reduction in overall cost of quality.
Organizations that wish to develop or advance their Quality Maturity would be best served by viewing it as an initiative that requires people, processes, and technology in order to be successful.
Proactive practices evolve Quality culture
In the beginning stages of maturity, processes are manual and reactive. They’re mainly compliance-driven as opposed to driven by quality improvement. Many organizations in this stage are facing the challenges of GMP readiness and compliance with new and evolving regulations, such as EU MDR for the Medical Device industry. At this phase of maturity, quality is seen more as a function or department. Many businesses at this phase are using a variety of point technology solutions that aren’t integrated with one another, or they are still using paper-based processes. These contribute to an overall lack of visibility and accountability for quality processes and results.
In higher stages of quality maturity, companies become more proactive and can harmonize processes across the business and even beyond their four walls to better manage supplier quality and activities. At the highest level of maturity, organizations begin developing a true culture of quality with end-to-end quality processes and the ability for metrics to help sustain and improve overall quality.
It’s also possible to move back and forth between quality maturity levels. It takes ongoing management commitment and a continuous improvement effort to drive maturity forward and to sustain it.
Awareness initiates the growth process
While there is no “one size fits all” approach to advancing an organization’s quality maturity, there are some steps you can take to get started. The first step for any improvement initiative is understanding the organization’s current state. First, identify where your company sits on the Quality Maturity scale. In general, your organization is only as mature as your weakest point. For example, you may be focused on prevention (a Level 3 – Integrated characteristic) but utilizing siloed, disparate systems (a Level 2 – Controlled characteristic). If that’s the case, your overall Quality Maturity is at Level 2. That’s your starting point.
Then, based on the current state, short-term and long-term goals to either sustain the current maturity level or advance in maturity level can be developed. As organizations advance on the quality journey, they can more effectively address regulatory challenges, better manage risk, and bring quality systems into alignment.
Technology improves Quality Maturity efforts
Technology can be thought of as the fuel for advancing Quality Maturity. In some cases, technology is the driver for moving from one level to the next. For example, it’s difficult to integrate systems, measure key metrics, or have a global platform for quality without a solid technology framework as a foundation.
Technology also improves efficiency and can take some of the time-intensive work out of managing a quality system. This in turn frees up time and resources, and better enables quality compliance personnel to focus more on prevention or other aspirational quality goals, rather than reacting to what’s in front of them now.
Finally, quality technology enables improved decision making, which is critical to advancing maturity. Integrated quality systems with business intelligence capabilities enable the development of quality metrics that drive maximum impact. For example, metrics can enable the understanding of the most frequently encountered failure mode to be corrected, the isolation of high-risk issues for immediate action, a deeper examination of quality process cycle times, and more. Quality team members can make faster, better decisions since they can quickly identify areas of concern and hone in on them for maximum impact.
Technology advances Quality Leadership levels
Some level of effort is needed to sustain quality leadership over time. Even for those organizations that are already functioning at high maturity levels may need ongoing support to sustain or improve their maturity initiative. Since high levels of maturity are often tied to technology, many of these organizations need ongoing support and enhancements to their Quality Management System (QMS). They may need to consider upgrading their current system, moving to a more robust quality system, or making improvements in their analytics capabilities.
Quality leadership strategies are also closely tied to regulatory and GMP compliance, so it’s important to keep a pulse on upcoming regulations to be sure that they’re being addressed in a proactive manner. Technology upgrades alone will not always be enough to maintain compliance with new regulations. Even when technology can assist with compliance, there are often people- or process-related changes that must occur to stay fully up to speed.
There are also situations where organizations have mature or compliant quality systems that are not necessarily efficient. Looking at improved processes and technology can improve even the most mature quality systems.
IQVIA Quality Compliance supports every rung on the ladder
IQVIA can assist in advancing your quality maturity, no matter where your organization is right now. By viewing quality as a people, process and technology journey, rather than just a challenge that technology alone can solve, we’re able to provide end-to-end offerings to develop quality leadership within an organization.
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