Matthew Littlefield, President & Principal Analyst, LNS Research
Nearly every executive responsible for quality and compliance in life sciences has the topic of culture on their mind. Why? Because in an industry driven by innovation, deep down it’s the people — the scientists, the engineers, the shop floor workers — that separate one company from another. And having a culture that puts quality and compliance first can be the foremost source of differentiation.
Although many executives understand the importance of a quality and compliance-based culture, few have actually been successful in developing their own. Our recent Quality Management Systems survey verifies this, revealing that 30% of life sciences executives feel their organization considers quality much more of a single department rather than an organizational responsibility.
Changing employees’ mindsets and establishing a quality culture is not something that can be done overnight. Rather, it’s a transformative process that must be initiated and driven by executive leadership. In this post, we’ll share seven different ways executives can help shape this initiative and ultimately foster a culture of excellence.
1. Dedicate a Portion of Your Annual Budget to an Internal Marketing Program
It often makes sense to support transformation with an internal marketing program. This could be as simple as a regularly distributed newsletter from executive leadership on the importance of quality and compliance and what’s being done to improve it. Or it could be more complex, such as a detailed analysis of the company’s performance broken down by business unit or even by facility.
2. Use Third-Party Audits to Get an Unbiased Picture of Performance
Conducting audits is second nature to life sciences companies. Doing so is a form of risk management, but unfortunately many companies tend to keep the entire process in-house, never reaping the full benefits. Third-party audits provide unbiased views of performance — typically highlighting where extra resources may be needed — which is crucial for initiating and then sustaining cultural transformation.
3. Make Managers More Accountable for Quality and Compliance Results
While cultural change has to come from the top, the rate at which it trickles down throughout the organization is almost equally as important. One way to accelerate this process and ensure it happens is to hold managers more accountable by requiring regular performance reports. This not only highlights who the effective leaders are, it also sheds light on which areas of the business may require more resources to contribute to your quality culture.
4. Create Quality and Compliance Performance-Based Incentives for Employees
This point builds upon the previous one. If you’re going to hold people more accountable for their actions as a means to build a better culture, it only makes sense to incentivize them to do so. And in an industry burdened by regulations and quality precision, rewards — either monetary or in-kind — can support this cultural transition and sometimes catalyze innovation.
5. Stay Current on Emerging Trends, Technologies, and Regulations
Quality and compliance are two dynamic areas in many industries — but especially in life sciences. As the one who’s responsible for driving cultural transformation, this means you have to be just as dynamic. Stay current on industry trends and news, be curious about emerging technology, and be as proactive as possible when it comes to regulations. The last thing you want is for something to pass you by.
6. Deploy Next-Generation Technology to Support People and Processes
People are what drive innovation in this industry. Though, when used effectively, today’s next-generation technology solutions can provide unprecedented levels of support for their actions. Companies are using solutions to automate processes, and enable communication and collaboration across drug/device lifecycles. This is resulting in increasingly proactive quality and compliance leaders.
7. Develop a Short-Term and Long-Term Plan for Supporting Cultural Change
There’s clearly many moving parts when it comes to cultural transformation, which makes it all the more important to approach such an initiative with a plan. This plan should have both short-term and long-term aspects to it. The shorter-term may focus on quick wins and tactical changes. The longer-term may focus more on plans for EQMS technology adoption, change management, incentives, and reporting.
Making Quality and Compliance Your Differentiator
After a successful survey taken by several hundred life sciences executives, we recently put together an extensive eBook called “A Roadmap for Addressing Quality and Manufacturing Challenges in Life Sciences.” The eBook covers emerging industry trends and challenges, as well strategies for getting the most out of people, process, and technology resources. You can read it by following the button below.
A Roadmap for Addressing Quality and Manufacturing Challenges in Life Sciences