Quality culture: Beyond compliance to improvement


10 ways life sciences organizations can cultivate a culture of quality


In an industry facing increasing competition, regulations, customer demands and a mandate for innovation, today’s life sciences leaders are committed to cultivating a culture of quality that transcends compliance to serve as a clear competitive differentiator. Driven by payers — including the Centers for Medicare and Medicaid Services (CMS) — the provider industry is moving from a reactive to a proactive approach to quality that requires, in part, a commitment to measuring quality investments. Life sciences companies, more and more, are being measured and paid based upon the quality of their products and services.

Beyond the commitment to patients, cultivating a culture of quality in the life sciences industry is especially critical today for four key reasons, according to Pat Shafer, Grant Thornton managing director of Healthcare and Life Sciences. First, organizations are trying to stop the hemorrhaging of lost value due to poor quality. Second, the FDA is advancing its expectations and the business case for an organizational commitment to quality.

A third, and increasingly compelling, reason for a culture of quality relates to customer demand. “A key driver of quality is the increasing patient voice in medicine, customer awareness of quality issues and the power of patient advocacy groups,” Shafer said.


“Until recently, it’s been a compliance culture, not a continuous improvement culture. But that’s changing, and organizations are embracing a fundamental shift in attitude.”

Pat Shafer

Managing Director, Healthcare and Life Sciences
Grant Thornton LLP

Lastly, the availability of real-world data is providing opportunities to measure quality effectively, making quality performance easier to assess. “Organizations are now focused on quality not only because they’re being asked to move beyond basic compliance, but also because there’s an understanding that it can produce top-line and bottom-line results,” Shafer said. “Until recently, it’s been a compliance culture, not a continuous improvement culture. But that’s changing, and organizations are embracing a fundamental shift in attitude.”

Clearly, today’s life sciences organizations are recognizing the need for a strong culture of quality and are investing in culture efforts. A Case for Quality survey conducted by the Medical Device Innovation Consortium revealed that 90% of organizations report that leadership actively promotes quality across activities and functions. Nearly two-thirds (63%) prioritize high-quality performance over costs and competing priorities, while most organizations proactively encourage understanding of how quality applies to jobs and performance reviews.

Facilitating a culture of quality, especially across multiple locations and divisions, is a transformative process that must be driven by executive leadership and embedded throughout the organization. Quality can no longer be the sole responsibility of a single department, but change is still needed. In fact, a Quality Management and Compliance Software survey by LNS Research revealed that 50% of life sciences executives report that their organization considers quality much more of a single department rather than an organizational responsibility.

When considering quality, life sciences organizations must look beyond mere compliance and consider the supply chain of the product, including a supply chain for information and data. This may include taking into account labeling claims, promotional material and other factors.

A healthy culture in the industry today requires a close examination of the role of quality, including alignment of cross-functional metrics, expanding HR processes to support change and recruiting the next generation of quality professionals. It also requires a holistic approach to culture, one that takes into account factors associated with instilling a consistent culture across multiple locations and divisions. In fact, according to Grant Thornton’s Return on Culture research, 42% of life sciences executives report difficulty in creating a healthy culture in organizations involving multiple locations.


Lisa Walkush, Grant Thornton National Life Sciences Sector leader, noted that large, global life sciences organizations must address the challenge of embedding their culture across different geographic locations and employees from varying ethnic backgrounds. “Organizations need to define a core set of values and create an adoption plan in a way that allows behaviors to be mapped to specific countries or regions,” she said. “Embedding your culture across different regions will require communicating in a manner that resonates with employees in that location.”

How can organizations move forward in fostering a performance-driven culture of quality? Conducting a gap analysis may be a good place to start. The analysis should serve to answer some key questions: What is the current status of quality culture on the shop floor, in the warehouse, laboratory and office areas? What is the organization’s vision for its quality culture? What are some key milestones it is seeking to achieve in its culture? What are the organization’s core goals for its culture?



10 ways to cultivate a culture of quality


Facilitating an effective culture of quality requires a multifaceted approach involving all areas of the organization. Here are 10 ways your organization can advance its culture of quality.

1. Define quality for your organization.


The definition of a culture of quality is unique to every organization. When defining quality for your organization, take into account customer needs, ideally supported by customer data. Make sure that all facets of quality are incorporated in your definition, including compliance, measurement, accountability and performance.

Grant Thornton’s Walkush noted that organizations need to define a culture of quality in terms of values, behavior and expectations. “They have to realize that it’s a journey they’re embarking on and they’re going to have to invest in it to generate positive outcomes.”



2. Lead by example.


“In order for a culture of quality to be driven throughout the organization, leadership needs to buy into the concept and support it. Executives need to live the values that are defined around quality.”

Lisa Walkush
National Life Sciences Sector Leader
Grant Thornton LLP

Your organization’s leaders can drive an enterprise-wide commitment to quality by leading through example. Embrace the change needed to make the shift to a quality culture as competitive advantage. Engage in open dialogue and be willing to be transparent about the changes needed — and their impact on employees. Make quality a way of life in the day-to-day operations of your organization.

Walkush noted: “In order for a culture of quality to be driven throughout the organization, leadership needs to buy into the concept and support it. Executives need to live the values that are defined around quality. Without that leadership commitment, it will be challenging to get the rest of the organization to adopt the culture of quality you’re seeking.”



3. Communicate, communicate, communicate.


Transforming a culture takes time and continuous effort. It is important to consistently and frequently communicate to employees the organization’s commitment to quality so they know what is expected of them and feel engaged in the process. Communication can be in the form of a newsletter, a report providing detailed analysis of the company’s quality efforts, or regular team meetings to share ideas, quality incidents or experiences.



4. Instill accountability for quality.


When it comes to making culture changes, it’s important to go beyond just talking the talk. Both managers and rank-and-file employees throughout the organization must be held accountable for a commitment to quality. Regular performance reports and review of targets are two ways to ensure quality standards are being met while also shedding light on those areas that may require more resources or changes.



5. Revise HR processes.


Incentivizing employees may be one way to help drive engagement in developing a culture of quality. Evaluate your current HR processes including performance evaluations, job descriptions, mentoring programs and other initiatives. Consider implementing specific methods to incentivize employees to help build a better culture. In an industry burdened by regulations and quality precision, awards can help drive engagement and change.



6. Recruit for quality.


Life sciences organizations that define quality as a core value should reflect that commitment in their recruiting and onboarding processes. Include a question or two in the interview process that can help assess a candidate’s approach to quality. Ask for specific examples of how they facilitated improved quality performance in previous roles. Introduce new hires to your organization’s quality values, goals and expectations during the onboarding process. Make sure to define behaviors and standards for meeting quality objectives in the organization. If possible, include a senior management representative in the training session to communicate the importance of quality at all levels of the organization.



7. Stay current on trends, regulations and technologies.


Quality and compliance are two areas that are constantly evolving in the life sciences industry. Take steps to stay current on trends, developments and emerging technology that can help inform and move forward your organization’s culture of quality. Be sure to share this information widely with your teams and adjust quality strategies as needed.



8. Develop short-term and long-term strategies.


Like any other business focus of your organization, culture requires a formal strategy, both for the short term and long term. Strategies should encompass a number of aspects of culture including resources, tactical changes, technology adoption, training, change management, incentives and reporting.



9. Implement a quality measurement program.


It’s critical to define a formal measurement program in order to evaluate the success of your quality culture investments and initiatives. Identify core KPIs and regularly analyze results so that adjustments in resources, goals and strategies can be made. Share your measurement objectives with employees so they can understand how they will be evaluated when it comes to quality.



10. Foster enhanced quality skill sets.


As life sciences organizations facilitate a culture of quality that goes beyond just compliance, it will be important to recruit for and foster enhanced skill sets within the workforce. This may include the ability to leverage next-generation technology solutions or advanced skills in risk management, data analytics and more.

“Creating a culture of quality is the combination of consistent and continuous leadership messaging,” Shafer said. “It involves rewarding employees who are advancing quality performance and demonstrating quality behaviors. An effective culture of quality requires measuring performance and weaving quality into every facet of day-to-day business life.”




Is your company culture out of alignment?


Take Grant Thornton’s culture benchmarking survey to determine your firm’s current areas of strengths and weaknesses. Designed to accommodate any given company’s unique profile, the benchmarking tool tests current performance against five key drivers that lead to healthier cultures including workplace environment; and direct investment in employees, diversity, sense of community and value systems.




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