A life sciences culture of quality beyond compliance

 

The world of life sciences is formed around a framework of requirements. These requirements include regulations as well as the needs of providers and patients.

 

Life sciences organizations must establish effective quality standards, and those standards must continue to evolve. “Organizations must continue to innovate new solutions, while ensuring these, too, meet the highest standards,” said Grant Thornton Transformation Senior Manager Nina Premnath.

 

To maintain quality for existing products and new innovations, life sciences organizations need to take a broad view that transcends compliance — they need to form a culture of quality.

 

 

 

Your culture of quality

 

 

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. However, many organizations still think of quality as a single department rather than an organizational responsibility.

 

Nina Premnath

“Quality cannot be the sole responsibility of a single department. Organizations must consider the supply chains for their products, including the supply chains for information and data.”

Nina Premnath

Grant Thornton Transformation Senior Manager

“Quality cannot be the sole responsibility of a single department. Organizations must consider the supply chains for their products, including the supply chains for information and data,” Premnath said. This may include taking into account labeling claims, promotional material and other factors.

 

A healthy culture in the industry today requires cross-functional metrics that are closely aligned, HR processes that are expanded to support change, and recruitment that builds the next generation of quality professionals. It also requires a holistic approach that instills a consistent culture and core set of values you communicate across locations and divisions.

 

Companies that invest in cultivating a culture of quality within their organization will be in a better position to pursue continuous improvement and innovation, embrace the benefits of new technologies and optimize risk taking throughout their organizations. The key is to go beyond a definition to truly bring your culture to life.

 

 

 

10 ways to bring your culture to life

 

 

To maintain an effective culture of quality, life sciences organizations need a multifaceted approach across all teams. This includes ten important actions:

 

 

1. Define or re-define your “culture of quality.”

 

A “culture of quality” has a unique meaning for every organization. For your organization, consider compliance, measurement, accountability and performance. Make sure to account for customer needs, as supported by customer data. Then, define your culture of quality in terms of values, behavior and expectations. Recognize that this definition will evolve, and you will have to invest in it to generate positive outcomes.

 

 

2. Conduct a gap analysis.

 

Conduct a quality culture gap analysis of your current state to help identify places where you have challenges in your culture of quality. The analysis should answer some key questions:

  1. What is the current status of quality culture on the shop floor, in the warehouse, laboratory and office areas?
  2. What is the organization’s vision for its quality culture?
  3. What are some key milestones it is seeking to achieve in its culture?
  4. What are the organization’s core goals for its culture?

 

3. Lead by example.

 

Your organization’s leaders can drive an enterprise-wide commitment by leading through example. Embrace the changes needed as driving a competitive advantage. Engage in open dialogue and be transparent about these changes — and their impact on employees. This helps to make quality a way of life in the daily operations.

 

Executives need to live out the values you defined for your quality culture. Without visible commitment from leaders, it will be challenging to get the rest of the organization to adopt the culture you’re seeking.

 

 

4. Communicate, communicate, communicate.

 

Transforming a culture takes time, effort and continuous communication. It is important to consistently and frequently dialog with employees about the organization’s commitment to quality, so they know what is expected and feel engaged in the process. Communicate metrics about progress and use team meetings to share ideas, issues and experiences.

 

 

5. Instill accountability at every level.

 

Go beyond communication to make employees at every level accountable for a commitment to quality. Regular performance reports and reviews of targets are two ways to ensure that quality standards are met, while also highlighting areas that require more resources or changes.

 

 

6. Build incentive systems.

 

Motivate employees to help drive engagement in developing a culture of quality by providing incentives for pushing quality forward. Evaluate your performance evaluations, job descriptions, mentoring programs and other HR initiatives. Consider implementing specific methods that incentivize employees to help build a better culture. In an industry burdened by regulations and quality precision, positive rewards can help drive engagement and change.

 

 

7. Recruit for quality.

 

Life sciences organizations should reflect their commitment to quality 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.

 

 

Nina Premnath

“During the onboarding process, introduce new hires to your organization’s quality values, goals and expectations. Make sure to define behaviors and standards for meeting quality objectives in the organization.”

Nina Premnath

Grant Thornton Transformation Senior Manager

“During the onboarding process, introduce new hires to your organization’s quality values, goals and expectations. Make sure to define behaviors and standards for meeting quality objectives in the organization,” Premnath said. If possible, include a senior management representative in the training session to communicate the importance of quality at all levels of the organization.

 

 

8. Foster quality skill sets.

 

As you recruit for quality, your organization also needs to foster the skills for quality within the workforce. Skill sets can include the ability to leverage next-generation technology solutions or advanced skills in risk management, data analytics and more.

 

 

9. Stay current on trends, regulations and technologies.

 

Quality and compliance are constantly evolving. Take steps to stay current on trends, developments and new technology that can help inform and improve your organization’s culture of quality. Be sure to share this information widely with your teams and adjust quality strategies as needed.

 

 

10. Track your progress.

 

It’s critical to define a formal measurement program that can 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.

 

 

 

Form your strategy for today and tomorrow

 

 

Like any business focus, your culture needs a formal strategy for the short and long term. This strategy should encompass multiple aspects of your culture, including resources, tactical changes, technology adoption, training, change management, incentives and reporting.

 

To carry out your strategy, you need consistent and continuous effort. Bring your quality culture to life by taking the 10 key actions and motivating others to do the same. An effective culture of quality weaves through every texture of daily work.

 

Cultivating a culture of quality is more than a one-time effort. It’s an ongoing mindset that should be embedded from the top of an organization down to every employee, to ultimately ensure the safety and efficacy of products and improve patient lives.

 

 

 

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