Creating a quality culture within the workplace is foundational to quality compliance. The keystones to cultivating quality culture include understanding the importance of operational communication, the framework of established systems, continuous improvement, and compliance.

What is Quality Culture?

There is no unanimous definition of quality culture, as the culture of each organization is sure to have unique standards based on each company’s performance requirements and needs. Perhaps the most encompassing definition of quality culture in the workplace is an environment in which quality surrounds every facet of the employee’s work experience; everyone is focused on delivering value to the customer. This means that not only do employees follow quality guidelines, but those guidelines permeate the actions, discussions, decisions, and work ethics of all individuals within the organization.

This complex set of values, beliefs, assumptions, and symbols is vital to ensuring compliance, which drives healthcare product manufacturing, reduces risk, and is fundamental to ensuring the safety and efficacy of products intended to improve patient lives. One knows his or her company has achieved a quality culture when there is an understanding amongst all employees that quality should be achieved for the integrity of the company, not just to maintain regulatory approval.

What Creates a Quality Culture?

A quality culture consists of three primary elements: communication, established processes for data-driven decision making, and continuous improvement. The first key element to developing a quality culture is ensuring that one has communicated with his or her colleagues not just the processes and procedures, but the why behind those processes.

If employees know the reason behind the drive for quality, they are more likely to take ownership and pride in their contribution to the process. Employees are also more willing to communicate when they see room for improvement or areas of weakness. It should go without saying that processes and data are vital to maintaining quality, as they ensure repeated outcomes and deliver consistent results. That said, creating processes that have quality at their core is imperative to creating a quality culture.

Lastly, a quality culture depends on continuous improvement. Continuous improvement is defined by minor, incremental changes that add up to major improvements over time. A communicative feedback loop between management and staff is vital to ensuring continuous improvement. Providing regular feedback, encouraging problem-solving, and creating a sense of purpose through company vision, mission, and values. The employees who work hands-on with processes and procedures daily may see the areas where those small changes are needed most. Therefore, a willingness to listen and be adaptable is imperative.

Overcoming Common Barriers to Creating Quality Culture:

While focusing on the primary elements of quality culture is sure to drive quality and compliance, there are a number of barriers that commonly stand in the way.

Lack of commitment from leadership is a major pitfall in creating a quality culture. Leaders must build and communicate a clear strategy, vision, and quality initiatives to prioritize quality across the company. Often, leadership's attitude makes quality seem optional, irrelevant, or burdensome. To overcome this, leadership teams should align on quality goals and demonstrate these goals through their actions. Involve them in planning and implementing the quality culture framework to encourage adoption.

Insufficient systems and processes will also challenge quality culture. Outdated or inconsistent policies, procedures, standards, metrics, and tools may thwart quality efforts. Regularly reviewing systems to ensure continued alignment with quality objectives and customer expectations is vital to maintaining quality culture. Simplifying and streamlining processes can be achieved by eliminating waste, duplication, and errors. Having relevant, intuitive processes will optimize quality efforts.

Finally, lack of engagement from employees is a major obstacle to achieving a quality culture. Employees are key stakeholders in quality management, so employee contribution to quality at any company is vital. However, if employees feel undervalued, unempowered, or unrecognized, they are not likely to work towards a company’s quality objectives. Creating a positive work environment where employees are appreciated, respected, and heard is key to creating a quality culture. Listening to employees and empowering them to drive quality by recognizing and rewarding their contributions to quality improvement.

What is Compliance?

Quality compliance addresses the basic needs and expectations of customers and patients while regulatory compliance addresses safety, environmental, and other requirements established by government or industry associations. Compliance is essential for ensuring the health and safety of customers as it urges adherence to external requirements.

Organizations dedicating all their time, energy, and efforts toward meeting regulatory requirements can develop a culture that is more concerned with compliance than quality, which may negatively impact customer and employee experiences.

Constantly honing in on strict regulatory requirements can become daunting to employees, however, when a company implements and fosters a lasting quality culture, regulatory compliance will accompany this quality-focused mindset.

How does quality contribute to compliance?

Consider this: When recommending a favorite restaurant to a friend, do you recommend it based on the delicious food and quality of service, or on their adherence to health and safety codes?

While it is critically important for a restaurant to maintain health and safety standards, the principle that creates lasting, happy customers is quality. From that quality comes compliance.

Similarly, medical device and pharmaceutical manufacturers must maintain a culture of quality if they hope to produce high-quality products and services. By setting a high standard of quality, you almost guarantee compliance. Without a robust culture centered around quality standards, employees may become disconnected from the impact their work has on consumers, potentially overlooking the significant ways the devices and services provided enhance and improve customer’s lives.

Conclusion

Without compliance to regulatory standards, valuable devices and products would never make it to market. Ensuring that a product is safe and compliant is imperative to the innovation and creation of lifesaving products. However, compliance means very little without a focus on quality. For companies driven by a quality culture, compliance is second nature.

Author: Rachel Henderson, Project Coordinator