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How does Quality Culture contribute to Compliance?


In Life Sciences, quality management systems are essential for ensuring the safety and efficacy of products. However, having a robust quality management system is only one part of the equation. 

To promote a culture of quality far beyond mere compliance, and to truly achieve excellence in quality and long-term success, organizations must cultivate a culture of quality that permeates every aspect of their operations.

Many organizations still limit the responsibility of quality to the Quality department, which is a traditional approach that may not align with modern quality management practices. It's important for companies to recognize that quality is everyone's responsibility and should be embedded throughout the organization.


What is Quality Culture?

In my view, a quality culture is an environment in which employees are committed to producing high-quality work, consistently following quality guidelines, and focusing on continual improvement of quality.

If you're wondering what a 'quality culture environment' means for a Life Sciences organization, allow me to explain.

The concept of a “quality culture environment” is an organizational culture where everyone is focused on delivering value to the customer. This requires a mindset that prioritizes quality processes, product quality, efficiency, effectiveness, and continuous improvement to meet patients’ needs.

In a quality culture, all behaviors, actions, and processes are evaluated based on their ability to deliver value. Therefore, anything that does not contribute to value is simply considered waste and must be avoided. This can include anything from unnecessary steps in a process that exceeds inventory or lead times that ties up resources.

By eliminating waste and focusing on value, organizations can streamline their operations, reduce costs, and improve product quality and patient safety.

This requires a commitment to continuous improvement and a willingness to challenge the status quo in pursuit of excellence.

This is why it is important to create a culture that values quality and encourages employees to take ownership of their work. Quality is everyone’s responsibility. Everyone needs to be committed to quality.


How to build a culture of quality in an organization? 

Establishing a quality culture is a gradual process that cannot be achieved overnight. It is not a static state. Rather, it is a dynamic process that requires ongoing attention and effort, from the top-level management to the frontline employees. 

Having the right quality mindset is key to encouraging behaviors, actions, and processes that provide value. This mindset is characterized by a commitment to focus on prevention rather than correction. If any waste is detected, it is discarded.

There are some areas that organizations must consider building a genuine quality culture. Here is a list of main topics:


1. Manage change

Managing employees’ attitudes toward change is crucial in the process. A positive attitude toward change is a key to success in a quality culture implementation.

It requires a shared understanding of the importance of quality, a commitment to living up to that importance, and a willingness to work together to achieve it.


2. Training, education, and practice

Employees need to have the necessary knowledge, tools, and skills to carry out their responsibilities and achieve quality goals. A quality mindset can be achieved through providing continual training, education, and practice. 

An organization must take special care to invest in employee training on quality management systems, regulations, and best practices, so they have the skills and knowledge to do their job well. This also gives them the confidence to take ownership of their work.

By personalizing learning paths for each employee, organizations can ensure that everyone is aware of quality requirements and understands the impact of their actions on product quality and patient safety.


3. Ownership and accountability

Organizations also need to foster a sense of ownership and accountability among their employees, empowering them to take the initiative and make decisions that will benefit the organization, stakeholders, and patients.

Here are some examples of how to empower employees to reinforce ownership and accountability:


Employees expectations

Ensure that you set clear expectations for your employees so they know what they are responsible for and what is expected of them. Make sure to provide clear and specific job descriptions, performance expectations, and goals.


Trust, Participation, and Communication

Overall, trust, participation, and communication form the cornerstone of an organization's approach to quality. 

By fostering a culture of trust and open communication, organizations can create an environment where everyone is focused on achieving quality excellence, and where employee participation is fundamental to the achievement of quality goals. 

Employees should feel free to raise concerns, offer suggestions, and participate in the decision-making process. This promotes a sense of ownership, accountability, and responsibility among the employees, which is essential for building a culture of quality.

Create channels where employees feel comfortable communicating with their managers and colleagues. Encourage open and honest communication, and actively listen to employees' concerns and ideas.


Foster a culture of trust 

Managers should trust their employees and empower them to make decisions. Trust is essential for employees to feel comfortable taking the lead in their everyday actions.


Recognize and reward good performance

Acknowledge employees when they do a good job and reward them for their achievements. This will encourage them to continue to take ownership of their work and strive for quality excellence.


Delegate the level of authority (but not final responsibility)

Give employees opportunities to take on new responsibilities and delegate tasks. This will show that you trust them and give them a sense of ownership. Remember that managers delegate tasks but should assume the final responsibility.


Provide regular feedback

Regular feedback helps employees stay on track and improve their performance. Make sure to provide both positive and constructive feedback.


Encourage problem-solving

Encourage employees to identify problems and come up with solutions. This will empower them to take ownership of their work and make decisions that benefit the organization.


Create a sense of purpose: vision, mission, and values

Employees are more likely to take ownership and be accountable when they feel their work has a purpose and contributes to something bigger than themselves. Communicate the organization's vision, mission, and values. Communicate how each employee's work contributes to it.


Lead by example

Managers and leaders should lead by example and demonstrate their commitment to quality by embracing it as a core value. This means taking ownership of their own work and being accountable for their actions. 

Leaders must emphasize the importance of quality culture, set a shared quality-based vision, mission,  goals, and expectations for quality, and provide the necessary resources to achieve those goals.

A culture of compliance

The Life Sciences are ruled by a set of guidelines and requirements that shape the industry. These requirements encompass regulatory policies, as well as the requirements of healthcare providers and patients' needs. This is compliance. 

If an organization focuses too much on meeting regulatory requirements and avoiding penalties, then it can create a culture where compliance is the primary concern, and this can impact other aspects of the business negatively. 

In such cases, the organization may lose sight of delivering value, which could impact the company's long-term success.


Culture of compliance vs quality culture

While strong culture compliance focuses on meeting regulatory requirements and avoiding penalties, quality culture focuses on delivering value to the customer.

Quality professionals in a Life Sciences landscape require a forward-looking approach that generates value far beyond regulatory compliance. 

Organizations must consistently push the boundaries of innovation, efficiency, and effectiveness, all the while ensuring that their advancements meet the highest possible requirements. 

They must maintain a culture of quality beyond compliance, to transform quality from a cost center to a value creator. For more information read the Smart Quality Manifesto.

In essence, it is imperative for Life Sciences establishments to develop and uphold exceptional quality standards, understanding that these benchmarks must adapt to stay current with compliance and generate continuous value. 


Discover how to empower Quality Culture in your organization with a Smart Quality QMS!