From a Culture of Compliance to a Culture of Quality : MDIC’s Leadership Engagement Playbook

The Medical Device Innovation Consortium (MDIC) is a public-private partnership formed in 2012 to advance the medical device regulatory process for patient benefit. It brings together the U.S. Food and Drug Administration (FDA) and the industry for knowledge sharing that can speed up the manufacturing of safe, affordable, and effective devices.

A Leadership Engagement Playbook published by MDIC highlights the leading practices and tools that can empower leaders to shift their companies implementing a culture of compliance to a culture of quality for competitive advantage. With the globalization of supply chains, increased customer awareness, and demand for quality and safe products, life sciences companies are realizing the need for quality beyond compliance.

The four factors that are driving this shift towards the culture of quality include:

1. Preventing the loss of value due to poor quality
2. The FDA promoting the business case for quality and not just compliance
3. The rising voice of the patient in medicine, greater awareness about quality issues, and the influential role played by patient advocacy groups are key drivers of quality
4. Access to real-time data to measure quality performance

These have enabled life sciences organizations to work towards establishing a strong culture of quality as a competitive advantage with greater efficiency and scope for innovation. Rather than taking a reactive approach to quality, businesses are becoming more proactive, and the implementation of Quality Management Software is better facilitating the integration of quality with enterprise-wide processes.

10 Best Practices to Facilitate a Culture of Quality

Based on the organizational practices, gaps and needs, the company can decide on the concepts, processes, techniques, and practices it will implement. The playbook offers best practices that can be customized for the unique needs of companies and recommends piloting one or two best practices that will have the most impact on performance.

The 10 best practices recommended by MDIC for implementing a Culture of Quality include:

1. Facilitating a Culture of Quality across multiple stakeholders
2. Developing a Quality Strategy
3. Making Quality a Priority
4. Measuring the Value of Quality
5. Being Proactive, Not Reactive
6. Clearly Defining Quality at the Individual Level
7. Encouraging Quality Behaviors
8. Using Quality Benchmarking
9. Using Quality Metrics
10. Recognizing and Rewarding Quality

The journey to establishing a culture of quality begins at the top. Leaders must believe in the culture of quality and lead by example for long-term success and competitive advantage. It requires defining quality and communicating it to the rest of the organization clearly and consistently for it to become a transformative process across geographic locations and functions of the business.

Conduct a gap analysis to understand the current state of quality in the organization and how to nurture a performance-driven culture of quality best suited to your organization and based on customer requirements. For it to become part of the organizational culture, embrace the change needed and be transparent with your employees.

Establish metrics and key performance indicators to measure progress and make necessary changes to achieve the goal. These measures need to be supported by recruiting the right people and incentivizing employees to adopt the quality culture. Keeping pace with the trends, regulations, and emerging technologies is also essential to remain compliant and competitive.

Organizational data can help to draw insights, identify potential and existing quality gaps and arrive at the strategy best suited to your organization. It is important to review and update the strategy periodically and establish and communicate quality expectations to drive and sustain quality as part of the company’s culture. Implementing a quality management system, supporting the efforts with tools and training, and developing and deploying workstreams to strengthen quality behaviors would be critical.

Data-based decision-making can improve compliance as well as customer experience and satisfaction by empowering employees to create new experiences, making the changes in behavior more sustainable. This approach can help with change management and be more intricately woven into the fabric of the organization.

Define a framework to measure key aspects such as cost of quality, investment in good quality, and the benefits of good quality. This can help prioritize issues that need attention as well as areas that need higher investments for better quality. Measure failure costs as well as the value of quality by arriving at a common understanding of quality performance.

Integrate quality processes right from the product development stage and in collaboration with the respective teams to push quality culture upstream into the product lifecycle. Loop feedback back to the R&D teams and suppliers to prevent current field and production issues. Enable continuous improvement to achieve the next level of excellence.

Establishing an overriding theme is essential to align employee behavior and performance with the organization’s quality goals and objectives and can be achieved through quality planning activities such as setting clear goals and developing value statements. Training also forms an essential part of this alignment.

Measuring, benchmarking and rewards and recognition are some of the other ways in which a culture of quality can be established, sustained, and improved continuously.

A Quality Management System such as the one from ComplianceQuest facilitates establishing the quality of culture by providing the different tools needed to define quality, establish parameters, implement and track training, document and provide access to enterprise-wide data to make informed decisions. Built on the Salesforce platform, we offer a robust, scalable, and flexible solution that can help you automate your QMS efforts and integrate processes for greater transparency and accountability.

To know more about the ComplianceQuest EQMS software and how it can help you establish a culture of quality in your organization, contact us here:https://www.compliancequest.com/contact-us