Quality Culture

Welcome to the first 1, 2, 3 Quality newsletter!

Today, we will explore the fundamentals of Quality Culture and its vital role in shaping the success of your organisation.

During my 20+ years working in clinical research as an employee and consultant, I have seen firsthand how quality impacts organisations of all sizes and types. Several real-life examples illustrate the importance of quality to an organisation's success. For instance, during my corporate career, I encountered a case study of a clinical trial at the pre-closure stage. After identifying critical gaps in the monitoring process of the originally contracted Clinical Research Organisation (CRO), the Sponsor contracted another CRO to re-monitor the data. This was a massive undertaking affecting the Sponsor financially, which resulted in a serious delay in the entire process.

Diverse Organisations, Diverse Quality Solutions

From tiny biotechnology companies with a handful of employees to market leaders with a global workforce, quality holds equal importance. However, there is no one-size-fits-all quality solution. Life science organisations have unique strengths, weaknesses, and quality approaches. For instance:

1. Big Organisations with Global Presence:

These companies often have a clear organisational structure and a well-established quality department. They rely on historical knowledge and have defined systems and tools to measure quality. Key Performance Indicators provide an overview of quality, but ensuring every employee operates with a quality mindset and adheres to regulatory standards remains a challenge.

1. Start-up Biotech Companies:

With very few team members wearing multiple hats, these startups face different challenges. While they may know who did what and when they often lack quality assurance expertise. Balancing business development and project delivery can take priority over setting up a proper Quality Management System. Also, their processes, like SOPs, training, etc., can be manual, which creates quality risks.

Establishing a Quality Culture: The Path to Excellence

So, how can all these diverse companies consistently operate and deliver products and services that meet the highest quality standards? I believe the answer lies in establishing a strong Quality Culture within the organization. At its core, a Quality Culture is a shared mindset and set of values that prioritise delivering products or services that positively impact patients and their families. While there are multiple definitions, each organisation can define it in its own words.

How to establish a Quality Culture in your organisation:

1. Make sure Leaders stay connected with your WHY:

Encourage leaders to approach tasks and decisions from a patient-centric perspective. Connecting to improve patients' lives through your products or services will drive a quality culture throughout the organisation.

1. Walk the talk:

Leaders must lead by example. Embrace a quality mindset in all your actions and decisions, demonstrating to the rest of the team the importance of quality in achieving the organisation's goals.

1. Create a community:

Foster an environment where all employees feel part of a united community working towards a common quality-driven vision. Encourage collaboration and open communication among team members at all levels.

1. Invite feedback:

Forget about blaming culture and stop penalising employees for their mistakes. Encourage constructive feedback from employees at all levels. This helps identify areas for improvement and demonstrates that the organisation values team input.

In Conclusion: Cultivating Excellence

Building a Quality Culture takes time and effort, but the rewards are immense. A strong Quality Culture not only ensures compliance and high-quality deliverables but also boosts employee morale, customer satisfaction, and overall organisational success.

I have seen this over and over again as a Project and People Manager for various teams and in different geographies. Employees value a quality culture. It improves staff retention, raises employee engagement, and contributes to better departmental and organisational outcomes. Nurturing a quality culture helped me build strong, determined, and successful teams that excel in project delivery and client satisfaction, and enjoy working together.

It can enable you to achieve your leadership and organisational goals too.