A narrow focus on regulatory compliance can hinder organizations from fully embracing and benefiting from quality and operational excellence.
In many life sciences organizations, there is a prevalent misconception that equates quality solely with compliance. This misunderstanding can pose significant risks to both products and patients, as it diverts focus from the core objective of safeguarding health to merely meeting regulatory requirements.
This article calls for a shift in mindset, advocating for a quality culture that prioritizes patient safety and product integrity over mere compliance.
The Quality Crimes: A Tale of Compliance
Quality and shortcuts are not friends.
This statement cuts to the heart of the issue—when organizations prioritize ticking boxes over ensuring genuine quality, they gamble with patient safety. Shortcuts in compliance can lead to devastating consequences: compromised product safety, non-conformities, product recalls, and regulatory penalties. Worse, they undermine the trust and put patients at serious risk.
Watch the video below to meet our quality crime-solving expert, QA Investigator Angel Buendía, who is on a mission to spread a culture of quality.
Misunderstanding the role of QA
Many believe that QA's role is primarily to ensure compliance with regulations. While compliance is important, QA's true purpose is to guarantee that products are safe, effective, and reliable for patients. Misunderstanding this can lead to a narrow focus on ticking boxes rather than ensuring genuine quality.
Examples of common misconceptions about QA:
- QA is just paperwork: Many think QA is merely about documentation and audits. In reality, it's about maintaining high standards throughout the product lifecycle.
- Compliance equals quality: There's a belief that meeting regulatory requirements means a product is high-quality. However, quality encompasses much more, including consistency, safety, and effectiveness.
- QA is a final step: Some see QA as a task to be completed at the end of the production process, rather than an integral part of every stage.
- QA is solely the responsibility of the QA department: In reality, quality is and should be everyone's responsibility within the organization.
- QA hinders innovation: Some believe that stringent QA processes can stifle creativity and innovation. However, robust QA can actually support innovation by ensuring new products are safe and effective.
Strategies to align QA efforts with your company culture
Over the past two decades, life sciences companies have viewed quality compliance as a necessary evil to get products to market. This perspective has led to a focus on meeting regulatory standards at the expense of true quality, which should ensure that products are safe, effective, and reliable for patients.
We’ve interviewed Angel Buendía, the star of our Quality Crimes series. As both the QA Crime Investigator on screen and Scilife’s Quality Knowledge Manager in real life, he provides valuable industry insights and best practices to ensure that quality remains a top priority for everyone.
Enhancing quality culture through strategic training and engagement
In our interview with Angel Buendia, we explored the critical role of training and education in fostering a robust quality culture within organizations.
Buendía highlighted the significance of training staff on quality and patient safety, emphasizing that it promotes high standards and ensures everyone understands their impact on patient outcomes. He noted, "An educated staff is better able to identify risks, mitigate errors, and contribute to a culture of continuous improvement."
Addressing the challenge of creating comprehensive and engaging training programs, Buendía suggested tailoring programs to meet diverse organizational roles. "Utilizing various methodologies like e-learning, hands-on training, and interactive webinars, along with incorporating real-life case studies, enhances engagement and knowledge retention," he explained. Buendía stressed the importance of a centralized source of truth with robust training tools and a learning management system to keep content updated and relevant.
Reflecting on challenges faced at Scilife, Buendía acknowledged initial resistance to training changes rooted in past experiences of a "shame, blame, and retrain" approach. "Many viewed quality initiatives as burdensome rather than integral," he observed.
Buendía shared successful strategies used at Scilife to overcome resistance and ensure participation in training programs. "We introduced interactive and engaging methods such as multimedia content, gamification, and hands-on activities," he described. "Our learning management platform facilitates quick content creation and centralized knowledge sharing, enhancing accessibility and communication."
Regarding Scilife’s evolving approach, Buendía emphasized a shift towards continuous improvement in training practices. "We’ve learned that a traditional approach is inadequate," he stated. "We now update programs regularly to incorporate industry best practices, regulatory changes, and feedback from our team." Furthermore, to get the whole organization on board beyond the quality department, Scilife launched an investigation challenge. In this challenge, teams were tasked with creating an adequate response to a real warning letter. This involved conducting a root cause analysis and developing Corrective and Preventive Actions (CAPAs). Prizes were awarded to the winning teams.
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Fostering organizational excellence through leadership and commitment
Leaders influence the organization through their decisions, actions, and communication, thereby shaping the overall quality culture. For a quality-centric culture to thrive, leadership must uphold quality as a non-negotiable value. "Their commitment to quality not only motivates employees but also sets the tone for the organization’s ethos," Buendia explains.
When asked about specific actions leaders can take to demonstrate their commitment to quality, Buendía outlines several key strategies. "Leading by example is crucial," he asserts. "It’s about walking the talk and embodying the principles of quality in everyday operations." Additionally, he emphasizes the importance of clear communication of quality initiatives to all staff members, ensuring transparency and alignment with organizational goals.
Moreover, Buendía suggests allocating sufficient resources to quality improvement initiatives and establishing recognition programs to celebrate employees who exhibit exceptional commitment to quality. "Open channels for employee feedback are also essential," he adds, noting that fostering a culture of continuous learning and involving staff at all levels in quality initiatives further strengthens organizational commitment.
Reflecting on initiatives that have successfully fostered a company-wide commitment to quality at Scilife, Buendía points to their eQMS (electronic Quality Management System) and the Smart Quality framework. "These frameworks streamline quality processes and ensure adherence to standards across departments," he explains. "They represent our proactive approach to embedding quality into every aspect of our operations."
Recommended learning: Discover what makes up a high-quality culture and how to implement one in your organization.
Building a collaborative quality culture
Buendía advocates for proactive measures to promote a quality-centric approach within teams. His suggestion to host lunch-and-learn sessions on corrective and preventive actions (CAPA) exemplifies this commitment. "Take the last three complaints, get the team together, and talk about them and how they might have been avoided," Buendía proposes, emphasizing the importance of learning from past issues to prevent future occurrences.
It is also important to encourage open and constructive discussions about quality issues among team members. "It’s crucial to create an environment where staff feel empowered to voice concerns and discuss quality matters without fear of retribution," he states. To facilitate this, he recommends organizing open forums, quality circles, and root cause analysis workshops. These platforms not only identify areas for improvement but also promote a positive approach to solving challenges.
A culture of accountability is vital for maintaining quality standards, Buendía asserts. "By defining clear roles, responsibilities, and expectations related to quality, employees understand their contributions to organizational success," he explains. Recognizing and rewarding individuals and teams for their commitment to quality further reinforces this culture of accountability and encourages continuous improvement efforts.
Smart quality as the way forward
Smart quality is a holistic approach to quality created by Mckinsey. This new quality model empowers life sciences organizations to transform quality into a key catalyst for value creation, rather than being merely an unavoidable cost of doing business. It’s about engaging staff to create value beyond regulatory requirements. This shift involves leveraging technology, advanced analytics, and predictive KPI trends to support informed decision-making based on real-time data and insights.
Identifying barriers to adopting a smarter quality culture, Buendía addresses common challenges. "Resistance to change is a significant barrier," he acknowledges. To overcome this, Buendía proposes clear communication of the benefits, early involvement of staff in the process, and targeted training to adapt to new processes and technologies.
Bonus resource: Take our smart quality maturity level quiz and find out how to improve your organization’s processes and quality culture.
Additionally, addressing leadership resistance to digital integration by providing necessary skills and emphasizing adaptability helps mitigate uncertainty and loss of authority in quality management processes.
Buendía emphasizes the correlation between a strong quality culture and organizational success. "A robust quality culture promotes continuous improvement, enhances employee engagement, and drives ownership of quality across the organization," he explains. This heightened focus on quality leads to improved products, increased customer satisfaction, and ultimately, higher revenue and profitability.
Assessing the strength of a quality culture requires tangible metrics and feedback mechanisms. "Customer and staff feedback through surveys, along with established quality metrics like customer satisfaction scores and defect rates, are crucial indicators," Buendía advises. Tracking audit findings, nonconformities, and corrective actions further gauges organizational commitment to quality. Continuous improvement initiatives, coupled with ongoing staff training and upskilling, serve as benchmarks for measuring the effectiveness of a quality culture in driving organizational excellence.
The path to achieving excellence through a quality culture
The journey from a compliance-focused mindset to a comprehensive quality culture is vital for life sciences organizations aiming for excellence. By focusing on a quality culture, life sciences organizations can achieve operational excellence, enhance patient safety, and drive innovation. This comprehensive approach not only meets regulatory requirements but also ensures sustained organizational success and improved patient outcomes.
Join the Smart Quality culture movement with Scilife’s Smart QMS. Start today!
