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In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman spoke with David Marks to discuss how to establish a genuine Quality Culture through a focus on communication pathways.
David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs.
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A few key points from the discussion:
Quality and Operations: separate but partnered
David stresses the importance of keeping Quality and Operations as distinct entities — but not siloed — to prevent any conflicts of interest. However, he also advocates for a robust partnership and transparent communication between the two. He emphasizes the significance of a proactive approach in Quality culture, which results in fewer audits, audit findings, and reactive measures. David further highlights the necessity of a strong partnership between Operations and Quality, where issues are addressed early and openly.
“I think in any healthy organization, you need to have Quality Assurance be separate from Operations. I realized that in the grand scheme of things, you all report to the CEO. So ultimately, you will report to the same person at some point. I feel like at a simple view, Quality being separate from Operations removes the appearance of conflict of interest.”
A few action items:
Establish Clear Roles and Boundaries: Document and communicate specific roles and responsibilities for QA and operations teams. Ensure that these roles are understood organization-wide to maintain clarity and prevent overlap. For example, QA roles might include conducting regular compliance audits while operations focus on process optimization.
Establish Independent Reporting Structures: Set up separate reporting lines for QA and operations to higher management.
Implement Cross-Departmental Meetings: Schedule monthly meetings with predefined agendas focusing on collaboration, project updates, and issue resolution. Assign a “moderator” to ensure balanced participation from both departments.
Develop Shared Goals and Objectives: Identify KPIs that require input from both QA and operations, like product defect rates or customer satisfaction scores. Regularly review these KPIs to assess collaboration effectiveness.
The role of Quality culture
David emphasizes the importance of a Quality culture in achieving operational efficiency, cost-effectiveness, and regulatory compliance. This culture involves proactive problem-solving and practical thinking rather than simply following procedures. A robust Quality culture aids in preventing issues and promotes smoother communication between different departments.
“Quality culture can mean so many things in so many groups within an organization, not just biopharma. But within the biopharma group, and I'm thinking about the clinical area, you need to have a culture of Quality, because Quality and Operations need to be separate. But then you'd be partners. And if they're not singing from the same hymn, so to speak, you're going to have, you're going to have friction. You're going to have problems. And either you'd end up with more audits, more audit findings, and more reactivity versus the proactivity. That I feel like a Quality culture really builds more mature, proactive organizations."
A few action items:
Implement a 'Preventive Action Report' System: Create a system where employees can report potential issues or areas for improvement before they become problems. For example, use a simple online form or a dedicated email address where staff can submit their observations or suggestions.
Regular 'Quality Circle' Meetings: Organize monthly Quality Circle meetings where teams discuss potential Quality issues and brainstorm preventive strategies. Focus these meetings on specific areas or processes within the organization to ensure targeted discussions.
Quality Forecasting Sessions: Conduct quarterly forecasting sessions to predict potential Quality challenges based on trends, customer feedback, and industry changes. Use these sessions to develop preemptive strategies and action plans.
Challenges in Quality assurance
David addresses the traditional view of Quality assurance as a 'necessary evil' and an added cost. He counters this by illustrating how investing in Quality can prevent more significant expenses down the line, akin to regular maintenance of a vehicle.
"I think, generally speaking, when people think of Quality, it's somewhat of a necessary evil. And it's an added cost. I don't know if you've ever seen the meme on LinkedIn. But I know a lot of other people have. There are two mason jars an it has QA budget before a warning letter and QA budget after right there are no coins in this one, and it's full over here. So investing in Quality with the understanding that it's not just an added expense. In fact, it can actually do the opposite and reduce costs that can come later on down the road."
A few action items:
Highlight the ROI of Quality Investments: Regularly communicate and demonstrate how investments in Quality lead to cost savings and efficiency improvements.
Case Studies and Success Stories: Share internal or industry case studies that illustrate the long-term benefits of investing in Quality.
Building trust and communication
David emphasizes the significance of trust and transparent communication between the Quality and Operations departments. Quality professionals must cultivate an approachable attitude and create a comfortable environment where Operations can confidently seek advice or report any issues. It is crucial to promote a culture where operations and Quality can exchange questions and answers freely.
"But I think ultimately, people want to do things right the first time. But also, again, you need to have a separation between Operations and Quality. But ultimately, if there's a healthy partnership there and you have a Quality culture, people are free to bring Quality in earlier rather than waiting until the — as we used to joke — ‘no, don't wait to the barn is on fire, yeah, go to QA and say, ‘hey, we've got a barn fire,’ versus saying, ‘key, we have this little thing, and if we don't address it now, we think it could kind of grow quickly.’ But that takes courage to really reach out to if you don't have a culture of Quality to reach out and bring Quality in."
Develop Trust-Building Initiatives: Implement initiatives aimed at building trust between the Quality and operations teams.
Make Quality Teams More Accessible: Ensure that Quality professionals are approachable and available for consultations with operations staff.
Encourage a Culture of Openness: Create an environment where asking questions and seeking clarifications is encouraged and valued.
Encouraging open dialogue and anonymity
David emphasizes the significance of having systems in place that enable employees to ask anonymous questions to their Quality group without any fear or hesitation. He suggests that informal discussions after work hours, known as "5:01 discussions," can create a more relaxed environment for open dialogues, leading to the resolution of minor issues before they escalate into bigger ones.
David highlights the importance of building a culture of trust, where employees feel secure to raise concerns without fearing consequences. He advises on encouraging employees to ask questions and raise issues, stressing the potential negative outcomes of not addressing small problems early.
"I think over time, something that started innocently with me that grew was what a colleague later called the ‘5:01 discussions,’ the things you talk about after five o'clock. We worked for a company that really didn't have good communication pathways between Operations and Quality. And so, at the time, I actually was dating a person who was in Operations and, so I sometimes found myself in the same social circles with her. And people were like, ‘oh my gosh, what's the QA guy doing here?’ But then after a while, it sometimes like, ‘hey, while you're here, yeah, I had this situation.’ You're in a safe environment, you may be at a restaurant or a sports bar is something you're out of the office. And, but I always like to help in Quality. I think you have a different mentality to having some people in Quality, who love the power of auditing.
A few action items:
Quality Feedback Boxes in Common Areas: Place physical feedback boxes in common areas like break rooms or near meeting spaces for anonymous Quality-related suggestions or concerns.
Organize Informal Discussion Sessions: Schedule regular, informal "5:01 discussions" or similar after-work meetings to encourage open dialogue in a relaxed setting.
Foster a Trust-Based Culture: Actively work towards creating an environment where employees feel safe to voice concerns without fear of repercussions.
Encourage Questioning and Reporting: Regularly remind and encourage staff to raise questions and report issues, no matter how small they may seem.
Investing in Quality as a cost-saving measure
Investing in Quality is likened to an investment for the future, where initial costs can lead to long-term savings and prevention of larger issues.
"I almost look at Quality is like maintenance on your automobile. I know a lot of people that don't want to spend the money on the maintenance. And then later on down the road, their engine fails, right? Or their braking system starts to fall apart. So the maintenance can save you money down the road. It's an investment for the future."
A few action items:
Allocate Budget for Quality Initiatives: Ensure that there is a dedicated budget for Quality assurance and improvement initiatives.
Educate on Long-Term Benefits: Conduct training or informational sessions to help staff understand how investing in Quality leads to long-term savings.
Monitor and Review Quality Investments: Regularly review the outcomes of investments in Quality to identify and communicate the cost-saving benefits.
Leadership's role in cultivating Quality culture
Leaders within an organization must actively demonstrate and reinforce a culture of Quality, going beyond mere statements to actual practice and collaboration with Quality assurance.
I think good leaders in Operations or Quality, or together, I could probably partner up with that impact analysis, or in a way to put some flesh on the bone of what that effort to prevent meant to the organization, and how that may have been cheaper or leaner than just the rest of the traditional Quality assurance operations. There's no one way to do it. But also those become, I think, good townhall topics to where leaders can come back to town hall and say, ‘hey, here's an example of where our Operations and Quality work together.’ Those are the feel good stories. Those aren't metrics, those aren't KPIs.”
A few action items:
Lead by Example in Quality Practices: Ensure that leadership consistently demonstrates commitment to Quality in their actions and decisions.
Collaborate with Quality Assurance Teams: Set up regular meetings between leadership and Quality assurance teams to discuss Quality issues and strategies.
Communicate Quality Goals and Achievements: Regularly communicate the organization's Quality goals and achievements to all staff.
Encourage Leadership Training in Quality Management: Provide opportunities for leaders to receive training in quality management and culture cultivation.
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The Link Between Quality Culture and QA Communication Pathways with David Marks