By: Kaitlyn Needham, Sr. Manager, Quality Assurance
At our research facility, we believe Quality is not a person, a department, or a final checkpoint. Quality is built into the process from the beginning.
We want our teams making Quality Decisions every day before the work begins, not after something has gone wrong.
We are building a culture where people are not afraid to speak up, ask questions, identify risks, or acknowledge when something doesn’t work. This requires us to create an environment where failure becomes valuable information, and this information informs how we improve our quality processes.
When our teams can reflect, learn, communicate, and bring ideas to the table, we become stronger as an organization and better partners to our sponsors.
We’re also structured differently than a lot of sites’ quality organizations.
At most sites, quality control sits inside the department it’s checking, so the same team ends up reviewing its own work. Here, our QC staff are a separate team. They don’t do the operational work themselves. They observe it and report on it, so the person catching a mistake was never the one who could have made it.
And this is where I see the role of Quality differently.
QA should not be the department that shows up at the end to tell you what went wrong, but in the room where the work is happening. QA can and should be a support system, helping teams build Quality into their day-to-day work.
Because when Quality is embedded in the way a research facility thinks, communicates, makes decisions, and operates, it becomes much more than compliance. It’s part of who we are, and what I think makes JCCT, Juno, and CRC great site partners.
This is the kind of research facility we are building: a facility where quality isn’t something we add at the end, but rather how we work from day one.
I’m proud of how our team approaches quality. Every FDA inspection we’ve been through this year has come back with zero findings, a testament to embedding this essential function into site operations from the start.
This is the commitment I want people to feel when working with us: not that we’re perfect, because no site ever is, but that we’re not waiting for a sponsor to find something, an auditor to find something, or a monitor to find something. We’re proactively monitoring and resolving issues well ahead of when they become problems.
This is the standard we hold at Sequoia Clinical Research, across each and every study.
The five questions above are the ones we ask before every study starts. If you’d like to see how that translates into a site initiation, a monitoring visit, or an inspection, let’s talk about your next protocol.