In celebration of International Quality Month, Anthea Dransfield (Head of Quality at Diligent Pharma) and Heather Olsen (Head of Quality at GenVault) sat down to discuss what really works in quality management. Their combined 57 years of experience in quality span pharmaceutical operations, food manufacturing, drug packaging, and biorepository management—and they had plenty to say about what works, what doesn’t, and what needs to change. Here are the key insights from their conversation.
Business Continuity: Practice Makes Perfect
On why testing matters more than documentation:
Heather: Training is very important, but it doesn’t stop there. Practice those drills and response plans with your employees and vendors, so everyone understands the ‘why’ behind what you’re doing and how to accomplish it. If you aren’t practicing regularly, the right response may not come to you quickly when something goes wrong. So, it’s really important to have those scheduled drills every six months or every quarter, depending on what the activity is.
Anthea: Training and practice really enable teams to adapt as the situation evolves.
On identifying evolving risks:
Heather: Your risks from two years ago could change today. The way that we identify changes in risk is by having strong metrics, measuring trends, reviewing data, how equipment is performing, non-conformances being reported through audits and inspections.
CAPA: Stop the Noise
On when CAPA becomes counterproductive:
Heather: Too many CAPAs create noise You want an effective CAPA program that addresses real issues and not one-off mistakes. If someone forgets a step, that doesn’t mean the whole process is broken. Overhauling everything for a single outlier isn’t helpful.
Anthea: Sometimes it just needs a correction. Someone didn’t follow the process, so you document what happened and fix it. But when minor issues start piling up across different areas, that pattern usually points to a deeper, more complex problem.
Root Cause Analysis: Beyond "More Training"
On digging deeper than the obvious answer:
Heather: When it comes down to it, asking, why did that happen? You have to really dig down to the why to get to the root cause if you want to address the underlying issue.
Anthea’s sticky note exercise:
Anthea: I once had a situation when I was head of quality for a clinical research unit. Everyone assumed the issue was training, but when we mapped out the process, using sticky notes to show what should have happened versus what actually happened, and applied tools like the Five Whys, Ishikawa diagrams, and even FMEA, we discovered the real problem. Training wasn’t the issue at all; a process change simply hadn’t been communicated to the team.
Heather’s documentation discovery:
Heather: We realized that a lot of our third party paperwork, was inconsistently signed off. A lot of minor findings were accumulating that turned into a bigger issue. It took reviewing all our procedures and realizing we were using different language instead of giving real examples. Getting everyone together to walk through real examples helped people open up with their questions and concerns. Hearing those gaps directly from the team allowed us to refine the process even further.
Writing Procedures That Work
On getting team buy-in:
Heather: Getting feedback from the team, is important to help develop the process. They feel like they had a part of that development and say-in, so they’re more likely to follow the processes that they had a buy-in to develop.
Anthea: We can write procedures all day, but the team can’t follow them and actually perform the activities if we’re not effective in having the right procedures in place.
Changing How Quality Is Perceived
On being a partner, not the police:
Anthea: When I started at a new company, I went and worked in the operational areas for a while. A few people asked why I was there, and I told them: if I don’t understand what you do every day, how can I make sure our procedures support you and prevent unnecessary CAPAs and deviations? They said, well, they’d never thought about it that way.
Heather: To me, having that partnership with operations is key for the quality team. Not micromanaging them, but being that partner to see if everything is effectively working as it should.
The Bottom Line
Heather: It’s very important to have everyone’s buy-in when it comes to quality. Having a quality program that works for everybody, not just for quality. Everyone should understand why we do things, how we do them, and if something goes wrong, how do we handle it together.
Anthea: Quality is so interwoven into everything. It really needs to be a true culture of quality and people thinking the same way so that we are setting both the business and the team members up for success.
Watch the full conversation to hear more insights from Anthea and Heather on navigating quality challenges in clinical trials.
