I’ve worked for CMOs making plasmids, protein products, vectors, etc., as well as a lot of facility and equipment validation work. I’ve also worked for industry and academia. I started in production, moved into validation, and then transitioned over to Quality about fifteen years ago.
It’s a recognised role in the EU and UK, and the legal basis is defined in the relevant EU directives or UK legislation. There’s really a three-step process to being qualified as an EU Qualified Person. First, you have to complete the required academic component, which exists to ensure that your understanding of the relevant syllabus topics is sufficiently robust. Second, workplace experience in a number of areas is required to provide real world problem experiences; essentially, you have to have lived it as well as learned about it. Finally, there’s a panel examination in which you are given questions by a QP panel of experts, allowing you to prove not only the depth of your understanding, but also your ability to effectively communicate what is needed to colleagues or clients. The exam can be taken more than once if necessary, but I passed mine the first time I took it.
We’re the ones people come to when they’ve got a problem and need to learn from it as an organization. You never want to treat a mistake or error as a one-off because without looking into the root cause you’ll have no idea how many other people have had that event happen, how many products or processes might have failed without your even knowing about it. Industries tend to treat Quality as a checkbox but it’s more accurate to think of it as a tool that helps drive business forward: as a business system, not just a quality system. I don’t know a single CEO who wouldn’t want to stop repeating the same mistakes if they could, and that’s what we’re here for. For the most successful companies, quality is a way of life. If it hasn’t been a centered concept in the past, though, the organizational change necessary can be immense. It’s natural for people to be concerned about a quality review but the fact is that a robust Quality System actually helps and supports everyone.
None of us really enjoy having our assumptions challenged, and that’s a step that you have to take first. We have to have open conversations across functional groups, we have to involve the operators on the floor and also senior management. How easy or difficult this is for everyone involved has a lot to do with the cultural fit of an organization. The great news is that once an organization has adapted to this way of viewing problems, continually levelling up and improving becomes the norm.
This may be a bias of my speciality, but I think sometimes organizations turn to risk assessment to get the answer they have already decided on, without really using the tool to dive deeper. The whole purpose should be to generate understanding of the problem: the process, the risks, the potential effects, and the all-important steps to control any risks. Risk assessment is a critical tool, but I don’t believe it should be used without at first acknowledging that improvements to existing process can be made.
Completion of a project is always a wonderful feeling. Quality has a cost, because it requires people, systems, time, functions, etc., but the payoff is huge. Professionally, it moves the project forward in a timely fashion, which is necessary and ultimately a cost savings, and personally almost nothing feels better than the confidence you have when you’re ready for an inspection. In a perfect Quality world, notification of a “surprise” inspection tomorrow shouldn’t change a thing about your day today, because on any given day you have everything under control.
I have a Biology degree (molecular genetics) and a Masters in molecular parasitology. It’s similar in some ways to what I work with now, but with mosquitos as the vector rather than a virus. I always liked being prepared and then the methodology, structure, and framework of science was just right for me. You plan something, execute it, and conclude. The structure is a natural Quality fit. Similarly, each time we discover something new we learn something about the interactions that take place, and that ties back to the root cause and the “why” behind it all.
I am a bit of a control freak, as you might expect. I’m not a fan of surprises, even for birthdays, because I always want to know what’s happening. Holidays and days out are planned to the letter, times, locations, tickets, the whole works…. “just winging it” doesn’t feature.
One of my interests is reading about human behaviour and psychology. You know how when a child tells you a white lie it’s usually very obvious? I’m intrigued by how deception works as we change and grow. Knowing a person in context changes how effectively you can read them and sense whether they have concerns that they may not have spoken of yet. I also enjoy watching how the concept of mirroring plays out in personal relationships. Once you watch the back and forth between people you can pick up on lots of conscious and unconscious mirroring. There’s a comfort in seeing ourselves in others and most people use this technique without even realizing it. In my position I think it’s greatly helpful to be able to facilitate a conversation and understand the baggage someone is bringing with them as well as what drives them. We have to know how to speak to and understand each other. Being able to read psychological cues helps me be a better partner to everyone, whether that person is a client or a colleague…or family member!
I balance my enjoyment of wine with time spent at the gym, and I’m a board game aficionado (as are my family members). And, I’ve got a pretty good green thumb and really enjoy growing vegetables in addition to decorative plants. Nine years ago I planted a bird of paradise but after many years of nurturing it still had no flowers. Then, due to a surprise cold snap three years ago, it almost died. I’ve been nursing it back to health since then and it just bloomed for the first time. See the picture above!
Pictured: Ian, surrounded by his birds-of-paradise and psychology books, including his current read, Chris Voss’ Never Split the Difference.