Streamlining Supplier Onsite Pre-Assessments: Insights From an Independent Auditor

In this interview, Meaghan Loy, Senior Category Director, In Vivo & GLP Services at Scientist.com, sits down with Sandra Burlock, an independent lab auditor based in Shanghai, China, to discuss her perspective on the VERIF.i® program, a standardized on-site pre-assessment program for suppliers. With firsthand experience as a lab auditor for VERIF.i, Sandra discusses how the program not only simplifies pre-assessments for suppliers but also enhances transparency and credibility in a competitive market. Join us as Meaghan and Sandra explore the impact of VERIF.i and the ways it addresses traditional auditing challenges, making it a game-changer for both suppliers and biopharmaceutical companies alike.

Can you tell us a bit about yourself and your professional background?

My name is Sandra Burlock, and currently I’m an independent consultant working and living abroad here in China. I’ve been in China for about almost 17 years now. I initially came out working for a CRO. It was a very small stepping stone of going in and then helping them set up and train, and then, it became three months to six months to a year and two years - and then I just never left. I’ve worked with different CROs located in Shanghai. My last job was with NYU Shanghai and once my term was over I just decided to continue as an independent consultant here in Asia.

How long have you been conducting assessments for the VERIF.i program?

My first one was in 2022, if I’m not mistaken. So it’s been about three years right now, going around and different areas of China doing assessments for the VERIF.i program.

How does the program streamline and simplify the pre-assessment process for suppliers?

Basically, I just see it as a way for suppliers to demonstrate their quality and the services they offer, as well as show their commitment and responsibility towards ethical research and ethical treatment of animals. It gives them a chance to be transparent and allow clients to assess and evaluate their capabilities.I just see it as being a one-stop shop, allowing clients to have all the information from different suppliers and be able to compare what they have to offer.

On the other side for the biopharmaceutical companies, how does VERIF.i streamline processes for them?

Most pharma companies tend to do due diligence work and then look at all these different companies and see which ones fit best. However, going through [VERIF.i] allows them to have everything there just for them at their ease, at their fingertips, and to be able to compare apples to apples rather than having to compare apples to oranges. Everything is centralized and everything is standardized, which makes it very easy for them to get the information they need.

How do you think that the program ensures that it has integrity and that its objective?

Well, having independent auditors, like me, you can be objective rather than going in with a mindset. Also thinking about any conflict of interest that might interfere with the audit. You have to put that all aside to be able to ensure the objectivity and integrity of the audit process.

How do you think that the program addresses the challenges that are posed by conducting traditional onsite supplier assessments? I know you mentioned the checklist and being objective, but the traditional audit process is a little bit different. So how does this address those challenges?

For any client or company that looks to outsource or work with other companies, I can just imagine the travel, the scheduling, and the costs and time associated with having an on-site assessment.

The great part about VERIF.i is that you have key auditors in key locations that are able to help and support the clients and their needs, because I can only imagine traveling across the world for a one-day site visit and just the cost related to it, the cultural differences and all of that put together just makes it very heavy and a pain to be able to deal with all of that. Having these key auditors in place reduces the hassle and risks that might be experienced by both the supplier and the researcher. I think having people locally available puts the supplier at ease and then at the other end, it also puts the clients in the perspective of, “Okay, we can get this done without all the hassle that’s behind it.” I think COVID actually put pressure on us to get moving and be a bit more forward on dealing with this than it was before.

For the suppliers that usually have to host multiple client evaluations, that’s kind of an operational burden for them. So how does this support them in that way?

I have been on that side of the fence (receiving auditors), knowing the time it takes for preparation, the communications behind it and then spending all that time and energy in preparation for receiving the auditor.

I think that having this in one platform with all the information easily ready and available to everyone really helps. I can only imagine that some suppliers may have one, two, or maybe up to three auditors in a week or in a month and then just think about all the time that it takes for the supplier to be able to host - being available and taking care of the auditor, managing and then overseeing the audit - meanwhile their actual daily work is not being done. So I think coming in at this angle, it just makes all these suppliers realize, “Hey, if we can avoid all of this, again, it’s going to save time, money and resources.”

You mentioned where you’re located a couple of times, and I know that it’s an area that has a lot of suppliers in this space. So how do you think this program helps them innovate or stand out in what is a really competitive market?

I think it’s being transparent. I think they want to use this platform to be able to, I guess show off. Like you said, there are a lot of companies here. They’re all around, they’re growing, the business is growing and competition is really high. So having everything in one place and being transparent, showing your innovation, proving that you’re willing to change, that you’re willing to work towards getting better and then providing more services is really important. Because in the end, it is a competition. And then to be able to use this platform to be able to show everything that they can do.

So we talked about this a little bit, you know, about what sets the VERIF.i program apart from other assessment processes. But have you felt like that has been a big impact on your approach, especially when you’re considering animal welfare?

For me personally, I just love the standardized templates and the standardized reporting template. I think it makes my job easier when I go in and just having that objective mindset that I can just go in and know what I need to focus on. In most cases, I have one day to just go and assess and depending on the size of the institution, it’s a lot. And then having that as a driving tool, just really helps and supports the work that I need to do in that one day.

Can you talk a little bit about when you’re completing what we call “the checklist”, what all goes into that?

Like you said, it’s not just a checklist and it’s not just yes or no questions. This is the tool that’s gonna be going out to clients with all that information in one place. It’s the tool that I use to clarify each category and clarify everything that I see. I am the eyes and ears of the client. I want to make sure that the information that I provide is accurate and that I don’t necessarily assume that they know what I’m trying to say and I know that there could be somebody that’s on the other side of the world that’s trying to understand what I’m trying to project.

So the checklist is a great tool to be able to just summarize, be clear, and then detail each finding or detail all the information, whether it’s negative or positive. Even if they’re doing something right, I still write into detail what they’re doing right. And then if there’s recommendations, then I put into detail with proper references to say this will need to be addressed or this will need to be looked into further down the line.

How do you feel that VERIF.i has incorporated your feedback or feedback that’s been shared with you during visits into the process?

Most places that I do visit, a lot of this, it’s new to them, especially because you see these decisions coming from higher management that they want to add this process in place, but then when I go and do visits, you might talk to the veterinarian, you might talk to like a lower line manager and they’re like, “All right, what are you doing? What’s this?” And then I have the chance to explain what VERIF.i is all about, which is good. Then they are like, “Really?” A lot of them didn’t know that something like this existed, which is good.

And then on the other side, I think that the suppliers are really welcoming to information that I share with them. For example, after each of my visits, you know, I’ll go through my good and bad observations throughout the day. And after that, I will summarize everything in an email because I do want to make sure that you understand what I communicated correctly, especially with the language differences. Then talking and coming back and replying to those emails and then you see that they want to get better. They want to do better.

They’re very transparent. They share documentation with me. They share SOPs with me - “This is what we’ve done. This is what we fixed”, which makes it very easy on my side working with these types of suppliers when you see that they want to bring that change. And then bringing that back to the VERIF.i program people. But, like I said, having people that do want to just close that gap and be able to improve, I think it’s very well received.

Even when I look at my first report that I did three years ago and compared to what I do now as an auditor, we also evolve. Then coming back with information that you get from clients, if they’re wanting more details, we do adapt and try to see how we can improve and make things easier and streamline the information back to the supplier and the clients. There’s always room to improve.

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