By combining her curiosity and scientific mind, Dr Sabine Lehmann found her calling in quality management over 20 years ago. Today, she tells us about her experiences and what “good” quality management means for biobanks.
Interview by Sarah Weiler (SW)
SW: Why did you choose to work in Quality Management?
Sabine Lehmann: I didn’t exactly choose to work in Quality Management, it was more by accident. My initial reason for studying science was that I wanted to understand how the human being functions. This was of course quite the ambition at my young age, but it was guiding me throughout. At the time, studies like Biochemistry or Molecular Biology didn’t exist, so I started Chemistry with the idea of then extending more into life sciences. After my PhD in inorganic chemistry, I got that opportunity, when I was offered a manager position for a Quality Control (QC) group at a diagnostics company.
One of the things that I really liked at that first job and that made me want to continue working in QC, is that you get the chance to look at all the different pieces that make a company or a department run smoothly. You oversee a vast array of activities, so it never gets boring and you can learn something new every day, which perfectly suits my curious mind.
Linked to this, I find it also very satisfying to interact with so many different people. At IBBL for example, I do not have my own team, but in a way the whole biobank is part of my team, because I work closely with each of them. One of my roles as Quality Manager is actually to foster interactions between people from different departments, because it is impossible for everyone in the organisation to know all the different bits and pieces.
SW: Every company wants to provide products and services of high quality. Why is it desirable to invest in a formal quality management system (QMS)?
Sabine Lehmann: In some cases, a QMS is probably not required, because there are other ways companies can harmonise and standardise their work, for example by following best practice guidelines. However, a formal quality system, based on national or international standards, has the advantage that these norms have already been agreed upon by the majority of the stakeholders. By following such standards and implementing a QMS, you can generally improve your efficiency and ensure the integrity of your activities. Ideally, it also allows you to prevent errors and non-conform products or services. Finally, some norms give you the opportunity to get certified or accredited, which can enhance your market credibility.
SW: Why do you believe it is important for biobanks in particular to have a good QMS?
Sabine Lehmann: There are a lot of biological resources in biobanks all over the world, which are not fit-for-purpose. In most cases these samples are of unknown quality, because the information about the way in which they were collected, processed or handled is not available. This makes it very difficult to know up-front if a certain sample is fit for a specific purpose.
This is one of the reasons why IBBL carries out biospecimen research and why we believe biobanks should have controlled processes. The easiest way to do this is by implementing a QMS. The quality of a biological sample is not only linked to the chain of custody, but also to the equipment and to the knowledge of the people working on these samples; from the medical personal to the lab technician. In the end, if the handling of biological samples is standardised, research results will be better comparable between samples from different biobanks and we do not waste money and time doing research on samples of unknown quality.
SW: What is a “good” QMS for biobanks?
Sabine Lehmann: My colleague Fay Betsou and I are part of the ISO technical committee ISO TC 276, which aims to establish standardised norms covering, amongst others, biobanks and bioresources. The suggestion that we made to this working group is that biobanks should focus on the ISO9001 standard for the general quality management requirements. On top of that, technical standards, which require harmonisation and more specificity to ensure good quality of biological resources, should be developed. These should cover ethical aspects, acceptability of biological resources, specific requirements for the facilities and equipment as well as specific organisational aspects. Additionally, for the sample processing and sample testing requirements, it should be defined that methods have to be robust, reliable, accurate and validated to produce resources of consistent quality.
At IBBL, we are seeking two external acknowledgements, first the certification for ISO9001 as well as for the French bioresources norm (NF S 96-900), the next step will then be the ISO17025 accreditation, where our competence as testing organisation is acknowledged. Our vision for biobanks is to have a combination of the certification and the accreditation, so that they can ensure the consistency and compliance of their processes on one hand and the competence to deliver correct testing results on the other hand.
SW: You have been building IBBL’s QMS from scratch. What was the most difficult and what was the easiest part?
Sabine Lehmann: Coming here and starting from scratch was a very high motivation for me to join IBBL because it’s very rare that you get the opportunity to do this. To be honest, setting up the structure of the QMS was almost the easiest part of my job because, from the beginning, we had defined a very clear strategy as to which norms we would like to adhere to. So, the scope was well defined and the framework for the QMS was given. In addition, several best practice guidelines were already available in our field, for example the ISBER guidelines for biorepositories. Overall, the whole process of setting up the system was quite smooth, because we have a young, highly-motivated team for whom producing quality is inherent, since they are used to a scientific approach.
Filling a QMS with life is the easy part, the most difficult part is to maintain the quality over time, while carrying out day-to-day operational work. This is because things change all the time; norms or laws can change, new collections start, you gain new clients or purchase new equipment. Changes can make it challenging to keep everything compliant with your quality standards. This is why it is crucial that one’s QMS allows for a lot of flexibility, while always keeping an eye on efficiency and efficacy.