Sonia Christensen Stewart, MS, RAC is the Associate Director of QA Development at Grifols Diagnostic Solutions. Sonia has nineteen years of experience in the diagnostics industry including positions of responsibility in Quality Assurance, Compliance and Regulatory Affairs at Grifols, Novartis, Siemens and Bayer Diagnostics.
Why is supplier quality important?
Suppliers impact the quality of our products and ultimately, the well-being of our customers and patients. We are reliant on our suppliers to provide products that will ensure that the products we manufacture are safe and effective. The bottom line is that the success of our business, the safety of our customers and our reputation are to some extent all reliant up our suppliers. Anyone who has ever dealt with the aftermath of an unforeseen product change which impacted the performance of a product or a supplier who fails to deliver on a critical material knows the importance of supplier quality.
Describe a supplier quality initiative you will be focusing on in 2014.
This year will almost certainly require the qualification and management of a new original equipment manufacturer with whom we will co-develop a new product. That is always fun and challenging, from the due diligence efforts to the everyday management the product development process between two companies.
How do you see supplier quality within the diagnostic industry evolving over the next 5 years?
Because we are a business which has dual roles… that is we supply product to our customers and we rely on our suppliers to supply us, we know what an expense it is to constantly host customer, notified body and regulatory agencies auditing our business. I hope that we are able to move toward a system where a third party may audit a supplier on behalf of multiple customers and some of the expense of performing audits of others and hosting audits of our business can be reduced.
What has been your greatest achievement within your current role?
I have been in my current role only a few months, so I would have to say the greatest achievements of this role are ahead of me. In my last role, I was able to build a very strong team of capable, well trained individuals who worked well together. I had inherited a department with some supplier management actions overdue. With the right team in place, the work to catch up the important actions of monitoring performance and reviewing and updating quality agreements was done very quickly.