By Katie Pawlosky, NBAF Communications Director
October 2021
Many organizations and industries have standard operating procedures, or SOPs, to maintain safety, quality and company integrity. At the U.S. Department of Agriculture’s National Bio and Agro-Defense Facility, or NBAF, those SOPs will be crucial to everything from ensuring safe and reliable facility operations to creating quality research, data and products.
These procedures provide a clearly defined order and method for many facility activities, particularly in containment. One of the individuals who will oversee those is NBAF’s new quality assurance manager, Veronica Fris.
“At NBAF, I will oversee activities and provide expert advice on quality management and quality assurance in the research biologics program,” Fris said. “Quality is not just my job but the responsibility of everyone in the organization in the same way that safety is also everyone’s responsibility.”
The quality assurance program will give stakeholders confidence in NBAF’s biological research products — such as vaccines, anti-virals and biological disease countermeasures. The program will work closely with NBAF’s Biologics Development Module, a proof-of-concept facility that will support and accelerate technology transfers from NBAF that was discussed in September’s update.
Fris has extensive experience in the biological sciences — a degree in microbiology, stints as a hospital medical microbiologist, private industry food safety testing lab microbiologist and finally two years as a microbiologist with the Kansas Department of Agriculture, or KDA, testing state-regulated milk and meat products for food safety. Through these roles, Fris found a passion for laboratory quality assurance and was promoted to KDA’s quality assurance manager over the entire laboratory before coming to NBAF in August.
All outstanding qualifications and experiences aside, Fris has been collaborating with the quality specialists at the Plum Island Animal Disease Center in New York to learn their best practices and quality procedures. By learning from Plum Island’s operations and diagnostic testing programs, NBAF’s quality assurance programs can continue and enhance a successful legacy as USDA’s science mission transfers to NBAF over the next few years.
Like Plum Island, NBAF’s quality assurance programs will follow the International Organization for Standardization, or ISO, and Good Laboratory Practice, or GLP, regulations. Fris will also incorporate a four-stage cycle of Plan, Do, Check and Act for continual improvement.
“Maintaining quality is never a static process and always needs to be adjusted,” Fris said. “All facilities want to have an operation free of mistakes. Quality assurance supports that by promoting continual improvement.”
The Plan stage includes review of all the requirements for doing the work, a risk assessment, objectives, performance goals and team feedback. The Do stage includes effective work instruction, training, quality assurance and control monitoring, deficiency identification and quality reporting. The Check stage includes reviews and performance results, audit and assessment results, trend analysis and discussions of opportunities for improvement. The Act stage includes root cause analysis, preventive and corrective action and plan revisions as needed. Then the whole process cycles back to the Plan stage.
Fris’ team will include internal auditors, who will follow checklists to make sure research teams are meeting all required regulations as well as any additional standards identified.
“A major part of my job is having accurate instructions for analysts and technicians so they follow standard operating procedures and know what they should be doing,” Fris said. “Imagine trying to assemble a complex piece of furniture without instructions. I provide step-by-step guidance, oversee the actual assembly, make sure that people follow the instructions the way they are written, and help if I notice someone missed a step.”
NBAF’s quality assurance programs will go hand in hand with NBAF’s safety programs and are critical to a successful mission of protecting U.S. livestock from foreign, emerging and zoonotic diseases. Follow NBAF’s social media accounts on Twitter at @USDA_NBAF and LinkedIn at usda-nbaf as the facility continues to grow its team — especially the quality assurance team.