Food security is influenced by food safety, and food safety cannot be achieved without testing laboratories. Data quality must be a priority for the laboratory performing the analyses for there to be food safety, but how is the quality of that laboratory and its results determined? Depending on the industry and the lab, there are several options. Some labs become accredited or certified, which requires proficiency testing (PT) to demonstrate the ability of the laboratory to receive samples, test samples, and report proficiently. However, quality within the lab starts well before PT with the development of a Quality Management System (QMS). A complete QMS needs to address many of the lab’s components. Such components include Quality Control and Quality Assurance and within those: method selection, standard operating procedures (SOPs), Quality Manual (if applicable), training and education, reporting, and proficiency testing, all while using some form of risk-based review (risk management, risk assessment, and risk analysis) to make sure the fit for purpose is appropriate for the lab.
A QMS can vary from lab to lab depending on many factors such as the analytes within their scope of accreditation or what is covered through their certification. QMSes are still needed for all labs, even those that might not yet be accredited or certified. This is of particular focus as part of AOAC’s partnerships in Africa. As an example, recently the African Food Safety Network (AFoSaN) has been training scientists on ISO 17025:2017 accreditation. AFoSaN is a group of food safety institutions including laboratories and other food safety stakeholders, uniting to strengthen food safety control systems in Africa, in collaboration with other stakeholders. The development of QMSes to support accreditation for African laboratories is of great importance.
Since QMSes can vary, a QMS developed for a lab performing microbiological analyses will differ from one conducting other types of analyses. Another group of labs newer to accreditation and/or developing QMSes are those analyzing dietary supplements. During this session, presenters will cover the various components and benefits of a QMS and how they are applied to their testing areas.
Bradley Stawick is the President of Stawick Laboratory Management, LLC, an independent consulting firm with 30 years of experience in testing, quality, and management. Through his career he has worked for multiple global and national contract laboratory providers where he served in senior management roles in operations and quality specializing in food, environmental, agriculture, and life science specialties. He has a Master of Science in Food Science, a Master of Business Administration, and a Bachelor of Science in Biology. He is a Certified Food Scientist, a professional member of the Institute of Food Technologists (IFT), the International Association for Food Protection (IAFP), and AOAC INTERNATIONAL. He is Chair of the Technical Division on Laboratory Management (TDLM), a member of the Analytical Laboratory Accreditation Criteria Committee (ALACC), a past member of the Official Methods Board (OMB), and an AOAC Fellow. He also serves on the A2LA Accreditation Council and President’s Advisory Council and is Chair of the Life Science Advisory Committee at A2LA.
Gary Swanson is senior vice president of Global Quality Assurance and Control at Herbalife Nutrition where he is responsible for all corporate and regional quality assurance teams, as well as the testing laboratories and quality operations at Herbalife Nutrition Innovation and Manufacturing (HIM) facilities in Lake Forest, California; Winston-Salem, North Carolina; and Suzhou, China. He is also responsible for Herbalife’s Quality Center of Excellence at HIM Changsha, China. Swanson has more than 30 years of experience in nutritional and pharmaceutical quality and operations roles and has been with Herbalife Nutrition since 2009. In that time, he has assembled and leads a world-class team that has completely transformed the quality assurance and control functions worldwide.