Laboratory Challenge
With a staggering list of recently tainted food and drug products in the U.S., product safety is understandably a growing concern of American consumers. The Food and Drug Protection Division of the North Carolina Department of Agriculture and Consumer Services (NCDA&CS) is playing a leading role in protecting the public from contaminated foods and drugs.
The Division’s laboratory, which tests samples for harmful substances and label claims, is the only food testing laboratory in North Carolina. To protect the state’s consumers, the laboratory must be able to rapidly produce accurate and defensible analytical results. As food and drug quality issues become more rampant and the Food and Drug Administration (FDA) becomes more reliant on state laboratories to test consumable products, the NC Food and Drug Protection Division laboratory must also ensure that its results are comparable to those at federal laboratories.
In an effort to demonstrate its competency and meet federal equivalency standards, the NC Food and Drug Protection Division laboratory is seeking accreditation under ISO 17025, General Requirements for the Competence of Calibration and Testing Laboratories, developed by the International Organization for Standardization (ISO). To be recognized by ISO, laboratories must demonstrate that they operate successfully under a rigorous quality management system. They must also prove their ability to generate technically valid results and demonstrate competent performance of their equipment, procedures, and personnel.
Because liquid handling is an important component of its sample testing processes, the laboratory focused on standardizing operator pipetting skills. The organization turned to Artel because of the company’s expertise in liquid handling, knowledge of best practices, and FDA-2400 compliance.
Solution
To demonstrate its ability to produce accurate results on par with federal standards and achieve accreditation to ISO 17025, the laboratory enrolled in Artel’s Pipetting Proficiency Training and Certification seminar, which is designed to minimize risk of operator error and improve data quality. Artel provides objective documentation of operator pipetting proficiency, helping the NC Food and Drug Protection Division laboratory meet ISO standards related to training and competence certification.
The Pipetting Proficiency Training and Certification program employs the Artel Method™ of training, which is a standardized, consistent teaching approach. The method includes education about the mechanical function of pipettes and various causes of failure, including choice of pipetting mode, tip insertion depth, and aspiration rates.
For standardized and comparable skills assessment, Artel tests pipetting technique pre- and post-training using the Artel PCS® Pipette Calibration System. The PCS provides NIST-traceable measurements of volume accuracy and precision and verifies volume in seconds, supplying instant feedback on proper technique. It also provides automatic documentation, an important component in ISO accreditation.
The NCDA&CS also uses the PCS to calibrate its pipettes. Based on ratiometric photometry, the PCS measures the absorbance of light by two standardized dyes to simultaneously determine the accuracy and precision of liquid volume dispenses. Prior to the PCS, the NC Food and Drug Protection laboratory calibrated its pipettes using mass analysis of de-ionized water. This method does not produce traceable results, is affected by environmental conditions, and can be time consuming.
Results
In light of recent cases of high profile food and drug contamination the responsibility of state testing laboratories to keep consumers safe is likely to grow. With Artel training and technology in place, the NC Food and Drug Protection Division laboratory has established a stringent liquid handling quality assurance program.
Artel’s on-site training gave NCDA&CS laboratory technicians a stronger understanding of the mechanics of pipettes and the importance of proper technique. The result is documentation to verify personnel pipetting proficiency and increased confidence in laboratory results. By equipping its personnel with critical pipetting skills, the NC Food and Drug Protection laboratory is strengthening the line of defense against the consumption of contaminated products.
About NC Department of Agriculture and Consumer Services
The NC Department of Agriculture and Consumer Services has responsibilities in regulatory and service areas covering agronomy; animal health; weights and measures; gas and oil inspection; crop and livestock statistics; USDA commodity distribution; state farm operations; food, drug and cosmetic testing for purity; agricultural marketing and promotion; agricultural marketing grading; international agricultural crop and livestock marketing; operation of the North Carolina State Fair and North Carolina Mountain State Fair; operation of five state farmers markets; research station operations; seed and fertilizer inspection; nursery and plant pest eradication activities; regulation of the structural pest control industry; agricultural environmental issues; state and federal agricultural legislation; and agricultural economic analysis.
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