1 MEASUREMENT UNCERTAINTY WORKSHOP Lab Accreditation Meeting St. Petersburg, FL. Jan. 24th 2017 2 Measurement Uncertainty Workshop • Welcome • Sue Humphries, Acting Quality System Manager, Office of Regulatory Affairs, Pacific Regional Laboratory Northwest, U.S. Food and Drug Administration • Patricia Hanson, Biological Administrator l-Microbiology Supervisor, Bureau of Food Laboratories, Florida Dept. of Agriculture and Consumer Services • Heidi Hickes, Bureau Chief, Analytical Laboratory Bureau, Montana Dept. of Agriculture 3 Outline • What is Measurement Uncertainty (MU) • Why does ISO 17025 care about MU • ISO17025 requirements • Microbiology/Chemistry MU examples applied in real LAB setting • Volunteers for hands on MU determinations • Take Away MU messages 4 What is Measurement Uncertainty ? • When repeated measurements give different answers • How widely spread are the values—wiggle room • Judge quality of measurement from the spread • Measure AVERAGE and STDEV in EXCEL 5 What is Measurement Uncertainty ? • Standard deviation-quantify spread • STDEV expressed in units measuring • %RSD: Relative Standard Deviation • %RSD=divide STDEV by AVERAGE multiply by 100 • Universal Unit 6 Why does ISO 17025 care? • Measurements are subject to errors. • Measurements have uncertainty associated with it. • Result is incomplete without a statement of MU. • Without MU give wrong impression to customer 7 ISO 17025 Requirements • Requires MU be estimated for your method • Requires procedures to estimate MU • Identify all components of uncertainty • Follow conventional methods 8 ISO 17025 Requirements • Make Reasonable estimation of MU • Express uncertainty values consistently and properly • Ensure report does not give wrong impression of uncertainty 9 ISO 17025 Requirements • Need to put a number to the uncertainty • Understandable and relevant • You do not have to hire a statistician! • Reasonable estimation based on method 10 Practical and User Friendly • Become familiar with uncertainty language • Become familiar with basic steps • Follow conventional methods • Make a Reasonable Estimation • Traceable: others need to understand what was done 11 “A person who never made a mistake never tried anything new.” Albert Einstein 13 Take Aways • ISO requires MU be determined for each method • ISO require procedures for determining MU • Follow conventional methods • Expressed properly • Understandable and usable • Traceable
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