PEPFAR Quality Control and Method Validation Activity 14 Job Aid: Introducing a New Method

167 Job Aid: Introducing a New Method 1407 1. Pre-purchase Assessment 2. Installation and Calibration 3. Familiarization Period 4. Method Validation Plan* 4.1. Define quality requirement in the form of an allowable total error 4.2. Select the appropriate types of experiments to reveal the expected types of errors 4.2.1. Validation vs. Verification 4.2.2. Types of Error 4.2.2.1. Random Error (RE) 4.2.2.2. Systematic Error (SE) 4.2.2.2.1. Constant 4.2.2.2.2. Proportional 4.2.3. Types of Experiments for Verification of Manufacturer's Claims 4.2.3.1. Linearity Experiment 4.2.3.2. Precision Experiment for RE 4.2.3.3. Comparative of Method Experiment for SE 4.3. Collect necessary experimental data 4.4. Use statistical tools to estimate the size of the analytical error 4.5. Compare the observed errors with the defined allowable error 4.6. Judge the acceptability of the observed method performance 4.7. If acceptable, then perform reference range experiment 5. Introduction into Routine Service HILS1746 *From Westgard.com. The Experimental Plan for Method Validation. Last accessed May 1, 2013. Effective Date: 12/6/2016