PEPFAR Quality Control and Method Validation Activity 10 Worksheet 1: Predicting PED Capabilities

Worksheet 1: Predicting PED Capabilities 1006 HILS1746 Effective Date: 12/6/2016 Directions: Determine the approximate probability of error detection (Ped) and percentage for the following methods when three levels of controls are used. Place a tic mark next to those QC rules that are candidate QC rules (Ped 2 .09 and Pfr < 0.05) for the analytical system. Example A Example B SEc = SEc = 3 Sigma = 5 Sigma = Candidate Rule Pfr ~Ped N R Candidate Rule Pfr ~Ped N R QC Rules QC Rules (%) (%) 1:3s/2 of 3:2s/R:4s/3:1s/6x 0.07 1:3s/2 of 3:2s/R:4s/3:1s/6x 0.07 6 (7%) (7%) m m 1:3s/2 of 3:2s/R:4s/3:1s/6x 0.03 1:3s/2 of 3:2s/R:4s/3:1s/6x 0.03 N (3%) (3%) 1:3s/2 of 3:2s/R:4s/3:1s 0.05 6 1:3s/2 of 3:2s/R:4s/3:1s 0.05 (5%) (5%) 1:3s/2 of 3:2s/R:4s/3:15 0.02 3 1:3s/2 of 3:2s/R:4s/3:1s 0.02 W (2%) (2%) 1:3s 0.01 6 1:3s 0.01 6 (1%) (1%) m m 1:2.5s 0.03 1:2.5s 0.03 (3%) (3%) m 0.01 1:3s 0.01 m 1:3s (1%) (1%) 1:3s 0.00 1:35 0.00 (0%) (0%) 104 Worksheet 1: Predicting PED Capabilities 1006 HILS1746 Effective Date: 12/6/2016 Example C SEc = Sigma = 3.0 Candidate QC Rule Pfr ~Ped N What additional actions besides statistical Rules (%) quality control (SQC) do you propose for this method? 1:3s/2 of 3:2s/R:4s/3:1s/6x 0.07 6 (7%) 1:3s/2 of 3:2s/R:4s/3:15/6x 0.03 3 (3%) 1:3s/2 of 3:2s/R:4s/3:1s 0.05 6 (5%) 1:3s/2 of 3:2s/R:4s/3:1s 0.02 m (2%) 1:35 0.01 (1% 1:2.5s 0.03 m (3%) 1:3s 0.01 m (1%) 1:3s 0.00 (0%) 105