2014 ERP New Member Book

G UIDELINES FOR S TANDARD M ETHOD P ERFORMANCE R EQUIREMENTS

AOACO FFICIAL M ETHODS OF A NALYSIS (2012)

Appendix F, p. 10

Table A7. POD andnumber of test portions a,b

Sample size required for proportion

Assume Inference

1. Binary outcome (occur/not occur). 2. Constant probability rho of event occurring. 3. Independent trials (e.g., simple random sample). 4. Fixed number of trials ( N )

95%Confidence interval lies entirely at or above specifiedminimum rho

Desired

Sample size N needed

1-Sided lower confidence limit on rho c ,%

Expected lower confidence limit on rho,%

Expected upper confidence limit on rho,%

Minimum probability rho,%

MinimumNo. events ( x )

MaximumNo. nonevents ( y )

Effective AOQL d rho,%

Sample size ( N )

50 50 50 50 50 55 55 55 55 55 60 60 60 60 60 65 65 65 65 65 70 70 70 70 70 75 75 75 75 75 80 80 80 80 85 85 85 90 90 90 95 95 95 95 98 98 99 99

3

3 8

0 2 6

52.6 54.1 51.6 52.0 50.8 59.7 65.2 56.8 57.1 55.9 64.9 65.2 62.2 62.4 61.0 68.9 65.2 67.8 65.1 65.0 72.1 78.7 73.8 70.7 70.4 76.9 78.7 80.4 76.5 75.9 80.3 80.4 82.7 80.2 88.1 86.0 86.1 93.7 90.4 91.0 95.7 96.7 95.2 95.5 98.0 98.2 99.0 99.1

43.8 49.0 48.1 49.5 49.0 51.0 59.6 53.1 54.6 54.1 56.5 59.6 58.4 59.8 59.2 61.0 59.6 64.0 62.5 63.2 64.6 72.2 69.9 68.0 68.6 70.1 72.2 76.4 73.9 74.2 74.1 76.4 80.1 78.5 83.9 83.5 84.6 91.2 88.6 89.5 94.0 95.4 94.0 94.3 97.1 97.7 98.6 98.8

100.0

71.9 71.7 66.8 63.7 59.5 75.5 79.8 71.0 68.2 64.3 78.3 79.8 75.2 72.8 69.1 80.5 79.8 79.4 75.1 72.7 82.3 86.1 83.6 79.7 77.4 85.0 86.1 88.2 84.2 82.2 87.1 88.2 88.8 85.8 91.9 91.1 90.6 95.6 93.9 94.1 97.0 97.7 97.0 97.2 98.6 98.8 99.3

10 20 40 80 10 20 40 80 10 20 40 80 10 20 40 80 10 20 40 80 10 20 40 80 11 20 40 80 20 40 80 40 60 80 60 80 90 96 4 5 6 7 9

94.3 85.5 77.9 70.0

14 26 48

14 32

4 9

0 1 5

100.0 100.0

15 28 52

88.8 81.9 74.5

12 28

5 9

0 1 4

100.0 100.0

16 30 56

91.9 85.8 78.9

10 24

6 9

0 1 3 9 0 0 2 7 0 0 1 5 0 1 3 0 2 6 0 2 3 0 0 1 1 0 1 0 1

100.0 100.0

17 31 59 10 18 33 63 10 19 35 67 11 19 37 70 20 38 74 40 58 77 60 80 89 95 7 9

94.8 87.7 82.1

21

100.0 100.0

97.2 91.3 86.3

17

100.0 100.0 100.0

94.5 90.3

13

100.0 100.0

97.4 93.1

10

100.0

98.6 96.5

100.0

99.1 98.7

100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0

130 240 280 480

130 239 280 479

99.4 a Table excerpted fromTechnical Report TR308, Sampling plans to verify the proportion of an event exceeds or falls below a specified value , LaBudde, R. (June 4, 2010) (not published). The tablewas produced as part of an informative report for theWorkingGroup for Validation of IdentityMethods for Botanical RawMaterials commissioned by theAOAC INTERNATIONALPresidential Task Force onDietarySupplements. The project was funded by theOffice of DietarySupplements, National Institutes of Health. b Copyright 2010 by Least Cost Formulations, Ltd.All rights reserved. c Based onmodifiedWilson score 1-sided confidence interval. d AOQL=Averageoutgoing quality level.

©2012AOAC INTERNATIONAL