OMB Meeting Book_9-11-14

Table 18: Reproducibility data for starch-based infant formula test sample

Sample ID: Sample 2 S-1111/S-2222 Analyte CMP

UMP

GMP

IMP

AMP

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

(mg hg -1 )

Laboratory

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

Rep-1

Rep-2

1 2

10.75 10.49

10.73

4.03 3.91 3.14 a 3.90 3.44 b

4.14 3.78 3.11 a 3.90 4.29 b

1.59 1.78

1.60 1.78

1.51 1.82

1.49 1.84

3.45 3.53

3.48 3.52

9.43

3

9.90

9.98

1.63

1.63

1.58

1.59

3.38

3.42

4

11.90

12.30

1.70

1.70

1.70

1.70

3.60

3.70

5

11.92

11.92

1.67

1.69

2.05

2.07

3.56

3.79

6

11.27

11.20

4.23

4.24

1.63

1.60

1.55

1.56

3.52

3.46

7

11.28

11.22

4.02

3.89

1.65

1.60

1.47

1.44

3.59

3.58

8

11.10

10.93

4.04 1.19 c

3.77 0.00 c

1.67 0.00 c

1.62 0.00 c

1.61 0.00 c 1.63 1.80 b

1.61 0.00 c 1.63 1.71 b

3.55 0.00 c

3.42 0.00 c

2.77 c

3.08 c

9

10

11.44

11.44

3.91

3.93

1.72

1.79

3.58

3.54

11

11.03

11.84

3.73

3.91

1.78

1.75

3.56

3.75

12

9.91

9.79

3.93

4.17

1.64

1.58

1.62

1.59

3.46

3.42

a Identified as Grubbs outlier; results kept in data set for statistical analysis. b Identified as Cochran outlier; results kept in data set for statistical analysis. c Problems were identified by participants and as Grubbs outlier results excluded from data set for statistical analysis.

Table 19: Reproducibility analysis for starch-based infant formula test sample

Sample ID: Sample 2 S-1111/S-2222

CMP

UMP

GMP

IMP

AMP

Analyte Symbol

Seq.

Item

Value

Value

Value

Value

Value

11 a

11 a

11 a

11 a

11 a

1

Total number of laboratories

n

2

Total number of replicates

2n

22

22

22

22

22

3

Overall mean of all data (grand mean)

10.99

3.88

1.67

1.66

3.54

4

Repeatability standard deviation

S r

0.30

0.21

0.03

0.02

0.08

5

Reproducibility standard deviation

S R

0.81

0.31

0.07

0.17

0.11

6

Repeatability limit in SMPR

≤6%

≤6%

≤6%

≤6%

≤6%

7

Repeatability relative standard deviation

RSD r

2.7%

5.4%

1.6%

1.4%

2.1%

8

Reproducibility limit in SMPR

≤11%

≤11%

≤11%

≤11%

≤11%

9

Reproducibility relative standard deviation

RSD R

7.4%

8.4%

4.2%

10.3%

3.0%

10

HorRat value

0.9

0.9

0.4

1.0

0.3

a Less than 2/9 laboratories removed from statistical analysis.