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ENFSI DWG Calculator for Qualitative Sampling of Seized Drug

(version July 2017)


Instructions
This file was created and validated by the Microsoft Excel 2003 software. Excel_2003 file was then also saved a
“Excel 2007 Macro-Enabled” format (.xlsm) and the basic functionality of application was retested. Inconsistenc
not detected. Therfore, the users of the Excel 2007 can save the aplication in "Excel 2007 Macro-Enabled" (.xlsm
In the .xlsm format the file size is reduced and calculations run faster.

Click "enable Macros" on file opening, otherwise macro buttons will not work! Macro Security level shall be adj
medium level to allow macros to run. To set up the Macro Security level go to: Tools/Macro/Security or equivale
command for excel 2007 and choose medium.

This Excel file has eight sheets (Tabs): Instructions, Hypg_Proportion, Hypg_Number, Bayesian N<50, Bayesian
Estimation of Weight, Estimation of tablets, Changes On Revision.

Hypergeometric Sampling Tool - version 2012

See the background of the Hypergeometric sample size calculation, some limitations-restrictions and the validatio
in the file: DWG-SGL-002-vers001_Hypgergeometric_CalculationBackground_And_Validation.pdf

1. Two types of calculation are enabled: For the calculation based on the proportion of positives select the Hypg_
tab and for the calculation based on the number of positives the Hypg_Number tab.

2. Enter data (steps 1 to 4) and see the results (steps 5 to 7).

3. Maximum population size (Nmax) is adjustable by user. To keep the file size relatively small, Nmax = 1000 is set
Click the appropriate macro button to change (extend/reduce) the population size, when needed. Important : Not
higher values of Nmax the file size will increase significantly, calculations are becoming slower and the idle tim
saving and opening will increase!

Other calculations - (version 2015) (changed but not revalidated)


See the validation reports in the file: DWG-SGL-001-vers002_ Validation Report on Qualitative Sampling Guide

Bayesian Sampling

1. Select either the Bayesian N>=50 or the Bayesian N<50 tab.


2. Enter the desired values for steps 1,2,3,4,5 &6.
Note 1: Although population size is not used in the calculations for the beta distribution, it is necessary to ent
the population size so that the software can decide whether to use beta or beta-binomial distribution in
calculations.
Note 2: The values selected for steps 5 and 6 (a & b values) will depend on the analyst’s prior knowledge or
assumptions about θ.
3. The required sample size will be given at step 7.

N >= 50
The Excel beta distribution function is used here as follows:

P(θ>k)=BETADIST (k, a+(n-r), b+r, lower limit for k, upper limit for k).

N <50
The Γ(x) function can be calculated in Excel by using a combination of the EXP and GAMMALN worksheet
functions as follows:
GAMMALN(x) = LN(Γ(x))
The EXP function is the inverse of the LN function therefore:
EXP(GAMMALN(x)) = Γ(x)

This function is incorporated into the beta-binomial distribution equation as follows:

P(Y>=y)=
( EXP(GAMMALN(n+a+b))*COMBIN(N-n,y) * EXP(GAMMALN(y+x+a)) * EXP(GAMMALN(N-x-y+b) )
/ ( EXP(GAMMALN(x+a) * EXP(GAMMALN(n-x+b)) * EXP(GAMMALN(N+a+b) )

Estimation of Weights.

1. Select the Estimation of Weight tab.


2. Enter the required values for steps 1 to 7.
3. The confidence interval is given in cells B12: D12

The confidence interval is calculated as follows:

C.I. = mean weight ± t*( √( (s/ √(n-r))^2 + (uw)^2 ))

In the event of any negatives being detected in the samples, a correction factor (n-r)/n is applied as follows:

C.I. = (mean weight) * (n-r)/n ± (t*( √( (s/ √(n-r))^2 + (uw)^2 )) * (n-r)/n

For smaller populations where n/N > 0.1 a further correction factor √((N-n)/N) is applied giving:

C.I. = (mean weight) * (n-r)/n ± (t*( √( (s/ √(n-r))^2 + (uw)^2 )) * (n-r)/n* √((N-n)/N)

Estimation of Tablet Numbers.

1. Select the Estimation of Tablets tab.


2. Enter the required values for steps 1 to 7.
3. The estimated number of tablets is given in cell B19
(The calculator incoroprates the uncertainty for two different balances because it is likely that different balances
may be used to determine the total tablet weight and individual tablet weights. If the same balance is used for bot
enter the same uncertainty value for both uw1 and uw2).
Calculation based on minimal PROPORTION (k) of positive samples in
population N
At least requested proportion (k) of population (N) contain drugs at a confidence level of
at least (1-α), if (n-r) tested samples are positive.
Max. population size Nmax
Enter data (steps 1 to 4) and see results (steps 5 to 7) allowed (current value):

1000
Step 1: Enter population size (N) Step 6:
= number of samples in Actual proportion (k`) for
population: 100
sample size n
q ###
Step 2: Enter proportion (k) of
positives in population:
0.8 0.80000
(range: 0.0001<k<=1)
###
Step 3: Enter expected number of Step 7:
negatives (r): Actual CL for sample size
(at max. 2) 2 n
q ###
Step 4: Enter confidence level
(CL) (1-a) 0.95 0.95767 1
(range:0.0001<=CL<=0.9999) ### -
P
Step 5: (
Sample size (n)
26 0
)
P(Sample Negatives>r) = confidence level criteria
Sample Size (n) actual CL fits? P(Sn=0)

1 0.00000 no ###
2 0.00000 no ###
3 0.00823 no ###
4 0.02832 no ###
5 0.06098 no ###
6 0.10509 no ###
7 0.15859 no ###
8 0.21900 no ###
9 0.28378 no ###
10 0.35060 no ###
11 0.41741 no ###
12 0.48256 no ###
13 0.54475 no ###
14 0.60303 no ###
15 0.65680 no ###
16 0.70571 no ###
17 0.74962 no ###
18 0.78859 no ###
19 0.82282 no ###
20 0.85256 no ###
21 0.87818 no ###
22 0.90004 no ###
23 0.91854 no ###
24 0.93407 no ###
25 0.94699 no ###
26 0.95767 yes ###
27 0.96642 yes ###
28 0.97354 yes ###
29 0.97930 yes ###
30 0.98391 yes ###
31 0.98758 yes ###
32 0.99048 yes ###
33 0.99275 yes ###
34 0.99453 yes ###
35 0.99589 yes ###
36 0.99694 yes ###
37 0.99774 yes ###
38 0.99835 yes ###
39 0.99880 yes ###
40 0.99913 yes ###
41 0.99938 yes ###
42 0.99956 yes ###
43 0.99969 yes ###
44 0.99979 yes ###
45 0.99985 yes ###
46 0.99990 yes ###
47 0.99993 yes ###
48 0.99995 yes ###
49 0.99997 yes ###
50 0.99998 yes ###
51 0.99999 yes ###
52 0.99999 yes ###
53 1.00000 yes ###
54 1.00000 yes ###
55 1.00000 yes ###
56 1.00000 yes ###
57 1.00000 yes ###
58 1.00000 yes ###
59 1.00000 yes ###
60 1.00000 yes ###
61 1.00000 yes ###
62 1.00000 yes ###
63 1.00000 yes ###
64 1.00000 yes ###
65 1.00000 yes ###
66 1.00000 yes ###
67 1.00000 yes ###
68 1.00000 yes ###
69 1.00000 yes ###
70 1.00000 yes ###
71 1.00000 yes ###
72 1.00000 yes ###
73 1.00000 yes ###
74 1.00000 yes ###
75 1.00000 yes ###
76 1.00000 yes ###
77 1.00000 yes ###
78 1.00000 yes ###
79 1.00000 yes ###
80 1.00000 yes ###
81 1.00000 yes ###
82 1.00000 yes ###
83 1.00000 yes ###
84 1.00000 yes ###
85 1.00000 yes ###
86 1.00000 yes ###
87 1.00000 yes ###
88 1.00000 yes ###
89 1.00000 yes ###
90 1.00000 yes ###
91 1.00000 yes ###
92 1.00000 yes ###
93 1.00000 yes ###
94 1.00000 yes ###
95 1.00000 yes ###
96 1.00000 yes ###
97 1.00000 yes ###
98 1.00000 yes ###
99 1.00000 yes ###
100 1.00000 yes ###
Confidence level (CL) vs sample size (n)

0.9

0.8

0.7

0.6
CL

0.5

0.4

0.3

0.2

0.1

0
sample size (n)
neg_0 neg_1 neg_2 CL requested
0.1

0
sample size (n)
neg_0 neg_1 neg_2 CL requested

Macro buttons
Ñ

Reduce Nmax! Unhide/Hide


To change Nmax
(smallest file size) side calculations
click appropriate button!
Calculation based on NUMBER (K) of positive samples
in population N
Exactly requested number (K) of population (N) contain drugs at minimum at requested
confidence level (1-α), if (n-r) tested samples are positive!
Max. population size Nmax
allowed (current value):
Enter data (steps 1 to 4) and see results (Steps 5 to 7) :
1000
Nmax =1000 Step 6:
Actual proportion (k`) for
2500
sample size n
q
Step 2: Enter number of positives
(K) in population:
(range 1<K<=N)
2427 0.97080

Step 3: Enter expected number of Step 7:


negatives (r): Actual CL for sample size n
(at max. 2) 0
q

Step 4: Enter confidence level (CL)


(1-a) 0.99 0.99012
(range:0.0001<=CL<=0.9999)

Step 5:
Sample size (n)
149

P(Sample Negatives>r) =
Sample Size (n) actual CL confidence level criteria fits?

1 0.02960 no
2 0.05834 no
3 0.08623 no
4 0.11331 no
5 0.13960 no
6 0.16512 no
7 0.18989 no
8 0.21394 no
9 0.23728 no
10 0.25994 no
11 0.28193 no
12 0.30328 no
13 0.32400 no
14 0.34412 no
15 0.36364 no
16 0.38259 no
17 0.40098 no
18 0.41883 no
19 0.43616 no
20 0.45298 no
21 0.46930 no
22 0.48514 no
23 0.50052 no
24 0.51544 no
25 0.52992 no
26 0.54398 no
27 0.55762 no
28 0.57086 no
29 0.58370 no
30 0.59617 no
31 0.60827 no
32 0.62001 no
33 0.63140 no
34 0.64246 no
35 0.65319 no
36 0.66360 no
37 0.67370 no
38 0.68351 no
39 0.69302 no
40 0.70225 no
41 0.71121 no
42 0.71990 no
43 0.72833 no
44 0.73651 no
45 0.74445 no
46 0.75215 no
47 0.75963 no
48 0.76688 no
49 0.77391 no
50 0.78074 no
51 0.78736 no
52 0.79379 no
53 0.80002 no
54 0.80607 no
55 0.81194 no
56 0.81763 no
57 0.82315 no
58 0.82851 no
59 0.83370 no
60 0.83874 no
61 0.84364 no
62 0.84838 no
63 0.85298 no
64 0.85745 no
65 0.86178 no
66 0.86598 no
67 0.87005 no
68 0.87400 no
69 0.87784 no
70 0.88156 no
71 0.88516 no
72 0.88866 no
73 0.89206 no
74 0.89535 no
75 0.89854 no
76 0.90163 no
77 0.90464 no
78 0.90755 no
79 0.91037 no
80 0.91311 no
81 0.91577 no
82 0.91835 no
83 0.92085 no
84 0.92327 no
85 0.92562 no
86 0.92790 no
87 0.93011 no
88 0.93225 no
89 0.93433 no
90 0.93635 no
91 0.93830 no
92 0.94020 no
93 0.94203 no
94 0.94382 no
95 0.94554 no
96 0.94722 no
97 0.94884 no
98 0.95042 no
99 0.95195 no
100 0.95343 no
101 0.95486 no
102 0.95626 no
103 0.95761 no
104 0.95892 no
105 0.96018 no
106 0.96141 no
107 0.96261 no
108 0.96376 no
109 0.96488 no
110 0.96597 no
111 0.96702 no
112 0.96805 no
113 0.96904 no
114 0.97000 no
115 0.97093 no
116 0.97183 no
117 0.97270 no
118 0.97355 no
119 0.97437 no
120 0.97517 no
121 0.97594 no
122 0.97669 no
123 0.97742 no
124 0.97812 no
125 0.97880 no
126 0.97946 no
127 0.98010 no
128 0.98072 no
129 0.98132 no
130 0.98191 no
131 0.98247 no
132 0.98302 no
133 0.98355 no
134 0.98406 no
135 0.98456 no
136 0.98504 no
137 0.98551 no
138 0.98597 no
139 0.98641 no
140 0.98683 no
141 0.98724 no
142 0.98765 no
143 0.98803 no
144 0.98841 no
145 0.98877 no
146 0.98913 no
147 0.98947 no
148 0.98980 no
149 0.99012 yes
150 0.99043 yes
151 0.99073 yes
152 0.99102 yes
153 0.99131 yes
154 0.99158 yes
155 0.99185 yes
156 0.99210 yes
157 0.99235 yes
158 0.99259 yes
159 0.99283 yes
160 0.99306 yes
161 0.99327 yes
162 0.99349 yes
163 0.99369 yes
164 0.99389 yes
165 0.99409 yes
166 0.99427 yes
167 0.99446 yes
168 0.99463 yes
169 0.99480 yes
170 0.99497 yes
171 0.99513 yes
172 0.99528 yes
173 0.99543 yes
174 0.99558 yes
175 0.99572 yes
176 0.99585 yes
177 0.99599 yes
178 0.99611 yes
179 0.99624 yes
180 0.99636 yes
181 0.99647 yes
182 0.99659 yes
183 0.99670 yes
184 0.99680 yes
185 0.99690 yes
186 0.99700 yes
187 0.99710 yes
188 0.99719 yes
189 0.99728 yes
190 0.99737 yes
191 0.99745 yes
192 0.99753 yes
193 0.99761 yes
194 0.99769 yes
195 0.99776 yes
196 0.99784 yes
197 0.99790 yes
198 0.99797 yes
199 0.99804 yes
200 0.99810 yes
201 0.99816 yes
202 0.99822 yes
203 0.99828 yes
204 0.99833 yes
205 0.99839 yes
206 0.99844 yes
207 0.99849 yes
208 0.99854 yes
209 0.99859 yes
210 0.99863 yes
211 0.99868 yes
212 0.99872 yes
213 0.99876 yes
214 0.99880 yes
215 0.99884 yes
216 0.99888 yes
217 0.99891 yes
218 0.99895 yes
219 0.99898 yes
220 0.99902 yes
221 0.99905 yes
222 0.99908 yes
223 0.99911 yes
224 0.99914 yes
225 0.99917 yes
226 0.99919 yes
227 0.99922 yes
228 0.99924 yes
229 0.99927 yes
230 0.99929 yes
231 0.99932 yes
232 0.99934 yes
233 0.99936 yes
234 0.99938 yes
235 0.99940 yes
236 0.99942 yes
237 0.99944 yes
238 0.99946 yes
239 0.99948 yes
240 0.99949 yes
241 0.99951 yes
242 0.99953 yes
243 0.99954 yes
244 0.99956 yes
245 0.99957 yes
246 0.99958 yes
247 0.99960 yes
248 0.99961 yes
249 0.99962 yes
250 0.99964 yes
251 0.99965 yes
252 0.99966 yes
253 0.99967 yes
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255 0.99969 yes
256 0.99970 yes
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287 0.99990 yes
288 0.99990 yes
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290 0.99991 yes
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294 0.99992 yes
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296 0.99992 yes
297 0.99993 yes
298 0.99993 yes
299 0.99993 yes
300 0.99993 yes
301 0.99994 yes
302 0.99994 yes
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375 1.00000 yes
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676 1.00000 yes
677 1.00000 yes
678 1.00000 yes
679 1.00000 yes
680 1.00000 yes
681 1.00000 yes
682 1.00000 yes
683 1.00000 yes
684 1.00000 yes
685 1.00000 yes
686 1.00000 yes
687 1.00000 yes
688 1.00000 yes
689 1.00000 yes
690 1.00000 yes
691 1.00000 yes
692 1.00000 yes
693 1.00000 yes
694 1.00000 yes
695 1.00000 yes
696 1.00000 yes
697 1.00000 yes
698 1.00000 yes
699 1.00000 yes
700 1.00000 yes
701 1.00000 yes
702 1.00000 yes
703 1.00000 yes
704 1.00000 yes
705 1.00000 yes
706 1.00000 yes
707 1.00000 yes
708 1.00000 yes
709 1.00000 yes
710 1.00000 yes
711 1.00000 yes
712 1.00000 yes
713 1.00000 yes
714 1.00000 yes
715 1.00000 yes
716 1.00000 yes
717 1.00000 yes
718 1.00000 yes
719 1.00000 yes
720 1.00000 yes
721 1.00000 yes
722 1.00000 yes
723 1.00000 yes
724 1.00000 yes
725 1.00000 yes
726 1.00000 yes
727 1.00000 yes
728 1.00000 yes
729 1.00000 yes
730 1.00000 yes
731 1.00000 yes
732 1.00000 yes
733 1.00000 yes
734 1.00000 yes
735 1.00000 yes
736 1.00000 yes
737 1.00000 yes
738 1.00000 yes
739 1.00000 yes
740 1.00000 yes
741 1.00000 yes
742 1.00000 yes
743 1.00000 yes
744 1.00000 yes
745 1.00000 yes
746 1.00000 yes
747 1.00000 yes
748 1.00000 yes
749 1.00000 yes
750 1.00000 yes
751 1.00000 yes
752 1.00000 yes
753 1.00000 yes
754 1.00000 yes
755 1.00000 yes
756 1.00000 yes
757 1.00000 yes
758 1.00000 yes
759 1.00000 yes
760 1.00000 yes
761 1.00000 yes
762 1.00000 yes
763 1.00000 yes
764 1.00000 yes
765 1.00000 yes
766 1.00000 yes
767 1.00000 yes
768 1.00000 yes
769 1.00000 yes
770 1.00000 yes
771 1.00000 yes
772 1.00000 yes
773 1.00000 yes
774 1.00000 yes
775 1.00000 yes
776 1.00000 yes
777 1.00000 yes
778 1.00000 yes
779 1.00000 yes
780 1.00000 yes
781 1.00000 yes
782 1.00000 yes
783 1.00000 yes
784 1.00000 yes
785 1.00000 yes
786 1.00000 yes
787 1.00000 yes
788 1.00000 yes
789 1.00000 yes
790 1.00000 yes
791 1.00000 yes
792 1.00000 yes
793 1.00000 yes
794 1.00000 yes
795 1.00000 yes
796 1.00000 yes
797 1.00000 yes
798 1.00000 yes
799 1.00000 yes
800 1.00000 yes
801 1.00000 yes
802 1.00000 yes
803 1.00000 yes
804 1.00000 yes
805 1.00000 yes
806 1.00000 yes
807 1.00000 yes
808 1.00000 yes
809 1.00000 yes
810 1.00000 yes
811 1.00000 yes
812 1.00000 yes
813 1.00000 yes
814 1.00000 yes
815 1.00000 yes
816 1.00000 yes
817 1.00000 yes
818 1.00000 yes
819 1.00000 yes
820 1.00000 yes
821 1.00000 yes
822 1.00000 yes
823 1.00000 yes
824 1.00000 yes
825 1.00000 yes
826 1.00000 yes
827 1.00000 yes
828 1.00000 yes
829 1.00000 yes
830 1.00000 yes
831 1.00000 yes
832 1.00000 yes
833 1.00000 yes
834 1.00000 yes
835 1.00000 yes
836 1.00000 yes
837 1.00000 yes
838 1.00000 yes
839 1.00000 yes
840 1.00000 yes
841 1.00000 yes
842 1.00000 yes
843 1.00000 yes
844 1.00000 yes
845 1.00000 yes
846 1.00000 yes
847 1.00000 yes
848 1.00000 yes
849 1.00000 yes
850 1.00000 yes
851 1.00000 yes
852 1.00000 yes
853 1.00000 yes
854 1.00000 yes
855 1.00000 yes
856 1.00000 yes
857 1.00000 yes
858 1.00000 yes
859 1.00000 yes
860 1.00000 yes
861 1.00000 yes
862 1.00000 yes
863 1.00000 yes
864 1.00000 yes
865 1.00000 yes
866 1.00000 yes
867 1.00000 yes
868 1.00000 yes
869 1.00000 yes
870 1.00000 yes
871 1.00000 yes
872 1.00000 yes
873 1.00000 yes
874 1.00000 yes
875 1.00000 yes
876 1.00000 yes
877 1.00000 yes
878 1.00000 yes
879 1.00000 yes
880 1.00000 yes
881 1.00000 yes
882 1.00000 yes
883 1.00000 yes
884 1.00000 yes
885 1.00000 yes
886 1.00000 yes
887 1.00000 yes
888 1.00000 yes
889 1.00000 yes
890 1.00000 yes
891 1.00000 yes
892 1.00000 yes
893 1.00000 yes
894 1.00000 yes
895 1.00000 yes
896 1.00000 yes
897 1.00000 yes
898 1.00000 yes
899 1.00000 yes
900 1.00000 yes
901 1.00000 yes
902 1.00000 yes
903 1.00000 yes
904 1.00000 yes
905 1.00000 yes
906 1.00000 yes
907 1.00000 yes
908 1.00000 yes
909 1.00000 yes
910 1.00000 yes
911 1.00000 yes
912 1.00000 yes
913 1.00000 yes
914 1.00000 yes
915 1.00000 yes
916 1.00000 yes
917 1.00000 yes
918 1.00000 yes
919 1.00000 yes
920 1.00000 yes
921 1.00000 yes
922 1.00000 yes
923 1.00000 yes
924 1.00000 yes
925 1.00000 yes
926 1.00000 yes
927 1.00000 yes
928 1.00000 yes
929 1.00000 yes
930 1.00000 yes
931 1.00000 yes
932 1.00000 yes
933 1.00000 yes
934 1.00000 yes
935 1.00000 yes
936 1.00000 yes
937 1.00000 yes
938 1.00000 yes
939 1.00000 yes
940 1.00000 yes
941 1.00000 yes
942 1.00000 yes
943 1.00000 yes
944 1.00000 yes
945 1.00000 yes
946 1.00000 yes
947 1.00000 yes
948 1.00000 yes
949 1.00000 yes
950 1.00000 yes
951 1.00000 yes
952 1.00000 yes
953 1.00000 yes
954 1.00000 yes
955 1.00000 yes
956 1.00000 yes
957 1.00000 yes
958 1.00000 yes
959 1.00000 yes
960 1.00000 yes
961 1.00000 yes
962 1.00000 yes
963 1.00000 yes
964 1.00000 yes
965 1.00000 yes
966 1.00000 yes
967 1.00000 yes
968 1.00000 yes
969 1.00000 yes
970 1.00000 yes
971 1.00000 yes
972 1.00000 yes
973 1.00000 yes
974 1.00000 yes
975 1.00000 yes
976 1.00000 yes
977 1.00000 yes
978 1.00000 yes
979 1.00000 yes
980 1.00000 yes
981 1.00000 yes
982 1.00000 yes
983 1.00000 yes
984 1.00000 yes
985 1.00000 yes
986 1.00000 yes
987 1.00000 yes
988 1.00000 yes
989 1.00000 yes
990 1.00000 yes
991 1.00000 yes
992 1.00000 yes
993 1.00000 yes
994 1.00000 yes
995 1.00000 yes
996 1.00000 yes
997 1.00000 yes
998 1.00000 yes
999 1.00000 yes
1000 1.00000 yes
Confindence level (CL) vs sample size (n)

0.9

0.8

0.7

0.6
CL

0.5

0.4

0.3

0.2

0.1

0
sample size n
0_neg 1_neg 2_neg CL requested

Macro buttons
Ñ
To change Nmax Reduce Nmax!
click appropriate button! (smallest file size)
Calculation based on probability that Y > g using the Beta-Binomial
Distribution
1

At least requested proportion (k) of population (N) contain drugs at a confidence level of
at least (1-α), if (n-r) tested samples are positive. 0.9
Max. population size
Enter data (steps 1 to 6) and see results (step 7) Nmax allowed: 0.8
49
Step 1: Enter population size (N) = Step 5: 0.7
number of samples in population. Enter value
49 a 0.6

CL
0.5

Step 2: Enter proportion (k) of positives in


population: 0.4
0.5
(range: 0.0001<k<=1) 1
Step 3: Enter expected number of Step 6: 0.3
negatives (r): Enter value
(at max. 2) 0
b 0.2

Step 4: Enter confidence level (CL) (1-a) 0.1


(range:0.0001<=CL<=0.9999) 0.99
1
0
Step 7:
Sample size (n) 6 1 3 5 7 9 11 13

confidence level
criteria
Sample Size (n) R(U>=g) fits?
1 0.7551020408 no
2 0.8226530612 no
3 0.9450716457 no
4 0.9749240122 no
5 0.9888551165 no
6 0.9951874367 yes
7 0.9979854386 yes
8 0.9991845823 yes
9 0.9996817882 yes
10 0.9998806706 yes
11 0.9999571638 yes
12 0.9999853455 yes
13 0.9999952472 yes
14 0.9999985478 yes
15 0.9999995851 yes
16 0.9999998902 yes
17 0.9999999734 yes
18 0.9999999942 yes
19 0.9999999989 yes
20 0.9999999998 yes
21 1 yes
22 1 yes
23 1 yes
24 1 yes
25 1 yes
26 1 yes
27 1 yes
28 1 yes
29 1 yes
30 1 yes
31 1 yes
32 1 yes
33 1 yes
34 1 yes
35 1 yes
36 1 yes
37 1 yes
38 1 yes
39 1 yes
40 1 yes
41 1 yes
42 1 yes
43 1 yes
44 1 yes
45 1 yes
46 1 yes
47 1 yes
48 1 yes
49 1
Confidence level (CL) vs sample size (n)

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49
sample size (n)
neg_0 neg_1 neg_2 CL requested
Calculation based on probability that q > k (actual proportion > desired G
proportion) using the Beta Distribution R
A
P
At least requested proportion (k) of population (N) contain drugs at a confidence level of H
at least (1-α), if (n-r) tested samples are positive.
Max. population size Nmax o
allowed (current value): f
Enter data (steps 1 to 6) and see results (step 7) f
1000 s
e
Step 1: Enter population size (N) Step 5: t
= number of samples in Enter value
population:
51
a v
a
l
u
Step 2: Enter proportion (k) of e
positives in population:
0.8 1.0
(range: 0.0001<k<=1)
c
a
Step 3: Enter expected number of Step 6: l
negatives (r): Enter value
(at max. 2) c
1 b u
l
a
t
Step 4: Enter confidence level i
(CL) (1-a) 0.95 1.0 o
1
(range:0.0001<=CL<=0.9999) n
-
P
(
Step 7:
Sample size (n) 22 0
)
confidence level criteria
Sample Size (n) R(q)>k fits? P(Sn=0)

1 -0.64000 no ###
2 -0.40800 no ###
3 -0.22880 no ###
4 -0.06496 no ###
5 0.08250 no ###
6 0.21357 no ###
7 0.32891 no ###
8 0.42957 no ###
9 0.51682 no ###
10 0.59198 no ###
11 0.65640 no ###
12 0.71138 no ###
13 0.75811 no ###
14 0.79769 no ###
15 0.83112 no ###
16 0.85926 no ###
17 0.88291 no ###
18 0.90272 no ###
19 0.91930 no ###
20 0.93313 no ###
21 0.94466 no ###
22 0.95425 yes ###
23 0.96222 yes ###
24 0.96883 yes ###
25 0.97431 yes ###
26 0.97884 yes ###
27 0.98259 yes ###
28 0.98569 yes ###
29 0.98824 yes ###
30 0.99034 yes ###
31 0.99208 yes ###
32 0.99350 yes ###
33 0.99468 yes ###
34 0.99564 yes ###
35 0.99643 yes ###
36 0.99708 yes ###
37 0.99761 yes ###
38 0.99805 yes ###
39 0.99840 yes ###
40 0.99870 yes ###
41 1.00000 yes ###
42 1.00000 yes ###
43 1.00000 yes ###
44 1.00000 yes ###
45 1.00000 yes ###
46 1.00000 yes ###
47 1.00000 yes ###
48 1.00000 yes ###
49 1.00000 yes ###
50 1.00000 yes ###
51 1.00000 yes ###
Confidence level (CL) vs sample size (n)

0.9

0.8

0.7

0.6
CL

0.5

0.4

0.3

0.2

0.1

0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
sample size (n)
neg_0 neg_1 neg_2 CL requested
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
sample size (n)
neg_0 neg_1 neg_2 CL requested

Macro buttons
Ñ
Reduce Nmax!
To change Nmax
(smallest file size)
click appropriate button!
Step 1: Enter Confidence level (1-a ) 0.99 a=

Step 2: Enter Population (N) 100 t=

Step 3: Enter Sample Size (n) 13 n/N=

Step 4: Enter Mean Weight () 0.5531 Q= √((N-n)/N) =

Step 5: Enter Sample Standard Deviation (s) 0.02622 rsd(%) =


Step 6: Enter Number of Negative
Results in Sample ( r ) 0 Pcorr =
Step 7: Enter the weighing balance uncertainty (uw) ux = s/√n =
0.00185
(Enter 0 if not using uw in the estimation) uc = √(ux2 + uw2) =
t*uc =
UT = Nuc =


Confidence Interval = 0.55310 �
W

Estimate of Weight = 55.310 �

Range
Lower
53.172 to
0.01

3.05454

0.130

0.933 Because n/N > 0.1, this 'Q' factor is also incorporated into calculations

4.740553

1
0.007272 ux(corr) = s/√(n-r) = 0.0072721
0.007504 uc(corr) = √(u + uw ) = 0.0075037
x(corr)
2 2

0.022920 UT(corr) = Nuc(corr) = 0.7503747


0.750375 Pcorr*Uc(corr)*t = 0.02292

t*uc

0.02292
t*UT Pcorr*t*UT(corr) Qcorr*t*UT Qcorr*Pcorr*t*UT(corr)

2.138

Upper
57.448
Step 1: Enter Confidence level (1-a ) 0.99 a=

Step 2: Enter Total Weight of Tablets (TW): 1020 t=

Step 3: Enter Number of Individual Weighings (n): 10 rsd(%) =

Step 3: Enter the Number of Tablets per


Individual Weighing: 1 u'TW = uw1 / TW =
Step 4: Enter Mean Weight
of Individual Weighings (): 0.29544 s/√n =

Step 5: Enter Sample Standard Deviation (s) 0.01855 u = √( (s/√n)2 + (uw2)2) =


Step 6: Enter the 'Total Weight' weighing balance uncertainty (uw1) u' = u /  =
0.3966
(Enter 0 if not using uw1 in the estimation) u'c = √( (u'TW)2 + (u')2 ) =
Step 7: Enter the 'Individual Weights' weighing balance uncertainty (uw2) uc = u'c * Tot No of Tablets =
(Enter 0 if not using uw2 in the estimation)
0.0015

TW /  t*uc

Estimated Number of Tablets = 3452 ± 230

RANGE
3222 to 3682
0.01

3.24984

6.27877

0.0003888235

0.0058660251

0.0060547708
0.0204940795
0.0204977676
70.76

Tablets

Tablets
Date Revision of software and documentation

The introduction page has been changed and the sheet "Changes on
Dec-12
the revision" has been added.
The HYPERGEOMETRIC TOOL - has been updated, while other
tools remain unchanged. Changes:
The hypergeometric calculation based on the proportion k of positives
(sheet Hypg_Proportion) was changed from the base. The main
difference is in the excel HYPGEOMDIST function third argument
definition, which is now rounded up (in previous version truncated).
Appropriate restrictions-limitations were set for some data cells.
New hypergeometric calculation based on the number K of positives
(sheet Hypg_Number) is included.
Dec-12 Graphic presentation (confidence level vs sample size) on both
hypergeometric sheets has been improved.
Some macro buttons have been added to enhance the flexibility of the
application
For in-depth background of the hypergeometric calculation and the
validation report see: DWG-SGL-002-vers-001.

Document "Validation Report on Qualitative Sampling Guideline" was


Dec-12
updated into the version 002.

Sep-14 Layout of Bayesian and Binomial sheets changed to match HPD format.
Bayesian tool split into two sheets - one for N<50 and one for N>=50.

Removal of 'Binomial' sheet from workbook.


May-15 'Estimation of Tablets' sheet amended to give a point-estimate only.
Instructions updated.

Oct-16 Incorporated the measurement uncertainty associated with the weighing


balance into the 'Estimation of Weight' and the 'Estimation of Tablets'
calculators. Added a weight range result box. Instructions updated
Correction to Qcorr factor in formula.
Jul-17
Qcorr now applied to UT instead of ux
Documents
active archived

none

DWG-SGL-002-vers-001

DWG-SGL-001-vers-002 DWG-SGL-001vers-001

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