Professional Documents
Culture Documents
•J
•R
•C
•Q
1
The tolerance level of risk
• Consumer risk
– The risk to accept defective products; 5% or (α<0.05) is
often used for nonfatal risks.
– It translate to 95% confidence to reject the defective
products.
• Vendor risk
– Has higher tolerance level depending on situations
2
Sample & Population
• Population – Total
quantity from which
sample is obtained sample
• Sample - Portion that
represents the whole
• Sample size – Number
of sampling units in a
sample
3
The closeness of estimation
• Population mean u
– the true value that we will estimate
• Sample mean
– Obtained after analysis of samples
• With sound sampling procedure
– larger sample size will allow a better estimation of u
using
– So let’s sample 100% of the population
4
The optimum sample size
Population mean
100%
95%
Sample mean curve
50%
0%
0% 4% 10% 100%
6
Decide your sample size
7
21 CFR § 156.3
Note: Cans are the containers in the lot. Each contains less than 2.2 lb of juice
8
Sampling plan for variables
• You are a manager of plant that produce
grape juice
• Customers are concerned about fructose
in their diet which may cause high blood
pressure and high blood triglyceride
• You like to evaluate fructose content in a
lot of products
9
Start from a preliminary experiment
• Population mean (the true value) u
• Pilot (preliminary) experiment
– Sample size n ; sample mean
10
Leaps of faith
Relative accuracy: set by yourself, at 0.05 or 1%, your sample mean will fall
in u±5%u range
12
Calculation !
• A preliminary experiment for n=10 bottle of juice
– Mean = 6.3 (% w/v) SD = 1.2 CV = 19%
13
Shall We Review ?
• Reliability of analytical data
– Accuracy
– Precision
• Data reporting
– Mean (mean of replicated tests of single sample, sample mean, population mean)
– Standard deviation
– CV
– Standard Error
14
What else ?
• Performance of analytical method
– LOD, LOQ
– Sensitivity
– Specificity
• Type of error
– Random
– Systemic
– Blunder
15
Sampling and sample preparation
• Two categories of sampling based on results
− Attribute
− Variable
16
Statistical consideration in sampling
• Non-probability sampling
− Judgment
− Convenience
− restricted
−Quota
• Probability or random sampling
− Single random
− Systemic
− Stratified
− Cluster
− Composite
17
Decide the sample size
• Sampling for attributes
− ANSI method
− CFR
18
The ultimate solution
19
Will continue on Chapter 13
20