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7. Product and Process Comparisons
7.2. Comparisons based on data from one process
7.2.4. Does the proportion of defectives meet requirements?

7.2.4.3.

Sample sizes required

Derivation of formula for required sample size when testing proportions The method of determining sample sizes for testing proportions is similar to the method for determining sample sizes for testing the mean. Although the sampling distribution for proportions actually follows a binomial distribution, the normal approximation is used for this derivation.
Definition of allowable deviation If we are interested in detecting a change in the proportion defective of sizedelta in either direction, the corresponding confidence interval for p can be written

phat - delta <= p <= phat + delta

Relationship to confidence interval For a (1-alpha)% confidence interval based on the normal distribution, wherez(alpha/2> is the upper critical value of the normal distribution which is exceeded with probabilityalpha/2,

delta = SQRT(p*(1-p)/N)*z(alpha/2)

Minimum sample size Thus, the minimum sample size is
  1. For a two-sided interval 

  2. N >= [p(1-p)/delta**2]*z(alpha/2)**2
     

  3. For a one-sided interval 

  4. N >= [p(1-p)/delta**2]*z(alpha)**2

Interpretation and sample size for high probability of detecting a change This requirement on the sample size only guarantees that a change of size delta is detected with 50% probability. The derivation of the sample size when we are interested in protecting against a changedelta with probability 1 -beta (where beta is small) is
  1. For a two-sided interval 

  2. N >= (z(alpha/2) + z(beta))**2*[p(1-p)/delta**2]*z(alpha/2)**2
     

  3. For a one-sided interval 

  4. N >= (z(alpha) + z(beta))**2*[p(1-p)/delta**2]*z(alpha)**2

where z(beta) is the upper critical value from the normal distribution that is exceeded with probabilitybeta.
Value for the true proportion defective The equations above require that p be known. Usually, this is not the case. If we are interested in detecting a change relative to an historical or hypothesized value, this value is taken as the value of p for this purpose. Note that taking the value of the proportion defective to be 0.5 leads to the largest possible sample size.
Example of calculating sample size for testing proportion defective Suppose that a department manager needs to be able to detect any change above 0.10 in the current proportion defective of his product line, which is running at approximately 10% defective. He is interested in a one-sided test and does not want to stop the line except when the process has clearly degraded and, therefore, he chooses a significance level for the test of 5%. Suppose, also, that he is willing to take a risk of 10% of failing to detect a change of this magnitude. With these criteria: 
  1. z.05 = 1.645; z.10=1.282 
  2. delta = 0.10 
  3. p = 0.10
and the minimum sample size for a one-sided test procedure is

N >= [p(1-p)/delta**2]*[z(.05)+z(.10)]**2 = 0.10*0.90*2.927**2/0.10**2
 is approximately 77

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