Note: Factors to consider when selecting a sampling table and sampling size may include the risk of the device being inspected or the records being sampled, and the amount of time you have located to this portion of the inspection.
A. There are no "acceptable" violations of the Quality System Regulation. All Quality System Regulation violations encountered must be handled appropriately according to current FDA policies and procedures. When using the "1 out of:" and "2 out of:" columns, it does not mean no more than that number of Quality System Regulation violations per the appropriate sample size is acceptable. It will only give you an initial understanding of how prevalent the problem may be.
B. When at all possible, all samples should be chosen at random.
Table 1
Binomial Staged Sampling Plans
Binomial Confidence Levels
Confidence Limit .95 <> | 0 out of: | 1 out of: | 2 out of: | |
---|---|---|---|---|
A | .30 ucl* | 11 | 17 | 22 |
B | .25 ucl | 13 | 20 | 27 |
C | .20 ucl | 17 | 26 | 34 |
D | .15 ucl | 23 | 35 | 46 |
E | .10 ucl | 35 | 52 | 72 |
F | .05 ucl | 72 | 115 | 157 |
Table 2
Binomial Staged Sampling Plans
Binomial Confidence Levels
Confidence Limit .99 <> | 0 out of: | 1 out of: | 2 out of: | |
---|---|---|---|---|
A | .30 ucl* | 15 | 22 | 27 |
B | .25 ucl | 19 | 27 | 34 |
C | .20 ucl | 24 | 34 | 43 |
D | .15 ucl | 35 | 47 | 59 |
E | .10 ucl | 51 | 73 | 90 |
F | .05 ucl | 107 | 161 | 190 |
*ucl = Upper Confidence Level
CRC Handbook of Probability and Statistics: Second Edition
Binomial Sampling may be used when trying to make a decision about an endpoint that only has two potential outcomes (e.g., The device history record is compliant or the device history record is noncompliant).