Sampling Plans

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.

1. When objectionable conditions are observed based upon samples chosen using these tables, report in the Establishment Inspection Report: (a) the total number of records included in the population from which the sample was chosen; (b) the table used to select your sample; (c) the row used to select your sample; and, (d) the sample size selected*. (* The information requested in instruction 4 must be reported whenever an Official Action Indicated (OAI) endorsement is considered. Reporting this information may not be necessary when Voluntary Action or No Action is indicated. However, caution is advised when using this reporting discretion because Voluntary Action Indicated endorsements are sometimes elevated to Official Action Indicated.)

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

Table 2
Binomial Staged Sampling Plans
Binomial Confidence Levels

*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).