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Sampling plans

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  • Tables Sampling Plan Instructions
  • Select the table based upon how sure you want to be about what is observed. For example, if you are reviewing Device History Records of a life supporting device, you may choose to use Table 2 (99% Confidence). You may choose to use Table 1 (95% Confidence) for the review of Device History Records regarding a device with lower risk.

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    Select a sample size. If the population of records to be sampled is small (approximately thirty or less), you may choose to review all of the records.

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    Review the sample of records selected. You can terminate your review of the entire sample if you observe objectionable conditions beyond the number stated in the column header*. However, if you do not review all of the records in the sample, you may not report additional infor-mation that could be useful in further understanding the potential prevalence of the objectionable condition observed, or you may not recognize whether other objectionable conditions exist.

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    (* If you choose to terminate your review prior to completing the review of the entire sample, in addition to the information contained in instruction 4, report in the Establishment Inspection Report how many records were reviewed prior to your termination of the review.)

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    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.

    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.)

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