Attachment 2 - CONTINGENCY PLAN FOR SELECTING EFFECTIVENESS CHECKS

Effectiveness checks are selected using the guidance in Attachment 1 of this document whenever possible. However, should a widespread PHIS/APM outage or other extenuating circumstance that prevents the selection of effectiveness checks in PHIS/APM occur, the Recall Officer (RO), after consultation with RMTAD, is to compile the electronic Master Consignee List (MCL) and remove duplicates as instructed in Attachment 1 of this document.

    A. Randomizing the MCL

    After eliminating duplicate listings of the same consignee, the RO is to randomize the consignee list. The RO can use the electronic spreadsheet program to assign a random number to each consignee on the list and then sort the consignees by random number. After randomizing the consignee list, the RO should follow the instructions in Section C of this attachment when preparing to select effectiveness checks.

    B. Determining the Total Number of Effectiveness Checks

    After eliminating duplicate listings and randomizing the MCL, the RO will determine the total number of effectiveness checks that will be performed by on-site verification and by telephone derived from the values given in Tables 2-5 of Attachment 1 of this document. A subset of the total number of effectiveness checks for Class I and Class II recalls will be selected for on-site visits to verify that consignees have located, retrieved, and controlled recalled product according to the recall notification (see Tables 2, 3, 4, and 5 for the number of verification disposition checks to be conducted for each recall class).

    NOTE: The RO should refer to Attachment 1 for information about grouping special consignee categories.

    C. Preparing to Select Effectiveness Checks

    The RO is responsible for selecting effectiveness checks.

        1. Using the appropriate table, determine the selection frequency.

        For a Class II recall and 600 consignees, the appropriate table is Table 4 and the number of effectiveness checks to conduct is 37, including 13 onsite disposition checks.

        2. If the RO decides to group effectiveness checks into special categories (e.g., schools, day care centers, hospital cafeterias, or retirement homes), then each group of consignees is considered separately. Use the tables to determine the number of effectiveness checks to be conducted for each group.

        In the example above, if the 600 consignees include three (3) special consignee groups of 200 consignees each, then Table 4 shows that each group would have 15 effectiveness checks conducted including 5 on-site disposition checks. Thus, the total sampling number of effectiveness checks for all three (3) groups would be 45, including 15 on-site disposition checks.

        Grouping consignees into separate categories should always result in an increase in the number of effectiveness checks to be conducted.

        3. The RO will determine a selection interval by dividing the total number of actual or estimated consignees by the number of effectiveness checks to be performed.

        In this example, divide 600 by the minimum sample size (example 37). The sampling interval would be 16 (600/37 = 16.2 rounded to the lower whole number).
            a. Randomly select a number from 1 to the selection interval to determine the starting point.

            For this example, select number 3.

            b. Start at the top of the MCL and count down until reaching the consignee located at the randomly selected starting point. This will be the first consignee selected for an effectiveness check. Then select subsequent consignees from the list according to the predetermined sampling interval.

    In the example above, the selection interval is 16, and the starting point is 3. Beginning at the 3rd consignee, add the selection interval (16). Select the 19th, 35th, 51st ... and so on until enough consignees are identified for the effectiveness checks.

        4. Provide information on the consignees selected for effectiveness checks to the FSIS personnel that will be conducting the checks. If the recalled product was distributed to consignees in more than one District or Region, distribute the list of selected effectiveness checks to the appropriate AOs. The AOs will assign FSIS personnel to perform the effectiveness checks in their District or Region.

    The information that the RO provides to the FSIS personnel conducting the effectiveness checks should include the consignees selected for effectiveness checks, the consignees that will need product disposition verification checks, the recommended timeframes for completion, the related recall numbers, and any other details that may help conduct the verification activities more effectively.