|IKE Scenario 02-05
Establishment Notification Prior to Sampling Ready-to-Eat
(RTE) Product: Process Example 2-Product Sliced over
You are a GS-9, CSI/IIC assigned to a patrol assignment, which includes a
very small processing facility that manufactures fully cooked sliced corned beef
under Alternative 2 (post lethality treatment), which you are verifying under
the 03G HACCP procedure code. Each Monday, the establishment places injected product
into a semi-permeable bag for cooking. Each Tuesday, the lethality step is
conducted and stabilization is met by chilling the bagged product in a
brine solution. The brine solution used on Tuesday for chilling purposes is
discarded at the end of each Tuesday's operations. Slicing operations are
conducted on every Wednesday, Thursday, and Friday-until all the lots are completed.
On Wednesday June 1, you receive an OPHS Directed Sample
Request (FSIS Form 10,210-3, Requested Sample Programs) for Project Number
As a critical thinker, you must determine (a)
when to notify plant management of your intention to collect the sample (b) when
you would need to collect the sample, and (c) determine a random sample
collection date and time.
You are aware that the purpose of the Agency's sampling activity is to verify
that the process, as designed and under normal operations, is
producing a safe product. Because of that fact, you would not
expect the company to alter their operations (e.g. change the brine more often)
once you notify plant management that you will be collecting a sample, although
the company can choose to do so after the sample has been collected.
Based on your knowledge of the establishment's
production operations, which can take up to three days to slice and package
several production lots that were exposed to the same brine solution during
stabilization, you would realize that all of that product would be affected
regardless of when the product is sliced. You are also aware that you
must notify plant management in advance of the sample collection so that the
establishment has the opportunity to place all product(s), which may be
affected, on hold in the event a positive result is returned. By using the
random number generator on your FAIM computer you select a date and a time to
collect the intact samples (in this case it is Thursday, June 9 at 1400 hours).
At 0700 hours on Wednesday June 8, you verbally notify
the establishment manager of your intent to collect intact samples of the sliced
corned beef product for microbial testing, sometime during slicing and packaging
operations on either Wednesday, Thursday or Friday. Although you will not
collect the sample until Thursday, you notify the establishment on Wednesday
June 8, since affected product may also include product sliced on Wednesday.
Prior to leaving the plant manager's office, you also provide the manager with
written notification of the intended sample collection (Form LW-A-0032.00, To:
Establishment Manager, which is included in the return sample shipping
At 1350 hours on Thursday June 9, you notify the
establishment manager(s) that you are going to collect the required intact
products (following the instructions in FSIS Directive 10,210.1 and 10,240.4)
and that you will be holding the samples under refrigeration, in the secured
USDA section of the cooler, until the establishment has signed pre-shipment
review for that lot. Plant management chooses not to take a companion sample
but they do inform you that they will place the three days of slicing production
on hold, since all production lots were stabilized in the same brine solution.
After you verify the establishment conducted pre-shipment review on the
identified lot, you remove the intact product samples from the secured area and
prepare the samples for shipment according to the instructions in FSIS Directive
7355.1 (Rev.2, Amend. 1) and contact Fed-Ex for a pick-up.
You complete your duties for the day by documenting an unscheduled 05B02
procedure into the schedule as performed.