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IKE
Scenario 01-05: Establishment Notification Prior to Sampling Ready-to-Eat
Product: Process Example 1—Brine Reused for Multiple Days You
are a GS- 9 CSI assigned to a large processing facility which manufactures hot
dogs which you verify under the 03G HACCP procedure code. The establishment uses
Alternative 2 (post lethality treatment) to meet the regulatory requirements of
9 CFR 430. The product is cooked in a semi-permeable casing and chilled in a
brine solution. The establishment reuses the brine for five consecutive days
prior to disposal. The brine reuse is addressed in the company’s hazard
analysis and meets the requirements of 9 CFR 416.2(g)(2). On
Wednesday June 1, you receive an OPHS Directed Sample Request (FSIS Form 10,
210-3, Requested Sample Programs), for Project Number RTERISK1. As
a critical thinker, how would you determine (a) when you need to collect
the sample and (b) when to notify plant management of your intention to collect
the sample? You
are aware that the purpose of 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. dispose of the brine chilling solution at the end of each
production day) 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, including the
fact that the company reuses their brine for five consecutive days, you
determine that you will collect the sample during the next full week of
operation, which begins on Monday June 6. Because the company reuses the brine
solution and does not dispose of it between batches, there will potentially be
five production days of product which could be affected if there is a positive
test result. You determine that you will need to notify plant management of your
intention to collect the sample by the beginning of operations next Monday. This
is ensure that you provide plant
management as much advance notice as possible in order to allow the
establishment to hold any product that they determine may be affected in the
event of a positive sample result . You
arrive at the establishment on Monday morning prior to the beginning of
operations where you meet with the plant manager regarding the sample
collection. You follow the instructions in FSIS Directive 10, 210.1, Project
Number RTERISK1 concerning Establishment Management Notification and advise
plant management that at some randomly selected time during the week’s
operations, you will be collecting a sample of the hot dogs. You also advise the
plant manager that you are providing them this information early enough in the
process to ensure that they will have the opportunity to hold all affected
product, should they elect to do so. You
return to the government office and use the random number generator on your FSIS
computer to select a day and time to collect your sample. You determine that the
collection day/time will be Wednesday, June 8, at You
hold the sample under refrigeration until the company has completed pre-shipment
review. At that time, you contact
Fed-Ex for pick-up and prepare the sample for shipment and seal it according to
the instructions in FSIS Directive 7355.1 (Rev.2, Amend. 1), Use of Sample Seals
for Laboratory Samples and Other Applications. The sample is picked up by Fed-Ex
before the close of business that day. You
complete your duties for the day by documenting an unscheduled 05B02 procedure
on the PBIS procedure schedule. |
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