|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
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
10:00 a.m. On Wednesday at 9:45 a.m. you proceed to the plant manager's office
where you notify him that you are on your way to the packaging area to collect
your sample. While in the manager's office, you provide further notification of
the sample collection to the plant manager by supplying him with the sampling
notification form (LW-A-0032, To: Establishment management) which is included in
each sample shipment box. The plant manager elects to accompany you in order to
collect a companion sample. You follow the instructions in FSIS Directive 10,
210.1 and 10, 240.4 and collect the sample of packaged product at 10:00 a.m. ,
after the product has received the post lethality treatment. The plant manager
decides to discard the current brine solution after the sample is collected to
limit the amount of any potentially affected product.
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.