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| IKE Scenario 03-08 - Conducting Weekly Meetings to Verify Changes in Plant Processes which May Affect the Hazard Analysis or Alter the HACCP Plan |
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IKE scenarios are a tool
that FSIS inspection program personnel can use to better understand
Agency policy. In addition, the IKE scenario result may be just one
approach to address a specific situation and is not intended to be
a definitive answer, indicating there may be multiple approaches.
Purpose:
This IKE highlights the questions that inspection
program personnel should ask when verifying whether a plant has made
any changes to its process that may affect its hazard analysis in any
way. Under
FSIS Directive 5000.1, Rev.3, inspection personnel are to
raise these questions periodically, about once a month, in the weekly
meeting.
Situation:
You are a GS-9 Consumer Safety Inspector
(CSI) assigned to a large processing facility that produces raw ground
and RTE meat and poultry products. As an IIC, you understand that you
are responsible for conducting weekly meetings with plant management.
At the weekly meeting, you ask whether the establishment has made any
changes in how it is processing product that would affect the safety
of the product. The establishment informs you that it has acquired
new microwave equipment, and that it will be using this equipment to
temper frozen beef blocks rather than tempering under refrigeration
as in the past for the Raw Ground HACCP plan. This will speed up the
grinding operation.
Discussion:
As you think about this process change with the introduction of the
microwave, you ask a series of questions about the change and its affect
upon the hazard analysis. You ask whether the establishment conducted
a reassessment before the microwave was installed to determine whether
the change would affect the establishment’s hazard analysis. You also
ask whether the establishment modified its Raw, Ground HACCP plan (9
CFR 417.4(a)(3)) based upon the reassessment.
The establishment listens and asks for examples of the type of process
changes that could affect the hazard analysis and that thus should
be shared with FSIS when they are made. You provide a few examples
that your Frontline Supervisor provided during a recent work unit meeting.
- Decide to formulate product with and without allergens in the
same processing room
- Add char-marked, heat-treated patties to the current fully
cooked pattie operation
- Decide to add ground beef to an exclusive ground pork business
- Start slicing the current intact cook-in-bag beef product for
a large account that services delis and school lunch programs
- Add seafood hors d’oeuvres to the operation in the RTE room
and will become a dual jurisdiction establishment (DJE)
- Change a sampling procedure and laboratory methodology
- Change the type of antimicrobial agent used an intervention
step
Resolution: The establishment states that it did not reassess the HACCP plan when
the microwave was installed and used for tempering frozen beef. A biological
hazard was addressed at the tempering step through the use of refrigeration
in the current hazard analysis. Therefore, you start documenting the
noncompliance for failure to reassess the HACCP plan whenever a change
occurs that could affect the hazard analysis or alter the HACCP plan,
417.4(a)(3). The 03B procedure code (Raw Ground Beef) and the verification
trend indicator are entered.
After discussing the NR for failure to reassess, you proceed with your
investigation to determine whether a food safety hazard has been created
in product that may still be in-plant or commerce.
NOTE: A subsequent IKE Scenario may describe the investigation.
If the establishment had reassessed, you would have asked what changes
the establishment may have made to ensure the safety of its product.
You would then verify the controls (e.g. prerequisite program) that
the establishment may have added.
Also, you inform plant management that you will be asking whether there
has been a plant process change that may affect food safety or alter
the HACCP plan at least once per month in coming weekly meetings.
You inform plant management that you are returning to your office to
complete the NR and to type the minutes of the meeting in a Memorandum
of Interview (MOI). You state that you will provide copies to them.
You thank them for their time and end the meeting.
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Last Modified:
September 15, 2008 |
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