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| IKE 06-07: Foreign Material Contamination
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Purpose: This IKE is being issued in
support of
FSIS Directive 7310.5 and addresses one example of when
inspection program personnel would verify that
establishments are properly addressing incidents of foreign
material in their product.
You are a Consumer Safety Inspector (CSI) in a beef grinding
facility that produces raw ground beef from beef trimmings.
The establishment purchases trimmings from multiple sources.
At the beginning of your tour of duty, you are notified by
the establishment’s Quality Control manager that they found
metal in one box of incoming product used in the last lot of
production the previous day.
You know that FSIS Directive 7310.5 provides the procedures
that inspection program personnel are to follow when foreign
material such as metal, plastic, rubber, glass, wood, steel,
or lead shot is found. You decide to review this Directive
so you can verify that the establishment is properly
addressing the foreign material. The directive describes
different options how an establishment may address foreign
material. Through your review of the Directive, you
determine that:
- It is the responsibility of the establishment to examine the suspect product and to sort out and properly decontaminate or dispose of any adulterated product.
- An establishment should use the most sensitive detection technique available
- An establishment should have a supportable
justification as to how the procedures it employs will
detect the foreign materials present.
The directive further states that you are to verify the
establishment follows its detection, segregation, and
disposition procedures and that you are not to take any
action if the procedures are properly followed.
You are scheduled to perform a 03B01 procedure today and you
decide to verify the recordkeeping requirements.
FSIS Directive 5000.1 Revision 2,
states that you can verify compliance with the recordkeeping
requirement by reviewing the hazard analysis, HACCP plan,
and supporting documentation. Through your review of the
hazard analysis, you find that the establishment determined
that foreign material is a food safety hazard that is
reasonably likely to occur in the operation. The
establishment has developed a CCP for metal detection at
grinding. The establishment has also determined the maximum
size that foreign material can be and still not be
considered a food safety hazard and has documents on file to
support its decision.
You review the HACCP records associated with the metal
detection CCP and you see no entries related to the previous
day’s production. You discuss your observation with the
Quality Control manager and are informed that the
establishment found a meat hook in a box of product prior to
grinding the product. They determined that the meat hook did
not meet the establishment’s criteria for a food safety
hazard and that they would address it as a Sanitation SOP
issue.
Discussion: You are scheduled to conduct a
01C01, so you review the establishment’s Sanitation SOP
corrective action records from the previous day to verify
that the establishment is meeting the regulatory
requirements. The records show that:
- The establishment had retained all the source material remaining from the previous day's production.
- The product that had already been ground was allowed to move freely as it had gone through the metal detection CCP, and no product had been found to be contaminated.
- The establishment conducted a 100% visual examination of the source material, in addition to running the material through the metal detector. No other foreign material was found.
- The segregated product was kept under QA control
until it could be ground.
- The establishment also
contacted the establishment that produced the product
and informed them what had been found. The grinding
establishment elected to notify the producer of the
source material that it would not purchase product from
that establishment in the future if foreign material was
found in the product again
You conclude that the establishment met the corrective
action requirements of 9 CFR 416.15(b).
The segregated source material is being ground today
following the establishment’s HACCP plan. You decide to
conduct the review and observation component of 03B01 to
verify the establishment’s monitoring at the metal detection
CCP. The establishment monitors the CCP in accordance with
the HACCP plan and documents the results appropriately. No
additional metal is found and the resulting ground product
is released from QA control.
Resolution: You conclude that the
establishment has conducted their operations in accordance
with the regulatory requirement of 9 CFR 416 and 417 as well
as with the criteria addressed in FSIS Directive 7310.5. You
document both the 03B01 and 01C01 verification procedures as
performed. In addition, because the metal had been found in
in-coming product, you complete FSIS Form 8140-1, Notice of
Receipt of Adulterated or Misbranded Product in accordance
with the instructions in
FSIS Directive 8140.1. You know that by documenting the
incident on this Form, inspection program personnel at the
producing establishment will, upon receipt of the form, know
that adulterated product was put into commerce. The
inspection program personnel at the producing establishment
will respond to this important information by conducting
appropriate verification procedures also outlined in FSIS
Directive 8140.1.
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Last Modified: August 8, 2007 |
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