provide her child an after-school snack. She exclaimed how much her child looked
forward to our products: He would speak of them during his breakfast. Her voice
reached a crescendo when she detailed how he had bitten into the product, only to
scream out in pain. To her horror, a piece of stainless steel wire had punctured the
roof of his mouth. My children were close to the age of her child and consumed the
products we manufactured as well. We identified the wire as a piece of freezer belt
but not the location of the source. My focus became apparent, and I am still as diligent today as I was the day I heard that mother’s voice.
Foreign material (FM) is one of the three categories reviewed in a Hazard Analysis; however, the focus of food safety professionals then was on microbial and chemical contamination because of the severity of those hazards to our health. The focus
is beginning to shift because of the litigious nature of FM contamination, which is
driving an increase in the number of recalls initiated by FM incidents.
A review of this past year’s data of U.S. Department of Agriculture Food Safety
and Inspection Service (FSIS) recalls for extraneous material and comparison with
the previous year’s data disclose a disturbing trend. In 2017, 43 percent of all FSIS-tracked recalls were for extraneous materials; in comparison, 11 percent of total
pounds recalled were for extraneous material in 2016.1 That is a 291 percent increase
in one year. If we isolate meat products, there was a 30 percent increase in pounds
of meat product recalls from 2016 to 2017. In any statistical review, we must take
into consideration variables that influence the frequency of the occurrence we are
measuring. Is there more focus on FM than in previous years, or is there a lower tolerance for FM by the customer and/or regulatory agencies? Does it matter why there
is an increase? In my opinion, no. As a food safety professional, my job is to implement an effective strategy to significantly reduce the risk of FM in the products I
manufacture. If you think like I do, then let’s get started with the basic concepts of
an FMPP, and then we will detail what the components are that make up the
Key Process Indicators
There are two types of key process indicators, lagging and leading. A lagging indicator is discovered after the fact, usually at the end of the process and most likely
when a customer/consumer complains about the issue. A leading indicator is a “
real-time” indicator that identifies a potential situation as it is happening or in some cases just prior. When you have developed key indicator sites that generate data prior to
an incident’s occurring, you are in the predictive-mode spectrum of processing. This
is not an easy accomplishment, and you will deserve the accolades and increased
business associated with that achievement.
An effective key processing indicator is performing a bone detection inspection
at the incoming raw material entry point of the process. Utilizing screening technology, vision systems, or manual inspection performed by production employees
to prevent larger bones entering a grinding operation is a leading indicator for the
grinder, and a lagging indicator for their supplier. Pieces of poly liner entering the
product stream, created by the combo dumping operator using a stainless fork to
pull the fresh trim out of the combo, and found by the customer and/or consumer
of a grinding operation would be a lagging indicator for the grinder. A leading indi-
cator would be requiring the dumping
operator to inspect the liner for missing
pieces prior to releasing the trim from
the dump station or removing the fork
and replacing it with a metal-detectable
plastic spade. Where do you want to be
in the lagging/leading indicator continuum?
Are You Purchasing FM or
In general terms, there are two ways
FM is introduced into the value stream.
The first method for FM to enter the
facility is via raw materials, and the second common way is generated internally by the production process. They offer
different challenges and each requires
specific strategies to address them.
Let’s start with a discussion on incoming raw materials and the risks associated with them, and then we will focus
on the internal factors that contribute to
You Need to Know What You
How many times have you heard
the phrase “you can’t inspect quality
in”? I agree with that; however, through
inspection, we can gain an understanding of what risks are associated with the
sample size, and in most instances, what
are the challenges with suppliers’ processes. The best method for introducing
a strategy to reduce FM is to set up an
acceptable quality limit (AQL) program.
If you have purchasing leverage, you can
require the supplier to perform this data
collection process at their factory. Either
way, you need to have an initial understanding of what type of FM is coming
in and what your rejection parameters
are. AQL inspections at the further processor can increase financial claims back
to the supplier because of rejections.
“Once we move away from the concept of a screening device as the ‘catchall’ and
view it as the verification of our prevention programs’ effectiveness, we can begin
to experience significant advances in our foreign material prevention programs.”
—John Butts, Ph.D.