developed to show all activities that are involved with the
product, from raw ingredients to the preparation of the product
by the end consumer. A generic flowchart for a frozen raw
cookie dough producer is shown in Figure 1.
To foodservice employees, the flowchart serves as a visual
outline to identify all of the steps in the production process
and shows the movement of the product through production.
The next step in the HACCP system is to identify any hazards
that may be associated with the product. These hazards may
be biological (e.g., bacteria), physical (e.g., glass or metal) or
chemical (e.g., pesticides or machine grease). In our example,
this would be that this particular cookie product contains eggs
and milk that constitute a risk of bacteria growth and, thus, a
biological hazard if not handled correctly. The chance of metal
or grease being introduced into the product within production
is an example of a physical hazard. Once hazards associated
with the product have been identified, a table can be used to
assess the likelihood of each hazard occurring and its level of
harm to the consumer. An abbreviated table of hypothetical
hazards and possible harm to consumers is presented in Table
1.
A risk assessment table provides a good model of the most
important hazards that must be addressed in the HACCP
plan. Those hazards that pose a medium or high possibility of
Hazard Likelihood Danger to consumer
Physical Glass (low) Glass (high)
Metal (medium) Metal (high)
Wood (low) Wood (low)
Chemical Pesticides (low) Pesticides (high)
Machinery grease Machinery grease
and oils (low) and oils (medium)
Cleaning agents (low) Cleaning agents (medium)
Biological All biological agents All biological agents
such as Salmonella such as Salmonella
and Escherichia coli and Escherichia coli
(medium) (high)
occurring, as well as a medium or high level of
possible harm to the consumer, are the hazards
that should be deemed critical to the safety
of your product. In this case, the most critical
hazards would be the physical contamination
from metal pieces and biological growth in the
product or ingredients that can cause illness.
After the most critical-to-safety hazards have
been identified, steps can be taken to reduce or
eliminate the possibility of them in the frozen
cookies. This is accomplished through the
identification of the most likely point that a
hazard could be introduced, or a point where
a hazard could be detected and eliminated.
These points are called Critical Control Points
Once the limits for these CCPs are set, a monitoring and
recording program can be implemented, and the HACCP plan
begins to protect consumers from these dangerous hazards. We
now have a quality program in place that deals with the quality
the consumer expects with regard to food safety: that the
cookies are safe to eat. With a HACCP plan in place, FMEA
can be implemented to achieve the nutrition, good taste and
visual appeal that constitute other aspects of cookie quality.
When not prodded, the food industry is often characterized
as being conservative and slow to change or adopt new quality
practices. 6 That is why FMEA is a good quality tool for this
industry. It is relatively easy to understand and implement, and
the groundwork has already been done in many instances with
HACCP planning.
FMEA developed alongside HACCP at NASA in the 1960s.
It was adopted by the automotive industry in the 1980s and
’90s and is now being used in other sectors such as healthcare. 7
A risk analysis process involves acquiring information, modeling, analyzing the information and the model and coming to a
decision that improves the product. 8
Navigating the Process
To get more insight into possible failures, a cross-functional
team is routinely used. The team breaks down the process into
fundamental components to detect all potential failures at each
component. 9 The actual FMEA of a system is then typically
developed with a form that outlines each part of the process. A
typical form will identify the following:
•;The;process;part;or;stage
•;The;potential;failure
•;The;effects;of;the;potential;failure
•;The;severity;of;the;failure;effects
