facility’s food safety plan.
Note: Example 1 is provided for illustration purposes only based on the
guidance published in Fish and Fishery
Products Hazards and Controls Guidance. 14
Manufacturing facilities must perform
Hazard Analysis and identify preventive
controls as appropriate to the nature of
the applicable control and its role in the
facility’s food safety system.
Example 2: Frozen bakery products
in which a cooking process is used to
significantly minimize or prevent
Salmonella spp. survival and is managed as an
OPRP in a facility’s food safety plan.
Note: The above example is provided
for illustration purposes only based on
the International Association for Food
Protection (IAFP) poster presentations
by Kottapalli et al. 15 and Kottapalli
and Schaffner. 16 Manufacturing facilities must perform Hazard Analysis and
identify preventive controls as appropriate to the nature of the applicable
control and its role in the facility’s food
safety system.
Advantages, Disadvantages, and
Limitations of Tools
The main advantage of using decision trees and/or risk matrices is that
they provide a straightforward, easily
documented approach to determining
the type of control measure needed
to address an identified hazard during risk analysis. For larger companies
with multiple facilities, these tools are
a good way to standardize the Hazard
Analysis approach across the company.
Codex Alimentarius recommends training in the use of the decision tree, 17
and in the Seafood HACCP guidance,
FDA recommends that users “not rely
exclusively on the decision tree, because
error may result.” 14 Each facility and
food safety plan is different and requires
expert review to ensure the decision tree
results are, in fact, appropriate to the
Hazard Analysis. Some examples of this
limitation are described below.
Earlier decision trees developed prior
to the introduction of the preventive
control concept have an inherently lim-
ited flexibility to consider OPRPs. These
early trees have only “CCP” and “Not
a CCP” options and do not describe
what needs to happen for those control
measures deemed “Not a CCP.” While
the assumption is that the “Not a CCP”
measure will be maintained as a Good
Hygiene Practice (GHP) or PRP, this is
not explicitly stated within the decision
trees themselves. Use of the modified
decision trees in Figure 1 could be more
helpful to facilities that have preventive
controls to be managed as OPRPs. The
Codex Committee on Food Hygiene
is considering adding the concept of
“Control Measures at Places other than
CCPs” or “Enhanced GHPs,” but this
terminology has not yet been final-
ized. 18 There is a proposed decision tree
(Figure 2) that accompanies this revi-
sion.
While the risk matrix approach may
seem a good quantitative technique,
the Hazard Analysis becomes more
difficult when it gets to the point of
assigning number rankings to certain
hazards. Questions can arise on how
much of a dose is considered a high
dose, what is really the difference be-
tween a consumer who is ill and one
who goes to the hospital, and what is
the difference between something that
occurs occasionally, occurs often, or is
a common occurrence? Another option
could be to take a more conservative
approach to risk analysis, and instead of
assigning number rankings to severity
and likelihood, the decisions are made
as to whether the hazard is or isn’t se-
vere, and whether the hazard is or isn’t
likely to occur. In this case, severity and
likelihood rankings are listed simply as
Yes or No. Combinations of Yes and
No will determine whether the hazard
is one that needs a preventive control
and what type of preventive control it
should be (Table 1).
Depending on the situation at the
individual facility, there are additional
HACCP
NO
YES
It is not an enhanced GHP
NO
YES
1. Do GHPs exist at this step?
Move to next step, begin with Q1 NO
YES Is GHP required at this step?
Modify step to apply appropriate GHP
2. Is this GHP generic or specific to a food safety hazard?
Generic Specific YES
3. Has this generic GHP been customized according to the food business/process?
Move to next step,
begin with Q1
4. Is this customized generic GHP sufficient to eliminate the hazard or
reduce it to an acceptable level?
This is an enhanced GHP
YES
Validate
NO
Apply HACCP
Figure 2. Proposed Decision Tree to Accompany the Codex Alimentarius Commission on Food
Hygiene’s Revisions for Enhanced GHPs