is yes. This decision tree could possibly
be used for USDA, Juice HACCP and
Seafood HACCP plans, but would not
be practical for facilities regulated under the FDA Preventive Controls rule.
While these trees can be very helpful
for determining CCPs, they are not as
useful when a facility has “preventive
controls other than CCPs” in their
HACCP system for certain identified
hazards. These preventive controls may
still be necessary for food safety but will
not meet the criteria for a CCP in these
other trees. For those situations, modified Codex decision trees could be more
helpful. Figure 4 shows modified trees
that allow for the possibility of OPRPs
in the decision-making process.
Using Other Tools to Determine the
Type of Preventive Control
Another commonly used tool to aid
with the determination of type of preventive control is a risk matrix. Typical
risk matrices used in the Hazard Analysis combine severity rankings with likelihood of occurrence rankings for a given
hazard. Examples are 3 × 3 and
5 × 5 matrices.
Ratings for a 3 × 3 matrix could look
Use of the 3 × 3 matrix is illustrated
in Figure 5.
12 Hazards rated as 1– 3
(indicated in green in the figure) are
managed by PRPs, hazards rated as 4–6
(indicated in yellow in the figure) are
managed by OPRPs, a combination of
OPRPs or CCPs, and hazards rated as 9
(indicated in red in the figure) are managed by CCPs.
Ratings for a 5 × 5 matrix could look
Use of the 5 × 5 matrix is illustrated
in Figure 6. Hazards rated in green are
managed by PRPs, hazards rated in yel-
low are managed by OPRPs or a combi-
nation of OPRPs, and hazards rated in
red are managed by a combination of
OPRPs or CCPs.
Hazard Analysis for food safety is
a complex process and is different for
every type of food product and food
manufacturing facility. It is easy to get
caught up in predetermined schemes
and rely on published guidance.
Those tools, while an excellent starting point, should not be used “straight
from the page” but adapted to each
unique manufacturing facility scenario.
Employing a combination of expert
knowledge, use of decision trees and
use of risk matrices is the most effective means of arriving at solid Hazard
Analysis and preventive control decisions. n
Bala Kottapalli, Ph.D., CQE, is Senior Principal Micro-
biologist, Food Safety & Microbiology at Conagra.
Loralyn H. Ledenbach is Principal Scientist at The
Kraft Heinz Company.
1. Federal Register, 9 C.F.R. Part 417. January 1,
2. GMA. HACCP — A Systematic Approach to
Food Safety: A Comprehensive Manual for Developing and Implementing a Hazard Analysis
and Critical Control Point Plan, 5th ed. (2014).
3. NACMCF. 1998. “Hazard Analysis and Critical
Control Point Principles and Application Guidelines.” J Food Prot 61:762–775.
4. Federal Register, 21 C.F.R. Part 120. January
5. Federal Register, 21 C.F.R. Part 123. December 19, 1995.
6. Federal Register, 21 C.F.R. Part 117. September 17, 2015.
7. Safe Food for Canadians Act S.C. 2012, c. 24.
8. Canadian Food Inspection Agency. Food
Safety Enhancement Program Implementation
Manual, Volumes 1 and 2 (Ottawa: Government
of Canada, 1993).
9. Codex Alimentarius Commission. 2003. “
Hazard Analysis and Critical Control Point (HACCP)
System and Guidelines for its Application,” Annex to CAC/RCP 1-1969 (Rev. 4-2003).
10. Fish and Fishery Products Hazards and Controls Guidance, 4th ed. (Department of Health
and Human Services, Public Health Service, FDA
Center for Food Safety and Applied Nutrition,
Office of Food Safety, 2011).
11. Campden BRI. Guideline 42, HACCP — A
Practical Guide, 5th ed. (2015).
12. CCP/OPPR Decision Tree. 2009. Coca-Cola
Company and Michigan State University; www.
fskntraining.org, licensed under CC-BY-SA.
1: Low or no risk, no proven risk of 1: Rare, not known or unlikely to
illness or injury happen
2: Medium risk, harmful with high dose 2: Frequent, occurs occasionally or
or cumulative dose, or causes spaced
discomfort but not injury
3: High risk, severe illness or injury 3: Recurring, occurs often
1: Not significant 1: Practically impossible
2: Consumer discomfort 2: Not expected to occur
3: Illness 3: Could occur
4: Hospitalization 4: Known to occur
5: Fatality 5: Common occurrence
Severity - > 1 2 3
1 12 3
Figure 5. Three-by-Three Matrix12
Severity - > 1 2 3 4 5
1 12 34 5
2 24 68 10
3 3 6 9 12 15
4 4 8 12 16 20
5 5 10 15 20 25
Figure 6. Five-by-Five Matrix