things to consider when determining
the type of preventive control. The
company or manufacturing facility food
safety culture may be such that employees are biased toward “CCP thinking”
and “prerequisite thinking.” In these
situations, operators are used to managing only two types of controls—either it
is critical or it is not. Without intensive
and appropriate training, having an
OPRP control could cause confusion
and result in less than optimal monitoring and verification of the control, since
operators may not be able to discern the
difference between an OPRP and the
PRPs they are used to implementing.
For facilities that operate under multiple
regulatory jurisdictions, again there are
opportunities for confusion among
floor operators. For example, in a facil-
ity that makes snack kits, some of which
contain meat and some that do not, a
particular preventive control needs to
be an OPRP in the FDA HACCP plan
for the meatless snack kits, and a PRP in
the USDA plan for the meat-containing
snack kits. The monitoring and verifica-
tion activities could be performed at
different frequencies, and corrective
actions could be different. Facili-
ties that are audited under any of the
various Global Food Safety Initiative
auditing schemes will need to justify
their decision-making process for the
choice of preventive controls, so a well-
documented procedure to follow when
making these decisions is a necessary
component of an HACCP/food safety
plan. Facility personnel will need to un-
derstand and be able to explain any and
all tools that were used to determine the
type of preventive control.
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 documents. 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 Microbiologist, Food Safety & Microbiology at Conagra
Loralyn H. Ledenbach, M.Sc., is Principal Scientist at The Kraft Heinz Company.
1. Almond Board of California. 2007.
Considerations for Proprietary Processes for Almond
Pasteurization and Treatment, v1.0.
2. Almond Board of California. 2007. Guidelines
for Process Validation Using Enterococcus fae-cium NRRL B-2354, v1.2.
3. Almond Board of California. 2007. Guidelines
for Validation of Blanching Processes, v1.0.
4. Almond Board of California. 2007. Guidelines
for Validation of Dry Roasting Processes.
Guidelines for Validation of Oil Roasting Processes.
5. Grocery Manufacturers Association. 2009.
Control of Salmonella in Low-Moisture Foods.
6. Grocery Manufacturers Association. 2010.
Industry Handbook for Safe Processing of Nuts.
7. Anderson, DG and LA Lucore. Validating the
Reduction of Salmonella and Other Pathogens
in Heat Processed Low-Moisture Foods (
Alexandria, VA: Alliance for Innovation & Operational
8. Codex Alimentarius Commission. Guideline
for the Validation of Food Safety Control Measures (CAC/GL 69-2008) (Rome: Joint FAO/
WHO Food Standards Program, 2008).
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Control Point Principles and Application Guidelines.” J Food Prot 61:762–775.
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Alternative Methods of Pasteurization.” J Food
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Inoculated Pack/Challenge Study Protocols.” J
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13. GMA. HACCP — A Systematic Approach to
Food Safety: A Comprehensive Manual for Developing and Implementing a Hazard Analysis
and Critical Control Point Plan, fifth ed. (2014).
14. Department of Health and Human Services,
Public Health Service, Food and Drug Administration Center for Food Safety and Applied
Nutrition, Office of Food Safety. Fish and Fishery Products Hazards and Controls Guidance,
fourth ed. (2011).
15. Kottapalli, B., A. Cunningham, Y. Huang, E.
Akins and S.J. Hermansky. “Survival of
Salmonella spp. and L. monocytogenes during Pancake Cooking Process.” Poster presentation at
IAFP 2015 Annual Conference, Portland, OR.
16. Kottapalli, B and DW Schaffner. “
Modeling the Risk of Salmonellosis Associated with
Consumption of Frozen Precooked Pancakes.”
Poster presentation at IAFP 2016 Annual Conference, St. Louis, MO.
17. Codex Alimentarius Commission. 2003.
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(HACCP) System and Guidelines for Its Application.” Annex to CAC/RCP 1-1969 (Rev. 4-2003).
18. Codex Alimentarius Commission. CX/FH
17/49/5 Proposed Draft Revision of the General
Principles of Food Hygiene (CAC/RCP 1-1969)
and its HACCP Annex.
Likelihood Severity Control Rationale
Yes Yes Yes Include the rationale for this analysis and manage
the risk by CCP or OPRP (at a minimum)
No No No Include the rationale for this analysis
No Yes No Include the rationale behind why the likelihood of
occurrence is a “No” (support the decision by
referring to appropriate PRPs)
Yes No No Include the rationale behind why the severity of the
hazard is a “No” (support the decision by referring
to appropriate PRPs)
Table 1. Risk Matrix