Individuals who have thorough understanding of the process, product, and
food safety plan should be assigned the
responsibility for oversight of corrective
actions. As appropriate, SMEs may be
consulted to perform a scientific evaluation to determine the disposition of the
nonconforming product. 13
Verification: The primary purpose of
the verification activity is to evaluate
if a facility’s food safety system is effectively functioning as intended. An
effective food safety system may require
little product testing, since it relies on
frequent reviews of their food safety
plan, effective management of preventive controls, and foundational food
safety programs (PRPs). Another aspect
of verification is the initial validation of
the food safety plan to determine that
the plan is scientifically and technically
sound, that all hazards have been identified, and that if the food safety plan is
properly implemented, these hazards
will be effectively controlled. Information needed to validate the food safety
plan often includes expert advice and
scientific studies, and in-plant observations, measurements, and evaluations.
For example, validation of the roasting
process of peanuts must include the scientific justification of the heating times
and temperatures needed to obtain an
appropriate destruction of pathogenic
microorganisms (e.g., Salmonella) and
studies to confirm that the conditions
of roasting will deliver the required time
and temperature to each peanut. Subsequent validations are triggered by major
changes to the food safety plan (e.g.,
change of process, use of new raw material supplier, emergence of new hazards,
installation of new equipment). 13
Records: Records maintained for the
food safety system should include the
following: 1) a summary of the Hazard Analysis, including the rationale
for determining hazards and control
measures, and 2) CCP/OPRP summary
tables identifying hazards of concern,
critical/operational limits, monitoring,
corrective actions, verification procedures, and record-keeping procedures.
In this article, we describe two exam-
ples to illustrate how Hazard Analysis
drives the decision to choose a CCP/
OPRP and eventually develop preven-
tive control management components
(monitoring, verification, corrective ac-
tions, and record keeping).
Example 1: High-moisture fishery
products in which temperature is the
sole requirement to prevent toxin formation and is managed as a CCP in a
Salmonella spp., based on scientific literature and
Yes. Salmonella is a reasonably foreseeable hazard
in raw flour. Consumption of food contaminated with
Salmonella can cause salmonellosis, one of the most
common bacterial foodborne illnesses.
No. Cooking is the only step in the process that will
effectively reduce Salmonella that is present in the
Yes. Cooking temperatures and times required to
produce a saleable product. Exit product temperatures
greater than 167 °F ensure at least a 5-log reduction in
Salmonella spp. 15
No. Exit product temperatures required for saleable
product are typically greater than 180 °F. Quantitative
microbial risk assessment estimations indicate that the
risk of salmonellosis from the proper cooking of raw
flour-based batters (where “proper” is defined as an
average internal temperature of 176 °F or above, and
no longer a slurry and suitable for sale) is extremely
low (99th percentile: one illness in every 312 years). 16
So, operational limits (176 °F) required to produce
a saleable product can be used to manage the food
safety risk. Hence, critical limits are not required.
Products must be heated to minimum internal temperature of 176 °F or more.
What: Exit product temperatures
How: Temperature-indicating device (e.g., a recording
When: Every 4 hours
Who: Performed by any designated employee who
understands the nature of the controls
Hold the affected product until an evaluation (including
root-cause analysis) of the total time and temperature
exposure is performed (OR) destroy the product (OR)
divert product for nonfood use.
Temperature charts, hold-and-release records, corrective action records, verification records, traceability
Preshipment review of internal temperature data, designated plant employee reviews all disrupted process
records, verification of temperature readout devices
shall be verified weekly (when production is running)
against a NIST-certified thermometer.
Considerations for Decision Making
What is the hazard of concern for this
type of product?
Based on the likelihood of occurrence
and the severity of the adverse health
effects, is this a hazard requiring
Will subsequent steps alone/in combination (including expected use by
consumer) guarantee the removal of
this significant hazard?
Are control measures or practices in
place at this step and do they exclude,
reduce or maintain this significant
hazard as necessary?
Is it necessary to establish the critical
limits for the control measure at this
step (consider scientific data and risk
assessment, involve SMEs and expert
statisticians as appropriate)?
What are the operational limits?
What are the monitoring procedures?
What are the corrective actions?
What are the record-keeping practices?
What are the verification procedures?
(continued from page 31)