sufficient to establish process control.
Process capability studies may be considered to determine the appropriate
frequency. Continuous monitoring at
a CCP/OPRP is preferred but may not
always be practical or necessary. Continuous monitoring becomes more of a
critical requirement if minor variations/
deviations in the critical limits may
otherwise go unnoticed. Automatic and
continuous monitoring is possible with
many types of physical (temperature,
time) and chemical measurements (pH,
chlorine concentration). In some cases,
modern technology has made it possible to continuously monitor variables
like temperatures on statistical process
control charts and electronically communicate (email alerts) to designated
where deviations from critical/operational limits are encountered. This will
not only facilitate real-time verification
of a facility’s food safety system but
also trigger corrective actions in a timely
Who will perform the monitoring:
Qualified individuals assigned to preventive
controls monitoring activities must receive appropriate training for the tasks.
Corrective actions: An important pur-
pose of corrective actions is to prevent
adulterated foods from entering com-
merce. Where there is a deviation from
established critical/operational limits,
Specific corrective actions should be
developed in advance for each CCP/
OPRP and included in the facility’s
food safety plan. At a minimum, the
food safety plan should identify what
was done in the event of deviation and
identify the role and responsibility of
the person performing the activity.
Yes. These products contain no barriers (other than
refrigeration) to toxin formation by C. botulinum type
E and nonproteolytic types B and F during finished
product storage and distribution.
No, because of the extremely toxic nature of C.
botulinum toxin, it is unlikely that the significance of
the hazard will be affected by the intended use of the
Yes. Refrigerated finished product storage is critical to
the safety of all products in this category and must be
identified as a CCP.
The product is held at a cooler temperature of 40 °F or
below. Note that allowance for routine refrigeration defrost cycles may be necessary. Also, note that you may
choose to set a critical limit that specifies a time and
temperature of exposure to temperatures above 40 °F.
What: The temperature of the cooler
How: Use a continuous temperature-recording device
(e.g., a recording thermometer)
When: Continuous monitoring by the device itself, with
a visual check of the recorded data at least once per
Who: Monitoring is performed by the device itself. The
visual check of the data generated by the device, to ensure that the critical limits have been met consistently,
may be performed by any designated employee who
understands the nature of the controls.
Chill and 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.
Printouts, charts or readings from continuous
temperature-recording devices (AND) record of visual
checks of recorded data.
Comparing the temperature reading on the device
with known accurate reference device [e.g., a National
Institute of Standards and Technology (NIST)-certified
thermometer] under conditions that are similar to how
it will be used (e.g., air temperature) (AND) check temperature records daily (AND) calibrate thermometers
(AND) review monitoring, corrective action and verification records within 1 week of preparation to ensure
they are complete and any critical limit deviations that
occurred were appropriately addressed.
Considerations for Decision Making
Is it reasonably foreseeable that
Clostridium botulinum will grow and
produce toxin during finished product
storage at the manufacturing facility if
temperature is not controlled?
Can growth and toxin formation by C.
botulinum that is reasonably foreseeable be eliminated or reduced to an
acceptable level based on intended
Is it necessary to establish critical limits
for control of the identified hazard?
What are the critical limits?
What are the monitoring procedures?
What are the corrective actions?
What are the record-keeping practices?
What are the verification procedures?
Example 1. (continued on page 34)