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HACCP
PRINCIPLE #4: Establish monitoring
procedures.
Monitoring is a planned sequence of observations or
measurements to assess whether a CCP is under control and to produce
an accurate record for future use in verification. Monitoring serves
three main purposes. First, monitoring is essential to food safety
management in that it facilitates tracking of the operation. If
monitoring indicates that there is a trend towards loss of control,
then action can be taken to bring the process back into control
before a deviation from a critical limit occurs. Second, monitoring
is used to determine when there is loss of control and a deviation
occurs at a CCP, i.e., exceeding or not meeting a critical limit.
When a deviation occurs, an appropriate corrective action must be
taken. Third, it provides written documentation for use in verification.
An unsafe food may result if a process is not properly
controlled and a deviation occurs. Because of the potentially serious
consequences of a critical limit deviation, monitoring procedures
must be effective. Ideally, monitoring should be continuous, which
is possible with many types of physical and chemical methods. For
example, the temperature and time for the scheduled thermal process
of low-acid canned foods is recorded continuously on temperature
recording charts. If the temperature falls below the scheduled temperature
or the time is insufficient, as recorded on the chart, the product
from the retort is retained and the disposition determined as in
Principle 5. Likewise, pH measurement may be performed continually
in fluids or by testing each batch before processing. There are
many ways to monitor critical limits on a continuous or batch basis
and record the data on charts. Continuous monitoring is always preferred
when feasible. Monitoring equipment must be carefully calibrated
for accuracy.
Assignment of the responsibility for monitoring is
an important consideration for each CCP. Specific assignments will
depend on the number of CCPs and control measures and the complexity
of monitoring. Personnel who monitor CCPs are often associated with
production (e.g., line supervisors, selected line workers and maintenance
personnel) and, as required, quality control personnel. Those individuals
must be trained in the monitoring technique for which they are responsible,
fully understand the purpose and importance of monitoring, be unbiased
in monitoring and reporting, and accurately report the results of
monitoring. In addition, employees should be trained in procedures
to follow when there is a trend towards loss of control so that
adjustments can be made in a timely manner to assure that the process
remains under control. The person responsible for monitoring must
also immediately report a process or product that does not meet
critical limits.
All records and documents associated with CCP monitoring
should be dated and signed or initialed by the person doing the
monitoring.
When it is not possible to monitor a CCP on a continuous
basis, it is necessary to establish a monitoring frequency and procedure
that will be reliable enough to indicate that the CCP is under control.
Statistically designed data collection or sampling systems lend
themselves to this purpose.
Most monitoring procedures need to be rapid because
they relate to on-line, "real-time" processes and there
will not be time for lengthy analytical testing. Examples of monitoring
activities include: visual observations and measurement of temperature,
time, pH, and moisture level.
Microbiological tests are seldom effective for monitoring
due to their time-consuming nature and problems with assuring detection
of contaminants. Physical and chemical measurements are often preferred
because they are rapid and usually more effective for assuring control
of microbiological hazards. For example, the safety of pasteurized
milk is based upon measurements of time and temperature of heating
rather than testing the heated milk to assure the absence of surviving
pathogens.
With certain foods, processes, ingredients, or imports,
there may be no alternative to microbiological testing. However,
it is important to recognize that a sampling protocol that is adequate
to reliably detect low levels of pathogens is seldom possible because
of the large number of samples needed. This sampling limitation
could result in a false sense of security by those who use an inadequate
sampling protocol. In addition, there are technical limitations
in many laboratory procedures for detecting and quantitating pathogens
and/or their toxins.
Source: FDA and National Advisory Committee on Microbiological
Criteria for Foods (NACMCF)
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