consumer understanding of food safety
information on labels. Surveys need to
be appropriately designed and executed
to ensure valid data.
A critical aspect of the protocol is to
understand the limitations of any study
conducted. These limitations define a set
of underlying assumptions. A critical assumption is determining if a validation
study was conducted under a worst-case
scenario. If this did not occur, then it is
essential to analyze both the monitoring
(present) and verification (past) results to
determine if any negative trends are occurring and whether corrective actions
have been taken prior to having a failure
of a food safety control measure.
For example, when determining critical factors for retort processes, the
process authority may conduct studies
on containers that are intentionally overfilled—the assumption being that this is
a worst-case scenario.
One question that crops up frequently is “Who should do the validation?” The HACCP regulations for juice
( 21 CFR Part 120) state, “The validation
of the hazard analysis shall be performed by
an individual or individuals who have been
trained in accordance with Sec. 120.13, and
records documenting the validation shall be
subject to the recordkeeping requirements of
Codex states that verification activities should be done by someone other
than the person doing the monitoring.
Neither Codex, the U.S. HACCP regulations, nor the National Advisory Committee on Microbiological Criteria for
Foods (NACMCF) guidelines state that
third parties must verify and validate the
HACCP plan. Ironically, several of the
company audits now require that a plan
be validated by a third party that are
happy to do so—for a fee.
The Codex guidelines describe a validation scenario for a Sanitation Standard
Operating Procedure (SSOP). 4 In this
scenario, environmental monitoring
samples were taken daily on food-contact surfaces over a period of three to
four weeks. The results of the environmental samples were then compared to
established microbiological criteria. Statistical tests were used to determine the
efficacy of the SSOPs. If the results met
the established criteria, then the SSOP
was considered to be validated.
In general, this Codex validation procedure for sanitation is good. The study
was conducted over a long period of
time, which allowed for some process
variation. But there are a number of
questions that can be asked about this
protocol, such as:
• What was done with the product during the validation study? Will the
product be held until the study is
completed before it is released into
What Is an Operational
oPRP is a term unique to ISO 22000.1 In many ways, the oPRPs are similar to the
Control Points (CPs) that are present in the U.S. definition of HACCP. Codex, and
thus, the rest of the world, does not define CPs in their HACCP literature.
oPRPs are identified by the hazard analysis. If a loss of control occurs, actions
need to take place to bring the process back into control. However, controlling an
oPRP does not prevent or eliminate a food safety hazard or reduce it to an acceptable level. Controlling an oPRP does reduce the likelihood of introducing a
food safety hazard or the proliferation of an existing food safety hazard in the
products or the processing environment. oPRPs must be validated, verified and
monitored to ensure effectiveness of the food safety system. For example, a
poultry further-processing plant purchases boneless chicken breasts and
processes them into a ready-to-eat product. As part of the food safety control
plan, there is a receiving specification that requires that all raw chicken breast be
received at temperatures less than 40 °F. In addition, the processing specification
requires that chicken be cooked in an oven to a minimum of 185 °F before freezing and packaging. The receiving temperature could be classified as an oPRP,
and the final cook temperature would be a CCP.
What are the published, accepted criteria for cleaning and sanitizing?
• What happens if one or more outlying factors are present in the data, but
do not statistically affect the outcome
of the validation study? Can the conditions that caused the outliers affect
the safety of the product?
Was the validation study conducted
during times when it is expected that
the largest bioburden levels would
One of the authors was involved in
validating a cleaning procedure. Essentially, the Codex procedure was used.
However, there were several critical modifications. This study was conducted
over consecutive days for two weeks. Environmental swabs were collected before
and after the cleaning process. During
the first week, the validated cleaning
chemicals were used to clean the equipment. This established a baseline for the
validated cleaning process.
During the second week, new cleaning chemicals were used in accordance
with the distributor’s recommended
cleaning instructions. Environmental
samples were collected before and after
the cleaning procedures. Following the
cleaning process using the new cleaning
chemicals, the equipment was re-cleaned
using the validated cleaning chemicals.
The number of environmental samples
was determined by a process authority
with experience in environmental design. Analysis of the environmental samples revealed that the proposed cleaning
chemicals were as effective as the existing
cleaning chemicals. Thus, the cleaning
process was validated for the use of the
proposed cleaning chemicals.
Other prerequisite programs are even
more difficult to validate. The question
can be asked, “How does one validate a
training program?” Is a test adequate?
Some people are excellent test takers,
but does that really mean they have
“learned” and understand the material?
Another that crops up is, “How does
one validate the handwashing process in
Some training companies will utilize
procedures to determine the qualifications of the instructors and then evaluate
the instructors during the sessions that
the instructors provide. In addition, the