PROCESS CONTROL
By John G. Surak, Ph.D., and Richard F. Stier
Validating
Controls
Food Safety
Validation has always been part of the Hazard Analysis and Critical Control Point (HACCP) system, but it is an even
greater issue in today’s food safety
management systems. HACCP has
mandated the validation of CCPs since
the introduction of the seven principles in 1989. Food safety man-
agement standards also require that some or all of the food safety
system be validated. Even though this has been required since “day
1,” it is surprising how many companies’ HACCP plans contain no
validation data.
The ISO 220001 and PAS 2202 standards require formal validation of CCPs and
operational prerequisite programs (oPRPs) (see sidebar on oPRPs, p. 20). In addition, cleaning and sanitizing programs must also be validated. Organizations must
properly design, document, implement and maintain prerequisite programs, even if
the standard does not specify a validation requirement for this part of the food
safety system.
One way to think of the differences among validation, verification and monitoring is to use the following questions that are linked to basic grammar:
• Monitoring: Are the operations being done as intended? (present)
• Verification: Was the work done according to plan? (past)
• Validation: Will the plan work? (future)
Validation is not a new concept to the food processing industry. In the early
days of the low-acid canned-food regulations, protocols were established to validate
the processing conditions for canning low-acid products. Parts of the protocol
could be classified as general, such as critical factors that established the time-tem-perature relationship to process a specific food product, including cook times, cook
temperatures, head space and drain-fill weight. These critical factors could be established and validated in a pilot plant with proper processing equipment. This re-
quirement did not make the European
manufacturers of aseptic systems very
happy in the early 1980s. When FDA
approved hydrogen peroxide as a sterilant, those manufacturers learned that
history was not enough. They had to
gather data to validate that the processing and packaging equipment not only
could be sterilized, but also would remain sterile during operations.
Today, different types of validation
need to be done on the manufacturing
equipment that is used to produce the
product. In canning low-acid foods, this
includes identifying the cold spot in a
retort-packaged food product, which is
critical in determining the schedule for
the process.
A recent example in the U.S. that has
cropped up as direct result of a foodborne outbreak has been the requirement that almonds must be processed to
reduce Salmonella by 4–5 logarithms.
The systems used for this must be validated by a process authority recognized
by the Almond Board of California as
able to achieve the required bioburden
limit. 3 Many times, process authorities
will establish a minimum process to ensure safety, but operating parameters exceed this minimum. Thus, the process
has built-in safety factors. The scheduled
processes are somewhat excessive, which
will minimize the potential for process
deviations, yet ensure both quality and
safety. However, the minimum processing parameters are determined as a result
of studies that utilize “worst-case scenario” processing conditions.
In 2008, Codex Alimentarius (
hereafter referred to as Codex) published the
standard, “Guidelines for the validation
of food safety control measures,” 4
which represents a major benchmark because it separates “validation” from “
verification” in the practice of HACCP. It
is an excellent document with respect to
the validation that is needed to follow
HACCP procedures and with respect to
its scope. It can be applied to many of
the existing control measures, as it incorporates a five-step process that can be
used for validation. The five steps are:
