Preventive
Controls in Food Safety
The
preventive controls approach has been universally accepted as a proactive and
systematic approach to food safety and adopted throughout the world and
continue to do so. Because it helps to attempt preventing issues before they
arise while focusing on the most important areas to prevent food safety issues rather
than reacting to problems as they arise. Preventive control programs are not
new to the world even though the nomenclature is as they are already in use in
combination in different models which has been structured to work in
conjunction more effectively. The most common examples are; Good Manufacturing
Practices (GMPs), good agricultural practices, good transportation practices including
HACCP, PRPs, OPRPs, etc. as the basis for food safety management. Successful
application of preventive controls approaches usually cover every angle of
intended and not intended risks within or outside which is not only helps to
ensure regulatory compliance, but also minimizes the risk of producing products
that can harm consumers.
As
of the history of preventive controls development in food industry, that dates
back to the Apollo missions, where risk‐based approaches to managing food safety were
pioneered during development of food for the U.S. space program in the 1960s. Initially,
end‐product testing was
the main focus of the quality control programs, where there were tremendous failures,
as end‐product testing
necessary to provide assurance that the food was safe would be so extensive
that little food would be available for space flights, while there was no 100%
credibility that leftover items are completely fit for use. Then focus was shifted
from final product testing to preventing hazards (by the Pillsbury Company and
Army laboratories as collaboration) through product formulation and process
control in a risk‐based approach which
was named as Hazard Analysis and Critical Control Point (HACCP). The HACCP
implementation was gradually expanded voluntarily in the food industry.
The
general understanding is that, food safety is best assured if each producer and
processor understands the significant hazards in their product and operation,
and if they use scientifically sound preventive controls to significantly
minimize or eliminate the hazards. As a front liner, FDA used HACCP principles
in the development of low‐ acid canned food
regulations in the 1970s. The development further expanded when the U.S.
National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and
the Codex Alimentarius Commission (Codex) published HACCP principles in the
1990s. The expansion further took turns in the world food production with
various applications into several subsectors, where FDA has HACCP regulations
for seafood and juice products; USDA has HACCP regulations for meat and poultry
products; and HACCP is endorsed by many countries, including Australia, Canada,
New Zealand and European Union.
What
is a Preventive Control Program?
The
preventive control programs are in a rise in the modern food industry, as US
FDA and Canadian Food Inspection Agency has already introduced preventive
control programs to their food safety management system requirement as food
safety modernization act (FSMA) and safe food for Canadians act (SFCA). However,
these programs are not very different from their predecessors as already
explains, but has been modernized, improved and additional requirements are brought
to justice with more rigorous and systematic approaches. In the previous models,
the HACCP principles are the heart of the program while rest is come around it,
which is still same but more extended support programs and more risks has been
considered. Thus, understanding of these principles are useful to understand
how the Preventive Controls for Human Food regulations complements the risk‐based HACCP approach.
In
a HACCP system, hazard analysis identifies process‐related hazards which,
in the absence of control, present a food safety risk. Therefore, when such
hazards are identified, Critical Control Points (CCPs) should be defined, while
identifying that are essential to control the process to prevent the hazard
from causing illness or injury to the human health. When these CCP process
controls are identified, the critical limits should be defined for the
operating conditions in the process that must be met to effectively manage the
hazard. Nonetheless, monitoring of the process is carried out to provide data
to demonstrate that critical limits are met, where corrective actions are
predefined to enable swift action when things go wrong, thus preventing
expansion of a food safety issue. All of the above activities are recorded and
verified to ensure the system is operating as intended and to provide data to
others (e.g., inspectors, auditors, management, new employees) to show that
this is the case, recognizing that a HACCP Plan essentially addresses most of
the requirements for process preventive controls.
However,
the preventive controls process incorporates controls beyond those managed as
process‐related CCPs in the
HACCP framework. Therefore, such preventive controls address not only CCPs, but
also controls for hazards related to food allergens, sanitation, suppliers and
others requiring a preventive control. The preventive controls approach also
recognizes that critical limits, defined by NACMCF as: “A maximum and/or
minimum value to which a biological, chemical or physical parameter must be
controlled at a CCP to prevent, eliminate or reduce to an acceptable level the
occurrence of a food‐ safety hazard”
may not be required for some preventive controls. The broader term, parameters
and values, supports identification of a frequency or other metric to assess
compliance, rather than setting a precise minimum or maximum value to which a
parameter must be controlled. i.e., immediate corrections (like re‐cleaning a line
before start up) may be more appropriate than formal corrective action
involving product risk evaluations for some preventive controls. Finally, the
extent of validation activities (or demonstrating the controls actually work)
may be less rigorous for some preventive controls than others.
Food
Safety Plans
The
Food Safety Plan is the primary document that guides the preventive controls for
food safety system. The Food Safety Plan is developed using a systematic
approach to identify those hazards that require preventive controls to prevent
foodborne illness or injury. Nonetheless, it is a dynamic document, which must
be kept current if changes are made to the system or to equipment when new
products are added, or new hazards are identified. Food Safety Plan includes a
number of elements such as hazard analysis, which is used to identify required
preventive controls for the process, for sanitation, for food allergens and
supply‐chain programs, where
production process necessary to address the hazards requiring a preventive
control. These given elements, along with a recall plan make up the Food Safety
Plan. Many GMPs and other prerequisite programs are managed outside of the Food
Safety Plan. While these are separate programs and may not require the same
level of documentation as the elements of the Food Safety Plan, which are
important. They are generally managed using standard operating procedures with
documents and records kept as appropriate. Keep in mind that elements of GMPs that
are not covered in the Food Safety Plan are still required by regulations,
since most of the food production facilities required to build based on
physical GMP requirements as primary requirement. Prevention‐based food safety
management can be integrated into any operation; however, the process can seem
complicated until the basic concepts are understood.
Developing
a Food Safety Plan, including determining where preventive controls are required;
involves a systematic process based on science to help ensure the safety of the
product. The basic is hazard analysis, which is intended to identify hazards
requiring a preventive control. When these hazards are known, preventive
controls that are essential to prevent the hazard from causing illness or
injury are to be identified. Thus, preventive controls may include process
preventive controls, allergen preventive controls, sanitation preventive
controls, supply‐chain preventive
controls or other preventive controls that are essential for the product. Once
preventive controls are identified, determination of relevant parameters that
define the conditions which must be met to effectively manage the hazard. Monitoring,
corrective action and verification procedures for each of the preventive
controls identified must also be included in your plan as appropriate to ensure
the effectiveness of the controls.
Monitoring
provides documentation that demonstrates these conditions are met, where corrective
actions or corrections are predefined to enable swift action when things go
wrong, thus preventing expansion of a food safety issue. Once, things go wrong
or out of control, it is necessary to clarify, if it was because a hazard was
overlooked (in which case you must adjust the hazard analysis), or if a
preventive control was not properly identified or implemented. All of the above
is recorded and verified to ensure the system is operating as intended and to
provide a record for others (e.g., inspectors, auditors, management) to show
that this is the case. Some elements of a preventive controls system which are
critical to the process also require validation to demonstrate that the
controls actually work. This activity may be less rigorous for some preventive
controls than others.
A
recall plan is also a mandatory element of a Food Safety Plan when a hazard
requiring a preventive control is identified. Nonetheless, system should have
procedures to maintain implementation records to document that organization has
implemented the given Food Safety Plan. Because your Food Safety Plan will be
used or reviewed by regulators, employees, auditors, customers and potentially consultants,
which may also be useful to include a brief description of the facility or
company along with a list of Food Safety Team members, product descriptions, a
process flow diagram and a process description to help people understand the
structure of the plan.
Reference:
https://www.uvm.edu/extension/necafs/clearinghouse/resources/fspca-preventive-controls-human-food-participant-manual
https://en.wikipedia.org/wiki/Hazard_analysis_and_risk-based_preventive_controls
https://www.fda.gov/downloads/food/guidanceregulation/fsma/ucm584807.pdf
https://www.uvm.edu/extension/necafs/clearinghouse/resources/food-safety-plan-builder-preventive-controls
