WHITE PAPER

PREREQUISITE PROGRAMS:
BUILDING YOUR HACCP FOUNDATION
Jeff Chilton
VP, Professional Services
Intertek Alchemy

Jorge Acosta
Director of Professional Services
Intertek Alchemy
INTRODUCTION
Prerequisite programs, or PRPs, are essential to the development of effective HACCP
systems. In theory, PRP’s act as the foundation of this system – the stronger a
facility’s foundation, the stronger its food safety plan. Thus, PRPs provide the basic
environmental and operating conditions necessary to produce safe and wholesome
food. The key is that these PRP’s are not only well documented, but properly
implemented and monitored to ensure compliance at all times, by employees and
visitors alike.

When we utilize PRPs properly, they keep several factors from becoming severe
issues in your facility that could eventually impact food safety. Historically, failures
of PRP’s in sanitation and labeling areas cause significant foodborne illness outbreaks
and product recalls. This white paper acts as a resource for what HACCP’s prerequisite
programs may look like in manufacturing and processing facilities.

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PRPS VS. HACCP
Though they are interdependent, PRPs and HACCP are different. PRP’s deal indirectly
with food safety issues. Manufacturing and production companies implement PRPs
as part of a HACCP system. They are more general than HACCP and may be applied
throughout the plant, crossing multiple product lines. Under current regulations, PRPs
become even more important. In some cases, what we typically refer to as a PRP
under the Preventive Controls for Human Food rule may become a Preventive Control.

On the other hand, HACCP deals solely with direct food safety issues. HACCP plans
grow from hazard analysis that are product and line specific. Deviations from a critical
limit within HACCP plans typically result in a corrective action against the product. To
learn more about building your HACCP plan, develop a better understanding of
HACCP principles, and learn industry best practices, consider Alchemy’s online
HACCP training courses.

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EXAMPLES OF
PREREQUISITE
PROGRAMS FOR HACCP
Many PRP programs are based on FSMA regulations, such as cGMPs and sanitation
regulations. These can include ingredient specifications for all inputs, meaning
raw materials, packaging, and processing aids a facility receives. These also include
consumer complaint management procedures, allergen management programs,
microbial monitoring of the plant environment, ingredient-to-product traceability
programs, and supplier approval programs. The FDA mandates that facilities take a
closer look at their PRPs and determine which of those programs, if not controlled,
will have an impact on food safety. These may include allergens, supplier guarantees
when a product is not undergoing a step to remove a significant hazard, and
sanitation controls for Ready to Eat Products, to name a few.

Let’s now take a closer look at practical PRP examples for HACCP plans.

Thermometer Calibration
Facilities need to have established standard operating procedures for thermometer
calibration that defines the method of calibration, frequency of calibration, a
responsible party, and types of records. These logs or records should include date,
time, thermometer number, reference temperature, actual temperature, adjustments,
and initials. If a thermometer is used to monitor critical limits associated with a CCP
or a Process Preventive Control, then the thermometer calibration procedure and
frequency must undergo validation.

Pest Control
Lack of pest activity in a facility is the key indicator of a successful pest control
program. Pest Control Operators (PCO) must be licensed and insured. Service reports
should provide adequate detail of the services provided, such as pesticides applied,
including dosage rate, quantities applied and treatment location. Facilities must
produce Safety Data Sheets (SDS) and sample labels for pesticides and rodenticides.
Companies need to provide in-depth evaluations of their pest control programs,
typically involving trend analysis by device type or verification procedures.

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Foreign Material Control
Foreign material control is a crucial perquisite program that starts with knowing
what your suppliers are doing to prevent foreign material contamination in their raw
materials. Internally, procedures must be in place to prevent contamination from metal,
plastic, wood, glass and other foreign materials, Foreign material detection devices
such as metal detectors, X-rays, magnets, screens and others should be used where
appropriate to remove potential contaminants. Routine inspection of facilities should
be completed assess potential sources of foreign material and mitigate the risk.

Water Potability
For buildings and facilities, water potability tests and certificates must prove
compliance with the United States’ EPA requirements. Any backflow protection device
must be on file and tested on a regular cadence.

Letters of Guarantee
Letters of guarantee (LOG) from suppliers of ingredients and packaging materials
must be on file for a facility to remain compliant. Some meat suppliers are required
to have LOG or Certificates of Analysis (COA) for certain raw products. Letters of
guarantee are also necessary to validate bacterial control on hazardous ingredients,
especially if they are not subject to a kill step, In this case, the LOG or COA becomes a
key element - it is not only a PRP, but a Supply Chain Preventive Control.

Receiving
On the receiving end, standard operating procedures define standards for acceptance.
Facilities must identify if testing is done in-house or by a COA, and the type of
evaluation performed on ingredients and packaging. Records must demonstrate
that the ingredients and packaging underwent evaluation and that the transporting
container did not compromise their integrity. Receiving records should also confirm
that materials come from Approved Suppliers as identified in a facility’s Supplier
Approval Program PRP.

Storage
Storage is another PRP that requires documented SOPs, especially with temperature-
sensitive ingredients. Beyond this, an adequate operational standard must be
verified via internal audits or GMP inspections. The proper segregation of wet vs. dry
ingredients and allergens is critical to this PRP. The storage of exposed or refrigerated
ingredients such as vegetables, fresh fish, milk, and more in distribution centers could
become a Preventive Control. Such operations must conduct adequate hazard analysis
to determine the risk levels and identify adequate control measures.

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Returned Product
If a facility accepts returns, they must document an evaluation process. Due to the
risk returns present, product and packaging standards must be defined to ensure that
items are intact and not expired or contaminated. Also, documentation should include
inspection procedures, responsibilities, and records. In general, it is not wise to receive
returned products since you cannot be certain what happened to that product when
it was out of your direct control.

Preventive Maintenance PRPs

Preventive Maintenance PRPs must record that your equipment does not present
contamination issues brought about by lack of maintenance or during the
maintenance activities themselves. Repairs, in particular, present stringent PRP
requirements. Records of each repair, what needs to be cleaned or sanitized before
and after the repair, and any mobile equipment inspection and tools are necessary
for compliance. Preventive maintenance programs must also include infrastructure,
outside grounds, and supporting areas such as steam and engine rooms as applicable.
Maintenance employee GMP procedures are also a key PRP to assure product and
product contact surfaces are not contaminated during repairs or PM activities.

Chemical Controls
Chemical controls assure adequate segregation of chemicals, food ingredients, and
materials. Chemical Control Programs must include controlled access to chemical
storage areas with restricted access. Knowing where your chemicals are at all times,
and that they will not present contamination issues, is crucial to chemical control.

The storage and handling of food grade or food contact cleaning chemicals must
be done in a manner that prevents such products from being contaminated by
conventional lubricants and cleaning agents. In addition, proper labeling of all
chemicals in all containers is a key component of this program. Safety Data Sheets
(SDS) must be on file and available for all chemicals in the facility.

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Recall and Crisis Management
Recall is a key element of crisis management. FSMA indicates that if a product has a
preventive control, that product must have a Product Recall Plan documented. This
lets teams know exactly what to do if a recall should arise. The written plan should
identify a recall team, that team’s leader, and should include:

• Recall classification and types

• Procedures regarding what triggers a recall
• Who to notify of the recall – maintaining current information of all
interested parties is key i.e. FDA, State Health Departments, Customers,
Stakeholders, Media, Employees, etc
• Who will take lead on notification responsibilities?
• Responsibilities of each department during the recall process
• Recall effectiveness checks

Environmental Monitoring Programs

An Environmental Monitoring Program (EMP) that monitors for the pathogens of
concern (E. Coli, Salmonella and/or Listeria) is a key PRP, and in some cases the EMP
becomes a key element of a Sanitation Preventive Control at FDA regulated sites
producing Ready-To-Eat products (RTE). In USDA regulated facilities, these plans must
be science-based per FSIS Directive 10,240.4, and results must be shared with the
USDA to prevent and intensified inspection.

Typically, EMPs utilize a four-tier sampling program by zone. Zone 1 includes food
contact surfaces. Zone 2 includes indirect equipment framework and over product
areas. Zone 3 includes processing area environment. Zone 4 includes common
areas outside of processing rooms. The EMP must be risk based with supporting
documentation available to justify the type sampling, frequency of sampling and sites
to be sampled.

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Employee Training
Employee training is one of the most critical programs included in PRPs. Without
effectively training employees, your HACCP plan and PRPs remain at-risk. Food safety
and personal hygiene training as well as job specific training are mandatory topics as
per FSMA’s Qualified Individual training requirements. Employees need to be trained
upon hiring and have access to routine refreshers to remain in compliance. Key
training concepts should be reinforced with visual reminders throughout the facility,
encouraging employees to follow food safety and HACCP plans.

In addition to the mandatory FSMA training topics, individuals involved in activities

related to monitoring critical control point and preventive controls might need
specialized training to ensure that all procedures are conducted accordingly and within
SSOP compliance of the Food Safety Plan.

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CONCLUSION &
REGULATORY
REFERENCES
With strong PRPs for food safety, sanitation, and workspace design in place, facilities
can effectively implement a HACCP system and protect consumers. While industry
standards continue to evolve, regular employee training ensures an operation stays
up to date with the latest regulations.

For more information on the regulatory requirements of PRPs, please consult:

FDA Preventive Control for Human Food 21 CFR Part 117 Subpart B: Current
GMPs and Hazard Analysis Risk-Based Preventive Controls

USDA Regulations 9 CFR Part 416: Sanitation

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