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WHITE PAPER / FOOD SAFETY MODERNIZATION ACT COMPLIANCE
10 STEPS TO DEVELOPING A DEDICATED FOOD SAFETY PLAN
With the Food Safety Modernization Act’s (FSMA) Preventive Controls for Human Food now in place, food manufacturers
are required to comply with the most sweeping food safety regulations in over 70 years. Compliance for some
businesses began in September 2016, starting the journey on the long road to meeting new food safety expectations.
WHITE PAPER / FOOD SAFETY MODERNIZATION ACT COMPLIANCE
© 2017 PAGE 2 OF 4
INTRODUCTIONThe Preventive Controls for Human Food rule includes
several key requirements:
1. Covered facilities must establish and implement
a food safety system that includes an analysis of
hazards and risk-based preventive controls.
2. The definition of “farm” is clarified to cover two
types of farm operations, which are not subject
to the preventive controls rule.
3. Supply-chain programs are more flexible, with
separate compliance dates established.
4. Current Good Manufacturing Practices (GMP)
are updated and clarified.
Under these new requirements, affected facilities must
establish and implement a food safety system that
includes an analysis of hazards and risk-based preventive
controls. This food safety system must include a GMP-
compliant food safety plan, supply-chain program and
other requirements laid out in the rule.
To become FSMA-compliant under these new conditions,
manufacturers and owners need to develop a plan that
considers all factors relating to the new rule. Through the
following 10-step process, that plan can be deployed to
help food manufacturers take the necessary steps toward
Preventive Controls for Human Food compliance.
1. ASSEMBLE THE FOOD SAFETY TEAMThe food safety team has two main functions: working
together to develop a thorough food safety plan that
minimizes the overlooking of risks in each operation, and
cultivating company involvement. It is important that
company personnel at all levels have a strong commitment
to food safety, given the potential changes that will take
place and the associated budget and resources required
to implement needed operation adjustments. Furthermore,
a management team committed to food safety will help all
employees understand the importance of the entire food
safety system and the team.
One of the members in the food safety team should be a
Preventive Controls Qualified Individual (PCQI). This PCQI
must have completed U.S. Food & Drug Administration
(FDA)-recognized food safety training or be qualified
through equivalent job experience. The PCQI may be an
outside consultant, and does not need to be assigned to
each location. In addition to the PCQI, it is advised that
the food safety team consists of individuals with a variety
of specialties to cover all aspects of the food safety plan,
from engineering to sanitation.
2. DETERMINE PRODUCT DESCRIPTIONS, DISTRIBUTION, CONSUMERS AND INTENDED USE
The product type, packaging, shelf life, intrinsic properties,
storage and distribution should be described for each
stock keeping unit (SKU) produced at the facility. This
information is helpful when performing the hazard analysis
and will become handy when grouping similar products
into the overall food safety plan.
For example, several SKUs may be grouped into a single
food safety plan provided they have similar properties
and failure modes. Determining the intended use of
the product will provide the food safety team with the
information necessary to capture all hazards associated
with the product. If the intended use of the product is
to be further processed, less preventive controls may be
needed to control the hazards.
Foods that will be consumed by at-risk populations —
the elderly, immunocompromised individuals or children
— may require additional controls to prevent an outbreak.
Knowing this before the hazard analysis is conducted
helps to create a more robust food safety plan.
3. UNDERSTAND COMMON HAZARDS ASSOCIATED WITH EACH INGREDIENTIngredients such as milk products are known historically
to become contaminated with salmonella, while
other ingredients such as oils are less susceptible to
microbiological hazards. To complete a thorough hazard
analysis, it is important to understand the risks associated
with each ingredient.
The FDA’s Reportable Food Registry Annual Reports, FDA
publications, peer-reviewed literature, trade association
publications and other resources may be used to build
an understanding of common hazards associated with
certain ingredients. Arming the food safety team with this
information before the hazard analysis will help determine
whether control of the hazard is needed through a process
preventive control or a supply-chain preventive control.
4. REVIEW PRODUCTS TO DETERMINE PREVIOUS RECALLS
Existing information found in the above-mentioned
resources also can be used to determine the history of
the product or products being produced. The FDA has
created guidance documents, such as the Juice HACCP
Hazards and Controls Guidance or the Food Safety
Preventive Controls for Human Food Hazards and Controls
Guidance, which help food manufacturers determine
microbiological hazards associated with different food
types. Using this information is beneficial to the creation
of a hazard analysis.
5. REVIEW PROCESS FLOW DIAGRAMA process flow diagram should include all steps of the
food manufacturing process. These steps should include
receiving, warehouse storage, rework and processing.
The receiving step encompasses both ingredients and
packaging, along with information on where these raw
materials enter the process. The purpose of the process
flow diagram is to capture all process steps for the
hazard analysis. Understanding critical parameters
and what occurs at each process step is important
to determining risks.
6. PERFORM A HAZARD ANALYSISThe hazard analysis is the most critical part of the food
safety plan. According to the FDA, a known or foreseeable
hazard is “a biological, chemical (including radiological), or
physical hazard that is known to be, or has the potential
to be, associated with the facility or the food.” Known
or foreseeable hazards may have preventive controls
established to prevent, eliminate or reduce the hazard.
During the hazard analysis, it will be necessary to focus
resources on the most important controls. In this way,
hazards that have the highest risks can be prioritized,
leading to the creation of an effective and implementable
food safety plan. The hazard risk level is based on the
severity of the hazard and the likelihood of occurrence.
Several factors should be considered to gauge the severity
of the hazard, including the intended consumer. Past
outbreaks, recalls, scientific literature and other resources
provide useful information for determining which hazards
are likely to occur in food products.
7. ASSIGN PROCESS, ALLERGEN, SANITATION AND SUPPLY-CHAIN PREVENTIVE CONTROLS TO HAZARDS
Once a hazard analysis is conducted, preventive controls
will need to be established for steps through which a
chemical, biological or physical hazard will be prevented,
eliminated or reduced. The preventive control chosen for
controlling a particular hazard is based on a risk-based
approach, and the control must be current with food
manufacturing practices.
The following are the four main preventive controls used
for the control of hazards:
• Process Preventive Controls: critical
control points (CCPs) used for controlling
microbiological hazards
• Allergen Preventive Controls: Used for the
control of allergens through allergen
management procedures
• Sanitation Preventive Controls: Used for
the control of allergens through allergen
management procedures
• Supply-Chain Preventive Controls: Used for
controlling the hazards of ingredients when
the originating facility does not have controls
in place for those hazards
WHITE PAPER / FOOD SAFETY MODERNIZATION ACT COMPLIANCE
© 2017 PAGE 3 OF 4
WHITE PAPER / FOOD SAFETY MODERNIZATION ACT COMPLIANCE
© 2017 PAGE 4 OF 4
8. ESTABLISH VERIFICATION AND VALIDATION PROCEDURES
Verification and validation procedures must be established
to confirm that the food safety plan is being followed as
written and that the controls in place can properly control
the identified hazards.
Verification procedures are routine and ongoing to
provide evidence that the food safety plan is executed as
intended. Validation of the preventive controls in the food
safety plan must be based on sound scientific knowledge
from publications, scientific literature or other resources
and must be performed or overseen by a PCQI. The
validation procedures for preventive controls must occur
before the food safety plan is implemented or within the
first 90 calendar days of production.
9. CREATE A RECALL PLANThe recall plan should be clear and concise and must
be written before an event takes place. It should include
important information to make sure a smooth and rapid
response takes place in the event of a recall. Some of this
information includes:
• Defined roles and responsibilities
• Contact lists for external notifications
including regulators, customers, media
information and the public
• Lot identification and verification information
• Effectiveness check procedures to be
implemented during the recall
• Recalled inventory information
• Forms to record information
The role of the plan is to assign responsibilities and
tasks in the event of a recall to garner quick recovery of
recalled product, especially in Class 1 and Class 2 recall
when public health is at risk. It is important that the recall
team includes all functions necessary to collect complete
information. Personnel from production, shipping, quality
assurance and others will provide information necessary to
recover the maximum amount of product and reduce the
consequences associated with the recall.
10. CONDUCT GMPS AUDIT AND PERSONNEL TRAINING
With the FSMA, GMPs were updated and moved from
21 CFR 110 to 21 CFR 117 Subpart B. Included in the new
GMP requirements, new provisions require protection
against contamination of food and protection against
allergen cross-contact. The updated GMPs also require
cleaning of non-food contact surfaces to protect food
against allergen cross-contact and contamination of food,
food-contact surfaces and food packaging.
Furthermore, personnel who manufacture, process, pack
or hold food must receive training in the principles of food
hygiene and food safety. Food manufacturers should have
a GMP audit conducted to ensure they follow new and
existing GMP requirements.
CONCLUSIONThere’s no doubt that new FDA regulations are making
compliance for manufacturers more involved than it has
been in years. Since compliance dates have already
begun, it’s important to be fully prepared. By following
these 10 steps, owners and operators can prepare their
facilities for this new rule and future changes in food
safety regulations.
ABOUT BURNS & McDONNELLBurns & McDonnell is a family of companies
bringing together an unmatched team of
engineers, construction professionals,
architects, planners, technologists and
scientists to design and build our critical
infrastructure. With an integrated construction and design
mindset, we offer full-service capabilities with offices,
globally. Founded in 1898, Burns & McDonnell is a
100% employee-owned company and proud to be
on Fortune’s list of 100 Best Companies to Work For.
For more information, visit burnsmcd.com.0
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