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.

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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

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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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