Food Safety Plans

Food safety entails specific methods and procedures for the handling, preparation, and storage of food in ways that prevent foodborne illness. Food safety systems help to ensure the safety of your food products, protecting both your consumers and your business. 

Hazard Analysis Critical Control Point (HACCP) is a specific food safety system that is a systematic science-based approach to the identification, evaluation, and control of food safety hazards. HACCP is neither a stand-alone nor reactive program. Rather HACCP is a preventative program designed to identify potential hazards associated with food, determining if they are likely to occur, and developing control measures that reduce or eliminate the identified hazards. The principles of HACCP are applicable across all aspects of food production from agriculture to processing to distribution.

The identification of potential hazards in products and processes and their likelihood to occur is known as Hazard Analysis. Your analysis should result the creation of a system of controls known as Critical Control Points (CCP). A common example of a common CCP in dairy processing is pasteurization as the appropriate heating and cooling of the raw milk eliminates most pathogens.

Flow Diagrams

An essential part of the HACCP Plan is accurate flow diagrams for each process within your plant. A flow diagram is a general diagram that describes the process step-by-step. It should include all steps in the process, in sequence, directly under control of the facility from raw material receipt through processing, packaging, storage and distribution.

Sample flow diagrams are available to download.


In order to begin creating a Food Safety/HACCP Plan, one must first have an understanding of what are considered hazards. A food safety hazard is a biological, chemical, or physical agent that, if not properly controlled, can cause illness or injury to the individual who consumes the food.

The main task of a Food Safety/HACCP plan is to prevent, eliminate, or reduce to an acceptable level those food safety hazards that are “reasonably likely to occur” and could cause disease or injury if they are not appropriately controlled.

There are four types of general food safety hazards: biological, chemical, physical, and radiological.

  • Biological hazards include bacterial, viral, and parasitic pathogens. A pathogen may be defined as a biological agent that causes disease or illness to its host.
  • Chemical hazards include toxins, pollutants, drugs, allergens, or ingredients that can cause illness due to immediate or long-term exposure. This also includes radiological hazards include ingredients and packaging received from areas with higher than typical radiation levels, proximity to nuclear power facilities, and acts of bioterrorism.
  • Physical hazards are foreign objects within a product such as glass, metal, or plastic fragments.

Additional Information

Comprehensive guidance regarding biological hazards may be found on our Bacteriology Fact Sheet.

Chemical Hazards
HazardPotential Source(s)Prevention
  • Ingredients
  • Sub-ingredients
  • Processing aids
  • Rework
  • Product change-overs
  • Adequate cleaning/sanitizing
  • Proper labeling
  • Proper ingredient receipt and storage
Drug Residues
  • Dairy ingredients
  • Raw ingredient testing

Mycotoxins-toxin produced by mold

  • Ingredients
  • Growth in product
  • Raw ingredient testing
  • Ingredients
  • Plant environment
  • Raw ingredient testing
  • Environmental sampling
  • Adequate cleaning/sanitizing
  • CIP cross-connections
  • Over application
  • Adhering to GMPs and SOPs


  • Over addition
  • Adhering to SOPs
  • Allergens are one the most common chemical hazards as researchers estimate that nearly 15 million American suffer from a food allergy. Eight foods account for 90 percent of all reactions: milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish. Even trace amounts of a food allergen can cause a reaction.
  • Radiological Hazards: The FDA has prepared Guidance Levels for Radionuclides in Domestic and Imported Foods with the most current information.
Physical Hazards
HazardPotential Source(s)Prevention
  • Bottles
  • Jars
  • Light fixtures
  • Gauge Covers
  • Ingredient Control
  • Sieves, screens, filters
  • Metal detection
  • X-ray systems
  • Visual Inspection
  • Preventative Maintenance
  • Shavings from metal-on-metal action
  • Equipment parts
  • Packaging Material
  • Pallets
  • Employees
  • Equipment
  • Pallets/Boxes
  • Plant environment

Preliminary Steps

Prior to developing your Food Safety Plan, it is necessary to complete five preliminary steps that provide the basis of you plan. 

Pasteurized Milk Ordinance defines a HACCP Team as the group of people who are responsible for developing, implementing, and maintaining the HACCP system. The team approach minimizes the risk in developing a plan as items are less likely to be excluded or poorly explained.

Determine Team Members

  • Team members dependent on specific food operation
    • Size of operation
    • Type of operation
    • Location(s) of operation(s)
    • Knowledge and background
    • Commitment Quotient
  • Team members should be multi-disciplinary
    • Quality Assurance/Laboratory
    • Production/Sanitation
    • Engineering/Maintenance
    • Upper Management
    • Outside experts/Consultants
  • Team Members should be trained in Food Safety Systems/HACCP


As a team:

  • Develop and update all written documentation
  • Implement and maintain Food Safety/HACCP plan and supporting programs
  • Verify and validate Food Safety/HACCP system as required
  • Provide training options for operational staff
  • Maintain effective communication with management
  • Interact with outside auditors and inspections
  • Interact with regulatory authority where applicable


  • Each member should know their role in development
    • Assigned roles and responsibilities
    • One person often responsible for the written plan and other documents
  • Each member should review all written materials
    • Provide comments and revisions prior to implementation
  • Each member should know their role in implementation
    • Oversight of monitoring, documentation, verification, and corrective actions
  • Team should meet frequently on a scheduled basis
    • Minutes should be taken with action items, goals, and target dates
  • Communication is the key!

The next step is to completely describe each food product that your facility produces. This should include a brief description of the process to help identify potential hazards.

The USDA’s Guidebook for the Preparation of HACCP Plans recommends asking the following questions about the product:

  1. Common name?
  2. How is it to be used?
    1. Categories may include: Ready-to-Eat (RTE), to be heated prior to consumption, or further processing
  3. Type of packaging?
  4. Length of shelf life?
  5. Where will it be sold?
    1. Will it be sold wholesale or retail?
  6. Labeling instructions?
    1. “Keep refrigerated” or “Best if kept frozen” may be some common instructions.
  7. How is the product distributed?
    1. Should product be shipped/distributed at a certain temperature?

In addition to a general description of each product, important factors to consider include:

  • Potential microbial hazards
    • pH
    • Water activity
    • Degree of processing
    • Product protection
  • Chemical and physical hazards
    • Ingredients used
    • Potential allergens
    • Equipment used
    • Packaging used
  • Describe the normal expected use of the food
    • Ready-to-eat
    • Requires further cooking
    • To be used with other ingredients
  • Describe the target audience for the product
    • General public
    • Particular institutions
      • Home use
      • School
      • Healthcare
      • Restaurant use
    • Particular users
      • Infants
      • Children
      • Immunocompromised individuals
      • Elderly

A flow diagram is a general diagram that describes the process step-by-step. It should include all steps in the process, in sequence, directly under control of the facility from raw material receipt through processing, packaging, storage and distribution. (NACMCF 1997)

Processes that require a flow diagram include:

  • Receiving and Storage
    • Raw materials
    • Ingredients
    • Packaging
  • Processing and Handling
    • Blending, batching, addition of  ingredients
    • Heating, cooking, cooling
    • Use of air and other gases
    • Filters, screens, metal/magnet detectors
  • Packaging
    • Pre/post treatment
    • Metal detection
  • Storage and Distribution
    • Refrigeration

Sample flow diagrams are available to download.

After the flow diagrams are created, it is necessary to verify the processes.

  • Verify accuracy
    • Ensure that the steps and sequence are correct
  • Verify completeness
    • Ensure that all critical steps are included
  • Modify
    • Update as needed
    • Document verification and changes
      • HACCP Team List
      • HACCP Team Meeting Minutes
      • Product description for each product
      • Flow diagrams for each product

Prerequisite Programs

Prerequisite programs are steps or procedures, including GMPs and SSOPs, which control the operational conditions within a food establishment and promote environmental conditions that are favorable for the production of safe food. Prerequisite programs are the foundation of a Food Safety/HACCP system. According to Appendix K of the PMO, prior to the implementation of a Food Safety/HACCP plan, plants must develop, document, and implement written prerequisite programs. 

Water, steam, and ice are used in every part of food processing from transport to cleaning and sanitizing to ingredient use. It is essential that potable water, cooling water, steam, and ice must be available in sufficient quantities, at suitable pressures and temperatures, to meet the needs of the operation. Factors that must be considered include:

  • Water Source
    • Both the water and the plumbing system that transport to the facility must provide a safe supply for all water needs.
    • When using a municipal water source, the water treatment authority is responsible for the safety of the source as well as the means of conveyance to the facility.
      • The processor/facility should have documentation to identify the source of the water and annual water quality test results.
      • The processor/facility should independently test for microbiological activity.
      • The municipality should immediately notify the facility when any tests is out of specification.
    • When using private water systems (wells, etc.), a facility is directly responsible for the monitoring and documentation of the safety of their water source.
      • Tests should be routinely performed to test for chlorine levels and microbiological activity.
  • Protection
    • Care must be taken to prevent contamination from potential cross-connections and backflow.
      • Backflow prevention devices should be inspected and tested routinely.
      • Connections without backflow prevention devices must also be routinely inspected and tested.
  • Control Measures
    • Monitoring
      • Water quality test results
      • Review of plumbing system records
    • Corrective Actions
      • Operations must cease production until a safe source and plumbing are assured.

All food contact surfaces, including but not limited to equipment, piping, and utensils, used in a food processing facility must be designed, fabricated, maintained in such a way that they are easy to clean and can withstand regular usage. Equipment should have smooth seams and be made of impervious materials such as stainless steel or plastic. Corroded or worn parts should be replaced.

  • Cleaning and Sanitizing
    • Procedures
      • Cleaning and sanitizing procedures for all food contact surfaces must be established and maintained. Cleaning should be done with appropriate detergents at the proper concentration and water at the appropriate temperature. Sanitizing is accomplished utilizing approved sanitizing agents at appropriate concentrations. Written documentation of cleaning, sanitizing, and maintenance procedures is necessary.
    • Frequency
      • Suggested frequencies for cleaning and sanitizing include:
        • Before use
        • After processing interruptions
        • At product changeover
        • After use
        • As necessary
  • Monitoring
    • What
      • Condition and construction of contact surfaces
      • Condition of gloves, outer garments, and utensils
      • Preventative maintenance programs and all repairs
      • Cleanliness and sanitation of food contact surfaces
      • Type and concentration of cleaning chemicals and sanitizers
      • Employee training and hygiene practices
      • CIP and COP systems
    • When
      • Many procedures must be monitored daily, while others may be monitored less frequently (such as preventative maintenance and training)
    • How
      • Pre-operation visual inspection
      • Recording instruments
      • Chemical testing
        • Sanitizer concentrations
        • Alkalinity/acidity of cleaning solutions
      • Verification Check
        • Microbial Test on surface
        • ATP Hygiene monitoring
        • Rinse water testing
        • Visual inspection

Contaminants such as bacteria are unable to move from one place to another on their own. Cross contamination occurs when food, water, air, people, or equipment carry these contaminants from one location to another. Many factors can contribute to cross contamination, but the most common causes include:

  • Poor hygiene
  • Employee mistakes
    • Non-compliance with GMPs
    • Employee traffic patterns
  • Poor food handling practices
  • Failure to separate raw and cooked/RTE products
    • Product flow
    • Common equipment and utensils
  • Inadequate cleaning and sanitizing
    • Utilizing color-coded brushes and cleaning equipment
  • Poor plant design
    • Especially important when dealing with allergens
    • No cross connections between raw and pasteurized product in piping or flow

It is imperative that in addition to clean food processing equipment, the facilities associated with production must be cleaned, stocked, and properly maintained.

  • Hand washing facilities
    • Should be at each location where GMPs require their use
    • Condition and cleanliness of facilities must be monitored daily
    • Much be equipped with soap, water at the appropriate temperature, disposal towels/hand  dryers, and adequate waste disposal
    • Employees should be properly trained in appropriate hand wash technique
    • Should be used for hand washing only, not cleaning of parts/COP
  • Sewage disposal
    • A properly functioning sewage disposal system is required
  • Toilet facilities
    • Should be adequate and readily accessible with self-closing doors to protect from airborne contamination
    • Must be in good repair and maintained in a sanitary condition
    • Must be properly supplied with paper products, soap, and warm water

Section 402 of the Food, Drug, and Cosmetic Act defines adulterated food if “food bears or contains any poisonous or deleterious substance which may render it injurious to health and/or if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious health.”  Ingredients, packaging materials, food contact surfaces, and finished product must be protected from various microbiological, chemical, and physical contaminants including but not limited to:

  • Sources of Contamination
    • Water
      • Condensate
      • Splashing from floors, walls, and/or ceilings
      • Leaks
    • Chemical Hazards
      • Fuels
      • Non-food grad lubricants
      • Cleaning and/or sanitizing compounds
      • Pesticides
    • Physical Hazards
      • Glass
      • Metal
      • Plastic
      • Dirt/Rust
      • Pests
    • Additives
      • Vitamins
    • Allergens
  • Monitoring
    • Procedures must be set in place to monitor any possible contamination of food or food contact surfaces according to GMPs.

Toxic compounds, such as cleaning and sanitizing chemical and pesticides, must be properly labeled, used, and stored in a way that protects food, food contact surfaces, and packaging materials from contamination. A secured area with limited access and removed from food storage, processing, and packaging areas is an essential condition in this prerequisite program.

  • Labeling
    • Original container label must remain intact, visible, and include:
      • Name of compound or solution in container
      • Name and address of manufacturer
      • Instructions for proper use
      • Potential hazards and cautions
    • Working container label must include:
      • Name of compound or solution in container
      • Instructions for proper use
      • Potential hazards and cautions
  • Storage
    • Room/area with limited access
    • Segregate food grade compounds from non-food grade
    • Segregated from food equipment, utensils, and other food contact surfaces
    • Working containers should be kept in a secure location that prevents misuse, spills, or product contamination
  • Use
    • Use according to the manufacturer’s instructions
    • Procedures should exist that will not result in the adulteration of products
    • Keep Material Safety Data Sheets (MSDS) for proper handling
  • Disposal
    • Dispose of unused compounds in an approved manner

Food processors and handlers with an apparent illness, wound, or open lesion are a potential source of microbiological contamination of food, food packaging, and food contact surfaces.

  • Policies
    • Policies must be in place that exclude or restrict employees who show or who are diagnosed with systems of an illness or wounds that could be a source of microbial contamination.
  • Monitoring
    • Daily
      • All employees should adhere to the Illness and Injury Notification Policy.
      • Supervisors should observe employees for signs of illness and/or exposed wounds.
    • Annually
      • Employees should undergo documented GMP training upon initial hiring and on an annual basis.

Pests, such as rodents, birds, and insects, are excluded from relevant areas of the plant to the extent possible and should also confirm that approved procedures are followed to prevent and/or eliminate infestation without contaminating foods or food processing equipment. In the event that pest control is contracted to an outside company, it is up to the processor to ensure that the facility is free of pests.

According to Appendix K of the Pasteurized Milk Ordinance, “in addition to the required prerequisite programs, any other prerequisites that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards shall also be monitored and documented.”

Some potential programs may include:

  • Ingredient and Packaging Supplier Management
  • Facilities
  • Environment
  • Temperature Control
  • Receiving
  • Training
  • Traceability
  • Recall
  • Allergen Management
  • Labeling
  • Calibration
  • Cleaning and Sanitation
  • Personnel Processing Practices
  • Storage and Transport
  • High Risk Processes
  • Control of Foreign Matter
  • On-Site Laboratories
  • Waste Disposal
  • Exterior


Principles of Food Safety Plans

After completing the preliminary steps and establishing prerequisite programs, it is time to develop the Food Safety/HACCP Plan. Plans are based on the seven basic principles.

The first step in creating a HACCP Plan is to conduct a Hazard Analysis which identifies all of the significant food safety hazards that are associated with the operations products and processes. You may remember that a hazard is defined as “a biological, chemical, physical agent that is reasonably likely to cause illness or injury in the absence of its control.”

The five steps in a Hazard Analysis are:

  1. List the process steps
  2. Identify all potential food safety hazards
  3. Determine if each hazard is significant
  4. Justify the decision
  5. Identify the control measure, which may be defined as “any action or activity that can be used to prevent or eliminate a significant hazard or reduce it to an acceptable level.”

For each significant hazard that was identified in the Hazard Analysis, there are one or more steps where the hazards can be controlled. These steps are considered critical control points.

A critical control point (CCP) is a step “at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.”  CCPs must be thoughtfully developed and closely monitored. Additionally, they must be used only for the purposes of product safety such as a specified heat treatment or refrigeration temperature. A tool to help determining whether a process is a CCP is the CCP Decision Tree:

CCP Decision Tree
CCP Decision Tree Chart courtesy Seafood HACCP Training Course, Cornell University

Identifying the appropriate step which contains the CCP is essential. If there is not an adequate control measure at a particular process step, this step would not be considered the CCP for that significant hazard. In other cases, control measures could be applied at a particular step, but that step may not be the best place to control the hazard. Additionally, there may be different control options for a single hazard. However, only one of these processing steps would be likely be the best CCP to control this hazard. Some additional items to keep in mind:

  • A single CCP may be used to control more than one hazard.
  • More than one CCP may be needed to control a hazard.

critical limit is 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 the occurrence of a food safety hazard to an acceptable limit.

 Each CCP must have one or more critical limits. If the process deviates from the critical limit, a corrective action must be taken to ensure that your product is safe. This process separates acceptability from unacceptability and safe from unsafe conditions. Critical limits may be based on:

  • Temperature
  • Time
  • Flow rate
  • Cooling rate
  • Physical dimensions
  • Titratable acidity
  • Product pH
  • Salinity
  • Moisture activity
  • Water activity
  • Available chlorine
  • Preservative levels weight
  • Viscosity

How to Determine Critical Limits

  • There are many different types of critical limits.
    • Must be specific for the CCP
    • Different critical limits may be needed differing types of hazards.
  • Each CCP must have one or more critical limits.
    • A critical limit must exist for each significant food safety hazard
    • An effective critical limit will define what can be measured or observed to ensure that the hazard is controlled at that CCP.
  • Critical limits must be science-based.
    • Scientific studies must determine the conditions that are necessary to control certain hazards.

Science-based sources of information on critical limits:

General Sources

  • Regulatory Guidelines
  • Experts (Internal/External)
  • Experimental studies
  • Publications


  • State and local guidelines, PMO, FDA Regulations
  • Consultants, trade associations, process authorities, academics
  • Challenge studies
  • Scientific journals

Monitoring is a planned sequence of observations or measurements used to assess whether a CCP is under control. These observations will be necessary to produce an accurate record and for future use in verification. Four elements are required to create an effective monitoring system:

1. What will be monitored?
a. Usually a measurement or observation to show that the CCP is operating within the critical limits.
b. Examples: 

  • Temperature
  • Flow rate
  • pH/acid level
  • Water activity
  • Metal detection
  • Screen integrity
  • Formulation sheet
  • Glass breakage
  • Machine wear
  • Visible rot

2. How will monitoring be performed?

a. Measurements

  • i. Preferred method because quantitative results can be obtained rapidly

b. Observations

  • i. Visually checking the source, a condition, or another attribute of the product
  • ii. These result are qualitative and difficult to measure

c. Tools

  • i. Employees must be trained to accurately measure, read, and record information utilizing the appropriate tools

d. Examples

  • Time and temperature of a process
  • Salinity
  • Internal temperature
  • Metal inclusion screening
  • Water activity
  • pH

3. What is the frequency of monitoring?

  • Monitoring frequency will depend on the critical limit and the observations and measurements that are needed.
  • The length of monitoring period will determine the amount of product affected by the critical limit deviation.
  • Continuous Monitoring is generally performed by an instrument that produces a continuous record. Tools include recording charts and continually-recording thermometers.
  • Non-continuous (intermittent/periodic) Monitoring is required when a continuous monitoring is not possible. The frequency of non-continuous monitoring may be influenced by past history and knowledge of the product and processes. Examples include visual checks and sensory evaluations.

4. Who will conduct the monitoring?

  • The person who conducts the monitoring should be trained to perform that specific monitoring activity.
  • Multiple individuals should be trained to conduct monitoring activities.
  • The trained individual should follow clearly delineated procedures, have initial responsibility for corrective actions, and be responsible for documentation.

corrective action describes to be followed when a deviation from a critical limit occurs. The PMO states that an appropriate Corrective Action plan should ensure that:

  • No product enters commerce that is injurious to health or otherwise adulterated as a result of the deviation
  • If such a product has entered commerce that it is immediately removed
  • The cause of the deviation is corrected and reoccurrence is prevented

When possible, Corrective Action plans should be predetermined which is to say that guidelines should exist to describe the steps required when a critical limit deviation occurs. Four general steps should be addressed:

  1. Determine if the product presents a safety hazard
    • If a critical limit is not met, then most likely yes
    • Based on evaluation by qualified individuals including outside expertise as needed
    • Based on physical, chemical, and microbiological testing
  2. If no hazard exists based on evaluations in Step 1, the product may be released
  3. In a potential hazard exists based on the evaluation in step 1, determine if the product can be:
    • Reworked or reprocessed
    • Diverted for safe use
    • Cannot be safely used and must be destroyed
  4. Determine the cause of a deviation and correct and test as needed. Determine of a change in the Food Safety plan is warranted.

Corrective Action records must be kept, including disposition of the product. The records will assist the facility in identifying reoccurring problems.

Verification includes those activities, other than monitoring, that determine the validity of the Food Safety/HACCP plan and verify that the system is operating according to the plan.

The purpose of verification is to produce a level of confidence that the plan is based on solid scientific principles, is adequate to control the hazards associated with product and process, and is being followed. This step is known as validation. In essence, verification may be thought of as “do you do what you say?” and validation as “are you doing the right thing?”
Types of verification procedures include:

  • Validation
    • Focused on collecting and evaluating scientific and technical information to determine of the Food Safety/HACCP plan will effectively control the hazards
    • Occurs before the plan is actually implemented
  • CCP verification
    • Needed to ensure that monitoring instruments are accurate and calibrated within appropriate ranges
    • May also include targeted sampling
    • Weekly record review
      • FDA regulation requires that all monitoring and corrective action records be reviewed within a week from the time that they are generated by a trained person.
  • HACCP system verification
    • It is recommended that the system verification occur at a frequency that ensures that the Food Safety/HACCP plan is being followed continuously.
    • The Food Safety/HACCP team is responsible for ensuring that this verification activity is performed.
    • Additional activities include finished product testing and independent third party audits. This concept is discussed in further detail in the “Audits and Inspections” section.
    • Situations that may trigger a plan reassessment include:
      • A change in products or processes
      • A change in critical limits
      • Relocation, construction, or re-configuration
      • Installation of a new piece of equipment
      • HACCP system failure
      • Adverse findings from regulatory inspection or third party audit
  • Regulatory verification
    • On-site activity that ensures that a facility that has implemented a HACCP plan is effective and is being followed correctly. This concept is discussed in further detail in the “Audits and Inspections” section.

Written records provide documentation of the Food Safety/HACCP plan, and demonstrate that critical limits have been met, and appropriate corrective actions and verification procedures have been taken.

Four types of records that are required include:

  • HACCP Plan and supporting documentation
  • CCP Monitoring Records
  • Corrective Action Records
  • Verification Records

Records must be retained for one year on-site and must be made available for review and copying by public health officials at reasonable times.