Tiny Characters with Microscope. and HACCP certificate

How to Implement HACCP for GFSI Schemes

Helen Timothy
May 3, 2021

eBook: A Step-by-Step Guide to Implementing a HACCP Plan

Download eBook

eBook: “A Step-by-Step Guide to Implementing a HACCP Plan”

HACCP is now a requirement for most food companies, and implementation of risk-based HACCP is now a fundamental requirement for all GFSI schemes. HACCP also serves as the foundation for the Food Safety Modernization Act’s (FSMA) Hazard Analysis and Risk-based Preventative Controls (HARPC). So how do you get started?

Download eBook

After you’ve implemented your necessary Good Manufacturing Practices (GMPs) programs, you are ready to develop Hazard Analysis and Critical Control Points (HACCP) plans for your GFSI scheme.


Companies use HACCP plans to determine all the hazards that may occur when manufacturing a product or group of products. Hazards may be related to personnel, operations, or the environment, GMPs, individual operators, or suppliers may control the hazards. Additionally, some hazards might need a new method, a new procedure, or a new machine to eliminate or reduce them.

HACCP is now a requirement for most food companies, and implementation of risk-based HACCP is now a fundamental requirement for all GFSI schemes. HACCP also serves as the foundation for the Food Safety Modernization Act’s (FSMA) Hazard Analysis and Risk-based Preventative Controls (HARPC).

To have a successful HACCP plan, you need to have comprehensive knowledge of:

  • Incoming materials and country of origin

  • All products

  • Food safety characteristics

  • Processes

  • Treatments

  • Packaging methods

  • Shelf life

  • Storage conditions

  • Intended use

All areas of the plant, including restrooms, lunch areas, and handwashing stations, should be familiar to the team. Employees should be aware of all activities taking place in each of the different areas at all times. Additionally, the movement of people, ingredients, packaging materials, chemicals, wastes, processing aids, allergens, and finished product and their associated hazards around the facility must be known.

Systematic gathering and analysis of information are required to determine all hazards, including critical control points (CCPs), and to apply the proper control measures. All companies develop HACCP plans using 12 steps, incorporating the seven principles of HACCP (steps 6-12). 

Step 1: Assemble the HACCP Team

This team should be multi-disciplinary and should represent individuals from all areas of the facility. Include team members from QA, R&D, Sanitation, Maintenance, and other necessary departments. A diverse team brings together different knowledge sets and unique views of the operation. Additionally, having various departments involved facilitates better communication within the organization, as everyone has a sense of involvement when it comes to the safety and quality of the products produced.

To assemble the team:

  • Assign a HACCP Leader

    • HACCP training certificate and experience in the field

  • Include managers of different departments

  • If you have a consultant, add as a secondary member

  • Provide HACCP team training

Step 2: Describe the Product and its Distribution

A full description of each product is required. You should include:

  • Relevant safety information

  • Finished products recipes

  • Ingredients

  • Processing aids

  • Packaging material

  • Exporting countries

  • Allergens

  • Restricted ingredients (food additives like aspartame, caffeine, etc.)

  • Country of origin

  • Vulnerable ingredients

Additionally, list any treatments or processes influencing product shelf life in this step. For example, the product may be raw, cooked, or ready to eat, pasteurized, or vacuum packed. The type of product should indicate storage requirements and how consumers should consume it.

When collecting information for ingredients, make sure to include all subcomponents. If you’re required to perform vulnerability assessments as it relates to food fraud, you will need to dig a little deeper to find whether there are secondary or tertiary suppliers for vulnerable ingredients (olive oil, fish, organics, etc.).

If the ingredients include subcomponents, make sure you know all the suppliers involved.

Step 3: Describe the Intended Use and Consumers of the Product

Identify the groups to whom you plan to target your product. For example, if you’re making a product for babies, the elderly, or gluten intolerant individuals, you need to identify the intended use.

Keep these points in mind when determining intended use:

  • Retail

  • Foodservice

  • Further processing

  • General public

  • Vulnerable population

  • Will the consumer heat the food?

  • Will there likely be leftovers?

If the customers should heat the food, you must provide them instructions and include them in your HACCP plan. 

Step 4: Develop a Flow Diagram Which Describes the Process

You must show all the steps in a manufacturing process for a product or group of products. The reason for this flow diagram is to have a clear and simple outline of the steps involved in the processes, the sequence of production, and how different parts of the process are interacting with one another. This clear view of processing steps is beneficial when conducting a hazard analysis.

The flow diagram should include:

  • Receiving ingredients

  • Packaging materials

  • Storage of ingredients

  • Process steps

  • Process step numbers

  • Recycle and rework products (work in progress should also be marked along with the materials used)

  • Introduction of packaging materials

  • Introduction of air, water, and steam

  • CCPs

  • Outsourced processes and subcontracted work

  • Process parameters

  • Potential for delay

  • Finished products

  • Intermediate/semi-processed products

  • Byproducts

  • Low/high-care/high-risk area segregation

Include all flows that will impact food safety, such as employee traffic patterns and waste flow. Additionally, identify any areas that require extra precaution or special treatment. For example, if you are a gluten-free processing plant, the lunchroom might also need to be a gluten control area.

Step 5: Verify the Flow Diagram

Confirm the flow diagram is an accurate representation of the operations. Reverify this confirmation at least once a year (unless processes change) to ensure it is still correct. Make sure:

  • The HACCP team verifies it

  • All shifts have been verified

  • Sign and date the flowchart for records and documentation

Step 6: Conduct a Hazard Analysis (Principle 1)

Until this point in your HACCP plan, you have gathered all the information on your finished products. All of this is necessary to develop a list of significant hazards that are resonantly likely to cause injury or illness if not adequately controlled. These hazards can be:

  • Potential biological hazards

  • Potential chemical hazards

  • Potential physical hazards

  • Allergens

  • Irradiation

A detailed hazard analysis is key to preparing an effective HACCP plan. If your team does not correctly perform the analysis, the plan will not adequately control the unknown hazard, which results in an ineffective HACCP plan.

For each identified hazard, analyze the risk. To conduct your assessment, look for:

  • Each identified hazard

  • Likelihood of occurrence

  • Severity

  • Risk level

Remember, if hazards happen once, they are likely to happen again.

Step 7: Determine CCPs (Principle 2)

After conducting the analysis and determining risk levels, you need to identify your CCPs, allowing a control to be applied to prevent, eliminate, or reduce to an acceptable level any potential risk. To determine your CCPs, you will need to ask a series of “yes” or “no” questions designed in a formal decision tree, which will ultimately inform you if the step is critical or not.

Step 8: Establish Critical Limits (Principle 3)

These limits are criteria that separate safe food from unsafe food—a maximum or minimum level set to control hazards:

  • Separate safe from unsafe products

  • Maximum or minimum value

  • Control potential hazards

  • To prevent, eliminate, or reduce physical, chemical, and biological hazards

Step 9: Establish Monitoring Procedures (Principle 4)

Establish monitoring standards for each CCP at this step. These are planned sequences of observations and/or measurements. When setting monitoring procedures, ask:

  • What should be monitored?

  • How should it be monitored?

  • At what frequency should it be monitored?

  • Who should be doing the monitoring?

Step 10: Establish Corrective Actions (Principle 5)

When there is a deviation from the established critical limits you will have listed above, corrective actions are necessary to prevent unsafe foods from reaching consumers. 

Step 11: Establish Verification Procedures (Principle 6)

Once you have critical limits and corrective actions in place, you need to verify these procedures to determine if your HACCP system is effective. To check your HACCP plan, utilize:

  • Methods

  • Procedures

  • Tests

  • Observations

  • CCP recordings and videos

  • Employee interviews

  • Monitoring

These will help determine if your HACCP system complies with your HACCP plan and whether the plan needs modification.

Step 12: Establish Recordkeeping and Documentation Procedures (Procedure 7)

This final step is a critical aspect of your system. Your records must reflect:

  • Accurateness

  • The entire process

  • Documented deviations

  • Corrective actions

  • Logs

  • Forms

  • Real-time data (never postpone entry or rely on memory)


The plan should be validated within the first months of implementation. Validation will confirm the HACCP system is effective in controlling biological, chemical, and physical hazards. Validation may include:

  • Collecting and evaluating scientific and technical information

  • Conducting validation studies

  • Reviewing regulations

Validation will also help to determine if the hazard analysis is appropriate and realistic, actually controlling hazards, and based on current science.

A reassessment of the HACCP plan should be reviewed annually at a minimum (or if there are any changes), and should include:

  • Food safety incidents

  • Rate and type of customer complaints

  • Various audits

  • Internal inspections

  • Deviation log

To help put together your HACCP plan, use references and resources that can include:

  • The latest scientific literature

  • Historical and known hazards

  • Relevant codes of practice

  • Industry experts

  • Generic models

  • Food processor organizations

  • Information from suppliers

  • Customer requirements

For a deeper dive, check out our eBook, "A Step-by-Step Guide to Implementing a HACCP Plan." Download it here