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With the updates to the Food Safety Modernization Act published by the FDA in 2024, food processors across the nation are left with many questions about what their facility needs to achieve compliance. Of these questions, many have to do with Food Safety Plans– What’s the difference between a FSP and a HACCP plan? Which one does my facility need? Does my business need more than one? Today we’re answering these questions to help food processors worldwide discover what their business truly needs to be compliant.
Food Safety Management Systems Defined
Confusion surrounding FSPs and HACCPs is not uncommon, as both fall under the category of Food Safety Management Systems, or FSMS. An FSMS is a critical part of food quality control, acting as a set of safety guidelines to which a food manufacturer will hold their operations to. The requirements of a FSMS can be quite varied, depending on the system selected and the industry that a company operates in. To dig into the differences between an FSP and a HACCP plan, let’s take a look at their official definitions.
In the latest 2024 version of Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food, a Food Safety Plan is defined as follows:
“A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding.”
The document then goes on to define a Hazard Analysis and Critical Control Points system as such:
“Hazard Analysis and Critical Control Points (HACCP) is a preventive food safety strategy that is a systematic approach to the identification and assessment of the risk of hazards from a particular food or food production process or practice and the control of those hazards that are reasonably likely to occur.”
So, what does this mean for food manufacturers? Although these may seem quite similar on the surface, there are some key differences that set the two apart from each other.
HACCP vs. Food Safety Plan
One way to clearly illustrate the contrast between FSP plans and HACCP plans is by understanding their intended purposes. Generally speaking, an FSP is broader in scope, including guidelines and procedures for ancillary controls such as supply chain controls and recall plans. Furthermore, an FSP is not just a set of guidelines, but a written record which must be maintained, especially as corrections and corrective actions are concerned. A HACCP plan is more often focused on the production of one particular facility’s operations, or even the production of just a single item at a facility.
For these reasons, many businesses will begin by developing an FSP, then use that documentation as a foundation to create an HACCP should they want or need both plans. In other cases, multiple HACCPs may be integral to a facility’s finalized FSP.
When it comes to the requirements of each type of plan, these are the key differences to note:
1 – Hazard Analysis
Both plans begin with a hazard analysis in which critical control points (CCPs) are identified. HACCP considers biological, chemical, and physical hazards. An FSP considers these in addition to radiological hazards and economically motivated hazards such as food fraud.
2 – Preventive Controls
HACCP requires preventive controls for every process with an identified CCP. FSP also requires this, along with preventive controls at other non-CCP points as deemed necessary.
3 – Parameters
In a HACCP plan, each CCP will have critical upper limits. In an FSP, there are both minimum and maximum values for any given parameter.
4 – Monitoring
Similar to preventive controls, HACCP requires monitoring at all CCPs while FSP requires monitoring at non-CCP points as appropriate.
5 – Corrective Actions
In a HACCP plan, corrective actions are taken when a CCP deviates from its critical limits. The same is true for an FSP– however, an FSP also gives facilities the flexibility to enact immediate corrections before a deviation occurs.
6 – Verification and Validation
HACCP requires verification activities for process controls, while an FSP will apply verification requirements to preventive controls as well. When it comes to validation, a HACCP plan is evaluated for effectiveness as a whole, while an FSP is evaluated by both its individual control measures and as a whole.
7 – Records
Similarly, record keeping is required for just process controls in a HACCP, while an FSP must keep records for preventive controls as well.
8 – Recall Plan
Possibly the most stark difference between the two is that HACCP does not require a recall plan, whereas FSP requires a recall plan for every instance that a hazard which preventive control is identified.
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Which Businesses Need FSP and HACCP Plans
FSP and HACCP plan requirements can vary by industry. For example, let’s take a look at the United States’ requirements. As per the 2024 FSMA updates, an FSP is required for all domestic and foreign facilities which manufacture, process, pack, or hold human food intended for consumption in the United States in order to comply with preventive controls for human food (PCHF) requirements. This means that even if a single business has multiple facilities which produce the same product, each individual facility will need to create and maintain their own dedicated FSP documentation.
HACCP plans, however, are required only for businesses which process juice, seafood, dairy products, meat, and poultry. All other food processing businesses may develop and enforce a HACCP plan at their facilities on a voluntary basis. For smaller businesses that may not require an immediate FSP or HACCP, developing a plan can still be beneficial in the long run as a means to improve food safety and increase shareholder value.
Where FSPs and HACCP Plans Are Required
Whether your business needs an FSP, a HACCP plan, or both depends greatly on your region of operation. In some countries FSPs may be more widespread, while others require HACCP plans, and others still have no requirements at all. As stated above, the requirements across the globe can also depend on the sector of which kind of food products are being processed. These are a few countries in which HACCP plans are implemented for safer food practices.
- United States
- Canada
- Australia
- New Zealand
- UK
- France
- Germany
- Japan
It’s important to note that there are many countries where HACCP plans are not necessarily required; however, HACCP principles are often adopted and applied in food safety management practices worldwide. At the same time, food processors in many countries encounter barriers which make it difficult to implement HACCP principles and plans such as funding, training, and a lack of educational resources on food safety.
Learn More About FSMA
Still have questions about FSPs, HACCP plans, or how the newest FSMA guidelines apply to your business? Be sure to visit the FSMA FAQ page, where the FDA has published answers to common FSMA-related questions. To build your own FSP, try the official Food Safety Plan Builder, a tool designed to assist owners, operators, and other preventive controls qualified individuals (PCQIs) develop an FSP tailored to their exact facility.
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