Most food safety systems have what is known as HACCP in place. HACCP is the acronym for Hazard Analysis And Critical Control Points. A similar system which we often come across is HARPC (Hazard Analysis and Risk-Based Preventive Controls).
These are both food safety standards that focus on prevention, they only differ in execution. Admittedly, they are both important for food processors. Neither though is a replacement for the other. In fact a HARPC plan is really an upgrade to the conventional HACCP plan.
The HACCP approach is based on a guideline recommended by the Codex Alimentarius and in the US, the national Advisory Committee on Microbiological Criteria For Foods. HARPC is based on the Food safety Modernization act (FSMA) and is primarily the final rule for Preventitive Control for Human Food.
The 12 Steps of HACCP
- Assemble the multidisciplinary HACCP team which is lead by a competent HACCP coordinator.
- Describe the product
- Identify its intended use
- Construct a flow diagram
- Conduct on-site confirmation of the flow diagram, and draw up the plant schematic
- List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
- Determine Critical Control Limits (Principle 2)
- Establish Critical Limits for each CCP (Critical Control Point) (Principle 3)
- Generate and establish a monitoring system for each CCP (Principle 4)
- Establish corrective actions (Principle 5)
- Establish verification procedures (Principle 6)
- Establish documentation and record-keeping (Principle 7)
HACCP considers food safety risks to fall into three categories which are conventionally, biological, chemical and physical. HACCP is mandatory for all establishments as stated by the US Food and drug Administration and the US Department of Agriculture (USDA). An HACCP plan is excluded or exempted unless mandated by those two US regulatory institutions. HACCP is voluntary whilst Good Manufacturing Practices (GMP) are mandatory.
This preventative approach was based on the FSMA or Food Safety Modernization Act of 2011 which came about during President Obama’s years in the presidency. The plan is mandatory for all establishments in the food supply chain that serve US consumers unless exempted.
In brief, this preventive control system which is mandated by FSMA is to be implemented by all food establishments unless specifically exempted. Thus, it applies to food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold or import food, and for those firms exporting foodstuff to the U.S. The FDA has issued implementation deadlines for each of the different facility types (kindly refer to updated guidelines on the FDA site, www.fda.gov). Within a HARPC plan, the food safety hazards assessment is broader; generally, the following risks are considered:
- Biological, physical, chemical and radiological hazards
- Natural toxins, pesticides, drug residues, decomposed material, parasites, allergens and unapproved food and color additives
- Naturally occurring hazards
- Unintentionally introduced hazards
- Intentionally introduced hazards, including acts of terrorism
The 7 steps of HARPC are:-
- Assess the hazards—This includes the normal product-specific hazards, along with a broad range of other hazards (listed above) and facility-specific concerns such as food defence and emergency management issues.
- Institute Preventive Controls—These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification and more.
- Monitor effectiveness of the controls—Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
- Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and nonconforming food product.
- Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
- Follow proper and required record keeping—As with any FDA ruling, nothing is properly done until it’s recorded.
- Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be re-evaluated.
The frequency as to when the preventive plan is being reviewed for each facility is every three years whereas HACCP must be reviewed at least once a year or as required.
HARPC is only exempted if you are on a list provided by the FDA. It does not exempt facilities from following at least current GMPs.