What is HARPC and Why Does It Matter?

What is HARPC?

HARPC (Hazard Analysis and Risk-Based Preventive Controls) is run by the FDA. The HARPC plan must conform to FDA standards and definitions about adulteration of foods, hazards, controls, facilities and it must be properly documented. HARPC requires every facility to document every part of its plan and constantly review it.

In order to comply, companies that pack, process, hold, or manufacture food in the United States will need to get a PCQI (Preventive Controls Qualified Individual). The application of a food safety plan that includes a hazard analysis and risk-based preventive controls will be overseen by this individual. The qualified individual should enforce preventive controls that minimize the risk of hazards, as well as understand why food safety hazards occur.

HARPC enforces preventive controls in order to recognize potential threats or risks to the food supply like contamination. It requires companies to have written plans that identify hazards and how to prevent them, to record the results and to have monitoring procedures, and lastly, to stipulate what will be done if any problems take place.

What are the Risks and Benefits of HARPC?

The benefits of compliance with HARPC include-

  1. Increased consumer protection and food safety
  2. Reduced risk of FDA action or enforcement
  3. Increased control and supervision over suppliers
  4. More transparent and better-defined manufacturing processes
  5. Increased confidence from partners and buyers
Those who will not comply with standards of HARPC will harm the company relationships between the suppliers and the company and will have substantial expenditures in funds, resources, and time. By not strictly controlling and observing each step of the process, there are a lot more chances for hazards to occur.

Through controlling major food risks, such as physical, chemical, and microbiological contaminants, the food industry can make consumers confident that the products are as safe as technology and good science allows. The protection of public health is strengthened by reducing foodborne hazards.

If a HARPC plan is inadequate or the facility doesnt have one, FDA can criminally charge the facility for possessing and operating a facility that does not comply with HARPC. It can also prevent the facility from producing and distributing food by suspending the facilitys food facility registration.

The 7 Steps of HARPC

The HARPC requirements are broken down into 7 steps, which are-

1. Assess the Hazards

The facility must identify hazards and evaluate each to assess the severity of the problem, as well as the probability of reoccurrence. This ensures that the facility s is ready for the next step of preventing or minimizing the dangers of developing at all.

The facility must consider the following threats-

  • Unintentionally introduced risks of naturally occurring risks such as mold
  • Natural toxins, color additives, unapproved food, allergens, parasites, decomposition, drug residues, and pesticides
  • Radiological, physical, chemical, and biological dangers
  • Hazards that are intentionally introduced like pesticides
  • Contaminated utensils and equipment
After the facility is done with the identification of the threats, they must evaluate them and consider transportation, storage, equipment, formulation, production flow, facilities, and ingredients that contribute to each threat. The facility must also look into things that could possibly add to each threat, like its personnel and operations.
2. Institute Preventive Controls

The part of HARPC that is called Risk-based Preventive Controls asks for companies to create and impellent risk-based controls that would prevent or minimize the identified hazards to ensure the safety of the food they distribute, hold, process, or manufacture. Companies must have a written recall plan for each hazard that requires preventive control.

3. Observe the Effectiveness of the Controls

Companies need to create and implement a written observation program that will make sure that the food facility is regularly evaluating its control measures to see if the preventive controls are effective. To identify shortages in the observation methods, the FDA will evaluate the companys observation system.

4. Establish Corrective Action Measures

The facility will have to write corrective action procedures that will take place if preventive controls are not implemented appropriately and if there is a question regarding the food safety plans effectiveness.

These procedures must include- identification of ineffective controls and their week spots, identification of new concerns, evaluating the processed food, performing steps necessary that reduce hazardous recurrences, and prevention adulterated food from entering commerce.

5. Establish Verification Measures

The company have to create verification steps and implement them to maximize food safety and to ensure that their HARPC plans are working correctly.

The verification measures should make sure that the appropriate corrective actions are taken, the observing is occurring as it is defined in the plan, the preventive controls are adequate, the potential food hazards are reduced, and that periodically evaluations are conducted so the HARPC plans remain working.

6. Follow Proper and Required Recordkeeping

FDA requires that documents and records that are related to process control systems and food hazards should be maintained for no less than two years. It requires a written record of the whole plan including the process itself, the problems, and proof that the plan works.

7. Reanalyze the Plan

The facility should reexamine its plan if theres an important alteration at the facility that may introduce a new hazard or increase a known one, such as an increase in harmful bacteria. If important changes dont occur, then the facility should reanalyze its plan every three years.

Is Anyone Exempt From HARPC?

Exempted from the HARPC plan requirement are the following categories-

  • Facilities under USDA shipping, processing, and handling eggs, poultry, meat, etc.
  • Operations under the Juice HACCP regulations and FDAs Seafood
  • Facilities under FDAs new criteria for Produce Safety Authorities like harvesters, growers and farms that handle fresh raw vegetables and fruits
  • Acidified and low acid canned food processors
  • Very small or small businesses
  • Facilities with revenue of less $500,000 or a prior 3-year average product value
  • Certain alcoholic beverages and dietary supplements facilities
  • Storage of the raw farming commodities



  • Based on the Final Rule for Preventive Controls for Human Food and the FSMA.
  • To prevent or significantly minimize foreseeable or known risks.
  • Mandatory for all establishments in the US food supply chain that serve customers, except the ones that are exempted.
  • The 7 Steps of Developing a HARPC Plan is a documented approach for making the plan.