A Comprehensive Guide to HARPC

Explore the essential elements of HARPC, particularly the key principles and best practices that help food producers identify hazards, create risk controls, and protect their consumers.

What is HARPC?

HARPC stands for Hazard Analysis and Risk-based Preventive Controls, a food safety standard developed under the US Food and Drug Administration’s FSMA (Food Safety Modernization Act). This science-based system helps food producers identify operational risks and control potential hazards that could result in illness upon consumption. By utilizing HARPC, companies can ensure the health and well-being of their consumers.


The US FDA, working alongside other agencies, has enforced numerous legislations since 1906 to protect the general public from foodborne illnesses. But more has to be done to alleviate this because, according to the CDC (Center for Disease Control), nearly 50 million people suffer from foodborne illnesses annually. Out of that number, over 100,000 get hospitalized, while 3,000 succumb to their symptoms.

HARPC is one of the newest food safety systems of the FDA, created in response to the continuously evolving needs and issues in the food industry. Unlike its predecessors like the HACCP (Hazard Analysis Critical Control Point), HARPC is focused on prevention rather than corrective actions. It also incorporates risk-based elements throughout the production process, considering not just the severity of the hazard but also the likelihood of its occurrence. Best of all, it is flexible and can be applied to a broad range of food production processes, including animal feed production.

5 Steps in the HARPC Process

Preventing hazards throughout the food production process is not an easy feat. A carefully planned strategy based on scientific methodologies will help businesses create an end product that consumers deserve. Here are the five critical steps of HARPC:

1. Create a Food Safety Plan

The first step is to assemble a cross-functional team composed of members from different departments (e.g., management, production, and quality control). Dedicated to this particular project, they will oversee the entire HARPC process.

The food safety plan should be composed of the following:

  • Detailed description of the food
  • Intended use of the product and targeted consumers
  • Rundown of the production and distribution plan
  • Flow diagram that clearly outlines the HARPC process
  • Plan for verifying the accuracy of the flow diagram created

Best Practices:

  • Get the commitment from top management to allocate the necessary funds and resources for the HARPC food safety plan.
  • Delegate the PCQI (preventive controls qualified individual) role to one team member with adequate HARPC training. This certified personnel is responsible for conducting audits, reviewing records, and evaluating the effectiveness of preventive and corrective actions.
  • Use a food safety plan builder to ensure the facility meets FDA requirements in the manufacturing practices.

2. Analyze Hazards, Create Preventive and Corrective Controls, and Continuously Monitor Parameters

As the name implies, hazard analysis is at the core of this food safety framework. All “reasonably foreseeable hazards” from every part of the manufacturing process must be listed.

  • Biological hazards include disease-causing bacteria, molds, parasites, and viruses.
  • Chemical hazards from pesticides, inorganic toxins, unapproved additives, and drug residues.
  • Physical hazards include glass or metal shards, insect parts, strands of hair, and soil in food.
  • Radiologic hazards, although uncommon, may come from raw materials harvested from contaminated soil and water.

To effectively control these hazards, the team should set specific parameters that they can monitor. Before critical limits are reached, the team should take preventive procedures. If those aren’t enough to remedy the problem, workers should be ready to take the appropriate corrective actions.

The different types of preventive controls include the following:

  • Process – This is based on the flow diagram created in the planning phase.
  • Sanitation – Referring to cleaning surfaces that come in contact with food, this prevents microbial and chemical contamination.
  • Allergens – Aside from properly labeling final products, this ensures no food allergens accidentally mix with any ingredients during processing.
  • Supply chain – This minimizes hazards in raw materials used in food manufacturing.

Best Practices:

  • Ensure thorough hazard analysis by seeking input from microbiologists, nutritionists, and other food safety specialists.
  • Establish clear monitoring protocols. It involves outlining what requires tracking, who is responsible for the job, and when, where, and how to accomplish the task.
  • Utilize real-time monitoring tools like IoT (Internet of Things) devices to keep tabs on critical limits more effectively. With the help of tools like SafetyCulture’s sensors, food safety teams can receive alerts when temperatures go out of range and quickly respond to food safety issues.

3. Verify and Validate Procedures

This step is required to ascertain that the food safety plan is appropriately created and consistently practiced and that the preventive or corrective actions established are working.

Best Practices:

  • Leverage data analytics for accurate assessments of the effectiveness of the preventive controls.
  • Schedule and conduct regular internal HARPC audits. Also, occasionally invite external auditors and experts for independent assessments.

4. Keep Records

All effective preventive control systems have good record-keeping. Aside from being one of the most critical HARPC requirements under the law, this also shows consumers and other stakeholders that businesses are committed to their health and safety. Here are some documents that should be prepared and stored:

  • Hazard analysis
  • Preventive controls for each hazard identified
  • Verification of the effectiveness of the controls established
  • Monitoring records
  • Testing results
  • Auditing results

Best Practices:

  • Digitize documents for easy storage and sharing.
  • Maintain an organized record-keeping system through automation.
  • Periodically review these records for continuous improvements or changes.

5. Prepare for Recall

Recall, defined as the removal of a product from distribution, is sometimes necessary when all efforts to eradicate food hazards have failed. Since the primary goal of HARPC is to protect the general public from illnesses or grave injury, the company should take all possible actions to minimize their exposure to harm.

Best Practices:

  • Create a detailed recall plan, defining roles and describing specific responsibilities, including communication, initiation, and management.
  • Conduct recall exercises to test HARPC’s effectiveness and the team’s preparedness for this situation.

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Aside from the close similarity in their designated acronyms, HARPC and HACCP (Hazard Analysis and Critical Control Point) are food safety systems focused on hazard analysis, control implementation, and monitoring.

Below is a table that will help dispel any confusion about these two once and for all:

This is based on the FSMA or Food Safety Modernization Act, which was passed in 2011 Initially developed by NASA (National Aeronautics and Space Administration) in the 1960s to ensure the safety of astronaut food in space, it was modified and adapted for the general food industry under the Codex Alimentarius in 1993.
Covers biological, physical, chemical, and radiological, and intentional or unintentional economically-motivated hazards (also known as Food Fraud) Covers biological, physical, and chemical hazards
Preventive and process controls, including suppliers and their activities, must be verified All set process controls must be verified.
Parameters are set in term of minimum and maximum values. The critical control point (CCP) is the established critical limit.
Creating a recall plan is mandatory. Recall plans are not required.

HARPC and FSMA Regulations

The Food Safety Modernization Act, also known as FSMA, was passed into law in 2011 and is said to be the most sweeping reform in the history of food safety. This law grants the FDA unprecedented powers to control how food is farmed, harvested, processed, and, if required, recalled.

Developed and enforced by the FDA, HARPC should be observed by all food growers, manufacturers, and distributors. Here are some of the requirements that companies should be able to furnish:

Non-compliance with these regulations will be met with sanctions, including public warnings (e.g., import alerts), temporary suspension of facilities and distribution, mandatory recalls, and even criminal charges.

FAQs about HARPC

Yes. All food facilities that report under the FDA must develop a HARPC system. They should be able to submit complete documentation that proves its implementation after receiving an oral or written request.

The majority of all food businesses are required to have comprehensive documentation of their HARPC. This includes farmers, processors, manufacturers, and all third-party service providers (e.g., packagers, distributors, transporters) part of the food supply chain.

Yes. Companies exempt from the FSMA law are usually under the purview of other government agencies. Here is a list of the exemptions:

  • Facilities regulated by the USDA (US Department of Agriculture)
  • Companies subject to Standard for Produce Safety
  • Facilities that utilize HACCP for seafood and juice production
  • Businesses that control specific microbiological contamination, like Botulism.
  • Small on-farm businesses with a recorded product value of less than $500,000 in the past three years.
  • Businesses serving as receiving or storage facilities for raw agricultural products.

Food safety plans must be reviewed and updated every three years or when a new hazard that could cause contamination or any problem that could impact food safety has emerged.

Eunice Arcilla Caburao
Article by
Eunice Arcilla Caburao
SafetyCulture Content Contributor
Eunice Caburao is a content contributor for SafetyCulture. A registered nurse, theater stage manager, Ultimate Frisbee athlete, and mother, she has written a wide range of topics for over a decade. Eunice draws upon her rich, multidisciplinary background to create informative articles about emerging topics on health, safety, and workplace efficiency.