Hazard Analysis and Risk-based Preventive Controls

Restaurants have long depended on HACCP guidelines to help establish safe food handling protocols. While some of those principles can be applied on a larger scale, food manufacturing and processing plants have some special food safety needs. The FDA has addressed these concerns with the implementation of the Hazard Analysis and Risk-based Preventive Controls, also known as HARPC.

HARPC Compliance

While HACCP is optional and typically used in restaurants, HARPC is required by law for all food manufacturers, packers, bottlers, and storage facilities. However, because these regulations are relatively new, they are still being rolled out for businesses of different sizes. The rules were finalized in September 2015 and most large businesses were required to be in compliance by September 2016. Small businesses, defined as having fewer than 500 employees, were to be in compliance by September 18, 2017.

On September 17, 2018, all businesses not already under compliance will need to have their HARPC plans completed and implemented. This includes very small businesses (those that average less than $1 million per year in food sales) and facilities that fall under the Pasteurized Milk Ordinance, which were given an extension.

Steps of HARPC

Much like HACCP, HARPC consists of a series of steps designed to help companies develop a system to ensure the safety of the food they produce. Food manufacturers, packers, bottlers, and storage facilities are now required to create and follow a HARPC plan, which can be achieved by following the steps outlined below.

  1. Identify Hazards: The first step in developing a plan to prevent hazards to food safety is finding the places in the food supply line where the risk of contamination is highest. This step requires being very familiar with the product being produced, as some concerns might be product- or facility-specific. When identifying points where these hazards might occur, consider potential physical, chemical, and biological contaminants, such as radiation, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved additives, naturally occurring hazards, and intentionally or unintentionally introduced hazards.
  2. Preventive Controls: Once you have identified potential hazards to the safety of the food you're producing and where those might occur, you can take steps to prevent them. Depending on the hazard in question, that may be sanitation procedures, limiting food contact points, employee training, environmental monitoring, supplier verification, or something else altogether. These steps should either eliminate or minimize the hazards identified in step one.
  3. Monitor Effectiveness: Develop a program that will regularly evaluate the effectiveness of the measures you have put in place. Implement the program and keep records so you can prove your HARPC plan's effectiveness if you're called on to do so.
  4. Corrective Actions: Establish a plan to address any hazards that manage to slip past your preventive controls. Once you determine a food product has been contaminated, it must be kept out of customers' hands, most often with a recall. It is important, for the sake of both customer safety and your operation's public reputation, to have an iron-clad recall plan in place that includes when to issue a recall, the point of contact to initiate a recall, and a public relations strategy.
  5. Verify: Verify that your facility is meeting food safety standards consistently. These verification procedures are what will alert you to the need for a recall, should it arise. Verification procedures will vary depending on the products involved and the preventive controls put in place.
  6. Recordkeeping: Keeping thorough records is essential to establishing a HARPC plan. These records are all you have to prove to the FDA that you have a HARPC plan in place, so its important to keep those in a convenient location, for both easy-to-access proof, as well as training purposes. HARPC requires you to keep these records for a minimum of 2 years. The paperwork should cover the process, the proof of verification, and a record of any problems encountered, as well as how those problems were resolved.
  7. Reassess: Because very few businesses remain stagnant, your HARPC plan must be reanalyzed periodically to ensure it is still working properly. According to the Food Safety Modernization Act, HARPC plans should be reevaluated every three years or as needed, such as when changes are made to the process or supply line.
  1. HACCP Made Simple. KaTom. Accessed November 2017.
  2. Code of Federal Regulations. U.S. Food & Drug Administration. Accessed November 2017.