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Decoding HARPC

Denis Storey
July 9, 2019

Checklist: “Supplier PRPs for HACCP”

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Checklist: Supplier PRPs for HACCP

The production of safe food products requires your HACCP plan to be built on a solid foundation of prerequisite programs (PRPs). PRPs provide the basic environment and operating conditions necessary for the production of safe food and beverage products.

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Under the Hazard Analysis and Risk-Based Preventive Controls (HARPC) regulations, mandates for food facilities in the United States require compliance with regulations, standards, and guidance above and beyond those of HACCP (Hazard Analysis and Critical Control Points). But what are these requirements, and how do you ensure compliance with HARPC?

The FDA upholds the HARPC mandate to ensure a comprehensive preventive controls plan exists to minimize significantly (or prevent) known or reasonably foreseeable hazards throughout the manufacturing, processing, packing, distribution, receipt, storage, and import of foods. Establishing, implementing, and maintaining the plan is the responsibility of a team of trained "preventive controls qualified individuals" (PCQIs), who use science-based preventive controls to consider the following food-related hazards within their HARPC plan:

  • Biological, physical, chemical, and radiological hazards

  • Allergens, unapproved food and color additives, natural toxins, pesticides, drug residues, decomposed material, and parasites

  • Naturally occurring hazards

  • Unintentionally introduced hazards

  • Intentionally introduced hazards, including acts of terrorism

To comply with the HARPC mandate, companies must perform the following tasks:

1 - Conduct Hazard Analysis

The first step in HARPC is to conduct a hazard analysis. In addition to the hazards listed above, companies will also want to identify any product-specific hazards, facility-specific hazards, emergency management, and food defense issues. Once those are identified, assess the probability of each hazard occurring and estimate the severity of the potential impact. This exercise provides deep insights into potential formulation, ingredient, facility, equipment, production, storage, transportation, and personnel hazards. During an inspection, this written analysis of possible hazards will be the first article requested by an FDA auditor for review.

2 - Institute Risk-based Preventive Controls

The second step is to institute adequate preventative controls to prevent the identified hazards and ensure food safety during manufacturing, processing, storage, and distribution. Controls must be designated at each food processing step to ensure food safety. Using Critical Control Points (CCPs) as a roadmap, companies can define controls to minimize hazards to acceptable levels under standard manufacturing operations. Sample preventive controls include:

  • Sanitation procedures at food surface contact points

  • Sanitation of utensils and equipment

  • Staff hygiene training

  • Food allergen control program

  • Recall plan

  • Current Good Manufacturing Practices (cGMPs)

  • Supply chain controls

  • Each hazard must have a written preventive control, complete with a recall plan. If a hazards is controlled at another facility, company records must include written assurances of control from that facility. 

3 - Monitor Effectiveness

The third step is to monitor the effectiveness of the implemented controls. Evaluating controls at regular intervals is important, even though not all controls can be numerically measured. These written programs monitor the regular evaluations put in place by the facility's control measures and prove that preventive controls are complete. Come audit time, the auditor will evaluate both the methods for monitoring, as well as the records of the monitored activities.

4 - Establish Corrective Actions

Next you must establish corrective action measures. The goal is to prevent unsafe and nonconforming food products from the production line. It is imperative that companies understand when something is wrong with a production run, and ensuring it doesn't get into consumers' hands. A recall is the last preventive measure, so it is crucial to understand the possible weak spots within each control and correct them whenever possible. 

Written corrective action procedures should go into effect when any of the following occur:

  • A preventive control is not properly implemented

  • A preventive control or food safety plan's effectiveness has come into question

  • Records are incomplete, or other discrepancies exist within the implementation of the food safety plan.

Corrective action procedures should include the following steps:

  • Identify weak spots within controls

  • Identify ineffective controls

  • Identify new hazards

  • Perform necessary steps to reduce the likelihood of a recurrence

  • Evaluate processed foods for safety

  • Prevent adulterated food from entering commerce

5 - Create Verification Measures

 The fifth step is to establish verification measures to ensure the facility effectively and consistently meets food safety. Food facilities are required to create and implement verification methods to ensure the success of their HARPC plan. These procedures cover hazard identification and analysis, preventive controls, control measures, monitoring, and corrective actions. Each step prevents or minimizes either a food safety or adulteration hazard, and should be comprehensive enough to include the following:  

  • The selected preventive controls are adequate

  • Monitoring is occurring as defined in the plan

  • Take appropriate corrective actions

  • Reduce potential food processing hazards

  • Conduct periodic reviews at proper intervals, so the HARPC plan remains working and takes into account new and emerging risks and hazards

6 - Supply Chain Program for Receiving Facilities

The sixth step pertains to receiving facilities and the level of control over incoming raw materials. Though the incoming supplier or third party may establish their preventive controls, it is still the responsibility of every receiving facility to implement risk-based supply-chain programs to ensure suppliers and third parties properly control relevant hazards. The supply chain program requires the receiving facility to approve suppliers based upon supplier performance and the nature of the hazard. Only at that point can the receiving facility determine the necessary verification steps to deem the supplier's controls significantly minimize or even prevent such a hazard. These verification steps can often include activities such as in-person audits and ingredient tests.

A comprehensive supply-chain program should include written receiving procedures that take into account the following supplier verification activities:

  • Identification and utilization of approved suppliers

  • Determining a supplier's verification activities

  • Conducting facility controls of hazards for another entity.

7 - Recordkeeping and Documentation

Step seven requires companies to follow mandatory recordkeeping procedures covering the manufacturing, processing, packing, and storage of food in their facilities. HARPC requires written records and documents on food hazards and process control systems to be accessible for a minimum of two years. These documents must include the following:

  • Preventive control monitoring

  • Corrective actions

  • Test results and verification steps ensuring preventive controls minimize or preventing hazards

  • Supply-chain programs

  • Training initiatives

All records and documentation must be made available to the FDA upon request. Under these recordkeeping requirements, a facility's documentation must tell the complete story to demonstrate HARPC compliance.

8 - Requirement to Reanalyze

The final step describes the requirement to reanalyze the plan every three years, or when process or product changes occur. Food facilities must reevaluate their food safety HARPC implementation with a plan to cover the following:

  • Significant changes within a facility capable of increasing a known hazard or introducing a new one

  • Every three years (if no other significant changes occur)

As facility changes are often planned events, HARPC requires a comprehensive hazard analysis and the implementation of new preventive controls before any operational changes can occur. All changes must be appropriately documented, including the basis for a decision not to make a change.

A hazard analysis plan is a critical component of any quality management program. We've put together a checklist to help companies better navigate their hazard analysis plans, download it here.