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HARPC System

Hazard Analysis and Preventive Controls Based on Risk



This system guarantees that all hazards related to food are prevented or minimized, complying with the FSMA Act of the FDA.

The FDA’s Food Modernization and Safety Act, also known as the FSMA Act, is final, and some companies—as required by the Law—have been working with it since 2016. The final standard is the result of the FDA’s unprecedented level of dissemination activities for the industry, groups of consumers, the agency’s representatives at local, state, and federal levels, and other interested parties. It is the first time in over sixty years that the development and application of food-safety regulations with a preventive focus is included.

The food producers, processors, and exporters to the United States must implement preventive measures to control the process, food allergens, and safety throughout the supply chain, as well as a recall plan to withdraw products from the market.


Each branch shall write a HARPC plan that includes the following:

  • Risk analysis, to identify and evaluate known and probable hazards in agreement with food and process type.
  • Preventive control shall ensure that identified hazards which could probable happen can be significantly minimized or prevented.
  • Monitoring. To make sure the preventive controls works as established and there are records.
  • Corrective actions. Actions that take place if there’s no control or ineffective which implies a reevaluation and change of plans.
  • Verification; To make sure the control works consistently. This includes to validate preventive controls effectiveness for identified hazards.
  • Registries; including hazard analysis, as well as preventive control, monitoring activities, corrective actions and verification (this includes validation).


Every HARPC plan shall be properly documented and fulfill regulations and FDA definitions related to facilities, hazard control and food adulteration. HARPC requests that each food facility records every plan aspect, to constantly review it, updated and record the verification steps.


Audit under GlobalSTD methodology

certificado harpc global std


These are some benefits that will be shown once established:

certificado de cumplimiento HARPC

To have a registry in FDA and an to have exporter characteristic.

To enter products to EE.UU.

Consumer trust.

Government regulations compliances in EE.UU. (FDA)


Process to obtain a compliance certificate with GlobalSTD

The certification process pays attention to every detail to make sure that the company duly complies with all of the standard’s requirements.

Quoting and signing of the contract

GlobalSTD will send you a quote that includes the cost of the certification process, considering the number of employees working at the company, the applicable standard, and the scope of the audited processes.

Planning and Development of Audit

GlobalSTD will plan the audit and assign auditors with demonstrated competencies to audit the industry sector that corresponds to your organization.

Closing of Non-Conformities

After the audit has ended and only when it applies, the organization will send evidence that corresponds to the closing of the detected non-conformities, which will be reviewed and approved by the auditor.

Certification Committee and Issuance of the Certificate

The Certification Committee will confer to review and approve the issuance of the certificate; once authorized, the certificate will be issued, and its delivery planned.

  Get to know the certification steps HARPC.

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