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  • 5.


    • A.

      Developing an Effective Compliance and Enforcement Protocol

Compliance and enforcement are essential elements of a regulatory program and encompass all voluntary and regulatory enforcement actions taken to achieve compliance with regulations. Standards 3 and 6 of the Program Standards explain the need of regulatory jurisdictions to establish a compliance and enforcement protocol that results in credible follow-up for each violation noted during an inspection, especially violations related to foodborne illness risk factors and Food Code interventions. Lack of follow-up on the part of the regulatory agency signals to the operator that the critical violations noted were not important.

The resolution of out-of-compliance foodborne illness risk factors and Food Code interventions must be documented in each food establishment record. The desired outcome of Standard 6 is an effective compliance and enforcement program that is implemented consistently to achieve compliance with regulatory requirements.

Compliance and enforcement options may vary depending on state and local law. It is essential that regulatory jurisdictions develop a written compliance and enforcement protocol that details the order in which both voluntary corrections may be taken on the part of the operator and involuntary enforcement actions are to be taken on the part of the regulatory authority. Involuntary enforcement actions include, but are not limited to, such activities as warning letters, re-inspections, citations, administrative fines, permit suspensions, and hearings.

Food establishment with a history of noncompliance at a level predetermined by the jurisdiction or with the number of foodborne illness risk factors and interventions violated warranting a regulatory action, signals the need either a strong regulatory response or an alternate approach to compliance to protect public health, e.g., active managerial control, behavioral change.

Voluntary corrections taken on the part of the operator include, but are not limited to, such activities as on-site corrections at the time of inspection, voluntary destruction, risk control plans, and remedial training. Obtaining voluntary corrections by the operator can be very effective in achieving long-term compliance. Voluntary corrections by the operator are referred to in FDA’s Regulator’s Manual as “intervention strategies.” Intervention strategies can be divided into two groups:

  • Those designed to achieve immediate on-site correction

  • Those designed to achieve long-term compliance.

Successful intervention strategies for out-of-control foodborne illness risk factors can be tailored to each operation’s resources and needs. This will require inspectors to work

Annex 5 – Conducting Risk-based Inspections 535

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