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Food Safety Plan

For those facilities that must comply with subpart C of 21 CFR part 117 a food safety plan is required. The food safety plan, as stated in §117.126(b) must be written and include:

  • Hazard analysis (identify hazards that require a preventive control)
  • Process, allergen, and/or sanitation preventive controls
  • Supply chain program
  • Recall plan
  • Procedures for monitoring implementation of preventive controls
  • Corrective actions
  • Verification activities

While some of these elements might already be in place at a facility as a part of a HACCP plan or 3rd party audit scheme, the food safety plan wraps everything in a centralized document.

Hazard Analysis

A thorough hazard analysis is the backbone of a strong food safety plan. A hazard analysis is: “The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore must be addressed in the Food Safety Plan.”  Food safety hazards can be chemical, physical, or biological in nature. The FDA has published a hazard guide that details hazards that are historically associated with a specific food product or type of commodity. Another valuable hazard analysis resource is the Reportable Food Registry (RFR). The RFR, which is administered through the FDA, is an online reporting system that tracks and compiles incidents of ‘reportable foods’. A reportable food is:

an article of food/feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.Scientific documents, industry specific concerns, and extension publications can also be valid sources of information for conducting a hazard analysis. 

The RFR is useful for looking at hazards that are commonly associated with a type of food product, which can be used to strengthen the hazard analysis. The RFR publishes annual reports that can be invaluable resources for a hazard analysis.

Once a food safety hazard is identified, a preventive control must be instituted to properly control for the food safety hazard.

Preventive Controls

Preventive controls are defined as:

…those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. (21CFR §117.3)

To adequately control a hazard identified in the hazard analysis, a firm can institute one of the following types of preventive controls:

  • Process preventive control
  • Food Allergen preventive control
  • Sanitation preventive control
  • Supply Chain preventive control

Each of these preventive controls has additional monitoring, corrective actions, verification, validation and record keeping requirements that are detailed in 21 CFR §117.135.

Recall Plan

A recall plan is required to be a part of the food safety plan and must include procedures that address the following:

  • Steps to be taken during a recall, and the responsibility for taking the appropriate steps
  • Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food
  • Notification of the public about any hazard that could affect public health
  • A method to conduct effectiveness checks to ensure the recall is being carried out
  • Appropriate disposition of the recalled food (reprocess, divert, destroy…)

Other Requirements

In addition to the elements listed above, a food safety plan is required to have:

  • Procedures for monitoring the implementation of preventive controls
  • Corrective action procedures for any preventive controls not implemented properly
  • Verification procedures for any process preventive controls
  • They supply chain program (if applicable)

Written By

Photo of Currey NoblesCurrey NoblesArea Specialized Agent, Food Safety Serves 49 Counties and EBCIBased out of Food, Bioprocessing and Nutrition Science(919) 515-9520 canobles@ncsu.eduFood, Bioprocessing and Nutrition Science - NC State University
Page Last Updated: 1 year ago
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