man inspecting food in factory

FSMA: Designing and Implementing the Food Safety Plan

Denis Storey
December 19, 2019

eBook: Raise the Bar on Your Food Safety Plan

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eBook: “Raise the Bar on Your Food Safety Plan”

As food safety management systems are growing in breadth and complexity, the data required to adhere to food safety requirements is skyrocketing. See how electronically captured data and information can help you be audit ready at any time.

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Are you being asked to design and implement a Food Safety Plan for your organization? Is it giving you anxiety? Are you hoping to find a definitive guide to meet the Food Safety Modernization Act's (FSMA) requirements, exceed your company's expectations, and handle the task with confidence? If the answers to these questions are "Yes, yes, and yes," let TraceGains provide you with a definitive roadmap for success.

Where Do I Begin?

Your Food Safety Plan outlines all of your Good Manufacturing Practices (GMPs), prerequisites, recall plans, non-compliance corrective action programs, and Critical Control Points (CCPs) to support your supply chain, allergens, sanitation, and more.  

Each area is a separate initiative and requires focused attention to achieve compliance. Luckily, the U.S. Food & Drug Administration (FDA) has developed the Food Safety Plan Builder. This comprehensive tool adheres to the Food Safety Modernization Act's (FSMA) Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC) rule (21 CFR Part 117), and helps you author a custom food safety plan tailored to your organization.  

The Fine Print

Before we begin, it is essential to understand two very important points.  First, in order to obtain compliance, your facility's Food Safety Plan must be created by a Food Safety and Quality Assurance (FSQA) professional, who is certified as a Preventive Controls Qualified Individual (PCQI). To learn more about becoming PCQI certified, read our blog post here.

Second, the Food Safety Plan Builder is only a tool provided by the FDA. Using this tool does not guarantee FDA compliance or approval for your Food Safety Plan, good manufacturing processes, preventive controls, or other food safety procedures. The tool provides guidance and direction to develop a comprehensive Food Safety Plan. It is the responsibility of a PCQI to use the tool as a roadmap to create a program tailored to the needs of your specific facility(s).

The tool includes a series of YouTube videos, produced by the U.S. FDA's Center for Food Safety and Applied Nutrition, and consists of the following modules:

  • Introduction here

  • Facility Information here

  • Preliminary Steps here

  • Good Manufacturing Practices (GMP) & Prerequisite Programs here

  • Hazard Analysis & Preventive Controls Determination here

  • Process Preventive Controls here

  • Food Allergen Preventive Controls here

  • Sanitation Preventive Controls here

  • Supply-Chain Preventive Controls here

  • Recall Plan here

  • Reanalysis of Food Safety Plan here

  • Food Safety Plan Report here

  • Signature here

  • Recordkeeping Procedures here

  • Important Contacts here

  • Supporting Documents here

Food Safety Plans are like fingerprints. No two are alike. A successful Food Safety Plan addresses your facility's specific needs, from purchasing and receiving, to storage and prevention, to manufacturing, packaging, transportation, and food display. Ensure you build a solid Food Safety Plan with our eBook, "Raise the Bar on Your Food Safety Plan." Download it here