FDA Food Safety and Audit System Documentation and Record Keeping

Recorded Webinar | Dr. John Ryan | From: Jun 20, 2024 - To: Dec 31, 2024

FDA and Food Safety Audit Systems Documentation and Record-Keeping Requirements

The FDA can now access records if the FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the FDA reasonably believes is likely to be adulterated. Each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, transports or imports food shall permit such FDA officer or employee to have access to and copy all records relating to such article and any other article of food that FDA reasonably believes is likely to be adulterated. The FDA shall have access to the records that are needed to assist them in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.

The FDA may establish requirements regarding the establishment and maintenance, for not longer than 2 years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that are required to be kept by these regulations are those needed by the FDA for inspection (That is called “Audit”) to allow the FDA to identify the immediate previous sources and immediate subsequent recipients of food (That is called “traceability”).

Areas Covered in the Session:

Establishing a documentation system: Policy, Procedures, Records Using required audit check sheets to develop record trails Check sheets, records, sign-in sheets Food Safety documentation (Forms) Organic farm documentation (Paper and Electronic Forms) Carrier (bin, tractor-trailer, truck, rail, air) documentation systems Real-Time Electronic data systems (and possible problems) Span of the law: Articles used for food or drink by man or animal.

Learning Objectives:

  • Understand documentation and record-keeping systems.
  • Who is responsible?
  • Paperwork: Policies, procedures, sign-in sheets and logs.
  • Where do you get them?
  • Understand what happens in an audit and what’s wrong with them.
  • Is anyone exempt?
  • Costs?
  • ISO.
  • Using your data to manage transportation, traceability, blending, pest control logs, water testing/treatment data, tracking chemicals, temperatures, equipment controls.
  • Developing procedures and flowcharts.
  • Recalls.
  • Employee forms and capturing data.
  • Risk assessment.
  • Electronic forms and systems.
  • Organic farm data.
  • Proactive procedures.


The FDA, your customers, and all food safety audit systems require extensive record systems. Establishing and maintaining complete documentation is critical to your operation’s success and certification. Regardless of your company’s place in the food supply chain, your customers will require your company to support their own food safety systems with your company’s data.

Why should you Attend?

If you have no records to prove you have implemented a food safety system, the FDA will consider that you have no food safety system. Records/forms/logs/signatures prove you are doing the job.

Who will Benefit?

All operations are registered with the FDA as a food supply entity Federal requirement. The president on down is required to participate.

  • Plant Operational personnel.
  • Suppliers to companies manufacturing.
  • Quality Assurance and Quality Control Personnel and Management.
  • Sanitation personnel · Lab and test managers · Purchasing Agents.
  • Document Control Personnel.
  • Auditors who review CGMP facilities' quality assurance programs.
  • Companies that must employ the best practices that they should require of their suppliers will benefit.
  • Executives will understand the key benefits of allocating resources toward these programs and will be able to communicate the market edge it gives them to their customers and shareholders.
  • Food Shippers, Processors, Retail and Restaurant Purchasing Groups.
  • Ingredient Buyers and Sellers
  • Food Safety Team Members
  • Food Testing Labs and Quality Personnel
  • cGMP Specialists.


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