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Avoiding The Pitfalls Of FSMA’s Recordkeeping and Sanitation Rules

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

  • Be kept as original or electronic records or true copies
  • Contain factual observations and values
  • Be legible, permanent, and accurate
  • Must be done in real time
  • Include the detail required to create a history of performed work
  • Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product

Record Retention Requirements

  • You must store and retain your records for a minimum of two years
  • Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
  • Records that have been discontinued (records related to changes) must be kept for a minimum of two years
  • Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
  • The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request

Food Safety Plan

  • Must be kept on-site at the plant or facility
  • Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.

Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.

First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.

Documentation in this program includes but is not limited to:

  • Approval of the supplier
  • Supplier verification
  • Sampling and testing
  • Suppliers food and safety records
  • Procedure for receiving ingredients and raw materials
  • Reanalysis documentation

Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.

Documentation requirements include, but are not limited to:

  • Preventative control monitoring and verification of monitoring
  • Any corrective measures that were taken and verification of actions taken
  • Environmental monitoring
  • Product testing
  • Training documentation
  • Reanalysis documentation

Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.

Documentation requirements include but are not limited to:

  • Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
  • A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard

Sanitation Controls
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:

  • Food contact surfaces (including utensils, equipment, and food packaging)
  • Food handling
  • Cross contamination
  • Food allergens

Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.

There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.

Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.

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Listen to FDA officials on March 19, 2013 explaining, who is exempt or not for registration, handling, shipping, and packing:

Exemptions for which small farms
Exemptions by products
Exemptions on labeling
Exemptions for Tester users
Non exemptions for Farmers Markets
Non exemptions for roadside markets
Non exemptions for CSA’s
Non exemptions for grower/packers

ScoringAg, the industry partner for food safety, recordkeeping, sanitation, and complete traceback has the inexpensive solution for any size of operation. For small and midsize operations we have Recordkeeping solutions for FSMA for $100 or less.

The data can be stored and accessed as long as needed for many years on a secure 256-bit encrypted dedicated server. We are not using a Cloud data storage computing system, as there is no security and the information in the cloud is owned by the US Government.

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What do vegetable, poultry, fruit, meat, egg, seafood and herbs have in common?  They have all been involved in a voluntary Food and Drug Administration recall in 2011.

If all these farms and processors had Hazard Analysis and Preventative Controls in place could this of been avoided?

That is what the Food and Drug Administration is hoping. 

Last week at the Southeast Regional Fruit & Vegetable Conference in Savannah, GA, the topic of food safety garnered several sessions in the educational tracks. As the Food Safety Modernization Act (FSMA) was signed into law more than a year ago, William C Hurst, a professor and Extension specialist at the University of Georgia, discussed how a new food safety plan that includes “Hazard Analysis” and “Preventive Control” will be a part of the new law.

“This plan (the Hazard Analysis Preventive Control program) is a prevention-oriented, risk-based tool that is designed to identify, control, and document hazards,” said Hurst. “You need to prove by documentation that you have control over those hazards you have identified.” Growers must identify any hazards from the time they plant the seed through to harvest, and then assign a control measure (i.e., sanitation step) to each defined hazard, he added.

A control measure is a physical, chemical, or other factor that can control or minimize risk. “Once you create a control measure, you have to go through monitoring and record keeping,” said Hurst. “You need to document that you have control of the hazards.”

For example, Hurst encourages growers to take samples of their irrigation water, have it analyzed, and then keep track of the results of the analysis. “This is documentation that your irrigation water is safe,” he explained.

Hurst was quick to point out to the growers in the room that the Hazard Analysis Preventive Control program isn’t a stand-alone food safety program. The new program is HACCP (Hazard Analysis Critical Control Point)-based, but geared to fresh produce. He compared these programs to a heavy oak table with the safety program as the top, supported by four legs, the “prerequisite programs” — GAPs (Good Agricultural Practices), SOPs (Standard Operating Practices), SSOPs (Sanitation Standard Operating Practices), and GMPs (Good Management Practices) — that need to go along with it.

For example, he said the “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” or “GAPs document” (1998) from FDA tells growers what to do to minimize pathogen contamination, but the document doesn’t tell them how to get the job done. An SOP indicating that harvest and packing lines must be cleaned daily to prevent product cross contamination provides growers with the “how-to” information they need to accomplish good agricultural practices.

The principles of food safety, added Hurst, are the same for all growers. These programs can be tailored for small, medium, and large operations. “It can be done and it needs to be done,” he said.

HACCP-based GAPs Workshop 
Check with local Extension offices for Fresh Produce GAPs/HACCP Workshops.

The University of Georgia will be hosting one on Feb. 21-23.

The hands-on workshop will focus in on developing a HACCP-based “Hazard Analysis Preventive Control Program,” including GAPs, SOPs, SSOPs, and GMPs, specifically for farm and field operations, packing facilities, cold storage operations, and produce shippers.

For more information, see the calendar at the Extension Food Service website at http://EFSonline.uga.edu

Thanks to Rosemary Gordon, editor of American Vegetable Grower for reporting on this event.

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