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FDA Food Safety Modernization Act (FSMA)

By May 25, 2016September 25th, 2023Articles of Interest, Fulfillment, TAGG News

Food safety - healthcare fulfillment

Have you heard of the Food Safety Modernization Act (FSMA)?  If your product is meant for human or animal consumption in the form of food, drink, supplements, dietary aids, etc. the FSMA is absolutely something you should be aware of.

At its core, FSMA is a sweeping reform to food safety laws regulating the entire food supply chain.  FSMA has been dubbed “the most sweeping reform to our food safety laws in more than 70 years.” This legislative reform is broad and implementation can feel utterly overwhelming.

I recently completed a FSMA compliance training course.  The information was pertinent and the material felt overwhelming.  I kept wondering “how am I going to implement all this?”  followed with “what do I need to do?”

As a result, I found it helpful to approach implementing FSMA requirements from a holistic standpoint.  After all, the most basic concept of FSMA is to ensure food is safe: “from farm to fork” as the FSMA catch phrase goes.

Organizations subjected to FSMA should begin by identifying where ingredients used in their products are sourced:  within the U.S. or internationally? Requirements 1-4 below are FSMA requirements for ingredients supplied by U.S. suppliers.  Requirements 1-5 are required for ingredients supplied from international sources.

  1. A written food safety plan.
  2. A Preventive Control Qualified Individual (PCQI).
  3. Inspection and compliance records which demonstrate adherence to the food safety plan.
  4. A traceability program and records documenting where ingredients originated from, which products the ingredients were used in and the customers who received the finished product.
  5. A Foreign Supplier Verification program.

The foundation of a FSMA compliant program is the written Hazard Analysis Risk based Preventive Control (HARPC) food safety plan. Prior to finalizing a HARPC plan, a series of activities will need to be conducted beginning with a food safety assessment for each facility.  The intent of the food safety assessment is to identify food safety hazards that are reasonably likely to occur. Once identified, the appropriate controls must be developed and implemented to manage identified hazards.

Identified control measures require a two-step approach:  controls must be proven effective (validation), and they must be proven to be working as intended (verification) through monitoring programs and maintained records.

The HARPC plan also incorporates the development of prerequisite programs.  Prerequisite programs incorporate current Good Manufacturing Practices (cGMPs), personal hygiene practices and facility sanitation protocols.

A successful HARPC plan relies heavily on the input and approval or a Preventive Control Qualified Individual (PCQI).  The PCQI must be someone who:

  1. has completed training in the development and application of risk-based preventive controls or
  2. is qualified to develop and apply a food safety system through job experience.

The PCQI for each registered food facility subject to HARPC are responsible for: evaluating the risks and control measures, validation of the preventive controls and for the approval and review of the HARPC plan.

Upon approval of the HARPC plan, records must be identified and maintained to demonstrate compliance to the HARPC plan.  Additionally, traceability records are required to document the source of ingredients, the products in which those ingredients were used, and who received the finished products.  Traceability is a cornerstone of the new regulations.

A Foreign Supplier Verification program must be implemented for food ingredients received from foreign suppliers. Under FSMA each manufacturer is responsible for ensuring foreign suppliers comply with FSMA requirements. Compliance can be demonstrated though the supplier’s written food safety plan (approved by a PCQI) and annual audits of the HARPC plan’s implementation.

Above are only the “basics” of FSMA.  As you embark on incorporating FSMA within your organization it is important to remain current and well versed with the regulations!

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