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FSMA Preventive Controls: Your Guide to Understanding and Implementation 

 June 28, 2024

By  Rachel Montgomery

The Food Safety Modernization Act (FSMA) is a crucial piece of legislation that empowers the FDA to ensure the safety of our food supply. A key component of FSMA is the mandatory hazard analysis and determination of needed preventive controls in food facilities. This article unpacks the FSMA preventive controls, offering insights into their implementation to help businesses navigate these essential measures.

What are FSMA Preventive Controls?

FSMA preventive controls rules are a proactive approach to ensuring food safety. The rules affect manufacturers and importers and require food facilities, anywhere in the world who supply food for US consumption, to establish and implement a written food safety plan focused on preventing hazards rather than reacting to them after contamination occurs. These controls target three main categories of hazards from ingredients and processing:

  • Physical hazards: Glass, metal fragments, and other physical hazards
  • Biological hazards: Bacteria, viruses, parasites, and environmental pathogens
  • Chemical hazards: Allergens, process chemicals (like cleaning solutions), pesticides, toxic elements, environmental chemicals, including radiological hazards, and economically motivated adulteration.

Food Safety Plans go beyond HACCP:   The FSMA rule outlines various preventive controls that can be implemented, including:

  • Process controls: Procedures to ensure critical parameters like cooking temperature or cooling times are met.
  • Food allergen controls: Measures to prevent cross-contact and ensure accurate labeling of allergens.
  • Sanitation controls: Practices to maintain a clean and sanitary environment throughout the facility, prevent direct and cross-contamination with pathogens.
  • Supply chain controls: Programs that a manufacturer implements to ensure control of hazards by its suppliers.

Implementing FSMA Preventive Controls: A Step-by-Step Approach

Here’s a simplified breakdown of implementing FSMA preventive controls:

  1. Hazard Analysis: Conduct a thorough hazard analysis to identify potential hazards associated with your specific products, ingredients, and processes and determine where preventive controls are needed.
  2. Preventive Control Determination: Based on the hazards determined to require a preventive control, establish preventive controls that will mitigate or eliminate those hazards.
  3. Implementation and Documentation: Develop and document written procedures for each preventive control measure. This includes details on what is the hazard, what needs to be done, how it will be done, how often, and by whom.
  4. Monitoring: Establish specific and planned written procedures to monitor the implementation of your preventive controls. This might involve regular temperature checks for a treatment step, checks on formulation, or other checks during processing or sanitation.
  5. Corrective Actions: Develop a written plan for handling situations where preventive controls fail. The plan should outline steps including evaluating and making appropriate disposition of the affected food while identifying the root cause and preventing similar occurrences.
  6. Verification: Establish written procedures to verify the effectiveness of your preventive controls. This involves verification of monitoring and corrective action records, instrument calibration, and product testing as needed. Validation is a subset of verification.
  7. Recordkeeping: Maintain thorough records of your food safety plan, monitoring results, corrective actions, verification, and relevant training conducted.

Who must prepare a Food Safety Plan?

A Food Safety Plan must be developed and implemented by a PCQI.  A PCQI is defined by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation in 21 CFR 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Animal Food regulation in 21 CFR 507.3. 

A PCQI is “a qualified individual who has completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.”    The FSPCA course curriculum is recognized by FDA.  The curriculum is delivered by Lead Instructors and provides the certificate demonstrating successful completion of the training.

Benefits of Implementing FSMA Preventive Controls

Implementing FSMA preventive controls offers a multitude of benefits for your business:

  • Enhanced Food Safety: A proactive approach minimizes the risk of foodborne illnesses and product recalls.
  • Consumer Confidence: Strong food safety practices build trust and brand reputation with consumers.
  • Compliance: Ensures adherence to FSMA regulations, to avoid findings in FDA inspections that can lead to enforcement activities.
  • Improved Efficiency: Preventive measures can help identify and address potential problems early on, saving time and resources in the long run.

Resources for Further Guidance

The FDA offers a wealth of resources to assist businesses in implementing FSMA preventive controls.Here are some helpful starting points:

About the author

Mrs. Montgomery is an FSPCA Lead Instructor for PCQI Human Food, PCQI Animal Food and Foreign Supplier Verification Programs (FSVP) courses with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery offers virtual training spread over multiple shorter days to fulfill the hours required yet allow team members more time to absorb the training and also stay in touch with their work teams. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists).

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