FDA Food Safety / HACCP Plan - Milk

Plan Guidance Introduction

Milk manufacturers and farms currently fall under the regulatory rules of local State Health Departments and the United States Food & Drug Administration’s Food Safety Modernization Act (FSMA) Preventive Controls for Human Food. This plan guidance page will walk through the basics of developing a FSMA Preventive Controls plan in order to achieve compliance with both State and Federal entities.

Types of companies that would use this plan would be:

  • Manufacturers
  • Retail

Types of food products that would use a version of this guidance would be:

  • Milk – Flavored
  • Milk – Reduced Fat
  • Milk – Whole

Food Safety / HACCP Plan

The Food Safety Plan (HACCP or Preventive Controls) is not a stand alone program, but rather part of a larger food safety system. The foundational programs that are part of the food safety system are frequently termed prerequisite programs. The term was coined to indicate that they should be in place before HACCP based systems are implemented in order to effectively manage risk from foodborne hazards. The Current Good Manufacturing Practice (GMP) regulations address requirements for many prerequisite programs. The regulation (117 Subpart B) that outlines the conditions and practices the regulated food industry must follow for processing safe food under sanitary conditions, including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels considerations. Elements of GMPs that are not covered in the Food Safety Plan are still required by regulations.

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Process Flow

The process flow of a food safety plan (HACCP or Preventive Controls) is the center of a food product’s food safety story. It tells how a company makes it’s products and also what hazards and controls are associated with each step. Here’s an example process flow for whole milk:

Potential Hazards

Biological

Chemical

Physical

Suggested Standard Operating Procedures (SOPs)

SOPs are related to both GMPs and Controls of Hazards in the Food Safety Plan. SOPs define the specific steps of how GMPs and Controls of Hazards mitigate food safety hazards and define a repeatable process.

  • Monitor Time and Temperature – Receiving, Storage, Transportation
  • Equipment Cleaning & Sanitization
  • Using and Calibrating Thermometers
  • Transporting Food to Remote Sites
  • Cleaning and Sanitizing Food Contact Surfaces
  • Storing and Using Poisonous or Toxic Chemicals
  • Preventing Cross-Contamination During Storage and Preparation
  • Receiving Deliveries
  • Cleaning Building and Facility
  • Allergen Control Program
  • Washing Hands – To prevent foodborne illness by contaminated hands
  • Employee Illness Program
  • Using Suitable Utensils When Handling Ready-to-Eat Foods

Suggested Logs and Records

Monitoring records and logs must include the actual values or observation that document the actual implementation of a Food Safety Plan . For example, if a temperature is being measured, the actual temperature must be recorded rather than a check mark indicating that the temperature complied with the critical limit. To comply with regulations, information must be recorded at the time it is observed.

Here are suggested record and log types to use:

  • Customer Complaints
  • Corrective Action Forms
  • Employee Training
  • Food Safety Quarterly Audit
  • Food Safety Checklist
  • Raw Materials/Receiving Log
  • Worker Illness Log
  • Refrigerator Log
  • Assembly Log
  • Shipping Temperature Log

Suggested Supply Chain Documents

The safety of your product depends on much more than just what you control within your own facility. Use of an ingredient that has a history of association with a specific hazard may require a supply chain program as a control within your food safety program. Companies may have extensive supplier programs that encompass much more than food safety elements to manage their supplier expectations and performance.

Here is a list of suggested documents to obtain from your supply chain:

  • Food Safety HACCP or Preventive Controls Plan for each product
  • Food Defense/Business Continuity Plan
  • Validation of each product and/or process and Ready-To-Eat statements (if applicable)
  • Certificates of Analysis (COA)
  • Third Party Audit Certificate, Report & Corrective Actions
  • Product Specification
  • Allergen Grid / Statement
  • SDS / MSDS Statement
  • Country of Origin

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