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.
ConnectFood.com offers plan templates, comprehensive step-by-step guidance, and on-demand expert services to assist in quickly completing and maintaining your plans.
Comprehensive Plan Templates – Quick Start
Want to get started right away with a Food Safety plan? Use our comprehensive templates, which include the process flow, hazards, controls, SOPs, and Logs as a baseline to build your plans.
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:
Example Biological, Chemical, and Physical Hazards
Here is a list of potential hazards:
Microbiological Contamination During Processing at Source of Origin – Supplier Management and HACCP in place and verified to eliminate and reduce potential presence of Microbiological contamination.
Microbiological Contamination – Microbiological growth due to breakdown of refrigeration units.
Chemical Contamination by pesticides at source of origin – Chemical/pesticide used at source is verified to be in conjunction with regulations.
Chemical Contamination from machine oils or lubricants, as well as cleaning chemicals.
Microbiological / Physical / Chemical Contamination from – Cross Contamination or Taint of finished product due to poor trailer
Physical Contamination from – External contamination from rain water, bird droppings, vermin/rodents, and flying insects during unloading process.
Glass contamination from internal light sources. – Pests/rodents and or Flying insects due to poor hygiene/debris build up- Physical risks from straps/thermocouples/staples/foreign bodies found on pallets on intake.
Physical Contamination from – Physical contamination from Quality Inspectors – Foreign Bodies found within product and/or packaging from source of origin or during transportation.
Physical Contamination from – Physical contamination from Warehouse operative, Pests/rodents, and/or Flying insects due to poor hygiene/debris build up – Physical Contamination from personnel Foreign body/Dust contamination from production environment.
Physical Contamination from – Physical contamination Warehouse operative, Quality inspectors – Glass contamination from internal light sources & window. – Pests/rodents and or Flying insects due to poor hygiene/debris build up.
Associated Components of the Food Safety Plan
The following associated food safety components are recommended to achieve compliance with State and Federal rules and regulations.
Good Manufacturing Practices and Other Prerequisite Programs
The Food Safety Plan is not a stand alone program, but rather part of a larger food safety system. The foundation 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 Food Safety Plan 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.
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.
Here is a list of suggested SOPs:
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
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
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
Allergen Grid / Statement
SDS / MSDS Statement
Country of Origin
Records / Logs
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:
Corrective Action Forms
Food Safety Quarterly Audit
Food Safety Checklist
Raw Materials/Receiving Log
Worker Illness Log
Shipping Temperature Log
According to the Food Safety Modernization Act, Preventive Controls for Human Food regulation requires the development of a written Recall Plan when a hazard analysis identifies a hazard requiring a preventive control. Recalls are actions taken by an establishment to remove an adulterated, misbranded or violative product from the market. In other words, a product for which FDA or a state could take legal action against the company would be subject to recall.
Validation / Verification
Verification is an important component of supply chain, sanitation, allergen and critical controls. It confirms that the Food Safety Plan is operating as intended. Validation confirms the effectiveness of the Food Safety Plan in controlling food safety hazards. The purpose of verification is to provide a level of confidence that the Food Safety Plan is 1) based on solid scientific principles that are adequate to control the hazards associated with the product and process, and 2) that the plan is being followed correctly every day of operation.
Plan Templates – How It Works
Loading HACCP / Preventive Control templates is an easy step process saving significant time and hassle to write and maintain your plans.
1. Load Plan Template
Load plan template which includes process flow, hazards, controls, procedures, and logs.
2. Print Plan Reports
To submit the plan to retail executives or regulators, print all available reports.
3. Maintain Plan Integrity with Logs / Records
“If you didn’t record it, it didn’t happen”. Maintain the safety status by maintaining records.
Get Started With Your Vegetable Produce Food Safety Plan Today!
Save time by registering for an account with ConnectFood and loading one of the plan templates to get started. Within the software, you will have all of the components (SOPs, Logs, GMPs, and more) accessible to give you a comprehensive and compliant food safety plan. If you ever need additional assistance with writing or get a review of your plan, ConnectFood Expert Services are always available On-Demand.
ConnectFood offers a step-by-step, food safety plan generator to comply with the Food Safety Modernization Act and HACCP. On-Demand plan reviews are available from a national network of food safety experts.