5 Steps to Develop a Food Safety Plan for Preventative Control & Compliance

Food Safety Plan Sanitary Processing

Eliminate complications of navigating compliance with the FDA Food Safety Modernization Act (FSMA) preventative controls regulation and start with a sound food safety plan. This plan is the groundwork for effectively identifying hazards and applying preventative controls principles.


Although a written food safety plan is not a requirement of the Preventative Controls for Human Food regulation, the information about products, processes and facility operations build a comprehensive picture of your facility and this insight is necessary for:


  •  Identifying potential hazards and
  •  Pinpointing preventative control measures

Effective food safety management not only protects the food, it also protects your business from the risk of food safety incidents or a regulatory non-compliance issue. The first step to eliminating the risk is developing a complete food safety plan. Each manufacturer’s food safety plan will vary depending on their operations, but there are 5 preliminary steps to jumpstart your plan.


Step #1: Assemble a Food Safety Team


Assembling a food safety team ensures that the appropriate resources are dedicated to this effort. Your team should consist of individuals with different specialties and areas of expertise as well as members from all different levels within the company. To develop and implement an effective food safety plan, a budget, resources, potential changes in equipment and new procedures may be required. Without commitment at all levels in management it may be difficult to effectively implement your food safety plan.


A “Preventative Controls Qualified Individual” is required for regulation compliance and should be included as one of your food safety team members. A preventative controls qualified individual is defined as: a qualified individual who has successfully completed training in the development and application of risk-based preventative 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 team approach reduces risk of missing key food safety considerations and encourages ownership of the plan.


Food safety team’s responsibilities include:


  •  Develops, documents, maintains and reviews the Food Safety Plan
  •  Oversees implementation of the Food Safety Plan
  •  Ensures personnel are trained to carry out their responsibilities

Step #2: Describe the Product & Its Distribution


Understanding basic information about the product and how it is distributed is necessary to determine if specific controls are important to ensure the safety of the product. 


The product description should include:


  •  The product name(s)
  •  Important food safety characteristics of the product, if any (for example: pH, preservatives, etc.)
  •  Ingredients
  •  Packaging type
  •  Shelf life
  •  Storage and distribution

Data on factors that potentially influence growth of pathogens (pH, water activity, preservatives) is helpful for products that have intrinsic properties for controlling potential growth of bacteria. It is imperative to understand these elements to identify the potential food safety hazards that need to be addressed by preventative controls.


Although the Preventative Controls for Human Food regulation does not mandate capturing this information, it is beneficial to have on hand to provide to an auditor if necessary or in the event of a recall.  It is also required to identify hazards that should be addressed with preventative controls.


Step #3: Describe the Intended Use & Consumers of the Food


Knowing your consumer is critical to identifying potential hazards and employing the right control measures. Describing the intended use can be combined with step #2 and should include:


  •  Intended use and reasonably foreseeable unintended use
  •  Intended consumers
  •  Labeling instructions relevant to food safety

Gathering this information provides valuable insight for the food safety team as they tackle hazard analysis and work to identify preventative control measures. It is particularly important to identify if at-risk populations are the intended consumer as these groups may be more susceptible to foodborne illness and certain hazards. At-risk population groups include infants and young children, elderly persons, pregnant women and immune-suppressed persons.


Step #4: Develop a Flow Diagram & Describe the Process


Creating a process flow diagram is an important tool to describe the process and serves as the organizational framework for hazard analysis. Be sure to include all the process steps from receiving through final product storage within the facility’s control. Don’t forget to include reworked product, by-product and diverted product if applicable. Be sure to include a written process description of what happens at each of the process steps. This should include information such as the maximum length of time that the product could be exposed to unrefrigerated temperatures, the maximum room air temperature or the internal product temperature. This data is important to understand the potential impact of food safety and accurate hazard analysis.


Step #5: Verify the Flow Diagram On-Site


Verifying the flow diagram and operational conditions ensures avoidance of overlooked potential hazard sources. Use this time to make observations related to sanitation, potential for cross-contamination or allergen cross-contact, and potential harborages or introduction points for environmental pathogens in addition to verifying the flow diagram for accuracy.


By successfully completing a comprehensive food safety plan you have effectively laid the necessary groundwork for accurate hazard analysis and preventative controls determination and implementation. This creates a foundation for food safety and regulation compliance.


(Source: FSPCA Preventative Controls for Human Food First Edition 2016 Participant Manual)

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