What Is A Scheduled Process?
Revised 5/1/2024
You just came up with a brand new product. Now, you want to get it distributed and produced on a large scale to send out to stores. Before you can do that, you want to ensure that it is safely produced and in most cases, that it is shelf stable.
The main document that proves this for you is called a scheduled process.
A scheduled process is a detailed recipe and procedure developed for your product. It is reviewed and edited by a recognized process authority. We have a short list of Process Authorities listed here. The scheduled process also includes information about your product’s ingredients, formulation tasks, packaging details, storage, and distribution guidelines. There are some important aspects of a scheduled process that you need to be aware of before starting to produce food.
Acidified Foods Must Have a Scheduled Process
Shelf stable Ready to Drink Beverages (RTDs), soups, sauces, jams and jellies that are acidified are required to have a scheduled process filed with the FDA. Acidified products are products that have an original pH of above 4.6 and require added acid to lower the pH. These products are considered by the FDA to be the most at risk.
For Acid foods, with an original pH of less than 4.5 (for example Lemonade) , a scheduled process is suggested, but is not required. As the FDA tightens regulation and enforces the Food Safety and Modernization ACT (FSMA), this is becoming more of a demand than a suggestion.
Also for refrigerated items such as salad dressings, or cold filled products, the scheduled process is suggested but not mandatory, for now.
If an acidified food or beverage is improperly processed and distributed, the health of your consumers may be adversely affected. The financial, legal, and brand reputation damage of a forced recall can be minimized with a proper Scheduled Process.
Records & Registration
The exercise of preparing a scheduled process provides the brand owner with the confidence that they are producing a safe and wholesome product and is a good start to learning to properly complete regulatory paperwork that will create a solid GMP (Good Manufacturing Process) program.
The two primary critical control points identified in the scheduled process must be followed. This becomes part of the regulatory documentation and proves the safety of your products for customers’ use should be one of your top concerns.
For each production, the scheduled process should be reviewed, records written and signed, indicating the CCPs (Critical Control Points) have been followed.The process should be reviewed and refiled every two years or anytime a change is made to the process. The food manufacturer is required to register all your documents with the FDA (Food and Drug Administration) and keep records on file for three years.
If you would like guidance or assistance with this process, you can complete the application with us at Organic Food Incubator, and we’ll help expedite this, or you can check out our course below to learn how to complete it yourself.
Filing A Scheduled Process
For most shelf-stable fluid products, it is necessary to obtain a scheduled process prior to producing the product.
A scheduled process is your recipe and procedure, which has been reviewed and edited by a recognized process authority. With very few exceptions, if you are making a product that is fluid and shelf-stable, you will be required to have a scheduled process.
The FDA regulates the production of food and requires that the scheduled process be registered with the FDA.
The links below will take you to some recognized process authorities:
Food Science New England – – Fred Jewett – fred.fsne@gmail.com
NorthEast Labs
Cornell University
University of Maine
North Carolina State University or NCSU Filing Page
To obtain a scheduled process, you must submit:
Your recipe. Each ingredient must be measured by weight (pounds, ounces, grams, kilograms). Choose one unit of measure and stick with it
Your method. These are the production steps.
The scheduled process is a formal document which must be followed exactly, by you or by your co-packer.
You may do this yourself, or we can do it for you. The advantage of using our services is that we have filed many processes and understand the pitfalls that slow acceptance. We are normally able to have the process approved faster with less difficulty than if you attempted to file the process yourself. We review your process and offer suggestions to help speed you on your way to production.
It is to your advantage to streamline the process and allow for as many variables as possible. For example, if you only make 5 fl oz bottles, but you think in the future you may want to make half gallons, ask the process authority to write it for “4 fl oz up to 128 fl oz”
You may also ask them to write statements such as “Water may be added to thin the product to the correct consistency” or “Vinegar may be added to adjust pH”. If it is not on the document, you are prohibited from making adjustments without permission from the processing authorities.
It is also important for you to know how many gallons of product (this is a unit of volume) or unit of product produced by this quantity.
The process authority will make adjustments to your recipe and procedure to ensure that it can be safely stored at room temperature. This may include the addition of acid, salt, sugar, or other additives to create the correct pH or water activity.
Do not be afraid to question the additions if you think that it will change the flavor or texture of the product. There may be other options.
Once you have your scheduled process, you are ready to go into production and can safely make a shelf-stable product.
We at Organic Food Incubator would love to assist you in obtaining your scheduled process. Click here to get started: Get Started Now!