Master Formulas
Master Formulas are often referred to as your "recipes" or "formulations." They contain all the details on how to make a product “your way” and are the heart and soul of your business.
Purpose
The purpose of the Master Formula is to ensure you will be able reproduce the same consistent high quality product—every time. Then, by following the documentation through the use of batch records, you can ensure that the product your customers purchase is what they expect—every time.
Master Formula Content
The content of the Master Formula includes all of the information necessary to prepare for and carry out the manufacturing process. All the things you know about how to make the product should be written into the Master Formula. It should be sufficiently complete that any person who is reasonably familiar with making that type of product could make your exact product.
Document Information
The first page of the Master Formula should clearly show the name of the product being produced, the formula/product number (if any), and the revision number (if any). That information could be in the first page header, or in the content on the first page. Subsequent pages should contain enough information to identify the document should the pages become separated.
History and Background
You may want to include some history or background information about the Master Formula. The date it was created and by whom. If it was adapted from another formulation it would be a good idea to note that, especially if you got or purchased the original formulation was from another person, website, or publication.
Product Description
A detailed product description of the end product is part of the Master Formula. If the end product is a finished and packaged product that is ready for sale, include the name under which it is, especially if different that the name used internally for the product. A brief description of how the end product is packaged and labeled may also be helpful.
Security
If you are keeping your Master Formula secret (i.e. it is "eyes only," like the formula for Coke®) detail how security should be handled and what authorization(s) are needed by those who access the formula.
Materials, Equipment & Supplies
Everything needed to make the product should be listed. That includes all materials, equipment and supplies. Be sure that the descriptions are sufficient to ensure that there is no confusion. For example, if you have several mixing devices, clearly specify which mixer to use and with what attachements.
Ingredients
Every ingredient that is used in the product must be listed. If you have implemented an ingredient tracking system, then ingredient should be identified by the item number. If not, then make sure it is sufficiently described so there is absolutely NO confusion about which ingredient to use.
Include the amount of the ingredient. Normally formulations are written in terms of percentages so the batch size can be set at the time the batch is made. Ingredient amounts are generally designated in terms of weight, not volume.
Ingredients are often broken out into "phases", usually identified by a letter or a number. Typically these relate to how the ingredients are combined (i.e. all the oil-based ingredients combined in Phase A, the water-based ingredients in Phase B, and the additives in Phase C). Any phases should be properly identified.
Packaging Materials
If the master formula includes packaging, the final packaging materials (container, closure, label) used for the product should be listed. Again, if you have implemented an ingredient/item tracking system, then item should be identified by its assigned number. If not, then make sure it is sufficiently described so there is no confusion.
If the product might be packaged in two different types/sizes of containers, then both should be specified.
Procedure Steps
These are exact steps of the procedure, from start to finish. They should be clear, concise and in the order they need to be performed. There shouldn’t be a lot of explanation as you’re assuming that the person who will be following the Master Formula is sufficiently trained to be able to follow the steps.
The procedure should include, as applicable:
Preliminary Steps:
What needs to be done before the procedure is started, such as: preparing and clearing the workspace; checking that the needed equipment is available, in working order, and ready for use; verifying the ingredients are available; gathering necessary documentation, starting the batch record.
Safety Precautions:
What safety materials and equipment should be used (protective clothing, goggles, gloves, mask) and where to find for handling spills, hazardous material contact, and SDS sheets for all ingredients
Instructions:
Step-by-step directions, broken out into as much detail as necessary, in the order that they need to be done. If the whole process takes several days or weeks (as in cold process soapmaking), then the actions should be grouped by when they are carried out.
Where a particular step has an in-process test or verification process, that should be described. For example, you have a way to determine the level of trace or the correct temperature a phase should be heated to.
Packaging and Labeling:
The final step in the procedure is usually packaging and labeling. The Master Formula should contain the details on how these steps are accomplished, and by whom. Often this step is done by someone other than the person who measures and mixes. This section may include details on how to cut and trim soap, how bottles or tubes are filled, and/or how the labels are printed applied
Quality Control:
Quality Control is where the product is checked to ensure that the quality standards have been met for the product. In many ways, it is one of the most important steps. Write out, in detail, exactly what should be looked for to make sure that the product quality is high enough for your standards. Depending on the product, checking by how the product looks, smells and/or feels can be appropriate. For packaged finished products, checking the label contents and application, fill levels and overall presentation would be in order.
Even if you know it will be just you doing these checks, keep in mind that you will be stepping back, becoming “the quality control person” and reviewing the product from a separate "hat" from that of the person doing the manufacturing steps.
This section of the master formula should also include what to do if the product does not pass the inspection or test and include criteria for whether the batch can be "fixed" or should be tossed out.
Ingredient Listing
If the initial listing of the ingredients in the formulation is arranged by phase, then it’s helpful to have separate listing of all the ingredients in descending order of predominance as they would be stated on in the ingredient declaration on the label. This is especially the case if any of the ingredients are blended or compounded ingredients that must have their components listed individually in the ingredient declaration.
Records & Samples
In this section, explain what Batch Record(s) need to be completed as the product is made and any other records that need to be kept. A blank Batch Record should be made which mirrors the Master Formula and can be copied and used each time a batch is produced.
Specify if any samples must be retained and what to do with them.
Reference Documents
Create and include a reference list of any other information or documentation that’s applicable to making this product. That could include specification sheets for the ingredients, packaging and labeling, SOPs for clean-up, or operating manuals for any equipment to be used.
Revision History
The revision history of the document should be kept, either in the document itself or in a log file elsewhere. For simplicity, it’s easiest to keep it in the document at the end after the general body, toward the footer.
Record Keeping
Keep your Master Formula (and any past versions) in a safe place. If you keep a paper version, store it in a way that you can easily find it (such as in a correctly filed file folder or a binder). If you have a digital version, suitably name the file so you can find it again and have a reliable file folder system on your computer.
A log, which just lists the Master Formula, version, an date created is a nice record to have if you want to be able to easily scan down a list of your Master Formulas. If you’re going paperless, the log can be easily kept in a spreadsheet and even link to the Master Formula files on your computer.
Of course, if you are keeping digital files keep back-ups! Ideally, you should have back-ups of all your records somewhere off-site or in the cloud, and preferably in two or more locations. Better safe than sorry.
