The Quality Assurance Process at Essential Wholesale & Labs

Written by: | October 2, 2017 | Leave a Comment

Natural & Organic Product Quality Assurance

Products you purchase from Essential have been through a minimum of a seven-day quality assurance process to verify consistency in color, viscosity, scent, pH and of course, to ensure the product is free from microbial bacteria, yeast, and mold (fungus). The only exception is for anhydrous products like oil blends and powders.  With no water in a product, there’s no need to check for the presence of bacteria.

When you order your products and ingredients from Essential, you’re buying not just a lotion or an essential oil or a peptide; you’re buying confidence in the products you sell your customers, which is what your customers are buying for you.  We’re sharing our QA process so that you can see what we do, but also so you can start to develop your own QA process using some of these techniques.

QA Starts Long Before we Manufacture

We source from vendors we trust and require supporting documentation on every item we bring into our facility.  (You can learn more about our vendor selection process here.) It’s why we’ll ask our private label customers to provide Certificates of Analysis and Saftey Data Sheets on any ingredients they provide.  We carefully monitor our ingredient inventory by lot number and expiry date so that when we’re ready to batch fresh products, we know they are made from fresh, responsibly sourced ingredients from around the world. For us, that’s where quality assurance begins.

Additionally, all USDA Certified Organic ingredients are quarantined in a separate section of the warehouse to maintain strict adherence to the chain of control. They also get marked with red tape so that visually, we can see which ingredients are organic when we’re batching.

Quality is also built into our batch sizes.  Because we’re a small batch manufacturer, we batch for what we need now and what our forecast, based on past sales, says we’ll need for the next few weeks or months depending on your product.  We do this because natural and organic ingredients have shorter shelf lives than synthetic products created from lab-manufactured ingredients.  We don’t want your products sitting on our shelves for months and months before they even get to you.  While our goal is to get your products in your hands as soon as possible, our passion for quality will sometimes mean you’ll occasionally receive a back-order notification that the product you want is still in our tanks or the QA process.  Know you’ll be getting the freshest product we can give you at any time.  If you have big orders coming or think you’ll be increasing your volume unexpectedly, you can call us and we can do a custom order for you.

What is a Batch Retention Sample?

We Batch Every Day — Monday through Thursday, and often Fridays, too.  We’ll often have 50 to 70 different batches produced each week. That’s a lot to keep track of. And a lot to ‘remember’.  So we do what GMP (good manufacturing process) requires and retain a batch sample (we do it in a 2 oz glass jar) for every single batch we make.  That batch is stored in a cool dark room with that batch’s lot code. That retention sample serves two purposes and is used by QA to determine:

  1. Is the next batch the same as the previous batch
  2. Is the product holding up over time

Every time we make a product, that ‘batch’ is unique to the date and time of manufacture. QA will compare the new batch with the retention sample and we’ll know what, if anything is different and can address it before is released for packaging. However, not everything is ‘fixable’. With natural and organic ingredients, products can vary from batch to batch depending on the ingredients. So for example, let’s say we make Travis’s favorite Calendula Butter Creme on July 17, 2017, and again on October 3, 2017. The Calendula Extract for those two batches likely came from two different ‘lots’ or ‘batches’ of Calendula Extract. The extract varies from crop to crop, just as apples, grapes, and oranges do. So in the same way as a Pinot Noir from the Willamette Valley is different from year to year, the Calendula flowers are, too. This can give us two different shades of yellow from batch to batch. That’s not something we can always fix.

So going back to the batch sample. In order to follow a batch through its life, we keep a sample from every batch we create and we label them with a Lot Code. Lot Coding is just a fancy way of saying we date the batch. We do this for traceability in case a customer, let’s call her Anna, has questions about their order. Once we have the Lot Code, we can tell that the container in question was made in October and not in January. Travis and his team will then pull the batch sample and can answer questions about the product Anna has in her hands. We also use batch retention samples to watch how a product changes over time. This is especially helpful for new products. We check the sample at regular intervals to see if the product is getting too soft, too hard, is separating or is just perfect. We use this information to fine-tune the compounding and formulation process.

Certificate of Analysis (CoA)

We create a CoA for every product we manufacture and require them on all ingredients we source. If your distribution partner requires one, we can provide one for you at no additional charge. You can ask our customer service team and we’ll be happy to get a copy of the CoA for your lot over to you. CoA’s are created during the QA process when microbial Assays are performed to check for the presence of microbial bacteria and fungus. An Assay is an investigative process for determining the presence of something in a sample. Assays are commonly used now in cosmetic manufacturing, and provide a strict standard of measure for assessing the levels of a component, such as a yeast, in a product.

QA is a Team Sport

Led by our chemist Travis Culley, the QA team tests the viscosity of the product, the pH, and the microbiology. They also analyze the products for the look, feel, and smell. The QA team is an integral part of the company, interacting with formulators and the compounders who make our products. During a pilot batch– the first time we make a product, QA, Formulators, and Compounders are nearly inseparable as the team collaborates on how to scale a product from a one-pound batch made in the lab to an 80 lb, 400 lb or even 4000 lb batch made in our tanks. We record everything we discover and integrate that data back into the manufacturing notes for future batches. QA is also a key member of the customer service team, helping our wholesale and lab customers get the exact right product every time.

So that’s a little about the QA process we have here. If you have any questions or areas you’d like to learn more about, please let us know at info@ewlnatural.com.

Your Role in QA

When your product or ingredient comes to you, we recommend you record the date, the product/ingredient name, and the lot code.  If you are selling the products ‘as is’, keep one for yourself from each batch you create.  If you add a lot code to your own finished products, you’ll want to note that lot code, too, so that if your customer calls, you can trace any issues they are having.  If you are mixing your own final formula, note not only your batch code but the lot code and source of every ingredient in that day’s batch.

Keep one sample of your finished product from each batch in the final packaging (keep the batch number on it) and one in a glass jar. Check them every 30 or 60 days and record what you’re finding.  It may be that you’ll see no changes in the glass jar, but the EOs in your product are eating at the seals on your finished package.  This info will help you see problems before your customer does and will keep you in good standing with customers if issues do arise.

If you have any questions, please let us know at info@ewlnatural.com and we can help you out.

 

 

 

 

Note: this blog was updated and republished on October 2, 2017 in reponse to

 

 

 

 

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