QC stands for Quality Control

June 20, 2008

In my house, it also stands for “quit complaining”, but that’s a story for another day…

As a refined women of excellent taste, you are likely aware of the countless bath and body products on the market today. As a self-proclaimed “product junkie”, I can walk down the aisle of your neighborhood Sephora store and point out hundreds of products I’ve indulged in and several hundred more that are on my “to do” list. Typically, we’re drawn to flashy packaging, luxurious aromas and luscious textures, without giving nearly as much though to product efficacy and ingredients. But rarely- if ever- do we think about the safety of those gleaming products that line the shelves.

Over the past several years, Bella Luccè has continually refined our production systems to ensure that what’s in the bottles is every bit as safe as it is luscious. So today we are pulling back the curtain to give you a sneak peek at the stringent quality control measures we put into place during the creation of every Bella Luccè product:

1. Every ingredient is sampled and assigned a lot number as they are delivered to our warehouse. This lot number indentifies several items, chief among them: the source of the material, date of delivery, pertinent order details and who/when/and why it cleared quality control. Furthermore, these raw materials are sampled and retained for 36 months in our warehouse.

2. Batch Worksheets (which are the foundation of every batch) are clear and concise and contain not just the raw formulas, but all relevant information with regards to proper weighing and blending techniques, appropriate preservation data and sterilization protocol. This improves accuracy and eliminates confusion as every Bella Luccè product has its own formulation worksheet and protocol so that we can yield consistent, reproducible product.

3. These Batch Worksheets require that a multitude of production variables be recorded for every batch. These include the temperature readings of the batch at various stages, the name of the staff member creating the batch, the creation date and the lot number of every raw material used in the formulation.

4. We use a team approach when creating each and every Bella Luccè product. At least two team members must sign off on every ingredient added to the batch. This technique involves a significant time investment on behalf of the company, as every raw material is individually weighed and then cross-checked by a second team member, but it ensures the accuracy of each step along the way.

5. All Bella Luccè products bear a unique batch number and all batch samples are retained on-site for 36 months. Batch Worksheets are maintained for the same period of time.

6. Every hydrous product (those that contain water) is tested for potential contamination of mold, fungus, yeast and/or bacteria. A third-party production director (who was not involved in the production itself) performs microbial testing and we incubate the plates on-site in a temperature and humidity controlled incubator for maximum accuracy. No batch is released for distribution until we have a “clear” screen for all contaminants. The Microbial Testing Report and individual plates are retained in our offices for a period of 36 months.

7. Production team members are continually trained to expand and reinforce their knowledge. Topics include proper compounding technique, instrument sterilization, new product launch training, personal safety, material handling, equipment training and proper checks and balances. Individual, biannual reviews with each production team member ensure the highest quality production personnel with an impressive degree of quality group and individual training.

8. Our production team members work in a dedicated, controlled environment that is sealed off from our shipping, storage and office facilities to better control the purity of the environment. Team members must wash hands upon entering the production areas and- at all times- wear hair nets, shoe covers and nylon gloves to ensure the integrity of the products themselves. We are fastidious about the cleanliness of our production kitchens and have an exhaustive daily cleaning protocol that guarantees the proper production setting.

9. While the FDA does not approve cosmetic production facilities, it does request a voluntary registration with federal officials. Though it is estimated that less than 35% of all U.S.-based facilities have voluntarily registered, Bella Luccè is proud to be “on record” with the FDA (registration # E1002789).

Though this type of training, sterilization and record keeping involves significant resources, fastidiousness and vigilance (not to mention an ungodly amount of patience), it is of paramount importance that we be totally confident in every product that bears the Bella Luccè name. We are are proud to be fully compliant with the Good Manufacturing Practices (cGMP), as set forth by the FDA. But what does that mean for you?

Essentially, the system that Bella Luccè has established ensures that we have complete transparency and traceability. If there is ever a concern about the integrity of a particular product, we are able to note the individual batch number and begin an investigation. The first step is to examine our retained batch sample for aesthetic changes, with possible laboratory testing to analyze its stability. Once the sample is assessed, we pull the corresponding Batch Worksheet, which identifies the creation date, team members involved, and production variables for that batch, including the lot number of every raw material used. Furthermore, Bella Luccè management can then pull retained samples and ordering records of each raw material and order more tests as needed. Finally, we review both the original Microbial Testing Report and actual plated samples and meet with the team members involved in the product’s creation. It’s a bit like CSI…for your body crème.

It’s been a long and challenging road to establish these procedures in a small but growing company. Unfortunately, our federal regulating agencies did not create these provisions with small businesses in mind and there is precious little help available to growing companies who want to walk on the right side of the law. Nonetheless, today we are incredibly proud of the steps we take at Bella Luccè to ensure the safety and stability of the products you’ve come to know and love. We applaud those of you who scrutinize what’s in your products as we encourage you to also scrutinize the procedures used in their creation.

Now, if you made it through that World Record For Longest Blog Entry, then kindly reward yourself with a warm cappuccino or a nice glass of Shiraz. You deserve it.

Tags