Regulations in almost every industry are highly detailed and important to manage with a laser-like focus. Without strong adherence to proper regulations, any manufacturer will quickly find themselves dealing with recalls, paying steep fines, and losing customers. Avoiding consequences like these is dependent on a robust quality control system with checks and balances in place so that mistakes are avoided every step of the way. Working with a strong organization with the proper procedures in place ensures all products meet the guidelines of the FDA, ISO9001, and other specific bodies approval is needed from. The following outlines some of the general guidelines to be aware of in quality manufacturing procedures.
Certifications and Audits
Each manufacturing facility is required to meet the Food and Drug Administration’s (FDA) Current Good Manufacturing Practice (CGMP) regulations. This ensures that things like sanitation, documentation and safety are not overlooked. Manufacturers undergo strict audits to evaluate their equipment and processes. Auditors will follow a test batch through the entire production setup, from source materials to final paperwork. Any anomalies in the assembly line will be highlighted and altered to meet the appropriate standards.
Some products may require additional certification – kosher and cruelty free products are examples of this. Occasionally certain industries have internal certifications, such as the National Supplements Foundation, but this is typically only necessary if niche retailers or end users request it.
Overall, if production facilities are meeting the proper standards for industry certifications, the client can feel confident in the final goods.
Maintaining Expertise and Avoiding Mistakes
FDA officials want to see a facility that is full of knowledgeable employees, from the CEO to each individual worker. Consistent training and followup with team members can create an environment where each person knows the particulars of their job, their unit, and the overarching goals and needs of the company.
Transparency is another important attribute of a successful manufacturing business. Perfection is the ideal, but the nature of dealing with large quantities, varying products and human fallibility is that mistakes will occasionally happen. In these outlying cases, it’s imperative that manufacturers be upfront with clients and regulatory bodies to quickly address and correct issues. There’s never a benefit to dishonesty.
When the minutiae of regulations is very complex, there are third party organizations who can help to navigate different licensing and legal hurdles. A top-tier manufacturing facility will maintain relationships with experts who can assist on questions of FDA approval and international certifications as needed.
Improvement Through Key Performance Indicators
Even after certifications are in order and regulatory hurdles are cleared, manufacturers must take advantage of new technology and processes to improve. Regulatory bodies will always be looking for a facility to surpass the standard set on their last audit. Production facilities should establish key performance indicators that are visible to everyone in the business, with measurable goals to demonstrate success along the way.
When evaluating technological advances and their value to the facility, customer needs should always be at the forefront. Large purchases of new equipment only make sense if there’s a client base that can make use of the equipment in a financially feasible way. If product developers aren’t getting the kind of scalable service they need from their current manufacturer, they might consider working with a more specialized factory to produce the goods they desire in conjunction with like-minded brands, sharing the cost of new technology in a larger group.
Manufacturers and entrepreneurs alike need to keep regulatory needs in mind through all stages of planning and creating products. Every detail — safety processes for manufacturing employees, the sourcing of raw materials, proper labeling, and quality inspections, among other things, will be scrutinized at some point. Failure to comply with regulations at each point in the process sets a brand up for problems at a later date. Proper certification up front, maintaining an atmosphere of proficient skill and focusing on process and technological improvements are what set the best production facilities apart.
By Jordan Erskine, President of Dynamic Blending, a contract manufacturer.