Mansfield-King understands that quality is critical to every one of our customers and their end-users. Quality protects your brand and our reputation. Therefore, all of our operations are governed by a comprehensive Quality Manual, administered by our Quality Control Unit.

Our proprietary Quality Manual covers the entire universe of quality processes, including SOPs, validation plans, and data collection. The collected data drives statistical process control, using control charts to create process capability improvement.

Quality is validated externally, as well; our FDA registration and our ISO 22716 certification ensure that every aspect of MK complies with the latest GMP requirements.


A commitment to quality requires a written program and detailed records. Without documentation, any quality program is merely aspirational. Our Quality Manual covers every aspect of production and operations, from incoming inspection to process and equipment validation to laboratory testing protocols and calibration. We record the data we collect and make it available for future use and inspection.


Our Quality Manual mandates extensive testing, including raw materials, bacteria/yeast/mold in bulk products and finished goods, water testing for our reverse osmosis purified water, stability, and finished product testing. Testing also takes place as the post-production, Quality Assurance stage, where statistical AQL processes are used to ensure compliance with quality requirements.


The data we collect does not gather dust. Instead, the Quality Control Unit continually analyzes the data to achieve process capability improvement. Production of each product is examined over time with control charts, seeking to find any unacceptable variation, determine root causes and eliminate variability.


We strongly believe that despite our extensive QC testing, quality cannot be inspected into a product. Therefore, we not only analyze and improve our processes, we also invest in equipment that helps ensure quality without human intervention, such as checkweighers, skew-cap detectors, and closure sensors.


When a process for production is validated, we do not merely test for failures in quality. Instead, we take every stable process and improve its quality through process capability improvement mechanisms, including narrowing control ranges, analyzing defects through Pareto analysis, and focusing on root causes of any deviations. Our goal is continuous improvement, not merely resting on our laurels.