QUALITY ASSURANCE is defined as: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.
Quality Assurance consists of that “part of quality management focused on providing confidence that quality requirements will be fulfilled.” The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties.
FMI Provides Confidence to You in the Following Ways:
FDA Registration
FMI is an FDA registered and inspected contract manufacturing facility. This is important for the products that are classified as drugs and regulated by the FDA such as sun care products with sunscreen and skin care products that make specific claims to treat skin conditions.
Documented Standards
Our regulatory department maintains documented standards such as Standard Operating Procedures (SOPs), Specifications, and your finished product targets—both physical and photographic references to represent the attributes of the final product such as the fill level and label placement.
Audits
FMI conducts internal quality audits and inspections of various manufacturing and administrative areas of the business to ensure compliance. Quality Assurance is also responsible for coordinating external audits conducted by our customers and responding to the results of those audits.
Complaint Resolution
Our QA department has procedures and tools in place for resolving customer issues—non-conforming product control, customer complaint resolution, and root cause analysis.
Continuous Improvement
In the spirit of continuous improvement, FMI monitors and analyzes quality related key performance metrics and documents and implements corrective and preventive actions.