What quality measures are in place?

Our laboratory quality practices encompass a set of systematic and standardized procedures that are implemented to ensure the accuracy, reliability, and precision of a high-quality product. We view these practices as essential for maintaining the overall quality and integrity of laboratory operations, as well as for providing 100 % pure, contamination free cultures. These practices include:

• Equipment Calibration: Laboratory instruments and equipment are regularly calibrated to establish and maintain optimum performance. As one example, our flow hoods are routinely tested to provide 0.2 micron filtered laminar air flow at all workstations. Calibration ensures that instruments are providing reliable and consistent outcomes.

• Quality Assurance (QA): we maintain a quality management system, conduct internal audits, and continuously monitor and evaluate laboratory performance.

• Quality Control (QC): We use control materials to monitor the accuracy and purity of culture products. Control materials are run alongside culture samples to assess performance of our methods. Any deviations from expected outcomes indicate issues with the process and prompt corrective action.

• Culture Testing: Quality assessment programs are in place, where each culture is tested on agar petri dishes on a regular interval. Virility of genetics performance is assessed by spot checking the strain in fruiting conditions. 

• Documentation and Record-Keeping: A crucial component of quality control. This includes documenting instrument maintenance, calibration records, QC data, corrective actions taken, and relevant product information. Proper documentation ensures traceability, allows for retrospective analysis, and facilitates compliance with our standardized process.

• Personnel Training and Competency: Laboratory staff receive appropriate training to perform their tasks competently. Training programs cover standard operating procedures, safety protocols, good laboratory practices, and quality control procedures. Regular competency assessments are conducted to ensure that staff members consistently perform at the required proficiency level.

• Error Investigation and Corrective Action: When errors or deviations occur, they are promptly investigated to identify root causes. Corrective actions are implemented to prevent the recurrence of errors and improve laboratory processes. We feel that documentation of errors, investigations, and corrective actions is crucial for continuous improvement and compliance with contamination free product.

• Quality Control Data Analysis: QC data is regularly analyzed to identify trends, shifts, or any patterns that may indicate a deterioration in process or product performance.
  
  By implementing these laboratory quality control practices, we can ensure accurate, contamination free products in order to enhance patient safety, and maintain our integrity.