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Quality Assurance & Quality Control

Nautilus follows a comprehensive Quality Assurance/Quality Control (QA/QC) program encompassing all testing and routine laboratory procedures. The laboratories are designed to provide controlled studies on marine, freshwater, and terrestrial organisms using standards based on “Good Laboratory Practices”. QA is defined as a definite plan for laboratory operations, which specifies standard procedures that ensure production of legally defensible data. The basic requirements of a QA program are to recognize possible errors, understand the measurement system used, and develop techniques and plans to minimize errors. Our QA program is designed: 1) to ensure that all tests are performed in accordance with applicable guidelines and regulations; and 2) to increase test performance and precision. The program is broken down into several systems, which are monitored by the QA Officer. These systems include: 1) Management of Change (MOC); 2) Corrective Action Records (CAR); 3) Equipment and Facility Maintenance; 4) Data Generation and Handling (Review, Analysis, Reporting, and Storage); 5) Technical Staff Training; 6) Laboratory Standard Operating Procedure (SOP) Development; and 7) Reference Manual Development.

QC is a system established to control possible errors. It helps to provide quality work that is satisfactory, dependable, and economical. It consists of the use of a series of procedures that must be followed. QC problems leading to poor condition of test animals, inadequate test procedures, or other symptoms may necessitate repeat testing, or lead to incorrect over- or under-estimations of toxicity, or improperly identified causative toxicants. QC practices address all activities that affect the final quality of the toxicity test data including: sample/material handling, water quality and test conditions, source and condition of test organisms, condition of equipment, instrument calibration and maintenance, measurement of test precision, record keeping, problem identification and corrective actions, data evaluation, and personnel training. All data generated by the laboratory is monitored for completeness and accuracy at the end of each day and at the end of each individual test period. The detail of record keeping and the general and statistical evaluation of test data are closely monitored to ensure generation of the highest quality data.