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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.
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