QUALITY ASSURANCE PROGRAM

The NCL Quality Assurance (QA) Program has been designed to ensure that all reported data and results produced by an analytical procedure are technically sound, statistically valid, and properly documented. QA objectives set by NCL are to produce data of known precision, accuracy, comparability, and completeness.

In order to comply with EPA Good Laboratory Practice Standards, NCL has a Quality Assurance Unit (QAU) that is independent and separate from personnel engaged in the direction and conduct of studies. This group consists of one full time QA professional and an assistant. QAU maintains the Master Schedule, maintains copies of all study protocols, inspects and audits the in-process, raw data and final report phases of all studies, and provides management with written reports regarding study status and any problems that may affect study integrity.

The QAU is also responsible for all GLP compliance training. New employees to the FIFRA Studies Division receive training that includes such topics as raw data collection and documentation procedures. Employees are given ongoing training in the form of discussions regarding audit findings, updates on EPA GLP Advisories, and informal presentations of information acquired from off-site meetings. QAU staff members undergo periodic training themselves through routine attendance at regional and national meetings of the Society of Quality Assurance.

All laboratory operations, including personnel training, analytical standards preparations, extraction procedures, and equipment operation and maintenance are documented in Standard Operating Procedures in accordance with federal GLP requirements. The QAU maintains archives of all Standard Operating Procedures and is responsible for assigning a unique number to each SOP. This arrangement provides a centralized and orderly system of maintaining SOP's.