LEGEND provides a wide variety of services to a broad range of customers. The Quality Assurance Program (QAP) is designed to assure the customer that our high quality standards are consistently applied to all services rendered by the laboratory.
LEGEND's QAP documents the quality system in accordance with industry specific guidelines to ensure the uniformity and consistency in the system. The QAP thoroughly addresses all of the requirements for all of the agencies it generates data for and all the accreditations and certifications it holds.
LEGEND's management and staff are committed and dedicated to the QAP in order to provide consistent quality to meet the data quality objectives of our clients.
STANDARD OPERATING PROCEDURES (SOPs)
LEGEND has produced and maintained a number of procedures where specific methodologies are maintained to include the dedicated equipment and instrumentation utilized by LEGEND. SOPs are produced, updated, and/or maintained to include new equipment and instrumentation and to conform to all regulatory requirements. Existing SOPs are reviewed on an annual basis or as needed. The Quality Assurance Manager maintains all official copies and distributes copies to all applicable personnel.
CALIBRATION & MAINTENANCE
To provide clients with the production of quality data, proper calibration and maintenance of all laboratory equipment and analytical instruments is incorporated into the daily process. LEGEND has implemented a preventative maintenance program to ensure that routine maintenance procedures are performed to prevent failure of instrumentation during use. The continual calibration process assures that equipment and instruments are within prescribed accuracy and precision limits. Utilizing manufacturers guidelines along with regulatory stipulations, analysts perform and document calibration and maintenance activities on all appropriate equipment and instruments.
DATA VALIDATION & REVIEW
One of LEGEND's quality control mechanisms is a validation and review process based on acceptance/rejection criteria. This process involves critical review of the data searching for the questionable values relative to the measuring tools available along with an evaluation of the quality control information relative to the sample data.
Training is an integral part of the QAP in the operation of an analytical laboratory. It is vital to ensure that all employees are knowledgeable in their areas of responsibility on a continuing basis. To accomplish this goal, the laboratory has a formal training program that covers all aspects of LEGEND's operations, with strong emphasis on quality assurance, safety, and analytical procedures.
INTERNAL AUDIT SYSTEM
In addition to external audits conducted by regulatory agencies and clients, the QAP sets forth steps, procedures, and documentation for insuring the quality of analytical data. The system uses an Internal Audit Program, where the QA Manager performs periodic audits of records. Internal auditing procedures exist to identify areas of improvement in the QAP for continuous improvements.
EXTERNAL QUALITY ASSURANCE
In order to validate the performance of an analytical laboratory, an ongoing program of blind performance evaluation (PE) samples are prescribed. The external PE sample program involves the analysis of blind samples to assess the continuing capability of each parameter for which samples are available. The blind samples are processed as a routine sample.
LEGEND participates in the American Industrial Hygiene Association-Laboratory Accreditation Program, LLC (AIHA-LAP,LLC) proficiency aptitude testing (PAT) program, AIHA-LAP, LLC Environmental Lead Laboratory Accreditation Program (ELLAP), and the National Voluntary Laboratory Accreditation Program (NVLAP Lab Code: 102081-0) samples.