Harry Reid Center for Environmental Studies
Chemistry Division

HRC >> Chemistry >> Quality Assurance

Quality Assurance

The HRC chemistry laboratory follows University-wide QA plan for U.S. DOE-sponsored research studies at the Yucca Mountain high-level radioactive waste disposal site. This QA plan (QAP) was developed and is currently administered by Amy Smiecinski and her staff. This QA program addresses the requirements of the U.S. EPA and the Yucca Mountain Project Office, its two most active sponsors. The HRC chemistry laboratory also maintains the lab certification from the State of Nevada for the analysis of contaminants under the Safe Drinking Water Act.

Quality Management Policy

Following each award of financial assistance, HRC prepares a Scientific Investigation Plan (SIP) for the new research studies. The QA philosophy reflected in HRC's QA Program is one of continuous quality improvement. The QA program supports the scientific research undertaken at HRC and is necessarily flexible to meet the variety of needs of the investigators, subcontractors, and sponsors. The QA program puts an emphasis on providing sufficient assistance in planning research activities and documenting all aspects of each study to assure that a complete record exists; that experiments are repeatable; and that the scientific progressions are traceable, reviewable, and logical.

It is the policy of the HRC that all products resulting from its activities meet the highest standards. To fulfill this commitment, the HRC management has established organizational responsibilities, including Cooperative Agreement HRC Project Managers, Principal Investigators, and a QA Staff, to ensure that quality is integrated into HRC studies, both in-house and for subcontractors. Because time and cost are realistic constraints at HRC, planning to achieve quality without waste of resources is top priority.

Data are developed and collected at the HRC for a variety of research purposes that can range from fate and transport to risk assessment and others. This broad range of research requires a multitude of analytical approaches and may require differing degrees of data quality. To ensure that the data meet the needs of the study, realistic quality objectives are established during the planning phase and experimental design of the study program. The evaluation of costs associated with the quality elements is an important consideration and, at the HRC, study planning to achieve the quality requirements of the internal and external researchers without waste is a high priority. The HRC works closely with its sponsors to set these objectives and monitor the need for adjustment as each study progresses.

Responsibilities and Authority

Quality is the responsibility of all managers and researchers in their respective work areas. The specific activities contributing to quality are listed in the research Implementing Procedures (Ips) and include: study objectives definition, experimental design, measurement procedures, calibration procedures and frequency, preventive procedures, quality controls, corrective action, data collection, reduction, and verification, and data validation and reporting.

Measurement and Test Equipment Controls

Measures are to be established to insure that laboratory equipment such as analytical balances, pH meters, instruments, and other measuring and test equipment used in activities that affect quality are controlled, calibrated, and adjusted properly at specified periods to maintain accuracy within necessary limits. SOPs are to be composed where necessary as specified in individual QA Project Plans for the proper use of these devices.

Equipment is to be calibrated against certified standards having known valid traceability to the National Institute of Standards and Technology or to other nationally recognized standards. Equipment is calibrated, adjusted, and maintained at prescribed intervals. If no nationally- recognized standards exist, the basis for calibration is documented. Records are maintained indicating calibration status.

Review and Evaluation of Quality Systems

All HRC activities are subject to planned and scheduled internal and external systems and performance audits to assure that procedures and activities comply with the overall QA Program and to determine their effectiveness. Audits provide an objective evaluation of quality-related practices, procedures, instructions, activities, and items, including the review of documents and records, to insure that the QA Program is effective and implemented properly.