Standard Operating Procedure for Quality Assurance in Analytical Chemistry Methods Development

摘要

The Environmental Protection Agency's (EPA) Office of Research and Development (ORD) are engaged in the development, demonstration, and validation of new or newly adapted methods of analysis for environmentally related samples. Recognizing that a 'one size fits all' approach to quality requirements will not work in organizations as diverse as the EPA, implementation of the EPA Quality System is based on the principle of graded approach. Applying a graded approach means that quality systems for different organizations and programs will vary according to the specific objectives and needs of the organization. The initiation of the development of a method may be the result of: an EPA Program Office request$ a request from a Region$ or the foresight of a scientist who sees the future needs for a method. Data quality objectives (DQOs) and the EPA Data Quality Objective Process may not always be appropriate for the method development process. The reason for this is that if quantifiable objectives are put before a research investigator, the danger exists that a bias may evolve from the administrative drive to reach the objective. In lieu of DQOs, scientists engaged in methods development should strive for Project Quality Objectives (PQOs). In some cases, science investigators will use this plan directly$ in other cases, this plan may be used as a 'blueprint' for developing a final QAPP due to the 'uniqueness' of research.