How is a graded approach applied to DESs Quality System?
Because of the diversity of work conducted by the Agency, DES recognizes that a “one size fits all” approach to quality requirements will not work. Therefore, the implementation of the DES QA System is based on a graded approach. Applying a graded approach means that quality system requirements for different programs will vary according to the specific objectives and needs of the project. For example, the quality controls of a research program are different from that of a regulatory compliance program because the purpose or intended use of the data is different. Once a graded approach has been applied to the components of a quality system, it is then applied to the documentation required by that system.