Book Description

Planning for quality assurance (QA) in research and development (R D) is like stealing eggs without waking up the chickens. The QA program should be as unobtrusive as possible. Researchers require a QA program that affords them an environment capable of supporting repeatable experiments with accurate data without unduly stifling their creative abilities. Careful advance planning ensures that the intensity of control provided by quality-related systems is commensurate with the importance and scope of the activities being performed. Good scientific practices applied to small bench-scale projects may require minimal additional controls. As projects increase in size and complexity the controls imposed through planning must, by necessity, be increased. Research and development QA planning, just like any other planning, involves all affected individuals. The application of control systems is determined by factors such as customer or sponsor requirements, the importance of an item or activity to the experiment's success, and the organizational complexity of the project. Many larger experiments are highly dependent on quality-related support activities such as calibration, engineering design, and inspection provided by organizations outside the R D group. Since, in most cases, the expense of support activities is taken directly from funds available for research, it is important for the researchers to be involved in the planning efforts to help determine and agree with the level of QA effort required. A single plan will often suffice for organizations engaged in large numbers of similar experiments. Complex experiments may require unique QA plans or additions to existing plans. Once implemented, the R D QA plans, like any others, require audits or surveillances and may require revisions if the scope of the experiment changes. 1 ref., 1 fig.