title: Evaluation of product failure rates for litigation.
abstract: Two classes of products can be purchased: 1) a product that has been tested and 2) one that has not been tested, but randomly selected samples of the production lot have been subjected to a performance test more demanding than that of the advertised performance level. Based on the results of such random testing, the decision is made to release units in the lot, including the untested units, for sale. An important aspect of this test procedure is careful examination of the range of performance levels of the tested samples, represented by the distribution curve of the numbers of units having specific performance levels versus the performance level. Even with stringent test requirements for the randomly tested samples, there will be a small number of product failures. Hence, an important question is how to draw engineering, scientific, and legal conclusions about the failure of a product that was not itself tested but was part of a batch of products from which a random sample was tested. A methodologic approach for dealing with this situation is presented.
authors.affiliation: Biomedical Engineering Department, Purdue University, West Lafayette, IN 47907-1296, USA.
authors.forename: L A
authors.initials: LA
authors.lastname: Geddes
authors.forename: G
authors.initials: G
authors.lastname: Salvendy
mesh_terms: D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards / Q000706:statistics & numerical data; D004864:Equipment and Supplies / Q000592:standards*; D005069:Evaluation Studies as Topic; D006801:Humans; D010138:Pacemaker, Artificial / Q000592:standards; D017751:Safety Management / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D014481:United States