ABSTRACT
Consider this statistic gathered from the FDA records: 186 medical device recalls occurred in 1999 due to product malfunction or product defect (FDA 1999). Consider also the following possible situations:
A product that was designed about three years ago is having problems in the field. Customers are complaining much more about the performance of this product. You have been looking through the test results created when the product was released initially, but could not find out how the results proved that the product met customer requirements.
