chapter  6
26 Pages

Validation of Product and Process

Why are validation or verification activities performed? The list below identifies some reasons for testing:1

Expose faults Demonstrate that requirements have been satisfied Assess the suitability of the product to customer needs Calibrate performance Measure reliability Make sure changes have not produced adverse side effects (regres-

sion testing) Establish a level of diligence that can be referenced in the event of

product liability litigation

The validation development team (example provided in Figure 6.1) consists of a variety of people. Available talent should be able to devise the tests and create the program when and where it does not exist. Management verifies that the appropriate resources are available to perform the validation, although such is not always the case. Below is one example of a team that works with the project manager. In our example, we have numerous other players who are involved but not shown; however, a functional area individual leader represents these individuals. As with the other phases, the customer will often have a role within this phase, up to and

including concurrent testing. Many customers perform audits or conduct a selected battery of tests duplicating the supplier’s work and compare the outcome of the two tests for discrepancies.