The Role of Designed Experiments in Developing and Validating Control Plans
Process validation is “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes” (1). Being able to validate a process first requires that a process be developed that meets the customer requirements. This development process requires taking the external customer requirements and translating them into internal requirements for the manufacturing parameters, materials, procedures, and environment that ensure that the customer requirements are met. It also requires establishing controls to ensure that these internal requirements continue to be met.