Development of a generic tool condition monitoring validation methodology

Good manufacturing practices (GMP) are enforced in different parts of the world by regulatory bodies; some of the more recognizable bodies being the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO)... [ view full abstract ]

Good manufacturing practices (GMP) are enforced in different parts of the world by regulatory bodies; some of the more recognizable bodies being the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO) and the European Union (EU). Validation is an essential part of GMP and the approach of bringing GMP validation techniques to Tool Condition Monitoring (TCM), in the medical devices industry, which relies heavily on validation, has received little attention in literature. Validation involves identifying and testing all aspects of a process that could affect the final product quality/safety and demonstrating with a high degree of assurance that uniform product will be produced, that meets the required quality specifications throughout the product lifecycle.

The focus of this paper is on the selection of whether validation or verification is the best approach for the Tool Condition Monitoring (TCM) system, which consists of a 3-axis force sensor, an acoustic emission sensor, 3-axis accelerometer, a data acquisition card, an industrial portable computer, custom Data Logging Software and custom Control Software, linked back to a Human Machine Interface (HMI).

One of the unique elements of this system is the incorporation of a neural network based Case-Based Reasoning (CaBR) control system into the TCM, an area which has received little attention in literature.