Validação de um processo em uma indústria de dispositivos médico-hospitalares: um estudo de caso

Abstract

The quality in the medical device sector is extremely relevant since defective products can cause serious problems to the final customer. In this sense, the Process Validation comes to ensure that the parameters are within the process specification window. In consequence, it assures that the specifications of the products are being met. The purpose of this present study is to describe the process validation of a catheter final assembly machine in a new system that performs the catheter and cannula siliconization. In addition, the process validation sought to ensure that products or process modifications would not interfere the final product specification, what affects customers’ satisfaction. Tools like DOE, FMEA and MSA are immensely important to define and identify the components such as process windows, critical factors that present quality risks, and evaluate statistical properties related to position measurements and variations of the measurement system. The implemented changes, although not the focus of the study, have brought excellent results, better than previous ones to changes, and also much learning of the new process.