Implantação das boas práticas de fabricação em indústria de indicadores biológicos

Abstract

All the industrial establishment has in the quality of its products one of the biggest competitive advantages to face its competitors. The Resolution of the collegial direction number 59/2000 (Good practices of Fabrication / Distribution), it is a set of requirements required by ANVISA to the manufacturers and distributors of medical and dental products. The enforcement of such requirements assurance to the consumers quality, safety and reliabity. So, this study aimed for the implantation of the RDC 59 in a manufacturer company of biological indicators for purposes of certification, along with the ANVISA. For this, periodic visits were made of monitoring in elaboration of the procedures (items of the standard) and training in loco to the enforcement of the standard and conscientization of the employees. One chart recognition was made allowing the visualization of the process, from this matrix of responsibility was created and describing clearly each function. The items required by the standard were described, proving its enforcement through the registrations named procedures (16 in all). After the implementation process with training, an internal auditing was made whose outcome generated a reporting for the company arranged the necessary actions adapting to this standard mentioned. The company required a certification was requested to ANVISA. Having implanted a quality system brought a standardized company of its services and goods, creating a simple general control of all its procedural flow, ensuring like that, the commitment with its process and customers, turning the activities into actions and direct quality, reliability and safety.