Avaliação de métodos para periodicidade de calibração de instrumentos de medição: um estudo de caso em uma indústria farmacêutica

Abstract

Calibration is a requirement in quality assurance standards and fundamental when determining the magnitude of the errors of a measurement instrument, in order to its approval and application in productive control. Other important requirement that precedes calibration is the formal definition of its period of application in the company’s documentation. The calibration frequency is a core factor in the instrumentation reliability. An upper calibration rate results in financial waste, a lower calibration rate results in inaccurate measurements. There is no consensus on the method for establishing an ideal period, although many standards establish the importance. The periodicity of calibration has been defined in the industrial environment, often based on empiricism. This paper analyzes four literature methods called A1 method, A2 method, A3 method and Schumacher method and applies them to a set of 634 calibration certificates from a certified industry in the pharmaceutical field. The goal is to evaluate whether the company’s methodology is consistent and whether there are any improvement points. The results indicate that it is possible to extend the calibration interval without any interfering in the measurement quality. A1 method and A2 method promote changes with a speed incompatible with the pharmaceutical industry, due to the safety required. However, A3 and Schumacher methods are options to be evaluated. Because it is a problem little explored in the industrial environment, the biggest challenge is currently the implementation of the methods.