Abstract

Calibration of instrumentation equipment in the pharmaceutical industry is an important activity to determine the true value of a measurement. Preliminary studies indicated that occur lead-time calibration resulted in disruption of production and laboratory activities. This study aimed to analyze the causes of lead-time calibration. Several methods used in this study such as, Six Sigma in order to determine the capability process of the calibration instrumentation of equipment. Furthermore, the method of brainstorming, Pareto diagrams, and Fishbone diagrams were used to identify and analyze the problems. Then, the method of Hierarchy Analytical Process (AHP) was used to create a hierarchical structure and prioritize problems. The results showed that the value of DPMO around 40769.23 which was equivalent to the level of sigma in calibration equipment approximately 3,24σ. This indicated the need for improvements in the calibration process. Furthermore, the determination of problem-solving strategies Lead Time Calibration such as, shortens the schedule preventive maintenance, increase the number of instrument Calibrators, and train personnel. Test results on the consistency of the whole matrix of pairwise comparisons and consistency test showed the value of hierarchy the CR below 0.1.

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