The aim of this study was to carry out the situational diagnosis regarding the temperature deviation in the transport and storage processes of investigational product (IP) and biological sample. The situational diagnosis was carried out in five clinical research centers, distributed throughout the Brazilian territory: Campo Grande / MS; Porto Velho / RO; Recife PE; Rio de Janeiro -RJ and Salvador BA. The mapping of deviations was performed locally according to the demands of the respective clinical research centers regarding quality control of the cold chain. For the data collection, the equipment temperature records of the referred research centers were used and analyzed by the six sigma quality tool. Six Sigma is a methodology that uses a set of quality automotive tools and statistical tools applied following a chronological sequence of project. It is a systematic solution facing chronic problems and improving processes and with the help of statistics, can be proven through facts and data. Several weak points were pointed out at this assessment, mostly issues related to the general aspects of the temperature control and maintenance of equipments and products. From the results found, it was possible to apply the Lean Six Sigma methodology and to draw up an intervention plan. From the analysed data, it was possible to verify the improvement of the efficiency of the transportation and storage processes investigated in the present work.
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