An ıntegrated approach by fmea & fuzzy prioritization method at pharmaceutical ındustry quality control

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Protecting public health, taking preventive measures and ensuring recovery in case of anydisease are conditions for creating a healthy life. In order to create this life, the manufacturingprocess of the pharmaceutical industry needs to be formed carefully. In this study there is arisk analysis application into operational processes of a pharmaceutical company. Inapplication study, operational processes of sample company were examined and analyzed fromOctober to May. Within the scope of the study, a two-stage approach was proposed in theanalysis of the data obtained. In the first phase, fishbone analysis was carried out to determinethe risks in the operational processes and the potential risks in two separate production lineswere determined. In the second stage, the risk prioritization method was used and risk prioritynumbers (RPN) were calculated for all risks. In all these analysis, more realistic and validresults were obtained with the usage of fuzzy logic and the calculations of RPNs were mademore objective and independent from analysts. After the determination of RPNs, precautionswere suggested for high risky failures. Following the implementation of precautions, newRPNs were calculated for all failures. The old and the new RPNs were compared for all riskyfailures and all precautions were examined with their impacts on the process. As a result, allexamined failures’ risk prioritization numbers were reduced in the ratio between 72% and90%, the operational processes were improved.


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Cumhuriyet Science Journal

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