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

G.nilay Yücenur; Seren Çataltepe; İrem Sakin

doi:10.17776/csj.567601

EN

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

Abstract

Protecting public health, taking preventive measures and ensuring recovery in case of any disease are conditions for creating a healthy life. In order to create this life, the manufacturing process of the pharmaceutical industry needs to be formed carefully. In this study there is a risk analysis application into operational processes of a pharmaceutical company. In application study, operational processes of sample company were examined and analyzed from October to May. Within the scope of the study, a two-stage approach was proposed in the analysis of the data obtained. In the first phase, fishbone analysis was carried out to determine the risks in the operational processes and the potential risks in two separate production lines were determined. In the second stage, the risk prioritization method was used and risk priority numbers (RPN) were calculated for all risks. In all these analysis, more realistic and valid results were obtained with the usage of fuzzy logic and the calculations of RPNs were made more objective and independent from analysts. After the determination of RPNs, precautions were suggested for high risky failures. Following the implementation of precautions, new RPNs were calculated for all failures. The old and the new RPNs were compared for all risky failures and all precautions were examined with their impacts on the process. As a result, all examined failures’ risk prioritization numbers were reduced in the ratio between 72% and 90%, the operational processes were improved.

Keywords

Failure mode and effect analysis,Fuzzy prioritization method,Pharmaceutical sector,Risk analysis

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Details

Primary Language

English

Subjects

-

Journal Section

Research Article

Authors

G.nilay Yücenur ^*
0000-0002-2670-6277
Türkiye

Seren Çataltepe
0000-0003-1988-7759

İrem Sakin
0000-0001-6384-0929

Publication Date

March 22, 2020

Submission Date

May 19, 2019

Acceptance Date

October 18, 2019

Published in Issue

Year 2020 Volume: 41 Number: 1

DOI

https://doi.org/10.17776/csj.567601

IZ

https://izlik.org/JA48PG53US

Cite

RIS / Bibtex

APA

Yücenur, G., Çataltepe, S., & Sakin, İ. (2020). An integrated approach by fmea & fuzzy prioritization method at pharmaceutical ındustry quality control. Cumhuriyet Science Journal, 41(1), 106-121. https://doi.org/10.17776/csj.567601

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Applied Mathematics and Nonlinear Sciences

https://doi.org/10.2478/amns.2023.2.00195

Öz

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

Abstract

Keywords

References

Details

Primary Language

Subjects

Journal Section

Authors

Publication Date

Submission Date

Acceptance Date

Published in Issue

DOI

IZ

Cite

Cited By

Implementation of Quality by Design in the Formulation and Development of Nanocarrier-Based Drug Delivery Systems

Information technology system to promote drug production command supervision