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Yıl 2020, Cilt: 41 Sayı: 1, 106 - 121, 22.03.2020

G.nilay Yücenur , Seren Çataltepe İrem Sakin

https://doi.org/10.17776/csj.567601
Cited By: 2

Öz

Kaynakça

  • [1] Carpitella S., Certa A., Izquierdo J. and Fata C.N.L., A combined multi-criteria approach to support FMECA analyses: A real-world case. Reliability Engineering and System Safety, 169 (2018) 394–402.
  • [2] Kutlu A.C., Ekmekçioğlu M., Fuzzy failure modes and effects analysis by using fuzzy TOPSIS-based fuzzy AHP. Expert Systems with Applications, 39(1) (2012) 61–67.
  • [3] Fattahi R., Khalilzadeh M., Risk evaluation using a novel hybrid method based on FMEA, extended MULTIMOORA, and AHP methods under fuzzy environment. Safety Science, 102 (2018) 290–300.
  • [4] Kumru M., Kumru P.Y., Fuzzy FMEA application to improve purchasing process in a public hospital. Applied Soft Computing, 13 (2013) 721–733.
  • [5] Mandal S., Maiti J., Risk analysis using FMEA: Fuzzy similarity value and possibility theory based approach. Expert Systems with Applications, 41 (2014) 3527–3537.
  • [6] Chen Z., Wu X. and Qin J., Risk assessment of an oxygen-enhanced combustor using a structural model based on the FMEA and fuzzy fault tree. Journal of Loss Prevention in the Process Industries, 32 (2014) 349-357.
  • [7] Chanamool N., Naenna T., Fuzzy FMEA application to improve decision-making process in an emergency department. Applied Soft Computing, 43 (2016) 441–453.
  • [8] Dağsuyu C., Göçmen E., Narlı M. and Kokangül A., Classical and fuzzy FMEA risk analysis in a sterilization unit. Computers & Industrial Engineering, 101 (2016) 286–294.
  • [9] Tooranloo H.S., Ayatollah A.S., A model for failure mode and effects analysis based on intuitionistic fuzzy approach. Applied Soft Computing, 49 (2016) 238–247.
  • [10] Adar E., İnce M., Karatop B. and Bilgili M.S., The risk analysis by failure mode and effect analysis (FMEA) and fuzzy-FMEA of supercritical water gasification system used in the sewage sludge treatment. Journal of Environmental Chemical Engineering, 5 (2017) 1261–1268.
  • [11] Lv Y., Liang Y., Application of FMEA based on fuzzy multi-criteria decision-making for HVAC in a pharmaceutical plant. Journal of Chemical and Pharmaceutical Research, 6(6) (2014) 1116-1123.
  • [12] Bhattacharya J., Quality risk management – Understanding and control the risk in pharmaceutical manufacturing industry. International Journal of Pharmaceutical Science Invention, 4(1) (2015) 29-41.
  • [13] Hajimolaali M., Asl A.A., Quality risk assessment production of beta lactams by FMEA model and fuzzy theory method. General Medicine: Open Access, 4(1) (2016).
  • [14] Su C.T., Chou C.J., Hung S.H. and Wang P.C., Adopting the healthcare failure mode and effect analysis to improve the blood transfusion processes. International Journal of Industrial Engineering, 19(8) (2012) 320-329.
  • [15] Liu H.C., Liu L., Liu N. and Mao L.X., Risk evaluation in failure mode and effects analysis with extended VIKOR method under fuzzy environment. Expert Systems with Applications, 39 (2012) 12926–12934.
  • [16] Liu H.C., You X.J., You X.Y. and Shan M.M., A novel approach for failure mode and effects analysis using combination weighting and fuzzy VIKOR method. Applied Soft Computing, 28 (2015) 579–588.
  • [17] Mohsen O., Fereshteh N., An extended VIKOR method based on entropy measure for the failure modes risk assessment – A case study of the geothermal power plant (GPP). Safety Science, 92 (2017) 160–172.
  • [18] Mikhailov L., Tsvetinov P., Evaluation of services using a Fuzzy Analytic Hierarchy Process. Applied Soft Computing, 5(1) (2004) 23-33.
  • [19] Özfırat P.M., A new risk analysis methodology integrating fuzzy prioritization method and failure modes and effects analysis. Journal of the Faculty of Engineering and Architecture of Gazi University, 29(4) (2014) 755-768.
  • [20] Rahimi S.A., Jamshidi A., Ait-Kadi D., Ruiz A. and Rebaiaia M.L., Prioritization of failures in radiation therapy delivery. IFAC-PapersOnLin, 49(12) (2016) 1898-1903.
  • [21] http://www.ispe.org/gmp-resources, Arrival date: 20.11.2017.
  • [22] Wessiani N.A., Sarwoko S.O., Risk analysis of poultry feed production using fuzzy FMEA. Procedia Manufacturing, 4 (2015) 270-281.
  • [23] Spreafico C., Russo D. and Rizzi C., A state-of-the-art review of FMEA/FMECA including patents. Computer Science Review, 25 (2017) 19–28.
  • [24] Villarini M., Cesarotti V., Alfonsi L. and Introna V., Optimization of photovoltaic maintenance plan by means of a FMEA approach based on real data. Energy Conversion and Management, 152 (2017) 1–12.
  • [25] Tague, N.R., The Quality Toolbox, 2th ed. United States of America: ASQ Quality Press Milwakee, Wisconsin, 2005; 35-54.
  • [26] Yazdi M., Daneshvar S. and Setareh H., An extension to Fuzzy Developed Failure Mode and Effects Analysis (FDFMEA) application for aircraft landing system. Safety Science, 98 (2017) 113–123.
  • [27] Ilbahar E., Karaşan A., Cebi S. and Kahraman S., A novel approach to risk assessment for occupational health and safety using Pythagorean fuzzy AHP & fuzzy inference system. Safety Science, 103 (2018) 124–136.
  • [28] Chang K.H., Evaluate the orderings of risk for failure problems using a more general RPN methodology. Microelectronics Reliability, 49 (2009) 1586–1596.
  • [29] Hassan A., Siadat A., Dantan J.Y. and Martin P., Conceptual process planning – an improvement approach using QFD, FMEA, and ABC methods. Robotics and Computer-Integrated Manufacturing, 26 (2010) 392–401.
  • [30] Feili H.R., Akar N., Lotfizadeh H., Bairampour N. and Nasiri S., Risk analysis of geothermal power plants using Failure Modes and Effects Analysis (FMEA) technique. Energy Conversion and Management, 72 (2013) 69–76.
  • [31] Wang Y.M., Chin K.S., Poon G.K.K. and Yang J.B., Risk evaluation in failure mode and effects analysis using fuzzy weighted geometric mean. Expert Systems with Applications, 36 (2009) 1195–1207.
  • [32] Xiao N., Huang H.Z., Li Y., He L. and Jin T., Multiple failure modes analysis and weighted risk priority number evaluation in FMEA. Engineering Failure Analysis, 18 (2011) 1162–1170.
  • [33] Chang D.Y., Applications of the extent analysis method on fuzzy AHP. European Journal of Operational Research, 95 (1996) 649–655.
  • [34] Wang Y.M., Chin K.S., Fuzzy analytic hierarchy process: A logarithmic fuzzy preference programming methodology. International Journal of Approximate Reasoning, 52(4) (2011) 541-553.
  • [35] Constantinescu A., Sum-fuzzy implementation of a choice function using artificial learning procedure with fixed fraction. Applications of Mathematics, 52(4) (2007) 321-326.
  • [36] Yu C.S., A GP-AHP method for solving group decision-making fuzzy AHP problems. Computers & Operations Research, 29(14) (2002) 1969-2001.
  • [37] Bisso C.S., Samanez C.P., Efficient determination of heliports in the city of Rio De Janerio for the Olympic games and world cup: A fuzzy logic approach. International Journal of Industrial Engineering, 21(1) (2014) 33-44.
  • [38] Yayla A.Y., Yıldız A., Fuzzy Analytic Network Process based multi criteria decision making methodology for a family automobile purchasing decision. South African Journal of Industrial Engineering, 24(2) (2013) 1-14.

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

Yıl 2020, Cilt: 41 Sayı: 1, 106 - 121, 22.03.2020

G.nilay Yücenur , Seren Çataltepe İrem Sakin

https://doi.org/10.17776/csj.567601
Cited By: 2

Öz

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.

Anahtar Kelimeler

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

Kaynakça

  • [1] Carpitella S., Certa A., Izquierdo J. and Fata C.N.L., A combined multi-criteria approach to support FMECA analyses: A real-world case. Reliability Engineering and System Safety, 169 (2018) 394–402.
  • [2] Kutlu A.C., Ekmekçioğlu M., Fuzzy failure modes and effects analysis by using fuzzy TOPSIS-based fuzzy AHP. Expert Systems with Applications, 39(1) (2012) 61–67.
  • [3] Fattahi R., Khalilzadeh M., Risk evaluation using a novel hybrid method based on FMEA, extended MULTIMOORA, and AHP methods under fuzzy environment. Safety Science, 102 (2018) 290–300.
  • [4] Kumru M., Kumru P.Y., Fuzzy FMEA application to improve purchasing process in a public hospital. Applied Soft Computing, 13 (2013) 721–733.
  • [5] Mandal S., Maiti J., Risk analysis using FMEA: Fuzzy similarity value and possibility theory based approach. Expert Systems with Applications, 41 (2014) 3527–3537.
  • [6] Chen Z., Wu X. and Qin J., Risk assessment of an oxygen-enhanced combustor using a structural model based on the FMEA and fuzzy fault tree. Journal of Loss Prevention in the Process Industries, 32 (2014) 349-357.
  • [7] Chanamool N., Naenna T., Fuzzy FMEA application to improve decision-making process in an emergency department. Applied Soft Computing, 43 (2016) 441–453.
  • [8] Dağsuyu C., Göçmen E., Narlı M. and Kokangül A., Classical and fuzzy FMEA risk analysis in a sterilization unit. Computers & Industrial Engineering, 101 (2016) 286–294.
  • [9] Tooranloo H.S., Ayatollah A.S., A model for failure mode and effects analysis based on intuitionistic fuzzy approach. Applied Soft Computing, 49 (2016) 238–247.
  • [10] Adar E., İnce M., Karatop B. and Bilgili M.S., The risk analysis by failure mode and effect analysis (FMEA) and fuzzy-FMEA of supercritical water gasification system used in the sewage sludge treatment. Journal of Environmental Chemical Engineering, 5 (2017) 1261–1268.
  • [11] Lv Y., Liang Y., Application of FMEA based on fuzzy multi-criteria decision-making for HVAC in a pharmaceutical plant. Journal of Chemical and Pharmaceutical Research, 6(6) (2014) 1116-1123.
  • [12] Bhattacharya J., Quality risk management – Understanding and control the risk in pharmaceutical manufacturing industry. International Journal of Pharmaceutical Science Invention, 4(1) (2015) 29-41.
  • [13] Hajimolaali M., Asl A.A., Quality risk assessment production of beta lactams by FMEA model and fuzzy theory method. General Medicine: Open Access, 4(1) (2016).
  • [14] Su C.T., Chou C.J., Hung S.H. and Wang P.C., Adopting the healthcare failure mode and effect analysis to improve the blood transfusion processes. International Journal of Industrial Engineering, 19(8) (2012) 320-329.
  • [15] Liu H.C., Liu L., Liu N. and Mao L.X., Risk evaluation in failure mode and effects analysis with extended VIKOR method under fuzzy environment. Expert Systems with Applications, 39 (2012) 12926–12934.
  • [16] Liu H.C., You X.J., You X.Y. and Shan M.M., A novel approach for failure mode and effects analysis using combination weighting and fuzzy VIKOR method. Applied Soft Computing, 28 (2015) 579–588.
  • [17] Mohsen O., Fereshteh N., An extended VIKOR method based on entropy measure for the failure modes risk assessment – A case study of the geothermal power plant (GPP). Safety Science, 92 (2017) 160–172.
  • [18] Mikhailov L., Tsvetinov P., Evaluation of services using a Fuzzy Analytic Hierarchy Process. Applied Soft Computing, 5(1) (2004) 23-33.
  • [19] Özfırat P.M., A new risk analysis methodology integrating fuzzy prioritization method and failure modes and effects analysis. Journal of the Faculty of Engineering and Architecture of Gazi University, 29(4) (2014) 755-768.
  • [20] Rahimi S.A., Jamshidi A., Ait-Kadi D., Ruiz A. and Rebaiaia M.L., Prioritization of failures in radiation therapy delivery. IFAC-PapersOnLin, 49(12) (2016) 1898-1903.
  • [21] http://www.ispe.org/gmp-resources, Arrival date: 20.11.2017.
  • [22] Wessiani N.A., Sarwoko S.O., Risk analysis of poultry feed production using fuzzy FMEA. Procedia Manufacturing, 4 (2015) 270-281.
  • [23] Spreafico C., Russo D. and Rizzi C., A state-of-the-art review of FMEA/FMECA including patents. Computer Science Review, 25 (2017) 19–28.
  • [24] Villarini M., Cesarotti V., Alfonsi L. and Introna V., Optimization of photovoltaic maintenance plan by means of a FMEA approach based on real data. Energy Conversion and Management, 152 (2017) 1–12.
  • [25] Tague, N.R., The Quality Toolbox, 2th ed. United States of America: ASQ Quality Press Milwakee, Wisconsin, 2005; 35-54.
  • [26] Yazdi M., Daneshvar S. and Setareh H., An extension to Fuzzy Developed Failure Mode and Effects Analysis (FDFMEA) application for aircraft landing system. Safety Science, 98 (2017) 113–123.
  • [27] Ilbahar E., Karaşan A., Cebi S. and Kahraman S., A novel approach to risk assessment for occupational health and safety using Pythagorean fuzzy AHP & fuzzy inference system. Safety Science, 103 (2018) 124–136.
  • [28] Chang K.H., Evaluate the orderings of risk for failure problems using a more general RPN methodology. Microelectronics Reliability, 49 (2009) 1586–1596.
  • [29] Hassan A., Siadat A., Dantan J.Y. and Martin P., Conceptual process planning – an improvement approach using QFD, FMEA, and ABC methods. Robotics and Computer-Integrated Manufacturing, 26 (2010) 392–401.
  • [30] Feili H.R., Akar N., Lotfizadeh H., Bairampour N. and Nasiri S., Risk analysis of geothermal power plants using Failure Modes and Effects Analysis (FMEA) technique. Energy Conversion and Management, 72 (2013) 69–76.
  • [31] Wang Y.M., Chin K.S., Poon G.K.K. and Yang J.B., Risk evaluation in failure mode and effects analysis using fuzzy weighted geometric mean. Expert Systems with Applications, 36 (2009) 1195–1207.
  • [32] Xiao N., Huang H.Z., Li Y., He L. and Jin T., Multiple failure modes analysis and weighted risk priority number evaluation in FMEA. Engineering Failure Analysis, 18 (2011) 1162–1170.
  • [33] Chang D.Y., Applications of the extent analysis method on fuzzy AHP. European Journal of Operational Research, 95 (1996) 649–655.
  • [34] Wang Y.M., Chin K.S., Fuzzy analytic hierarchy process: A logarithmic fuzzy preference programming methodology. International Journal of Approximate Reasoning, 52(4) (2011) 541-553.
  • [35] Constantinescu A., Sum-fuzzy implementation of a choice function using artificial learning procedure with fixed fraction. Applications of Mathematics, 52(4) (2007) 321-326.
  • [36] Yu C.S., A GP-AHP method for solving group decision-making fuzzy AHP problems. Computers & Operations Research, 29(14) (2002) 1969-2001.
  • [37] Bisso C.S., Samanez C.P., Efficient determination of heliports in the city of Rio De Janerio for the Olympic games and world cup: A fuzzy logic approach. International Journal of Industrial Engineering, 21(1) (2014) 33-44.
  • [38] Yayla A.Y., Yıldız A., Fuzzy Analytic Network Process based multi criteria decision making methodology for a family automobile purchasing decision. South African Journal of Industrial Engineering, 24(2) (2013) 1-14.
Toplam 38 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Bölüm Natural Sciences
Yazarlar

G.nilay Yücenur 0000-0002-2670-6277

Seren Çataltepe 0000-0003-1988-7759

İrem Sakin 0000-0001-6384-0929

Yayımlanma Tarihi 22 Mart 2020
Gönderilme Tarihi 19 Mayıs 2019
Kabul Tarihi 18 Ekim 2019
Yayımlandığı Sayı Yıl 2020Cilt: 41 Sayı: 1

Kaynak Göster

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

Cited By

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https://doi.org/10.2478/amns.2023.2.00195
Implementation of Quality by Design in the Formulation and Development of Nanocarrier-Based Drug Delivery Systems
Critical Reviews™ in Therapeutic Drug Carrier Systems
https://doi.org/10.1615/CritRevTherDrugCarrierSyst.2022042927