Identification, Evaluation and Ranking of Manufacturing Risks in the Pharmaceutical Industry using the FMEA Method (Case study: Sobhan Darou Company)
Subject Areas : medical documents
Mojtaba Moradi
1
(
Assistant Professor, Department of Industrial Engineering, East Gilan Faculty of Engineering and Engineering, Guilan University, Rudsar, Iran
)
MohammadAli Mirzazadeh
2
(
Assistant Professor, Department of Engineering, Faculty of Engineering and Engineering of Guilan, Guilan University, Rudsar, Iran
)
Keywords: Pharmacy, Production Risk, Failure mode and effects analysis (FMEA),
Abstract :
Introduction: The important role of risk and its challenges in organizations is one of the reasons for the importance of examining the risks of production. Considering the classification of the pharmaceutical industry as one of the most important industries, the investment risks in this industry have been analyzed using the Failure mode and effects analysis (FMEA) method. This method is one of the risk management techniques to identify, analyze, and ranking risk factors in order to increase the efficiency of the industry. Methods: This descriptive study suggests FMEA as a quantitative method for identifying production risks and, by computing risk priority numbers (RPNs), represents the probability of their risks and effects in the pharmaceutical industry. Results: In this research, after identifying the risks of drug production through literature review and interviewing experts, a questionnaire was designed that out of 66 identified risks, 19 risks were identified and ranked by experts as important risks. Conclusion: Good manufacturing practices (GMP), exchange rate fluctuation, no marketing strategy and lack of proper estimation of market trends, inventories of raw materials and inventory of supplies was identified as the most important risks of drug production.
1- Kerzner H. Project Management: A Systems Approach to Planning, Scheduling and Controlling. 12th ed. Hoboken: John Wiley & Sons; 2017.
2- Bijl MGH, Hamann RJ. Risk Management Literature Survey, Technical Report. Delft University of Technology; 2002.
3- Avazkhah H, Mohebi A. Project risk management. Tehran: Kian Rayaneh; 2009. [Book in Persian]
4- Cooper DF, Grey S, Raymond G, Walker P. Project Risk Management Guidelines: Management Risk in Large Projects and Complex Procurements. Chi Chester, John Wiley and Sons; 2005.
5- Lee E, Park Y, Shin JG. Large Engineering Project Risk Management using a Bayesian Belief Network. Expert Systems with Applications 2009; 36(1), 5880-5887.
6- Nazari A, Jaberi M, Amalnik MS. Developing a Risk Management Model for Project Based Organizations. Journal of Industrial Engineering 2013, 47(1), 93-104.
7- Burkeh R. Project management Planning & control techniques. John wiley & Sons; 1999.
8- Olfat L, Khosravani F, Jalali R. Identification and Ranking of Project Risk Based on PMBOK Standard by Fuzzy Approach. Industrial Management Studies 2010; 8 (19): 147-163. [Persian]
9- Hu Y, Feng B, Mo X, Zhang X, Ngai EW, Fan M, and Liu M. Cost sensitive and ensemble-based prediction model for outsourced software project risk prediction. Decis. Support. Syst. 2015; 72(2): 11-23.
10- Shameli-Sendi A, Aghababaei-Barzegar R, Cheriet M. Taxonomy of information security risk assessment (ISRA). Computers & Security 2016, 57(1): 14–30.
11- Ghaljahi M, Namrudi S. Identification and assessment of hazard risks in a flour mill by the JSA and FMEA methodology. J Health Res Commun. 2017; 3 (3): 82-89
12- AliAhmadi A, Ghazinoori S. Prioritizing policy instruments for supporting new technology-based firms in Iran, using a fuzzy MCDM model. Journal of Science and Technology Policy. 2008; 1 (3): 73-89. [Persian]
13- Heidari MH, Salmani H, Nazari Y. Usage of Failure Mode & EffectAnalysis Method (FMEA) forsafety assessment in a drug manufacture. Iran Occupational Health Journal. 2006; 3(1):70-5. [Persian]
14- Elhami Gh.H, Maleki MR. Designing a model of drug quality assurance for Iran. Horizon Med Sci, 2008; 14 (3): 49-63. [Persian]
15- Heidari M, Salmani H, Nazari Y. Usage of Failure Mode & EffectAnalysis Method (FMEA) for safety assessment in a drug manufacture. Iran Occupational Health Journal, 2006; 3(1): 70-75. [Persian]
16- Spath PL. Using failure mode and effects analysis to improve patient safety. AORN journal, 2003; 78(1): 15-37.
17- Mirmohammadi T, NaseriPouya Z, Hosseinalipour Z. Risk Factors Assessment in Educational Equipment Manufacturers Company Using FMEA. J Health Res Commun, 2016; 2(2): 9-18. [Persian]
18- Jafari H, Moradi R, Bahman ziari N, Yazdi H, Jannesari A , Rahmani K. Usage of FMEA to Review the Risk Associated With Ventilators in Al-Zahra Hospital of Isfahan, Journal of Healthcare Management, 2015; 6(3): 21-28. [Persian]
19- Mansouri T, Alimohammadi M, Nabizadeh Nodehi R, Yaghmaeian K, Azari A. Risk Assessment of Sari Fatemeh Zahra Hospital Using Failure Mode Effect Analysis, Individualized Rapid Assessment Tool, and Preliminary Hazard Analysis. J Mazandaran Univ Med Sci, 2018; 28(161): 89-107. [Persian]
20- Attar Jannesar Nobari F, Tofighi Sh, Hafezimoghadam P, Maleki MR, Goharinezhad S. Risk Assessment of Processes of Rasoule Akram Emergency Department by the Failure Mode and Effects Analysis (FMEA) Methodology. Hakim Health Sys Res, 2010; 13(3): 165-176. [Persian]
21- Godini H, Karimpour Roshan S, Imanian Z, Naji T, Mirza Hedayat B. Risk detection and assessment of hospital waste management and approaches for risks reduction in children's medical center hospital using failure mode and effects analysis. Ijhe, 2017; 10(3): 363-374. [Persian]
22- Nnemati M, Mohammadzadeh Zarankesh S, Ebrahimi Abyaneh E. Factors affecting errors in the operating rooms: study of employees' viewpoint. MEDICAL SCIENCES, 2018; 28(2): 153-161. [Persian]
23- Vazdani S, Sabzghabaei G, Dashti S, Cheraghi M, Alizadeh R, Hemmati A. Application of FMEA Model for Environmental, Safety and Health Risks Assessment of Gas Condensates Storage Tanks of Parsian Gas Refining Company in 2016. JRUMS, 2018; 17(4): 345-358. [Persian]
_||_1- Kerzner H. Project Management: A Systems Approach to Planning, Scheduling and Controlling. 12th ed. Hoboken: John Wiley & Sons; 2017.
2- Bijl MGH, Hamann RJ. Risk Management Literature Survey, Technical Report. Delft University of Technology; 2002.
3- Avazkhah H, Mohebi A. Project risk management. Tehran: Kian Rayaneh; 2009. [Book in Persian]
4- Cooper DF, Grey S, Raymond G, Walker P. Project Risk Management Guidelines: Management Risk in Large Projects and Complex Procurements. Chi Chester, John Wiley and Sons; 2005.
5- Lee E, Park Y, Shin JG. Large Engineering Project Risk Management using a Bayesian Belief Network. Expert Systems with Applications 2009; 36(1), 5880-5887.
6- Nazari A, Jaberi M, Amalnik MS. Developing a Risk Management Model for Project Based Organizations. Journal of Industrial Engineering 2013, 47(1), 93-104.
7- Burkeh R. Project management Planning & control techniques. John wiley & Sons; 1999.
8- Olfat L, Khosravani F, Jalali R. Identification and Ranking of Project Risk Based on PMBOK Standard by Fuzzy Approach. Industrial Management Studies 2010; 8 (19): 147-163. [Persian]
9- Hu Y, Feng B, Mo X, Zhang X, Ngai EW, Fan M, and Liu M. Cost sensitive and ensemble-based prediction model for outsourced software project risk prediction. Decis. Support. Syst. 2015; 72(2): 11-23.
10- Shameli-Sendi A, Aghababaei-Barzegar R, Cheriet M. Taxonomy of information security risk assessment (ISRA). Computers & Security 2016, 57(1): 14–30.
11- Ghaljahi M, Namrudi S. Identification and assessment of hazard risks in a flour mill by the JSA and FMEA methodology. J Health Res Commun. 2017; 3 (3): 82-89
12- AliAhmadi A, Ghazinoori S. Prioritizing policy instruments for supporting new technology-based firms in Iran, using a fuzzy MCDM model. Journal of Science and Technology Policy. 2008; 1 (3): 73-89. [Persian]
13- Heidari MH, Salmani H, Nazari Y. Usage of Failure Mode & EffectAnalysis Method (FMEA) forsafety assessment in a drug manufacture. Iran Occupational Health Journal. 2006; 3(1):70-5. [Persian]
14- Elhami Gh.H, Maleki MR. Designing a model of drug quality assurance for Iran. Horizon Med Sci, 2008; 14 (3): 49-63. [Persian]
15- Heidari M, Salmani H, Nazari Y. Usage of Failure Mode & EffectAnalysis Method (FMEA) for safety assessment in a drug manufacture. Iran Occupational Health Journal, 2006; 3(1): 70-75. [Persian]
16- Spath PL. Using failure mode and effects analysis to improve patient safety. AORN journal, 2003; 78(1): 15-37.
17- Mirmohammadi T, NaseriPouya Z, Hosseinalipour Z. Risk Factors Assessment in Educational Equipment Manufacturers Company Using FMEA. J Health Res Commun, 2016; 2(2): 9-18. [Persian]
18- Jafari H, Moradi R, Bahman ziari N, Yazdi H, Jannesari A , Rahmani K. Usage of FMEA to Review the Risk Associated With Ventilators in Al-Zahra Hospital of Isfahan, Journal of Healthcare Management, 2015; 6(3): 21-28. [Persian]
19- Mansouri T, Alimohammadi M, Nabizadeh Nodehi R, Yaghmaeian K, Azari A. Risk Assessment of Sari Fatemeh Zahra Hospital Using Failure Mode Effect Analysis, Individualized Rapid Assessment Tool, and Preliminary Hazard Analysis. J Mazandaran Univ Med Sci, 2018; 28(161): 89-107. [Persian]
20- Attar Jannesar Nobari F, Tofighi Sh, Hafezimoghadam P, Maleki MR, Goharinezhad S. Risk Assessment of Processes of Rasoule Akram Emergency Department by the Failure Mode and Effects Analysis (FMEA) Methodology. Hakim Health Sys Res, 2010; 13(3): 165-176. [Persian]
21- Godini H, Karimpour Roshan S, Imanian Z, Naji T, Mirza Hedayat B. Risk detection and assessment of hospital waste management and approaches for risks reduction in children's medical center hospital using failure mode and effects analysis. Ijhe, 2017; 10(3): 363-374. [Persian]
22- Nnemati M, Mohammadzadeh Zarankesh S, Ebrahimi Abyaneh E. Factors affecting errors in the operating rooms: study of employees' viewpoint. MEDICAL SCIENCES, 2018; 28(2): 153-161. [Persian]
23- Vazdani S, Sabzghabaei G, Dashti S, Cheraghi M, Alizadeh R, Hemmati A. Application of FMEA Model for Environmental, Safety and Health Risks Assessment of Gas Condensates Storage Tanks of Parsian Gas Refining Company in 2016. JRUMS, 2018; 17(4): 345-358. [Persian]
