Journal of Quality Engineering and Management

Identification and Analysis of Product Quality Risks in pharmaceutical industry (Case study: Daana Pharmaceutical Co.)

Document Type : Original Article

Authors

Farnaz Orang Zaman 1
Morteza Mahmoudzadeh 2

1 Department of Industrial Engineering, Al-Ghadir Institute of Higher Education, Tabriz, Iran.

2 Department of Industrial Management, Tabriz Branch, Islamic Azad University, Tabriz, Iran.

https://doi.org/10.48313/jqem.2021.148872
Abstract
Abstract: The production of low quality drugs in addition to wasting resources, leads to risks to public health. Quality risk management can ensure the high quality of the drug for the patient by controlling quality risks during the product manufacturing process. The present study aimed to identify and analyze the particle contamination risk of the vial product at Daana Pharmaceutical Company by implementing quality risk management process based on the ICH Q9 guideline. For this purpose, in order to identify the risk, the failure modes and effects analysis (FMEA) method and to identify the root causes of failure, the "Why" root cause analysis (Why RCA) technique and to analyze the risk, a combination of the failure modes, effects and criticality analysis (FMECA) and Bayesian Belief Network (BBN) analysis methods were used. Comparison of the results of the FMECA and BBN-FMECA approaches showed that at Daana Company, risk analysis with both methods gives similar results. Also quality of raw material powder and primary packaging materials, personnel performance and air conditioning monitoring system are identified as the most important causes of product contamination risk

Keywords

Quality Risk Management(QRM)
Failure Modes and Effects and Criticality Analysis(FMECA)
Bayesian Belief Network(BBN)
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Journal of Quality Engineering and Management
Volume 11, Issue 3
Autumn 2021
Pages 261-284

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