Abstract
Risk analysis is a systematic and widespread methodology to analyze and evaluate risks which are exposed in many working areas. One of the Quantitative Risk Analysis (QRA) methods for risk assessment is Bow-Tie analysis which combines features of fault-tree analysis and event-tree analysis to identify the top event; its causes and consequences (outcomes); and possible preventive and protective control measures or barriers. This study proposes an occupational risk assessment approach, which is known as Fuzzy Bow-Tie analysis, for pharmaceutical industry processes and work units. The aim is to evaluate critical risks and risky pharmaceutical work units and take safety precautions against accidents which caused by risky conditions. Thus, this methodology combines the concept of uncertainty which comes from different (Decision Maker) DM’s evaluations and the whole performance of the Bow-Tie analysis for hazard identification and risk assessment. To apply and validate the proposed method, a case study is performed for pharmaceutical industry processes and work units. Based on the computed risk score, which is calculated by multiplying probability ranking and impact ranking of criterion, the risks are prioritized and some measures are suggested for management to prevent accidents occur in the industry.
Highlights
Pharmaceutical industry is usually considered to have high quality levels since healthcare products require manufacturing processes in safe conditions, protection under a substantial control hygiene against chemical and biological contaminants, and keeping equipments at optimum working conditions [1]
Since the main aim is to produce medical substances with pharmacological processes, many factors in pharmaceutical Research and Development (R&D) and manufacturing are hazardous for employees
The main objective of this paper is to propose a Risk Assessment framework and develop extensive risk analysis methodology to assess and prioritize risk factors for occupational safety in pharmaceutical industry
Summary
Pharmaceutical industry is usually considered to have high quality levels since healthcare products require manufacturing processes in safe conditions, protection under a substantial control hygiene against chemical and biological contaminants, and keeping equipments at optimum working conditions [1]. Moving machine parts (exposed equipment e.g., belts and shafts), manual handling of materials and equipments, unsafe energy systems (electrical, thermal, pneumatic, etc.); high-pressure vapor, hot water and heated areas; combustible and corrosive liquids; and high sound degree are other health and safety risks for workers during manufacturing process in pharmaceutical industry. These occupational risks cause illnesses, including occupational asthma, adverse reproductive concerns, pharmacologic impacts and dermatitis among pharmaceutical workers [2]
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