Salāmat-i kār-i Īrān (Apr 2006)
Usage of Failure Mode & EffectAnalysis Method (FMEA) forsafety assessment in a drug manufacture
Abstract
Background and Aims: This study was hold in purpose of recognizing and controlling workplacehazards in production units of a drag ManufactureMethod:So for recognition and assessment of hazards, FMEA Method was used. FMEASystematically investigates the effects of equipment and system failures leading often toequipment design improvements. At first the level of the study defined as system. Then accordingto observations, accident statistic, and interview with managers, supervisory, and workers highrisk system were determiner. So the boundaries of the system established and informationregarding the relevant Components, their function and interactions gathered. To preventConfusion between Similar pieces of equipment, a unique system identifier developed. After thatall failure modes and their causes for each equipment or system listed, the immediate effects ofeach failure mode and interactive effect on other equipment or system was described too. Riskpriority number was determined according to global and local criteriaResults: After all some actions and solution proposed to reduce the likelihood and severity offailures and raise their delectability.Conclusion :This study illustrated that although of the first step drug manufacture may seem safe,but there are still many hazardous condition that could cause serious accidents, The result proposedit is necessary: (1) to develop comprehensive manual for periodical and regular inspection ofinstruments of workplaces in purpose of recognize unknown failures and their causes, (2) developa comprehensive program for systems maintenance and repair, and (3) conduct worker training.
