A Failure Modes and Effects Analysis – Based Approach for Risk Assessment Inside an Asset Standardization Project and Implementation of a Spare Parts Optimization Tool in the Pfizer site of Ascoli Piceno

Maintenance processes have a large share on total cost over the life cycle of industrial equipments. Studies underline that energy and maintenance are typically major cost drivers over an industrial product life cycle. Therefore, it is a major task for production companies to minimize maintenance costs and optimize related processes like spare part supply. A risk-based maintenance (RBM) strategy is a useful tool to design a cost-effective maintenance schedule; its objective is to reduce the overall risk in the operating facility. In risk assessment of a failure scenario, consequences often have three key features: personnel safety effect, environmental threat, and economic loss. High safety and reliability levels rely heavily on proper maintenance activities that will reduce the incidence of unexpected breakdowns and unscheduled downtimes. During production downtime, much time is lost to fault finding, repairs, and replacement of faulty components within production lines. This transforms into low throughput in production, and performance gradually declines during the operational life cycle of the equipment. This paper presents an approach widely applied to prevent such instances in a pharmaceutical manufacturing context, which considers an optimized condition-based maintenance approach to predict the condition of each component and assembly line using Failure-Mode-and-Effect-Analysis (FMEA). The condition-based performance level prediction is designed to help in formulating maintenance schedules and strategies that eliminate unplanned downtimes. FMEA is an effective and accepted tool in the application to prevent or reduce the breakdown problems of many machines. It considers potential failure modes, causes of failure modes and effects, and represents the risk in the RPN (Risk Priority Number) determined by the product of Severity (S), Occurrence (O) and Detection (D). Once the risk assessment is done, the next step is to find corrective or preventive actions to cope with causes of failure or failure modes. The present work shows the application of FMEA in the Pfizer industrial site of Ascoli Piceno according to an Asset Standardization project. In particular, the analysis here presented was carried out on a Coating machine. The final part of the work is centered on Spare Parts Management that represents one of the most important maintenance problems that results critical because of the locking up of capital, the holding costs, and the disposal expenses. The theme let us wonder about the correct level of stock, balancing the carried holding costs and the shortage costs. Although spare parts can be considered similar to productive materials from the physical and the trade perspectives, they need of a specific logistic management to reduce their impact on direct maintenance costs. For this reason, a structured framework in managing spare parts is proposed with the aim to define rational stock volumes, re-ordering points and protection levels for each component stocked.