Failure Modes And Effect Analysis (FMEA)

INTRODUCTION
Every pharmaceutical manufacturing plant features an area in which raw materials are weighed and transferred to clean containers. Almost all of the pharmaceutical manufacturers utilize the dispensing center as a single unit to prepare all starting chemical substances for each production batch in clean room environment. The main tasks of this dispensing unit are to acquire starting materials from store or warehouse, to weigh and transfer to the production line.
The starting materials from the warehouse are divided into two separated bundles i.e. bulk and loose packs. The unopened bulk packs will then be weighted and sorted in the control area. The loose packs will be transferred to the classified area and then to the dispensing

As a result, counterfeit products may be inadvertently produced. It is very crucial that all of the possible risks must be identified, evaluated, and prioritized so that appropriate actions for alleviation adverse effects will be set. One of the systematic procedures for the analysis of a system is the Failure Modes and Effect Analysis (FMEA). The purpose of this system is to identify failure modes and effects on hardware, software, and/or process performance.
FMEA is therefore used to determine the severity of potential failure modes and subsequently to provide the mitigating measures to reduce risk. It’s a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of

The problem of uncontrolled pressure receives high magnitude in criticality matrix. This problem jeopardizes the cleanness of the classified area and it is very crucial. Thus, mitigation actions must be established. One of the main reasons that this failure mode deserved attention is that the door at air lock room is the only entrance of starting materials to dispensing area. These facilities tend to malfunction and can cause problems. Likewise the hinges of the door at air lock room tend to dislocate and are not able to position the door at the right angle. Thus, the door is uneven due to heavy use. The recommendation is to request dispensing personal constantly observe the pressure gauge. The preventive maintenance of air lock door must be included in CAPA (corrective and preventive actions) of the factory. Moreover, a warning system when pressure drops is highly