Browsing by Subject "MES"

Manufacturing execution systems (MES) are computer systems which are used for controlling and automating manufacturing processes. They are increasingly adapted in pharmaceutical industry. Implementation solutions differ, however, and there is no single solution which would be the optimal one for all facilities. Each manufacturing facility has their unique properties and needs which have to be reflected in the implementation. A successful MES project will bring plenty of benefits such as more efficient use of resources and automated data transfer, but the roll out phase might turn to be problematic if the processes of the organization have not been analysed thoroughly enough at decision making. This creates the need for systematic analysis of possible to-be implementation scenarios which is based on the value-drivers of the organization and considers the decision from multiple viewpoints. This study presents a holistic value driver-based framework with a mathematical weighing method to allow for a systematic and scientifically justified decision for identification of the optimal implementation depth of equipment management (EQM) in MES. A Delphi study method was utilized in this study to create the framework. The framework was developed based on literature and brainstorming sessions with experts and validated by means of a Delphi questionnaire round with expert panel consisting of professionals representing the major stakeholders of MES system in a pharmaceutical manufacturing facility. Classical additive weighing method was applied to create a mathematical basis for valuation and comparison of the scenarios. The robustness of mathematical method was tested by means of a sensitivity analysis. A benchmarking survey was done to obtain information on current implementation solutions and decisions leading to current situation. The presented method not only addresses the costs but also takes into account intangible factors. Intangible factors include aspects such as good manufacturing practice (GMP) quality and user acceptance which are not directly transferable into quantitative units but are crucial both for pharmaceutical industry and the success of the implementation project. The framework describes the decision in the form of a value tree with three main branches, namely GMP, cost and process&organization which cover the main viewpoints important for the decision. The presented method also allows the weighing of different factors according to current needs of the facility and decision in question. Hence, the presented framework leads the decision maker through a systematic and comprehensive analysis of different to-be scenarios for EQM implementation. The benchmarking survey identified three major factors of a successful MES implementation, namely effort in design phase, well-defined processes and close discussion with production. The value drivers valued highest by the expert panelists were related to GMP quality. As a use case, the presented framework was applied in a parenterals clinical manufacturing facility to evaluate six different to-be scenarios and based on the results one of them was selected by the management to be implemented. The results from the use case indicate that the framework is a valuable tool in a decision making process, and encourage the further utilization of the framework in future implementation decisions.