Considering Royal Hayat is based on Jabriya, explain in at least 500 words where you would put the facility to produce respirators. You have to discuss at least 5 factors and explain your reasoning by providing sufficient proof. You have to explain how you will bring the respirator, how will you make subcontracts, contracts with logistics, which road to use, lead times, raw materials to bring to your facility and so on. Your grade will be determined based on your ability to provide details and support of ideas. (50 Points)Important Note: Notice that based on your assumptions, design and thinking, each and every group gets different answers to these questions. Therefore, what you say, what you do, what you defend in your report is more important than simply obtaining an answer. Keep that in mind and always use systemic approach to this project, define your assumptions clearly and support them with your mind.The first factor is the integration management structure that includes all the activities involved in setting up the respirator assembly. It extends to the general infrastructure needed to meet the safety and quality requirements. In uwait it includes the medical device regulations defined by the Ministry of Health. Drug and Food control but in international terms it includes the necessary requirements from the World Health Organization. Additionally it includes the need to meet the quality control standards and the need to attain safety of consumer plus the use of such respirators in modern healthcare systems. Such medical requirement include the “Law of Soud Food and Drug Authority,” Article Five abbreviated as 25/1/1428H as issued from the Royal Decree. The regulations make it clear that Saudi Food and Drug Authority should monitor the health care equipment plus their conformity with their safe operation with other medical devices.The second factor is the scope associated with this respirator that includes the responsibilities of each stakeholder, healthcare providers handling the final respirators, the internal biomedical engineering department plus the requirements of all third part service contractors. Also it includes the manufactuer instructions for the PPM and CM, accuracy of the inventory information and maintenance management system, pre-installation and pre-procurement of medical devices, listing of manufactured respirators with market authorization or listing numbers, review of published data with respect to technical difficulties.The third factor is the resources associated in the assembly of this respirators; scheduling, human-related and organization. The scheduling includes the time frames needed to complete manufacturing the respirators in meeting the local and international demands. The human-resources includes the labor and compensation schemes of workers both technical and non-technical all working to deliver quality respirators for the public. The organizational includes the financial resources needed to set-up the infrastructure, train the team members, manage the sales, logistics and marketing ventures. In this part the most important factor is the source of these funds and direct/indirect costs involved in manufacturing the respirators.The fourth factor is the risk management involved in overcoming the manufacturing defect rates. It includes the technological/innovational risk associated with future improvement in the structure, aesthetics or working of the current respirators and how it should meet international expectations. Ethical and legal risks composed of the regulations, policies, and standards from a local, regional, and international perspective. The social/cultural risks attributed to various norms and practices by the citizens that affect directly or indirectly the finished product of these respirators. Finally, the economic risk that includes the competition from other manufacturing firms producing respirators.
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