Unit 1 Assignment: Risk of Production of Circuit Boards (Research Paper Sample)

Topic: Risk of production of circuit boards
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Risks involved in the production of circuit boards used in medical devices.
According to Ariel Braidot, (2015), in almost all these devices, to give us intelligent and interactive services, a circuit board is usually installed. In the last few years, we have seen a revolution in medicine sector, which is using the latest technology in handling various medical conditions. These includes sophisticated machines such as heart implants, dialysis machines among others. Being electronic therefore means that they need circuit boards to operate. In this project, the company is embarking on manufacturing a new board to be used in various medical devices, which is a big leap for the company which means that the risks involved need to be thoroughly checked.
Health risks.
Risk of failure while implanted in the body: during production the boards will have to go through various separate manufacturing processes such as chemical and galvanic processes. Ariel Braidot, (2015) states that the boards will undergo thermal stress during their manufacturing, and this may later cause failure later on which is extremely dangerous for the patients. If this happens, the company will be obliged to recall the product or may be forced to stop manufacturing the product by regulatory boards.
Hazardous substances in the boards: the boards used in these medical devices may contain various hazardous substances which may be harmful to the body in cases where they are implanted and to the environment if they are not disposed of properly. There are also cases where several patients may be allergic to various metals that may be used in these circuit boards which may cause severe reactions and health complications. Keith Wilson, (2013) states that there are also cases whereby some substances are naturally occurring and harmless, but when they undergo the manufacturing process, they become hazardous such as chromium which becomes chromium VI.
Market risks
Market time: body implants are high-risk gadgets which means that they have to undergo serious quality checks before they reach the market. The time taken for them to reach the market is long which may take between 18-30 months. Ariel Braidot, (2015) says that this causes huge problems because the delay may result in financial losses and risk of losing customers due to the delay in delivery.
Market size limitation: the market for medical devices is limited to hospitals and pharmaceutical industries. The limited market is also very particular about the specifications of the product and the competition for this market is steadily rising due to the rise in the number of companies offering the same product, Keith Wilson, (2013) connotes.
Market competition: in the recent past we have seen a huge growth in the middle-class sector. This rapidly growing group demands more of these medical devices that require our boards but this market has an acute price sensitivity. Ariel Braidot, (2015) noted that this attracts various companies, to serve this growing demand and ambitious companies from China and India are now taking their low-cost designs to these target market.
Human resources risk
Staff size: this project is the biggest the company has had and since the boards are being developed in house, there is a huge problem in the staff size. Since the company does not intend on increasing the size of the workforce, this will bring big problems when it comes to the product quality and the projected time limit, Keith Wilson, (2013) expresses.
Lack of committee of experts in this field: the company is required to have a commission of experts who have the various skills required in the design and production of these boards and have experience and knowledge in quality assurance and risk management methods. Keith Wilson, (2013) says that without this committee, the company cannot assess the market, train its workers on this new venture, and ensure that it is producing quality products.
Lack of risk management training: since the personnel involved in the project are used to the production of ordinary computer boards, they lack the training in risk management when it comes to these boards used in medical devices. They also have inadequate information to ensure a smooth production process, Keith Wilson, (2013) expounds.
Lack of in-house expertise: the company lacks the in-house expertise to develop both the hardware and the software required in this project. To develop these new boards, Keith Wilson, (2013) states that the company will have to adapt and acquire new hardware, software and experienced workers.
Lack of a quality assurance system: before the boards are distributed, they have to undergo various processes. Installation qualification makes sure that the customer receives the product the same way it was designed and that it is correctly installed. According to Keith Wilson, (2013), operational qualification ensures that the board is operating as it was specified by the manufacturer and performance qualification ensures that the product consistently performs as it was specified over a certain period of time. Being a new product, the company does not have a quality assurance system for this type of board.
Increased work load: Keith Wilson, (2013) illustrates that since the company does not intend on increasing the workforce, the workers will have to balance their schedules with the new project. This creates a problem because the workers will undergo work strain which eventually leads to poor work quality.
Financial risks
Budget: this being a bigger project than the company is used to, the estimated budget is bigger as well. This means that the company will have to look for extra finances for the project since it will have to train its workers, acquire new hardware and software and outsource services...