Quality_Management_in_Healthcare

Quality Management in Healthcare Antonio Theodore HCS/451 11/24/12 Jodie Sapaugh Quality and risk management are important factors in any organization. The company that this essay is concerned with, (National Power Corporation), builds custom battery packs for various devices including internal and external medical devices. Given that the battery pack could end up in a person’s body, quality and risk management for each pack has numerous inspection points. “Quality management refers to strategies that reduce the possibility of a specific loss. The systematic gathering and utilization of data are essential to this concept and practice” ("Quality Management and Medical Liability", 2011). Quality management procedures may contain both affecting and affected components. Affecting components include activities to prevent adverse occurrences i.e., losses, and affected components include actions in response to adverse occurrences. In both cases, the risk management process includes a diagnosis (identification of risk or potential risk), assessment (calculation of the risk situation), prognosis, (estimation of the impact), and management (control of the risk). This brief essay will touch on quality management situation with a medical device manufacturer company, explaining their steps in identifying risks, typical risks, and training in reducing risks and increasing quality. One of the processes the company uses is called a FMEA (Failure Mode and Effects Analysis) table, which is a detailed examination of each internal component, FMEA is generally presented in a table that shows each component’s failure mode, its cause, and the corresponding effects. A component failure can cause a linked component or subsystem to fail. From the FMEA (or included as part of it), methods to control or indicate failures can be developed. Design changes may be made to eliminate a failure or alarms might be included in the design. In short, it is a spread sheet of every point in the battery packs creation that list possible quality or risk issues that we can attack before they arise. This process has helped us tremendously but there are always unseen troubles that are discovered later in the process that could potentially cause great risk to the user of the battery pack. Leadership in any movement, project, or system is very important. What is more important is the type of leadership involved with the event. Micromanagement and too little management can cause a project to fail. Leadership is an important function of management which helps to maximize efficiency and to achieve organizational goals. Most people respond positively to being kept informed, while old fashioned management wisdom might say “managers manage and others do”. If this happens, it can result in communication vacuums, which is the opposite of best project management practice. Communication is the epitome of projects. Open communication must be encouraged and managed. To avoid information overload, there are practices that can be employed, aligned to effective team based organization, that encourage effective communication Long and short term goals for health care quality should be should included in a mission statement so it will be forever remembered. National Power’s mission statement is summarizes in the acronym “QUEST”, which stands for Quality, Understanding, Excellence, Safety, and Timeliness. This is an accurate description of a mission statement that has a short and long term in mind. accurate depiction of a healthcare organization should be when striving for quality excellence. It focuses on Continuous quality improvement strategies which consists of strategic focus, customer focus, a systems overview including data gathering and information systems, finances, and staff efficiency/professional competency. I like that it stresses continuum care and patients actively participating. However, that is the same thing that I feel will never be 100 percent achievable. Patient participation and education depends on the individual and will not be totally influenced by the efforts of a healthcare organization. I also like the fact that staff satisfaction and self pride is a goal in this definition of quality care. Attitude and teamwork is crucial in a medical environment. Given the ratio between patient and health care professional in densely populated areas, health care workers are overworked and stressed due to the need of care. It is important to keep morale high ad to promote an environment that is stress and fear free and also rewarding for a job well done. I am surprised that this definition did not include reference to a well functioning information system. The way a health organization stores, retrieves, and sends its information defines whether the organization is efficient and versatile when communicating with other aspects of health facilities. Five factors that may affect the outcome of quality in this organization is the quality of materials, the quality of the production process, tracking inventory, adhering to rules and regulations, and management decisions. Material is an important part of the process because the dimensions of most devices of critical to the function. If the material that is received is warped and nonconforming it cannot be used, if used, this could result in a defective pack that is released into society. The production process is critical because it is the way the pack is assembled. This will also dictate if the pack is conforming to standards of organization like UL and IEC. Tracking inventory is a vital part in ensuring that items are accounted for and that funds are being appropriately spent. Management decisions will be an important factor in any organization. If management decisions are poor, the organization doesn’t have a very good chance of surviving. Within medical device manufacturing lays medical standards. If an organization decides to make a device that will aid in the function of human life, they must be sure that the device will withstand the test of time and prolong the person’s life. The ultimate price is a person’s life and all risks must be taken into account before product is shipped out of the organization. Identification is the first attack at risks. Identifying simple and complex risk factors will lead to a starting point at identifying and eliminating all risks. The manufacturing company decides to hire a specialist that will help identify all risk in the operation and determine the cause of potential future risks. With the implementation of a process called “5why” the company will be able to locate the starting point of most risks. It is said that only by asking "Why'" five times, successively, you can delve into a problem deeply enough to understand the ultimate root cause. By the time you get to the 4th or 5th why, you will likely be looking squarely at management practices. By repeatedly asking the question “Why” you can peel away the layers of symptoms which can lead to the root cause of a problem. Very often the ostensible reason for a problem will lead you to another question. Although this technique is called “5 Whys,” you may find that you will need to ask the question fewer or more times than five before you find the issue related to a problem. Risk management is a major aspect in this company’s survival. Being an organization that makes battery packs for household items and medical devices, there are certain standards that we have to adhere to. ISO (International Standards Organization) 9001 and 13485 sets standards and necessary procedures to follow in maintaining a quality management system. Complying with these standards means a company has defined roles, responsibilities, documentation, and action plans for managing performance and continuously improving operations in each of these areas. In a way, implementing one of these standards can be thought of as a well proved risk mitigation action, but risk mitigation is only one piece of the overall Operational Risk Management framework. A complete risk management framework has multiple risk capabilities. There must be the creation of procedures, instructions, and forms which will establish that they are adhering to a quality management system that ranges from organizational structure, customer focus, document control and data entry, internal audits, control of nonconforming product, corrective and preventive action, training, shipping, and employee evaluation. Key steps in managing these risks are identification and prevention. The first thing to understand in risk management is that it's an ongoing activity. It's not about identifying risks upfront and then forging ahead regardless. It's too easy to forget the risks once the project is started and fail to recognize and raise new risks when the project is underway. The key steps to risk management are risk Assessment, risk reduction, risk monitoring, risk reporting, and risk evaluation. A key part to project management is a common language. The diagram below shows the key steps of risk management in the overall context of analysis and control. Through risk control we manage action, through risk analysis we manage awareness. In today's complex world of manufacturing it is the prudent owner or operator of a manufacturing company that integrates risk management into his production process. By integrating risk management in the design and development process the successful business owner takes a proactive step in minimizing all loss. Yet a note of caution should be extended here for the risk management process to be successful it should be introduced early in the design process and diligently managed throughout a product's life cycle. This risk management process can become extremely crucial in some industries. For example, successful risk management is critical to the design and development of safe and effective medical devices. To many manufacturers view risk management as an isolated activity that must be performed merely to fulfill a regulatory requirement. This is often due to a misunderstanding or confusion as to what risk management really does. In conclusion, educating manufacturers about the methods of risk management, this provides manufacturers with tools that will improve their design and development efforts. The end results include device designs that are safe and effective, a shorter and more-efficient design and development timeline, and fewer post launch problems. Risk management when it is done correctly can involve the development and transfer of safe, reliable and effective devices in the manufacturing process. This in turn reduces costs and monitors risk through a device's life cycle. It is extremely important that some fundamental principles be applied to the risk management process for the most successful and thereby most profitable design to be achieved. These need to be closely integrated with the total design and development effort. REFERNCES Risk Management and Medical Liability. (2011). Retrieved from http://www.ihs.gov/riskmanagement/index.cfm'module=part01 Practice Advisory 2100-3: Internal Audit’s Role in the Risk Management Process. March 2001. The Institute of Internal Auditors. July 2010. http://www.theiia.org/ecm/guide-frame.cfm'doc_id=73 Santomero, Anthony M., Commercial Bank Risk Management: an Analysis of the Process. Pennsylvania: The Wharton School, 2012. International Settlements and Basel Committee on Risk Management. July 2011. http://www.bis.org/publ/bcbs86.htm