Quality Management in Healthcare
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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,...
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,...