Failure Analysis Process

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Failure Mode and Effects Analysis
The U.S. Healthcare systems, specifically hospitals, experience clinical risks resulting in multiple adverse events in patient care, safety, and financial burdens in the health systems. In 2000, the Institute of Medicine’s issued report stated that clinical risks typically stem from deficiencies and failures in the healthcare system (Kohn, Corrigan, & Donaldson 2002).
In response, multiple healthcare facilities have adopted the Six Sigma discipline in order to produce excellent patient safety and customer service. Six Sigma, a data driven methodology for eliminating defects or risks, adopts multiple risk assessment tools for use in the healthcare industry. Risk management or more specifically, clinical risk management performs a critical role in assisting hospitals in promoting patient safety by identifying, correcting, and/or managing identified risks. Within hospitals, healthcare providers are obliged to position an effective system to continually monitor and improve the safety of employees and patients. An effective risk management system must possess a tailored, proactive, integrated plan with inclusion of incident reporting and ownership by the frontline healthcare providers as well as other employees (Edozien 2013). Eliminating the culture of blame with the development of Just Culture, requires a balanced approach between healthcare providers and healthcare systems. The implementation of multiple risk management tools provides risk management programs with integrated structure, framework, and benefits the healthcare facility providing optimal outcomes (Edozien 2013). The Six Sigma discipline recognizes the failure mode and effects analysis (FMEA) as an exceptional tool in risk management as illustrated in the following definition, benefits, and staff response. FMEA Defined FMEA, the failure mode and effects analysis model, employed in manufacturing industries for over half of a century, establishes a pathway to identify and correct risks prior to occurrence (Fibuch & Ahmed 2014).
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Healthcare risk management tools are necessary since every healthcare product or process possess an associated risk, requiring effective quality management to promote excellence in patient care and safety. Primarily, mode is a term used to identify how a product or process might fail and effects equals the consequences of the failure. The FMEA process continues to improve the design of products, components, and processes by developing a system to evaluate, identify, and implement corrections in risk assessment such as preventive maintenance, improving tests and verification process, and safety hazards (Carlson 2012). FMEA used as a preventive tool assist healthcare facilities in developing new processes, changing current systems, and providing information as a preventive tool in high risk situations. Benefits Combining well-established patient safety tools such as situation briefing, FMEA, and root cause analysis provide structured communication, prospective and retrospective review of components that present as risks for safety issues. …show more content…
Situation briefing, currently in use in healthcare facilities, exists as an adaptation from the United States Navy, the situation, background-assessment-recommendation (SBAR). The SBAR is instrumental in diminishing sentinel events by promoting excellent communication especially in transference of care from one practioner to another (Fassett 2011). While root cause analysis is essential in uncovering the critical facts and reasons for an occurrence of an adverse reaction, FMEA assist healthcare facilities in identifying future causes for adverse reactions and preventing the future calamities. The implementation of FMEA assists hospitals and other facilities in identifiying causative factors of sentinel events prior to occurrence therefore preventing the adverse event. Combined FMEA and RCA are essential elements in patient safety programs in acute care healthcare facilities. As Joint Commission requires accredited healthcare facilities to institute RCA for the investigative tool of sentinel events, Joint Commission also requires accredited healthcare organizations to perform at least one proactive risk assessment on an identified high-risk process yearly. In addition, FMEA allows facilitlies to document and track risk reduction activities, create and maintain historical records, establisihing a baseline, and ultimately increase customer satisfaction and safety. FMEA is a widely accepted tool in healthcare, satisfying the Joint Commission requirement and assist organizations in provision of excellence in patient safety and treatment. Staff response As the new risk manager of our hospital, I would like to thank the dynamic employees that institute and perform high quality patient care. As this institution strives to adapt to the changes institututed by healthcare reform, I would like to advance your knowledge on the risk management opportunities. Primarily risk management is a portion of a high quality medical

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