FMEA
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FMEA is a quality tool that is useful the most before initiating a project. It is recomended to include such tool in the decision-making process goaling to prevent any failure that could occure.
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The document discusses the Failure Mode and Effects Analysis (FMEA) process, which is used to prevent and detect failures. The 6-step FMEA process involves: 1) identifying potential failure modes, 2) determining failure effects, 3) identifying potential causes, 4) listing current controls, 5) calculating a Risk Priority Number (RPN) based on severity, occurrence, and detection ratings, and 6) determining recommended actions to reduce high RPNs. The overall goal is to analyze a process and identify weaknesses so they can be addressed.
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FMEA is a step-by-step approach to identify potential failures in a design, manufacturing process, or product/service. It studies the consequences of failures and prioritizes them based on how serious the consequences are, how frequently failures occur, and how easily they can be detected. Originating in the 1940s, FMEA aims to eliminate or reduce the highest priority failures. The procedure involves assembling a cross-functional team to identify potential failure modes and their causes and effects. Failures are then ranked by severity, occurrence, detection, and risk priority to determine which should be addressed first through corrective actions.
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In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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Learning objectives:
1. Describe the organisation of respiratory center
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4. Describe the influences of the Pneumotaxic and Apneustic centers
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7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
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FMEA
- 1. Failure Mode & Effect Analysis (FMEA) By: Fowzy Alrashed 1
- 2. FMEA – Purpose – Importance • What is FMEA? • How to conduct FMEA? • Video about FMEA • Conclusion • Q’s & A’s • Resources 2
- 3. What is FMEA • A quality assurance tool that is used to: – Identify failure possibilities for service, product, or process – Estimate risk associated with failure – Prioritize failure-prevention actions – To evaluate plans 3
- 4. Conducting FMEA • Review the process (flow chart) • Brainstorm & list failures that could occur • List failure consequences • Scale the following from 1-10: – Severity – Likeliness – Detectability • Calculate risk priority number (RPN) • Prioritize failures • Improve process (eliminate failure) • Implement the improvements 4
- 5. Data collecting example (ask me about Excel!) 5
- 6. Video 6 What is FMEA - YouTube.website
- 7. Conclusion • FMEA main goal is to prevent failure by anticipating it • It can enhance patient safety • FMEA helps in: – Improving plans – Making decisions – Preventing failure – Reducing costs 7
- 8. 8
- 9. References • George, M. L., & Maxey, J. (2005). The lean six sigma pocket toolbook, a quick reference guide to nearly 100 tools for improving process quality, speed, and complexity. New York: McGraw-Hill Professional. • Kelly, D. L. (2007). Applying quality management in heathcare, a systems approach. (2 ed., p. 60). Washington, DC: Health Administration Press. 9
- 10. References • George, M. L., & Maxey, J. (2005). The lean six sigma pocket toolbook, a quick reference guide to nearly 100 tools for improving process quality, speed, and complexity. New York: McGraw-Hill Professional. • Kelly, D. L. (2007). Applying quality management in heathcare, a systems approach. (2 ed., p. 60). Washington, DC: Health Administration Press. 9
Editor's Notes
- What is FMEA= simple introduction of the analysis and what category in healthcare it could serve (patients’ safety) How to conduct FMEA= introduce the 8 steps, then show Excel sheet example (present the 6sigma example with title: ask me for real example=as reminder.