Failure Mode & Effect Analysis
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The document outlines the fundamentals of Failure Mode and Effect Analysis (FMEA) as a risk management tool used to identify and mitigate potential failures in systems and processes. It details the FMEA methodology, its historical background, key concepts, and important terms such as failure modes, causes, and effects, along with the process for conducting FMEA effectively. Additionally, it emphasizes the application of FMEA in various industries, including healthcare, and highlights related tools for failure analysis.
Failure Mode & Effect Analysis
- 1. Dr. Nafis Ahmad Professor Department of IPE, BUET Email:nafis@ipe.buet.ac.bd AEM-6235 Maintenance and Safety Management
- 2. Topics ▷ Introduction ▷ Maintenance Management and Control ▷ Preventive Maintenance ▷ Corrective Maintenance ▷ Reliability Centered Maintenance ▷ FMEA ▷ Safety and Maintenance 2
- 4. 6. Failure Mode & Effect Analysis 4
- 5. Topics Introduction of FMEA Definition, Activities, important terms, factors, RPN Process of FMEA Steps of FMEA Types of FMEA FMEA Application FMEA Related Tools • Root Cause Analysis • Pareto Chart • Cause Effect Diagram Conclusion 5
- 6. Introduction • Managing risk is a must for any organization. • ISO 9004 mentions risk management along with cost consideration and benefit considerations. • Risk management is also important when dealing with equipment failures and their consequence on production, safety and the environment. • It is used to manage risk . • 6
- 7. Background of FMEA • Dhillon traced the history of FMEA in 1950s when it was used for the design of flight control systems. • FMEA emerged as a formal technique in the aerospace and defense industries. • Used on the NASA Apollo missions. • The Navy developed an FMEA military standard. • FMEA then spread to the American automotive industry in 1970. • The International Electrochemical Commission in 1985. • Nuclear power industry in 1998. • Software in 2000. • Healthcare in 2002. 7
- 8. Some Logical Question for a Product Development 8 What problems could arise? How likely these problems will occur? How serious they are, if they happen? How can these problems be prevented?
- 9. FMEA Defined It is an engineering technique used to define, identify, and eliminate known and/or potential problems, errors, and so on from the system, design, process, and/or service before they reach the customer. FMEA is a systemic methodology intended to perform the following activities: Identify and recognize potential failures including their causes and effects; Evaluate and prioritize identified failure modes since failures are not created equal; and Identify and suggest actions that can eliminate or reduce the chance of the potential failures from occurring. 9
- 10. Important terms Failure Mode: the manner by which a failure is observed. Failure Cause: the physical or chemical processes, design defects, quality defects, part misapplication, or other processes which are the basic reason for failure or which initiate the physical process by which deterioration proceeds to failure Failure Effect: the consequence(s) a failure mode has on the operation, function, or status of an item. Failure effects are classified as: Local effect Next higher level effect End effect 10
- 11. Important terms Failure Effect: Local effect: the consequence(s) a failure mode has on the operation, function, or status of the specific item being analyzed. Next higher level effect: the consequence(s) a failure mode has on the operation, function, or status of the items in the next higher level of indenture above the indenture level under consideration End effect: the consequence(s) a failure mode has on the operation, function, or status of the highest indenture level. Here, levels which identify or describe relative complexity of assembly or function. The levels progress from the more complex (system) to the simpler (part) division 11
- 12. FMEA Factors 12 Detection • The probability of the failure being detected before the impact of the effect is realized. Occurrence • The probability or frequency of the failure occurring. Severity • Consequence of the failure when it happens.
- 13. Risk Priority Number (RPN) RPN reflects the priority of the failure modes identified. Risk Priority Number = Severity x Occurrence x Detection Important FMEA task is to focus limited resources on critical design and/or process issues to improve reliability, quality and safety. 13
- 14. FMEA Process It is a proactive methodology, i.e. be ahead of potential problems and designing them out of processes or preventing them from occurring. 14 FMEA Process • Proactive methodology. • Potential problems designing to make out of processes. • Preventing Problem from occurring. Traditional Process • Reactive methodology. • Identifying Problems. • Eliminating Problem
- 15. FMEA Process Typical Steps 1. Select a high-risk process. 2. Review the process ( FMEA Team ) 3. Brainstorm potential failure modes. 4. Identify the root causes of failure modes. 5. List potential effects of each failure mode. 6. Assign severity, occurrence, and detection ratings for each effect. 7. Calculate the risk priority number (RPN) for each effect. 8. Prioritize the failure modes for action using RPN. 9. Take action to eliminate or reduce the high-risk failure modes. 10.Calculate the Resulting RPN as the failure modes are reduced or eliminated 15
- 16. Assigning Severity Ratings For Each Effect 16
- 17. Assigning Occurrence Ratings For Each Effect 17
- 18. Assigning Detection Ratings For Each Effect 18
- 19. Calculate The Risk Priority Number (RPN) For Each Effect 19
- 20. Types of FMEA 20 • Focuses on Manufacturing and assembly Process • Focuses on service functions • Focuses on components and subsystems • Focuses on global system functions System FMEA Design FMEA Process FMEA Service FMEA
- 21. Areas of FMEA Application • Started in the aerospace and automobile industry. • Healthcare industry. FDA has recognized FMEA as a design verification method for Drugs and Medical Devices. To prevent the possibility of process errors and mistakes leading to incorrect surgery or medication administration errors. Now an integral part of many hospitals’ continuous improvement program. • In other manufacturing industries and service industries 21
- 22. Related tools for FMEA • Root cause analysis • Pareto Chart • Cause & Effect Diagram 22
- 23. Root Cause Analysis (RCA) 23 A step-by-step method used to analyze failures and problems down to their root cause. Every equipment failure happens for a number of reasons. Definite progression of actions and consequences that lead to a failure. RCA traces the cause and effect trail from the end failure back to the root cause Powerful tools in improving plant reliability and performance. Failure investigation process steps are as follows: • Problem definition and data gathering • Control barriers • Event and causal factor charting • Cause and effect analysis • Root cause identification • Corrective actions effectiveness assessment. • Report generation
- 24. Root Cause Analysis (RCA) 24 Questions that help define the problem and gather data What What happened?, What are the symptoms?, What is the complaint?, What went wrong?, What is the undesirable event or behavior? Where Where did it happen? What process? What production stream? What equipment? When When did it occur: what date and what time? During what phase of the production process? How How was the situation before the incident? What happened during the incident? How is the situation after the incident? What is the normal operating condition? Is there any injury, shutdown, trip, or damage? How frequent is the problem? How many other processes, equipment or items affected by this incident?
- 25. 25 Event and causal factor charting is an analysis tool whereby events relations, conditions, changes, barriers, and causal factors are charted on a timeline using a standard representation.
- 26. Pareto Chart Illustrates the fact that 80 % of the problems stem from 20 % of the causes. Steps to construct a Pareto Chart…. • Record the raw data • Order the data • Label the left-hand vertical axis • Label the horizontal axis • Plot a bar for each category • Find the cumulative counts • Add a cumulative line • Analyze the diagram 26
- 27. Cause & Effect Diagram • It helps to identify, sort, and display possible causes of a specific problem or quality characteristic. • Graphically illustrates the relationship between a given outcome and all the factors that influence the outcome. • Also called a "fishbone diagram“ & “Ishikawa diagram”. 27
- 28. Conclusions • Increase customer satisfaction by improving safety and reliability • Improve development efficiency in terms of time and cost • Document, prioritize, and communicate potential risks by making issues to FMEA team members, management, and customers. • Help to reduce the chances of failure. • Optimize maintenance efforts by suggesting applicable and effective preventive maintenance tasks for potential failure modes. 28
- 29. Thanks! Any questions? You can find me at: @ahmadn nafis@ipe.buet.ac.bd 29