The document provides an overview of Failure Mode and Effects Analysis (FMEA) as a tool to identify, analyze, and prevent potential product and process failures. It discusses the history and definitions of FMEA, the different types of FMEAs (system, design, process), how to conduct an FMEA including forming a team, terminology, scoring, and developing action plans to address high risks.
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
We all want to support the accomplishment of safe and trouble-free products and processes. Failure Mode and Effects Analysis has the potential to be a powerful reliability tool to reduce product design and manufacturing risk in a cost effective manner. With shorter product development times, tighter budgets and intense global competition, Design for Reliability tools such as FMEA must be applied correctly. Yet in practice, FMEA does not always achieve the expected results. Why is it that some companies have outstanding success in their FMEA application and others do not? What is the difference between well done and poorly done FMEAs? What are the essential elements of an effective FMEA process? These questions and more are answered in these three new short courses on FMEA.
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
We all want to support the accomplishment of safe and trouble-free products and processes. Failure Mode and Effects Analysis has the potential to be a powerful reliability tool to reduce product design and manufacturing risk in a cost effective manner. With shorter product development times, tighter budgets and intense global competition, Design for Reliability tools such as FMEA must be applied correctly. Yet in practice, FMEA does not always achieve the expected results. Why is it that some companies have outstanding success in their FMEA application and others do not? What is the difference between well done and poorly done FMEAs? What are the essential elements of an effective FMEA process? These questions and more are answered in these three new short courses on FMEA.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
Legal Aspects of FMEA, overview of Canadian Law,
Due Diligence vs Negligence, Criminal Negligenced and what everyone needs to know about duty of care
www.6sengineering.com
Detailed and comprehensive contents:
History of FMEA
Overview (What is FMEA and What it can do for you?)
Scope/when to use?
Objective of FMEA
FMEA terminology
AIAG FMEA 4th edition (Old edition)
Introduction of AIAG VDA FMEA (New edition)
Why new AIAG VDA FMEA?
Major changes
Steps of FMEA
Severity rating
Occurrence rating
Detection rating
AP Table
Case study
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
Is your FMEA performing for you?
This is advance level of PFMEA, Have basic understanding fo Core IATF Tools before refering to this presentation.
Failure mode and effects analysis (FMEA)—also "failure modes", plural, in many publications—was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis.
A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an organization, business unit, or cross-functional team to identify and evaluate the potential failures of a process. PFMEA helps to establish the impact of the failure, and identify and prioritize the action items with the goal of alleviating risk. It is a living document that should be initiated prior to process of production and maintained through the life cycle of the product.
PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following variables:
Severity — Assesses the impact of the failure mode (the error in the process), with 1 representing the least safety concern and 10 representing the most dangerous safety concern. In most cases, processes with severity scores exceeding 8 may require a fault tree analysis, which estimates the probability of the failure mode by breaking it down into further sub-elements.
Occurrence — Assesses the chance of a failure happening, with 1 representing the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1 may be assigned to a failure that happens once in every 5 years, while a score of 10 may be assigned to a failure that occurs once per hour, once per minute, etc.
Detection — Assesses the chance of a failure being detected, with 1 representing the highest chance of detection and 10 representing the lowest chance of detection.
RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a lower RPN number.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
Legal Aspects of FMEA, overview of Canadian Law,
Due Diligence vs Negligence, Criminal Negligenced and what everyone needs to know about duty of care
www.6sengineering.com
Detailed and comprehensive contents:
History of FMEA
Overview (What is FMEA and What it can do for you?)
Scope/when to use?
Objective of FMEA
FMEA terminology
AIAG FMEA 4th edition (Old edition)
Introduction of AIAG VDA FMEA (New edition)
Why new AIAG VDA FMEA?
Major changes
Steps of FMEA
Severity rating
Occurrence rating
Detection rating
AP Table
Case study
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
Is your FMEA performing for you?
This is advance level of PFMEA, Have basic understanding fo Core IATF Tools before refering to this presentation.
Failure mode and effects analysis (FMEA)—also "failure modes", plural, in many publications—was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis.
A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an organization, business unit, or cross-functional team to identify and evaluate the potential failures of a process. PFMEA helps to establish the impact of the failure, and identify and prioritize the action items with the goal of alleviating risk. It is a living document that should be initiated prior to process of production and maintained through the life cycle of the product.
PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following variables:
Severity — Assesses the impact of the failure mode (the error in the process), with 1 representing the least safety concern and 10 representing the most dangerous safety concern. In most cases, processes with severity scores exceeding 8 may require a fault tree analysis, which estimates the probability of the failure mode by breaking it down into further sub-elements.
Occurrence — Assesses the chance of a failure happening, with 1 representing the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1 may be assigned to a failure that happens once in every 5 years, while a score of 10 may be assigned to a failure that occurs once per hour, once per minute, etc.
Detection — Assesses the chance of a failure being detected, with 1 representing the highest chance of detection and 10 representing the lowest chance of detection.
RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a lower RPN number.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
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Failure mode and effects analysis is the process of reviewing as many components, assemblies, and subsystems as possible to identify potential failure modes in a system and their causes and effects
FMEA failure-mode-and-effect-analysis_Occupational safety and healthJing Jing Cheng
Failure mode and effect analysis (FMEA) is one of the methods of hazard analysis. Through FMEA, failures in a system that may lead to undesirable situation can be identified
To identify which failures in a system can lead to undesirable situation.
FMEA failure-mode-and-effect-analysis_Occupational safety and health
Advanced Pfmea
1. Process Failure Mode Effect Analysis Northrop Grumman Corporation Integrated Systems CA/PA-RCA : Advanced Tool
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4. Agenda Why does it always seem we have plenty of time to fix our problems, but never enough time to prevent the problems by doing it right the first time?
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6. What is FMEA ? Cause & effect, Root Cause Analysis, Fishbone Diagram Etc Failure Mode Effect Analysis
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8. What is FMEA ? What it can do for you! 1.) Identifies Design or process related Failure Modes before they happen. 2.) Determines the Effect & Severity of these failure modes. 3.) Identifies the Causes and probability of Occurrence of the Failure Modes. 4.) Identifies the Controls and their Effectiveness . 5.) Quantifies and prioritizes the Risks associated with the Failure Modes. 6.) Develops & documents Action Plans that will occur to reduce risk.
9. Types of FMEAs ? System/Concept “S/CFMEA”- (Driven by System functions) A system is a organized set of parts or subsystems to accomplish one or more functions. System FMEAs are typically very early, before specific hardware has been determined. Design “DFMEA”- (Driven by part or component functions) A Design / Part is a unit of physical hardware that is considered a single replaceable part with respect to repair. Design FMEAs are typically done later in the development process when specific hardware has been determined. Process “PFMEA”- (Driven by process functions & part characteristics) A Process is a sequence of tasks that is organized to produce a product or provide a service. A Process FMEA can involve fabrication, assembly, transactions or services.
10. Types of FMEAs ? System/Concept “S/CFMEA”- (Driven by System functions) A system is a organized set of parts or subsystems to accomplish one or more functions. System FMEAs are typically very early, before specific hardware has been determined. Design “DFMEA”- (Driven by part or component functions) A Design / Part is a unit of physical hardware that is considered a single replaceable part with respect to repair. Design FMEAs are typically done later in the development process when specific hardware has been determined. Process “PFMEA”- (Driven by process functions & part characteristics) A Process is a sequence of tasks that is organized to produce a product or provide a service. A Process FMEA can involve fabrication, assembly, transactions or services.
11. The FMEA Team Roles FMEA Core Team 4 – 6 Members Expertise in Product / Process Cross functional Honest Communication Active participation Positive attitude Respects other opinions Participates in team decisions Champion / Sponsor Provides resources & support Attends some meetings Promotes team efforts Shares authority / power with team Kicks off team Implements recommendations Recorder Keeps documentation of teams efforts FMEA chart keeper Coordinates meeting rooms/time Distributes meeting rooms & agendas Facilitator “ Watchdog“ of the process Keeps team on track FMEA Process expertise Encourages / develops team dynamics Communicates assertively Ensures everyone participates Team Leader “ Watchdog” of the project Good leadership skills Respected & relaxed Leads but doesn’t dominate Maintains full team participation Typically lead engineer
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15. Getting Started on FMEA Determine “ Controls” Detection Rating Determine “ Effects” of The Failure Mode Severity Rating What Must be done before FMEA Begins! Determine “ Causes” of The Failure Mode Occurrence Rating Determine Product or Process Functions Determine Failure Modes of Function Understand your Customer Needs Develop & Evaluate Product/Process Concepts Create an Effective FMEA Team Develop and Drive Action Plan 1 3 2 4 6 =QFD =Brain Storming =4 to 6 Consensus Based Multi Level Experts = What we are and are not working Define the FMEA Scope 5 Calculate & Assess Risk 6 7 Ready?
16. The FMEA Worksheet If an FMEA was created during the Design Phase of the Program, USE IT! Create an Action Plan for YOUR ROOT CAUSE and Re-Evaluate the RPN Accordingly 1 6 2 3 4 5 7 Determine Product or Process Functions Determine Failure Modes of Function Determine “ Effects” of The Failure Mode Severity Rating Determine “ Causes” of The Failure Mode Occurrence Rating Determine “ Controls” Detection Rating Calculate & Assess Risk Develop and Drive Action Plan
17. FMEA Scoring Severity Severity of Effect Rating May endanger machine or operator. Hazardous without warning 10 May endanger machine or operator. Hazardous with warning 9 Major disruption to production line. Loss of primary function, 100% scrap. Possible jig lock and Major loss of Takt Time 8 Reduced primary function performance. Product requires repair or Major Variance. Noticeable loss of Takt Time 7 Medium disruption of production. Possible scrap. Noticeable loss of takt time. Loss of secondary function performance. Requires repair or Minor Variance 6 Minor disruption to production. Product must be repaired. Reduced secondary function performance. 5 Minor defect, product repaired or "Use-As-Is" disposition. 4 Fit & Finish item. Minor defect, may be reprocessed on-line. 3 Minor Nonconformance, may be reprocessed on-line. 2 None No effect 1 Extreme High Moderate Low
18. FMEA Scoring Occurrence Likelihood of Occurrence Failure Rate Capability (Cpk) Rating 1 in 2 < .33 10 1 in 3 > .33 9 1 in 8 > .51 8 1 in 20 > .67 7 1 in 80 > .83 6 1 in 400 > 1.00 5 1 in 2000 > 1.17 4 Process is in statistical control. 1 in 15k > 1.33 3 Low Process is in statistical control. Only isolated failures associated with almost identical processes. 1 in 150k > 1.50 2 Remote Failure is unlikely. No known failures associated with almost identical processes. 1 in 1.5M > 1.67 1 Failure is almost inevitable Process is not in statistical control. Similar processes have experienced problems. Process is in statistical control but with isolated failures. Previous processes have experienced occasional failures or out-of-control conditions. Very High High Moderate
19. FMEA Scoring Detection Likelihood that control will detect failure Rating Very Low No known control(s) available to detect failure mode. 10 9 8 7 6 5 4 3 2 1 The process automatically detects failure. Controls will almost certainly detect the existence of a failure. Controls have a good chance of detecting the existence of a failure Low Moderate High Very High Controls have a remote chance of detecting the failure. Controls may detect the existence of a failure
20. FMEA Scoring RPN or Risk Priority Number S everity x O ccurrence x D etection= RPN The Calculation !
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22. Failure Modes & Effect Analysis Questions? Call or e-mail: Kevin M. Treanor Bob Ollerton 310-863-4182 310-332-1972/310-350-9121 [email_address] [email_address]