A Process Failure Modes and Effects Analysis (PFMEA) is a structured analysis that uses a cross-functional team to identify potential failures in a process, determine their causes and effects, and identify actions to address potential failures. The document outlines how to conduct an effective PFMEA, including establishing objectives, choosing team members, conducting a failure modes analysis, identifying corrective actions, and documenting results. It also describes how to organize the PFMEA team and the forms used to document the analysis.
This document provides an overview of conducting a Process Failure Modes and Effects Analysis (P-FMEA). A P-FMEA helps improve processes, reduce failures, monitor production issues, improve quality checks, and teaches systematic analysis. The key steps include: 1) Listing all process steps and potential failures, 2) Estimating the likelihood of failures, 3) Recording prevention and detection actions, 4) Calculating a Risk Priority Number, and 5) Proposing improvements for high priority risks. An example of analyzing a solar concentrator subsystem in a solar power system is provided. The assumptions, inputs/outputs, and 6-step approach to conducting a P-FMEA are outlined.
The document discusses Process Failure Modes and Effects Analysis (PFMEA) which analyzes manufacturing and assembly processes to identify potential failure modes caused by process deficiencies. A PFMEA includes a process flow diagram, failure analysis matrix, and process control plan. It assumes the design is valid, analyzes failure causes and effects, and recommends actions to eliminate root causes and detect failures. Benefits include improved processes, performance monitoring, and prioritizing resources to ensure process improvements benefit customers.
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.
The document discusses efforts to align the Failure Mode and Effects Analysis (FMEA) methods of the German VDA and American AIAG standards. A working group with representatives from automakers and suppliers met over several years to harmonize differences in how the VDA and AIAG FMEA manuals evaluate potential failures. The group standardized criteria for severity, occurrence, and detection ratings and developed common approaches for design and process FMEAs. The ultimate goal is to create a single, global FMEA process that satisfies customers in both Europe and North America.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). It discusses that FMEA is a systematic group activity to recognize and evaluate potential failures, identify actions to address failures, and document findings. The document outlines the different types of FMEAs, including Design FMEA and Process FMEA. It also describes the typical steps to conduct a Process FMEA, including developing a process flow, identifying failure modes and their causes and effects, and estimating the risk priority number. The FMEA is presented as a team tool to prevent failures.
The document discusses Process Failure Mode and Effect Analysis (PFMEA). It explains that every product or process can have failure modes, even established ones, and that effective FMEAs require a team effort and should be done early in the design process. It also outlines the basic steps for a process FMEA, which involves identifying potential failures, effects, risks, and taking actions to reduce high-risk failures. The objective is to uncover process problems and reduce the risk of failures affecting products, efficiency or safety.
The document provides an overview and agenda for a training on Failure Mode and Effects Analysis (FMEA). It discusses the history and purpose of FMEAs, how they are used to systematically identify and prevent potential failures in products and processes, and the benefits of conducting FMEAs. The training will cover both Design FMEAs (DFMEA) and Process FMEAs (PFMEA) and include exercises for participants to work through.
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.
This document provides an overview of conducting a Process Failure Modes and Effects Analysis (P-FMEA). A P-FMEA helps improve processes, reduce failures, monitor production issues, improve quality checks, and teaches systematic analysis. The key steps include: 1) Listing all process steps and potential failures, 2) Estimating the likelihood of failures, 3) Recording prevention and detection actions, 4) Calculating a Risk Priority Number, and 5) Proposing improvements for high priority risks. An example of analyzing a solar concentrator subsystem in a solar power system is provided. The assumptions, inputs/outputs, and 6-step approach to conducting a P-FMEA are outlined.
The document discusses Process Failure Modes and Effects Analysis (PFMEA) which analyzes manufacturing and assembly processes to identify potential failure modes caused by process deficiencies. A PFMEA includes a process flow diagram, failure analysis matrix, and process control plan. It assumes the design is valid, analyzes failure causes and effects, and recommends actions to eliminate root causes and detect failures. Benefits include improved processes, performance monitoring, and prioritizing resources to ensure process improvements benefit customers.
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.
The document discusses efforts to align the Failure Mode and Effects Analysis (FMEA) methods of the German VDA and American AIAG standards. A working group with representatives from automakers and suppliers met over several years to harmonize differences in how the VDA and AIAG FMEA manuals evaluate potential failures. The group standardized criteria for severity, occurrence, and detection ratings and developed common approaches for design and process FMEAs. The ultimate goal is to create a single, global FMEA process that satisfies customers in both Europe and North America.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). It discusses that FMEA is a systematic group activity to recognize and evaluate potential failures, identify actions to address failures, and document findings. The document outlines the different types of FMEAs, including Design FMEA and Process FMEA. It also describes the typical steps to conduct a Process FMEA, including developing a process flow, identifying failure modes and their causes and effects, and estimating the risk priority number. The FMEA is presented as a team tool to prevent failures.
The document discusses Process Failure Mode and Effect Analysis (PFMEA). It explains that every product or process can have failure modes, even established ones, and that effective FMEAs require a team effort and should be done early in the design process. It also outlines the basic steps for a process FMEA, which involves identifying potential failures, effects, risks, and taking actions to reduce high-risk failures. The objective is to uncover process problems and reduce the risk of failures affecting products, efficiency or safety.
The document provides an overview and agenda for a training on Failure Mode and Effects Analysis (FMEA). It discusses the history and purpose of FMEAs, how they are used to systematically identify and prevent potential failures in products and processes, and the benefits of conducting FMEAs. The training will cover both Design FMEAs (DFMEA) and Process FMEAs (PFMEA) and include exercises for participants to work through.
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.
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.
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.
The document provides information on Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It discusses the APQP process which consists of four phases - planning, product design, process design, and validation. The goal of APQP is to plan quality in from the beginning to reduce costs and ensure customer satisfaction. PPAP is then described as the process used to get formal approval for a production part by providing evidence that the manufacturing process is capable of meeting requirements. It involves a first article inspection and data submission from a production run.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method to identify and prevent potential failures before production. It involves identifying all possible failures, their causes and effects. Teams then evaluate the severity, occurrence, and detection of each failure and prioritize issues to address based on their risk priority number. The document outlines the FMEA process and how to develop one to proactively address potential product and process failures.
The document provides guidance on developing an effective control plan with three key sections:
1. The administrative section identifies critical information about the part or process including part numbers, suppliers, and required approval signatures.
2. The main section defines the key process parameters and controls for each step, including specifications, measurement techniques, sample sizes, frequencies, control methods, and reaction plans.
3. Effective control plans also include audit plans as a separate line to regularly validate that the documented controls match actual practice and ensure continuous improvement.
APQP or Advanced Product Quality Planning is a structured 5-phase method for ensuring a product satisfies the customer. The 5 phases are: 1) Plan and Define, 2) Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. Key activities include understanding customer needs, design reviews, failure analysis, verification and validation, and proactive feedback. The benefits are early planning, directing resources to the customer, identifying required changes early, providing quality on time and at lowest cost.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
Failure Modes Effect Analysis (FMEA) is a methodology to identify and eliminate potential failures early in development. It involves a team identifying ways a process can fail, estimating risk from causes, and prioritizing actions. There are two types - design FMEA analyzes product design, while process FMEA analyzes manufacturing processes. The team rates the severity, occurrence, and detection of failures and causes to calculate a Risk Priority Number and identify high risk items.
This document outlines a training for Litens Automotive on Design Failure Mode and Effects Analysis (DFMEA). The training covers DFMEA basics, consequences of poorly performed DFMEAs, identifying single points of failure, using design of experiments to optimize designs, and reviewing DFMEA examples. It emphasizes that critical dimensions must be derived from the DFMEA and that DFMEAs are important legal documents that demonstrate due diligence in design and product safety.
This document provides an overview and introduction to quality management systems and the ISO 9001:2015 and IATF 16949:2016 standards. It discusses key aspects of quality management including the basics of a QMS, requirements of the ISO and IATF standards, differences between the versions, transitioning processes, and implementing risk-based thinking. The document is intended to educate participants on quality management system requirements and certification.
The document discusses problems with the current failure mode and effects analysis (FMEA) process at a company called RPL. It notes that before 2010 there was no formal FMEA conducted during new model introductions, leading to inconsistent quality. In 2012 an FMEA template was introduced based on a 5-scale system, but this was found to have issues with accurately capturing severity, occurrence, and detection ratings. Compared to industry standards, the company's FMEA process differs in using a 5-scale instead of a more common 1-10 scale and in not requiring a cross-functional team approach. The document investigates these facts to develop an improved FMEA template and methodology to meet the company's robust manufacturing
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
What is a PPAP (production part approval process) and how does it work? We answer the basic questions about PPAP and how it's used in this presentation.
The document discusses failure mode and effects analysis (FMEA). It provides definitions and descriptions of different types of FMEAs, including design FMEA (DFMEA) which focuses on potential design failures, and process FMEA (PFMEA) which focuses on potential process failures and their causes. The document outlines the key steps in conducting a PFMEA, including developing a process flow diagram, identifying potential failure modes and their effects and causes, analyzing the risks associated with failures, and creating a process control plan to address potential failures.
The FMEA relates to a very broad spectrum on how effective this tool can be utilized as solver aid in dealing with the histories/pattern of failure in the product.
And how well can it be hierarchically deal with analysis the root cause of the problem.
This methodology is widely adopted in almost all manufacturing branch industries, due to its efficiency is tracking down all the possibilities occurrence in failure with the severity, occurrence, etc and other parameters to define the intensity of the failure being occurred.
To understand the tools usage a bit further, I have enumerated a case study via a example in this slides.
FMEA is a procedure for analyzing potential failures in a system. It helps identify failures, classify them by severity, and determine how failures affect the system. FMEA is used in manufacturing to design quality and reliability into products early in development. It involves identifying potential failure modes, studying their effects, and recommending actions to address failures with high risks. FMEA aims to improve reliability by analyzing failures before problems occur.
This document provides guidance on conducting a Design Failure Mode and Effects Analysis (DFMEA). It begins with defining the purpose of a FMEA and what it involves. It then discusses current DFMEA practices and concerns. The remainder of the document offers detailed instructions on performing a DFMEA, including how to construct a process flow diagram, interface matrix, evaluate potential failure modes and their effects/severity, occurrence, detection, and risk priority numbers. It provides examples and criteria for properly analyzing risk and prioritizing corrective actions. The overall summary is that the document aims to refine the approach to DFMEAs by outlining the full process and key considerations for effectively conducting a thorough design risk assessment.
This document provides an overview of process failure mode and effects analysis (PFMEA). It discusses the steps to conduct a PFMEA, including identifying critical process steps and their potential failure modes, effects, causes, controls, and risk priority numbers. The goals of a PFMEA are to proactively identify potential process failures, prioritize issues based on risk, and determine actions to reduce failures and improve process quality, reliability, and customer satisfaction. Conducting a thorough PFMEA requires a cross-functional team approach.
The document discusses Advanced Product Quality Planning (APQP). It describes APQP as involving organizing a team, defining the scope, involving customers and suppliers, and using simultaneous engineering. The benefits of APQP are listed as directing resources to satisfy customers, promoting early identification of required changes, and avoiding late changes to promote a quality product on time at the lowest price. Key stages and inputs of the APQP process are also outlined.
This document provides guidance on completing a Process Failure Mode and Effects Analysis (Process FMEA). It outlines the 25 steps to complete a Process FMEA, including identifying the process, potential failure modes and causes, severity, occurrence, detection, and risk priority number. It also includes examples for each step. The overall aim of a Process FMEA is to proactively identify potential failures in a manufacturing process to take actions to reduce risks and ensure process capability.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceuticals
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.
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.
The document provides information on Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It discusses the APQP process which consists of four phases - planning, product design, process design, and validation. The goal of APQP is to plan quality in from the beginning to reduce costs and ensure customer satisfaction. PPAP is then described as the process used to get formal approval for a production part by providing evidence that the manufacturing process is capable of meeting requirements. It involves a first article inspection and data submission from a production run.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method to identify and prevent potential failures before production. It involves identifying all possible failures, their causes and effects. Teams then evaluate the severity, occurrence, and detection of each failure and prioritize issues to address based on their risk priority number. The document outlines the FMEA process and how to develop one to proactively address potential product and process failures.
The document provides guidance on developing an effective control plan with three key sections:
1. The administrative section identifies critical information about the part or process including part numbers, suppliers, and required approval signatures.
2. The main section defines the key process parameters and controls for each step, including specifications, measurement techniques, sample sizes, frequencies, control methods, and reaction plans.
3. Effective control plans also include audit plans as a separate line to regularly validate that the documented controls match actual practice and ensure continuous improvement.
APQP or Advanced Product Quality Planning is a structured 5-phase method for ensuring a product satisfies the customer. The 5 phases are: 1) Plan and Define, 2) Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. Key activities include understanding customer needs, design reviews, failure analysis, verification and validation, and proactive feedback. The benefits are early planning, directing resources to the customer, identifying required changes early, providing quality on time and at lowest cost.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
Failure Modes Effect Analysis (FMEA) is a methodology to identify and eliminate potential failures early in development. It involves a team identifying ways a process can fail, estimating risk from causes, and prioritizing actions. There are two types - design FMEA analyzes product design, while process FMEA analyzes manufacturing processes. The team rates the severity, occurrence, and detection of failures and causes to calculate a Risk Priority Number and identify high risk items.
This document outlines a training for Litens Automotive on Design Failure Mode and Effects Analysis (DFMEA). The training covers DFMEA basics, consequences of poorly performed DFMEAs, identifying single points of failure, using design of experiments to optimize designs, and reviewing DFMEA examples. It emphasizes that critical dimensions must be derived from the DFMEA and that DFMEAs are important legal documents that demonstrate due diligence in design and product safety.
This document provides an overview and introduction to quality management systems and the ISO 9001:2015 and IATF 16949:2016 standards. It discusses key aspects of quality management including the basics of a QMS, requirements of the ISO and IATF standards, differences between the versions, transitioning processes, and implementing risk-based thinking. The document is intended to educate participants on quality management system requirements and certification.
The document discusses problems with the current failure mode and effects analysis (FMEA) process at a company called RPL. It notes that before 2010 there was no formal FMEA conducted during new model introductions, leading to inconsistent quality. In 2012 an FMEA template was introduced based on a 5-scale system, but this was found to have issues with accurately capturing severity, occurrence, and detection ratings. Compared to industry standards, the company's FMEA process differs in using a 5-scale instead of a more common 1-10 scale and in not requiring a cross-functional team approach. The document investigates these facts to develop an improved FMEA template and methodology to meet the company's robust manufacturing
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
What is a PPAP (production part approval process) and how does it work? We answer the basic questions about PPAP and how it's used in this presentation.
The document discusses failure mode and effects analysis (FMEA). It provides definitions and descriptions of different types of FMEAs, including design FMEA (DFMEA) which focuses on potential design failures, and process FMEA (PFMEA) which focuses on potential process failures and their causes. The document outlines the key steps in conducting a PFMEA, including developing a process flow diagram, identifying potential failure modes and their effects and causes, analyzing the risks associated with failures, and creating a process control plan to address potential failures.
The FMEA relates to a very broad spectrum on how effective this tool can be utilized as solver aid in dealing with the histories/pattern of failure in the product.
And how well can it be hierarchically deal with analysis the root cause of the problem.
This methodology is widely adopted in almost all manufacturing branch industries, due to its efficiency is tracking down all the possibilities occurrence in failure with the severity, occurrence, etc and other parameters to define the intensity of the failure being occurred.
To understand the tools usage a bit further, I have enumerated a case study via a example in this slides.
FMEA is a procedure for analyzing potential failures in a system. It helps identify failures, classify them by severity, and determine how failures affect the system. FMEA is used in manufacturing to design quality and reliability into products early in development. It involves identifying potential failure modes, studying their effects, and recommending actions to address failures with high risks. FMEA aims to improve reliability by analyzing failures before problems occur.
This document provides guidance on conducting a Design Failure Mode and Effects Analysis (DFMEA). It begins with defining the purpose of a FMEA and what it involves. It then discusses current DFMEA practices and concerns. The remainder of the document offers detailed instructions on performing a DFMEA, including how to construct a process flow diagram, interface matrix, evaluate potential failure modes and their effects/severity, occurrence, detection, and risk priority numbers. It provides examples and criteria for properly analyzing risk and prioritizing corrective actions. The overall summary is that the document aims to refine the approach to DFMEAs by outlining the full process and key considerations for effectively conducting a thorough design risk assessment.
This document provides an overview of process failure mode and effects analysis (PFMEA). It discusses the steps to conduct a PFMEA, including identifying critical process steps and their potential failure modes, effects, causes, controls, and risk priority numbers. The goals of a PFMEA are to proactively identify potential process failures, prioritize issues based on risk, and determine actions to reduce failures and improve process quality, reliability, and customer satisfaction. Conducting a thorough PFMEA requires a cross-functional team approach.
The document discusses Advanced Product Quality Planning (APQP). It describes APQP as involving organizing a team, defining the scope, involving customers and suppliers, and using simultaneous engineering. The benefits of APQP are listed as directing resources to satisfy customers, promoting early identification of required changes, and avoiding late changes to promote a quality product on time at the lowest price. Key stages and inputs of the APQP process are also outlined.
This document provides guidance on completing a Process Failure Mode and Effects Analysis (Process FMEA). It outlines the 25 steps to complete a Process FMEA, including identifying the process, potential failure modes and causes, severity, occurrence, detection, and risk priority number. It also includes examples for each step. The overall aim of a Process FMEA is to proactively identify potential failures in a manufacturing process to take actions to reduce risks and ensure process capability.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceuticals
The document discusses Failure Mode and Effects Analysis (FMEA) and how to conduct a Process FMEA, including defining the scope, identifying potential failures and their causes and effects, and establishing current process controls. It provides examples and templates to help participants understand how to properly perform a Process FMEA. The goal is to enable participants to effectively use FMEA to achieve robust capable designs and processes.
This document discusses standard data analysis tools for evaluating measurement repeatability and reproducibility (R&R) using statistical methods. It covers topics such as distribution and variation, measurement errors, process control and capability, basic statistics, and methods for evaluating repeatability, reproducibility, and gauge R&R including the range method, average/range method, and ANOVA method. Examples of tables and charts used in R&R studies are also presented.
1. The document discusses 7 quantitative quality control tools and techniques for decision making: checksheets, Pareto charts, cause-and-effect diagrams, scatter diagrams, histograms, control charts, and stratification.
2. It provides examples and explanations of how each tool is used, such as using checksheets to track defects over time, Pareto charts to identify the most common issues, and scatter diagrams to analyze relationships between variables.
3. The tools help identify sources of variation, recognize changes in processes, and determine if quality improvements are effective. Strategic use of these techniques aids in problem diagnosis and driving processes toward statistical control.
The document discusses the 7 quality tools including flow charts, cause-and-effect diagrams, and Pareto charts. It explains that Kaoru Ishikawa developed the basic 7 tools to make statistical analysis more accessible. Flow charts map out process steps to identify problems and improvements. Cause-and-effect diagrams help determine root causes of issues through a graphical format. Pareto charts follow the 80/20 rule to identify the most important causes of problems based on frequency data. The tools provide visual aids to improve understanding of processes and identify areas for data collection and enhancements.
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This document provides an agenda for a training program on enhancing product quality through Six Sigma and 7 quality control tools. The program will take place over 4 sessions covering topics like Six Sigma approach, objectives, measurement, identifying vital vs. trivial factors, developing objectives, and calculating first time yield. The goal of Six Sigma is to minimize defects by identifying and removing causes of variation in processes. It aims to "do it right the first time" through disciplined data collection and analysis to determine the best solutions.
The document discusses Kaoru Ishikawa's development of the Seven Basic Tools of Quality Control. Ishikawa was inspired by W. Edwards Deming's lectures on quality control tools in Japan in the 1950s. Ishikawa formalized seven graphical tools - including fishbone diagrams, histograms, Pareto charts, flowcharts, scatter plots, run charts, and control charts - that could be easily understood and applied by all workers to solve 95% of quality-related problems. The tools provide visual means to analyze processes, identify issues, and monitor quality improvements.
Measurement System Analysis is the first step of the Measure Phase of an improvement project. Before you can pass judgment on the process, you need to ensure that your measurement system is accurate, precise, capable and in control.
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7 QC Tools are simple statistical tools used for problem solving. Nilesh Arora presented basics of 7 QC Tool training and details about Pareto Diagram.
The document describes 7 quality control tools: 1) Flow chart, 2) Check sheet, 3) Histogram, 4) Pareto chart, 5) Cause and effect diagram, 6) Scatter plot, and 7) Control chart. It provides examples and brief explanations of each tool. Flow charts help communicate and analyze processes. Check sheets gather data on problems. Histograms show data distribution and outliers. Pareto charts rank issues to prioritize improvements. Cause and effect diagrams explore causes of outcomes. Scatter plots show correlations. Control charts have limits and plot process data over time.
The Seven Basic Tools of Quality is a designation given to a fixed set of graphical techniques identified as being most helpful in troubleshooting issues related to quality.They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
This document provides an introduction to Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects, and Criticality Analysis (FMECA). It defines what FMEA/FMECA are, discusses their importance and history of use. The document outlines the FMEA/FMECA process, including defining the system, identifying failure modes and effects, performing criticality analysis, and documenting results. It also covers FMEA/FMECA standards and guidelines and provides examples of different types that can be performed.
Measuremen Systems Analysis Training ModuleFrank-G. Adler
The Six Sigma Measurement Systems Analysis (MSA) Training Module includes a MS PowerPoint Presentation including 62 slides covering an Introduction to Measurement Systems Analysis - Relevance - Discrimination - Accuracy - Stability - Linearity - Precision, Variable Gage R&R Study, and Attribute Gage R&R Study.
The document discusses 7 quality control tools used to identify, analyze, and resolve problems in a systematic manner. The tools include check sheets, histograms, Pareto charts, cause-and-effect diagrams, scatter plots, defect concentration diagrams, and control charts. These simple but powerful tools can help solve day-to-day work problems and identify solutions by collecting and analyzing process data.
The document provides an overview of a presentation on Process Failure Mode and Effects Analysis (PFMEA) which is a tool used to identify potential failures in a manufacturing or assembly process and ensure product quality. It discusses the purpose and benefits of a PFMEA, the roles of team members, how to conduct a PFMEA including developing a process flow diagram, and key terms used in a PFMEA. The overall goal is to familiarize participants with PFMEAs and how they can be used to prevent failures and improve processes.
Tonex.com pfmea training process fmea trainingCarlos Lucio
This document provides information about a 2-day PFMEA (Process Failure Mode and Effects Analysis) training course offered by TONEX for $1,699. The training will cover the theory, logic, and techniques of PFMEA including how to assess potential process failures, evaluate risk, and prioritize corrective actions. Attendees will learn how to apply PFMEA to problem solving, daily improvement efforts, and will receive techniques to create value-added PFMEAs in less time. The training objectives are to define PFMEA, explain the procedure, evaluate risks, and apply PFMEA in various improvement initiatives.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method for evaluating potential failure modes within a design, identifying their causes and effects, and prioritizing risks. The document outlines the history and purpose of FMEA, defines key terms, and describes how to conduct an FMEA, including establishing a team, documenting the process on a worksheet, scoring risks, and developing action plans. FMEA is a useful tool for proactively identifying and mitigating risks within a product or process design to improve quality and prevent failures.
Better processes produce lower cost, higher revenues, motivated employees, and happier customers. Business Process Management (BPM) is an approach that’s designed to produce better processes through the combination of technology and expertise. Business Process Management (BPM) is a collaborative effort between business units and the IT world, and this effort fosters a new paradigm of efficient and logical business processes.
The document provides an overview of a Process Excellence Framework module. The core module focuses on equipping learners with tools to identify and create control certification for a given process. These tools include SIPOC (supplier, input, process, output, customer), process mapping, and FMEA (failure mode and effects analysis). The supplementary module explains additional quality tools like cause-and-effect diagrams and control impact matrices. The goal is for learners to understand how to use these tools to map processes, identify potential failures, and establish controls and metrics to improve process quality.
The document discusses Failure Modes and Effects Analysis (FMEA), which is a systematic method used to evaluate processes and identify potential failures, causes, and effects. It also assesses the impact of different failures to identify parts of the process most in need of improvement. FMEA involves reviewing process steps, potential failure modes and causes, failure effects, and uses a team approach. It aims to evaluate processes proactively for failures and prevent them by correcting processes before failures occur. FMEA is useful for new processes prior to implementation and assessing changes to existing processes. It provides a structured way to identify risks in processes.
Failure Modes and Effects Analysis (FMEA).pptGURU DATTA
The document discusses Failure Mode and Effects Analysis (FMEA), which is a step-by-step approach to identify all possible failures in a design, manufacturing process, product, or service. There are different types of FMEAs, including system, design, process, service, and software. The FMEA procedure involves 16 steps, such as describing the product/process, creating a block diagram, identifying failure modes and their causes and effects, determining likelihood ratings, reviewing risk priority numbers, and determining and implementing recommended actions. The goal is to mitigate risks by taking actions to address potential failures with high risk priority numbers.
The document discusses communication and reporting in project management. It provides templates and guidelines for project status reports, meeting agendas, presentations, and software reviews. The key aspects covered are:
- Setting agendas for status meetings with items like action items, change requests, and meeting summaries.
- Best practices for effective presentations including clear structure, supporting ideas, and handling questions.
- Roles and guidelines for different types of software reviews including management reviews, technical reviews, inspections, and walkthroughs. The reviews follow standard processes and produce reports on findings.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic process used to evaluate potential failures in a design, manufacturing or process and identify actions to address or prevent these failures. It involves identifying potential failure modes and ranking them based on severity, occurrence likelihood and ability to detect. Actions are then recommended to reduce the highest risk failures based on their Risk Priority Number. FMEA is intended to be preventative and identify issues before they occur.
This document discusses Failure Mode and Effects Analysis (FMEA). It describes FMEA as a structured approach to identifying ways a product or process can fail, estimating risks from specific causes, and prioritizing actions to reduce risk. The document outlines the FMEA process, which involves a team identifying failure modes and their effects, potential causes, current controls, and calculating a Risk Priority Number. It distinguishes between design FMEAs, which analyze product design, and process FMEAs, which analyze manufacturing processes.
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate risks from specific causes, and prioritize actions to reduce risk. The document outlines the FMEA process, including establishing a team, identifying failure modes and their effects, analyzing severity, occurrence and detection, calculating a risk priority number, and developing recommended actions. It also distinguishes between design FMEA and process FMEA.
This document provides an overview of Hazard and Operability Studies (HAZOP). It defines HAZOP as a formal procedure to identify hazards in chemical processes. The summary includes:
- HAZOP identifies potential hazards, failures, and operability problems through a team approach including designers, operators, and safety experts.
- The HAZOP process involves dividing the system into nodes, applying guide words like "no," "more," and "part of" to process parameters to suggest deviations, and evaluating causes and consequences to recommend actions.
- Benefits of HAZOP include fewer problems during commissioning and operation, improved safety and product quality, and evidence of due diligence for insurers.
TO IMPEOVE THE PERFOMANCE OF THE PLANT USING OEEMohamed Fayas
The document outlines an agenda for a BMW TPM management training covering the philosophy and pillars of Total Productive Maintenance (TPM). The agenda includes presentations on TPM overview and philosophy, the eight pillars of TPM, and workshops on problem solving, action planning, and creating a 2005 TPM plan.
The document provides guidance on conducting a HAZOP (Hazard and Operability) study. It discusses:
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FAA HUMAN FACTOR IN AVIATION MAINTENANCE HF MROAmnat Sk
This manual is in response to the industry’s requests for a simple and manageable list of actions to implement a Maintenance Human Factors (MHF) program. A panel of experts selected the following six topics for such a program to be successful:
Event Investigation
Documentation
Human Factors Training
Shift/Task Turnover
Fatigue Management
Sustaining & Justifying an HF Program
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Why is the topic important?
How do you implement it?
How do you know it is working?
Key references
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The selected six topics are critical because they are based on operational data and practical experience from the US and other countries. Transport Canada (TC), United Kingdom Civil Aviation Authority (UK CAA), and the European Aviation Safety Agency (EASA) regulations contributed to this manual. The steps are derived from a panel of ten industry and government contributors who have worked in aviation maintenance for an average of twenty-five years and in MHF for fifteen years. The contributors characterized these six topics and related steps as “information they wish they had known 15 years ago.”
These straightforward suggestions provide the key components for implementing a successful MHF program that will benefit your company, business partners, external customers, and the entire industry. Information is presented in summary bullets as follows:
These are six topics, from many, that a MHF program may consider.
Topics are not necessarily in order of importance, except that the data obtained from Event Investigation (Section 1) provide the foundation for many Human Factors activities.
You may implement any or all of the topics, however, they should be coordinated.
Your MHF activity should be based on the identified requirements and resources of your organization.
You are encouraged to supplement this Operator's Manual with additional references.
This document satisfies the industry request for a short and straightforward list of important actions.
This document provides guidance on completing a Process Failure Mode and Effects Analysis (Process FMEA). It outlines the 25 steps to complete a Process FMEA, including providing details for each process being analyzed, potential failure modes and effects, severity, occurrence, detection ratings, risk priority numbers, recommended actions, and responsibilities. The goal is to proactively identify potential failures in manufacturing processes to improve quality and customer satisfaction.
This document provides an overview of failure mode and effects analysis (FMEA). FMEA is a systematic process for identifying potential failures in a design, manufacturing or production process. It involves reviewing all possible failures, their causes and effects. Potential failures are then ranked according to severity, occurrence, and detection. This allows teams to prioritize high risk failures and identify actions to address them. The document outlines the basic FMEA process including defining potential failures and their effects, identifying causes, current controls and assigning ratings. It also describes how to calculate a risk priority number and use FMEAs to drive process improvement.
This document provides an overview of failure mode and effects analysis (FMEA). FMEA is a systematic process for identifying potential failures in a design, manufacturing or production process. It involves reviewing all possible failures, their causes and effects. Potential failures are ranked according to severity, occurrence, and the ability to detect the failure. This ranking is used to identify areas that need improvement and prevent potential problems. The document discusses the different types of FMEAs (e.g. design, process), how to conduct one including using a worksheet to document the analysis, and how FMEAs can benefit processes by reducing risks and costs.
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.
International Conference on NLP, Artificial Intelligence, Machine Learning an...gerogepatton
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The proper function of the integrated circuit (IC) in an inhibiting electromagnetic environment has always been a serious concern throughout the decades of revolution in the world of electronics, from disjunct devices to today’s integrated circuit technology, where billions of transistors are combined on a single chip. The automotive industry and smart vehicles in particular, are confronting design issues such as being prone to electromagnetic interference (EMI). Electronic control devices calculate incorrect outputs because of EMI and sensors give misleading values which can prove fatal in case of automotives. In this paper, the authors have non exhaustively tried to review research work concerned with the investigation of EMI in ICs and prediction of this EMI using various modelling methodologies and measurement setups.
Embedded machine learning-based road conditions and driving behavior monitoringIJECEIAES
Car accident rates have increased in recent years, resulting in losses in human lives, properties, and other financial costs. An embedded machine learning-based system is developed to address this critical issue. The system can monitor road conditions, detect driving patterns, and identify aggressive driving behaviors. The system is based on neural networks trained on a comprehensive dataset of driving events, driving styles, and road conditions. The system effectively detects potential risks and helps mitigate the frequency and impact of accidents. The primary goal is to ensure the safety of drivers and vehicles. Collecting data involved gathering information on three key road events: normal street and normal drive, speed bumps, circular yellow speed bumps, and three aggressive driving actions: sudden start, sudden stop, and sudden entry. The gathered data is processed and analyzed using a machine learning system designed for limited power and memory devices. The developed system resulted in 91.9% accuracy, 93.6% precision, and 92% recall. The achieved inference time on an Arduino Nano 33 BLE Sense with a 32-bit CPU running at 64 MHz is 34 ms and requires 2.6 kB peak RAM and 139.9 kB program flash memory, making it suitable for resource-constrained embedded systems.
CHINA’S GEO-ECONOMIC OUTREACH IN CENTRAL ASIAN COUNTRIES AND FUTURE PROSPECTjpsjournal1
The rivalry between prominent international actors for dominance over Central Asia's hydrocarbon
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geopolitical, geostrategic, and geoeconomic variables. Topics including trade, political hegemony, oil
politics, and conventional and nontraditional security are all explored and explained by the researcher.
Using Mackinder's Heartland, Spykman Rimland, and Hegemonic Stability theories, examines China's role
in Central Asia. This study adheres to the empirical epistemological method and has taken care of
objectivity. This study analyze primary and secondary research documents critically to elaborate role of
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Presentation of IEEE Slovenia CIS (Computational Intelligence Society) Chapte...University of Maribor
Slides from talk presenting:
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This paper describes a speed control device for generating electrical energy on an electricity network based on the doubly fed induction generator (DFIG) used for wind power conversion systems. At first, a double-fed induction generator model was constructed. A control law is formulated to govern the flow of energy between the stator of a DFIG and the energy network using three types of controllers: proportional integral (PI), sliding mode controller (SMC) and second order sliding mode controller (SOSMC). Their different results in terms of power reference tracking, reaction to unexpected speed fluctuations, sensitivity to perturbations, and resilience against machine parameter alterations are compared. MATLAB/Simulink was used to conduct the simulations for the preceding study. Multiple simulations have shown very satisfying results, and the investigations demonstrate the efficacy and power-enhancing capabilities of the suggested control system.
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2. PFMEA Training
1
1.0 What is a PFMEA?
l A Process Failure Modes and Effects Analysis provides a structured,
qualitative, analytical framework which taps the multi-disciplined
experience of the team to brainstorm answers to such questions as:
l How can this process, function, facility, or tooling fail?
l What effect will process, function, facility, or tooling failures have on the
end product (or customer)?
l How can potential failures be eliminated or controlled?
l Based on the success of Failure Modes and Effects Analysis (FMEA),
the PFMEA concept was developed to incorporate a broader analysis
team to accomplish a thorough analysis in a short time
l A PFMEA can be used to assess any process. The most
common use of the PFMEA involves manufacturing processes
l PFMEAs may be performed on new processes or to improve
current processes
l To maximize its value, a PFMEA should be performed as early in
the manufacturing development cycle as possible
3. PFMEA Training
2
1.0 What is a PFMEA? (cont)
l Because most PFMEAs involve manufacturing area processes, the
manufacturing engineer is usually the team leader
l The effectiveness of the team depends upon the expertise of its members,
and the quality of the team output depends on the willingness of each team
member to give his or her best effort
l Teams may include:
l Manufacturing Engineer
l Design Engineer
l Tooling Engineer
l System Safety Engineer
l Industrial Engineer
l Handling Specialist
l Line Foreman/Operators
l Customer
l Materials & Process Engineer
l Others as required
4. PFMEA Training
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2.0 How to Conduct an Effective PFMEA
l Prior to the first meeting, the team leader
should
l Establish objectives and scope
l Choose experts for the PFMEA team
l The team leader is responsible for the effectiveness of the
review
l Brainstorming used to increase creativity and bring out a wide
range of ideas
l Discussion allows team to look at things from different view points
l A visit(s) to the work area with an overview of the process/ test/
operation gives team members basic understanding of the
process
l Limit meetings to one hour
5. PFMEA Training
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2.0 How to Conduct an Effective PFMEA (cont)
l STEP 1
l Team leader organizes the team; defines the goals, methods, scope,
responsibilities of each team member; and establishes a tentative
schedule
l After reviewing engineering, drawings, and planning, team develops a
flow chart showing the major functions or operations of the process to
help team members understand the process
l STEP 2
l For each process function, team determines all credible failure modes
l Team discusses and records the failure effects, failure causes, and
current controls for each potential failure mode
l Team rates occurrence, severity, and detection for each failure cause
l It is helpful to rate all failure causes for occurrence first, next rate for severity,
and then rate for detection
l The Risk Priority Number (RPN) is the product of these ratings
6. PFMEA Training
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2.0 How to Conduct an Effective PFMEA (cont)
l STEP 3
l Identify corrective action to improve the process/test
l Failure causes with the highest RPN should be analyzed first
l High occurrence number indicates the causes should be eliminated or
controlled
l High detection number indicates a need for additional controls
l High severity number indicates product or process redesign may be needed
l Conduct additional brainstorming to develop effective and innovative
ways to reduce failure
l Proposed changes identified as “Resulting Action Taken” and new
occurrence, severity, detection, and RPN ratings are assigned
7. PFMEA Training
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2.0 How to Conduct an Effective PFMEA (cont)
l STEP 4
l Proposed changes for high/significant RPN ratings that have not
been completed are listed on the PFMEA form as “Open Work –
Preventive Action Report (PAR) Required” along with applicable
name and organization
l PFMEA team reaches agreement on items to keep open and carry
forward
l All “Open Work – PAR Required” items will be included in the
executive summary of the PFMEA TWR
l Individual members will be responsible for the implementation of
their respective “Open Work” items
l Presenting the PFMEA results to management and releasing the
final report completes the PFMEA effort
8. PFMEA Training
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3.0 PFMEA Team Organization
l PFMEA team members are assigned to function as team leader,
scribe, recorder, and facilitator
l Team Member – uses personal knowledge, expertise, and
perspective; participates in meetings helping the team reach full
potential
l Checklist
l Be prepared
l Be innovative – Ask questions, challenge
assumptions
l Complete and close all action items
assigned
9. PFMEA Training
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3.0 PFMEA Team Organization (cont)
l Team Leader – responsible for planning, organizing, staffing, and
chairing; ensures a thorough and credible PFMEA analysis is
performed
l Checklist
l Select 5-10 team members to represent engineering organizations and/or work
operations involved
l Select appropriate team members to function as scribe, recorder, and facilitator
l Prior to the first team meeting
l Develop scope for PFMEA
l Review PFMEA guidelines and forms
l Develop schedule
l Resolve any questions about performing the PFMEA
l Distribute guidelines, objectives, scope, and schedule to each team member
l After each team meeting, review team’s progress
l Ensure any required changes in engineering, planning, etc. are included in team’s
recommendations
l Prepare final report and report all open action items
10. PFMEA Training
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3.0 PFMEA Team Organization (cont)
l Scribe – record team members’ comments on white board or flip chart
as the team brainstorms
l Recorder – record team’s thoughts as listed on board/chart
l Checklist
l Record points outlined on white board or flip chart
l Expand, summarize, and/or edit the ideas as they are recorded
l Provide notes to the team leader or draft team minutes according to
the team leader’s direction
l Help complete PFMEA work sheets
l Checklist
l Document comments on white
board/flip chart
l Get team concurrence with what was
documented
l Clarify comments as necessary
11. PFMEA Training
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3.0 PFMEA Team Organization (cont)
l Facilitator – the system safety/reliability engineer is generally the
PFMEA facilitator. The facilitator supports the team by enhancing
process consistency
l Checklist
l Provide copies of PFMEA instructions and other materials to the
team leader
l Assist team leader in evaluating team performance as requested
l Function as a consultant throughout the PFMEA analysis
l Assist team leader and team in effectively utilizing PFMEA analysis
12. PFMEA Training
11
4.0 PFMEA Form and Documentation
l The PFMEA form provides the structured format for meetings,
analysis, and documentation of findings
l Two variations of the form are available; use depends on the
complexity of the process and/or potential need for review
l Long form includes follow-up documentation for evaluation of initial
recommendations:
l First time process review
l New processes
l Major process enhancements or changes
l Short form used for:
l Repeat evaluated
l Simple processes
13. PFMEA Training
12
Process Failure Modes and Effects Analysis (PFMEA) – Long Form
PROCESS: DATE:
Process
Function
Potential
Failure
Mode
Potential
Effects of
Failure
Potential
Cause of
Failure
Current
Controls
Recommended
Actions
RPN
Responsible
Activity and
Status
S
E
V
O
C
C
D
E
T
RPN
S
E
V
O
C
C
D
E
T
Legend: OCC = occurrence DET = detection
SEV = severity RPN = Risk Priority Number
14. PFMEA Training
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Process Failure Modes and Effects Analysis (PFMEA) – Short Form
PROCESS:
Process
Function
Potential
Failure
Mode
Potential
Effects of
Failure
Potential
Cause of
Failure
Current Controls Recommended ActionsRPN
S
E
V
O
C
C
D
E
T
Legend: OCC = occurrence DET = detection
SEV = severity RPN = Risk Priority Number
DATE:
15. PFMEA Training
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4.0 PFMEA Form and Documentation (cont)
l Potential Failure Modes – list all credible failure modes or ways
the process/test can fail before addressing failure effects and
failure causes
l “What can possibly go wrong with this process/test?”
l “How can the part (component, assembly, or product) fail to meet
the engineering criteria or specification?”
l In each instance, the assumption is made that the failure could
occur, but will not necessarily occur
l Each failure mode should be credible
l Do not list acts of God or freak accidents
l Examples of failure modes include
Bent Cracked Contaminated Loosened
Leakage Damaged Deformed Gouged
Misaligned Corroded Broken Tooling Wrong Tooling
Wrinkled Scratched Humidity Handling Damage
16. PFMEA Training
15
4.0 PFMEA Form and Documentation (cont)
l Potential Effects of Failure – assuming the failure mode has
occurred, list all potential failure effects of the process failure
l Worst case effects such as “leakage past an O-ring seal” should be
considered first
l Less serious failure effects such as “rework – schedule impact”
may then be noted
l In each case, understand that a process failure can affect the
immediate process, the subsequent processes, the end item, end
item users, or the customer
l Potential Failure Causes – failure cause of each potential failure
mode should be thoroughly discussed and listed by the team
l “What conditions can bring about this failure mode?”
17. PFMEA Training
16
4.0 PFMEA Form and Documentation (cont)
l Current Controls – usually verification techniques; list all
controls intended to detect or eliminate the failure causes thus
preventing the failure mode from occurring
l “If a defect or process failure occurs, will it be detected or
prevented by the current controls”?
l If current controls are adequate, no corrective action is needed
l If current controls are not adequate, corrective action should
recommend additional or enhanced controls
l Quantitative vs Qualitative Evaluation – evaluating failures for
occurrence, severity, and detection may be accomplished
using quantitative or qualitative techniques – the two
methods should not be combined
l Quantitative approach relies on numerical data
l Qualitative approach relies on team members’ experience,
judgment, involvement, and participation
18. PFMEA Training
17
5.0 Occurrence Rating
l When estimating the occurrence rating, consider the probability that
the potential failure cause will occur and thus result in the indicated
potential failure mode
l Disregard detection at this point in the process
Occurrence Rating Criteria
1
Low probability of occurrence. Relatively few failures have occurred. 2-3
Moderate probability of occurrence. Occasional failure, but not in
major proportions
High probability of occurrence. Process has experienced higher than
normal failure rate
7-8
Very high probability of occurrence. Process failure is almost certain. 9-10
Remote probability of occurrence. The team is not aware of this
failure having ever occurred.
4-5-6
Criteria Rating
19. PFMEA Training
18
6.0 Severity Rating
l Severity is the factor that represents the seriousness or impact of the failure
to the customer or to a subsequent process
l Severity of failure relates to process failure effects and is independent of occurrence
and detection
l Severity of a failure effect is therefore the same for all failure causes
l Severity should be considered as though no controls are in place
Severity Rating Criteria
1
Low severity rating. Failures have minor effect on further processing or product
performance.
2-3
Moderate severity rating. A failure that causes customer concern or program impact,
but will not cause a Criticality 1 failure of the end item or anequivalent process failure.
High severity rating. Failure causes severe impact to component or process and may
contribute to a Criticality 1 failure of the end item or an equivalent process failure.
7-8-9
Very high severity rating. Failure contributes to a known or highly probable Criticality 1
failure of the end item or an equivalent process failure involving loss of life or a major
loss of manufacturing facilities
10
Failure would have very little effect on further processing or product performance.
4-5-6
Criteria Rating
20. PFMEA Training
19
7.0 Detection Rating
l Estimate probability of detecting a process or product defect (caused
by the failure identified) before the part/component/assembly leaves
the manufacturing location
l Consider only the controls contained within the process planning
Detection Rating Criteria
1
Low probability of product leaving the manufacturing area containing the defect.
The defect is easily detectable.
2-3
Moderate probability of product leaving the manufacturing area containing the defect.
The defect is somewhat more difficult to detect.
High probability of product leaving the manufacturing area containing the defect.
Detection may require special inspection techniques.
8-9
Very high probability of product leaving the manufacturing area containing the defect.
Defect may elude even the most sophisticated detection technique.
10
Remote probability of product leaving the manufacturing area containing the
defect. An obvious defect.
4-5-6-7
Criteria Rating
21. PFMEA Training
20
8.0 Risk Priority Number (RPN)
l The RPN is the product of the occurrence, severity, and detection
ratings for each cause of a failure mode
l The highest RPNs are considered the most critical and should be
tracked using the PAR system until closed and agreed to by the
team
l These RPNs should also be given first consideration for
corrective actions
9.0 Recommended Actions
l The most important feature of the PFMEA is formulation and
implementation of the recommended actions
l Actions are developed as part of an overall strategy to reduce the
risk of a process failure
l If the resulting RPN has not changed, the logic of the
recommended action should be questioned
22. PFMEA Training
21
10.0 Resulting RPN
l Resulting RPN is the product of the occurrence, severity, and detection
ratings that result from the implementation of a recommended action
11.0 Responsible Activity and Status
l Specific actions recommended by the team for high/significant RPN
ratings are assigned to the organization and actionee who can most
effectively implement the change or enhancement
l Significant open work action items agreed to by the team will be tracked by
the PAR
12.0 PFMEA Reporting
l Upon completing the PFMEA, a
report is written to document the
team’s accomplishments