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Failure Mode Effects Analysis
Rating: 3.8 out of 5(30 ratings)
124 students

Failure Mode Effects Analysis

FMEA Project Execution
Created byAW Schultz
Last updated 9/2022
English

What you'll learn

  • Lean how to manage a FMEA Project
  • What is System, Process, and Product Criticality Ranking
  • Deference between a design and process FMEA
  • FMEA process from initiation to closer
  • Build FMEA Report
  • Real Case Studies
  • How to apply FMEA Internally and Externally
  • What is the FMEA Rating Scale
  • Tools to engage FMEA team
  • Reverse FMEA

Course content

9 sections58 lectures4h 34m total length
  • Course Introduction3:44

    This course introduces the topic potentials Failure Mode and Effects Analysis (FMEA) and gives guidance in the application of the technique. An FMEA can be described as a systemized group of activities intended to

    1.Recognize and evaluate the potential failure of produce or process and its effects

    2.It helps to identify actions that could eliminate or reduce the chance of the potential failure occurring

    3.Gives a documented process that is complementary to the design process of defining positively what a design must do to satisfy the customer

  • The Cost of Failure9:50

    The Cost of Failure or the Cost of Quality is much misunderstanding about quality despite the various definitions in circulation. Quality of product and process can mean different things to many people, but the quality is also not some things that have been assumed over time. We will look at the different ways how failures occur by first understanding what drives decisions around determining the cost of quality and losses in either product or process of quality.

    • An expensive process — One of the first questions, when a quality improvement effort is proposed, is "How much will this cost?" The cost of failure is always a valid question, but an uninformed view can produce an invalid answer. Conventional wisdom, perhaps better called "conventional ignorance" in this case, has it that better quality costs more.

    • An expensive product — This may be the most significant misunderstanding because of the tendency to view quality in terms of products. An automobile with leather seats and little mechanical wipers on the headlights costs more than one without these features. A fine "writing instrument" costs more than a plastic ballpoint pen. Nevertheless, price does not confer quality. Review the definitions of quality. None of them mentions price. Quality arises from an ability to satisfy customer needs. If a customer's goal is to spend money, an expensive product may not be viewed as top quality. Customers generally seek the lowest price for a product that meets their functional needs, not the highest. Considering accuracy and maintenance, an inexpensive digital watch from a drugstore provides better quality than a more expensive mechanical watch from a jewelry store. A customer may want the jewelry item, but only because it serves a purpose other than timekeeping, not because it is a better-quality watch.

    Failure costs may result from either internal or external failure. The significant costs associated with internal failures, which occur before a product has been delivered to a customer, are scrap and rework could occur. At the end of some process, a product may not conform to prescribed specifications. The degree of nonconformance may be so severe that the product cannot be fixed and must be discarded. Any costs associated with production to this point are lost and considered scrap.

    In some cases, the degree of nonconformance may not be so severe. A reasonable amount of additional effort may bring the product into conformance, so the effect is re-entered into the process, and any other work adds to the overall cost of production. This is rework. An FMEA can work to prevent early in the process. The scrap and rework costs are more than the sum of lost product and additional work. Costs associated with

    • disposal

    • storage

    • transportation

    • inventory control determines total costs.

    External failures after a product have been delivered to a customer may generate costs for repairs following product warranty obligations. They may also cause product recalls, which can be far more expensive. Consider the potential cost of fixing a defective part during assembly versus recalling 1.2 million automobiles to replace the bad part. Recall costs are orders of magnitude higher than repeat costs. The cost of human suffering and loss of life cannot be calculated, but courts will do their best. Resulting awards in compensatory and punitive damages can be astronomic. External failure costs include those associated with complaints and complaint handling.

    In 2009 Toyota Motor Company faced one of the most expensive recalls in our generation. One of the most feared scenarios is a driver not being able to stop a car. After several car accidents, Toyota issued a large recall that it nearly equaled the same amount of vehicles sold by all U.S. carmakers combined. In this case, it was determined that the pedals were sticking down to the ground; the pedals were made of weak materials, and that caused the pedal to crack, bend, or break.

    Another example of failing to identify risk is when an estimated 1 million Infantino SlingRider and Wendy Bellissimo baby slings were recalled in the U.S. and other nations. It was raised to concern when 3 infant deaths and the Consumer Product Safety Commission issued a warning that the slings posed a suffocation risk. The slings were designed to hold babies close to their mother's chest, but the fabric would then press against the baby's nose or mouth and cause suffocation hazards to babies.

    Businesses must pay exceptionally skilled staff members to receive and respond to complaints. These employees must be empowered to offer satisfaction of various kinds, all of which have a cost. Loss of customers is a cost of nonconformance that has been characterized as unknown and unknowable. Suppose a  man buys an expensive suit at a high-end store. He wears it to a special event where a careless guest spills something on it. He has it dry-cleaned but notices that one of the side seams has opened up on its return. He takes it back to the store, where his money is promptly returned because the shop stands by its products. Is the man a satisfied customer? Sure, he got her money back, but what about all the inconvenience and disappointment? Will he ever shop there again? There is no way to tell because no device has been invented to count the number of customers who do not come back through the front door.

    Moreover, what about his friends or colleagues who will never shop there after hearing about his experience? Again, no device exists to count the number of customers who do not initially come through the front door. There is a bit of wisdom in retail sales regarding the buying habits of dissatisfied customers: "The goods come back, but the customers do not understand that failure are significant and many. Unhappy customers do just the opposite, and research shows they do so to a greater degree than satisfied customers. With a corps of complainers working against them, organizations may experience a loss of customers, which leads to loss of business, loss of revenue, loss of jobs, and eventual failure of the organization. Failure cost is not a trivial matter to be accepted or analyzed in a spreadsheet. Another reason a Failure Mode Effects Analysis paves the way to determining risk early.

    Prevention costs are fundamentally different from failure costs. These costs are related to things that an organization does rather than to the outcomes of a process. Prevention costs begin with planning. One of the most significant errors a project manager can make is to leap into the performance without sufficient planning. Planning may be limited for many reasons, none of them perfect. Urgency may be a reason, but if the need for the product is so urgent, the product should be correct when delivered. Management's desire to cut costs may be a reason, but would management be willing to fund the effort required to do the work and make it right if it is not delivered? Planning generates early costs, but good planning prevents later costs from changing to a preliminary plan. The cost of changes goes up as the project progresses. Changes made during implementation are far more expensive than changes made during planning. Process planning establishes the steps to produce the project's product. Process control ensures that the process performs as expected. A well-trained workforce may produce defective products if the established procedures cannot have a high degree of conforming product. Methods tend to be somewhat static, but other things (materials, management, working conditions, tools, requirements) change around them. Processes must be monitored and analyzed to ensure that they are current with the organization's needs and not something that is done because it seemed like a good idea at the time of implementation. Process planning will cause an organization to incur costs for the plan and additional costs for control activities and process improvements. Still, these costs will pay back in reduced defects over time. Product reviews constitute another prevention cost. Customer coordination and requirements definition, internal design reviews, and reliability engineering all generate early costs that contribute to the quality of the final product. Suppliers are a critical component of quality.

    To look as examples, we look back at an article published in 2017 by EHS Daily Advisor called The Cost of Catastrophe:? The  Chemical Safety and Hazard Investigation Board (CSB) issued a report resurfacing four investigations: The 1st was West Fertilizer Company, then Chevron Richmond Refinery, the Deepwater Horizon Well Blowout, and the BP Texas City Refinery. These investigations revealed both the human and the financial toll of large-scale catastrophes:

    April 17, 2013, an explosion at West Fertilizer Company in West Texas caused 15 fatalities and more than 260 injuries. It cost more than $247 million, including $16 million in federal disaster assistance and $230 million in insurance-related losses. Worse, the company was only insured for $1 million.

    August 6, 2012, an explosion at the Chevron Richmond Refinery in Richmond, California, caused more than 15,000 injuries. It cost nearly $450 million, including $2 million in fines and restitution, leading to a $447 million increase in gas prices.

    The March 23, 2005, explosion at the BP Texas City Refinery in Texas City, Texas, killed 15 workers and injured 180 more. Financial losses in the incident totaled $1.5 billion.

    A final April 20, 2010, explosion aboard the Deepwater Horizon in the Gulf of Mexico left 11 workers dead and 17 injured. Employers were paid more than $21 billion in settlements and more than $11 billion in economic and medical claims—that is almost as much as the entire budget proposed for the Department of Energy in 2017 ($32.5 billion). Worse, litigation remains ongoing in the case, and the settlement for medical costs was uncapped and remained an ongoing cost.

    When the costs of quality can be in the hundreds of millions or even in the tens of billions of dollars, it ought to be relatively simple to make the case that prevention is a far more cost-effective option. A stronger focus on FMEA and Risk could have prevented these problems.


  • Purpose of FMEA7:09

    The purpose of FMEA is to stop failures before they occur; preventing process and product problems is the intention of Failure Mode and Effect Analysis (FMEA). They substantially reduce product design, and manufacturing processes costs by identifying product and process improvements early in the development when alterations are less expensive. In addition, holding an FMEA is a more rigid process since the need for after-the-fact corrections and late change is reduced or eliminated.

    While FMEAs can be effective alone, a company will not benefit without supporting FMEAs and implementing improvements.

    When should you do an FMEA?

    • When designing a new system, products, and processes

    • When changing existing designs or processes

    • When carry-over technique is used in recent application

    • After strategy, development, or process functions, but before beginning detailed final design

    • In the Define stage of a project to understand the risks of a product

    • To know-how process steps relate to risk and to prioritize

    • To understand the improvements implementation risks

    • Assess the effectiveness of a plan


    The cost of not doing FMEA can be devastating. Dr. David M. Anderson wrote an article about Design for Manufacturability where he talks about "The Rule of 10 ".

    He claims that it costs ten times more to find and repair a defect at the next assembly stage, and then it costs ten times more at each subsequent stage of assembly.


    An FMEA can have a practical impact on the business. Here are just a few examples where FMEA offered process improvement and quality assurance to the organization. Ford automotive required an FMEA on its automobile liquid-level floats due to high defect rates and customer complaints. Ford asked to conduct a design FMEA and a process FMEA on its supplier. The supplier would establish three FMEA teams, each assigned a different aspect of the process and product. Three team leaders were given the responsibility for the completed FMEA. The groups’ combined efforts decreased defectives to 0.2 parts per million. The equipment increased its uptime from 74 percent to 89 percent. According to Ford, the customer complaints dropped from an average of two per year to none. They saw a productivity per labor hour increase by 22 percent. Each team delivered its results.

    The second example of FMEA success involves an aircraft engine manufacturer conducting an FMEA on its engine assembly operation. Although all were familiar with assembly, a cross-functional team assembled that included individuals from the outside department. The team identified the most significant risk of failure and mistake-proofed the process to the point where there were no recurring occurrences. As a result, internal losses saw a reduction of one-third; they could eliminate problems that had existed for many years but were not high enough a priority to address until the FMEA. As a result, the manufacturer saved $6,000 per month on engine teardowns.

    The final example dealt with a small, printed circuit board manufacturer with thirty-five employees that trained and created an FMEA team. In this example, the manager was a team member; his role was to keep notes and lead the team. After a brief FMEA training session, the group collected and gathered information from other operators that were not part of the team. Having this information, they could complete the FMEA in four two-hour sessions. As a result, they created a list of the highest-priority items. The team determined that many of the failure modes were related to preventive maintenance of the soldering unit. After establishing and implementing a preventative maintenance program, the team decreased production defects on the complex boards they manufactured from 11 to 1 reduction boards. These three examples display an excellent example of the function of an FMEA, the FMEAs value in different segments, and team calibration and structure problem-solving.


    There are two types of FMEA's: Design FMEA and Process FMEA.


    The Design FMEA is a methodology used to analyze risks associated with a new, updated, or modified product design. It explores the possibility of product/design malfunctions, reduced product life, and safety and regulatory concerns/effects on the customer derived from:


    Some examples of designs that FMEA may look at are…


    · Material Properties which may include Strength, Lubricity, Viscosity, Elasticity, Plasticity, Malleability, and Machinability

    · The Geometry of the Product. It is Shape, Position, Flatness, or Parallelism,

    · An FMEA will also look at how it Interfaces with other Components or Systems. It could be Physical Attachment/Clearance; Energy Transfers; Material Exchange, or Flow Gas/Liquid.

    · How might data exchanges and communication, such as commands, Signals, Timings

    · Engineering Noise including User Profile, Environments, Systems Interactions & Degradation



    The Process FMEA follows the same process however looks specifically at processes. The FMEA will discover risks associated with process changes, including failure that impacts product quality, reduced reliability of the process, customer concerns, and safety or environmental hazards derived from the following.


    · Human Factors / Human Error

    · Methods involved in processes of product/service including assembly lines, supply chains, and communications standards

    · Materials used in the process

    · Machines utilized to do the work

    · Measurement systems and impact on acceptance

    · Environment Factors on process performance


    Regardless of which type of FMEA, either design or process, having the following information plays an essential part in building an effective FMEA strategy.

  • History of FMEA and FMECA4:25

    The historical view of the FMECA goes as far back as the 1940s (almost 20 years before Six Sigma would see its value). The FMECA was practiced in the United States Military Procedure called the MIL-P-1629, which is the titled procedure for performing a failure mode, effects, and criticality analysis. It served as a reliability assessment technique to show the effects of system and equipment failures. The errors were rated according to their impact on success, people, and equipment safety.

    Moving forward to the 1960s, NASA used what was called an FMEA; Failure Mode and Effects Analysis for the Apollo project as a means of assuring that hardware built for space applications has the desired reliability characteristics. The failure mode and effects analysis is a qualitative reliability technique for systematically analyzing each possible failure mode within a hardware system, and identifying the resulting effect on that system, the mission, and personnel. The criticality analysis is a quantitative procedure that ranks the critical failure modes according to their probability of occurrence. By 1965 the aerospace industry adopts this method. Jump ahead 10 years and it was adapted with the nuclear technology programs. To this day it is still a standard practice in automotive and in 1977 Ford began using FMEA for preventive quality assurance after the Ford Pinto model encountered severe problems following its release.

    Even today, FMEA is standard practice before releasing new automobiles into the market. In 1990 procedures at DGQ (German Society for Quality and German Institute for Standardization) were completed. This is followed by use in a wide variety of areas of medicine and communications technology. In 1994 the first joint edition of the QS-9000 by Chrysler, Ford, and General Motors regarding the FMEA manual. By 1996 moving forward, there is a uniform FMEA procedure that everyone recognizes. The car manufacturers specify requirements for suppliers to create FMEAs for their products.

    The internationally valid ISO 9001: 1994 standard is the basis for the extended needs of the automotive industry. Although developed by the military, the FMEA method is now extensively used in various industries, including semiconductor processing, food service, plastics, software, automotive, healthcare, medical technology, food industry (as HACCP system), plant construction, and software development, to name a few. Due to so many industries that began using the lead to the standard MIL-STD-1629 to be canceled so as not to force a standard the couldn’t be used throughout other industries. we start learning about how to do an FMEA. IATF 16949:2016 is a technical specification aimed at developing a quality management system that provides a continual improvement, emphasizing defect prevention and reducing variation and waste in the automotive industry supply chain and assembly process. It is based on the ISO 9001 standard, and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016.

    In 2019, AIAG (Automotive Industry Action Group,) and VDA two of the leading automotive trade associations, unveiled a major revision to FMEA methodology. The result is one common foundation for FMEAs across the global automotive sectors represented by AIAG and VDA. It represents the culmination of a three-year project revising and improving FMEA methodology

  • When to use FMEA3:11

    FMEA is a tool; understanding where to use it is vital. FMEAs provide a structure and a common language used in manufacturing and service, profit and not-for-profit, public, private, or governmental organizations. FMEA is a tool for the manufacturing, maintenance, or engineering department and improves support processes.

    The FMEA is a tool to identify and correct safety hazards to its function. It allowed users to anticipate and eliminate safety problems before they occur. Consequently, FMEAs can improve the safety of manufacturing a product and improve the safety performance of the product itself. When these safety focus FMEAs arise in manufacturing, a balanced combination of people who operate the equipment and others who are not involved in using the equipment. This combination of user knowledge and outsider observations provides a comprehensive analysis of the hazards. In addition, FMEAs conducted on products to determine their safety are critical in today's quarrelsome society. Companies want to assure their customers that their products are safe and fit for use.

    In many cases, product instructions are not sufficient to spell out safe operating procedures of products. It is helpful to involve consumers or end-users of the product in an FMEA. Asking the customers to use the product, other FMEA team members should observe functionality in a Design FMEA or be asking about the capabilities in a Process FMEA. It can also be possible for a product to be incorrectly used or not for its intended purpose. Uncovering these risks during the FMEA gives the final product safeguards to protect the consumer and prevent possible recalls.

    FMEAs can determine financial strategies and assess credit or investment risks.

    Problems created by software bugs or incorrect programs can lead to potentially fatal disasters. As with a product or design FMEA, a software design quality FMEA can identify problems before they can be eliminated or reduced. As a result, FMEAs can help make information systems' design and installation robust. An FMEA conducted before advertising or marketing launch can help businesses avoid costly and sometimes embarrassing mistakes in marketing. An FMEA can be used to identify offensive or misleading advertising copy. The FMEA Project can preplan reaction and response to potentially damaging product disasters.

    In almost every industry where preplanning and risk can occur, an FMEA can serve as a valuable tool to identify priorities in future work.

  • The 7 Steps to FMEA Project9:50

Requirements

  • Basic understanding of your FMEA process
  • Knowledge of Excel templates
  • Ability to build and report out presentations

Description

FMEA is now a common strategy in organizations all over the world. In this course, you will learn the fundamental concepts you need to act as an agent for FMEA projects in your organization. This course will outline historical insights, primary methodologies, and core concepts associated with Process and Design FMEA. You will learn what FMEA means, how to run your FMEA from concept to completion, how to scope your FMEA project, and how to facilitate an effective FMEA and core methodologies of Process and Design FMEA. The course will also cover foundational concepts of FMEA. Students are asked to complete projects throughout the course. Our goal is to teach you the key concepts you need to act as an agent for FMEA in your organization. This course will outline a Foundation of knowledge for you. You will learn about the History of FMEA, Some Key methodologies used in FMEA, including the Risk Priority Number. This course will launch you into the world of FMEA.

What would you get after taking this course: FMEA Project?

  • You become FMEA Project leader.

  • Become a pro at asking tough brainstorming questions

  • Understand several real-life anecdotes from industry experts

  • Receive trainer assistance using the Q&A Discussion board

  • Add the FMEA credential to your resume

  • Become a problem solver for your business

  • Learn root-cause analysis techniques

  • Learn how to create an FMEA project dashboard

This FMEA Project is suitable for individuals from:

  • Engineering

  • Manufacturing

  • Maintenance and Reliability

  • Transaction processing

  • Business Process Outsourcing (BPO)

  • Knowledge Process Outsourcing (KPO)

  • Or any repeatable nature of business in the Service Industry

This FMEA project is not for anyone outside of the given scope.

This FMEA Project is comprehensive yet straightforward designed to help you learn FMEA Project tools and techniques using practical, real-life examples and lots of activities. As a bonus, in this FMEA Project, you will also learn to create complex statistical analyzes such as Hypothesis Testing, Design of Experiments, and Mistake Proofing.

Whether you want to:

  • Become an in-demand FMEA professional for potential service industry organizations

  • Go freelance and work from home, set your schedule and rates

  • Sharpen your process improvement skills to reach the advanced level

  • Bring your ideas to life with your first FMEA case study

This complete FMEA course is what you need and more. (You'll even get a certificate of completion to add to your arsenal).

What makes this course great?

Like you, thousands of others were frustrated and fed up with fragmented online know-it-all tutorials, which assumed you could understand the complex manufacturing jargon and left you without having you practice what you have learned.

Like you, they were tired of low-quality lessons, poorly explained topics and generally confusing info presented in the wrong way. Its high-definition, comprehensive tutorials are designed with simplicity and seamless progression in mind.

You will get the best-in-class support from the instructor for any questions you have related to the course.

The course is very well structured:

  • The course duration is 4.5 hours

  • You become an expert in FMEA tools and techniques

  • These 7 steps  over 50 short lectures

  • Each lecture covers bite-sized information; easy to grasp and apply

  • Each lecture consist of a video screencast

  • Each section is well-rounded with:

    • A section objective discussed at the beginning

o Then, the concept discussed at length

o Have examples are discussed to review concepts from a practical perspective

o This is followed either by an activity or a quiz

o Real Life Proficiency Hacks are added for you to be proficient in using this methodology

o Each section ends with an apt summary

· Numerical activities are supplemented with live process data

· There are several downloadable ready-to-use templates that are comprehensive and pertinently cover everything you'll need to run your FMEA Project

Using the Q&A discussion board, you receive trainer assistance on course-related questions.

The market is never short of jobs in quality, process excellence functions. There are great jobs. They only need skilled individuals. They are ready to hire individuals with hands-on knowledge who outshine the interview process.

**** A little more detail on FMEA Project Training and its Benefits ***

What is an FMEA?

The FMEA is a strategically designed set of tools and techniques that help improve business processes within an organization. The primary goal of FMEA is to drive access to organization access and prioritize risk.

What are the benefits of FMEA?

  • FMEA's helps your organization reduce variation and eliminate errors

An organization has several business processes. Each business process has its own unique set of procedures followed by individuals working in that business. Completing this training enables YOU to become crucial to your organization to identify and eliminate variation and repeatable process errors.

With an FMEA Project, you can help transform and enable your organization to increase revenue by identifying and eliminating errors that would otherwise have brought poor customer satisfaction and losses to the business. FMEA Project professionals can help reduce variation, errors, customer complaints, cycle time, cost, schedule delays, and spending/revenue leakages.

  • Improve your business and sustain the gains

Once you have your FMEA Project certification, you'll be able to prove you have the knowledge to identify gaps in an organization's business process, and you will be able to measure, analyze and improve those gaps. You will also have the ability to conduct a complete review of the current process and gain a clear understanding of their impact on the output.

You'll also develop the ability to achieve exceptional improvements in your business and sustain them by monitoring processes closely to ensure there is little or no deviation from the mean and taking corrective measures to improve your implemented actions.

  • FMEA is applicable across industries

What is the value of FMEA? FMEA techniques are applied in aerospace, electronics, telecom, banking and finance, IT, HR, marketing, and many more industries as an industry-independent methodology.

Getting an FMEA can lead to better job opportunities and improved salaries -. FMEA professionals get so much respect because the practical applications of FMEA tools and techniques require creative and out-of-the-box thinking - and executives and hiring managers at major companies are well aware.

With an FMEA Project, you will position yourself as a change agent, spearheading quality improvement throughout your team or organization, showcasing your leadership skillset. With FMEA Project, you become knowledgeable in dozens of different methods to streamline business processes, improve employee acceptance, reduce costs, and increase revenue - all of which lead to a better bottom line, no matter the industry.

As a professional, you need to adapt yourself to the changing demands of your industry. No matter what industry you are a part of, it would help adjust your knowledge to different situations.

Improve Your Managerial and Leadership Ability

FMEA Project training also prepares you for leadership roles, with the techniques and know-how to cut costs, increase revenue, and improve the business process's efficiency. Those who achieve complete this course are educated on the methodologies of FMEA. They are also prepared to become a change agent within their organization, leading efforts to improve processes, product quality, customer services, and Gain Hands-On Experience In Quality Management

Unlike a few other FMEA training, it includes hands-on work on industry projects and experience implementing theoretical principles to real-life scenarios. It looks at FMEA as a Project, not a spreadsheet.

Who this course is for:

  • Service Industry and Manufacturing Operations Professionals
  • Design Responsibility Engineers
  • Reliability Professionals
  • Maintenance Professionals
  • Executives Seeking Advanced Knowledge