Failure Mode Effects Analysis (FMEA)

Failure Mode Effects Analysis (FMEA)
Doc #: FME004 FMEA Presentation Document & Process Owner: Fluke Quality Group Rev: 003

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Introductions Name Job Responsibilities Experience with FMEA
Hobby or Fun Fact Course expectations Facilitator Notes: The purpose of this exercise is to get everyone acquainted since they will be working together for the next couple of days. Even intact teams should introduce themselves. Each participant should take about 1 min. Participant Notes: Take 1 minute or less to introduce yourself. FME004 FMEA Presentation

Flashlight Ice Breaker
Instructions: You are responsible for the launch of the Luminastic Company’s latest LED flashlight. Customers have been returning flashlights because they simply do not shine any light. Returned parts show the batteries were installed correctly and had adequate charge. Break into OpCo teams Divide a flipchart down the middle and label the left side Design and the right side Process Brainstorm as many possible causes of the issue and list them on the appropriate side. List as many as possible in 2 minutes. Deliverable: Each team report out 3 different design and 3 different process causes Time allotted: 10 minutes total with discussion Facilitator Notes: Ask how many people have had PSP training. Note how many possible causes were listed. Which ones do you pursue? Which should have been pursued during development? How many items on your list have a Design and Process cause for the same failure mode? Which is it? Did anyone use 5-whys to get to the root cause? FME004 FMEA Presentation

Flashlight System Flow Down Example
Sub-systems System Housing / LED system Battery system Facilitator Notes: If you don’t have an actual flashlight or are giving training online, use this slide. End cap switch FME004 FMEA Presentation

Flashlight Ice Breaker
You are responsible for the launch of the Luminastic Company’s latest LED flashlight. Customers have been returning flashlights because they simply do not shine any light. Returned parts show the batteries were installed correctly and had adequate charge. Process Battery cartridge upside down Bad solder joints to battery contacts Bad solder joints to LEDs Spring doesn’t make contact with batteries No final test to ensure flashlight works Design Battery cartridge is able to go in upside down (not pokayoke) Tolerance stack up leaves gap from battery to contacts Spring designed undersized and doesn’t maintain contact Metal specified corrodes within normal use conditions. Facilitator Notes: Answer key: These are just some of the options for issues that could go wrong FME004 FMEA Presentation

Please observe scheduled break times by returning on-time
Kaizen Event Rules There is no rank among team members Keep an open mind to change and be POSITIVE Involve associates from the Kaizen area, allow them to review new layouts and processes Don’t let “perfect” get in the way of “better” Reach for the mind before the wallet Respect each other Don’t find fault, find a remedy Ask “why?” Plans are only good if they can be implemented; plans succeed only if gains are sustained Just do it! Please observe scheduled break times by returning on-time FME004 FMEA Presentation VRK LEADER'SGUIDE ENG REV November 5, 2003

What is FMEA? FMEA (Failure Mode and Effects Analysis)
A systematic group of activities intended to: Recognize and evaluate the potential failures Identify actions that could eliminate or reduce potential failures Document the process and capture lessons learned Facilitator Note: Read slide aloud. Provide clear explanation and definition of FMEA Participant Notes: What is FMEA? A systematic group of activities intended to: Recognize and evaluate the potential failure of a product/process and the effects and causes of that failure. Identify actions that could eliminate or reduce the chance of the potential failure occurring and reaching the customer. Document the process. It is complementary to the process of defining what a design or process must do to satisfy the customer. (Society of Automotive Engineers, FMEA Standard Rev 2008). Study Potential Failures ….. learn to avoid them FME004 FMEA Presentation

Why is FMEA Important? Majority of issues (50-80%) could have been prevented in design Much more cost effective to design in reliability Minimize change after product release Participant Notes: Over half the issues found in after launch could have been prevented in development. Consider the cost to eliminate a failure by making a change to the 3D model verses making a change once hardware is under test or once the product has launched. DfR does require more effort and resources up front, however the total lifecycle cost will be significantly lower. FME004 FMEA Presentation

PSP vs. FMEA in Fluke Problem Solving Process (Reactive)
Used to identify and define known problems, root causes and corrective actions FMEA (Proactive) Used to recognize potential problems, root causes and identify actions that could eliminate or reduce potential failures before reaching the customer Participant Notes: It is important to know when to use each tool. Quite often you will use PSP on existing products. FMEA is a proactive tool used before a product is designed or launched. FMEA is also used after a product launches, however the DFMEA should rarely be updated after about a year after launch. The PFMEA should remain dynamic and be updated anytime there is an issue on the production line. FME004 FMEA Presentation

FMEA Initiative Goal Empower the entire organization to proactively identify, quantify and manage product and process issues and hazards, before launch and throughout the product life cycle Facilitator Note: Read slide aloud. Learn by thinking and anticipating FME004 FMEA Presentation

FMEA Training Pre-work
Identify FMEA company process owner and / or Champion Facilitator Bring real life FMEA project or production line Identify a development project or production line you will apply the FMEA process to during training Bring actual product (or similar), drawings, schematics, 3D models etc. For a Design FMEA bring technical specifications and for Process FMEA bring detailed process flow chart and test and assembly specifications / instructions Bring known problems from customer’s perspective or production line issues Facilitator Notes: Read this slide. Say “before we go any further, I’d like to do a process check against pre-work requirements. Let’s be sure we are prepared and have the items below before proceeding. IMPORATANT: if this is a FMEA Boot Camp, FMEA champions are strongly encouraged to attend the FMEA teach back session. Identify the FMEA company process owner and/or Champion Facilitator who will be responsible for Leading the FMEA efforts, mentoring, and training for your OpCo Identify the project or product that you will apply the FMEA process to during training. Bring VOC of known problems in customer words for similar or same product. FME004 FMEA Presentation

OpCo Introductions Instructions: Deliverable: Time allotted:
Describe your current state for identifying, quantifying and managing risk to customers and producers Provide 3-minute overview of your real life project Deliverable: Verbal report out on the above Time allotted: 5 minutes Facilitator Notes: Be prepared to provide an explanation of how the training will address most of their issues FME004 FMEA Presentation

Regulatory Considerations
Regulated OpCos must consider impact to their Risk Management Process ISO IEC GHTF / SG3 / N15R8 Consider both Patient/User Safety :: Hazards and Harm Design Quality :: Customer Satisfaction Review Participant Notes regarding FDA requirement Review Participant Notes regarding ISO requirement Participant Notes: ISO Medical devices — Application of risk management to medical devices IEC Analysis techniques for system reliability — Procedures for failure mode and effects analysis (FMEA) GHTF/SG3/N15R8 – Implementation of risk management principles and activities within a Quality Management System Key Points FMEA is a Risk Assessment tool Provides input into the Risk Management Process Approach used (scales, format, etc.) aligned to business process Applied throughout product lifecycle FMEA is one of many tools within the Risk Management Process FME004 FMEA Presentation

Fortive Reliability System
Participant Notes: The six-pillar model is really just a framework for understanding the many different tools involved in driving Reliability Improvement and in organizing our approach. Within each pillar is a view of What Good Looks Like. These are pragmatic, proven best practices from top reliability OpCos that can be used to drive improvement within your own organization. The FMEA tool fits mainly in the Design for Reliability pillar, however it is equally important in the Manufacturing Process Control Pillar. Input to the FMEA process comes from a variety of locations including many of the pillars shown above. Output from the FMEA process also drives activities within those same pillars. More information on the Fortive Reliability System can be found on FortiveConnect.com. You can also click the hyperlink above for an overview of each DRS tool. FMEA FME004 FMEA Presentation

FMEA Learning Objectives
FMEA Process Understand what an FMEA is, what the columns are and what they mean Understand and apply severity, occurrence and detection scales Apply risk mitigation techniques Perform example FMEAs FMEA Input and Pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Facilitator Notes: Say “We will cover the following major segments; FMEA Process, FMEA Input and Pre-work, and Integration and Product Development System. You will perform all of these objectives during this training”. We’ll practice applying the FMEA process with simulation exercises and you will apply FMEA to the real project you brought with you. FME004 FMEA Presentation

Review the Getting started with Stature Presentation
Go through the “Getting started with Stature” presentation if walking people through the Stature as well.

FMEA Process Go through the “Getting started with Stature” presentation if walking people through the Stature as well.

Functions, Failure Modes and Effects
FMEA Process Identify Functions, Failure Modes and Effects Identify Causes, Controls and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques FMEA input and pre-work Integration with Product Development System Facilitator Notes: Read each segment introduction aloud. Say “during this segment you will… Identify Functions, Failure Modes and Effects Identify Causes, Controls, and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques Say “First, we want to identify Functions, Failure Modes and Effects FME004 FMEA Presentation

Various FMEA Approaches
System FMEA (not currently used at Fluke) Focuses on how the overall system might fail Design FMEA Focuses on how product design might fail Process FMEA Focuses on how processes might fail Software FMEA Focuses on how software / firmware might fail Facilitator Notes: Be prepared to provide examples of each approach. These are the various, most widely used FMEA approaches: System FMEA A System FMEA is an analysis of the defined system to identify issues such as system integration, system safety, interfaces between subsystems and other issues that could cause the overall system to not work as intended. Design FMEA Focuses on design-related issues with an emphasis on how the design can be improved to ensure that minimum product related problems occur during the useful life of the equipment. Process FMEA Focuses on assembly or manufacturing related issues with an emphasis on how the manufacturing process can be improved to ensure that minimum process related problems occur with the equipment. Service FMEA Focuses on servicing products post installation with an emphasis on how the product will be maintained/repair in the field and can be used to identify issues in the field that could cause units to be costly to repair. Application FMEA Focuses on the use or misuse of the product by end user Many others FME004 FMEA Presentation

FMEA – Process Template
What is the function Product Component Process Software How can it FAIL? What’s the EFFECT? How severe is it (S)? What’s the Root Cause? Would the current design prevent the failure? How likely would the failure occur (O)? Would the current verification detect the failure? How likely will the failure be detected (D)? Take actions to mitigate risk Continuously update FMEA to improve Severity (S) Occurrence (O) Detection (D) Participant Notes: Tell participants we will work across the form to add clarity to each column. Use this slide as a reference slide showing a summary of each process step. FME004 FMEA Presentation

Function Design intent or functional requirement
Describe using an action verb Should be quantitative or binary Answers these questions: What does the selected product feature / process step do? How does it do that? Participant Notes: Include information regarding the environment in which the system operates; temperature, pressure, and humidity ranges for example Other questions: If a product feature or process step is deleted, what functions/requirements disappear? If you were this element, what are you supposed to accomplish? Why do you exist? Flashlight example: Flashlight must output lumens up to 2 meters Must last a minimum 15 hours Must survive a 1m fall FME004 FMEA Presentation

Potential Failure Mode
Concise description of how a system, part, or process may fail Primary Failure Mode is the inverse of the Function Common Failure Mode Categories Loss or absence of function Incomplete, partial, intermittent or decayed function Excess or too much function Unintended function Failure to meet requirements Participant Notes: Ask yourself ”How could this design fail to meet the customer requirement?” Concise description of how a system, part, or process may fail to perform its function(s) or requirement(s) Regulatory Consideration: Reference ISO annex Tables for additional examples Potential Failure Mode Process Reference Assembly Torque Drilling holes Missing parts Loose or over torque Missing Damaged Missing fastener Location Orientation Cross threaded Deep or shallow Contamination Over/under size Off location Concentricity Angle Machining Sealant Too narrow Missing Too deep Wrong material applied Angle incorrect Insufficient or excessive material Finish not to specification Dry Flash or not cleaned FME004 FMEA Presentation

Potential Effect of Failure
Description of the consequence or ramification of a failure What the customer might notice or experience May have several effects, depending on customer(s) – severity ranking based on worst Internal and external customers Participant Notes: Describes the symptom from the user’s perspective Consider the consequences of the effect on all customers Internal and external customers Regulation violation Level of dissatisfaction Failure Effect Examples Loss of performance Reduced life System failure Hard to load in next operation Software lock-up Damaged equipment Scrap Violates government regulation Rework Can’t assemble Becomes loose Degraded performance Operator injury Loss of efficiency Noise (e.g. rattles) Customer gets wet FME004 FMEA Presentation

FMEA Exercise Instructions: Deliverables: Time Allotted:
Identify several potential failure modes and effects Deliverables: Fill in all empty boxes Time Allotted: 8 minutes Facilitator Notes: Ask associates to refer to their “Printed Exercises” handout for this exercise. They should complete the exercise in the handout. Participant Notes: What additional Failure Modes might there be? FME004 FMEA Presentation

FMEA Exercise Instructions:
Identify several potential failure modes and effects Deliverables: Fill in all empty boxes Time Allotted: 8 minutes Facilitator Notes: Ask associates to refer to their “Printed Exercises” handout for this exercise. They should complete the exercise in the handout. Participant Notes: What additional Failure Modes might there be? FME004 FMEA Presentation

Severity / Classification
Determine the severity of the failure effects Based upon OpCo – defined criteria (reference AIAG) Classification Critical to Quality items (details in upcoming section) Participant Notes: Recommended Ranking Criteria starts on page 116 FME004 FMEA Presentation

Criteria: Severity of Effect on Product (Customer Effect)
Design Severity Effect Criteria: Severity of Effect on Product (Customer Effect) Rank Failure to Meet Safety and / or Regulatory Requirements Potential failure mode affects safe use of product and / or noncompliance with government regulation. Failure will occur WITHOUT warning. 10 Potential failure mode affects safe use of product and / or involves noncompliance with government regulation. Failure will occur WITH warning. 9 Loss or Degradation of Primary Function Loss of primary function (product inoperable, does not affect safe operation of product). 8 Degradation of primary function (product operable, but at reduced level of performance.) 7 Moderate Loss of secondary function. Product / item usable but comfort / convenience functions are inoperable. 6 Degradation of secondary function. Product / item usable but comfort / convenience functions at a reduced level of performance. 5 Annoyance Appearance or Audible Noise, product operable, item does not conform and noticed by most customers (> 75%). 4 Appearance or Audible Noise, product operable, item does not conform and noticed by many customers (50%). 3 Appearance or Audible Noise, product operable, item does not conform and noticed by discriminating customers (< 25%). 2 No Effect No discernible effect. 1 Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition

Process Severity Effect Criteria: Severity of Effect on Product (Customer Effect) Rank Criteria: Severity of Effect on Process (Manufacturing / Assembly Effect) Failure to Meet Safety and / or Regulatory Requirements Potential failure mode affects safe use of product and / or noncompliance with government regulation. Failure will occur WITHOUT warning. 10 May endanger associate (machine or assembly) WITHOUT warning. Potential failure mode affects safe use of product and / or involves noncompliance with government regulation. Failure will occur WITH warning. 9 May endanger associate (machine or assembly) WITH warning. Loss or Degradation of Primary Function Loss of primary function (product inoperable, does not affect safe operation of product) 8 Major Disruption 100% of product may have to be scrapped. Line shutdown or stop shipment of product. Degradation of primary function (product operable, but at reduced level of performance.) 7 Significant Disruption A portion of the production run may have to be scrapped. Deviation from primary process including decreased line speed or added manpower. Loss or Degradation of Secondary Function Loss of secondary function. Product / item usable but comfort / convenience functions are inoperable 6 Moderate Disruption 100% of the production run may have to be reworked off line and accepted. Degradation of secondary function. Product / item usable but comfort / convenience functions at a reduced level of performance 5 A portion of the production run may have to be reworked off line and accepted. Annoyance Appearance or Audible Noise, product operable, item does not conform and noticed by most customers (> 75%) 4 100% of product may have to be reworked in station before it is processed. Appearance or Audible Noise, product operable, item does not conform and noticed by many customers (50%) 3 A portion of product may have to be reworked in station before it is processed. Appearance or Audible Noise, product operable, item does not conform and noticed by discriminating customers (< 25%) 2 Minor Disruption Slight inconvenience to process, operation or operator. No effect No discernible effect. 1 Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition

Software Severity Rank Effect Impact Criteria: Severity of Effect on Product (Customer Effect) 10 Failure to Meet Safety and / or Regulatory Requirements Safety Potential failure mode affects safe use of product and / or noncompliance with government regulation. Failure will occur WITHOUT warning. 9 Regulation Potential failure mode affects safe use of product and / or involves noncompliance with government. Impacts integrity of results 8 Loss or Degradation of Primary Function Data Loss Loss of primary function (product inoperable, unrecoverable data loss). 7 Showstopper Degradation of primary function (product operable, substantial performance issue) 6 High Extremely High Loss of secondary function. Product / item usable but some (secondary) functionality fails, minor performance issue 5 Very High Missing "Must have" feature of functionality 4 Incomplete requirement or misinformation 3 Moderate Minor incorrect functionality, deviation of standard ways of implementation (i.e. invalid shortcuts) that does not affect product functionality or performance. 2 Annoyance Low Appearance (i.e. type or grammatical error, cosmetic error in UI presentation that do not impact intended use) or other minor defect in software that does not affect how product is operable. 1 No Effect Tech Debt Design of a product can be slightly improved by refactoring. No impact on customer Participant Notes: FME004 FMEA Presentation

Causes, Controls and Actions
FMEA Process Identify Functions, Failure Modes and Effects Identify Causes, Controls and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques FMEA input and pre-work Integration with Product Development System Facilitator Notes: Say “Next, we want to identify Causes, Controls, and Actions”. FME004 FMEA Presentation

Potential Cause Description of the root cause of the design or process deficiency Clearly describe the root cause and be specific Look for causes not symptoms of the failure Use 5-Why Usually more than one potential cause Must be controllable or correctable Participant Notes: Causes must be identified for each failure mode Fishbone charts may help identify root cases (man, machine, measurement, material, method, mother nature…) What design choices, process variables, or circumstances could result in the failure mode(s)? Avoid using one or two words to describe Cause. Try to add enough color to describe the root cause and what it may lead to. Use words like “Leads to…” or “Due to…” For example: Nails specified too short lead to horse shoe falling off Horse shoe falls of due to improperly specified nails Design Cause examples Process Cause Examples Tolerance stack up Tool wear Insufficient material strength Inadequate pressure Insufficient lubrication capacity Worn locator Vibration Broken tool Interference Gauging out of calibration Incorrect material thickness specified Inadequate fluid levels Temperature expansion Improper torque Over-stressing Selected wrong part Incorrect tooling Incorrect feed or speed rate Mishandling Assembled upside down Assembled backwards FME004 FMEA Presentation

Subsystem /Interfaces
5-Why to Root Cause Function: Flashlight must output Lumens Failure mode: Intermittent light Effect: Customer dissatisfied – must tap to get working System Poor connection between battery system and switch Subsystem /Interfaces Why is the flashlight intermittent? Process Spring wire diameter undersized Switch spring does not make good contact Why? Design Why? Spring force insufficient Participant Notes: What are other potential causes? Facilitator Notes: Click through each step explaining how the 5-why process identifies root cause for each level. For example the “Poor connection between battery system and switch” is the root cause at the System level. Why? Spring does not provide sufficient force under all tolerance conditions FME004 FMEA Presentation

Partial Why Tree Example: Car
Participant Notes: The Problem Solving Process identifies the one actual root cause. FMEA identifies all the potential root causes and ranks them based on Severity and Occurrence FME004 FMEA Presentation

Assumptions with Cause!
Design FMEAs Assume: Parts are manufactured and assembled in compliance with specifications Process FMEAs Assume: Design is correct and meets customer requirements Previous operations and purchased materials, components and services comply with design specifications (exception: inspection operations) Design Failures Process Failures Participant Notes: Note that causes, effects and failure modes can change depending on the function that is being analyzed. Functions can change depending on what is being analyzed: a product or a process. This highlights how key it is to define the FMEA scope. Insufficient lubrication capability Insufficient lubrication applied Incorrect material specified Incorrect material used Operator error is not a valid root cause! FME004 FMEA Presentation

Exercise Function: A hydraulic line must flow 10 L / min
Failure mode: Flows less than 10 L / min Effect: Customer dissatisfied – equipment performance impacted Instructions: List 4 potential Design Causes __________________ _________________ __________________ _________________ List 4 potential Process Causes __________________ _________________ __________________ _________________ Deliverable: Every person in class list 4 for each One person report out Time Allotted: 5 minutes Facilitator Notes: Be prepared to discuss specific examples related to the hose example. Emphasize the importance of separating Design and Process causes. Design Cause considerations Hose and connectors Fluid Environment Application Process Cause considerations Assembly Component selection FME004 FMEA Presentation

Current Controls Existing controls that identify and reduce failures
Prevent the failure mode and / or root cause from occurring (preferred) Or reduce the rate of occurrence Participant Notes: Prevention controls are critical to making the FMEA process a proactive tool Reminder Preventative - before the part is made Detection - after the part is made FME004 FMEA Presentation

Prevention Controls Finite Element Analysis DFMEA: Tolerance Study
Simulation / Analysis (correlated to test) Adherence to Engineering Standard Reuse of proven part / application Electronic component derating / design margin Design history Supplier input PFMEA Poka-yokes Established process control (example: better than 1.67 Cpk) Automated stop mechanisms Standard Work DFM / DFA Finite Element Analysis Facilitator Notes: Emphasize the importance of Prevention Controls. Many people assume risk reduction can only be achieved by testing more. Other Process Controls Work instructions Preventative Maintenance Set up verification Operator training Proactive prevention is much more cost effective than reactive FME004 FMEA Presentation

Occurrence Likelihood the failure mode will occur due to the cause
Considers effectiveness of Controls Prevention Participant Notes: Consider the entire design life Recommended Ranking Criteria starts on page 116 FME004 FMEA Presentation

Criteria: Occurrence of Cause - DFMEA (Incidents per item)
Design Occurrence Likelihood of Failure Criteria: Occurrence of Cause - DFMEA (Design life / reliability of item / vehicle) Criteria: Occurrence of Cause - DFMEA (Incidents per item) Rank Very High New Technology / new design with no history > 100 per thousand > 1 in 10 10 High Failure is inevitable with new design, new application, or change in duty cycle / operating conditions 50 per thousand 1 in 20 9 Failure is likely with new design, new application, or change in duty cycle / operating conditions. 20 per thousand 1 in 50 8 Failure is uncertain with new design, new application, or change in duty cycle / 10 per thousand 1 in 100 7 Moderate Frequent failures associated with similar designs or in design simulation and testing. 2 per thousand 1 in 500 6 Occasional failures associated with similar designs or in design simulation and testing. 0.5 per thousand 1 in 2000 5 Isolated failures associated with similar designs or in design simulation and testing. 0.1 per thousand 1 in 10,000 4 Low Only isolated failures associated with almost identical design or in design simulation and testing. 0.01 per thousand 1 in 100,000 3 No observed failures associated with almost identical design or in design < per thousand 1 in 1,000,000 2 Very Low Failure is eliminated through preventive control. 1 Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition

Criteria: Occurrence of Cause - PFMEA (Incidents per item)
Process Occurrence Likelihood of Failure Criteria: Occurrence of Cause - PFMEA (Incidents per item) Rank Very High > 100 per thousand > 1 in 10 10 High 50 per thousand 1 in 20 9 20 per thousand 1 in 50 8 10 per thousand 1 in 100 7 Moderate 2 per thousand 1 in 500 6 0.5 per thousand 1 in 2000 5 0.1 per thousand 1 in 10,000 4 Low 0.01 per thousand 1 in 100,000 3 < per thousand 1 in 1,000,000 2 Very Low Failure is eliminated through preventive control. 1 Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition

Criteria: Occurrence of Cause – SW FMEA
Software Occurrence Rank Likelihood of Failure Criteria: Occurrence of Cause – SW FMEA 10 Very High New Technology / new design with no history 9 High Design knowledge is reused, but application\component uses new technology 8 Similar designed exists but component is rewritten 7 Failure is uncertain with new design, new application 6 Moderate Frequent failures associated with similar designs when new environment condition is introduced or\and comoponent is on critical path, low-no test coverage 5 Occasional failures associated with similar designs when new environment condition is introduced or\and comoponent is on critical path, low-no test coverage 4 Isolated failures associated with similar designs, moderate test coverage 3 Low Only isolated failures associated with almost identical design, high test coverage or component is reused and low test coverage 2 Component is reused and no failure is observed with another applications that uses the component. High test coverage for reusable component 1 Very Low Failure is eliminated through preventive control. Participant Notes: FME004 FMEA Presentation

Flashlight Compression Testing
Current Controls Detects the failure mode and / or root cause before it is released and leads to corrective actions DFMEA: before it is released to production PFMEA: before it is released to final customers (internal or external) Participant Notes: It is good practice to always have at least one Prevention control and one Detection control Process Controls Detection examples Functional test Visual inspection Touch for quality Gauging Final test Flashlight Compression Testing FME004 FMEA Presentation

Current Control or Recommended Action?
Current Control if… The Prevention or Detection control has physically been completed The control is part of your development process and is a required deliverable OR Participant Notes: Only list items that meet one or both of the above criteria If neither apply the item should be captured as a Recommended Action and ranked high Reminder Preventative - before the part is made Detection - after the part is made Otherwise capture as a Recommended Action and rank high FME004 FMEA Presentation

Detection Quantifies how likely the failure mode will be detected, assuming the failure has occurred Participant Notes: Recommended Ranking Criteria starts on page 116 FME004 FMEA Presentation

Design Detection Participant Notes: FME004 FMEA Presentation
Opportunity for Detection Criteria: Likelihood of Detection by Design Control Rank Likelihood of Detection No detection opportunity No current design control; Cannot detect or is not analyzed. 10 Almost Impossible Not likely to detect at any stage Design analysis / detection controls have a weak detection capability; Virtual Analysis (e.g., CAE, FEA, etc..) is not correlated to expected actual operating conditions 9 Very Remote Post Design Freeze and prior to launch Product verification / validation after design freeze and prior to launch with pass / fail testing (subsystem or system testing with acceptance criteria such as ride and handling, shipping evaluation, etc..). 8 Remote Product verification / validation after design freeze and prior to launch with test to failure testing (subsystem or system testing with acceptance criteria such as ride and handling, shipping evaluation, etc..). 7 Very Low Product verification / validation after design freeze and prior to launch with degradation testing 6 Low Prior to Design Freeze Product validation (reliability testing, development or validation tests) prior to design freeze using pass / fail testing (e.g., acceptance criteria for performance, function checks, etc..). 5 Moderate using test to failure testing (e.g., acceptance criteria for performance, function checks, etc..). 4 Moderately High using degradation testing (e.g., acceptance criteria for performance, function checks, etc..). 3 High Virtual Analysis – Correlated Design analysis / detection controls have a strong detection capability. Virtual analysis (e.g., =CAE, FEA, etc..) is highly correlated with actual or expected operating conditions prior to design freeze. 2 Very High Detection not applicable; Failure Prevention Failure cause or failure mode can not occur because it is fully prevented through design solution (e.g., proven design standard, best practice or common material, etc..). 1 Almost Certain Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition

Process Detection Participant Notes: FME004 FMEA Presentation
Opportunity for Detection Criteria: Likelihood of Detection by Process Control Rank Detection No detection opportunity No current process control; Cannot detect or is not analyzed. 10 Almost Impossible Not likely to detect at any stage Failure Mode and / or Error (Cause) is not easily detected (e.g., random audits). 9 Very Remote Problem Detection Post Processing Failure Mode detection post-processing by operator through visual / tactile / audible means. 8 Remote Problem Detection at Source Failure Mode detection in-station by operator through visual / tactile / audible means or post-processing through use of attribute gauging (go / no-go, manual torque check / clicker wrench, etc..). 7 Very Low Problem Detection Post Processing Failure Mode detection post-processing by operator through use of variable gauging or in-station by operator through use of attribute gauging (go / no-go, manual torque check / clicker wrench, etc..). 6 Low Failure Mode or Error (Cause) detection in-station by operator through use of variable gauging or by automated controls in-station that will detect discrepant part and notify operator (light, buzzer, etc..). Gauging performed on setup and first-piece check (for set-up causes only). 5 Moderate Failure Mode detection post-processing by automated controls that will detect discrepant part and lock part to prevent further processing. 4 Moderately High Failure Mode detection in-station by automated controls that will detect discrepant part and automatically lock part in station to prevent further processing. 3 High Error Detection and / or Problem Prevention Error (Cause) detection in-station by automated controls that will detect error and prevent discrepant part from being made. 2 Very High Detection not applicable; Error Prevention Error (Cause) prevention as a result of fixture design, machine design or part design. Discrepant parts cannot be made because item has been error-proofed by process / product design. 1 Almost Certain Participant Notes: FME004 FMEA Presentation

Software Detection Rank Likelihood of Detection
Criteria: Likelihood of Detection by Design Control 10 Almost Impossible No detection mechanism in place; Cannot detect or is not analyzed. 9 Very Remote System detects failure but suppresses it and does not alert user, no visual inspection 8 Remote 7 Very Low System detects failure, and logs it, but user not notified 6 Low System detects failure and alerts user without useful information 5 Moderate System detects failure and alerts user providing basic information about failure, application need to restart 4 Moderately High System detects failure and alerts user, providing basic information about failure, process interrupted 3 High System detects failure and alerts user providing information about failure, process put on hold and can continue after failure gets fixed 2 Very High System detects failure and alerts user, providing information about failure, software implements recovery function 1 Almost Certain Failure cause or failure mode can not occur because it is fully prevented through design solution (e.g., proven design standard, best practice or common material, etc..). Participant Notes: FME004 FMEA Presentation

Risk Priority Number (RPN)
RPN: Risk Priority Number = S × O × D S: Severity ranking (1 to 10) Seriousness of effect of failure O: Occurrence ranking (1 to 10) Likelihood failure mode occurs D: Detection ranking (1 to 10) Expectation that verification detects weakness RPN value ranges from 1 to 1000 Participant Notes: FME004 FMEA Presentation

DFMEA Exercise Instructions: Deliverables: Time Allotted:
Complete DFMEA below Deliverables: Fill in empty boxes Time Allotted: 10 minutes Participant Notes: Use Ranking Criteria starting on page 116 FME004 FMEA Presentation

PFMEA Exercise Instructions: Deliverables: Time Allotted:
Complete PFMEA below Deliverables: Fill in empty boxes Time Allotted: 10 minutes Participant Notes: Use Ranking Criteria starting on page 116 FME004 FMEA Presentation

Recommended Action Responsibility and Target Completion Date
Critical or significant failures should have recommended actions Focus on design and mitigating the root cause of failure or eliminating the failure mode Recommended actions must have an owner and target completion date Participant Notes: Don’t hesitate to write a Recommended Action even if the RPN number is low. If an idea is sparked during the FMEA session capture it as and action, but try to avoid going into too much detail during the event. A recommended action could also be to simply have a brainstorming session or investigate alternative designs. FME004 FMEA Presentation

Action Results Update S, O and D to reflect actions taken
Unless the failure mode has been eliminated severity should not change If ratings are not improved, additional actions must be defined Participant Notes: Remember, Severity will not change unless the Failure Mode is eliminated. Occurrence and Detection may or may not be lowered based upon the results of actions FME004 FMEA Presentation

Link the System, Design & Process
FMEA Process Identify Functions, Failure Modes and Effects Identify Causes, Controls and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques FMEA input and pre-work Integration with Product Development System Facilitator Notes: Say “Next, we want to link the System, Design and Process”. FME004 FMEA Presentation

FMEA Process Assessment of Complex Systems
Participant Notes: Utilize time and resources wisely Manage scope as you “plan” your FMEA Large FMEA should be broken down into manageable pieces FME004 FMEA Presentation

Flashlight System Flow Down Example
Sub-systems System Housing / LED system Battery system Facilitator Notes: To illustrate this we have a simple LED flashlight. The flashlight can easily be broken down into 4 major Sub-systems (the housing and LED system cannot be easy separated) End cap switch FME004 FMEA Presentation

Identifying Key Features Critical To Quality
FMEA Process Identify Functions, Failure Modes and Effects Identify Causes, Controls and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques FMEA input and pre-work Integration with Product Development System Facilitator Notes: Say “Next, we want to identify key features that are Critical to Quality”. FME004 FMEA Presentation

RPN scale Focus on highest risk
Participant Notes: The above Criticality Matrix is just an example. Each OpCo must determine what is Critical to Quality Regulatory Consideration: ISO refers to the above matrix as a Risk Chart and has additional examples FME004 FMEA Presentation From ASQ

When to use FMEA during NPI?
Product Definition Product & Process Design Metrics & Project Review PHASES Project Definition Product Launch Product Design Verification Project Close BC PC PRR MRR Reliability Assessment PDSP DFMEA DFMEA revisit PFMEA All FMEAs closed *FMEA time is flexible within that stage of the project FME004 FMEA Presentation

Apply Risk Mitigation Techniques
FMEA Process Identify Functions, Failure Modes and Effects Identify Causes, Controls and Actions Link the System, Design and Process Identify the key features that are Critical to Quality Apply Risk Mitigation Techniques FMEA input and pre-work Integration with Product Development System Facilitator Notes: Say “Next, we want to try to mitigate risk”. FME004 FMEA Presentation

Order of Mitigation Eliminate the Function or part Eliminate the Cause
1 2 3 4 5 6 Eliminate the Function or part Eliminate the Cause Make the Cause impossible or less likely to occur Decouple the Cause and Effect Improve ability to Detect and mitigate earlier Reduce the impacts / consequences of failure Facilitator Notes: Prompt the class to come up with examples for each. You can also share a few examples to get them started. Participant Notes: Mitigation means: What are you going to do about the situation? Examples: Change the design Change material, increase strength, decrease stress Add redundancy, pausing, notification, guiding Constrain usage (lock out features) Develop fail safe designs, early warning system “Limp Home” strategy (car engine failure – still runs but at lower performance or on fewer cylinders) FME004 FMEA Presentation

Decouple cause and effect
Mitigation Examples Decouple cause and effect Gas pumps are equipped with hose couplings that break-away and quickly shut-off the flow of gasoline Overflow protection in sink Pausing Notification, Guiding Participant Notes: Taken from Visit website for more examples Do these example reduce the likelihood of failure, occurrence, or effect? Gas Light Must push both buttons Milk Standard FME004 FMEA Presentation

Cost effective controls 8M vs. $20
A toothpaste factory had a problem: they sometimes shipped empty boxes, without the tube inside. This was due to the way the production line was set up, and people with experience in designing production lines will tell you how difficult it is to have everything happen with timings so precise that every single unit coming out of it is perfect 100% of the time. Small variations in the environment (which can’t be controlled in a cost-effective fashion) mean you must have quality assurance checks smartly distributed across the line so that customers all the way down the supermarket don’t get ticked off and buy someone else’s product instead. Understanding how important that was, the CEO of the toothpaste factory got the top people in the company together and they decided to start a new project, in which they would hire an external engineering company to solve their empty boxes problem, as their engineering department was already too stretched to take on any extra effort. The project followed the usual process: budget and project sponsor allocated, RFP, third-parties selected, and six months (and $8 million) later they had a fantastic solution — on time, on budget, high quality and everyone in the project had a great time. They solved the problem by using some high-tech precision scales that would sound a bell and flash lights whenever a toothpaste box weighing less than it should. The line would stop, and someone had to walk over and yank the defective box out of it, pressing another button when done. A while later, the CEO decides to have a look at the ROI of the project: amazing results! No empty boxes ever shipped out of the factory after the scales were put in place. Very few customer complaints, and they were gaining market share. “That’s some money well spent!” – he says, before looking closely at the other statistics in the report. It turns out, the number of defects picked up by the scales was 0 after three weeks of production use. It should’ve been picking up at least a dozen a day, so maybe there was something wrong with the report. He filed a bug against it, and after some investigation, the engineers come back saying the report was actually correct. The scales really weren't picking up any defects, because all boxes that got to that point in the conveyor belt were good. Puzzled, the CEO travels down to the factory, and walks up to the part of the line where the precision scales were installed. A few feet before it, there was a $20 desk fan, blowing the empty boxes out of the belt and into a bin. “Oh, that — one of the guys put it there ’cause he was tired of walking over every time the bell rang”, says one of the workers. Participant Notes: Have participants take a few minutes and read to themselves. Are these prevention or detection controls? FME004 FMEA Presentation

Knowledge Check A Function should: A. Be described as an action verb
B. Be quantitative C. Always be defined by the customer D. All of the above E. Answers A and B above When a Failure Mode has several Effects depending which customers are considered, which do you choose? What is the best actions to take to reduce a failure mode? A. Decouple the Cause and Effect B. Eliminate the Cause C. Improve ability to Detect and mitigate earlier Participant Notes: E. Both A and B are correct. See slide on Function. You always choose the most severe for the severity column. Order is B, A, C FME004 FMEA Presentation

Key Take Away Separate Design and Process Causes and capture the root cause Spend more time on Prevention Controls and less on Detection FMEA is a powerful tool that is as complex or simple as you make it Follow the risk Use common sense Facilitator Notes: FME004 FMEA Presentation

FMEA INPUT AND PRE-WORK
Participant Notes: The items and resources required prior to engaging in an FMEA session will be covered next. These items should be completed prior to engagement. It is important to understand and gain consensus on scope, history, customer requirements, etc.. See below. We will cover these in greater detail in this segment. Identify the FMEA approach and scope Utilize boundary diagrams as needed Identify relevant prior history on product/process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business

Identifying the FMEA Approach and Scope
FMEA Process FMEA input and pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Integration with Product Development System Facilitator Notes: Read each segment introduction aloud. Say “during this segment you will… Identify the FMEA approach and scope Utilize boundary diagrams as needed Identify relevant prior history on product/process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Say “ the first thing we want to cover is identifying the FMEA approach and determining the scope”. This is critical to a successful FMEA. FME004 FMEA Presentation

When to Generate or Update FMEA
Situation / Use 1 New design, technology, or process 2 Modifications to existing design / process or interactions 3 Existing design / process in new environment, location, application or duty cycle 4 Customer report, internal quality information and changes to standards / requirements 5 Existing design / process where proactive improvement is needed Facilitator Notes: Be sure to provide examples. There are four basic cases for which FMEAs are generated, each with a different scope or focus: Situation 1: New designs, new technology, or new process. The scope of the FMEA is the complete design, technology, or process. Situation 2: Modifications to existing design or process. The scope of the revision efforts should focus on the modification to design or process, possible interactions due to the modification, and field performance. Modifications include removal or addition of new parts or processing operations. Modifications also include changes to existing product or process functions. Situation 3: Use of existing design or process in a new environment, location, or application. The scope of the revision is the impact of the new environment or location on the existing design or process. Situation 4: Whenever new information is received from customers that flag a unrecognized failure mode or unusual frequency review/ update FMEA. Likewise, as standards (internal, regulatory or industry) referenced in FMEA are changed, the document should be reviewed for update. Situation 5: Use on existing designs or processes where proactive improvement is needed. The scope of the analysis would be based on where the data says the greatest amount of impact can be achieved through identification and implementation of improvement activities. FME004 FMEA Presentation

Suggested Prerequisites
System Design Process Service General system interface arrangement All System Prerequisites All Design Requirements All Process Requirements Assembly Diagrams System FMEA Design FMEA Process FMEA Past, current, similar or baseline SFMEA Past, current, similar or baseline DFMEA Past, current, similar or baseline PFMEA Past, current, similar or baseline Service FMEA Sample parts, Customer parts, prototypes, etc. Sample Parts, prototypes, similar products, etc. Sample tooling, prototypes, similar tooling, etc.. Service Parts Customer Requirements Technical Specifications including performance and reliability Process Specifications Service Requirements including interval Usage environment: Intended regional market, within application, etc. Assembly and component designs (models and drawings) Manufacturing Work instructions Failed part Instructions System Manual Bill of Materials System model files Description of change and impact Block or Boundary Diagrams of system Block or Boundary Diagram of product Process Flow Diagrams Service Process Diagrams Warranty Data - System Warranty Data - Subsystem/comp Warranty Data - Manufacturing Mean Time to Repair Data The more information you have the better the analysis Facilitator Notes: Highlight 3 or 4 from the chart to speak to. You may want to highlight these in the slide prior to the training. Participant Notes: You may not have all of the information listed. However, the more of this information that is available the more thorough the FMEA can be. When obtaining warranty data getting just the data is good. Getting the failure analysis from the warranty data is better. What requirements are needed for system, design, and process? System: The system performance requirement is derived from the customer needs Design: Lower level Performance Requirements need to be quantitative requirements Process: Process performance requirements need to be considered as well as product performance requirements Regulatory Consideration: The FDA requires a review of Class I and II public recalls on similar products FME004 FMEA Presentation

Pre-work Guidelines Identify Facilitator
Identify Subject Matter Experts Define Scope Identify FMEA type to be used Develop / modify boundary / block / process flow diagram Select / modify rating scales to be used Pre-fill Function section of FMEA Participant Notes: These are guidelines for FMEA Pre-work. This should not be confused with Pre-work for this training. FME004 FMEA Presentation

Gain agreement from the team upfront
Defining The Scope What is the objective? What is new or changed? What is the size or boundaries of the system? What is critical? What should not be included? Consider using a charter to capture the items above Participant Notes: Defining and bounding scope is critical to conducting an efficient FMEA session. Gain agreement from the team upfront FME004 FMEA Presentation

Utilizing Boundary Diagrams
FMEA Process FMEA input and pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Integration with Product Development System Facilitator Notes: Say “ Next, we want to talk about using Boundary Diagrams as a tool to help us determine our scope.” Again, determining scope is critical to success. FME004 FMEA Presentation

System FMEA: Boundary Diagram
A visual tool to facilitate analysis of system interfaces Helps simplify a complex system Helps the team align and focus Facilitator Notes: Ask: Who’s using Boundary Diagrams? Participant Notes: The Boundary Diagram defines the analysis scope, responsibility, and provides guidelines for structured brainstorming Note: block diagrams are not necessary when your product or process is considered simple Tip: Post on the wall during session FME004 FMEA Presentation

Process FMEA: Process Flow Diagram
A graphical representation of the movement of product or service Includes primary process flow, as well as secondary operations Participant Notes: You want to consider all steps and movements in the process. FME004 FMEA Presentation

Example Symbol Key Facilitator Notes:
Prepare to use quick analogies using H&B and Flashlight. Participant Notes: These are possible symbol key’s you can use. Symbols force you to focus. These are out of the AIAG (Automotive Industry Action Group) FME004 FMEA Presentation

Constructing Block Diagrams
Boundary Diagram Process Flow Diagram GO TO GEMBA Identify the system boundary Sequentially write each step Create a block for each subsystem or component Write down the inputs identifying as controlled or variable Write a name or number for each block Write a sequential number with a title Define product performance outputs for each block and system Write the process and product character outputs for each step Define the interactions between each block Identify the end point Establish a method to control the documents Participant Notes: Process Flow Diagram inputs include: 1. New parts, 2. Machinery 3. Tooling 4. Operator 5. Prints 6. Instructions 7. Geographic location 8. Environment Remember the diagram defines the scope Do not include items that are out of your scope Supplier processes (define scope: in or out) Customer Processes (define scope: in or out) Shipping processes (define scope: in or out) FME004 FMEA Presentation

Exercise Instructions Deliverable: Time Allotted:
In your group build a boundary or process flow diagram for a real life project Deliverable: Boundary Diagram or Process flow Time Allotted: 20 minutes Facilitator Notes: Take about 20 min. for this exercise. Call-out box for slide takeaway FME004 FMEA Presentation

Identifying Relevant Prior History
FMEA Process FMEA input and pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Integration with Product Development System Facilitator Notes: Say “After we’ve determined our scope we want to identify any relevant history on the products or process.” IMPORTANT: explain the benefit of identifying relevant history. FME004 FMEA Presentation

What Data to Consider Data Type Example Where Same Similar New
Existing parts / product used in design Warranty data, Design Standard and Release parts database Similar Modification of existing components for fit and function or reposition of existing product to new market Reference same parts / product database New New product / components for the company or new product /component to the world Market data, or data may not be available Facilitator Notes: Provide examples using flashlight. Explain how Similar can be the most risky because people do not take into consideration changes in application, environment, or duty cycle when reusing parts and subsystems. FME004 FMEA Presentation

Exercise: Identify Failure History for Real Life Project
Instructions Identify relevant prior failure history on product / process for real life project Consider the following: Design related? Process related? Service related? How many repeat? Deliverable: Discuss within your group. One team report out to the group. Time Allotted: 5 Minutes Facilitator Notes: Take about 5 min. for this exercise. FME004 FMEA Presentation

Translating Customer Requirements Into Design Specs
FMEA Process FMEA input and pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Integration with Product Development System Facilitator Notes: Say “ After we’ve understood relevant history, you’ll want to be sure to translate customer requirements into the product design specs”. Hopefully you or your company have gathered relevant VOC (voice of the customer) or information on what the customer really wants. FME004 FMEA Presentation

VOC Example Facilitator Notes: Read caption at each phase and ask the class what resonates with them from this example: “If you are not well informed in your job, you might miss a great opportunity” FME004 FMEA Presentation

Voice of Customer Example of translating a customer need into a quantitative functional requirement VOC Keypad must function under all weather conditions House of Quality (HOQ) Design Requirements Keypad must function from -20 to 50 degrees C Keypad must not allow moisture to reach the circuit board Participant Notes: Ensuring that designs will meet customers’ needs starts with an understanding of: Full design requirements Environment hazards Potential product use and foreseeable misuse Reliability service life needs We will not teach House of Quality in this training. HOQ is an example of an available tool used to translate VoC into design requirements. FME004 FMEA Presentation

Exercise Instructions:
Participant will list their specs and determine where they will get the info for their real life project. In other words, where will Gemba be? Deliverable: Report out on list of specs Time Allotted: 10 Minutes Facilitator Notes: Take about 10 min. for this exercise. FME004 FMEA Presentation

Real Life FMEA Exercise
Instructions: Choose one function of your real life project and complete FMEA below Deliverables: Fill in empty boxes Time Allotted: 15 minutes Participant Notes: Use Ranking Criteria starting on page 116 FME004 FMEA Presentation

Modifying Ranking Criteria
FMEA Process FMEA input and pre-work Identify the FMEA approach and scope Utilize boundary diagrams, as needed Identify relevant prior history on product / process Translate customer requirement into product design specifications or requirements Modify ranking criteria to be relevant to your business Integration with Product Development System Facilitator Notes: Say “Next, modify ranking criteria to be relevant to your business” FME004 FMEA Presentation

Standard Rankings Severity Occurrence Detection Ranking Considers
What is the effect(s) on the customer? How severe is it? Occurrence How likely the failure mode will occur, due to the cause? Detection How likely the problem will be detected assuming the failure has occurred? Facilitator Notes: Reference ranking criteria in appendix Participant Notes Severity Severity is a ranking number associated with the most serious effect for a given failure mode for the operation being evaluated. Occurrence Occurrence is a ranking number associated with each cause for a given failure mode being evaluated. The occurrence ranking considers the likelihood of occurrence during usage, according to defined criteria. Detection Detection is the rank associated with the best design/process control from the list of detection-type design/process controls. The detection ranking considers the likelihood of detection of the failure mode/cause according to defined criteria. FME004 FMEA Presentation

Modify Ranking Criteria to be Relevant to Your Business
Start with default scales and modify as needed Include examples relative to your business Make a controlled document Participant Notes: Start with default scales (see recommended examples in appendix) and modify to address organizational/project specific terminology Overall intent needs to be consistent in the organization with a defined method to prioritize issues Make the ranking criteria a controlled document with infrequent updates Consistency across the organization is critical FME004 FMEA Presentation

Knowledge Check What is the fundamental difference between PSP and FMEA? State 2 reasons why you should create a Boundary Diagram? A power supply in production for 2 years is being used in a new design. The new application requires the unit to be powered on 12 hours per day. The existing application is powered on 2 hours per day. Should the power supply be considered Same, Similar or New? For a System level FMEA you must have which of the following: Component specifications Completed 3D model of your system System or product design requirements All of the above Participant Notes: FME004 FMEA Presentation

Key Take Away Pre-work is essential to executing efficient FMEA sessions Leveraging prior history is critical to future success System level functions must be derived directly from customer requirements Facilitator Notes: FME004 FMEA Presentation

RANKING CRITERIA Participant Notes:

Design Severity Effect Criteria: Severity of Effect on Product (Customer Effect) Rank Failure to Meet Safety and / or Regulatory Requirements Potential failure mode affects safe use of product and / or noncompliance with government regulation. Failure will occur WITHOUT warning. 10 Potential failure mode affects safe use of product and / or involves noncompliance with government regulation. Failure will occur WITH warning. 9 Loss or Degradation of Primary Function Loss of primary function (product inoperable, does not affect safe operation of product). 8 Degradation of primary function (product operable, but at reduced level of performance.) 7 Moderate Loss of secondary function. Product / item usable but comfort / convenience functions are inoperable. 6 Degradation of secondary function. Product / item usable but comfort / convenience functions at a reduced level of performance. 5 Annoyance Appearance or Audible Noise, product operable, item does not conform and noticed by most customers (> 75%). 4 Appearance or Audible Noise, product operable, item does not conform and noticed by many customers (50%). 3 Appearance or Audible Noise, product operable, item does not conform and noticed by discriminating customers (< 25%). 2 No Effect No discernible effect. 1 Participant Notes: FME004 FMEA Presentation Based on AIAG 4th edition