Legal Aspects of FMEA, overview of Canadian Law,
Due Diligence vs Negligence, Criminal Negligenced and what everyone needs to know about duty of care
www.6sengineering.com
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
Detailed and comprehensive contents:
History of FMEA
Overview (What is FMEA and What it can do for you?)
Scope/when to use?
Objective of FMEA
FMEA terminology
AIAG FMEA 4th edition (Old edition)
Introduction of AIAG VDA FMEA (New edition)
Why new AIAG VDA FMEA?
Major changes
Steps of FMEA
Severity rating
Occurrence rating
Detection rating
AP Table
Case study
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
Design FMEA training helps design engineers, verification engineers, and project/product managers to proactively break down, examine, investigate and reveal potential failure, quality, execution, and security and risks issues.
What is DFMEA?
DFMEA, or Design Failure Mode and Effects Analysis, is commonly utilized in the beginning period of the product lifecycle and improvement as an investigating and affirmation process and apparatus.
Objectives:
Explain the concept and the purpose of Failure Mode and Effects Analysis (FMEA)
Discuss the benefits, requirements, and goals of FMEA
Decide when to use Design FMEA and when Process-FMEA
Discuss the steps and process of the FMEA
Gather up an FMEA team
Define the Design FMEA scope
Conduct all the steps of Design FMEA
Conduct the ranking scales for Severity, Occurrence, and Detection
Choose the appropriate technology methods to use as supplement to their DFMEA action plan
Make the Design FMEA into an active document
Develop a Control plan based on Design FMEA
Determine corrective actions in order to develop a more correct FMEA
Outline:
Overview of FMEA and DFMEA/Design FMEA
Purpose of an FMEA
Design-FMEA vs. Process-FMEA
Principles of DFMEA/Design-FMEA
Design FMEA Relations to Process-FMEA
Design FMEA Training Hands-on and In-Class Activities
Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below.
DFMEA Training ,Design FMEA Training
https://www.tonex.com/training-courses/dfmea-training/
[To download this poster, visit:
https://www.oeconsulting.com.sg/training-presentations]
The Quality Maintenance (Hinshitsu Hozen) Poster describes the systematic approach for establishing and maintaining zero-defect conditions to create 100% good products.
The poster comes in four monochrome variations. Formatted in PDF and in editable PPTX, the poster can be easily printed on an A3 or A4-sized paper from an office copier machine and displayed on employee workstations, or distributed together with your workshop handouts.
The Quality Maintenance Poster complements the 'Quality Maintenance (Hinshitsu Hozen)' training presentation materials. It serves as a takeaway and summary of your TPM and Quality Maintenance presentation.
The 8 Steps of Quality Maintenance are:
Step 1: Verify the Existing Situation
Step 2: Investigate the Processes where Defects Occur
Step 3: Identify & Analyze 4M Conditions
Step 4: Plan Action to Correct Deficiencies
Step 5: Establish Conditions that Allow Good Products to be Achieved
Step 6: Eliminate Flaws in 4M Conditions and Finalize
Step 7: Consolidate Checking Methods
Step 8: Determine Standard Values for Checks & Revise Standards
To downoad this poster, visit:
https://www.oeconsulting.com.sg/training-presentations
Detailed and comprehensive contents:
History of FMEA
Overview (What is FMEA and What it can do for you?)
Scope/when to use?
Objective of FMEA
FMEA terminology
AIAG FMEA 4th edition (Old edition)
Introduction of AIAG VDA FMEA (New edition)
Why new AIAG VDA FMEA?
Major changes
Steps of FMEA
Severity rating
Occurrence rating
Detection rating
AP Table
Case study
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
Design FMEA training helps design engineers, verification engineers, and project/product managers to proactively break down, examine, investigate and reveal potential failure, quality, execution, and security and risks issues.
What is DFMEA?
DFMEA, or Design Failure Mode and Effects Analysis, is commonly utilized in the beginning period of the product lifecycle and improvement as an investigating and affirmation process and apparatus.
Objectives:
Explain the concept and the purpose of Failure Mode and Effects Analysis (FMEA)
Discuss the benefits, requirements, and goals of FMEA
Decide when to use Design FMEA and when Process-FMEA
Discuss the steps and process of the FMEA
Gather up an FMEA team
Define the Design FMEA scope
Conduct all the steps of Design FMEA
Conduct the ranking scales for Severity, Occurrence, and Detection
Choose the appropriate technology methods to use as supplement to their DFMEA action plan
Make the Design FMEA into an active document
Develop a Control plan based on Design FMEA
Determine corrective actions in order to develop a more correct FMEA
Outline:
Overview of FMEA and DFMEA/Design FMEA
Purpose of an FMEA
Design-FMEA vs. Process-FMEA
Principles of DFMEA/Design-FMEA
Design FMEA Relations to Process-FMEA
Design FMEA Training Hands-on and In-Class Activities
Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below.
DFMEA Training ,Design FMEA Training
https://www.tonex.com/training-courses/dfmea-training/
[To download this poster, visit:
https://www.oeconsulting.com.sg/training-presentations]
The Quality Maintenance (Hinshitsu Hozen) Poster describes the systematic approach for establishing and maintaining zero-defect conditions to create 100% good products.
The poster comes in four monochrome variations. Formatted in PDF and in editable PPTX, the poster can be easily printed on an A3 or A4-sized paper from an office copier machine and displayed on employee workstations, or distributed together with your workshop handouts.
The Quality Maintenance Poster complements the 'Quality Maintenance (Hinshitsu Hozen)' training presentation materials. It serves as a takeaway and summary of your TPM and Quality Maintenance presentation.
The 8 Steps of Quality Maintenance are:
Step 1: Verify the Existing Situation
Step 2: Investigate the Processes where Defects Occur
Step 3: Identify & Analyze 4M Conditions
Step 4: Plan Action to Correct Deficiencies
Step 5: Establish Conditions that Allow Good Products to be Achieved
Step 6: Eliminate Flaws in 4M Conditions and Finalize
Step 7: Consolidate Checking Methods
Step 8: Determine Standard Values for Checks & Revise Standards
To downoad this poster, visit:
https://www.oeconsulting.com.sg/training-presentations
FMEA has been around for many decades and has a long history as a method to support product designs, manufacturing processes, service, and maintenance. The plain truth is FMEA has the potential to be a very powerful tool to achieve high reliability in products and processes; and when done well, it is remarkably effective. Yet in practice, FMEA does not always achieve the expected results. Based on the experience of over two thousand FMEAs and working with many companies in a wide variety of applications, certain common mistakes show up repeatedly. What are the primary ways that FMEAs can be done wrongly (mistakes made), and what are the quality characteristics that make for effective FMEAs (quality objectives)? These questions are answered in this new short course on FMEA
Get faster design success eliminating mistakes and proyect bugs by preventive use of DFMEA preventive and corrective actions. Practical experiences and tips
Failure Mode and Effect Analysis (FMEA) Manual.
- The role and function of FMEA.
- Concepts and techniques of Design FMEA and how to apply it.
- Concepts and techniques of Process FMEA and how to apply it.
- The role and function of FTA.
- Concepts of Zero Quality Control and Mistake Proofing and its implications for FMEA.
Snapon Modis Ultra Owner’s Manual
>> READ MORE: https://www.obdadvisor.com/snap-on-modis-review/
Here is a detailed review of the Snapon Modis Ultra scan tool:
- Compatibility
- Functionality
- Interface
- Software
Check it out to get the REVIEW and some NOTES about using this scanner based on my own experience.
MUSTR Rule R 29.2107, "class c operator" means an individual responsible for responding to alarms or other indications of emergencies caused by spills, releases, overfills, and other emergency conditions associated with an underground storage tank (UST) system.
HM-215: Are you ready for the border patrol? If you ship Dangerous Goods, don’t let new border measurement regulations for labels and placards catch you unprepared.
Ship damaged batteries in a fiberboard box? Yes, you can! Just in time for the largest cell phone recall ever—new Special Permit Packaging makes reverse logistics easier and less expensive.
DG assessment: How confident are you? Take this quick quiz to learn where your company stands on the compliance confidence scale.
Dangerous Goods Symposium 2016: Highlights from the best-attended, most insightful DGS ever.
Labelmaster Solutions. Products and resources to keep your Dangerous Goods compliant and safe.
Evolution of Vehicle aftter it has been released, How its made and managedSamuel Festus
a research project based on the theme: Evolution of vehicle after it has been released, how it’s made, and how it’s managed.
Focusing on the Renault system design used in the manufacturing of Automotive and also Serial life management.
Snap-On Solus Edge Owner’s Manual
>> READ MORE: https://www.obdadvisor.com/snap-on-solus-edge/
Here is a detailed review of the Snap-On Solus Edge scan tool:
- Large touch-responsive display
- Superfast boost-up
- Proven tips at your fingertips
- Powerful battery system
- Functionality
- Connectivity
- Vehicle coverage and compatibility
Check it out to get the REVIEW and some NOTES about using this scanner based on my own experience.
Deployed Lean Manufacturing in fabrication of Exhaust After Treatment System Rack made for VOLVO / Mack Trucks used Lean to increase productivity by 50% and Six Sigma
methodology to resolve complex design issues, improve quality controls for sustained improvement
Overview of Lean Manufacturing types of production , comparison between Batch vs Continuous Flow , how to convert batch to continuous flow and the savings
1000 TON TRANSFER PRESS SAFE WORK PROCEDURE ;DIE SETUP/CHANGEOVERJulian Kalac P.Eng
The reviewer has developed a proper Safe Work Procedure for die changeovers and die setups, which lists the proper steps to be taken to lock out the press flywheel by locking out the master stop, and how to verify zero energy state.
summary of 16 Lean Six Sigma improvement projects in manufacturing, bio-manufacturing, supply chain
including 2 machine safeguarding . Total savings over $8Mil
Overview of Lean and in Supply chain management and Warehouse distribution, identifying the value and NVA steps, streamlining the supply-distribution network to reduce warehouse storage, inventory and lead time
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
DFMEA DUE DILIGENCE TRAINING FOR LITENS AUTOMOTIVE
1. I S O / T S 1 6 9 4 9 R E G I S T E R E D • I S O 1 4 0 0 1 R E G I S T E R E D • w w w . l i t e n s . c o m
DFMEA
DUE DILIGENCE
developed by Julian Kalac, P.Eng for LAP training
2. AGENDA TRAINING for LITENS AUTOMOTIVE
Recap on DFMEA BASICS ,
Canadian Law- Legal requirements
DFMEA consequences of not doing it properly
NEGLIGENCE vs DUE DILIGENCE
CRITICAL DIMENSIONS/TOLERANCES
Good vs Bad DFMEA Litens Examples
September 14, 2016
Page 2
3. Canadian Powers Regulations
Under the Canadian constitution, the federal government
regulates a variety of areas related to product liability, most
notably
1. Food and drugs,
2. Consumer products,
3. Hazardous products and
4. Safety standards for motor vehicles
September 14, 2016
Page 3
4. CANADIAN LAW
Under Canadian law, manufacturers have a duty
1. to warn consumers of the dangers inherent in the use of their
products of which the manufacturer has, or ought to have,
knowledge.
2. A manufacturer will be held liable under Canadian law for
foreseeable injury or damage caused by products that were
negligently designed.
3. A manufacturer will also be held liable Liable for any
manufacturing defects
FMEA are specifically developed for that purpose.
September 14, 2016
Page 4
5. DUTY TO WARN & DUTY TO KNOW
Under Canadian law, manufacturers have a duty to warn consumers
of the dangers inherent in the use of their products of which the
manufacturer has, or ought to have, known
A manufacturer, likewise, has a duty to warn consumers where it
knows, or should know, of safety related dangers caused by a
product’s negligent design or manufacture, or from using the
product
A manufacturer must also advise consumers of any risk of injury
associated with the use of a product , even where the product is
generally safe
September 14, 2016
Page 5
6. WHAT IS DFMEA ?
• Failure Mode and Effects Analysis (FMEA) is an engineering analysis tool used to
identify and prevent failures before they actually happen
• DFMEA are used early in the development phase while the design can be
changed as a Design Verification method
• The most efficient way to do a DFMEA is during the design review when, the
entire design is being reviewed and the FMEA form can be used as a guide
• DFMEA IS NOT A FORM TO FILL OUT FOR COMPLIANCE REASONS
September 14,
2016
Page 6
7. Why is FMEA important?
1. Due Diligence – Product Safety Risks, Design Reliability,
Regulations AIAG, CSA, OHSA, TS-16949 Design Verification,
2. To know what the design failures are in order to warn
consumers and customers of such failures ) before the design is
released into production
3. Reduces warranty costs - far less expensive to prevent problems
early in product development than fix problems after launch.
4. Litens VP Engineering –Critical Dimensions MUST be DERIVED
FROM DFMEA and tolerances justified –WHY IS THAT IMPORTANT?
8. DESIGN FMEA
• Design FMEA evaluates the entire Product Design all
levels contained within the boundaries of the product , (Final
Assy, components, sub-assy)
• The scope of the Design FMEA includes the subsystem or
component itself, as well as the interfaces between adjacent
components.
• Critical dimensions are developed from critical failure modes
within the DFMEA
• DVP&R Tests criteria are developed and confirmed
9. Process FMEA
• Process FMEA focuses on the design of the assembly
process, development of process specifications in order to
meet the critical dimensions specified in the DFMEA
• The scope of a Process FMEA can include manufacturing
and assembly operations, shipping, incoming parts,
transporting of materials, storage, conveyors, tool
maintenance, and labeling.
10. WHEN TO DO A DFMEA?
Case 1: NEW DESIGNS, new technology, or new process. The scope
of the FMEA is the complete design, technology or process.
Case 2: MODIFICATIONS TO EXISTING DESIGN or process (assumes
there is a FMEA for the existing design or process). The scope of the
FMEA should focus on the modification to design or process, possible
interactions due to the modification, and field history.
Case 3: APPLICATION - Use of existing design in a new
environment, or Application . The scope assumes there is an FMEA
for the existing design or processes of the FMEA is the impact of the
new APPLICATION or Environment on the existing design or process.
11.
12. Criminal negligence
219 (1) Every one is criminally negligent who
• (a) in doing anything, or
• (b) in omitting to do anything that it is his duty to do,
shows wanton or reckless disregard for the lives or safety of other
persons.
Duty of persons undertaking acts
217 Every one who undertakes to do an act is under a legal duty to do
it if an omission to do the act is or may be dangerous to life.
September 14, 2016
Criminal negligence
Page 12
13. NEGLIGENCE VS DUE DILIGENCE
Lack of due diligence is negligence
September 14, 2016
Page 13
16. 1- Scenario One
An FMEA is done properly and no significant design
deficiencies are identified. No legal consequences
should result from the FMEA
2- Scenario Two
An FMEA is done properly and design deficiencies
identified, with risk fully addressed. There should be no
legal consequences resulting from the FMEA.
September 14, 2016
Scenario 1 and 2
Page 16
17. Scenario 3 and 4
3- Scenario Three
An FMEA is done improperly and no design deficiencies are
identified. NEGLIGENCE claim can be made that design deficiencies
were possibly missed due to incompetency in the FMEA procedure.
4- Scenario Four
An FMEA is completed and design deficiencies identified. However,
the risk from the design deficiencies is not fully addressed.
Negligence claim can be made that the company knew of
deficiencies in design or manufacturing process and did not take
adequate action to address the associated risk.
September 14, 2016
Page 17
21. September 14, 2016
GM IGNITION SWITCH FMEA
Page 23
GM IGNITION SWITCH FMEA
FAILURE MODE FAILIURE EFFECT S CAUSE OF FAILURE O
DESIGN
CONTROLS
D RPN RECOMMENDED ACTION
STALLS VEHICLE ON
HIGHWAY---NOT
SAFETY CAN STEER
CAR OFF TO THE SIDE-
-DRIVER NUISANCE
10
IGNITION SWITCH
REQUIRES LOW TORQUE
TO TURN --KEY CHAIN
TOO HEAVY --
1
FOB
SPECIFICATI
ON FOR
WEIGHT
1 8
ISSUE TSB TO REMOVE ALL
KEYS FROM FOB -CLOSE
FMEA
DRIVER NUISANCE 8 IGNITION SWITCH LOW TORQUE 2
VEHICLE
RESTART
1 8 NONE CLOSE FMEA
Requirement not defined in units
of measure (VALUES)
22. Lessons Learned from GM ignition Switch
The Federal Crown Prosecutor report suggest that the original GM
ignition switch specification contained vague and ambiguous
targets for the detent torque, which were never achieved, and
provides no evidence that the specification or acceptance criteria
were developed using failure modes effects analysis or similar
techniques.
As a direct result GM engineers failed to understand the significance
of the available evidence for over ten years - and they never asked "Is
the specification is fit for the purpose?" - with serious consequences
for the company and it's consumers.
September 14, 2016
Page 24
24. DFMEA and PFMEA connection
Critical / special
characteristics
25. Brooks Approval:
Date Approved:
Effectivity Date:
Part Number: PCP Number Prepared by:
Part Number Revision: PCP Revision Checked by:
Part Name: PCP Rev Date: Approval:
Characteristic Description
Specification
&
Tolerance
Key
Dim
Measurement Technique
Sample size&
Frequency
Record
CoC Verification Every lot
Dimensions caliper
AQL 1.0
Every lot
diameter Ø160±1 CMM
diameter Ø130±1 CMM
diameter Ø120 G6 Y CMM
diameter Ø65±.0.1 CMM
chamfer C2 CMM
dim 10 -0.1/0 HG
dim 5±0.2 HG
dim control 19 to19.2 Caliper
Roughness 63 √ C SRT/Comparator
3rd Process,
0.02 Y CMM
0.02B Y CMM
Ø0.02B Y CMM
4th process
Hole Ø5H8 PG
dim 26.5±0.03 Y CMM
Tap M6 Tap hole Thread Gauge
Hole
Ø4.5(all the hole
dimension)
CMM
50 De-Burring De-burring tools work instruction #: xxxx
Break All Sharp
Edges and burrs
visual Inspection
AQL1.0
every lot
Record on QA Plan
XXXX
StopDe-
burringRework &
CAR
Tap M6 Tap hole Thread Gauge
Hole Ø5H8 PG
Roughness 63 √ C SRT/Comparator
Appearance to Spec XXXX Visual inspection
70
Treatment/Finish
ing
Treatment House
Specification #:xxxx
Treatment PCP #:xxxxx
Electroless Nickel Plating [0.003-0.005mm]
X-Ray Visual
inspection
AQL0.65
Every lot
COC from Supplier Rework
Qualified Plater
(ABC Company)
diameter Ø120 G6 CMM
hole Ø5H8 PG
tap M6 Tap hole TG
roughness All surface Roughness SRT/Comparator
Appearance
No stain, masking,
color to sample
Visual inspection
90 Packaging
work instruction xxx-
xxxx
Visual
Each Lot
Received
STD packaging
method
Repack and
Validate
Supplier Name:
Process Control Plan
Supplier Number:
Workcell / Location
Process
Step
Number
Process Name /
Operation
Description
Machine, Device, Jig,
Tools for
Manufacturing
Ref Doc. Number/
Specification No
Control Methods/Measurement
Reaction Plan
Remarks
(Special Process)
10
work instruction xxx-
xxxx
STEEL, CORROSION RESISTING, 304 OR 304L
IQC inspection
sheet
Product / Process Characteristics
Receive Raw
Material
Incoming
Return to Supplier.
RMA process XXX
Notify production of new
delivery date.
40
Manufacture work
instruction #: xxxx
Machining
Hole, Profile
cutting, Tap
holes
30
Manufacture work
instruction #: xxxx
Bottom plane
CNC Milling#:xxx
Tool #:xxx
Fixture#:xxx
20
Drawing #:xxx
Manufacture work
instruction #: xxxx
80
Post-treat Inspection
procedure xxxx
Pre-Treatment
Post-Treatment
Inspection
60
Specification #:xxxx
Treatment PCP #:xxxxx
Machining
N/A
CNC Lathe#:xxx
CNC Program #:xxxx
Tool#:xxxx
Fixture#:xxxx
Grinding#:xxx
Tool #:xxx
Fixture#:xxx
2pcs Every
machine Set up
1pcs every two
hours
In-Process
In-Process Insp.
From CMM
2pcs Every
machine Set up
1pcs every hour
In-Process
In-Process Insp.
From CMM
2pcs Every
machine Set up
1pcs every two
hours
In-Process
In-Process Insp.
From CMM
AQL0.65
Every lot
Pre-treatment
inspection record
AQL0.65 for
critical
dimensions and
100% for Visual
inspection
COC from
supplier and Post
treatment
inspection record
Rework/CAR send
for rework
Raise CAR send for
rework
Stop machining/
Fine-tune the
Setting and re-
inspect
Notify Supervisor
Stop machining/
Fine-tune the
Setting
Qualified Operator
Stop machining/
Fine-tune the
Setting
Critical Dimensions &
tolerances from DFMEA
26. DFMEA and DVP&R connection
Test description input
to the DVP&R.
27. Email: Email:
Phone: Phone:
Fax: Fax:
Sample
Size or
Truck #
Req. Start End Start End
1)
Material Compliance
DRD# 3.2.3.1.1
Rev #
Dated ##/##/##
Per CEMS D-28
Rev #
Dated ##/##/##
1a) No 6.3 Resin Requirements Table 2 1 day PV
All Must
Pass
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 1 2013-12-31 2013-12-31 1 Lot
1b) No
6.3 Specific Gravity Table 4 Per ASTM
D792
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 2 2013-12-31 2013-12-31 1 Lot
1c) No
6.3 Tensile Strength - Ultimate
Table 4
Per ASTM
D638
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 3-4 2013-12-31 2013-12-31 1 Lot
1d ) No 6.3 Ultimate Elongation Table 4
Per ASTM
D638
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 5-6 2013-12-31 2013-12-31 1 Lot
1e) No 6.3 Flexural Modulus Table 4
Per ASTM D
790
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84555 by
GE
D 5-6 2013-12-31 2013-12-31 1 Lot
1f) No
6.3 Flexural Strength Table 4 Per ASTM D
790
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 7-8 2013-12-31 2013-12-31 1 Lot
1g) No
6.3 Impact Resistance Table 4
Per CEMS-DT-4 /
Rev #
Dated ##/##/##
Per ASTM D
790
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 9-10 2013-12-31 2013-12-31 1 Lot
1h) No
6.3 Deflection Temperature
Table 4
Per ASTM D
790
1 day PV
All Must
Pass
Test
Plaques
D 1 Lot 2013-12-31 2013-12-31
84576 by
GE
D 11-12 2013-12-31 2013-12-31 1 Lot
1i) No 6.3 Color Table 4 1 day PV
All Must
Pass
Molded Part
Detail D.01
D 2 Parts 2013-12-31 2013-12-31 ASD256 D 13-14 2013-12-31 2013-12-31 2 Parts
1j) No
6.3 Dimensional Stability Table
4
4 hours PV
All Must
Pass
Molded Part B 2 Parts 2013-12-31 2013-12-31
ETA Lab
Rpt 56843
C 13-14 2013-12-31 2013-12-31 2 Parts
2) No 6.3 Table 4 Other Characteristics 1 day PV
All Must
Pass
Plated part C 1 Part 2013-12-31 2013-12-31
HB dated
8/21/06
C 15-16 2013-12-31 2013-12-31 8 parts
3) No 6.3 Table 4 Other Characteristics 1000 Hours PV
All Must
Pass
Painted part C 1 Part 2013-12-31 2013-12-31
LCL
Reported C 17-18 2013-12-31 2013-12-31 9 Parts
Z2 = Finish Paint per TMS-9008 Color: Argent, NAV
8752
Pass Accept
Testing completed by Supplier
see Paint Tab
Grille, Painted, Fixed
Testing to be
completed by Supplier
Z1 = Chrome Plate per MS-7071B_fk Pass Accept
Testing completed by FGH
Platers, Inc, See Chrome Plate
Tab
Salt Spray applied at 16,
32 56 Hours (Grille,
Chrome, Fixed )
Testing to be
completed by FGH
Platers, Inc, See
Chrome Plate Tab
AA88 = 4 hours at 88° C
Parts will conform to the dimensions and tolerances shown
on the engineering drawings after four hours exposure in
an oven at the temperature indicated by the numeral of the
suffix AA - symbol expressed in degrees Celsius.
Pass Accept
Part Testing Performed by ABC
on Molded Part
Molded part (No
Assembly)
Part Testing to be
performed by ABC
AC1 = Integrally colored Part Pass Accept Verified by ABC To be verified by ABC
S90 = 90° min. deflection temperature at 1820 Kpa
98 C
Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
R235 = 36 in/lbs force at minus 30° F
Parts will show no evidence of cracking when impact
tested at point or points indicated on engineering drawing.
299 in-lbs. - Material
Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
N60 = 60 MPa min.
72 MPa
Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
M17 = 1700 MPa min.
2060 MPa
Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
L100 = 100% min. 150% Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
K-40 = 40 MPa min. 50 MPa Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
DF1140 = 1.140+/- 0.05 01-Jan-00 Accept
Material Testing Performed by
GE on Test Plaques
Material to be tested
by GE
PC+ABS = Polycarbonate + Acrylonitrile / Butadiene /
Styrene
PC+ABS = Polycarbonate
+ Acrylonitrile / Butadiene /
Styrene
Accept
Material Testing Performed by
GE
Material to be tested
by GE
Sample ID
Actual Timing Sample
Size Tested
PC + ABS DF1140 K40 L100 M17 N60 R235 S90 /
AC1 AA88 Z1 Z2
Test Location / Test
Verification Resp.
Rqmt
Source
Sample
Type
Scheduled Timing
Report #
Sample
Level
Actual Results
Test Results Status
Accept / Reject
Tests Completed by Notes / Remarks Test Stage
Target
Rqmts
Test
Number
Compliance /
Regulatory /
S C/CC/KP C
Specification / Test Name
Test Method
or Test
Procedure
Duration of
Test
Acceptance Criteria
630-123-4568 815-123-4568
Testing details and Results Planning information Actual Timing
steve.peterson@navistar.com j.foley@onetwothree.com
Test Stage ED = Engineering Devel't Test, DV = Design Verification, PV = Production Verification, CCT = Continued Compliance Testing
Target Requirements. State required probability or reliability and confidence of meeting criteria, e.g. R90, C90 or all must pass. Sample
Type / Level A = Prototype (Handmade), B = Prototype (Tooled), C = Production Tool (Not Process), D = Production Tool & Process
630-123-4567 815-123-4567
Title: Chief Engineer Title: Engineering MGR
Grille, Chrome, Fixed 123659749 C
State: MN Country:
Zip / Postal Code: 60586
X
Component (s):
w/ Navistar Part
Number(s)
Rev
USA
Grille, Chrome, FIxed 1315449691 D
Navistar Design Engineer Supplier Design Engineer (Key Contact)
Grille, Asm 23614649 A
Name: Steve Peterson Name: James Foley
Grille, Asm
Assembly Name:
w/ Navistar Part
Number(s)
Rev Supplier
Address:
12364 Jackson St.
23614649 B
City: Andrewsville
Date:
1236364 A 2012-02-13
Subsystem: Grille Fixed Supplier Code: 12345 Affected Navistar Program(s): XVY 1235
DESIGN VERIFICATION PLAN AND REPORT ISQ-011-FO
Rev: A Date: 04/01/2013
System: Exterior Trim Supplier Name: One, Two, Three 123 Inc.
Core Team:
(list names)
A. Hernandez, B. McGruff, S. Orlander, K.
Keller
DVP&R Number: Revision Level:
DVP&R example
Acceptance Test Criteria from DFMEA--
-example Min Torque= 70Nm
32. September 14, 2016
OCCURRENCE –FAILURE RATE
Page 34
FAILURES
PREVENTED BY
DESIGN
NEW APPLICATION
FAILURES
NEW DESIGN,
FAILURE RATE NOT
KNOWN
33. September 14, 2016
DETECTION by DESIGN
Page 35
DEGRADATION
TESTING
FEA, CAE, PROVEN
DESIGN STANDARD
DVP&R TEST FAILURES
100% EOL TEST
FAILURE CANNOT BE
DETECTED BY DESIGN
35. September 14, 2016
CAR WONT START FAILURE TREE
Page 37
TOP LEVEL SINGLE
POINT FAILURES
Potential Causes of Failure = Components of the top level
36. FAILURE MODE : CAR WONT START
September 14, 2016
Page 38
AMBIGUOUS FAILURE MODE
FAILURE MODE SYMPTOM POTENTIAL CAUSES
PROBABILITY
OF FAILURE
CAR DOES NOT START NO CRANK BATTERY VOLTAGE < 12 V 0.15
IGNITION SWITCH DEFECTIVE 0.12
ENGINE PROBLEM 0.11
STARTER MOTOR FAILURE 0.11
ALTERNATOR VOLTAGE < 11V 0.09
FUEL PUMP FAILING 0.07
DISTRIBUTOR COIL FAILURE 0.06
VEHICLE SECURITY SYSTYEM IMMOBILIZED 0.05
SPARK PLUGS 0.04
OTHER 0.2
53%PROBABILITY OF FINDING CAUSE OF FAILURE=
Many possible causes ,
how do you know which
one is the cause ?
37. FAILURE MODE : CAR WONT START
September 14, 2016
Page 39
DETAILED FAILURE MODE
FAILURE MODE EFFECT POTENTIAL CAUSES
PROBABILITY
OF FAILURE
UNABLE TO START CAR IN
COLD TEMPERATURES < -10 C
COLD START FAILURE BATTERY VOLTAGE < 12 V 0.49
FROZEN /LOOSE TERMINAL BATTERY 0.32
ALTERNATOR VOLTAGE < 14V 0.17
0.98PROBABILITY OF FINDING CAUSE OF FAILURE=
MORE DETAILED FAILURE MODE NARROWED THE POOL OF POSSIBLE CAUSES DOWN FROM
11 TO 3 . NOW WHAT ? HOW TO FIND THE REAL CAUSE ?
38. DETAILED vs AMBIGUOUS FAILURE MODE
September 14, 2016
Page 40
AMBIGUOUS FAILURE MODE
FAILURE MODE EFFECT POTENTIAL CAUSES
PROBABILITY
OF FAILURE
CAR DOES NOT START VEHICLE INNOPERABLE BAD BATTERY 0.15
IGNITION SWITCH DEFECTIVE 0.12
ENGINE PROBLEM 0.11
STARTER MOTOR FAILURE 0.11
ALTERNATOR VOLTAGE < 11V 0.09
FUEL PUMP FAILING 0.07
SHORT CIRCUIT 0.01
DISTRIBUTOR COIL FAILURE 0.06
VEHICLE SECURITY SYSTYEM IMMOBILIZED 0.05
SPARK PLUGS 0.04
OTHER 0.2
54%
DETAILED FAILURE MODE
FAILURE MODE EFFECT POTENTIAL CAUSES
PROBABILITY
OF FAILURE
UNABLE TO START CAR IN
COLD TEMPERATURES < -10 C
COLD START FAILURE BATTERY VOLTAGE < 12 V 0.49
FROZEN /LOOSE TERMINAL BATTERY 0.32
ALTERNATOR VOLTAGE < 14V 0.17
0.98
PROBABILITY OF FINDING CAUSE OF FAILURE=
PROBABILITY OF FINDING CAUSE OF FAILURE=
11 possible causes
narrowed down to 3.
But which one is the
root cause?
39. September 14, 2016
5 WHY - ROOT CAUSE WHY CAR WON’T START
Page 41
WHY DOES THE
CAR NOT START?
•CHARGE LIGHT KEEPS
COMING ON
WH DOES THE
CHARGE LIGHT
COME ON?
• ALTERNATOR
NOT CHARGING
WHY ALT NOT
CHARGING?
• BECAUSE THE ALT
VOLTAGE < 11V
WHY IS IT < 11V ?
WHY IS THE ALT
VOLTAGE DROPPING?
ALTERNATOR CANNOT
HOLD CHARGE
OLD DEFECTIVE
BATTERY
CUSTOMER INFO: CAR NOT STARTING
REPLACED OAD & ALTERNATOR CHARGE
LIGHT OFF THEN ON AGAIN WHY?
40. Do your Failure Analysis diligently
Identify all the failures and correct them
The ones you cannot fix warn the customer of them
DO NOT WAIT FOR CUSTOMERS TO FIND THE FAILURES FOR YOU!!
Be Proactive and advise them , in most cases they will understand
REMEMBER YOU ARE LIABLE FOR YOUR FMEA
FMEA ARE LEGAL DOCUMENTS AND CAN BE USED TO
DEMONSWTRATE THE LACK OF DUE DILIGENCE , NEGLIGENCE
September 14, 2016
RECAP
Page 42
41. GOOD PRACTICES TO AVOID BAD EVIDENCE
It has to be done correctly:
A well-done and properly completed FMEA can be a
strong ally in the defense for the manufacturer in
product litigation.
Poorly done and haphazard completion of an FMEA
can be used to support the prosecution.
September 14, 2016
Page 43
42. FMEAs are legal documents
It is important for the FMEA team to
understand that FMEAs are legal documents that
support the demonstration of due care in
product development. As legal documents, they
are subject to subpoena for legal proceedings.
Effective FMEAs, published by John Wiley & Sons. [1]
September 14, 2016
Page 44