dfmea due diligence training for litens automotive

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

May 3, 2023

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

May 3, 2023

Canadian Powers RegulationsUnder 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

May 3, 2023

CANADIAN LAWUnder 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.

May 3, 2023

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

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

May 3, 2023

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?

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

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.

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.

WHAT IF WE DO NOT DO ANYTHING?

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.

May 3, 2023

Criminal negligence

May 3, 2023

NEGLIGENCE VS DUE DILIGENCE Lack of due diligence is negligence

May 3, 2023

NEGLIGENCE or DUE DILIGENCE?

May 3, 2023

Potential Consequences failing DUE DILIGENCE

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.

May 3, 2023

Scenario 1 and 2

May 3, 2023

Scenario 3 and 43- 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.

May 3, 2023

OVERVIEW OF FMEA

May 3, 2023

GM IGNITION SWITCH FAILURE

OVER 300 deaths23 Mil cars recalled from 2004 2014

May 3, 2023 Page 21

May 3, 2023

GM IGNITION SWITCH FMEAPage 23

GM IGNITION SWITCH FMEAFAILURE 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 2VEHICLE RESTART

1 8 NONE CLOSE FMEA

Requirement not defined in units of measure (VALUES)

May 3, 2023

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.

Page 24

May 3, 2023

EXPLOSIVE PINTO FUEL TANK DESIGNPage 25

DFMEA and PFMEA connection

Critical / special characteristics

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 DescriptionSpecification

&Tolerance

KeyDim Measurement Technique Sample size&

Frequency Record

CoC Verification Every lot

Dimensions caliper AQL 1.0 Every lot

diameter Ø160±1 CMMdiameter Ø130±1 CMMdiameter Ø120 G6 Y CMMdiameter Ø65±.0.1 CMMchamfer C2 CMM

dim 10 -0.1/0 HGdim 5±0.2 HGdim control 19 to19.2 Caliper

Roughness 63 √ C SRT/Comparator3rd Process,

0.02 Y CMM0.02B Y CMM

Ø0.02B Y CMM4th process

Hole Ø5H8 PGdim 26.5±0.03 Y CMMTap M6 Tap hole Thread Gauge

Hole Ø4.5(all the hole dimension)

CMM

50 De-Burring De-burring tools work instruction #: xxxxBreak All Sharp Edges and burrs visual Inspection

AQL1.0 every lot

Record on QA Plan XXXX

StopDe-burringRework &

CARTap M6 Tap hole Thread GaugeHole Ø5H8 PG

Roughness 63 √ C SRT/ComparatorAppearance to Spec XXXX Visual inspection

70 Treatment/Finishing

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 CMMhole Ø5H8 PGtap M6 Tap hole TG

roughness All surface Roughness SRT/Comparator

Appearance No stain, masking, color to sample

Visual inspection

Supplier Name:

Process Control Plan Supplier Number:

Workcell / Location

Proc

ess

Step

N

umbe

r

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

30Manufacture work instruction #: xxxxBottom plane

CNC Milling#:xxx Tool #:xxx

Fixture#:xxx

20Drawing #:xxx

Manufacture work instruction #: xxxx

80 Post-treat Inspection procedure xxxx

Pre-Treatment

Post-Treatment Inspection

60Specification #: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

hoursIn-Process

In-Process Insp.From CMM

2pcs Every machine Set up 1pcs every hour

In-Process


2pcs Every machine Set up 1pcs every two

hoursIn-Process


AQL0.65 Every lot

Pre-treatmentinspection record

AQL0.65 forcritical

dimensions and100% for Visual

inspection

COC fromsupplier and Post

treatmentinspection record

Rework/CAR send for rework

Raise CAR send forrework

Stop machining/ Fine-tune the

Setting and re-inspect

Notify Supervisor


SettingQualified Operator


Setting

Critical Dimensions & tolerances from DFMEA

DFMEA and DVP&R connection

Test description input to the DVP&R.

Email: Email:

Phone: Phone:

Fax: Fax:

Sample Size or Truck #

Req. Start End Start End

1)

Material ComplianceDRD# 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

PassTest

Plaques D 1 Lot 2013-12-31 2013-12-31 84576 by GE D 2 2013-12-31 2013-12-31 1 Lot

1c) No6.3 Tensile Strength - Ultimate

Table 4Per ASTM

D638 1 day PVAll Must

PassTest

Plaques D 1 Lot 2013-12-31 2013-12-3184576 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

PassTest

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

PassTest


1f) No6.3 Flexural Strength Table 4 Per ASTM D

790 1 day PVAll Must

PassTest

Plaques D 1 Lot 2013-12-31 2013-12-3184576 by

GE D 7-8 2013-12-31 2013-12-31 1 Lot

1g) No

6.3 Impact Resistance Table 4Per CEMS-DT-4 /

Rev #Dated ##/##/##

Per ASTM D 790 1 day PV All Must

PassTest


1h) No6.3 Deflection Temperature

Table 4Per ASTM D

790 1 day PVAll Must

PassTest

Plaques D 1 Lot 2013-12-31 2013-12-3184576 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) No6.3 Dimensional Stability Table

4 4 hours PVAll Must

Pass Molded Part B 2 Parts 2013-12-31 2013-12-31ETA 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 partsZ1 = Chrome Plate per MS-7071B_fk Pass AcceptTesting 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° CParts 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 Kpa98 C

Accept Material Testing Performed by GE on Test Plaques

Material to be tested by GE

R235 = 36 in/lbs force at minus 30° FParts 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


N60 = 60 MPa min. 72 MPa AcceptMaterial Testing Performed by

GE on Test PlaquesMaterial to be tested

by GE

M17 = 1700 MPa min.2060 MPa

Accept Material Testing Performed by GE on Test Plaques


L100 = 100% min. 150% Accept Material Testing Performed by GE on Test Plaques


K-40 = 40 MPa min. 50 MPa Accept Material Testing Performed by GE on Test Plaques


DF1140 = 1.140+/- 0.05 01-Jan-00 Accept Material Testing Performed by GE on Test Plaques


PC+ABS = Polycarbonate + Acrylonitrile / Butadiene / Styrene

PC+ABS = Polycarbonate + Acrylonitrile / Butadiene /

StyreneAccept Material Testing Performed by

GE Material to be tested

by GE

Sample IDActual 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 TimingReport # Sample

LevelActual Results Test Results StatusAccept / Reject Tests Completed by Notes / Remarks Test Stage Target

RqmtsTest

N

umbe

r

Compliance / Regulatory / SC/CC/KPC

Specification / Test NameTest Method

or Test Procedure

Duration of Test Acceptance Criteria

630-123-4568 815-123-4568

Testing details and Results Planning information Actual Timing

[email protected] [email protected]

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 MGRGrille, Chrome, Fixed 123659749 C

State: MN Country:

Zip / Postal Code: 60586

X

Component (s): w/ Navistar Part Number(s) Rev

USAGrille, Chrome, FIxed 1315449691 D

Navistar Design Engineer Supplier Design Engineer (Key Contact)

Grille, Asm 23614649 AName: Steve Peterson Name: James Foley

Grille, Asm

Assembly Name: w/ Navistar Part Number(s) Rev Supplier

Address: 12364 Jackson St.

23614649 BCity: Andrewsville

Date:

1236364 A 2012-02-13Subsystem: 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 EXAMPLE

Acceptance Test Criteria from DFMEA---example Min Torque= 70Nm

FAILURES, SYMPTOMS AND ROOT CAUSE ANALYSIS

Design FMEA31

Failure Mode

ANTI-FUNCTION

(FAILURE MODE)

05/03/2023

Page 32

FMEA Thought Process

May 3, 2023

SEVERITY OF FAILUREPage 33

NOISE

DURABILITY

PERFORMANCE

SAFETY WITH & W/O WARNING

May 3, 2023

OCCURRENCE –FAILURE RATEPage 34

FAILURES PREVENTED BY

DESIGN

NEW APPLICATION FAILURES

NEW DESIGN,FAILURE RATE NOT

KNOWN

May 3, 2023

DETECTION by DESIGNPage 35

DEGRADATION TESTING

FEA, CAE, PROVEN DESIGN STANDARD

DVP&R TEST FAILURES 100% EOL TEST

FAILURE CANNOT BE DETECTED BY DESIGN

May 3, 2023

FAILURE MODE: CAR WONT START ---WHAT IS THE CAUSE?

Page 36

FIND THE CAUSE IN 10MIN—ONLY 1 CHANCE, 1 CAUSE

May 3, 2023

CAR WONT START FAILURE TREEPage 37

TOP LEVEL SINGLE POINT FAILURES

Potential Causes of Failure = Components of the top level

May 3, 2023

FAILURE MODE : CAR WONT START Page 38

AMBIGUOUS FAILURE MODEFAILURE MODE SYMPTOM POTENTIAL CAUSES PROBABILITY

OF FAILURE

CAR DOES NOT START NO CRANK BATTERY VOLTAGE < 12 V 0.15IGNITION SWITCH DEFECTIVE 0.12

ENGINE PROBLEM 0.11STARTER MOTOR FAILURE 0.11

ALTERNATOR VOLTAGE < 11V 0.09FUEL PUMP FAILING 0.07

DISTRIBUTOR COIL FAILURE 0.06VEHICLE SECURITY SYSTYEM IMMOBILIZED 0.05

SPARK PLUGS 0.04OTHER 0.2

53%PROBABILITY OF FINDING CAUSE OF FAILURE=

Many possible causes , how do you know which one is the cause ?

May 3, 2023

FAILURE MODE : CAR WONT START Page 39

DETAILED FAILURE MODEFAILURE 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 0.32ALTERNATOR 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 ?

May 3, 2023

DETAILED vs AMBIGUOUS FAILURE MODE Page 40

AMBIGUOUS FAILURE MODEFAILURE MODE EFFECT POTENTIAL CAUSES PROBABILITY

OF FAILURE

CAR DOES NOT START VEHICLE INNOPERABLE BAD BATTERY 0.15IGNITION SWITCH DEFECTIVE 0.12

ENGINE PROBLEM 0.11STARTER MOTOR FAILURE 0.11

ALTERNATOR VOLTAGE < 11V 0.09FUEL PUMP FAILING 0.07

SHORT CIRCUIT 0.01DISTRIBUTOR COIL FAILURE 0.06

VEHICLE SECURITY SYSTYEM IMMOBILIZED 0.05SPARK PLUGS 0.04

OTHER 0.254%

DETAILED FAILURE MODEFAILURE 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 0.32ALTERNATOR 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?

May 3, 2023

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?

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

May 3, 2023

RECAPPage 42

May 3, 2023

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.

Page 43

May 3, 2023

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]

Page 44

THANK YOU

dfmea due diligence training for litens automotive

Education