Post on 13-Apr-2017
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
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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
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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.
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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
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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
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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.
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Criminal negligencePage 12
May 3, 2023
NEGLIGENCE VS DUE DILIGENCE Lack of due diligence is negligence
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May 3, 2023
NEGLIGENCE or DUE DILIGENCE?Page 14
May 3, 2023
Potential Consequences failing DUE DILIGENCEPage 15
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 2Page 16
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.
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May 3, 2023
OVERVIEW OF FMEA
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May 3, 2023
GM IGNITION SWITCH FAILURE Page 19
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.
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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
In-Process Insp.From CMM
2pcs Every machine Set up 1pcs every two
hoursIn-Process
In-Process Insp.From CMM
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
Stop machining/ Fine-tune the
SettingQualified Operator
Stop machining/ Fine-tune the
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
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) 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
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) 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
Material to be tested by GE
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
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 /
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
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 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)
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FMEA Thought Process
May 3, 2023
SEVERITY OF FAILUREPage 33
NOISE
DURABILITY
PERFORMANCE
SAFETY WITH & W/O WARNING
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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?
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FIND THE CAUSE IN 10MIN—ONLY 1 CHANCE, 1 CAUSE
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CAR WONT START FAILURE TREEPage 37
TOP LEVEL SINGLE POINT FAILURES
Potential Causes of Failure = Components of the top level
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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
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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.
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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]
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THANK YOU