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

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.

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

14. September 14, 2016
NEGLIGENCE or DUE DILIGENCE?
Page 14

15. September 14, 2016
Potential Consequences failing DUE DILIGENCE
Page 15

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

18. OVERVIEW OF FMEA
September 14, 2016
Page 18

19. September 14, 2016
GM IGNITION SWITCH FAILURE
Page 19
OVER 300 deaths
23 Mil cars recalled
from 2004 2014

20. September 14, 2016 Page 21

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

23. September 14, 2016
EXPLOSIVE PINTO FUEL TANK DESIGN
Page 25

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

28. FAILURES, SYMPTOMS AND ROOT
CAUSE ANALYSIS

29. Design FMEA
31
Failure Mode
ANTI-FUNCTION
(FAILURE MODE)

30. 2016-09-14
FMEA Thought Process
32

31. September 14, 2016
SEVERITY OF FAILURE
Page 33
NOISE
DURABILITY
PERFORMANCE
SAFETY WITH & W/O
WARNING

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

34. September 14, 2016
FAILURE MODE: CAR WONT START ---WHAT IS THE CAUSE?
Page 36

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

43. THANK YOU