FMEA

What is FMEA ?

1
 FMEA
FMEA is an analytical methodology used to
ensure that potential problems have been
considered and addressed throughout the
APQP process
Most visible result is the documentation of
the collective knowledge of cross functional
teams
Part of the evaluation and analysis is the
assessment of risk
2
 FMEA
Each FMEA should ensure that attention is
given to every component within the product
or assembly
Critical and safety related components or
processes should be given a higher priority

3
 FMEA

What is purpose of conducting the FMEA ?

4
 Purpose of conducting FMEA
To reduce the following :
Customer complaints
In-house rejections
Final rejections
Reduce rework, scrap
Overall to enhance customer satisfaction and to
reduce manufacturing cost

5
 Basic concepts
One of the most important factor for
successful
implementation of FMEA program is
timeliness
It is meant to be a before the event action
and not an after the fact exercise
Ideally, the design FMEA process should be
initiated in the early stages of the design and
the process FMEA before tooling or
manufacturing equipment is developed and 6
 FMEA - Cases
Following are three basic cases for which the
FMEA are generated each with different scope
or focus :
New designs, new technology or new
process. Here, the scope is the complete,
design, technology or process
Modifications to existing design or process.
Here, the scope is to focus on the
modification to design or process, possible
interactions due to modification and field
7
history
 FMEA - Cases
Use of an existing design or process in a new
environment, location, application or usage
profile (including duty cycle, regulatory
requirements)

8
 Impact on organization
FMEA is developed by a multi-functional
team
Team size depends on the complexity of the
design and the size of the company
Team members need relevant expertise,
available time and authority sanctioned by
the management
A comprehensive training program should be
implemented including management
overview, training of users, supplier training
and facilitator training 9
 Follow up and continuous improvement
Actions should be communicated to all
affected activities
FMEA is a living document and should
always reflect the latest level, as well as the
latest relevant actions including those
occurring after the start of production
Team leader is responsible for ensuring that
all recommended actions are implemented

10
 Overview of FMEA
FMEA development either design or process
to address :
potential product or process failure to meet
expectations
potential causes of the failure mode
application of current controls
level of risk
risk reduction
Before starting FMEA process, team must
define the scope of the project and collect
existing data 11
 Data

What are the existing data that you

need to collect before carrying out
FMEA ?

12
 Data to be collected
Drawings
BOM
Process flow diagrams
Customer complaints
Application details
Rejections at particular process stages
Current method of measurements
Process validation results
Functional objectives / Targets
13
TGW/TGR
 Customers

Who are the customers ?

14
 Customers
End user person or organization who will
utilize the product
OEM assembly and Manufacturing centers
OEM locations where the operations and
vehicle assembly takes place
Supply chain manufacturing supplier
location where manufacturing, fabricating or
assembling of parts takes place. Example
heat treating, impregnation, welding,
painting, plating, or other finishing services
15
 Customers
Regulators government agencies that define
requirements and monitor compliance to
safety and environmental specifications
which can impact the product or process
Knowledge of the above customers can help
to define functions, requirements and
specifications more robustly and in
determining the effects and of related failure
modes

16
 Steps involved
Identify and understand functions,
requirements and specifications relevant to
the scope
Identify potential failure modes
Identify potential effects
Identify potential cause of failure

17
 Potential failure mode

What is potential failure mode ?

18
 Potential failure mode
Failure mode is defined as the manner in
which a product or process could fail to meet
the process requirements
Assumption is made that the failure could
occur but may not necessarily occur
Should be described in technical terms and
not as a symptom necessarily noticeable by
the customer
Large number of failure modes identified
may indicate that defined requirement is not
concise 19
 Potential failure mode
Pose and answer the following questions :
How can the process/part fail to meet
requirements?
Regardless of engineering specifications,
what would a customer (end user,
subsequent operations or service) consider
objectionable?
Start by comparing similar processes and
reviewing customer claims relating to similar
components 20
 Potential failure mode

Examples of process potential failure mode

21
 Potential effects of failure

What is potential effects of failure ?

22
 Examples of potential effects
Potential effects of failure are defined as the
effects of failure mode as perceived by the
customer
To be described in terms of what the customer
might notice or experience
Customer may be an internal as well as the
end user
Includes analysis of the consequences of
failures and the severity or seriousness of
those consequences 23
 Potential effects of failure
External customers
Noise, High effort, Unpleasant odor,
Intermittent operation, Water leak, Rough idle
Unable to adjust, Difficult to control, Poor
appearance

24
 Potential effects of failure
Internal customers
Unable to assemble at operation X
Unable to attach at customer facility
Unable to connect at customer facility
Cannot bore at operation X
Causes excessive tool wear at operation X
Damages equipment at operation X
Endangers operator at customer facility
Rejection, Rework, scrap
25
 Examples of potential effects

Examples of process potential effects of failure mode

26
 Potential causes of failure

What are potential causes of failure ?

Are these causes for failure mode or effect
of failure?

27
 Potential causes of failure
Potential cause of failure is defined as an
indication of how the failure could occur,
described in terms of something that can be
corrected or can be controlled.
Potential cause is for the failure mode
There is direct relation between a cause and
its resultant failure mode (i.e. if the cause
occurs, then the failure mode occurs)

28
 Examples of potential cause

Examples of process potential cause of failure mode

29
 Steps involved
Controls are those activities that prevent or
detect the cause of the failure or failure mode
Identifying and assessing risk Risk is
evaluated in following three ways :
Severity
Occurrence
Detection
Customer requirements to be clearly
understood for risk assessment

30
 Severity

What is severity ?

31
 Severity
Severity is an assessment of the level of
impact of a failure on the customer
Severity is the value associated with the
most
serious effect for a given failure mode
Severity is a relative ranking within the
scope
of individual FMEA

32
 Severity
The team should agree on an evaluation
criteria and a ranking system and apply them
consistently, even if modified for individual
process analysis

33
 Criteria for Severity

Criteria for severity (PFMEA)

34
 Occurrence

What is occurrence?
Is it the occurrence of effect of failure or
failure mode or the cause of the failure
mode ?

35
 Occurrence
Occurrence is how often the cause of a
failure may occur

36
 Criteria for occurrence

Criteria for Occurrence (PFMEA)

37
 Detection

What is detection?
Is the detection related to effect of failure
or failure mode or the cause of the failure
mode ?

38
 Detection
Detection is an assessment of how well the
product or process controls detect the cause
of the failure or the failure mode

39
 Criteria for detection

Criteria for detection (PFMEA)

40
 Recommended actions and results
Recommended actions and results The
intent of recommended actions is to reduce
the overall risk and likelihood that the failure
mode will occur
Recommended actions address reduction of
the severity, occurrence and detection
Following are some of the actions :
Ensuring design requirements including
reliability are achieved
Reviewing engineering drawings and
specifications 41
 Recommended actions and results
Confirming incorporation in assembly /
manufacturing processes
Reviewing related FMEAs, control plans and
operations instructions
Responsibility and timing to complete the
recommended actions should be recorded
Once actions are completed and results
captured, the updated ratings for severity,
occurrence and detection should also be
recorded
Management owns the FMEA process 42
 FMEA Format

How to fill the FMEA Form ?

43
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

44
 Filling up of details in format
FMEA number Enter an alphanumeric
string which is used to identify the FMEA
document

45
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

46
 Filling up of details in format
Enter the name or number of system, sub
system or component for which the process is
being analyzed

47
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

48
 Filling up of details in format
Process responsibility Enter the OEM,
organization, department or group who is process
design responsible. Also, enter supplier name, if
applicable

49
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

50
 Filling up of details in format
Enter the intended model year(s) /program(s) that
will use and/or be affected by the process
being analyzed (if known)

51
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

52
 Filling up of details in format
Key date
Enter the initial PFMEA due date, which
should not exceed the scheduled
start of production date (In the case of a
supplier, this date should not exceed the
customer required PPAP submission date)

53
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

54
 Filling up of details in format
FMEA date
Enter the date the original PFMEA was
completed and the latest revision
date

55
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

56
 Filling up of details in format
Core team
Enter the team members responsible for
developing the PFMEA
Contact information (eg name, organization,
telephone number and e mail) may be
included in a referenced supplemental
document

57
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

58
 Filling up of details in format
Prepared by
Enter the name and contact information
including the organization of the
engineer / team leader responsible for
preparing the PFMEA

59
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
Process S Current O Current R sibility O
l Potential e S R
step / Potential Potential Process c Process & e
a cause(s)/M Recommen
Function/ Failure effects of e Controls c Controls P Target Actions c
echanism(s t ded actions e P
Requireme mode failure Preventi u Detectio Compl taken c t
s ) of failure e
nts v on r n N etion u e
Date v N
s c r
c

60
 Filling up of details in format
Process step/Function/Requirements (a)
Process/Function can be separated into two
(or more) columns or combined into a single,
bridged column

61
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

62
 Potential failure mode
Potential failure mode is defined as the
manner in which the process could potentially
fail to meet the process requirements

63
 Potential failure mode
List the potential failure mode(s) for a
particular operation in terms of potential
requirement(s)
Verification of completeness of potential
failure modes can be made through a review
of past things-gone-wrong, concerns, reject or
scrap reports or group brainstorming

64
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

65
 Potential effects of failure
List the potential effects of failure

66
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

67
 Severity
Assign the severity ranking as per the criteria
It is not recommended to modify the criteria
ranking values of 9 and 10
Failure modes with a rank of severity 1 should
not be analyzed further

68
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

69
 Classification
This column may be used to highlight high
priority failure modes and their associated
causes or to classify any special
product/process characteristics (ex critical,
key, major, significant) for components,
subsystems or systems that may require
additional product / process controls

70
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

71
 Potential causes of failure
List all the possible potential causes of failure

72
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

73
 Current Process Controls
Following are two types of process controls to
consider:
Prevention Prevent the cause/mechanism of
failure or the failure mode from occurring or
reduce their rate of occurrence
Detection Detect the cause/mechanism of
failure or the failure mode, and lead to
corrective action(s)
74
 Examples of prevention control

Examples of prevention control :

Operator training
Password protected control panel
Training of set up personnel
Setting added to set-up instructions

75
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

76
 Occurrence
Assign the occurrence ranking as per the
criteria

77
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

78
 Examples of Detection control
Examples of detection control :
Sensor included
Torque validation included in set up procedure
to validate setting prior to running

79
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

80
 Detection
Assign the detection ranking as per the criteria

81
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

82
 RPN
Risk priority number is the product of the
severity (S), occurrence(O) and detection (D)
rankings
(S) X (O) X (D) = RPN
The use of an RPN threshold is NOT a
recommended practice for determining the
need for actions

83
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

84
 Determining action priorities
Initial focus of the team should be oriented
towards failure modes with the highest severity
rankings
When the severity is 9 or 10, it is imperative
that the team must ensure that the risk is
addressed through existing design controls or
recommended actions
For failure modes with severities 8 and below,
the team should consider causes having
highest RPN, occurrence or detection rankings85
 Recommended actions
If engineering assessment leads to no
recommended actions for a specific failure
mode/cause/control combination, indicate this
by entering None in this column

86
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

87
 Responsibility and Actions
Responsibility for the recommended action(s)
Enter the name of the individual and
organization responsible for completing each
recommended action including the target
completion date
The process responsible engineer /team
leader is responsible for ensuring that all
actions recommended have been implemented
or adequately addressed 88
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility O
Process l Potential e S R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen
Failure effects of e Controls c Controls P Target Actions c
Requireme echanism(s t ded actions e P
mode failure Preventi u Detectio Compl taken c t
nts s ) of failure e
v on r n N etion u e
Date v N
s c r
c

89
 Responsibility and Actions
Action results This section identifies the
results of any completed actions and their
effect on S, O, D rankings and RPN
Action(s) taken and completion date After
the action has been implemented, enter a brief
description of the action taken and actual
completion date

90
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility
Process l Potential e S O R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen c
Failure effects of e Controls c Controls P Target Actions
Requireme echanism(s t ded actions e c P
mode failure Preventi u Detectio Compl taken t
nts s ) of failure e u
v on r n N etion e
Date v r N
s c
c

91
 Resultant S, O, D
After the preventive/corrective actions has
been completed, determine and record the
resulting severity, occurrence and detection
rankings

92
 PROCESS FMEA

FMEA Number

Item Process responsibility Page

Model Year(s)/Vehicle(s) Prepared by

Core Team Key Date FMEA Date

Action Results
C D
Respn D
S Current O Current R sibility
Process l Potential e S O R
Potential Potential Process c Process & e
Function/ a cause(s)/M Recommen c
Failure effects of e Controls c Controls P Target Actions
Requireme echanism(s t ded actions e c P
mode failure Preventi u Detectio Compl taken t
nts s ) of failure e u
v on r n N etion e
Date v r N
s c
c

93
 Resultant RPN
Calculate and record the resulting action (risk)
priority indicator (eg RPN)

94
 S, O, D and RPN
All the revised ratings should be reviewed
Action alone do not guarantee that the
problem was solved (i.e cause addressed), thus
an appropriate analysis or test should be
completed as verification
If further action is considered necessary,
repeat the analysis
The focus should always be on continuous
improvement 95
Thank you