Training Module

On
Failure Mode Effect Analysis - FMEA
(Refer : FMEA AIAG Manual - 4th Edition)

Neel Auto Private Limited,

Gurgaon
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Contents :
 Introduction

 Process FMEA

 Steps to do FMEA

 Evaluation Criteria- Severity , Occurrence & Detection

 RPN Evaluation Criteria

 Recommended Actions

 Example PFMEA

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Introduction

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WHAT IS FMEA ?
FMEA is an acronym that stands for Failure Modes and Effect
Analysis.

It is a systematic group of activities intended to:

Recognize the potential failure(s) of a product or
process and the severity of effect of that failure(s).
Identify critical characteristics.
Rank order potential design and process deficiencies.
Identify actions that can eliminate or reduce the
chance of the potential failure from occurring and
reaching the customer.
Document the process.
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Where did it originate from ?
 First used in the 1960’s by NASA during the Apollo
missions
 In 1974, the Navy developed MIL-STD-1629 regarding the
use of FMEA
 Ford- the first Automotive company using FMEA
 Incorporated by “Big Three”.
 AIAG and American Society for Quality Control copyright
standards in 1993.
 Published fourth Edition in 2008.

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 When PFMEA Required?
• New process being designed
• New equipment developed or purchased
• Existing process being designed or redesigned
• To monitor and track improvement over time

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Types of FMEA

System
Focus is on functions and interactions among systems.

Design
Focus is on potential failure modes of products due to
design deficiencies and errors.

Process
Focus is on potential failure modes caused by process
deficiencies.

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FMEA Team

Team approach is necessary

Examples of team representatives:
- Design
- Manufacturing Operators/Supervisors
- Quality
- Reliability
- Materials
- Testing
- Supplier
- Customers

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 FMEA Inputs and Outputs

Inputs Outputs
Actions designed to
Process Flow diagram
prevent failures or detect
effects.
Characteristics Matrix
History of imp. project
Control Plan for existing FMEA under-taken
product
Input to control Plan
Customer
Requirements

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 Definition of Terms

Failure: A ‘Failure’ is that a component, assembly or system which does
not meet the requirements or function in accordance with design intent.
(Ex. Not meeting the specification, heat treatment failure)


Failure Mode - the way in which a specific process input fails - if not
detected and either corrected or removed, will cause Effect to occur. Can
be associated with a defect (in discrete manufacturing) or a process input
variable that goes outside of specification.


Effect - impact on customer requirements. Generally external customer
focus, but can also include local effect or downstream processes. Can be
product or process.


Cause
- Sources of process variation that causes the Failure Mode to occur.
For example, for the Failure Mode, Temperature too High, the Cause
might be a faulty temperature sensor.
- Identification of Causes should start with Failure Modes associated
with the highest severity ratings.

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 Definition of Terms - continued

Current Controls
- Systematized methods/devices in place to prevent or detect failure modes
or Causes (before causing effects).
- Prevention consists of foolproofing, automated control and set-up
verifications
- Controls consists of audits, checklists, Inspection, laboratory testing,
training, SOP’s, preventive maintenance, etc.

Severity (of Effect)- importance of effect on customer requirements - could also
be concerned with safety and other risks if failure occurs (1=Not Severe,
10=Very Severe)

Occurrence (of Cause)- frequency with which a given Cause occurs and creates
Failure Mode. Can sometimes refer to the frequency of a Failure Mode (1=Not
Likely, 10=Very Likely)

Detection (capability of Current Controls) - ability of current control scheme to
detect:
- the causes before creating failure mode
- the failure modes before causing effect
- 1=Likely to Detect, 10=Not Likely at all to Detect


RISK PRIORITY NUMBER (RPN) is multiplication of severity , occurrence &
detection
i.e. RPN = Severity X Occurrence X Detection

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Process FMEA

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Process

“Any activity, or set of activities

that uses resources to transform
inputs to outputs
can be considered a Process”
Process Approach
Work
Environment

Customer
Next
Inputs PROCESS Outputs
Operation
OEM ASSY USER

Human Infra
Resources Structure
- Equipment
- Tooling etc.

Every Process has at least one customer, who is affected by the

output of the Process.
 FMEA Format
PROCESS FMEA

PROTOTYPE/PRELAUNCH/PRODUCTION
CUSTOMER :
Step-1 Step-2 SUPPLIER CODE VEHICLE / MODEL DOC. NO.
PART NO./REV. NO. CUSTOMER : SUPPLIER : PART NAME DATE(ORIG)
ASSY. NO./REV.NO. CUSTOMER : SUPPLIER : ASSY. NAME REV NO / DATE
CORE TEAM : PROCESS RESPONSIBILITY DVM P.E.
RESP./
C
POTENTIAL CURRENT CURRENT TARGE
PROCESS POTENTIAL S L O D R S O D R
POTENTIAL CAUSE(S) PROCESS PROCESS RECOMMENDED T ACTION
OPN.NO. FUNCTION EFFECT(S) OF E A C E P E C E P
FAILURE MODE V MECHANISM(S) OF C CONTROL CONTROL T N ACTIONS COMPL TAKEN V C T N
REQUIREMENT FAILURE S
FAILURE PREVENTION DETECTION ETION
Step-3 Step-4 S
Step-7 Step-8
DATE Step-9

Step-5 Step-6

PREPARED BY : APPROVED BY ISSUED BY:- ISSUE DATE

FMEA Road Map

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 STEPS to do FMEA
• Step 1 - Select a process to evaluate
• Step 2 - Recruit a multidisciplinary Team
• Step 3 - Have the team meet to list all the steps in the process
• Step 4 - Have the team list failure modes and causes
• Step 5 - For each failure mode have the team assign likelihood of
occurrence, likelihood of detection and severity.

– Likelihood of occurrence – How likely is it that the failure mode will

occur?
– Likelihood of detection – If this failure mode occurs, how likely is it
that the failure will be detected?
– Severity : if this failure mode occurs how likely is it that harm will
occur?
 Steps to do FMEA - continued
• Step 6 - Multiply S, O & D to calculate RPN Nos. for Each failure mode.
• Step 7 - Identify the failure modes with the top 10 highest RPNs.
• Step 8 - For failure modes with top 10 RPNs recommend action plan
(With responsibility and Completion date)for improvement (to reduce
severity & occurrence or improving detection).

Note: Severity can be reduced by product/ process design change.

Occurrence can be reduced by improving Preventive controls.
Detection rank can be reduced by improving detection controls.
• Step 9 – Recalculate RPN No. For action taken.
Evaluation Criteria &
Recommended Actions

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 Suggested PFMEA Severity Evaluation Criteria

Effect Criteria: Severity of effect Criteria: Severity of effect Ranking

This ranking results when a potential failure This ranking results when a potential failure
mode results in a final customer and/or a mode results in a final customer and/or a
manufacturing/ assembly plant defect. The manufacturing/ assembly plant defect. The
final customer should always be considered final customer should always be considered
first. If both occur, use the higher of the two first. If both occur, use the higher of the two
severities. severities.
(Customer Effect) (Manufacturing/ Assembly Effect)
Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 10
without failure mode affects safe vehicle operation assembly without warning.
warning and/or involves noncompliance with
government regulation without warning.
Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 9
with failure mode affects safe vehicle operation assembly) with warning.
warning and/or involves noncompliance with
government regulation with warning.
Very high Vehicle/ item inoperable (loss of primary Or 100% of product may have to be 8
function). scrapped, or vehicle item repaired in repair
department with a repair time greater than
one hour.
High Vehicle/ team operable but at a reduced level Or product may have to be sorted and a 7
of performance. Customer very dissatisfied. portion (less than 100%) scrapped, or
vehicle/ item repaired in repair department
with a repair time between a half-hours and
an hour.

Contd…
 Suggested PFMEA Severity Evaluation Criteria (Continued)

Moderate Vehicle/ item operable but Comfort/ Or a portion (less than 100%) of the product
convenience item(s) inoperable. may have to scrapped with no sorting, or 6
Customer dissatisfied. vehicle/ item repaired in repair department with
a repair time less than a half-hour.

Low Vehicle/ item operable but comfort/ Or 100% of product may have to be reworked,
convenience item(s) operable at a or vehicle/ item repair off-line but does not go to 5
reduced level of performance. repair department.

Very low Fit and finish/ squeak and rattle item Or the product may have to be sorted, with no
does not conform. Defect noticed by scrap, and a portion (less than 100%) reworked. 4
most customers. (greater than 75%)

Minor Fit and finish/ squeak and rattle item Or a portion (less than 100%) of the product
does not conform. Defect noticed by may have to be reworked, with no scrap, on-line 3
50% of customers. but out-of-station.

Very minor Fit and finish/ squeak and rattle item Or a portion (less than 100%) of the product
does not conform. Defect noticed by may have to be reworked, with no scrap, on-line 2
discriminating customers (less than but in-station.
25%)
None No discernible effect. Or slight inconvenience to operation or
operator, or no effect. 1
 Suggested PFMEA-Occurrence evaluation criteria with Ppk values

Probability Likely Failure Rates * Ppk Ranking

Very High : Persistent Failure > 100 per thousand pieces. < 0.55 10

50 per thousand pieces. > 0.55 9

High : Frequent Failures 20 per thousand pieces. > 0.78 8

10 per thousand pieces. > 0.86 7

Moderate : Occasional Failures 5 per thousand pieces. > 0.94 6

2 per thousand pieces. > 1.00 5

1 per thousand pieces. > 1.10 4

Low : Relatively Few Failures 0.5 per thousand pieces. > 1.20 3

0.1 per thousand pieces. > 1.30 2

Remote : Failure us unlikely <0.01 per thousand pieces. > 1.67 1

 Suggested PFMEA Detection Evaluation Criteria
Detection Criteria Inspection Suggested Range of Detection Methods Ranking
Types
A B C
Almost Absolute certainty of non-detection. X Cannot detect or is not checked. 10
Impossible

Very remote Controls will probably not detect. X Control is achieved with indirect or random checks 9
only.
Remote Controls have poor chance of detection. X Controls is achieved with visual inspection only. 8

Very low Controls have poor chance of detection. X Control is achieved with double visual inspection only. 7

Low Control may detect. X X Control is achieved with charting methods, such as 6
SPC {Statistical Process Control}.
Moderate Controls may detect. X Control is based on variable gauging after parts have 5
left the station, or Go/No Go gauging performed on
100% of the parts after parts have left the station.

Moderate Controls have a good chance to detect. X X Error detection in subsequent operations, or gauging 4
high performed on setup and first-piece check (for set-up
causes only).
High Controls have a good chance to detect. X X Error detection in-station, or error detection in 3
subsequent operations by multiple layers of
acceptance : supply, select, install, verify. Cannot
accept discrepant part.
Very high Controls almost certain to detect. X X Error detection in-station (automatic gauging with 2
automatic stop feature). Cannot pass discrepant part.

Very high Controls certain to detect. X Discrepant parts cannot be made because item has 1
been error proofed by process/ product design.

Inspection Types:
A. Error-proofed
B. Gauging
C. Manual Inspection
 Suggested PFMEA RPN Evaluation Criteria
• RPN = (S) x (O) x (D)

• RPN used for prioritizing the area of concern.

That is, for each process we get RPN. Take highest
number to take action.

• Regardless of RPN, special attention required when

'SEVERITY' is high.
Recommended Actions :
Intent is to reduce rankings for:
 Severity
 Occurrence
 Detection

Severity can be reduced only if design of production process is changed.

Occurrence can be reduced by Improving Preventive control e.g :

 Mistake proofing in Manufacturing Process
 Reduced variation in Process parameters
 Revised Instruction
 Validation & Revalidation of Processes (Through DOE)

Detection can be reduced by improving detection control e.g.:

 Automated On-line Detection
 Design of Experiments (Optimizing Product & Process parameters)
 SPC implementation
After Taking Recommended Actions :
Is improvement VISIBLE ?
PFMEA being a Living Document, review / revise at
defined frequency including when :
• Customer complaints have rising trend and / or
repetitive in nature.
• Increased trend of In-house product / Process non –
conformances.
• Continual Improvement of Process -
“AN ON – GOING ACTIVITY“

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 HMSI-Suggested PFMEA RPN Evaluation Criteria
• RPN = (S) x (O) x (D)

• RPN used for prioritising the area of concern

• Regardless of RPN, special attention required when

'SEVERITY' is high.
 Example-Process Map - Making Coffee

Install Filter and

Inputs Fill Pot With Water Brew Coffee
Coffee

Coffee Maker Coffee Pot Coffee Recipe

Electricity Coffee Maker - Brand Filter Coffee Maker
Measuring Devices Water - Amount Filter holder Operating Instructions
Coffee -Type Coffee Maker Electricity
Water -Temperature Measuring instrument Completed Coffee
Filter Clean - Temperature
Cup - Pot - Strength
- Brewer Coffee in filter - Color
Correct amount of water
Recipe and filter in brewer
in Coffee Maker

Output Serve Coffee

12 oz in cup Cup
Great Taste Brewed Coffee
- Strength
- Color
- Temperature
- Freshness
 Example-PFMEA - Making Coffee
S O D R p
r
E C E P p p p p
Part/Process Failure Mode Failure Effects V Causes C Controls T N Actions Plans S OD n
Install Filter Not Installed Coffee grounds in pot 5 Operator 2 Work Instructions 2 20 0

Operator T raining 2 20 0
Filter package
Wrong T ype Coffee grounds in pot 5 mislabled 1 None 5 25 0
Filter package
None 1 mislabled 1 None 5 5 0
T oo many filters
installed None 1 Filters stuck together 3 Filter T exture 4 12 0

Operator T raining 3 9 0
Filter Skewed/Folded
Over Coffee grounds in pot 5 Operator 3 Operator T raining 3 45 0

None 1 Operator 3 Operator T raining 3 9 0

Measuring tool by
Install Coffee T oo much coffee strong coffee 3 wrong measuring tool 2 coffee equipment 1 6 0

Work Instructions 2 12 0
Did not level after
measuring 3 Operator T raining 2 18 0
Different coffee brand 4 Recipe 2 24 0
Measuring tool by
T oo litt le coffee weak coffee 3 wrong measuring tool 2 coffee equipment 1 6 0

Work Instructions 2 12 0
Didn't fill measuring
tool full 3 Operator T raining 2 18
Different coffee brand 4 Recipe 2 24 0
Determine if
premade filter and
coffee packets are
available, cost Julie - 3/17/98:
effective, and taste Report at next
0 acceptable meeting 1 1 1 1
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