TRAINING DATE:

CONDUCTED BY:
KAIZEN CONSULTANTS

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 FMEA COURSE MATERIAL
1. INTRODUCTION:
 Traditionally quality activities have focused on detecting manufacturing and material defects that cause failures
early in the life cycle

 Today, activities focus on failures that occur beyond the infant mortality stage

 Emphasis on Failure Prevention

 FMEA is a systematic method of identifying and preventing system, product and process problems before they
occur

 FMEA is focused on preventing problems, enhancing safety, and increasing customer satisfaction

 Ideally, FMEA’s are conducted in the product design or process development stages, although conducting an
FMEA on existing products or processes may also yield benefits

2. EVOLUTION:

 The history of FMEA/FMECA goes back to the early 1950s and 1960s.

 U.S. Navy Bureau of Aeronautics, followed by the Bureau of Naval Weapons:

 National Aeronautics and Space Administration (NASA):

 Department of Defense developed and revised the MIL-STD-1629A guidelines during the 1970s.

 Ford Motor Company published instruction manuals in the 1980s and the automotive industry collectively
developed standards in the 1990s.

 Engineers in a variety of industries have adopted and adapted the tool over the years

 AIAG FMEA-IV from the Automotive Industry Action Group for the automotive industry.

3. FMEA AS A TOOL:
FMEA is a tool that allows you to:

 Prevent System, Product and Process problems before they occur

 reduce costs by identifying system, product and process improvements early in the development cycle

 Create more robust processes

 Prioritize actions that decrease risk of failure

 Evaluate the system, design and processes from a new vantage point

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 4. A SYSTEMATIC PROCESS

o FMEA provides a systematic process to:

o Identify and evaluate

 potential failure modes

 potential causes of the failure mode

o Identify and quantify the impact of potential failures

o Identify and prioritize actions to reduce or eliminate the potential failure

o Implement action plan based on assigned responsibilities and completion dates

o Document the associated activities

5. BENEFITS
 Cost effective tool for maximizing and documenting the collective knowledge, experience, and insights of the
engineering and manufacturing community

 Format for communication across the disciplines

 Provides logical, sequential steps for specifying product and process areas of concern

 Contributes to improved designs for products and processes.

o Higher reliability

o Better quality

o Increased safety

o Enhanced customer satisfaction

 Contributes to cost savings.

o Decreases development time and re-design costs

o Decreases warranty costs

o Decreases waste, non-value added operations

 Contributes to continuous improvement

6. TYPES OF FMEA

 When it is applied to interaction of parts it is called System Failure Mode and Effects Analysis (SFMEA)

 Applied to a product it is called a Design Failure Mode and Effects Analysis (DFMEA)

 Applied to a process it is called a Process Failure Mode and Effects Analysis (PFMEA).

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 7. OBJECTIVES :

 Uncover problems with the product that will result in safety hazards, product malfunctions, or
shortened product life, etc..

 Ask ourselves “how the product will fail”?

 How can we achieve our objective?

8. PROCESS FMEA DEFINITION

– A documented analysis which begins with a team’s thoughts concerning

requirements that could go wrong and ending with defined actions which
should be implemented to help prevent and/or detect problems and their
causes.
– A proactive tool to identify concerns with the sources of variation and then
define and take corrective action.

9. DEVELOPMENT OF PROCESS FMEA

1. Prepare a flow chart. This Flow chart should identify the Product/Process characteristics associated with each
operation as finalized by CFT during APQP stage. Carry out risk assessment and conduct FMEA for all high-risk process
steps. Copy of Flow Chart/ risk assessment should accompany the process FMEA.

2. Document the Potential failure and their consequences in the FMEA format. The usage of this format is given below

3. FMEA NUMBER - Enter the FMEA document number as per the numbering system described in

4. ITEM – Enter the name and number of the family for which the process is being carried out.

5. PROCESS RESPONSIBILITY – Enter the Section / Department responsible for maintaining the process.

6. PREPARED BY – Enter the name of the CFT leader and his signature

7. MODEL YEAR (S) / VEHICLE (S) – Enter the Intended model year(s) and vehicle line(s) if known.

8. KEY DATE – Enter the key date from APQP form. The key date should not exceed the schedule start of Production
date.

9. FMEA DATE – Enter the date when the original FMEA was compiled and the revision dates as and when the FMEA
undergoes revision.

10. CORE TEAM - Enter the names of Team members, their department and designation.

11. PROCESS FUNCTION / REQUIREMENT - Enter a simple description of the process/operation being analyzed.
Indicate as concisely as possible the purpose of the process or operation being analysed.

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Example: Blanking, Forming etc.

12. POETNTIAL FAILURE MODE – Enter the Potential failure mode for each process requirement separately by asking
how the process/component can fail to meet the process requirement. The assumption is that the failure could occur but
may not necessarily occur.

13. POTENTIAL EFFECT OF FAILURE – Enter the Potential effect of failure i.e., the effect of failure mode on the
customer. The customer may be next operation or end user. Each must be considered when assigning the Potential effect
of failure.

14. SEVERITY (S) – Severity is an assessment of the seriousness of the effect (listed in the column 11) of the potential
failure mode to the internal or external customer. Severity is estimated as per FMEA reference manual.

15. CLASSSIFICATION- Indicate the classification of special characteristics by the use of Symbol finalized by CFT /
customer.

16. POTENTIAL CAUSES / MECHANISM OF FAILURE- List to the extent possible, each and every Conceivable failure
causes assignable to each potential failure mode. Describe the cause in terms of something that can be corrected or can
be controlled.

Assume all inputs are conforming to specification and process design of the product is acceptable during first interaction.

17. Ambiguous phrases like operator error, machine malfunction, etc., should be avoided.

List out first level causes like Man, Machine, Method, Material etc., and write the root cause under each first level causes.
Typical examples are Tool Wear, Improper set up, inaccurate gauging etc.

For failure, which has no direct relation to a cause, a cause and Effect diagram should be drawn.

While generating the causes, the potential failure only should be considered not the effects. Refer the historical Quality
records to verify that all causes occurred are listed.

18. OCCURANCE (O) - Occurrence is how frequently the specific failure cause is projected to occur. Estimate the
likelihood of occurrence of a cause as per FMEA Manual. Only occurrence resulting in the failure mode should be
considered for ranking. Failure detecting measures should not be considered here.

19. CURRENT PROCESS CONTROL- Enter the proposed or current controls that detects the failure mode, should it
occur, or prevent the failure mode for occurring.

The types of Control are:

20. DETECTION: eg; Inspection

21. PREVENTION: e.g. SPC charts

22. The control should be written against each cause listed in potential causes Column. If no control on the causes then
write “No Control’.

23. All Controls listed should be presently being practiced in the process and should be referred in any of the documents
such as Control Plans, Work Instruction etc.

24. DETECTION (D) – Detection is an assessment of probability that the proposed type of controls listed under current
control column will detect a cause or failure.

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Estimate the detection ranking from FMEA Manual. The controls such as control charts, 100% inspection, and sampling
done on statistical basis is valid detection control and deserves low ranking. The low occurrence does not deserve low
detection ranking.

25. Random Quality checks are unlikely to detect the existence of an isolated defect. Sampling done on a statistical basis
is a valid detection.

26. RISK PRIORITY NUMBER (RPN) – The risk priority number is the product of Severity, Occurrence and Detection.

27. RPN = (S) X (O) X (D)

28. The RPN will be in between 1 to 1000. For higher RPN, the team must undertake efforts to reduce the risk through
corrective actions. In general, regardless of the resultant RPN, special attention should be given when the severity of
potential effect of failure is high.

29. RECOMMENDED ACTION- After completion of the steps described above, the

RPN are to be analyzed in pareto fashion to identify the priority for control.

30. Risk priority numbers with greater than 100, action will be initiated. However, the severity ranking more than 8 is to be
considered with high priority irrespective of the RPN value. The above will be reviewed once in a year and if required it will
be modified.
31. To reduce the probability of occurrence, process revisions are required. The actions recommended should be to
prevent / eliminate the causes to reduce the occurrence ranking. The preventive techniques, such as, mistake proofing
methodology, SPC method to be considered.

32. RESPONSIBILITY AND TARGET TO COMPLETE - Enter the department / individual responsible for the
recommended action and the target date of completion.

33. ACTION TAKEN- After an action has been taken, enter the brief description of the action taken and effective date.

34. ACTION RESULTS – After the corrective action taken, the Team Leader is to verify the action for implementation.
Estimate and record the resulting S, O, D ranking. Calculate the RPN. If no action is taken leave the related ranking
column blank.

35. All resulting RPN should be reviewed and if further action is considered necessary, repeat step-19 through step 22

FMEA REVIEW AND UPDATING:

36. FMEA is a living document and should always reflect the latest changes and incorporation in the process. FMEA
should be reviewed whenever, process is changed, and process becomes unstable and/or non capable and controlled as
per ….

37. Whenever FMEA is reviewed, the concerned process related documents like Control plans, Stage Drawings, Work
Instructions etc. are to be reviewed and updated if required.

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Examples:

Functions Failure modes Effects Causes

No lubrication
Bent
Miss -location of part
Crack
Rough Noise Worn out of locator
surface Leaks
Turning
Burr Scrap Worn out of tool
Drilling
Deformation Inoperative
Tapping Broken tool
Hole off the Unstable
welding
location Poor performance
Assembling Presence of chip
Missing the Customer
hole Dissatisfaction Improper machine
Hole is too set up
deep
Improper
programming

Description of FMEA Requirements:

Severity ( S) Occurrence (O) Detection(D)

Rank associated with most

serious effect of the failure
Possible failure rates  Sampling done on statistical
 Can be reduced basis is valid detection control
through design changes
 Ranking 9 and 10 can’t
be modified  Rank -1 should be –Certain to
 Rank 1 should not be detect
further analyzed
 If severity is 9/10,
attention should be  To reduce detection ranking
given to design use mistake proofing
Controls/CAPA
irrespective of RPN value

 RPN = Risk Priority Number

 S X O X D = RPN
 RPN cut off value can be decided by the organization considering the nature of their processes

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 PFMEA RANKING TABLES

Suggested PFMEA Severity Evaluation Criteria

Criteria: Severity Of Effect On

Criteria: Severity of effect on
Effect Rank Effect Process(Manufacturing Assembly
product (customer effect)
Effect)

Potential failure mode effect safe

vehicle operation and/or involves May endanger operator (machine or
10 Failure to
noncompliance with government assembly ) without warning
Failure to meet
regulation without warning.
Meet safety safety
and/or and/or
Regulatory Potential failure mode effect safe regulatory
Requirement vehicle operation and/or involves requiremen May endanger operator (machine or
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noncompliance with government ts assembly) with warning
regulation without warning

Loss of primary function (vehicle 100% of product may have to be

Major
inoperable, does not affect safe 8 scrapped. Line shutdown or stop
disruption
Loss or vehicle operation) ship
Degradation
of primary A portion of the production run may
Degradation of primary function
Function Significant have to be scrapped. Deviation from
(vehicle operable, but at reduced 7
disruption primary process including decreased
level of performance)
line speed or added manpower.

Degradation of primary function

(vehicle operable, but comfort
Loss or
convenience function inoperable).
Degradation
of secondary
Degradation of secondary function
Function
(vehicle operable, but
comfort/convenience)
100% of product may have to be
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reworked off line and accepted.
Moderate
disruption
A portion of the production run may
5 have to be reworked off line and
accepted

Appearance or Audible Noise,

100% of product may have to be
vehicle operable, items does not
4 reworked in station before it is
conform and noticed by most
processed.
customer (>75%)
Moderate
Appearance or Audible Noise,
disruption A portion of the production run may
vehicle operable, items does not
Annoyance 3 have to be reworked in-station
conform and noticed by most
before it is processed
customer (50%)

Appearance or Audible Noise,

vehicle operable, items does not Minor Slight in-convenience to process,
2
conform and noticed by most disruption operation, or operator.
customer (<25%

No effect No discernible effect 1 No effect No discernible effect

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 SUGGESTED PFMEA OCCURRENCE EVALUATION CRITERIA

Criteria: occurrence of cause- PFMEA

Likelihood of failure Rank
(incidents per items/vehicles)rank

≥100 per thousand

Very high 10
≥ 1 in 10

50 per thousand
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1 in 20

20 per thousand
High 8
1 in 50

10 per thousand
7
1 in 100

2 per thousand
6
1 in 500

.5 per thousand
Moderate 5
1 in 2,000

.1 per thousand
4
1 in 10,000

.01 per thousand

3
1 in100,000
Low
≤.001 per thousand
2
1 in 1,000,000

Very low Failure in eliminated through preventive control 1

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 Suggested Process FMEA Detection Evaluation Criteria

Opportunity for Likelihood of

Likelihood of detection by process control Rank
detection detection

No current process control; cannot detect or is not Almost

No detection opportunity 10
analyzed impossible

Not like to detect at any Failure mode and/or error(cause)is not easily
9 Very remote
stage detected (e.g random audit)

Problem detection post Failure mode detection post processing by

8 Remote
processing operator through visual/tactile/audible mean

Failure mode detection in-station by operator

through visual/tactile/audible mean or post
Problem detection at
processing through use of attributes gauging 7 Very low
sources
(go/no-go, manual torque check/ clicker wrench,
etc).

Failure mode detection post processing by

operator through use of variable gauging or in-
Problem detection post
station by operator through use of attributes 6 Low
processing
gauging (go/no-go, manual torque check/ clicker
wrench, etc).

Failure mode detection post processing by

operator through use of variable gauging or by
Problem detection at automated controls in-station that will detect
5 Moderate
sources discrepant part and notify operator (light, buzzer,
etc). gauging performed on setup and first-piece
check (for set-up causes only).

Failure mode detection post processing by

Problem detection post
automated controls that will detect discrepant part 4 Moderately High
processing
and lock part to prevent further processing.

Failure mode detection post processing by

Problem detection at automated controls that will detect discrepant part
3 High
sources and automatically lock part in station to prevent
further processing

Error (cause) detection in-station by automated

Error detection and/or
controls that will defect error and prevent 2 Very high
problem prevention
discrepant part from being made.

Error (cause) prevention as a result of fixture

Detection not applicable, design, machine design or part design. Discrepant
1 Almost Certain
error prevention parts cannot be made because items have been
error-proofed by process/product design

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