Failure Mode and Effect Analysis-FMEA

Potential
FAILURE MODE AND EFFECT ANALYSIS

Training By Kishor Bhatia
1
INTRODUCTION
It is a specific methodology to evaluate a system, design, process or services for possible ways in which failures can occur and help identify actions which could eliminate or reduce the chance of failure occuring For each of the failures identified an estimate is made of its effect on total system/design, its causes and its control method. It is a prevention based methodology, Defect prevention is most effective, if it is done before product/process is launched/designed. The cost of defect rectified during product/process launch is far greater than same defect identified and rectified during design/drawing stage itself
INTRODUCTION
It will help to reduce the number of complaints and failures after product launch and despatch. FMEA is a structured mean for evaluating the problem that are likely to be encountered and the consequences of such problem.
This is also useful for evaluating the effects of significant engineering changes or product/process designs.
FMEA is of two type 1. Design FMEA 2.Process FMEA
HISTORY
The failure mode and effect analysis (FMEA) has been developed at the mid-sixties in the USA for the Apollo Project by the NASA. After applying that method in aeronautics and the aerospace industry, as well as in the nuclear technology, its usage had been introduced soon in the automobile industry. The FMEA finds now globally a widespread application.
The FMEA nowadays a methodical component of quality management systems for many automobile manufacturers and their suppliers.
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Advantages of FMEA
Increase in performance,reliability,dependability of products Reducing of guaranty cost and goodwill commitments Shorten development processes.
Less chance to failures during start of series production

Improve faithfulness to deadlines More economical manufacturing Improved services Improved internal communication
5
Advantages of FMEA
Aiding in the objective evaluation of design requirements and design alternatives.
Aiding in the initial design for manufacturing and assembly requirements.

Providing additional information to aid in the planning of thorough and efficient design test and development programs. Developing a list of potential failure modes ranked according to their effect on customers.
Providing an open issue format for recommending and tracking risk reducing actions.
Providing future reference to aid in analysing field concerns. 6

System : Sub-System :
Component : Model : Core Team :
Occurrence Potential Potential Failure Effect of Function Mode Failure Item / Severity Class Potential Causes of Failure
Design Responsibility
Key Date
FMEA Number : Page : of Prepared By :
FMEA Date (Ori.):
(Rev.)
Severity Occurrence Detection R.P.N. 7
`
R.P.N. Current Design Control Detection
Action Results Recom. Responsi Action Action bility & Taken Target Date
1. FMEA NUMBER : Enter the FMEA document number, which may be used for tracking.

Key Date
FMEA Date (Ori.):
(Rev.)
`
2. System, Subsystem or component Name & number : Indicate the appropriate level of analysis and enter the name and number of the system, subsystem or component being analysed.

Key Date
FMEA Date (Ori.):
(Rev.)
`
3. Design Responsibility : Enter the OEM, Department and group. Also include the supplier name if known.

Key Date
FMEA Date (Ori.):
(Rev.)
`
4. Prepared By : Enter the OEM, Department and group. Also include the supplier name if known.

Key Date
FMEA Date (Ori.):
(Rev.)
`
5. Model : Enter the intended model and vehicle line that will utilize and/or affected by the design release date.

Key Date
FMEA Date (Ori.):
(Rev.)
`
6. Key Date : Enter the initial FMEA due date which should not exceed the scheduled production design release date.

Key Date
FMEA Date (Ori.):
(Rev.)
`
7. FMEA Date : Enter the date the original FMEA was compiled and the latest revision date.

Key Date
FMEA Date (Ori.):
(Rev.)
`
8. Core Team : List the names of the responsible individuals and Departments which have the authority

Key Date
FMEA Date (Ori.):
(Rev.)
`
9. Item/Function : Enter the name and item being analysed and show the design level as indicated on drawing. Enter the function of the item to meet design intent. Include environment issues (e.g.Temp., pressure, humidity etc.) If the item has more than one function with different potential modes of failure, list all the functions separately.

Key Date
FMEA Date (Ori.):
(Rev.)
`
10. Potential Failure Mode : Identify and list the each failure that could potentially fail to meet the design intent. A recommended starting point is a review of past things gone wrong, concern reports and group brainstorming.

Key Date
FMEA Date (Ori.):
(Rev.)
`
11. Potential Effect of Failure Mode : Identify the effect of the failure mode on the function as perceived by the customer. It is stated in terms of the specific system, subsystem or component being alanysed.

Key Date
FMEA Date (Ori.):
(Rev.)
`
12. Severity (S) : It is an assessment of the seriousness of the effect of the potential failure mode to the next component, system, subsystem or customer. Severity applies to the effect only. A reduction in severity ranking index can be affected only through a design change. It could be estimated on a 1 to 10 scale.
SUGGESTED EVALUATION CRITERIA FOR SEVERITY

Hazardous without warning Hazardous with warning Very High Very high severity ranking when a potential failure affects safe vehicle operation and/or involves noncompliance 10 with government regulation without warning Very high severity ranking when a potential failure affects safe vehicle operation and/or involves noncompliance 9 with government regulation with warning Vehicle/item inoperable with loss of primary function 8 Vehicle/item operable but at reduced level of High 7 performance, customer dissatisfied Moderate Vehicle/item inoperable but comfort/convenience item(s) 6 inoperable. Customer experiences discomfort Vehicle/item inoperable but comfort/convenience item(s) Low operable at reduced level of performance. Customer 5 experiences some dissatisfaction Very low Fit & finish/squeak & rattle item does not conform. Defect 4 noticed by most customers. Fit & finish/squeak & rattle item does not conform. Defect Minor 3 noticed by average customers. Very Minor Fit & finish/squeak & rattle item does not conform. Defect 2 noticed by discriminating customers. 19 No effect None 1
Effect
Criteria : Severity of Effect
Rank

Occurrence Potential Potential Failure Effect of Function Mode Failure Item / Severity Class. Potential Causes of Failure
Key Date
FMEA Date (Ori.):
(Rev.)
`
13. Classification : Classify any special product characteristics (e.g.critical, key major, significant) for components, subsystem, system that may require additional process controls. Each item identified here in Design FMEA should have the special process controls identified in the Process FMEA.

Key Date
FMEA Date (Ori.):
(Rev.)
`
14. Potential causes of failure : It is an indication of a design weakness, the consequences of which is the failure mode. The cause should be listed so that remedial efforts can be aimed at pertinent causes.

Key Date
FMEA Date (Ori.):
(Rev.)
`
15. Occurrence (O) : It is the likelihood that a specific cause will occur. The occurrence rank has a meaning rather than value. Design change is the only way to reduce the ranking. It could be estimated on a 1 to 10 scale. The occurrence ranking number is related to the rating scale and does not reflect the actual likelihood of occurrence.
SUGGESTED EVALUATION CRITERIA FOR OCCURRENCE

Probability of Failure Possible Failure Rates
Very High : Failure is almost inevitable.

High : Repeated failures Moderate : Occasional failure Low : Relatively few failures Remote : Failure is unlikely
>
Rank CpK
1 in 2 1 in 3 1 in 8
10 >1.67 9 >1.50 8 7 6 5 4 3 2 1 >1.33
1 in 20
1 in 80 1 in 400
>1.17
>1.00 >0.83 >0.67
1 in 2,000 1 in 15,000
1 in 150,000
>0.51
>0.33 < 0.33
23
<
1 in 1,500,000

Key Date
FMEA Date (Ori.):
(Rev.)
`
16. Current Design Control : List the prevention, design validation/verification (which will assure the design adequacy for the failure and cause under consideration. There are 3 types of design controls : 1) Prevent the cause or failure mode effect from occurring or reduce 2) Detect the cause and lead to corrective action and 3) Detect the failure mode.

Key Date
FMEA Date (Ori.):
(Rev.)
`
17. Detection : It is an assessment of the ability of the proposed type (2) current design control, to detect a potential cause or the ability of the proposed type (3) current design controls to detect the subsequent failure mode before the component, system, subsystem is released for production.
SUGGESTED EVALUATION CRITERIA FOR DETECTION

Design control will nor and/or can not detect a potential Absolute Uncertainty cause and subsequent failure mode or there is no Design 10 control. Very remote chance the design control will detect a Very 9 potential and subsequent failure mode. Remote Remote chance the design control will detect a potential Remote 8 and subsequent failure mode. Very Low Very low chance the design control will detect a potential 7 and subsequent failure mode. Low chance the design control will detect a potential and Low 6 subsequent failure mode. Moderate Moderate chance the design control will detect a 5 potential and subsequent failure mode. Moderately Moderately high chance the design control will detect a 4 High potential and subsequent failure mode. High chance the design control will detect a potential and High 3 subsequent failure mode. Very High chance the design control will detect a Very High 2 potential and subsequent failure mode. Almost Design control will almost certainly detect a potential and 26 1 certain subsequent failure mode.
Detection Criteria : Likelihood of detection by Design Control
Rank

Key Date
FMEA Date (Ori.):
(Rev.)
`
18. Risk Priority Number (R.P.N.) : The RPN is the product of the severity (S), Occurrence (O) and Detection (D) ranking. RPN = (S) X (O) X (D). It is the majority of design risk. This value should be used to rank order the concerns in design. The RPN will be between 1 to 1000. For higher RPN corrective action must be taken.

Key Date
FMEA Date (Ori.):
(Rev.)
`
19. Recommended Action(s) : Corrected action should be first directed at the highest ranked concerns and critical items to reduce occurrence, severity and/or detection rankings.

Key Date
FMEA Date (Ori.):
(Rev.)
`
20. Responsibility : Enter the organization and individual responsibility for the recommended action and the target completion date

Key Date
FMEA Date (Ori.):
(Rev.)
`
21. Action(s) Taken : After an action has been implemented, enter a brief description of the actual action and effective date.

Key Date
FMEA Date (Ori.):
(Rev.)
`
22. Resulting RPN : After the corrective action have been identified, estimate and record the resulting severity, occurrence and detection rankings to calculate resulting RPN. All resulting RPN(s) should be reviewed and further action is considered necessary. Repeat all the steps from 119 through 22
System/Design/Process FMEA links

System FMEA
Failure Mode
Cannot generate Light
Effect
Dissatisfied customer
Cause
Output from input mechanism missing
Design FMEA
Failure Mode
Switch fails because of an open circuit
Effect
Dissatisfied customer Lighting system fails, Switch inoperative
Cause
Switch orientation tab dimensions not specified correctly
Process FMEA
Failure Mode
Switch orientation tab dimensions incorrect or tab missing
Effect
Dissatisfied customer Lighting system fails, Switch inoperative
Cause
Mold Temp.Low Insufficient material injected into mold
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INPUT TO DEVELOP DESIGN & PROCESS FMEA

DESIGN FMEA Design Goals Reliability and quality goals Preliminary Bill of Material PROCESS FMEA Characteristics matrix Warranty information Customer complaints/returns Corrective/preventive actions Process flow chart
Preliminary list of special product/process characteristics

Management support
System and/or Design FMEA

PFMEA of similar product/process
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ACTION AND PROCESS FMEA Improve Detection This approach is typically desirable in short run only. It often reduce but does not eliminate defects. Examples include product inspection systems like : Successive Check System Operators inspect output from previous process prior to performing work. This is time consuming but promotes objectivity Self Check System Each operators 100% inspects for defects prior to send parts to the next operation. This is less time consuming than other inspection systems but suffers judgement errors due to familiarity
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ACTION AND PROCESS FMEA Reduce or Eliminate Occurrence This approach is more costly in short run only. It is more cost effective and desirable in the long run Various approaches include : Product Redesign : Design the product so that the defect either cannot occur or is very unlikely to occur. Process Redesign : Design the process so that the defect either cannot occur or is very unlikely to occur. This involves such things as changes in tooling or the elimination or simplification of process steps Error proofing Inspection System : This rely on error to detect before it becomes defect. It reduces and not eliminate the occurrence. 35
ACTION AND PROCESS FMEA Error Proofing Control Functions Regulatory Control Methods : Stop the operation & prevent occurrence of serial defects. Regulatory Warning Methods : Alert the operator to a process abnormality by using a sensory device Contact Methods : Detect abnormalities in a products shape or dimension by using sensing devices. Fixed Value Methods : This rely on error to detect before it becomes defect. It reduces and not eliminate the occurrence. Motion Step Methods : Detect abnormalities by checking for deviation in required motion. 36
VARIATION AND CONTROL METHODS Understanding the causes of characteristic variation plays a vital role in guiding the team to correct method of control. Materials
Metallurgy Chemistry Dimensions
Equipment
Machine Mtl.Hold Fixture Tooling
Input
Teamwork Continual Improvement

Teamwork Humidity Set-Up Lighting Instructions Temperature Maintenance Ergonomics
Variation
Communication Training Opn. Variation
Cleanliness
People
Environment
Methods
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Continual Improvement Loop
DETERMINING IMPORTANCE LEVEL

When evaluating characteristics it is necessary to consider both
the Voice of the Customer as well as the Voice of the Process
Voice of the Customer

Process Flow Product & Process Characteristic Characteristic Importance Characteristic Variation Control Methods
Voice of the Process

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RELIABILITY FMEA
It can be used as an effective tool in Total Productive Maintenance The goal of TPM is to maximize output and to work to zero downtime. TPM accomplishes its goal by eliminating losses common in Mfg. It mobilize the work force with the attitude that `equipment effectiveness is everyones responsibility. For each operation failure mode is related to six losses : Equipment failure Setup and adjustment Idling and minor stoppages Reduced speed Process defects Reduced yield (from start-up to stable production) For each failure mode team then lists. The effect of the failure to the department, plant or the customer The cause for each failure The current controls to manage the loss. If severity, occurrence and detection ratings are used, a consensus must be reached on the rating scales for each category before losses can be rated., Develop rating scales for reliability FMEA 39

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Potential

FAILURE MODE AND EFFECT ANALYSIS

Less chance to failures during start of series production

Aiding in the initial design for manufacturing and assembly requirements.

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

SUGGESTED EVALUATION CRITERIA FOR SEVERITY

Criteria : Severity of Effect

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

SUGGESTED EVALUATION CRITERIA FOR OCCURRENCE

Very High : Failure is almost inevitable.

10 >1.67 9 >1.50 8 7 6 5 4 3 2 1 >1.33

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

SUGGESTED EVALUATION CRITERIA FOR DETECTION

Detection Criteria : Likelihood of detection by Design Control

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :

FMEA Date (Ori.):

FAILURE MODE AND EFFECT ANALYSIS

FMEA Number : Page : of Prepared By :