FMEA (Failure Mode Effect Analysis)

Essae Chandran Institute
Essae
Failure Mode and Effects Analysis
202 / FMEA / B 01
Dont Let This Happen To You
Essae
202 / FMEA / B 02
Increasing Customer Expectations

Additional Functions Increasing complexity Systems Products Higher Efficiency Processes Extreme Operating conditions Increased Reliability Service Friendliness Products with value for the money Shorter Development cycles
Essae
202 / FMEA / B 03
Quality Planning
System Development Component Concept Development Design Tryout
Essae
Mfg. Planning M/C: Eqpt, Tool Planning Procurement
System FMEA
Finalise Measures
Further updating
Design FMEA
First Development
Finalise Measures
Further updating
Process FMEA
First Dev.
Finalise Measures Pilot Run
Further updating Production
Preliminary Special characteristics
QA1
Finalise special characteristics
QA2
Product SupplyRelease
QA3
Ensure Special Characteristics e.g. Cpk
System Dev.- order
Component Dev. - order
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Start B (C) Proto sample Mfr. & Tryout
Plan & order Product pre-release
Product Release
Time Start Production
Cost Effective in using FMEA

Identification and Prevention of Potential defects Design FMEA Process FMEA Detection and Removal of Internal defects. SPC PPM Goods Inwards Inspection SPC Final Inspection Detection and Elimination of External defects Inspection by customer
Essae
Design and Development
Manufacturing planning
Planning
Purchase
Manufacturing
Useage
Customer
Manufacturer
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What is An FMEA
A tool used to evaluate potential failure modes and their causes. Prioritizes Potential Failures according to their Risk and drives actions to eliminate or reduce their likelihood of occurrence Provides a discipline / methodology for documenting this analysis for future use and continuous process improvement By its self, an FMEA is NOT a problem solver. It is used in combination with other problem solving tools. The FMEA presents the opportunity but does not solve the problem.
Essae
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Application
Fundamental New Development Significant changes Technical Safety requirements Customer request
Essae
Updating on
Product changes New conditions / applications New materials / processes Complaints
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QFD Process
Design Requirement Customer Requirements
Essae
Part Characteristics Design Requirements
Product
Manufacturing Operations
Part Characteristics
Part
Production Requirement Manufacturing Operations
Process
Production
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Origin & History

Failure Mode and Effect Analysis 1960s and 70s The FMEA discipline was developed in the United States Military. Military Procedure MIL-P-1629, It was used as a reliability evaluation technique to determine the effect of system and equipment failures. Failures were classified according to their impact on mission success and personnel/equipment safety. In 1988, the International Organization for Standardization issued the ISO 9000 series of business management standards. QS 9000 is the automotive analogy to ISO 9000 In accordance with QS 9000 standards, compliant automotive suppliers utilize Advanced Product Quality Planning (APQP), including design and process FMEAs, and develop a Control Plan.
Essae
QS 9000 compliant automotive suppliers must utilize Failure Mode and Effects Analysis (FMEA) in the Advanced Quality Planning process and in the development of their Control Plans.
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The FMEA Process

Identify Functions Identify Failure Modes Identify Effects of the Failure Mode Define severity Apply procedure for potential consequences Identify Potential Causes Determine occurrence Calculate criticality Identify Design or Process Control(s) Determine Detection RPN & Final Risk Assessment Take Actions to Reduce Risks Identify Special Characteristics Identify Root Causes
Essae
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Cause and Effect Cascade

Cause Design Effect Environmental Exposure Cause Moisture Effect
Essae
Cause = Corrosion Effect=High Resistance

Cause = High Resistance Effect = Insufficient Current
Cause Effect Corrosion
Cause = Insufficient Current Effect = Dim Bulb

Poor contact (High Resistance) Cause
Cause = Design Effect=Env. Exposure Cause = Env. Exposure Effect = Moisture
Cause Effect
Effect
Insufficient Current Cause
Cause = Moisture Effect = Corrosion
Effect Dim Bulb
202 / FMEA / B 011
Automotive FMEAs
Failure Mode
System FMEA
The ramification of the problem
Essae
Effect
Cause
The Cause(s) of the Problem
The Problem
Design FMEA
The Cause(s) of the Problem from the System FMEA
The effect from the system FMEA with a Better Definition
New root causes for the design failure Modes
Process FMEA
The Cause(s) of the Problem from the Design FMEA
The Same effect as the Design FMEA
Specific root Causes for the Process Failure Modes
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Automotive FMEA Timeline

System FMEA
Essae
Design FMEA
Process FMEA
Concept
Design Go-Ahead
Design Completion
Prototype Build
Eng/Mfg Sign off
Production Start
Design FMEA
Start early in process, complete by the time preliminary drawings are done but before any tooling is initiated.
Process FMEA
Start as soon as basic manufacturing methods have been discussed. Complete prior to finalizing production plans and releasing for production
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Essae
Important Factors Timeliness i.e. before the event Action and not after-the-Fact Exercise. Greatest value: before failure mode is designed into. Up front time spent on changes alleviate late changes crisis.
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Specific Uses
Design FMEAs are used to analyze products before they are released to production Focus on potential failure modes of products caused by design deficiencies. Identify potential designated characteristics called Special Characteristics Process FMEAs are used to analyze manufacturing and assembly processes. Focus on potential product failure modes caused by manufacturing or assembly process deficiencies. Confirm the need for Special Controls in manufacturing and confirm the designated potential Special Characteristics from the Design FMEA. Identify process failure modes that could violate government regulations or compromise employee safety.
Essae
202 / FMEA / B 015
FMEA Outputs
Design FMEA Outputs A list of potential product failure modes. A list of potential Critical Characteristics and/or Significant Characteristics. A list of design actions to reduce Severity, eliminate the causes of product failure modes, or reduce their rate of Occurrence, or improve detection. Confirmation of the Design Verification Plan (DVP). Feedback of design changes to the design committee. Process FMEA Outputs A list of potential process failure modes. A list of confirmed Critical Characteristics and/or Significant Characteristics. A list of Operator Safety and High Impact Characteristics. A list of recommended Special Controls for designated product Special Characteristics to be entered on a Control Plan. A list of processes or process actions to reduce Severity, eliminate the causes of product failure modes, or reduce their rate of Occurrence, and to improve product defect detection if process capability cannot be improved. Changes to process sheets and assembly aid drawings.
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Essae
General Benefits of FMEAs

Prevention Planning Identifies change requirements Cost reduction Increased through-put Decreased waste Decreased warranty costs Reduce non-value added operations
Essae
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FMEA TEAM
Main Team
System FMEA System Dev.:
Application Moderator
Essae
Design FMEA Design:

Tryout Plant (Q or Engg) Moderator
Process FMEA Process Engg.:

Q.A. Design or Tryout
Partly
Component Dev. Sales
Application Reliability testing Corporate Depts. Sales Plant
Production Tryout or Design Corporate Depts.
Others: Interface FMEA; Logistics FMEA

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FMEA Prerequisites
Select proper team and organize members effectively Select teams for each product/service, process/system Create a ranking system Agree on format for FMEA matrix (Typically set by AIAG) Define the customer and customer needs/expectations Design/Process requirements Develop a process flow chart **
202 / FMEA / B 019
Essae
FMEA Format Columns

Design FMEA
Occurrence Detection Occurrence
Essae
Detention
Severity
RPN
Process FMEA
Process Function Requirements
Severity
RPN
Nomenclature & Number. Enter all to be analysed. Basis for selection = importance to Q. function
Design FMEA System, Sub-system, component If > one function with diff. failure modes list all Basic function /Purpose to meet Example: Actuate relay Open valve Process FMEA Process / Opns./Opnl. Steps If numerous opns, eg., Assly) with difference Failure Modes list all Example: Grind taper Insert shaft
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RPN
Potential Failure Mode
Potential Effects of Failure
Potential Causes/ Mechanism (s) of Failures
Current Design Controls
Recommended Actions and Status
Action Taken
Occurrence Severity Detention
Occurrence
Detection
Responsible Activity and Target completion Date
RPN
Severity
ItemFunction
Design FMEA
A Design FMEA is an analytical technique utilized primarily by a Design FMEA team to ensure potential failure modes and their associated causes are identified, considered and addressed.
Essae
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Design FMEA Foci

Customers include: End User Repair Functions Dealership or other Sales Outlet Designer of the next level system or product Process Engineers Assembly Engineers Test Engineers Product Analysis
Essae
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Typical Design Considerations

Design Intent Customer Needs - Can be specified and measured Customer Wants - Some cant be explained Product Requirements Manufacturing assembly requirements
Quality Function Deployment Customer Contacts Competitive Analysis Known Product Quality Reliability Requirements Manufacturing Requirements
Start with a list of: What the design is expected to do What the design is expected NOT to do
Essae
Think about what documents in your company are used to define these
202 / FMEA / B 023
Design FMEA Benefits

Aids in the objective evaluation of design requirements and alternatives. Increases the probability that potential failure modes and their effects on the system / product have been considered. Aids in the planning of design test and development programs. Aids in analyzing field concerns, design changes and in developing advanced designs. Ranks potential failure modes according to their effect on the customer, thus prioritizing improvements and development testing. Provides an open issue format for recommending and tracking risk reducing actions. Can reduce product development timing, production startup problems, reduce costs and enhance product quality, reliability and safety.
Essae
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More Design FMEA Considerations

The Design FMEA is a living document and should be initiated at, or by, design concept completion. The Design FMEA should be continually updated as changes occur throughout all phases of product development. The Design FMEA should be fundamentally complete along with the final product drawings. The Design FMEA addresses the design intent and assumes the design will be manufactured / assembled to this intent. The Potential Failure Modes/Causes which can occur during manufacturing or assembly process are covered by the Process
Essae
FMEA and therefore should NOT be included in a Design FMEA.

202 / FMEA / B 025
CAUTION! DO NOT mix up:

Design Failures & Causes with Process Failures & Causes
Design Failures
Insufficient lubrication capability
Essae
Process Failures
Insufficient lubrication applied
Incorrect material specified
Incorrect material used
202 / FMEA / B 026
Design Block Diagram Example
Essae
If the product function is complex, break it down into smaller sub-systems. Identify Primary Vs Secondary functions
System
Body
Sub System Component
Doors
Exterior
Window
Interior
Door Inner Panel
Glass
Sealing With Strip
Latch / Lock
202 / FMEA / B 027
FMEA Basic Columns

Column 2 : Failure Modes (potential)
Occurrence Detection Occurrence Severity
Current Design Controls Responsible Activity and Target completion Date
Essae
Severity
RPN
Manner in which
A component / sub-system Process Could potentially fail to meet design intent Process requirements and / or design intent
Can be a cause of F.Mode in higher level sub-system in down stream opns. an effect of one in a previous opn.
in lower level component

202 / FMEA / B 028
RPN
ItemFunction
Detention
Failure Mode (Potential)

Assumption: Failure could occur but may not necessarily occur for PFMEA, incoming Parts / materials are correct.
Typical Modes: Design* : Mech: Broken, Deformed, Sticky Hydraulic: Untight, blocked, No Pressure. Electrical: Shorted, wrong poles, interrupted
Essae
* - In physical terms not as a symptom noticed by customer. * - also modes under certain opr. Conditions / usage conditions.
202 / FMEA / B 029
Failure Mode (Potential)

Process FMEA: In terms of components etc., or Process characteristic for the particular opn. Questions: How can the process / part fail to meet specifications? What would a customer (end user, subsequent operations) consider objectionable Starting point: Design FMEA: Past failures, concerns reports, Brain storming. Process FMEA: comparison of similar Process, Customer claims
202 / FMEA / B 030
Essae
FMEA Basic Columns

Column 3: Failure Effects
Potential Causes/ Mechanism (s) of Failures Current Design Controls Responsible Activity and Target completion Date
Essae
Severity
RPN
Design FMEA On the function as Perceived by the Customer Internal as well as ultimate end user In terms of specific component etc., under analysis
Process FMEA On the customer
In terms of what the customer (s) might notice or experience
202 / FMEA / B 031
RPN
ItemFunction
Detention
Effect(s) of Failure (Potential)

Two considerations 1. How does the failure affect ...? Component groups Product Vehicle Environment. System
Essae
Actuating Piston connects Piston Rod with Piston: Fails due to Fatigue resulting in Disengagement from Piston with Consequential Effect Loss of Braking Function.
202 / FMEA / B 032
Effect(s) of Failure (Potential)

2. How does the customer notice / experience the failure?
ANNOYANCE - Noise, smell - Ventilation Vapours - Vibration
SAFETY - Vehicle out of control - Failure of Brakes - Failure of steering systems
Essae
FUNCTIONAL IMPAIRMENT
- Starting Difficulties - Irregular Function - Leakages
Next process (Opn.): Can not mount; does not connect Does not match; can not bore / tap.
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FMEA Basic Columns

Column 5: Failure Causes
Essae
RPN
Definition: Design FMEA: A Design weakness consequence is failure mode. Process FMEA : How failure could occur, in terms what can be corrected / controlled.
List every conceivable cause for each Failure Mode Concise and completeness
202 / FMEA / B 034
RPN
Severity
ItemFunction
Detention
FMEA Failure Causes

Typical Causes: Examples
Design FMEA: Incorrect Material Specification, Overstressing, Inadequate Lubrication Capability, Error in dimensioning Process FMEA: Torque less / more; Gauging inaccurate, Inadequate gating / venting, Improper HT temp., Timing Only specific Errors: Example: Opr. Fails to install seal. Not ambiguous Phrases : Example: Opr. Error; M/c. Malfunction TYPICAL FAILURE MECHANISM: YIELD, CREEP, CORROSION, WEAR
202 / FMEA / B 035
Essae
Design Failure Cause Examples

Improper Tolerancing Incorrect Stress Calculations Wrong Assumptions Wrong Material Call Out Lower Grade Component Lack of Design Standards Improper Heat Treatment Improper Torque Call Out
Essae
Correcting the cause has direct impact on Failure Mode? If so FMEA thought process complete. DOE to find root cause (s) for correction or control
202 / FMEA / B 036
FMEA Basic Columns

Column 7: Current Design Control
Potential Causes/ Mechanism (s) of Failures Current Design Controls Responsible Activity and Target completion Date
Essae
Severity
RPN
(What measures to avoid failure causes have been implemented) Reduction in Ranking of Occurrence Severity Thro -Design Validation / Verification No No - Design Revision (removal / controlling causes Yes Yes Actions DOE; Revised test Plan Revised Design: material specification
(and/or) Detention No Yes
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RPN
ItemFunction
Detention
Design Controls
Design controls are those actions taken as a normal part of the development process that are designed into the process to minimize the occurrence of failure or to detect specific failure modes . Design controls should directly relate to the prevention and / or detection of specific causes of failures
202 / FMEA / B 038
Essae
Design Control Examples

Essae
Reliability tests / prototype testing Design reviews Worst case stress analysis Consider Interpretation of Robust design data Environmental stress testing Designed experiments Finite element analysis Variation simulation FT Analysis
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Process FMEA Current Control

Hazardous to personnel Mfg. / Assembly? Prevention by eliminating or controlling causes (e.g Mistake proofing) OR operator Protection
Occurrence: To reduce probability - Process and / or Design Revision Initiate Process Study / Improvement for Defect Prevention
Severity: Design Revision Only brings Reduction in severity
Essae
202 / FMEA / B 040
Process FMEA Current Control

Detection: Process and/or Design revisions - Costly & Ineffective - Q.C. Inspection only to be temporary - Design change to specific part - Control system changes
Essae
Prefer SPC & Process Improvement to Random Q. checks & Associated Inspection
202 / FMEA / B 041
FMEA Basic Columns

Column 8: Detection
Essae
RPN
Assessment of ability of controls to identify:

* Design FMEA : Potential cause before production Release. Process FMEA: Failure Mode before part leaves Mfg. * For Lower ranking : improve validation / verification (Enter checks / Symptoms to detect the failure mode and / or Cause)
202 / FMEA / B 042
RPN
Severity
ItemFunction
Detention
Assessment of ability of controls to identify:

* Design FMEA : Potential cause before production Release. Process FMEA: Failure Mode before part leaves Mfg.
Essae
* For Lower ranking : improve validation / verification
(Enter checks / Symptoms to detect the failure mode and / or Cause)
202 / FMEA / B 043
Generic Design FMEA Severity

FMEA Basic Column 4
Effect
Hazardous without Warning Hazardous with Warning Very High High Moderate Low
Essae Ranking
10
Criteria: Severity of Effect

Very high severity ranking when a potential failure mode affects safe vehicle operation and /or involves non-compliance with government regulation without warning Very high severity ranking when a potential failure mode affects safe vehicle operation and /or involves non-compliance with government regulation without warning Vehicle / item inoperable, with loss of primary function. Vehicle / item operable but at a reduced level of performance, customer dissatisfied Vehicle /item operable, but control / convenience item(s) inoperable; customer experiences discomfort Vehicle / item operable, but comfort / convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction Fit & finish/squeak & rattle item does not conform. Defect noticed by most customers. Fit & finish/squeak & rattle item does not conform. Defect noticed by average customers. Fit & finish/squeak & rattle item does not conform. Defect noticed by discriminating customers.
8 7 6 5
Very Low Minor Very Minor
4 3 2
None
No effect.
202 / FMEA / B 044
Generic FMEA Occurrence

FMEA Basic Column 6
Probability of Failure Possible Failure Rates
Essae
Ranking
10 9 8 7 6 5 4 3 2 1
Very High: Failure is almost 1 in 2 inevitable 1 in 3 High: Repeated Failures 1 in 8 1 in 20 Moderate: Occasional failures 1 in 80 1 in 400 1 in 2,000 Low: Relatively Few Failures 1 in 15,000 1 in 150,000 Remote: Failure Unlikely 1 in 1,500,000
202 / FMEA / B 045
Generic FMEA Detection

Essae
FMEA Basic Column 8

Detection
Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
Criteria: Likelyhood of detection by Design Control

Design Control will not and/or can not detect potential cause / mechanism and subsequent failure mode; or there is no design control Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode. Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode. Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode. Low chance the design control will detect a potential cause/mechanism and subsequent failure mode. Moderately high chance the design control will detect a potential cause/mechanism and subsequent failure mode. Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode. High chance the design control will detect a potential cause/mechanism and subsequent failure mode. Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode. Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode.
Ranking
10 9 8 7 6 5 4 3 2 1
202 / FMEA / B 046
DFMEA Recommended Actions

When the failure modes have been ranked by their RPN, Corrective actions should be first directed at the highest ranked concerns and critical items identified The intent of any recommended action is to reduce one or more (or all) of the occurrence, severity and/or detection rankings. Only a design revision can bring about a reduction in the severity ranking. If no actions are recommended for a specific cause, this should be indicated. A reduction in the occurrence ranking can only be effected by removing or controlling one or more of the causes of the failure mode through a design revision. An increase in design verification actions will result in a reduction in the detection ranking only. Design FMEA doesnt rely on process controls to overcome potential weaknesses in the design; however, it does take technical and physical limitations of a process into consideration (Design Rules)
202 / FMEA / B 047
Essae
Essae
202 / FMEA / B 048
Essae
202 / FMEA / B 049
Essae
202 / FMEA / B 050
Process FMEA Foci

Customers include: End User Next Manufacturing or Process Step Process Engineers Repair Functions Test Engineers Product Analysis Dealership or other scales outlet
202 / FMEA / B 051
Essae
Process FMEA Benefits

As a systematic approach, the process potential FMEA parallels and formalize the mental discipline that an engineer goes through in any manufacturing planning process. The process potential FMEA identifies potential product related process. The process potential FMEA assesses the potential customer effect of the failures. The process potential FMEA identifies potential manufacturing and/or assembly process causes. The process Potential FMEA identifies significant process variables to focus controls for occurrence reduction and detection of failure conditions. The process potential FMEA develops a list of potential failure modes ranked according to their affect on the customer, thus establishing a priority system for corrective and preventive action considerations.
202 / FMEA / B 052
Essae
More Process FMEA Consideration

The process FMEA is living document. The process FMEA should be continually updated as changes occur throughout all phases of product development and on into and through to the end of production. The process FMEA should begin with a flow chart of process from receiving through shipping and warehousing. The potential failure modes/causes which can occur during manufacturing or assembly process are covered by the process FMEA but some information (severity ranking, identification of some effects) may come from the design FMEA.
Essae
A reduction in occurrence ranking can only be achieved by implementing a process change that controls or eliminates one or more causes of the failure mode.
202 / FMEA / B 053
Process Failure Causes

1. 2. 3. 4. 5. 6. Omitted processing Processing errors Errors setting up work pieces Missing parts Wrong parts Processing wrong work piece 11. Poor control procedures 13. Bad recipe
Essae
12. Improper equipment maintenance
14. Fatigue
15. Lack of safety 16. Hardware failure 17. Failure to enforce controls
7.
8. 9. 10.
Mis-operation
Adjustment error Equipment not set up properly Tools and/or fixtures improperly prepared
18. Environment
19. Stress connections 20. Poor FMEA(s)
202 / FMEA / B 054
Process Control Examples

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Standardized work instructions/procedures Fixtures and jigs Mechanical interference interfaces Mechanical counters Mechanical sensors Electrical/electronic sensors Job sheets or process packages Bar coding with software integration and control Marking Training and related educational safeguards Visual Checks Gage studies Preventive maintenance Automation (real time control)
Controls can be process controls such as fixture fool-proofing or SPC, or can be post-process inspection testing
Essae
Inspection / testing may occur at the subject operation or at subsequent operation(s) that can detect the subject failure mode.
11. 12. 13. 14.
202 / FMEA / B 055
Typical Process Documents

SPC records Visual aides Work instructions Inspection instructions / records Equipment operating instructions Training records Traceability records
Essae
202 / FMEA / B 056
Generic PFMEA Severity

FMEA Basic Column 4
Effect
Hazardous without Warnin g Hazardous with Warnin g Very High High
Essae
Ranking
10
Criteria: Severity of Effect

May endanger machine or assembly operator. Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves non complaisance with government regulation. Failure will occur without warning May endanger machine or assembly operator. Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves non complaisance with government regulation. Failure will occur without warning Major disruption to production line. 100% of product may have to be scrapped. Vehicle/item inoperable, loss of primary function. Customer very dissatisfied. Minor disruption to production line. Product may have to be sorted and a portion (less than 100%) scrapped. Vehicle/item operable, but at reduced level of performance. Customer dissatisfied. Minor disruption to production line. A portion (les than 100%) of the product may have to be scrapped (no sorting). Vehicle/item operable but some comfort/convenience item(s) inoperable. Customers experiences discomfort. Minor disruption to production line. 100% of product may have to be reworked. Vehicle/item operable, but some comfort/convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction. Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked. Fit & finish / squeak & rattle item does not conform. Defect noticed by most customers. Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked online but out of station. Fit & Finish/squeak & rattle item does not conform. Defect noticed by average customers. Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked on line but in station. Fit & finish/squeak & rattle item does not conform. Defect noticed by a discriminating customers. No effect.
8 7
Moderate
Low
Very Low
Minor
Very Minor
None
202 / FMEA / B 057
Generic PFMEA Occurrence

Essae
FMEA Basic Column 4

Probability of Failure Very High: Failure is almost inevitable Possible Failure Rates 1 in 2 1 in 3 High: Generally associated with process similar to previous process which have often failed Moderate: Generally associated with process similar to previous process which have experienced occasional failures, but not in major proportions. Low: Isolated failures associated with similar processes. Very Low: Only isolated failures associated with almost identical processes. Remote: Failure Unlikely. No failures ever associated with almost identical processes. 1 in 8 1 in 20 1 in 80 1 in 400 1 in 2,000 1 in 15,000 1 in 150,000 1 in 1,500,000 Cpk < 0.33 0.33 0.51 0.67 0.83 1.00 1.17 1.13 1.50 1.67 Ranking 10 9 8 7 6 5 4 3 2 1
202 / FMEA / B 058
Generic PFMEA Detection

FMEA Basic Column 8
Detection Criteria: Likelyhood the existence of a defect will be detected by process controls before next or subsequent process, or before part or component leaves manufacturing assembly location. Ranking
Essae
Almost No known control(s) available to detect failure mode. impossible Very Remote Very remote likelyhood current control(s) will detect failure mode. Remote Remote likelyhood current control(s) will detect failure mode. Very Low Very low likelyhood current control(s) will detect failure mode. Low Low likelyhood current control(s) will detect failure mode. Moderate Moderate likelyhood current control(s) will detect failure mode.
10 9 8 7 6 5
Moderately Moderately high likelyhood current control(s) will detect failure mode. High
High High likelyhood current control(s) will detect failure mode. Very High Very high likelyhood current control(s) will detect failure mode.
4
3 2
Almost Certain Current control(s) almost certain to detect the failure mode. Reliable detection controls are known with similar processes.
202 / FMEA / B 059
Contd
Generic PFMEA Detection
FMEA Basic Column 8
Essae
Assume the failure has Occurrence and then assess the capabilities of all current controls to prevent shipment or the part having this failure mode or defect Random quality controls checks would unlikely detect the existence of an isolated defect and therefore would result in low to remote detection ranking. Sampling done on a statistical basis is a valid detection control. A reduction in detection ranking can only be achieved by improving process control system(s)
202 / FMEA / B 060
PFMEA Essae Chandran Institute

Recommended Actions Corrective action should first directed at the highest concern as rank ordered by RPN. The intent of any recommended action is to reduce the occurrence, severity and/or detection rankings. If no action are recommended for a specific cause, then this should be indicated. Only a design revision can bring about a reduction in the severity ranking. To reduce the probability of occurrence, process and/or specification revisions are required. To increase the probability of detection, process control and/or inspection changes are required. Improving detection controls is typically costly. The emphasis should be placed on preventing rather than detecting, defects.
202 / FMEA / B 061
Essae
Contd
PFMEA Recommended Actions

The severity applies to the effect only. The effect of a given failure will not change unless you change the design of the system or part. In the parachute example. If the chute doesnt open, you probably die and therefore it is a 10 (failure occurs without warning). Now suppose I design a smart chute that has built in diagnostics that emits a loud audible alarm telling me it is not going to openIt still doesnt open, but warns me that I am about to die, therefore making it a 9 (failure occurs with warning). If I take it step further, and add a smaller backup chute that deploys, that allows me to land without dying, I can make a case for the severity being a 7 (item operable, but at a reduced level of performance. Customer dissatisfied)
202 / FMEA / B 062
Essae
Action on severity
The Question of action should be based on the RPN, not severity alone. If the severity is high, we at least think about any changes that might be made. Often times, we have no control on what the vehicle does when our parts fail. This is determined by the car companies and we all know they are infinitely wise in areas of quality and safety. If changes are not feasible, we then focus on occurrence and detection to bring the RPN into an acceptable level.
202 / FMEA / B 063
Essae
Essae
202 / FMEA / B 064
Five Methods of Mistake-Proofing

Variation control using assembly aids Identification by visual techniques Standardized work and workplace organization Self-check (in-process)
Essae
Poka-Yoke
Is a method which prevents a mistake from occurring or which
prevents a defective piece from further passing down the line POKA: Accidental or unintentional occurrence of a mistake. YOKE: Avoiding the production of a defective piece or its passage down the line.
202 / FMEA / B 065
Risk Assessment (RPN) Factors

RPN=(S)x(0)x(D) S=Severity O= Likelihood of Occurrence D= Likelihood of Detection
Prevention Vs Detection Automotive Expectations: 1000 is the Maximum and 75 is considered OK High and low numbers are the important ones to consider input concept
Essae
202 / FMEA / B 066
Assessment Rating Vs Actions

Assessment Rating O S 1 1 10 10 1 10 10 D 1 10 1 10 1 1 Causes of Failure Action Taken
Essae
1
1 1 1 10 10 10
Ideal situation
Assured mastery Failure does not reach user Failure reaches user Freq. fails w/o major impact Trouble!
No Action N/A N/A YES YES YES YES YES
Freq. fails, detectable, costly YES
10
202 / FMEA / B 067
Mistake-Proofing
Emphasizes Prevention! Principles

Essae
Build into processes Eliminate inadvertent errors Stop doing it wrong Do it Right! Work Together Find True Cause!
Guide for part (fixture) Error detection alarm Limit switch Counter Check List
Examples
202 / FMEA / B 068

FMEA (Failure Mode Effect Analysis)

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FMEA (Failure Mode Effect Analysis)

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Essae Chandran Institute

Failure Mode and Effects Analysis

Essae Chandran Institute

Dont Let This Happen To You

Essae Chandran Institute

Increasing Customer Expectations

Essae Chandran Institute

Mfg. Planning M/C: Eqpt, Tool Planning Procurement

Finalise Measures Pilot Run

Further updating Production

Preliminary Special characteristics

Finalise special characteristics

Ensure Special Characteristics e.g. Cpk

System Dev.- order

Component Dev. - order

Start B (C) Proto sample Mfr. & Tryout

Plan & order Product pre-release

Time Start Production

Essae Chandran Institute

Cost Effective in using FMEA

Design and Development

Essae Chandran Institute

Essae Chandran Institute

Essae Chandran Institute

Part Characteristics Design Requirements

Production Requirement Manufacturing Operations

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Origin & History

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The FMEA Process

202 / FMEA / B 010

Essae Chandran Institute

Cause and Effect Cascade

Cause = Corrosion Effect=High Resistance

Cause = Insufficient Current Effect = Dim Bulb

Cause = Design Effect=Env. Exposure Cause = Env. Exposure Effect = Moisture

Cause = Moisture Effect = Corrosion

Effect Dim Bulb

202 / FMEA / B 011

Essae Chandran Institute

The Cause(s) of the Problem from the System FMEA

The effect from the system FMEA with a Better Definition

New root causes for the design failure Modes

The Cause(s) of the Problem from the Design FMEA

The Same effect as the Design FMEA

Specific root Causes for the Process Failure Modes

202 / FMEA / B 012

Essae Chandran Institute

Automotive FMEA Timeline

Eng/Mfg Sign off

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202 / FMEA / B 014

Essae Chandran Institute

202 / FMEA / B 015

Essae Chandran Institute

Essae Chandran Institute

General Benefits of FMEAs

202 / FMEA / B 017

Essae Chandran Institute

Design FMEA Design:

Process FMEA Process Engg.:

Application Reliability testing Corporate Depts. Sales Plant

Production Tryout or Design Corporate Depts.