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Essae
Failure Mode and Effects Analysis
202 / FMEA / B 01
Essae Chandran Institute
Dont Let This Happen To You
Essae
202 / FMEA / B 02
Essae Chandran Institute
Increasing Customer Expectations
Additional Functions Increasing complexity Systems Products Higher Efficiency Extreme Operating conditions Processes Increased Reliability Service Friendliness Products with value for the money Shorter Development cycles
Essae
202 / FMEA / B 03
Essae Chandran Institute
Quality Planning
System Development Component Development Tryout Design Concept Mfg. Planning M/C: Eqpt, Tool Planning Procurement
Essae
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
202 / FMEA / B 04
Start B (C) Plan & order Proto sample Product Mfr. & Tryout pre-release
Product Release
Time Start Production
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Cost Effective in using FMEA
Identification and Prevention of Potential defects Design FMEA Process FMEA Detection and Removal of Internal defects. SPC PPM SPC Detection and Elimination of External defects
Essae
Goods Inwards Inspection
Design and Manufacturing Development planning Planning Purchase
Manufacturing
Final Inspection
Manufacturer
202 / FMEA / B 05
Inspection by customer
Useage
Customer
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What is An FMEA
Essae
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.
202 / FMEA / B 06
Essae Chandran Institute
Application
Fundamental New Development Significant changes Technical Safety requirements Customer request
Essae
Updating on
Product changes New conditions / applications New materials / processes Complaints
202 / FMEA / B 07
Essae Chandran Institute
QFD Process
Design Requirement
Essae
Customer Requirements
Part Characteristics
Design Requirements
Part Characteristics
Product
Manufacturing Operations
Part
Production Requirement
Process
Manufacturing Operations
Production
202 / FMEA / B 08
Essae Chandran Institute
Origin & History
Essae
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. 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.
202 / FMEA / B 09
Essae Chandran Institute
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
202 / FMEA / B 010
Essae Chandran Institute
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 Effect Insufficient Current Cause Effect Dim Bulb
Cause = Design Cause Effect=Env. Exposure Cause = Env. Exposure Effect = Moisture Cause = Moisture Effect = Corrosion
Effect
202 / FMEA / B 011
Essae Chandran Institute
Automotive FMEAs
Failure Mode
System The ramification FMEA of the problem
Essae
Effect
The Problem
Cause
The Cause(s) of the Problem
The Cause(s) of the The effect from the Design Problem from the system FMEA with a FMEA System FMEA Better Definition
New root causes for the design failure Modes
Process The Cause(s) of the The Same effect as Problem from the the Design FMEA FMEA Design FMEA
202 / FMEA / B 012
Specific root Causes for the Process Failure Modes
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Automotive FMEA Timeline
System FMEA Design FMEA
Essae
Process FMEA
Concept
Design Go-Ahead
Design Prototype Completion 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
202 / FMEA / B 013
Start as soon as basic manufacturing methods have been discussed. Complete prior to finalizing production plans and releasing for production
Essae Chandran Institute
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.
202 / FMEA / B 014
Essae Chandran Institute
Specific Uses
Essae
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.
202 / FMEA / B 015
Essae Chandran Institute
FMEA Outputs
Essae
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.
202 / FMEA / B 016
Essae Chandran Institute
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
202 / FMEA / B 017
Essae Chandran Institute
FMEA TEAM
Main Team
System FMEA Design FMEA System Dev.: Design:
Application Moderator
Essae
Process FMEA Process Engg.:
Tryout Q.A. Plant (Q or Engg) Design or Tryout Moderator
Partly
Application Reliability testing Component Dev. Corporate Depts. Sales Sales Plant
Production Tryout or Design Corporate Depts.
Others: Interface FMEA; Logistics FMEA
202 / FMEA / B 018
Essae Chandran Institute
FMEA Prerequisites
Essae
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 Chandran Institute
FMEA Format Columns
Occurrence Detection Occurrence
Design FMEA
Essae
Detention Severity
RPN
Process FMEA
Potential Failure Mode Potential Effects of Failure Potential Causes/ Mechanism (s) of Failures Current Design Controls
Process Function Requirements
Detection
Severity
Responsible Activity and Recommended Action Target Actions and completion Taken Status Date
Occurrence Severity Detention
Occurrence
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 202 / FMEA / B 020 Process FMEA Process / Opns./Opnl. Steps If numerous opns, eg., Assly) with difference Failure Modes list all Example: Grind taper Insert shaft
RPN
RPN
ItemFunction
Potential Failure Mode
Potential Effects of Failure
Severity
Potential Causes/ Mechanism (s) of Failures
Current Design Controls
Recommended Responsible Actions and Activity and Status Target completion Date
Essae Chandran Institute
Design FMEA
Essae
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.
202 / FMEA / B 021
Essae Chandran Institute
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
202 / FMEA / B 022
Essae Chandran Institute
Typical Design Considerations
Essae
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
Think about what documents in your company are used to define these
202 / FMEA / B 023
Essae Chandran Institute
Design FMEA Benefits
Essae
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.
202 / FMEA / B 024
Essae Chandran Institute
The 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 FMEA and therefore should NOT be included in a Design FMEA.
202 / FMEA / B 025
More Design FMEA Considerations and Design FMEA is a living document
Essae
Essae Chandran Institute
CAUTION! DO NOT mix up:
Design Failures & Causes with Process Failures & Causes
Design Failures
Insufficient lubrication capability Incorrect material specified
Essae
Process Failures
Insufficient lubrication applied Incorrect material used
202 / FMEA / B 026
Essae Chandran Institute
Design Block Diagram Example
System
Body
Essae
If the product function is complex, break it down into smaller sub-systems. Identify Primary Vs Secondary functions
Sub System
Doors
Exterior
Window
Interior
Component
Door Inner Panel
Glass
Sealing With Strip
Latch / Lock
202 / FMEA / B 027
Essae Chandran Institute
FMEA Basic Columns
Column 2 : Failure Modes (potential)
Occurrence Occurrence Detection
ItemFunction Potential Failure Mode Potential Effects of Failure Potential Causes/ Mechanism (s) of Failures Current Design Controls Recommended Responsible Actions and Activity and Status Target completion Date
Essae
Detention
Severity
Severity
RPN
Manner in which A component / sub-system Process Could potentially fail to meet design intent Process requirements and / or design intent
2
Can be a cause of [Link] in higher level sub-system in down stream opns. an effect of one in lower level component in a previous opn.
202 / FMEA / B 028
RPN
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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
Essae Chandran Institute
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
Essae
202 / FMEA / B 030
Essae Chandran Institute
FMEA Basic Columns
Column 3: Failure Effects
Occurrence Detection Occurrence
ItemFunction Potential Failure Mode Potential Effects of Failure Potential Causes/ Mechanism (s) of Failures Current Design Controls Recommended Responsible Actions and Activity and Status Target completion Date
Essae
Detention
Severity
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
Essae Chandran Institute
Effect(s) of Failure (Potential)
Two considerations 1. How does the failure affect ...? Component groups Product Vehicle Environment.
Essae
System
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
Essae Chandran Institute
2. How does the customer experience the failure?
Effect(s) of Failure (Potential)
Essae
notice
FUNCTIONAL ANNOYANCE SAFETY IMPAIRMENT - Noise, smell - Vehicle out of control - Ventilation Vapours Failure of Brakes - Starting Difficulties - Vibration - Failure of steering - Irregular Function - Leakages systems
Next process (Opn.): Can not mount; does not connect Does not match; can not bore / tap.
202 / FMEA / B 033
Essae Chandran Institute
FMEA Basic Columns
Column 5: Failure Causes
Occurrence Detection Occurrence RPN
ItemFunction Potential Failure Mode Potential Effects of Failure
Essae
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
Potential Causes/ Mechanism (s) of Failures
Current Design Controls
Recommended Responsible Actions and Activity and Status Target completion Date
Detention
Severity
Severity
Essae Chandran Institute
Typical Causes: Examples
FMEA Failure Causes
Essae
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 Chandran Institute
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
Essae Chandran Institute
FMEA Basic Columns
Column 7: Current Design Control
Occurrence Detection Occurrence RPN
ItemFunction Potential Failure Mode Potential Effects of Failure
Essae
(What measures to avoid failure causes have been implemented) Reduction in Ranking of Occurrence Severity (and/or) Detention Thro -Design Validation / Verification No No No - Design Revision (removal / controlling causes Yes Yes Yes Actions DOE; Revised test Plan Revised Design: material specification
202 / FMEA / B 037
RPN
Potential Causes/ Mechanism (s) of Failures
Current Design Controls
Recommended Responsible Actions and Activity and Status Target completion Date
Detention
Severity
Severity
Essae Chandran Institute
Design Controls
Essae
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 Chandran Institute
Design Control Examples
Essae
Reliability tests / prototype testing Design reviews Worst case stress analysis Consider Robust design Interpretation of Environmental stress testing data Designed experiments Finite element analysis Variation simulation FT Analysis
202 / FMEA / B 039
Essae Chandran Institute
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
Essae Chandran Institute
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 Prefer SPC & Process Improvement to Random Q. checks & Associated Inspection
Essae
202 / FMEA / B 041
Essae Chandran Institute
FMEA Basic Columns
Column 8: Detection
Occurrence Detection Occurrence RPN
ItemFunction Potential Failure Mode Potential Effects of Failure
Essae
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
Potential Causes/ Mechanism (s) of Failures
Current Design Controls
Recommended Responsible Actions and Activity and Status Target completion Date
Detention
Severity
Severity
Essae Chandran Institute
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
Essae Chandran Institute
Generic Design FMEA Severity
FMEA Basic Column 4
Effect Criteria: Severity of Effect
HazardousVery high severity ranking when a potential failure mode affects safe vehicle withoutoperation and /or involves non-compliance with government regulation Warningwithout warning HazardousVery high severity ranking when a potential failure mode affects safe vehicle withoperation and /or involves non-compliance with government regulation Warningwithout warning Very HighVehicle / item inoperable, with loss of primary function. HighVehicle / item operable but at a reduced level of performance, customer dissatisfied ModerateVehicle /item operable, but control / convenience item(s) inoperable; customer experiences discomfort LowVehicle / item operable, but comfort / convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction Very LowFit & finish/squeak & rattle item does not conform. Defect noticed by most customers. MinorFit & finish/squeak & rattle item does not conform. Defect noticed by average customers. Very MinorFit & finish/squeak & rattle item does not conform. Defect noticed by discriminating customers. NoneNo effect. 10
Essae Ranking
8 7 6 5
4 3 2 1
202 / FMEA / B 044
Essae Chandran Institute
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 Failures1 in 8 1 in 20 Moderate: Occasional failures1 in 80 1 in 400 1 in 2,000 Low: Relatively Few Failures1 in 15,000 1 in 150,000 Remote: Failure Unlikely 1 in 1,500,000
202 / FMEA / B 045
Generic FMEA Detection
Essae Chandran Institute
Detection
Criteria: Likelyhood of detection by Design Control
FMEA Basic Column 8
Essae
Ranking
10
Absolute Design Control will not and/or can not detect potential cause / mechanism Uncertainty and subsequent failure mode; or there is no design control Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost 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
9 8 7 6 5 4 3 2 1
202 / FMEA / B 046 subsequent failure mode. Certain and
Essae Chandran Institute
DFMEA Recommended Actions
Essae
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 Chandran Institute
Essae
202 / FMEA / B 048
Essae Chandran Institute
Essae
202 / FMEA / B 049
Essae Chandran Institute
Essae
202 / FMEA / B 050
Essae Chandran Institute
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
Essae
202 / FMEA / B 051
Essae Chandran Institute
Process FMEA Benefits
Essae
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 Chandran Institute
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. 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.
More Process FMEA Consideration
Essae
202 / FMEA / B 053
Essae Chandran Institute
Process Failure Causes
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Omitted processing Processing errors Errors setting up work pieces Missing parts Wrong parts Processing wrong work piece Mis-operation Adjustment error Equipment not set up properly Tools and/or fixtures improperly prepared 11. Poor control procedures 12. Improper equipment maintenance 13. Bad recipe 14. Fatigue 15. Lack of safety 16. Hardware failure 17. Failure to enforce controls 18. Environment 19. Stress connections 20. Poor FMEA(s)
Essae
202 / FMEA / B 054
Essae Chandran Institute
Process Control Examples
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 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)
Essae
Controls can be process controls such as fixture fool-proofing or SPC, or can be postprocess inspection testing Inspection / testing may occur at the subject operation or at subsequent operation(s) that can detect the subject failure mode.
202 / FMEA / B 055
Essae Chandran Institute
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
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FMEA Basic Column 4
Effect Criteria: Severity of Effect
HazardousMay endanger machine or assembly operator. Very high severity ranking when a potential failure without mode affects safe vehicle operation and/or involves non complaisance with government Warning regulation. Failure will occur without warning 10
Essae
Ranking
HazardousMay endanger machine or assembly operator. Very high severity ranking when a potential failure with mode affects safe vehicle operation and/or involves non complaisance with government Warning regulation. Failure will occur without warning Very HighMajor disruption to production line. 100% of product may have to be scrapped. Vehicle/item inoperable, loss of primary function. Customer very dissatisfied. HighMinor 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. ModerateMinor 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. LowMinor 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. Very LowMinor 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. MinorMinor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked on-line but out of station. Fit & Finish/squeak & rattle item does not conform. Defect noticed by average customers. Very MinorMinor 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. NoneNo effect.
8 7
202 / FMEA / B 057
Generic PFMEA Occurrence
Essae Chandran Institute
FMEA Basic Column 4
Probability of Failure Possible Failure Rates Very High: Failure is almost inevitable 1 in 2 1 in 3 High: Generally associated with1 in 8 process similar to previous process 1 in 20 which have often failed Moderate: Generally associated with1 in 80 process similar to previous process 1 in 400 which have experienced occasional failures, but not in1 in 2,000 major proportions. Low: Isolated failures associated with1 in 15,000 similar processes. Very Low: Only isolated failures1 in 150,000 associated with almost identical processes. Remote: Failure Unlikely. No failures 1 in 1,500,000 ever associated with almost identical processes. Cpk < 0.33 0.33 0.51 0.67 0.83 1.00 1.17 1.13 1.50 Ranking 10 9 8 7 6 5 4 3 2
Essae
1.67
202 / FMEA / B 058
Generic PFMEA Detection
Essae Chandran Institute
FMEA Basic Column 8
Essae
DetectionCriteria: Likelyhood the existence of a defect will be Ranking detected by process controls before next or subsequent process, or before part or component leaves manufacturing assembly location. AlmostNo known control(s) available to detect failure mode. impossible Very RemoteVery remote likelyhood current control(s) will detect failure mode. RemoteRemote likelyhood current control(s) will detect failure mode. Very LowVery low likelyhood current control(s) will detect failure mode. LowLow likelyhood current control(s) will detect failure mode. ModerateModerate likelyhood current control(s) will detect failure mode. ModeratelyModerately high likelyhood current control(s) will detect High failure mode.
202 / FMEA /HighHigh likelyhood current control(s) will detect failure mode. B 059
10
9 8 7 6 5 4 3
Contd
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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
Essae Chandran Institute
PFMEA
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.
Contd
Essae
202 / FMEA / B 061
Essae Chandran Institute
PFMEA Recommended Actions
Essae
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 Chandran Institute
Action on severity
Essae
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 Chandran Institute
Essae
202 / FMEA / B 064
Essae Chandran Institute
Five Methods of Mistake-Proofing Essae
Variation control using assembly aids Identification by visual techniques Standardized work and workplace organization Self-check (in-process)
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
Essae Chandran Institute
Risk Assessment (RPN) Factors
RPN=(S)x(0)x(D) S=Severity O= Likelihood of Occurrence D= Likelihood of Detection
Essae
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
202 / FMEA / B 066
Essae Chandran Institute
Assessment Rating Vs Actions
Action Taken O 1 1 1 1 10 S 1 1 10 10 1 D 1 10 1 10 1 1 10
Ideal situation Assured mastery Failure does not reach user Failure reaches user Freq. fails, detectable, costly Freq. fails w/o major impact Trouble!
Essae
Assessment Rating Causes of Failure
No Action N/A N/A YES YES YES YES YES YES
10 10 10 10
202 / FMEA / B 067
Essae Chandran Institute
Mistake-Proofing
Emphasizes Prevention! Principles
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
Essae
Examples
202 / FMEA / B 068
