Essae Chandran Institute

Essae

Failure Mode and Effects Analysis

202 / FMEA / B – 01

Essae Chandran Institute

Don’t 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

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Planning M/C: Eqpt. . & Tryout pre-release Product Release Time Start Production .order 202 / FMEA / B – 04 Start B (C) Plan & order Proto sample Product – Mfr.g. Cpk System Dev.Essae Chandran Institute Quality Planning System Development Component Development Tryout Design Concept Mfg.order Component Dev. 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..

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 .Essae Chandran Institute Cost Effective in using FMEA Identification and Prevention of Potential defects Design FMEA Process FMEA Detection and Removal of Internal defects.

’ 202 / FMEA / B – 06 . an FMEA is NOT a problem solver.Essae Chandran Institute What is An FMEA Essae A tool used to evaluate potential failure modes and their causes. It is used in combination with other problem solving tools. • 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. ‘The FMEA presents the opportunity but does not solve the problem.

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 – 1960’s and 70s • The FMEA discipline was developed in the United States Military. It was used as a reliability evaluation technique to determine the effect of system and equipment failures. 202 / FMEA / B – 09 . Failures were classified according to their impact on mission success and personnel/equipment safety. and develop a Control Plan. compliant automotive suppliers utilize Advanced Product Quality Planning (APQP). the International Organization for Standardization issued the ISO 9000 series of business management standards. including design and process FMEAs. Military Procedure MIL-P-1629. • In 1988. • 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. • QS 9000 is the automotive analogy to ISO 9000 • In accordance with QS 9000 standards.

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 .

Exposure Cause = Env.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 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 .

complete by the time preliminary drawings are done but before any tooling is initiated. Complete prior to finalizing production plans and releasing for production . Process FMEA 202 / FMEA / B – 013 Start as soon as basic manufacturing methods have been discussed.Essae Chandran Institute 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.

202 / FMEA / B – 014 . • Greatest value: before failure mode is designed into.Essae Chandran Institute Essae Important Factors • Timeliness i. • Up front time spent on changes alleviate late changes crisis.e. “before the event” Action and not “after-the-Fact” Exercise.

202 / FMEA / B – 015 . 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. – Identify process failure modes that could violate government regulations or compromise employee safety.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. – Confirm the need for Special Controls in manufacturing and confirm the designated potential “Special Characteristics” from the Design FMEA.

A list of design actions to reduce Severity. and to improve product defect detection if process capability cannot be improved. or improve detection. A list of Operator Safety and High Impact Characteristics. Feedback of design changes to the design committee. eliminate the causes of product failure modes. A list of potential Critical Characteristics and/or Significant Characteristics. or reduce their rate of Occurrence.Essae Chandran Institute FMEA Outputs Essae  Design FMEA Outputs A list of potential product failure modes. A list of recommended Special Controls for designated product Special Characteristics to be entered on a Control Plan. eliminate the causes of product failure modes. Changes to process sheets and assembly aid drawings.  Process FMEA Outputs A list of potential process failure modes. A list of confirmed Critical Characteristics and/or Significant Characteristics. or reduce their rate of Occurrence. A list of processes or process actions to reduce Severity. 202 / FMEA / B – 016 . Confirmation of the Design Verification Plan (DVP).

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 .

•Corporate Depts. Others: Interface FMEA.: •Tryout •Q.A.Essae Chandran Institute FMEA TEAM Main Team System FMEA Design FMEA • System Dev. Logistics FMEA 202 / FMEA / B – 018 . •Sales •Sales •Plant •Production •Tryout or Design •Corporate Depts.: •Design: •Application •Moderator Essae Process FMEA •Process Engg. •Plant (Q or Engg) •Design or Tryout •Moderator Partly •Application •Reliability testing •Component Dev.

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 .

failure modes list all • Basic function /Purpose to meet Example: Actuate relay Open valve 202 / FMEA / B – 020 Process FMEA • Process / Opns. component • If > one function with diff.Essae Chandran Institute 1 FMEA Format Columns Occurrence Detection Occurrence Design FMEA Essae Detention Severity RPN 1 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 1 • Nomenclature & Number. eg./Opnl.. Sub-system. Steps • If numerous opns. function Design FMEA • System. 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 . Basis for selection = importance to Q. Enter all to be analysed.

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 .Some can’t 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 .Can be specified and measured Customer Wants .

• Increases the probability that potential failure modes and their effects on the system / product have been considered. • Can reduce product development timing. 202 / FMEA / B – 024 . thus prioritizing improvements and development testing. • Ranks potential failure modes according to their effect on the customer.Essae Chandran Institute Design FMEA Benefits Essae • Aids in the objective evaluation of design requirements and alternatives. • Aids in the planning of design test and development programs. reliability and safety. • Aids in analyzing field concerns. production startup problems. reduce costs and enhance product quality. design changes and in developing advanced designs. • Provides an open issue format for recommending and tracking risk reducing actions.

• The Design FMEA should be continually updated as changes occur throughout all phases of product development. design concept completion.Essae Chandran Institute • The should be initiated at. • The Design FMEA addresses the design intent and assumes the design will be manufactured / assembled to this intent. • The Design FMEA should be fundamentally complete along with the final product drawings. 202 / FMEA / B – 025 More Design FMEA Considerations and Design FMEA is a living document Essae . or by. • 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.

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 .

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 Design Block Diagram Example System Body Essae If the product function is complex.

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 F. an effect of one in lower level component in a previous opn. 202 / FMEA / B – 028 RPN .Mode in higher level sub-system in down stream opns.

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

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

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 3 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 .

…. 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 Effect(s) of Failure (Potential) Two considerations 1.

smell .Irregular Function .Vehicle out of control .Starting Difficulties . can not bore / tap. 202 / FMEA / B – 033 .Vibration . How does the customer experience the failure? Effect(s) of Failure (Potential) Essae notice / FUNCTIONAL ANNOYANCE SAFETY IMPAIRMENT .Leakages systems Next process (Opn. does not connect Does not match.Failure of steering .Noise.): Can not mount.Essae Chandran Institute 2.Ventilation Vapours Failure of Brakes .

in terms what can be corrected / controlled.Essae Chandran Institute FMEA Basic Columns Column 5: Failure Causes Occurrence Detection Occurrence RPN ItemFunction Potential Failure Mode Potential Effects of Failure Essae 5 Definition: Design FMEA: A Design weakness – consequence is failure mode. • 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 . Process FMEA : How failure could occur.

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

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 .

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 .Design Revision (removal / controlling causes Yes Yes Yes Actions DOE.Essae Chandran Institute FMEA Basic Columns Column 7: Current Design Control Occurrence Detection Occurrence RPN ItemFunction Potential Failure Mode Potential Effects of Failure Essae 7 (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 controls should directly relate to the prevention and / or detection of specific causes of failures 202 / FMEA / B – 038 .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 .

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 .

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 Hazardous to personnel – Mfg. / Assembly? • Prevention by eliminating or controlling causes (e.

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

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 FMEA Basic Columns Column 8: Detection Occurrence Detection Occurrence RPN ItemFunction Potential Failure Mode Potential Effects of Failure Essae 8 Assessment of ability of controls to identify: * Design FMEA : Potential cause before production Release.

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

MinorFit & finish/squeak & rattle item does not conform. with loss of primary function. but control / convenience item(s) inoperable. 10 Essae Ranking 9 8 7 6 5 4 3 2 1 202 / FMEA / B – 044 . customer dissatisfied ModerateVehicle /item operable. NoneNo effect. HighVehicle / item operable but at a reduced level of performance. but comfort / convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction Very LowFit & finish/squeak & rattle item does not conform. customer experiences discomfort LowVehicle / item operable.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. Defect noticed by most customers. Defect noticed by discriminating customers. Defect noticed by average customers. Very MinorFit & finish/squeak & rattle item does not conform.

000 1 in 150.500.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 Remote: Failure Unlikely≤ 1 in 1.000 202 / FMEA / B – 045 .000 Low: Relatively Few Failures1 in 15.

Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode.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. Certain and . Moderate high 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. 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. 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. Very low 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. Remote 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.

this should be indicated. severity and/or detection rankings.Essae Chandran Institute DFMEA Recommended Actions Essae • When the failure modes have been ranked by their RPN. • Design FMEA doesn’t rely on process controls to overcome potential weaknesses in the design. 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. • Only a design revision can bring about a reduction in the severity ranking. it does take technical and physical limitations of a process into consideration (Design Rules) 202 / FMEA / B – 047 . • An increase in design verification actions will result in a reduction in the detection ranking only. • 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. If no actions are recommended for a specific cause. however.

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 .

• The process potential FMEA identifies potential product related process. • The process potential FMEA assesses the potential customer effect of the failures. 202 / FMEA / B – 052 . • 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.Essae Chandran Institute Process FMEA Benefits Essae • As a systematic approach. thus establishing a priority system for corrective and preventive action considerations. the process potential FMEA parallels and formalize the mental discipline that an engineer goes through in any manufacturing planning process. • The process potential FMEA develops a list of potential failure modes ranked according to their affect on the customer.

Essae Chandran Institute • The process FMEA is living document. • The potential failure modes/causes which can occur during manufacturing or assembly process are covered by the process FMEA but some information (severity ranking. • 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. identification of some effects) may come from the design FMEA. More Process FMEA Consideration Essae 202 / FMEA / B – 053 . 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. • The process FMEA should begin with a flow chart of process from receiving through shipping and warehousing.

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

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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

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Vehicle/item operable but some comfort/convenience item(s) inoperable. but at reduced level of performance. The product may have to be sorted and a portion (less than 100%) reworked. Very MinorMinor disruption to production line. NoneNo effect. Fit & Finish/squeak & rattle item does not conform. MinorMinor disruption to production line. Defect noticed by most customers. A portion (les than 100%) of the product may have to be scrapped (no sorting). Defect noticed by average customers. ModerateMinor disruption to production line. Customer dissatisfied. Fit & finish/squeak & rattle item does not conform. The product may have to be sorted and a portion (less than 100%) reworked on-line but out of station. Very high severity ranking when a potential failure with mode affects safe vehicle operation and/or involves non complaisance with government Warning regulation. Customer experiences some dissatisfaction. Vehicle/item inoperable. Defect noticed by a discriminating customers. Very high severity ranking when a potential failure without mode affects safe vehicle operation and/or involves non complaisance with government Warning regulation. The product may have to be sorted and a portion (less than 100%) reworked on line but in station. LowMinor disruption to production line. loss of primary function. 100% of product may have to be scrapped. but some comfort/convenience item(s) operable at reduced level of performance. Vehicle/item operable. 9 8 7 6 5 4 3 2 202 / FMEA / B – 057 1 . 100% of product may have to be reworked. Failure will occur without warning Very HighMajor disruption to production line. Customers experiences discomfort. Customer very dissatisfied. Failure will occur without warning 10 Essae Ranking HazardousMay endanger machine or assembly operator. Fit & finish / squeak & rattle item does not conform. Product may have to be sorted and a portion (less than 100%) scrapped. HighMinor disruption to production line.Generic PFMEA Severity Essae Chandran Institute FMEA Basic Column 4 Effect Criteria: Severity of Effect HazardousMay endanger machine or assembly operator. Very LowMinor disruption to production line. Vehicle/item operable.

13 ≥ 1.67 ≥ 0.50 Ranking 10 9 8 7 6 5 4 3 2 Essae ≥ 1. Cpk < 0.500. Very Low: Only isolated failures1 in 150. Remote: Failure Unlikely.000 ever associated with almost identical processes. but not in1 in 2.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.000 major proportions.33 ≥ 0.83 ≥ 1.00 ≥ 1. No failures≤ 1 in 1. Low: Isolated failures associated with1 in 15.17 ≥ 1.67 1 202 / FMEA / B – 058 .33 ≥ 0.000 similar processes.000 associated with almost identical processes.51 ≥ 0.

LowLow likelyhood current control(s) will detect failure mode. or before part or component leaves manufacturing assembly location. AlmostNo known control(s) available to detect failure mode. 202 / FMEA /HighHigh likelyhood current control(s) will detect failure mode. RemoteRemote likelyhood current control(s) will detect failure mode. impossible Very RemoteVery remote likelyhood current control(s) will detect failure mode.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. ModeratelyModerately high likelyhood current control(s) will detect High failure mode. B – 059 10 9 8 7 6 5 4 3 Contd… . Very LowVery low likelyhood current control(s) will detect failure mode. ModerateModerate likelyhood current control(s) will detect failure mode.

• A reduction in detection ranking can only be achieved by improving process control system(s) 202 / FMEA / B – 060 .Essae Chandran Institute 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.

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

In the parachute example.Essae Chandran Institute PFMEA Recommended Actions Essae The severity applies to the effect only. that allows me to land without dying. but warns me that I am about to die. If the chute doesn’t open. The effect of a given failure will not change unless you change the design of the system or part. 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 open…It still doesn’t open. therefore making it a 9 (failure occurs with warning). Customer dissatisfied) 202 / FMEA / B – 062 . If I take it step further. I can make a case for the severity being a 7 (item operable. and add a smaller backup chute that deploys. but at a reduced level of performance. you probably die and therefore it is a 10 (failure occurs without warning).

Essae Chandran Institute Action on severity Essae • The Question of action should be based on the RPN. If the severity is high. not severity alone. If changes are not feasible. we have no control on what the vehicle does when our parts fail. we at least think about any changes that might be made. This is determined by the car companies and we all know they are infinitely wise in areas of quality and safety. 202 / FMEA / B – 063 . • Often times. we then focus on occurrence and detection to bring the RPN into an acceptable level.

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. 202 / FMEA / B – 065 . YOKE: Avoiding the production of a defective piece or its passage down the line.

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 .

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 . detectable. fails. costly Freq.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.

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 .