Essae Chandran Institute

Essae

Failure Mode and Effects Analysis

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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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Cpk System Dev.g.order Component Dev. & Tryout pre-release Product Release Time Start Production .. . Finalise Measures Pilot Run Further updating Production Preliminary Special characteristics QA1 Finalise special characteristics QA2 Product SupplyRelease QA3 Ensure Special Characteristics e.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.order 202 / FMEA / B – 04 Start B (C) Plan & order Proto sample Product – Mfr.

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.

It is used in combination with other problem solving tools. an FMEA is NOT a problem solver. • 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 What is An FMEA Essae A tool used to evaluate potential failure modes and their causes.’ 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 .

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

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 .

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. 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.

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

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

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

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 .

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

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 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. 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 . Steps • If numerous opns. eg. failure modes list all • Basic function /Purpose to meet Example: Actuate relay Open valve 202 / FMEA / B – 020 Process FMEA • Process / Opns. Enter all to be analysed./Opnl. Basis for selection = importance to Q.. component • If > one function with diff. Sub-system.

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 .

Can be specified and measured Customer Wants .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 .Essae Chandran Institute Typical Design Considerations • • • • • Essae Design Intent Customer Needs .

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

• The Design FMEA should be fundamentally complete along with the final product drawings.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 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. • The Design FMEA addresses the design intent and assumes the design will be manufactured / assembled to this intent. 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. 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 . break it down into smaller sub-systems.

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

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

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

.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 .

Essae Chandran Institute Effect(s) of Failure (Potential) Two considerations 1.? Component groups Product Vehicle Environment. How does the failure affect ……….…. 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 ..

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

Process FMEA : How failure could occur.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 . in terms what can be corrected / controlled.

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

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 .

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 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 .

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.g Mistake proofing) OR operator Protection Occurrence: To reduce probability . / Assembly? • Prevention by eliminating or controlling causes (e.

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

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. * 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 . Process FMEA: Failure Mode before part leaves Mfg.

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 .

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

000 Low: Relatively Few Failures1 in 15.000 202 / FMEA / B – 045 .000 1 in 150.500.000 Remote: Failure Unlikely≤ 1 in 1.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.

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

however. • 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. severity and/or detection rankings. If no actions are recommended for a specific cause. 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.Essae Chandran Institute DFMEA Recommended Actions Essae • When the failure modes have been ranked by their RPN. 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.

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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. 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. • 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.

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. identification of some effects) may come from the design FMEA. • 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. More Process FMEA Consideration Essae 202 / FMEA / B – 053 . • 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.Essae Chandran Institute • The process FMEA is living document.

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.

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

Very Low: Only isolated failures1 in 150.000 associated with almost identical processes.000 major proportions.13 ≥ 1.00 ≥ 1.500.000 ever associated with almost identical processes.33 ≥ 0. Remote: Failure Unlikely.67 ≥ 0.000 similar processes.67 1 202 / FMEA / B – 058 . Cpk < 0.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.33 ≥ 0.83 ≥ 1. Low: Isolated failures associated with1 in 15. but not in1 in 2.51 ≥ 0. No failures≤ 1 in 1.17 ≥ 1.50 Ranking 10 9 8 7 6 5 4 3 2 Essae ≥ 1.

LowLow likelyhood current control(s) will detect failure mode. or before part or component leaves manufacturing assembly location. 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. B – 059 10 9 8 7 6 5 4 3 Contd… . AlmostNo known control(s) available to 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. Very LowVery low likelyhood current control(s) will detect failure mode. ModerateModerate likelyhood current control(s) will detect failure mode.

• 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 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.

Contd… Essae 202 / FMEA / B – 061 .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. To reduce the probability of occurrence. then this should be indicated. If no action are recommended for a specific cause. defects. severity and/or detection rankings. The intent of any recommended action is to reduce the occurrence. To increase the probability of detection. process control and/or inspection changes are required. Improving detection controls is typically costly. process and/or specification revisions are required. The emphasis should be placed on preventing rather than detecting.

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

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

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 .

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 . costly Freq. fails. detectable.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 .

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