FMEA
FMEA
AGENDA
Ice breaker Opening DFMEA Break DFMEA exercise Lunch PFMEA Break PFMEA Exercise FMEA Jeopardy Closing and Survey
FMEA/FMECA History
The history of FMEA/FMECA goes back to the early 1950s and 1960s.
U.S. Navy Bureau of Aeronautics, followed by the Bureau of Naval Weapons: National Aeronautics and Space Administration (NASA):
Department of Defense developed and revised the MIL-STD-1629A guidelines during the 1970s.
FMEA is a Tool
FMEA is a tool that allows you to: Prevent System, Product and Process problems before they occur reduce costs by identifying system, product and process improvements early in the development cycle Create more robust processes Prioritize actions that decrease risk of failure Evaluate the system,design and processes from a new vantage point
A Systematic Process
FMEA provides a systematic process to: Identify and evaluate
potential failure modes potential causes of the failure mode
Identify and quantify the impact of potential failures Identify and prioritize actions to reduce or eliminate the potential failure Implement action plan based on assigned responsibilities and completion dates Document the associated activities
Purpose/Benefit
cost effective tool for maximizing and documenting the collective knowledge, experience, and insights of the engineering and manufacturing community format for communication across the disciplines provides logical, sequential steps for specifying product and process areas of concern
Benefits of FMEA
Contributes to improved designs for products and processes. Higher reliability Better quality Increased safety Enhanced customer satisfaction Contributes to cost savings. Decreases development time and re-design costs Decreases warranty costs Decreases waste, non-value added operations Contributes to continuous improvement
Benefits
Cost benefits associated with FMEA are usually expected to come from the ability to identify failure modes earlier in the process, when they are less expensive to address. rule of ten If the issue costs $100 when it is discovered in the field, then It may cost $10 if discovered during the final test But it may cost $1 if discovered during an incoming inspection. Even better it may cost $0.10 if discovered during the design or process engineering phase.
System
Components Subsystems Main Systems
Design
Components Subsystems Main Systems
Process
Manpower Machine Method Material Measurement Environment Focus: Minimize failure effects on the Processes Objectives/Goal: Maximize Total Process Quality, reliability, Cost and maintenance
Focus: Minimize failure effects on the System Objectives/Goal: Maximize System Quality, reliability, Cost and maintenance
Focus: Minimize failure effects on the Design Objectives/Goal: Maximize Design Quality, reliability, Cost and maintenance
Machines
Tools, Work Stations, Production Lines, Operator Training, Processes, Gauges
Why do FMEAs?
Examine the system for failures. Ensure the specs are clear and assure the product works correctly ISO requirement-Quality Planning
ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures, and the applicable documentation
Assumptions of DFMEA
All systems/components are manufactured and assembled as specified by design Failure could, but will not necessarily, occur
S e v
C l a s s
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
General
Item Potential Failure Mode
Function
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
Every FMEA should have an assumptions document attached (electronically if possible) or the first line of the FMEA should detail the assumptions and ratings used for the FMEA. Product/part names and numbers must be detailed in the FMEA header All team members must be listed in the FMEA header Revision date, as appropriate, must be documented in the FMEA header
Function
Item Potential Failure Mode
Function
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: HVAC system must defog windows and heat or cool cabin to 70 degrees in all operating conditions (-40 degrees to 100 degrees) - within 3 to 5 minutes or - As specified in functional spec #_______; rev. date_________
Failure Mode
Item Potential Failure Mode
Function
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLES: HVAC system does not heat vehicle or defog windows HVAC system takes more than 5 minutes to heat vehicle HVAC system does not heat cabin to 70 degrees in below zero temperatures HVAC system cools cabin to 50 degrees HVAC system activates rear window defogger
Usage
Above average life cycle Harsh environment below average life cycle
Describe or record in physical or technical terms, not as symptoms noticeable by the customer.
Effect(s) of Failure
Item Potential Failure Mode
Function
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: Cannot see out of front window Air conditioner makes cab too cold Does not get warm enough Takes too long to heat up
Severity
Definition: assessment of the seriousness of the effect(s) of the potential failure mode on the next component, subsystem, or customer if it occurs Severity applies to effects For failure modes with multiple effects, rate each effect and select the highest rating as severity for failure mode
Severity
Item Potential Failure Mode
Function
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: Cannot see out of front window severity 9 Air conditioner makes cab too cold severity 5 Does not get warm enough severity 5 Takes too long to heat up severity 4
Classification
Item Potential Failure Mode
Function
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
Classification should be used to define potential critical and significant characteristics Critical characteristics (9 or 10 in severity with 2 or more in occurrence-suggested) must have associated recommended actions Significant characteristics (4 thru 8 in severity with 4 or more in occurrence suggested) should have associated recommended actions Classification should have defined criteria for application EXAMPLE: Cannot see out of front window severity 9 incorrect vent location occurrence 2 Air conditioner makes cab too cold severity 5 - Incorrect routing of vent hoses (too close to heat source) occurrence 6
Cause(s) of Failure
Item Potential Failure Mode
Function
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: Incorrect location of vents Incorrect routing of vent hoses (too close to heat source) Inadequate coolant capacity for application
Potential Cause
Tolerance build up insufficient material insufficient lubrication capacity Vibration Foreign Material Interference Incorrect Material thickness specified exposed location temperature expansion inadequate diameter Inadequate maintenance instruction Over-stressing Over-load Imbalance Inadequate tolerance
Mechanism
Yield Fatigue Material instability Creep
Wear
Corrosion
Occurrence
Definition: likelihood that a specific cause/mechanism will occur Be consistent when assigning occurrence Removing or controlling the cause/mechanism though a design change is only way to reduce the occurrence rating
Occurrence
Item Potential Failure Mode
Function
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: Incorrect location of vents occurrence 3 Incorrect routing of vent hoses (too close to heat source) occurrence 6 Inadequate coolant capacity for application occurrence 2
Control must be allocated in the plan to be listed, otherwise its a recommended action 3 types of Controls 1. Prevention from occurring or reduction of rate 2. Detect cause mechanism and lead to corrective actions 3. Detect the failure mode, leading to corrective actions
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
EXAMPLE: Engineering specifications (P) preventive control Historical data (P) preventive control Functional testing (D) detective control General vehicle durability (D) detective control
Examples of Controls
Type 1 control
Warnings which alert product user to impending failure Fail/safe features Design procedures/guidelines/ specifications
Detection
Item Potential Failure Mode
Function
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
Detection values should correspond with AIAG, SAE If detection values are based upon internally defined criteria, a reference must be included in FMEA to rating table with explanation for use Detection is the value assigned to each of the detective controls Detection values of 1 must eliminate the potential for failures due to design deficiency EXAMPLE: Engineering specifications no detection value Historical data no detection value Functional testing detection 3 General vehicle durability detection 5
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
Risk Priority Number is a multiplication of the severity, occurrence and detection ratings Lowest detection rating is used to determine RPN RPN threshold should not be used as the primary trigger for definition of recommended actions
EXAMPLE: Cannot see out of front window severity 9, incorrect vent location 2, Functional testing detection 3, RPN - 54
RPN Considerations
Rating scale example:
Severity = 10 indicates that the effect is very serious and is worse than Severity = 1. Occurrence = 10 indicates that the likelihood of occurrence is very high and is worse than Occurrence = 1. Detection = 10 indicates that the failure is not likely to be detected before it reaches the end user and is worse than Detection = 1.
1 5 10
Recommended Actions
Definition: tasks recommended for the purpose of reducing any or all of the rankings Only design revision can bring about a reduction in the severity ranking Examples of Recommended actions
Perform:
Designed experiments reliability testing finite element analysis
Recommended Actions
Item Potential Failure Mode
Function
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D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
All critical or significant characteristics must have recommended actions associated with them Recommended actions should be focused on design, and directed toward mitigating the cause of failure, or eliminating the failure mode If recommended actions cannot mitigate or eliminate the potential for failure, recommended actions must force characteristics to be forwarded to process FMEA for process mitigation
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Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
All recommended actions must have a person assigned responsibility for completion of the action Responsibility should be a name, not a title Person listed as responsible for an action must also be listed as a team member There must be a completion date accompanying each recommended action
Action Results
Item Potential Failure Mode
Function
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O c c u r
D e t e c
Action Results R P N Response & Recommended Target Actions Complete Date Action Taken S E V O C C D E T R P N
Unless the failure mode has been eliminated, severity should not change Occurrence may or may not be lowered based upon the results of actions Detection may or may not be lowered based upon the results of actions If severity, occurrence or detection ratings are not improved, additional recommended actions must to be defined
Process FMEA
Definition:
A documented analysis which begins with a teams thoughts concerning requirements that could go wrong and ending with defined actions which should be implemented to help prevent and/or detect problems and their causes. A proactive tool to identify concerns with the sources of variation and then define and take corrective action.
PFMEA as a tool
To access risk or the likelihood of significant problem Trouble shoot problems Guide improvement aid in determining where to spend time and money Capture learning to retain and share knowledge and experience
Customer Requirements Deign Specifications Key Product Characteristics Machine Process Capability
Process FMEA
PFMEA Assumptions
The design is valid All incoming product is to design specifications Failures can but will not necessarily occur Design failures are not covered in a PFMEA, they should have been part of the design FMEA
Machining
Too narrow Too deep Angle incorrect Finish not to specification Flash or not cleaned
Torque
Loose or over torque Missing fastener Cross threaded
Drilling holes
Missing Location Deep or shallow Over/under size Concentricity angle
Potential effects
Think of what the customer will experience
End customer Next user-consequences due to failure mode
May have several effects but list them in same cell The worst case impact should be documented and rated in severity of effect
Potential Effects
End user
Noise Leakage Odor Poor appearance Endangers safety Loss of a primary function performance
Next operation
Cannot assemble Cannot tap or bore Cannot connect Cannot fasten Damages equipment Does not fit Does not match Endangers operator
Severity Ranking
How the effects of a potential failure mode may impact the customer Only applies to the effect and is assigned with regard to any other rating Potential effects of failure Cannot assemble bolt(5) Endangers operator(10) Vibration (6) Severity
Classification
Use this column to identify any requirement that may require additional process control
KC - key characteristic F fit or function S - safety Your company may have a different symbol
Potential Causes
Cause indicates all the things that may be responsible for a failure mode. Causes should items that can have action completed at the root cause level (controllable in the process) Every failure mode may have multiple causes which creates a new row on the FMEA Avoid using operator dependent statements i.e. operator error use the specific error such as operator incorrectly located part or operator cross threaded part
Potential Causes
Equipment
Tool wear Inadequate pressure Worn locator Broken tool Gauging out of calibration Inadequate fluid levels
Operator
Improper torque Selected wrong part Incorrect tooling Incorrect feed or speed rate Mishandling Assembled upside down Assembled backwards
Occurrence Ranking
How frequent the cause is likely to occur Use other data available
Past assembly processes SPC Warranty
Process Controls
Preventative
SPC Inspection verification Work instructions Maintenance Error proof by design Method sheets Set up verification Operator training
Detection
Functional test Visual inspection Touch for quality Gauging Final test
Detection
Probability the defect will be detected by process controls before next or subsequent process, or before the part or component leaves the manufacturing or assembly location Likely hood the defect will escape the manufacturing location Each control receives its own detection ranking, use the lowest rating for detection
Recommended actions
Control
Influence
Recommended Action
Definition: tasks recommended for the purpose of reducing any or all of the rankings Examples of Recommended actions
Perform:
Process instructions (P) Training (P) Cant assemble at next station (D) Visual Inspection (D) Torque Audit (D)
Process Changes
Requirements
No injury to operators or users Finished dimension fits into envelope All items present (info sheet, contribution form, and return envelope) {KEY} All pages in proper order (info sheet, contribution form, return envelope) {KEY} No tattered edges No dog eared sheets Items put together in order (info sheet [folded to fit in legal envelope], contribution sheet, return envelope) {KEY} General overall neat and professional appearance Proper first class postage on envelopes Breast cancer seal on every envelope sealing the envelope on the back Mailing label, stamp and seal on placed squarely on envelope {KEY} Rubber band sets of 25
Process steps
Fold information sheet to fit in legal envelope Collate so each group includes all components Stuff envelopes Affix address, postage, and seal Rubber bands sets of 25 Deliver to post office for mail today by 5 pm
Software Recommendations
Numerous types and specialized formats Many have free trials
X-FMEA Reliasoft FMEA Pro-7 Access Data bases Excel formats