FMEA F

FMEA Failure Mode Effects Analysis
FMEA Definition
A procedure & tool that help to identify every possible failure mode of a process or product;
To determine frequency and impact of the failure To determine its effect on other sub-items & on the required function of the product or process
Also used to rank & prioritize the possible causes of failures To develop and implement preventative actions For each failure identified (known or potential), an estimate is made of its occurrence, severity and detection
Failure Rate
Majority of products follow a familiar pattern Failure modes are classified into 3 categories
Debug- Due to flaws in design or Mfg, have high failure rate in the initial stages Chance- Due to accidents, poor maintenance, or limitations in the design Wear out- Failures after product/process life has ended
Periods of failure are modeled by exponential distr, prob of product/process survival may viewed as;
Rt = e-t = e-t/
Rt= Period of operation without failure t = Time specified for operation without failure = Failure rate, = mean time to failure
How is FMEA performed?

Good understanding of equipment design and operation is an essential starting point Qualitatively consider the ways in which individual parts or assemblies in the equipment can fail. These are the failure modes that we wish to list Each Failure mode is then evaluated for each effect on - the component itself (local effect) - next higher level of assembly - the top level of assembly or system
Types of FMEA
Design FMEA- Aids in the design process
Identifies known and foreseeable failure modes and then ranks them according to relative impact on product Helps to establish priorities based upon expected failures Reduces dev time, cost of Mfg process by eliminating potential failure modes prior to operation and specifying appropriate test to prove the product Documents the results for future references as well
Process FMEA- Aids in monitoring and control of process

Utilized to identify potential process failure modes by ranking failures Helps to establish priorities according to the relative impact on the internal or external customer Identifies potential Mfg or assembly causes in order to establish controls for occurrence reduction and detection Documents the results for future references as well
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 Tools, Quality, reliability, Work Stations, Cost and Production Lines, maintenance Operator Training, Processes, Gauges
Machines
FMEA Documentation
FMEA practices always existed in the thinking process but now it helps to keep those ideas available for future use Reps from all affected areas are involved while documenting Block Diagram- Design FMEA always begin with it
Used to show different flows (info, fluid etc) involved with the component being analyzed and included in all phases of FMEA Purpose is to know the input of block, its function & output and to establish a logical order to the analysis It starts by listing the components of the system, their function and means of attachment/connection b/w them Then components are placed in blocks & their functional relationships are represented by lines connecting the block For complicated system of components, a hierarchical representation is used to aid in determining interconnection b/w components
FMEA Documentation
Other Documentation
The other three documents needed are the; Design or Process intent, The customer needs and wants and, The FMEA form
Stages of FMEA- The four stages of FMEA are;

1.
Specifying Possibilities
Functions, Possible Failure Modes, Root causes, Effects, Detection/Prevention
2.
Quantifying Risk
Probability of cause, Severity of defect, Effectiveness of control to prevent cause, Risk priority number
3.
Correcting High Risk Causes

Prioritizing work, Detailing Action, Assigning action responsibility, Check points on completion Re-evaluation of Risk- Recalculation of Risk priority number
4.
What tools are available to meet our objective?

Benchmarking Customer warranty reports Design checklist or guidelines Field complaints Internal failure analysis Internal test standards Lessons learned Returned material reports Expert knowledge
Design FMEA Document

The top section in the form is used mainly for document tracking and organizing
FMEA #, Item, Design Responsibility, Prepared by, Model number/year Key Date- The date when initial FMEA is due FMEA Date- The date when FMEA was compiled and latest revision date should be placed Core Team- including names, depts and phone numbers of people, if they are not familiar with each other
Every FMEA should have an assumption document attached (electronically if possible) or the first line of the FMEA should detail the assumptions and ratings used for the FMEA
Design FMEA Format

Item Potential Failure Mode
Function
Potential Effect(s) of Failure
S e v
C l a s s
Potential Cause(s)/ Mechanism(s) Of Failure
O c c u r
Current Design Controls

Prevent Detect
D e t e c
Action Results R P N Responsib & Response & Recommended Target Traget Actions Complete Date Action Taken S E V O C C D E T R P N
Function-What is the part supposed to do in view of customer requirements? Describe what the system or component is designed to do
Include information regarding the environment in which the system operates Define temperature, pressure, and humidity ranges
List all functions Remember to consider unintended functions
Function
Function
S e v
C l a s s
O c c u r

Prevent Detect
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
Each function must have an associated measurable condition
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
Potential Failure Mode

Definition: the manner in which a system, subsystem, or component could potentially fail to meet design intent Ask yourself- How could this design fail to meet each customer requirement? Remember to consider:
Absolute failure Partial failure Intermittent failure Over function Degraded function Unintended function
Failure Mode
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Failure modes may be one of two things; method in which it fail to meet the design criteria or method that may cause potential failure in a higher level system or may be the result of failure of a lower level system Failure modes should be written as anti-functions e.g cracked, leaking, short cct etc EXAMPLES: HVAC system does not heat vehicle or defog windows HVAC system takes more than 5 minutes to heat vehicle HVAC system does heat cabin to 70 degrees in below zero temperatures HVAC system cools cabin to 50 degrees HVAC system activates rear window defogger
Consider Potential failure modes under:

Operating Conditions
Hot and cold Wet and dry Dusty and dirty
Usage
Above average life cycle Harsh environment Below average life cycle
Consider Potential failure modes under:

Incorrect service operations
Can the wrong part be substituted inadvertently? Can the part be serviced wrong? E.g. upside down,
backwards, end to end

Is the part difficult to assemble?
Describe or record in physical or technical terms, not
as symptoms noticeable by the customer
Effect(s) of Failure
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Effects must be listed in a manner customer would describe them Effects must include (as appropriate) safety / regulatory body, end user, internal customers manufacturing, assembly, service Must also forecast what effects the particular failure may have on other sub/ systems in immediate contact with the system failure EXAMPLE: A part may fracture, which may cause vibration of the sub-system in contact with the fractured part, resulting in an intermittent system operation. This could cause performance to degrade leading to customer dissatisfaction Some typical effects of failure may include noise, erratic operation, poor appearance, lack of stability etc
Examples of Potential Effects

Noise loss of fluid seizure of adjacent surfaces loss of function no/low output loss of system
Intermittent operations rough surface unpleasant odor poor appearance potential safety hazard Customer dissatisfied
Severity
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
It is the assessment of the seriousness of the effect of the potential failure mode to the next sub/component, system or customer if it occurs It applies only to the effect of failure and not the potential failure mode It is rated from 1 to 10 by the team and different for all designs, reduced only after direct design change EXAMPLE: Cannot see out of front window severity 9 Air conditioner makes cab too cold severity 5 Takes too long to heat up severity 4
Classification
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Classification should be used to define potential critical and significant characteristics Critical characteristics (9 or 10 in severity with 2 or more in occurrence) must have associated recommended actions Significant characteristics (4 thru 8 in severity with 4 or more in occurrence) should have associated recommended actions Classification should have defined criteria for application
Cause(s) of Failure
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Some potential failure modes may have more than one cause of failure for each failure mode Each of the causes must be identified for a failure mode with equal relative weight Causes at component level analysis should be identified as part or system characteristic (a feature that can be controlled at process) EXAMPLE: Incorrect material specified Over stressing and poor environment protection
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
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Occurrence are the chances that one of the specific causes/mechanisms will occur Occurrence ratings for design FMEA are based upon the likelihood that a cause may occur, based upon past failures, performance of similar systems in similar applications, or percent new content It is rated from 1 to 10 for every cause and reduced only after direct design change
EXAMPLE: Incorrect routing of vent hoses (too close to heat source) occurrence 6 Inadequate coolant capacity for application occurrence 2

Definition: activities which will assure the design adequacy for the failure cause/mechanism under consideration Confidence that Current Design Controls will detect cause and subsequent failure mode prior to production, and/or will prevent the cause from occurring
If there are more than one control, rate each and select the lowest for the detection rating
Control must be allocated in the plan to be listed, otherwise its a recommended action There are three 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

Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Preventive controls are those that help reduce the likelihood that a failure mode or cause will occur affects occurrence value Detective controls are those that find problems that have been designed into the product assigned detection value If detective and preventive controls are not listed in separate columns, they must include an indication of the type of control
EXAMPLE: Engineering specifications (P), 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
Type 2 and 3 controls

Road test Design Review Environmental test fleet test lab test field test life cycle test load test
Detection
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
It is a relative measure of the assessment of the ability of the design control to detect either a potential cause or the failure mode before the completion of production
It is rated from 1 to 10 for every cause and reduced only after direct design change
EXAMPLE: Engineering specifications no detection value Historical data no detection value Functional testing detection 3 General vehicle durability detection 5
Risk Priority Number(RPN)

RPN is the product of Severity (S), Occurrence (O) and Detection (D) RPN is mainly used to prioritize concerns/actions and may also be viewed as a relative measure of the design risk RPN ranges from 1-1000, greater the value of RPN greater the concern Low RPN may however be misleading as S may be high
RPN as a measure of risk

An RPN is like a medical diagnostic, predicting the health of the patient At times a persons temperature, blood pressure, or an ECG can indicate potential concerns which could have severe impacts or implications
RPN (Risk Priority Number)

Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
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
RPN ratings are relative to a particular analysis

An RPN in one analysis is comparable to other RPNs in the same analysis but an RPN may NOT be comparable to RPNs in another analysis
10
RPN Considerations (continued)

Because similar RPN's can result in several different ways (and represent different types of risk), analysts often look at the ratings in other ways, such as:
Occurrence/Severity Matrix (Severity and Occurrence) Individual ratings and various ranking tables
10
Recommended actions
Control
Influence
Cant control or influence at this time
Recommended Actions
After every concern is examined and given a risk priority number, the team should begin to examine the corrective actions that may be employed, beginning with the concern with the greatest RPN These are tasks recommended for purpose of reducing one or more of the criteria that constitute the RPN Only design revision can bring about a reduction in the severity ranking Examples of Recommended actions to reduce RPN are
Perform:
Reliability Testing Finite Element Analysis
Revise design Revise test plan Revise material selection/specification
Recommended Actions
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
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
Responsibility & Target Completion Date

Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
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
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Action taken must detail what actions occurred, and the results of those action Actions must be completed by the target completion date Unless a failure mode has been eliminated, severity should not change Occurrence and 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 be defined If no actions are taken, this section should be left blank. If same RPN is written future users will think that actions were taken but the had no effect
Process FMEA Document

PFMEA is required for all new processes/ parts, and carryover parts/processes in new applications or environment It is initiated before or at the feasibility stage, prior to tooling for production Takes into account all Mfg ops from individual components to assemblies PFMEA is much similar to DFMEA Teams are cross functional from respective departments
PFMEA Assumptions
The design is valid Design failures are not covered in PFMEA, they be part of the design FMEA All incoming product is in compliance to design specifications Failures can but will not necessarily occur
Inputs for PMEA

Process flow diagram Assembly instructions Design FMEA Current engineering drawings and specifications Data from similar processes
Scrap Rework Downtime Warranty
PMEA as an Info Hub Current or Expected quality performance
Customer Design requirements
Process Flow Diagram
Process Changes
Implementation and verification
Process FMEA document
Recommended Corrective actions i.e. Error proofing
Process Control Plan
Continuous Improvement Efforts And RPN reduction loop
Operator Job Instructions
Communication of standard of work to operators
Process Function Requirement

Instead of the item being analyzed and its function, as in DFMEA, a brief description of the process being analyzed is given here PFMEA should follow the actual work process or sequence, same as the process flow diagram The purpose of the process should be given completely and concisely If the process involves more than one operation, each operation should be listed separately along with its description E.g include turning, drilling, tapping, welding etc
Potential Failure Mode

How the process or product may fail to meet design or quality requirements
One or more of the three possible types of failure are listed here The process could fail to meet the process requirements, potential failure mode in up/downstream operation
Some knowledge of DFMEA is needed in this aspect of PFMEA
Common Failure Modes

Assembly
Missing parts Damaged Orientation Contamination Off location
Machining
Too narrow Too deep Angle incorrect Finish not to specification Flash or not cleaned
Potential Effects of Failures

Think of what the customer will experience
End customer or next
May have several effects but list them in same cell The worst case impact should be documented and rated in severity of effect It must also be stated that whether the failure will impact personal safety or break any product regulations
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 Applies only 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
10 Take the highest effect ranking
Potential Causes of Failure

Cause indicates all the things that may be responsible for a failure mode
Causes should be items that can be corrected or controllable in the process
Every failure mode may have multiple causes which creates a new row on the FMEA
DoE may be considered to determine which root causes are major contributors and can be controlled
Only specific errors and malfunctions should be listed

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 projected to occur Use other data available
Past assembly processes SPC Warranty
Each cause should be ranked according to the guideline
Current Process Controls

These are the descriptions of the controls that either prevents or detects the failure mode Document both types of process controls
Preventive- before the part is made
Prevent the cause, use error proofing at the source
Detection- after the part is made

Detect the cause (mistake proof) Detect the failure mode by inspection
All controls should be listed, but ranking should occur on detection controls only List the controls chronologically
Don not include controls that are outside of your plant
Process Controls
Preventive
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
It is the detection of probability that defect will be detected by process controls before subsequent process, or before the part or component leaves the manufacturing or assembly location Assume that failure has occurred and then assess the capabilities of the current process control to prevent shipment of the part having this NC Each control receives its own detection ranking, Assess the ability of the process controls to detect low frequency failure modes or prevent them from going further in the process
10 steps to conduct a FMEA

1. Review the design or process
2.
3. 4. 5. 6. 7. 8. 9. 10.
Brainstorm potential failure modes

List potential failure effects Assign Severity ratings Assign Occurrence ratings Assign detection rating Calculate RPN Develop an action plan to address high RPNs Take action Reevaluate the RPN after the actions are completed
Reasons FMEAs fail

1. 2. One person is assigned to complete the FMEA Not customizing the rating scales with company specific data, so they are meaningful to your company 3. The design or process expert is not included in the FMEA
or is allowed to dominate the FMEA team

4. Members of the FMEA team are not trained in the use of FMEA, and become frustrated with the process
5.
FMEA team becomes bogged down with minute details of

design or process, losing sight of the overall objective
Reasons FMEAs fail

6. Rushing through identifying the failure modes to move onto the next step of the FMEA 7. Listing the same potential effect for every failure i.e. customer dissatisfied.
8. Stopping the FMEA process when the RPNs are calculated

and not continuing with the recommended actions. 9. Not reevaluating the high RPNs after the corrective
actions have been completed.
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FMEA Failure Mode Effects Analysis

How is FMEA performed?

Process FMEA- Aids in monitoring and control of process

Stages of FMEA- The four stages of FMEA are;

Correcting High Risk Causes

What tools are available to meet our objective?

Design FMEA Document

Design FMEA Format

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

List all functions Remember to consider unintended functions

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Each function must have an associated measurable condition

Potential Failure Mode

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Consider Potential failure modes under:

Consider Potential failure modes under:

backwards, end to end

Describe or record in physical or technical terms, not

as symptoms noticeable by the customer

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Examples of Potential Effects

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Current Design Controls

Current Design Controls

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Type 2 and 3 controls

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

Risk Priority Number(RPN)

RPN as a measure of risk

RPN (Risk Priority Number)

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) Of Failure

Current Design Controls

RPN ratings are relative to a particular analysis

RPN Considerations (continued)

Cant control or influence at this time