FMEA

Introduction

What is FMEA ?
Means to assure that potential failure modes and their associated cause and mechanism, have been addressed though earlier detection. A tool for design and process engineers. Before-the-event action NOT an After-the-fact exercise.

FMEA Application
Case 1 : New designs, new technology, or new process.

Case 2 : Modification to existing design or process.

Case 3 : Use of an existing design or process in a new environment, location or application.

Do not forget Rule of Ten

COST OF QUALITY

SPC Proces PPM Design s At FMEA FMEA Supplier end

Design Advanced and product developm quality ent planning Potential defect Manufacture
Rs.1/Rs. 10/Rs. 100/-

SPC PPM At prodn

Manufac turing

Evaluation mechanism

Purchasing

Use

Product flow stage

Internal defect
Rs. 1000/-

External defect Customer Rs. 10,000/External failure

Defect report point Defect Stage Ratio of cost Nature of cost

Prevention cost

Internal failure cost

FMEA Stage
Product Concept Product Brief
Product Proto Design System, Sub system, Part Design

Product Start of Production

+ Review Of issues At Pilot

Product PILOT Build

+ Review Of issues At Proto

Product Proto Build

Process Flow Design

Potential Failure Mode & Effects Analysis Sequence

PFMEA - SEQUENCE

Application

Application
Design FMEA Purpose Meeting specification / Customer & Legal requirements. Design and development Avoiding design failures Process FMEA Production in compliance with drawing Production / Mfg Engg. Avoiding failures during process planning, production implementation

Responsibility Objective

Timing for commencement

Period of review FMEA first completion

Before or at design concept finalization

Prior to the first trial run Prior to production drawing release for tooling

Before or at feasibility stage or prior to looking for production

Prior to any investment Prior to bulk production

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

1. PFMEA Process Scope

Formulate cross functional team Understand customer/process requirements. Define start and end of process All team members walk and observe the process. Get the process worker to explain the operation/process under review. Make notes/observations. Defining Scope of FMEA is CRITICAL!

1. Design FMEA Block Diagram Example

Switch on/off

C
2 Bulb Assembly D

3
4

Housing A
5

Plate E +

Batteries B

Spring F --

Attaching Method 1. Skip Fit 4. Snap Fit 2. Rivets 5. Compressive Fit 3. Thread

1. PFMEA process scope

System Level
Bicycle
Design Objectives: 1. Minimum 3000 hours of riding without need for maintenance and 10000 hours of riding for design life . 2. Accommodates male adults comfortably to the 99.5th percentile 3. ...etc.... Function1: * Ease of use Potential failure model(s): * Difficult to steer * difficult to pedal Function2: * Provide reliable transportation Potential failure model(s): * Chain break frequently * Tire require frequent maintenance Function3: * Provide comfortable transportation Potential failure model(s): * seating position is not comfortable

Subsystem Level
Frame
Function1: * provide stable attachment for seat support Potential failure model(s): * Structural failure of seat support * Excessive deflection of seat support . Function 2: * Provide pleasing appearance. Potential failure model(s): * Finish (Shine ) deteriorates * Paint chips Handle bar assembly Front Wheel assembly Real wheel assembly Sprocket assembly Seat assembly Chain assembly

Component Frame
Upper Frame
Function 1: * Provide structural support Potential failure model(s): * Structural Failure * Excessive deflection Function 2: * Provide dimensional control for correct finished fame geometry Potential failure model(s): * Length of frame mounting point too long * Length of frame mounting point too short Function 3: * Support frame assembly production methods (welding) Potential failure model(s): Lower front tube Lower rear tube Sprocket tube

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

2. Potential Failure Mode

Potential Failure Mode is defined as the manner in which a component, subsystem, or system could potentially fail to meet the design intent. The assumption is made that the failure could occur, but may not necessarily occur. A recommended starting point is a review of past things-gone-wrong, concern reports, and group brainstorming. Typical failure modes could be, cracked leaking, fractured, oxidized, no signal, drift, etc. ( Described in physical or technical terms, not as symptom noticed by the customer).

2. Potential Failure Mode - examples

Bent Cracked Contaminated Loosened Leakage Damaged Deformed Gouged Misaligned Corroded Broken Tooling Wrong Tooling Wrinkled Scratched Humidity Handling Damage

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

3. Potential Effect(s) of Failure

Effect of failure mode on the customer (s). Describe effects of failure in terms of what customer(s) might notice or experience. Customer End user Effect In terms of product / system performance e.g. noise, inoperative, poor appearance. In terms of process/ operation performance e.g. fitment problem, damage

Next operation/ subsequent Operation/ location

3. Potential Effect(s) of Failure

Example could be : - For end user : Noise, rough, inoperative, leaks, unstable, erratic operation, etc. - For next/ subsequent operations: does not fit, can not mount, damages equipment, excessive tool wear, etc.

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

4. Determining Severity
Severity is an assessment of the seriousness of the effect of the potential failure mode to the next component, subsystem, system or customer if it occurs. Severity applies to the effect only. A reduction in Severity Ranking index can be effected only through a design change. Severity should be estimated

on a to scale.

4. Suggested PFMEA Severity Ranking

Criteria : Severity of effect This ranking result when a potential Failure mode result in a final customer and/or a manufacturing/assembly plant defect .The final customer should always be considered first if both occur, use the higher of the two severities. (Customer Effect) Very high Severity ranking when a potential Hazardous failure mode affect safe vehicle operation Without and/or involves noncompliance with warning government regulation without warning Very high Severity ranking when a potential Hazardous failure mode affect safe vehicle operation With and/or involves noncompliance with warning government regulation with warning Very High Vehicle/item inoperable (loss of primary Function) High Effect Criteria : Severity of effect Rankin This ranking result when a potential Failure g mode result in a final customer and/or a manufacturing/assembly plant defect .The final customer should always be considered first. if both occur, use the higher of the two severities . (Manufacturing/ Assembly Effect) Or may endanger operator(machine or 10 assembly without a warning

Or may endanger operator(machine or assembly with a warning

Or 100% of product may have to be scrapped or vehicle item repaired in department with a repair time greater than one hour Vehicle/item operable but at reduce level of Or product may have to be a stored and a performance customer very dissatisfied portion(less than 100% )of scrapped or vehicle item repaired in department with a repair time greater than one hour.

4. Suggested PFMEA Severity Ranking

Moderate Vehicle? Item operable but Comfort/ Or a portion (less than 100%) of the product may convenience item(s) inoperable. have to scrapped with no sorting, or vehicle/item Customer dissatisfied. repaired in repair department with a repair time less than a half- hour.
Vehicle/item operable but comfort/ convenience item(s) operable at a reduced level of performance. Or 100% of product may have to be reworked, or vehicle/item repair off-line but does not go to repair department.

Low

Very low

Fit and finish/squeak and rattle item Or 100% of product may have to sorted, with no scrap does not conform. Defect noticed by and a portion (less than 100%) reworked. most customers. (greater than 75%) Fit and finish/ squeak and rattle item does not conform. Defect noticed by 50% of customers. Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but out-ofstation.

Minor

Very minor Fit and finish/ squeak and rattle item does not conform. Defect noticed by discriminating customers (less than 25%)
None No discernible effect.

Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but in-station.

Or slight inconvenience to operation or operator, or no effect.

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

5. Potential Causes(S)/ Mechanism(s) of Failure ( Design)

Potential Cause of Failure is defined as an indication of a design weakness, the consequence of which is the failure mode. Typical failure causes may include: Incorrect Material Specified. Inadequate Design Life Assumption Over-stressing. Insufficient Lubrication Capability. Poor Environment Protection. Incorrect algorithm. In progress tolerance specified. Typical failure mechanisms may include: Creep Fatigue Wear Corrosion

5. Potential Cause(s) of Failure

Every conceivable failure cause assignable to each potential failure mode. Specific causes where remedial efforts can be aimed. Examples - Part missing or mis-located, - Improper torque, - Improper welding, - Inaccurate gauging, etc. - Inadequate lubrication, - Chip on located, etc.

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

6. Occurrence(O)

Occurrence is the likelihood that a specific cause/ mechanism will occur. Removing or controlling one or more of the causes/mechanism of the failure mode through a design change is the only way a reduction in the occurrence ranking can be effected. Estimate the likelihood of occurrence of potential failure cause mechanism on a 1 to 10 scale. Questions such as the following should be considered:

What is the service history/field experience with similar components or subsystems?

Is component carryover or similar to a previous level component or subsystem?

Contd

6. Occurrence(O) (contd)
- How significant are changes from a previous level component or subsystem? - Is component radically different from a previous level component ? - Is component completely new ? - Has the component application changed? - What are the environmental changes? - Has an engineering analysis been used to estimate the expected comparable occurrence rate for the application?

6. Determine Occurrence Rating

Suggested Evaluation Criteria: Design
Probability of failures
Very High: persistent failures

Possible Failure Rates

100 per thousand vehicles/ item.

Ranking
10

50 per thousand vehicles/ item. High : Frequent failures 20 per thousand vehicles/ item. 10 per thousand vehicles/ item. Moderate :occasional failures 5 per thousand vehicles/ item. 2 per thousand vehicles/ item. 1 per thousand vehicles/ item. Low : Relatively few failure 0.5 per thousand vehicles/ item. 0.1 per thousand vehicles/ item. Remote : Failures is Unlikely 0.010per thousand vehicles/ item.

9 8 7 6 5 4 3 2 1

6. Determine Occurrence Rating Process FMEA

Suggested PFMEA occurrence evaluation criteria with Ppk values

Probability
Very High: Persistent Failure

Likely Failure Rates *

100 per thousand pieces 50 per thousand pieces.

Ppk
< 0.55 0.55 0.78 0.86 0.94 1.00 1.10 1.20 1.30 1.67

Ranking
10 9 8 7 6 5 4 3 2 1

High : Frequent Failures

20 per thousand pieces. 10 per thousand pieces.

Moderate : Occasional Failures

5 per thousand pieces. 2 per thousand pieces. 1 per thousand pieces.

Low : Relatively Few Failures

0.5 per thousand pieces. 0.1 per thousand pieces.

Remote : Failure us unlikely

0.01 per thousand pieces.

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

7. Current Controls (Design)

List the preventing, design validation/verification (DV), or other activities which will assure the design adequacy for the failure mode and/or cause/ mechanism under consideration. Current controls are those that have been or are being used with the same or similar designs. Three types of Design Controls: - prevent the cause/mechanism of failure mode effect from occurring, or reduce their rate of occurrence. - detect the cause/mechanism and lead to corrective actions, and - detect the failure mode.

7. Current Design Controls (contd)

Design control

Prevention (P) e.g. building redundancy, oriented failsafe arrangement, Pokayoke,

Detection (D) oriented

e.g. lab test, design verification, road test, inspection etc

Specify P & D controls in separate columns. If one column is used for current design control, specify P or D before each control.

7. Current Process Controls

Types of Process Controls
Prevent the cause / mechanism or failure mode / effect from occurring or reduce their rate of occurrence. Detect the cause / mechanism & lead to Corrective Actions. Detect the failure mode.

Affects
Occurrence Ranking

Detection Ranking Detection Ranking.

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

8. Detection (d)
Detection is an assessment of the ability of the current design controls, to detect a potential cause /mechanism (design weakness), or The ability of the current design controls to detect the subsequent failure mode, before the component, subsystem Or system is released for production. In order to achieve a lower ranking generally the planned design control has to be improved.

8. Detection Ranking
Suggested Evaluation Criteria: For Design detection
Detection
Absolute uncertainty
Very Remote

Criteria : Likelihood of Detection by Design Control

Design Control will not and/or can not detect a potential causes /mechanism an subsequent failure mode ; or there is no design control
Very remote chance the Design Control will detect a potential causes /mechanism and subsequent failure mode .

Ranking
10
9

Remote
Very low Low Moderate Moderate High High Very High Almost Certain

Remote chance the Design Control will detect a potential causes /mechanism and subsequent failure mode .
Very low chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . Low chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . Moderate chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . Moderate High chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . High chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . Very high chance the Design Control will detect a potential causes /mechanism and subsequent failure mode . Design Control will almost certainly detect a potential causes /mechanism an subsequent failure mode .

8
7 6 5 4 3 2 1

8. Detection Ranking
Suggested PFMEA Detection Evaluation Criteria
Detection Criteria Inspection Suggested Range of Detection Method Types A B C X Cannot detect or is not checked X Control is achieved with indirect or Random check only X Control is achieved with Visual inspection only X Control is achieved with double visual inspection only. X X Control is achieved with charting methods, such as SPC. Control is based on variable gauging after parts have left the station, or Go/No Go gauging performed on 100% of the parts after parts have left the station. Error detection in subsequent operation, or gauging performed on setup and first-piece check( for set-up causes only). Error detection in-station, or error detection in subsequent operations by multiple layers of acceptance : supply, select, install, verify. Cannot accept discrepant part. Error detection in station ( automatic gauging with automatic stop feature). Cannot pass discrepant part. Discrepant parts cannot be made because item has been error proofed by process/product design. C. Manual Inspection Rank Almost Absolute certainty of non detection Impossible Very remote Control will probably not detect Remote Very low Low Moderate Control have poor chance of detection Control have poor chance of detection Control may detect Controls may detect 10 9 8 7 6 5

Moderate High High

Controls have a good chance to detect Controls have a good chance to detect Controls almost certain to detect. Controls certain to detect.

Very high Very high

X X

2 1

Inspection Types: A. Error-proofed

B. Gauging

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

9. Determine Risk Priority Number (RPN) Risk Priority Number (RPN)

= Severity x Occurrence x Detection

To be used for prioritization of corrective actions. Ranges between 1 and 1000. Regardless of RPN value, special attention should be given when severity is high.

FMEA Model
Potential Failure Mode

Cause of Failure

Current Design/Process Control

Effect of failure

Frequency of Failure

Possibility of finding failure or Cause of failure

Severity Rating

Occurrence Rating

Detection Rating

FMEA STEPS
Step # Step details

1 2 3 4 5 6 7 8 9 10

Define Project Scope Brainstorm all potential failure modes Identify the potential effects of failures Determine severity rankings Identify the causes of failures Determine Occurrence rankings Identify the current controls Determine the detection rankings Evaluate Risk Priority Numbers(RPN) Prioritise corrective actions.

10. Recommend Action(s)

The intent of any recommended action is to reduce any one or all of the occurrence, severity, and/or detection rankings. An increase in design validation/verification action will result in a reduction in the detection ranking only. A reduction in the occurrence ranking can be effected only by removing or controlling one or more of the cause mechanisms of the failure mode through a design change. Only a design revision can bring about a reduction in the severity ranking Examples include revised design geometry, and /or tolerance, revised material specifications, modify the mfg process

10. Prioritise & implement action(s)

Enter a brief description of the actual action and effective date.
Resulting RPN Estimate & record resulting S,O,D and RPN rankings. Resulting RPNs should be reviewed and new set of actions should be decided accordingly till the desired RPN is not achieved. This ensures FMEA is a Living Document, FMEA can also be updated as and when new failure modes are discovered.