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FAILURE MODE AND EFFECTS ANALYSIS Definition of FMEA Types of FMEA and Scope Trigger Points for Changing FMEAs Benefits of a Process FMEA Procedure for Process FMEA

FMEA DEFINITION A Failure Mode and Effects Analysis (FMEA) is a systematized group of activities used to:

Recognize and evaluate a product/process potential failure and its effects Identify actions to eliminate/reduce the chance of occurrence Document the process

AIAG version 4.1 based on SAE J1739 (August 2002)

FMEA DEFINITION (Contd)

Failure is NOT an option. - Customer

FMEA DEFINITION (Contd) An FMEA is not

an after-the-fact exercise but a before-the-event action just for audit purposes or for display but a living document designed by one person but by a team

FMEA DEFINITION (Contd)

Costs of several historical failures
Product
NASA Mars Climate Orbiter

Date
1999

Costs
$134.5M launch & operating; $125M orbiter

Dead
0

Ford Explorer/ 1991- 6.5M recalled tires; lawsuits >203 Firestone Tires 2000 incl $7.5M injury settlement & $41.5M settlement w/ states

Titanic

1912

$7.5M construction

1,491

http://mml.stanford.edu/publications/2003/DETC2003-DFM-48146.pdf

TRIGGER POINTS FOR CHANGING FMEAs New designs, new technology, new process Modifications to existing design or process Use of existing design or process in a new environment, location or application

FMEA TYPES AND SCOPE Types and Scope

Design FMEA (DFMEA) Process FMEA (PFMEA)

BENEFITS OF A PROCESS FMEA Identifies process functions and requirements Identifies potential product and process-related failure modes Assesses the effects of the potential failures of the customer Identifies the potential manufacturing or assembly process causes and process variables on which to focus controls for occurrence reduction or detection of the failure conditions

BENEFITS OF A PROCESS FMEA (Contd)

Develops a ranked list of potential failure modes Documents the results of the manufacturing or assembly process Feeds information on design changes required and manufacturing feasibility back to the design community Identifying process failure modes that could violate government regulations or compromise employee safety

FMEA PROCEDURE Team Engineer for the responsible activity to lead Engineers with expertise in design, analysis/ testing, manufacturing, assembly, service, recycling, quality and reliability to form the core team

FMEA PROCEDURE Inputs to Process FMEA Process Flow Diagram Product Characteristic Matrix P-Diagram (optional)

FMEA PROCEDURE Form Header

FMEA PROCEDURE Form Header (Contd)

Item name and number of the system, subsystem or component Model Year(s) / Program (s) Model year and product line Core Team Name, Contact Number and Department / Company of each team member Process Responsibility Company Name, Department and Group Key Date due date should not exceed start of production date Page FMEA Number control number Prepared by Name, Contact Number and Department / Company of the engineer responsible for leading the FMEA FMEA Date Original FMEA compilation date and latest revision number

FMEA PROCEDURE Form Header (Contd)

S Process Function / Requirements Potential Failure Mode Potential Effects E V

O Potential Causes / Classification C Failure Mechanism C

Current Process Control Prevention Detection

D E T

R P N Recommende Responsibility d Actions

Action Results Target Completion Date Actions Taken SEV OC DE RPN C T

1. Process Function Requirements

Process Function / Requirements

Determine Function: What is this step in the process supposed to do?

Verb-noun/measurable format
Specific: Weld wire Do not use provide, facilitate, allow

Measurable
All end-product and in-process requirements Can be verified / validated Additional constraints or design parameters Part characteristics being created and modified incl. position, depth, diameter and hardness

1. Process Function Requirements (Contd)

Determine Function (Contd)

Components of Functions
Process characteristics or process requirements (e.g. job rates, production maintenance requirements) Product specification requirements for the operations (e.g. engineering specifications, performance specifications)

Include intermediate operations

2. Potential Failure Modes

Potential Failure Mode

Classification

Four types of failure modes

No function Partial Function / Over Function / Degraded Function Over Time Intermittent Function Unintended Function

2. Potential Failure Modes (Contd)

Ask the ff. questions:
Why would the item be rejected at this process operation? How would the item not conform to specification at this process operation? What would the next operator, or subsequent operators, consider unacceptable? What would the ultimate customer find unacceptable? Is there a possibility to fail (government) regulatory compliance?

The characteristic matrix may be used to track special characteristics (SCs) / critical characteristics (CCs)
Color-coding may be used to highlight the SCs and CCs

3. Potential Effect(s) of Failure

Potential Effects

Identify the consequences of each failure mode for:

Operator safety Next user Downstream users Machines / equipment Vehicle operation Ultimate customer Compliance with government regulations

3. Potential Effect(s) of Failure (Contd) Describe the effects of failure in terms of what the customer(s) might notice or experience
End User: in terms of product or system performance (noise, poor appearance, etc.) Next operation / Location: in terms of process or operation performance (does not fit, cannot mount, etc.)

If the failure mode may have an adverse effect on safety or government regulation, enter an appropriate statement, e.g.: May not comply with government environmental regulation XYZ.

4. Severity
S E V

Definition: ranking of the seriousness of the effects of the failure mode It is not recommended to modify the criteria for ranking values of 9 and 10. Severity ranking of 1 need not be further analyzed. Suggested PFMEA severity evaluation criteria (next page)

4. Severity (Contd)

4. Severity (Contd) Recommended actions should:

Eliminate the failure mode Mitigate the effect

Change the design (product characteristic) Change the process (process characteristic or operator-safety-related)

5. Potential Cause(s)/Mechanism(s) of Failure

Potential Causes / Failure Mechanism

Definition: How the failure could occur, described in terms of something that can be corrected or controlled Only specific errors or malfunctions should be listed (e.g., operator fails to place cap); Avoid general phrases (e.g., operator error, machine malfunction) Start identifying causes for effects of failure modes with the highest severity rating.

5. Potential Cause(s)/Mechanism(s) of Failure (Contd) Brainstorm potential causes by asking:

What could cause an item to fail in this manner? What circumstance(s) could cause the item to fail to perform its functions? How could the item fail to meet its engineering specifications? What could cause the item to fail to deliver its intended function?

5. Potential Cause(s)/Mechanism(s) of Failure (Contd) Brainstorm potential causes by asking: (Contd)

How could interacting items be incompatible or mismatched? What specifications drive compatibility? What information developed in the characteristic matrix may identify potential causes? What can historic global 8Ds and FMEAs provide for potential causes?

5. Potential Cause(s)/Mechanism(s) of Failure (Contd) Identify first-level (immediate) causes. Separate causes are recorded and rated separately. Causes are never combined unless they must both occur together to have the failure occur (joined by AND not OR).

5. Potential Cause(s)/Mechanism(s) of Failure (Contd) Two assumptions

Incoming parts / materials to the operation are correct. (Note: This is AIAG assumption. Disregard this assumption for suppliers who do not supply high-quality parts or suppliers who do not do FMEAs. The aim is to reduce the risk of passing bad parts to customers.) Consider incoming sources of variation.

6. Occurrence
O C C

Definition: Likelihood that a specific cause or mechanism will occur. Estimate rate of occurrence, if not possible, use possible failure rate. Suggested ratings (next slide)

6. Occurrence (Contd)

6. Occurrence (Contd) Special characteristics

6. Occurrence (Contd) Identify recommended actions for high severity and high criticality ratings as well as operator safety and high-impact process errors.

7. Process Controls
Current Process Control Prevention Detection

Identify
Current process prevention controls used to establish occurrence ratings Current process detection controls used to establish detection ratings Effectiveness of the process detection controls on a detection scale of 1 to 10 Initial risk priority number (RPN) Recommended actions (prevention and detection)

7. Process Controls (Contd) Definition: Descriptions of controls that either prevent to the extent possible the failure mode or cause from occurring or detect the failure mode or cause should it occur
Error / mistake proofing Statistical process control (SPC) Post-process evaluation

7. Process Controls (Contd) Identifying controls:

Identify and list all historical methods to detect the listed failure mode (previous FMEAs, previous control plans, robustness checklist, global 8Ds). List all historical process controls to detect first-level causes listed.

7. Process Controls (Contd) Identifying controls: (Contd)

Identify other possible methods.
In what way can the cause of this failure mode be recognized? How could I discover that this cause has occurred? In what way can this failure mode be recognized? How could I discover that this failure mode has occurred?

7. Process Controls (Contd) Improving detection controls are usually costly and ineffective for quality improvements. Increasing quality control or inspection frequency is only a temporary measure. Permanent corrective actions are required.

7. Process Controls (Contd) Control methods

8. Detection
D E T

Definition: Rank associated with the best detection control listed in the process control column. Prevention controls will have ratings of 1. Estimate the effectiveness of each detection control. When several detection controls are listed, enter the lowest rating (best detection method).

8. Detection (Contd) 100% Automatic Gaging as Control

Condition of gage Calibration of gage Variation of gage measurement system Likelihood of gage failure Likelihood gaging system will be bypassed

8. Detection (Contd) 100% Visual inspection as control

80% - 100% effective depending on local conditions Number of individuals who may potentially observe the failure mode Nature of the failure mode: obvious or not?

Single visual inspection is usually rated for detection not lower (not better) than 8.

8. Detection (Contd)

9. Risk Priority Number (RPN)

R P N

RPN = Severity (S) x Occurrence (O) x Detection (D)

10. Recommended Actions

Recommended Actions

The purpose is to reduce risk. Special attention should be given to failure modes with severity ratings of 9 or 10 regardless of RPN. Only a design and/or process revision can reduce Severity ranking. Prevention is prioritized over detection.

10. Recommended Actions (Contd) Priority for action should be based not solely on RPN but on the ff:
First consider the causes with the highest severity ratings. Then, identify actions with the highest criticality = S x O ratings. Finally, recommend actions with the highest RPN.

11. Actions Taken

Action Results Responsibility Target Completion Date Actions Taken SEV OC DE RPN C T

Contents
Individual responsible for the recommended action Target completion date After implementation, enter a brief description of actual action and effective date.

The PFMEA team leader should implement a follow-up program for recommended actions.

11. Actions Taken The FMEA is a living document and should reflect the latest item level and the latest relevant actions. Identical processes with different teams should have different FMEAs since each team environment is unique.

12. Resulting RPN

Action Results Responsibility Target Completion Date Actions Taken SEV OC DE RPN C T

After corrective actions have been identified, estimate and record the resulting severity, occurrence and detection ratings. Calculate and record the resulting RPN. If no actions are taken, leave the resulting RPN and related ranking columns blank. If the action is completed, enter the rankings even if there are no changes.

FMEA PROCEDURE Outputs from PFMEA Process Control Plan 8D

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