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Failure Mode and Effect Analysis. *. Learning Objectives. Provide familiarization with FMEA principles and techniques. Summarize the concepts, definitions, application options and relationships with other tools. Learn how to integrate FMEA into your Company SOPs. *. Definition of FMEA.

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learning objectives

*

Learning Objectives
  • Provide familiarization with FMEA principles and techniques.
  • Summarize the concepts, definitions, application options and relationships with other tools.
  • Learn how to integrate FMEA into your Company SOPs
definition of fmea

*

Definition of FMEA

FMEA is asystematicdesign evaluation procedure

whose purpose is to:

1. recognize and evaluatethe potential failure modes and causes associated with the designing and manufacturing of a new product or a change to an existing product,

2.identifyactions which could eliminate or reduce the chance of the potential failure occurring,

3.documentthe process.

fmea is function driven

Manufacturing

Engineer

Supplier

Quality

Design

Engineer

Reliability

Engineer

Production

Program

Management

*

FMEA is Function-driven

FMEA begins with a definition of the FUNCTIONS an item is supposed to perform. The inputs must come from several sources to be effective:

background

*

Background

Developed in early 60’s by NASA to “fail-proof” Apollo missions.

Adopted in early 70’s by US Navy .

By late 80’s, automotive industry had implemented FMEA and began requiring suppliers do the same. Liability costs were the main driving force.

Used sporadically throughout industry during 1980’s.

Adopted by Seagate in 1996. Initial application in design centers. Now it’s time to apply FMEA to process applications in Seagate. Six Sigma is the catalyst.

slide6
NASA used FMEA to identify Single Point Failures on Apollo project (SPF = no redundancy & loss of mission). How many did they find?

420

and we thought we had No problems!

types of fmea s

*

Types of FMEA’s

System FMEA is used to analyze systems and subsystems in the early concept and design stages.

SYSTEM

Design FMEA is used to analyze products before they are released to production

DESIGN

Process FMEA is used to analyze manufacturing, assembly and administrative processes

PROCESS

when is the fmea started
When Is the FMEA Started?

AS EARLY AS POSSIBLE

Do the best you can with what you have.

Guideline:

when to start
When to Start
  • When new systems, products and processes are being designed
  • When existing designs and processes are being changed
  • When carry-over designs or processes will be used in new applications or environments
  • After completing a Problem Solving Study, to prevent recurrence of a problem
process failure mode
Process Failure Mode
  • The potential failure mode is the manner in which the process could fail to perform its intended function.
  • The failure mode for a particular operation could be a cause in a subsequent (downstream) operation or an effect in associated with a potential failure in a previous (upstream) operation.

PREVIOUS

OPERATION

NEXT

OPERATION

FAILURE

MODE

EFFECT

CAUSE

process causes

OPERATOR

SET-UP

MACHINE

METHOD

ENVIRONMENT

MEASUREMENT

Process Causes

Process FMEA considers process variability due to:

current controls
Current Controls
  • Assessment of the ability of the control to detect the failure before the item leaves the manufacturing area and ships to the customer.
  • Capability of all controls in the process to prevent escapes

Process Capability

Sampling

DoE

Testing

Gage R&R

SPC

types of measures

*

Types of Measures

Typically, three items are scored:

SEVERITY

As it applies to the effects on the local system, next level, and end user

OCCURRENCE

Likelihood that a specific cause will occur and result in a specific failure mode

DETECTION

Ability of the current / proposed control mechanism to detect and identify the failure mode

detection escape
Detection (“Escape”)

This is best thought of as Escape Potential - the higher the

score, the greater the problem

risk priority number

*

Risk Priority Number

RPN = O x S x D

Occurrence x

Severity x

Detection

basic steps
Basic Steps
  • Develop a Strategy
    • Form a FMEA team
basic steps20
Basic Steps

1. Develop a Strategy

2. Review the design/process

  • Develop process map and identify all process steps
basic steps21
Basic Steps

1. Develop a Strategy

2. Review the design /process

3.List functions

  • List all the value-added process
  • For each process step, list process inputs (process characteristics
basic steps22

CAUSES

EFFECT

Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

basic steps23
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences of each failure mode

basic steps24

PRODUCT:

FMEA NO.

PROCESS/OPERATION:

PAGE

OF

PLANNING REFERENCE:

DATE:

BY:

DESIGN (OR PROCESS) FMEA

Oklahoma City

SEVERITY

OCCURRENCE

DETECTION

RPN = S x O x D

S

O

D

RPN

RESULTING

ACTION

POTENTIAL

POTENTIAL

POTENTIAL

CURRENT

CORRECTIVE

RESPONSIBILITY

ACTION

FUNCTION

FAILURE MODE

EFFECTS OF

CAUSE(S) OF

CONTROLS

PRIORITY

ACTION

& DATE DUE

TAKEN

S

O

D

RPN

FAILURE

FAILURE

Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences of each failure mode

6. Assign severity (SEV) score

basic steps25
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences of each failure mode

6. Assign severity (SEV) score

7. Identify the cause(s) of each failure mode.

basic steps26
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

basic steps27
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the potential cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

9. Identify current controls to detect the failure modes.

basic steps28
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the potential cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

9. Identify current controls to detect the failure modes.

10. Assign an escaped detection (DET) score for each cause and control.

basic steps29
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the potential cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

9. Identify current controls to detect the failure modes.

10. Assign an escaped detection (DET) score for each cause and control.

11. Calculate the Risk Priority Numer (RPN) for each line in the FMEA.

basic steps30
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the potential cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

9. Identify current controls to detect the failure modes.

10. Assign an escaped detection (DET) score for each cause and control.

11. Calculate the Risk Priority Numer (RPN) for each line in the FMEA.

12. Determine the action to be taken.

basic steps31
Basic Steps

1. Develop a Strategy

2. Review the design /process

3. List functions

4. Brainstorm potential failure modes

5. List the potential consequences (effect) of each failure mode

6. Assign severity (SEV) score

7. Identify the potential cause(s) of each failure mode.

8. Assign occurrence (OCC) scores.

9. Identify current controls to detect the failure modes.

10. Assign an escaped detection (DET) score for each cause and control.

11. Calculate the Risk Priority Numer (RPN) for each line in the FMEA.

12. Determine the action to be taken.

13. Recalculate the RPNs based on the actions plans.

shortcomings of rpn

*

Shortcomings of RPN

Effectiveness

RPN

Occurrence

Failure Mode

A 84 3 96

B 48 3 96

Severity

SAME RESULT

slide34

INITIAL PROBLEM

POTENTIAL

PROBLEM

WALK INTO DOOR

LIKELY

CAUSE

LIKELY

EFFECT

CAN’T SEE

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

GET GLASSES

WEAR HELMET

REMOVE DOORS

slide35

1st WHY

PROBLEM

BECOMES EFFECT

CAUSE BECOMES

NEW PROBLEM

POTENTIAL

PROBLEM

WALK INTO DOOR

LIKELY

CAUSE

LIKELY

EFFECT

CAN’T SEE

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

GET GLASSES

WEAR HELMET

REMOVE DOORS

slide36

1st WHY

CAN’T SEE

POTENTIAL

PROBLEM

WALK INTO

DOOR AND

NEAR

SIGHTED

LIKELY

CAUSE

LIKELY

EFFECT

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

SURGERY

GET GLASSES

slide37

2ND WHY

CAN’T SEE

POTENTIAL

PROBLEM

WALK INTO

DOOR AND

NEAR

SIGHTED

LIKELY

CAUSE

LIKELY

EFFECT

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

SURGERY

GET GLASSES

slide38

2ND WHY

NEAR

SIGHTED

POTENTIAL

PROBLEM

CAN’T SEE

WALK INTO

DOOR AND

LIKELY

CAUSE

LIKELY

EFFECT

TOO MUCH T.V.

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

SURGERY

CUT OUT

STAR TREK

HAVE WE FOUND ROOT CAUSE?

slide39

2ND WHY

NEAR

SIGHTED

POTENTIAL

PROBLEM

CAN’T SEE

WALK INTO

DOOR AND

LIKELY

CAUSE

LIKELY

EFFECT

TOO MUCH T.V.

BUMP HEAD

PAIN

TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT

- ADAPTIVE

-CORRECTIVE

SURGERY

CUT OUT

STAR TREK

OR GONE TOO FAR !

determining level of analysis
Determining Level of Analysis

PRODUCT:

SEAGATE DRIVE STXXXXX

SUBSYSTEMS

SPINDLE MOTOR

DRAWING OR SPEC REFERENCE:

DESIGN FMEA

Oklahoma City

SEVERITY

OCCURRENCE

EFFECTIVENESS

S

O

E

RPN

PROCESS DESCRIPTION

POTENTIAL

POTENTIAL

POTENTIAL

CURRENT

FAILURE MODE

EFFECTS OF

CAUSE(S) OF

CONTROLS

FUNCTION

FAILURE

FAILURE

SPINDLE ROTATES

NO SPIN, OR DRIVE RUNS

DRIVE INOPERABLE

FAILURE OF FLEX

RESISTANCE

MEDIA AT FIXED RPM

IN REVERSE

SOLDER JOINT DUE

MEASUREMENT

TO INSUFFICIENT

AT INCOMING

STRAIN RELIEF

INSPECTION

Here’s a Seagate Example

Handbook pg. 43

determining level of analysis41
Determining Level of Analysis

PRODUCT:

SEAGATE DRIVE STXXXXX

SUBSYSTEMS

SPINDLE MOTOR

DRAWING OR SPEC REFERENCE:

DESIGN FMEA

Oklahoma City

SEVERITY

OCCURRENCE

EFFECTIVENESS

S

O

E

RPN

PROCESS DESCRIPTION

POTENTIAL

POTENTIAL

POTENTIAL

CURRENT

FAILURE MODE

EFFECTS OF

CAUSE(S) OF

CONTROLS

FUNCTION

FAILURE

FAILURE

SPINDLE ROTATES

NO SPIN, OR DRIVE RUNS

DRIVE INOPERABLE

FAILURE OF FLEX

RESISTANCE

MEDIA AT FIXED RPM

IN REVERSE

SOLDER JOINT DUE

MEASUREMENT

TO INSUFFICIENT

AT INCOMING

STRAIN RELIEF

INSPECTION

Cause becomes Failure Mode

Handbook pg. 43

determining level of analysis42
Determining Level of Analysis

PRODUCT:

SEAGATE DRIVE STXXXXX

SUBSYSTEMS

SPINDLE MOTOR

DRAWING OR SPEC REFERENCE:

DESIGN FMEA

Oklahoma City

SEVERITY

OCCURRENCE

EFFECTIVENESS

S

O

E

RPN

PROCESS DESCRIPTION

POTENTIAL

POTENTIAL

POTENTIAL

CURRENT

FAILURE MODE

EFFECTS OF

CAUSE(S) OF

CONTROLS

FUNCTION

FAILURE

FAILURE

SPINDLE ROTATES

NO SPIN, OR DRIVE RUNS

DRIVE INOPERABLE

FAILURE OF FLEX

RESISTANCE

MEDIA AT FIXED RPM

IN REVERSE

SOLDER JOINT DUE

MEASUREMENT

TO INSUFFICIENT

AT INCOMING

STRAIN RELIEF

INSPECTION

Failure Mode becomes Effect

Handbook pg. 43

determining level of analysis43
Determining Level of Analysis

PRODUCT:

SEAGATE DRIVE STXXXXX

SUBSYSTEMS

SPINDLE MOTOR

DRAWING OR SPEC REFERENCE:

DESIGN FMEA

Oklahoma City

SEVERITY

OCCURRENCE

EFFECTIVENESS

S

O

E

RPN

PROCESS DESCRIPTION

POTENTIAL

POTENTIAL

POTENTIAL

CURRENT

FAILURE MODE

EFFECTS OF

CAUSE(S) OF

CONTROLS

FUNCTION

FAILURE

FAILURE

WHY?

SPINDLE ROTATES

FAILURE OF FLEX SOLDER

NO SPIN, OR DRIVE

MEDIA AT FIXED RPM

JOINT DUE TO

RUNS IN REVERSE

INSUFFICIENT STRAIN

CAUSING DRIVE TO

RELIEF

BE INOPERABLE

PROVIDES A DEEPER LEVEL OF ANALYSIS BY ASKING

YOU FOR THE DESIGN CAUSES AND VERIFICATION

OF INSUFFICIENT STRAIN RELIEF

Handbook pg. 43

what s wrong with this picture

*

What’s Wrong With This Picture?

NUMBER OF PROCESS FAILURE CAUSES

actions

*

Actions

A well-developed FMEA will be of limited value without positive and effective corrective actions.

The design or process must be improved based on the results of the FMEA study.

elements of fmea
Elements of FMEA

Failure Mode Any way in which a process could could fail to meet some measurable expectation.

Effect Assuming a failure does occur, describe the effects. List separately each main effect on both a downstream operation and the end user.

Severity Using a scale provided, rate the seriousness of the effect. 10 represents worst case, 1 represents least severe.

Causes This is the list of causes and/or potential causes of the failure mode.

OccurrenceThis is a ranking, on a scale provided, of the likelihood of the failure occurring. 10 represents near certainty; 1 represents 6 sigma. In the case of a Six Sigma project, occurrence is generally derived from defect data.

Current Controls All means of detecting the failure before product reaches the end user are listed under current controls.

Effectiveness The effectiveness of each current control method is rated on a provided scale from 1 to 10. A 10 implies the control will not detect the presence of a failure; a 1 suggests detection is nearly certain.

fmea is most effective when
FMEA is most effective when

It is conducted on a timelybasis

and

It is applied by a product team

and

Its results are documented

integrating fmea into sops
Integrating FMEA into SOPs

Example of how FMEA can be used in SCAR.

Section of SCAR procedure

FMEA can be used to identify the potential cause of failure and determine whether the current control is sufficient.

link tools integration tasks to work breakdown structure
Link Tools Integration Tasks to Work Breakdown Structure

The effort to integrate FMEA into SCAR procedures should be translated into specific tasks in the Work Breakdown Structure.

end of topic
End of Topic

Any Question ?