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Failure Modes and Effects Analysis (FMEA)

Breakthrough Management Group October 23, 2001


Module Objectives
Identify where FMEA fits into the Blueprint for
Breakthrough
Define the different types of FMEAs
Explain the fields of the FMEA form
Identify a method for constructing an FMEA
Work through an in-class example
Demonstrate how to integrate C&E matrix with the
FMEA
Use the Excel form to setup an FMEA

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Blueprint for Breakthrough
8 7 6 5 4 3 2 1

H
Define Measure Analyze Improve Control H

Six Sigma Refine the ID Variation:


G Screen Critical Optimize the G
Exploratory
Overview Project Inputs (DOE) Outputs
Analysis
F F

Project Identify Inputs ID Variation: Search for Control Xs


Statistical Interactions
E Management and Outputs Analysis ( DOE) & Monitor Ys E

D
Computer Analyze Establish D
ID Variation:
Measurement Define Y=f (X) Long-Term
Applications ANOVA
C
Systems Quality C

Determine BMG
Breakthrough Management Group

B B
Basic Statistics Process Plan for DOE 6
Blueprint for Breakthrough

Capability SIZ
E
FSCM NO DWG NO
RE
V
A
SC SH 1
A AL 1:1 EE 1 OF 5 A
E T

8 7 6 5 4 3 2 1

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Analyze Phase Potential Deliverables
8 7 6 5 4 3 2 1

H
Project Recap & Remaining Session 1 Deliverables H

ID Variation: Graphical Data Analysis


G Support Tools: FMEA & Data Manipulation using Excel G

Multi-Vari Charts / Analysis


F Correlation & Regression F

ID Variation: Statistical Analysis


E E
Confidence Intervals, Central Limit Theorem
Hypothesis Testing and Sample Size
D D
Testing for Variation and Central Tendency
Attribute Testing
C C

ID Variation: ANOVA
Breakthrough Management Group
B Planning for DOE BMG B

6 Blueprint for Breakthrough


Complete Phase Summary SIZE FSCM NO DWG NO REV

Conclusions, Issues, & Next Steps


A 1
A A
SCALE 1 :1 SHEET 3 OF 5

8 7 6 5 4 3 2 1

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Background
Failure Modes and Effects Analysis (FMEA)
First developed in the 1950s
Appropriated by NASA in the 1960s for the space program
Ford Motor Company was the first North American company to widely
implement the use of FMEAs
Types of FMEA
System Top-level, early stage analysis of complex systems
Design Systems, subsystems, parts & components early in design
stage
Process Focuses on process flow, sequence, equipment, tooling,
gauges, inputs, outputs, set points, etc

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Who? When?
Who constructs the FMEA?
The Black Belt is the team leader.
The process owner inherits the finished FMEA.
Use the process mapping, C&E matrix team.
May need to add a rep from quality, a supplier, reliability

When should the FMEA be constructed?


After the process map & the C&E matrix
Before or after the control plan, depending on the maturity
of the process

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Why?
Warm up exercise:
You have 60 seconds to document:
What would you want to know about a defect?
For the process:
FMEA improves the reliability of the process
An FMEA identifies problems before they occur
FMEA serves as a record of improvement & knowledge

For the future:


FMEA helps evaluate the risk of process changes
FMEA identifies areas for other studies
multi-vari, ANOVA, DOE

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
FMEA Inputs and Outputs
Detailed
Process Map Actions designed
to prevent failures
or detect effects.

C&E Matrix
Historical record

FMEA of improvement
projects under-
taken
Control Plan

Inputs to the
Customer Control Plan
Requirements

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
6s Process FMEA -- Terminology
FMEA: A systematic analysis of a process used to identify potential
failures and to prevent their occurrence
Potential Failure mode: The manner in which the process could
potentially fail to meet the process requirements.
Potential Failure Effect: The results of the failure mode on the customer.
Severity: An assessment of the seriousness of a failure mode. Severity
applies to the effects only.
Cause: How the failure could occur, described in terms of something that
can be corrected or controlled.
Occurrence: The likelihood that a specific failure mode is projected to
occur.
Detection: The effectiveness of current process controls to identify the
failure mode (or the failure effect) prior to occurring, prior to release to
production, or prior to shipment to the customer.
RPN -- Risk Priority Number: The product of Severity, Occurrence &
Detection

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
FMEA & CP Form.xls

Parts of the FMEA Form


Initial Assessment Actions and History
Responsibility Action Results
S O Current D R
Process Potential Effects Potential Cause(s)/ Recommended and S O D R
Potential Failure Mode E C Process E P
Function of Failure Mechanism(s) of Failure Action(s) Completion Actions Taken E C E P
V C Controls T N
Date V C T N
The highest value In what ways might the What is the effect of each How can the failure occur? What are the existing controls and What are the actions for Who is List the completed actions

What is the new process


How well can you detect
How Severe is the effect

Are the detection limits


process steps process potentially fail to failure mode on the outputs Describe in terms of something procedures (inspection and test) that reducing the occurrence, or responsible for that are included in the

Recomkpute RPN after


SEV x OCC x DET
cause or failure mode

actions are complete.


from the C&E meet the process and/or customer requirements? that can be corrected or either prevent failure mode from improving detection, or for the recalculated RPN.

How often does the


to the cusotmer?
matrix. requirements and/or design The customer could be the next controlled. Be specific. Try occurring or detect the failure should identifying the root cause if it recommended Include the implementation

What is the new


cause or FM?
intent? operation, subsequent identify the causes that directly it occur? Should include an SOP is unknown? Should have action? date for any changes.

capability?

improved?
operations, another division or impacts the failure mode, i.e., root number. actions only on high RPN's or

severity?
the end user. causes. easy fixes.

occur?
0 0

0 0

0 0

0 0

0 0

0 0

The first section of the FMEA form, initial assessment, is used to


evaluate initial conditions of the process.

After completing the initial assessment, the team then generates a list
of actions to reduce the occurrence or increase the detection.

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
FMEA Examples
Plating Example
An aerospace plating company was shipping product to its
customers with nickel plating that was too thin. Parts were failing
corrosion testing at the customer.

Shipping Example
The shipping department of an electronics company is unable to
ship an assembly without its clam shell protective packaging. This
causes occasional late shipments to the customer.

In the following examples, a single line from the FMEA is used as an


illustration for each of the above examples.

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Part I: Initial Assessment
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the How can the What are the

How often does the cause

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode on Describe in terms and procedures
C&E matrix. meet the process the outputs of something that (inspection and

to the cusotmer?

cause or FM?
requirements and/or customer can be corrected test) that either
and/or design requirements? or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Process Function
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the How can the What are the

How often does the cause

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the The process steps
potentially fail to failure mode on to be analyzed
Describe in terms in and procedures
C&E matrix. the FMEA,
meet the process the outputsshould be ofthe top three
something that or (inspection and

to the cusotmer?

cause or FM?
requirements four and/or
that customer
were identified in corrected
can be in the C&E test) that either
and/or design requirements? or controlled. Be prevent or detect
intent?
Matrix. specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Potential Failure Mode
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the How can the What are the

How often does the cause


List all the ways that a process can controls

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to fail to
failure mode on meet the requirements
Describe in terms and/or
and procedures
C&E matrix. meet the process design intent.
the outputs A giventhat
of something process(inspection
step and

to the cusotmer?

cause or FM?
requirements and/or customer can be corrected
can have more than one failure test)
mode.that either
and/or design requirements? or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

?
Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Potential Effects of Failure
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the


Effects are the impact on
How can the What are the

How often does the cause

How well can you detect


customer requirements.

How Severe is the effect


value process might the process effect of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode on These
Describe should beand
in terms the same
procedures
C&E matrix. meet the process the outputs of something that row of(inspection and

to the cusotmer?
as the top the C&E

cause or FM?
requirements and/or customer can be corrected test) that either
and/or design requirements? or controlled. Be
matrix.prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Severity
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V
Severity
of Failure
is aC ranking ona
Controls
1-10
T
scale,
N
10 being the most severe. Low
The highest In what ways What is the How can theseverities What are the that are
are those

How often does the cause

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls
unnoticeable or locally reworkable.

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode on Describe in terms and procedures
C&E matrix. meet the process the outputs Very
of something thathigh severities are usually
(inspection and

to the cusotmer?
reserved
corrected for safety oreither
liability issues.

cause or FM?
requirements and/or customer can be test) that
and/or design requirements? or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Severity Scale
Severity of Effect Rating
May endanger machine or operator.

Extreme
10
Hazardous without warning
May endanger machine or operator.
9
Hazardous with warning
Major disruption to production line.
8
High

Loss of primary function, 100% scrap


Reduced primary function performance.
7
Product requires sorting, some scrapping
Minor disruption of production. Some Scrap.
6
Loss of secondary function performance
Moderate

Minor disruption to produciton. 100% Rework.


5
Reduced secondary function performance.
Minor defect noticed by most customers
4
Product requires sorting and some reworked.
Fit& Finish/Squeak & Rattle item. Minor defect
3
Low

noticed by some customers.


Defects may be reworked on-line.
2
Minor defect noticed by observant customers.
None

No effect 1

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Potential Causes of Failure
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

To theInextent
The highest what wayspossible,
What islist
theevery How can the What are the

How often does the cause

How well can you detect


How Severe is the effect
conceivable
value process might thecause
process of each
effect failure
of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the potentially
mode. Rememberfail to failure
themode6Mson -- Describe in terms and procedures
C&E matrix. meet the process the outputs of something that (inspection and

to the cusotmer?
man, machine,and/or method,

cause or FM?
requirements customer can be corrected test) that either
measurement,
and/or designmaterials, mother
requirements? or controlled. Be prevent or detect
intent? nature. specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

?
Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Occurrence
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
Occurrence is the likelihood that aVspecific
of Failure C Controls T N
cause will occur andWhat
The highest In what ways
willisresult
the
in a specific
How can the What are the

How often does the cause


failure mode. Rank on a scale from 1-10. If

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


thefrom
steps cause is either
the potentially fail unknown oronits frequency
to failure mode Describeis in terms and procedures
C&Enotmatrix. meet the
tracked, process
then the the outputs
occurrence refersofto
something
the that (inspection and

to the cusotmer?

cause or FM?
requirements and/or customer can be corrected test) that either
failure
and/or design
mode.
requirements? or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Occurrence Scale
Failure Capability
Likelihood of Occurrence Rate (Cpk) Rating

1 in 2 < .33 10
High
Very

Failure is almost inevitable


1 in 3 > .33 9

1 in 8 > .51 8
High

Process is not in statistical control.


Similar processes have experienced problems.
1 in 20 > .67 7

1 in 80 > .83 6
Moderate

Process is in statistical control but with isolated failures.


Previous processes have experienced occasional 1 in 400 > 1.00 5
failures or out-of-control conditions.
1 in 2000 > 1.17 4
Low

Process is in statistical control. 1 in 15k > 1.33 3


Re- Very

Process is in statistical control. Only isolated


mote Low

1 in 150k > 1.50 2


failures associated with almost identical processes.
Failure is unlikely. No known failures associated
1 in 1.5M > 1.67 1
with almost identical processes.

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Current Process Controls
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the How can the What are the

How often does the cause

How well can you detect


How Severe is the effect
value process might the process effect of
Controls areeach
methods failure
that occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode on Describe in terms and procedures
C&E matrix.
either prevent
meet the process the outputs
the failure mode
of something that (inspection and

to the cusotmer?
from occurring or detectcanthe
be a

cause or FM?
requirements and/or customer corrected test) that either
failurerequirements?
and/or design mode when it occurs. or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

?
Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Detection
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the How can the What are the

How often does the cause


Detection is a ranking of the ability

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode of
on the control
Describesystem
in terms to detect the
and procedures
C&E matrix. meet the process the outputs failure mode before
of something thatthe unit(inspection
leaves and

to the cusotmer?

cause or FM?
requirements and/or customer can be corrected test) that either
the manufacturing operation.
and/or design requirements? or controlled. Be prevent or detect
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Detection Scale
Very Likelihood that control will detect failure DPPM Probability Rating
Low
No known control(s) available to detect failure mode. 100,000 1 in 10 10

50,000 1 in 20 9
Low

Controls have a remote chance of detecting the failure.


20,000 1 in 50 8

10,000 1 in 100 7
Moderate

Controls may detect the existence of a failure 5,000 1 in 200 6

2,000 1 in 500 5

1,000 1 in 1,000 4
High

Controls have a good chance of detecting the existance


of a failure
500 1 in 2,000 3

The process automatically detects failure. 200 1 in 5,000 2


High
Very

Controls will almost certainly detect the existence of a


failure. 100 1 in 10,000 1

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Risk Priority Number
S Potential O Current D R
Process Potential Failure Potential Effects
E Cause(s) C Process E P
Function Mode of Failure
V of Failure C Controls T N

The highest In what ways What is the


The riskHow can the What are the

How often does the cause


priority number (RPN) is the

How well can you detect


How Severe is the effect
value process might the process effect of each failure occur? existing controls
product of the severity, occurrence,

or failure mode occur?

SEV x OCC x DET


steps from the potentially fail to failure mode on Describe in terms and procedures
C&E matrix. meet the process the outputs and detection.
of something that (inspection and

to the cusotmer?

cause or FM?
requirements and/or customer can be corrected test) that either
and/or design requirements? RPN SEV
or controlled. Be OCC DETor detect
prevent
intent? specific. occurrence?

Nickel Plating Thin Coating Corrosion Too-High Contact XRF Thickness


5 Resistance 6 Measurement 5 150

Packaging Understock of Late Shipments Variable Supplier Stock-On-Hand


7 8 3 168
Supply Clam-Shells Delivery Audits

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Shortcomings of the RPN
The Risk Priority Number is only a guideline and must be
combined with common sense, intuition and logic.
Consider: Two RPNs rated 160 and 200.
Failure Mode Severity Occurrence Detection RPN
A 10 4 4 160
B 4 10 5 200

Though both failure modes require action, Mode A requires


immediate action to prevent injury, even though it has a
lower RPN.
The ease of implementation should also be considered
when deciding the order of action.

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Rating Summary
Rating Severity of Effect Likelihood of Occurrence Detection Ability
10 Hazardous without warning Cannot detect
Very High:
Very remote chance
9 Hazardous without warning Failure is almost inevitable
of detection
Remote chance
8 Loss of primary function
High: of detection
Reduced primary Repeated Failures Very low chance
7
function performance of detection
Loss of secondary Low chance
6
function performance of detection
Reduced secondary Moderate: Moderate chance
5
function performance Occasional Failures of detection
Minor defect noticed Moderately high chance
4
by most customers of detection
Minor defect noticed
3 High chance of detection
by some customers Low:
Minor defect noticed Relatively few failures Very high chance
2
by observant customers or detection
Remote:
1 No effect Almost certain detection
Failure is unlikely

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Part II: Actions and History
Action Results
Responsibility
Recommended S O D R
and Completion
Action(s) Actions Taken E C E P
Date
V C T N
What are the actions for Who is List the completed

What is the new severity?

What is the new process


reducing the occurrence, responsible for actions that are

Are the detection limits

Recomkpute RPN after


actions are complete.
or improving detection, the included in the
or for identifying the recommended recalculated RPN.
root cause if it is action? Include the

capability?

improved?
unknown? Should have implementation date
actions only on high for any changes.
RPN's or easy fixes.
Add auto-sensor for B. Carlson Sensor Added,
voltage/current 6/8/99 Software upgraded 5 3 5 75
7/7/99
Establish Forecast and C.S. Soo Auto-ship system
7 2 3 42
Auto-ship w/ supplier 9/2/99 in-place 10/1/99

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Recommended Actions
Action Results
Responsibility
Recommended S O D R
and Completion
Action(s) Actions Taken E C E P
Date
V C T N
What are the actions for WhoCorrective
is actions
List are the point of the
the completed

What is the new severity?

What is the new process


reducing the occurrence, FMEA. for
responsible If no actions
actions are generated for
that are

Are the detection limits

Recomkpute RPN after


actions are complete.
or improving detection, the
a particular included
cause inthisthe should be noted.
or for identifying the recommended recalculated RPN.
Correction actions should first be
root cause if it is action? Include the
directed toimplementation
the highestdate priority items.

capability?

improved?
unknown? Should have
actions only on high for any changes.
RPN's or easy fixes.
Add auto-sensor for B. Carlson Sensor Added,
voltage/current 6/8/99 Software upgraded 5 3 5 75
7/7/99
Establish Forecast and C.S. Soo Auto-ship system
7 2 3 42
Auto-ship w/ supplier 9/2/99 in-place 10/1/99

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Responsibility
Action Results
Responsibility
Recommended S O D R
and Completion
Action(s) Actions Taken E C E P
Date
V C T N
What are the actions for Who is List the completed

What is the new severity?

What is the new process


reducing the occurrence, responsible for Thethat
actions team
are should agree on the

Are the detection limits

Recomkpute RPN after


actions are complete.
or improving detection, the actionsin to
included thebe taken and who will be
or for identifying the recommended responsible
recalculated RPN. for those actions.
root cause if it is action? Include the
Include the due date for the

capability?

improved?
unknown? Should have implementation date
completion of the action.
actions only on high for any changes.
RPN's or easy fixes.
Add auto-sensor for B. Carlson Sensor Added,
voltage/current 6/8/99 Software upgraded 5 3 5 75
7/7/99
Establish Forecast and C.S. Soo Auto-ship system
7 2 3 42
Auto-ship w/ supplier 9/2/99 in-place 10/1/99

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Actions Taken
Action Results
Responsibility
Recommended S O D R
and Completion
Action(s) Actions Taken E C E P
Date
V C T N
Include
Whata brief
are thedescription of the
actions for Who is List the completed

What is the new severity?

What is the new process


actual actionthecompleted.
reducing Many for
occurrence, responsible actions that are

Are the detection limits

Recomkpute RPN after


actions are complete.
times anor improving detection, during
action changes the the included in the
or for identifying the recommended recalculated RPN.
implementation. Include the actual
root cause if it is action? Include the
completion date for the action.

capability?

improved?
unknown? Should have implementation date
actions only on high for any changes.
RPN's or easy fixes.
Add auto-sensor for B. Carlson Sensor Added,
voltage/current 6/8/99 Software upgraded 5 3 5 75
7/7/99
Establish Forecast and C.S. Soo Auto-ship system
7 2 3 42
Auto-ship w/ supplier 9/2/99 in-place 10/1/99

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
The Form Recalculation
Action Results
Responsibility
Recommended S O D R
and Completion
Action(s) Actions Taken E C E P
Date
V C T N
WhatGenerate new
are the actions for ratings
Who is for severity,
List the completed

What is the new severity?

What is the new process


occurrence
reducing and responsible
the occurrence, detectionforbased onthat are
actions

Are the detection limits

Recomkpute RPN after


actions are complete.
the results
or improving of thetheactions. The
detection, new in the
included
or forvalues
identifying
of the
the RPN recommended recalculated
will determine if RPN.
root cause
new ifactions
it is areaction?
required for Include
thosethe

capability?

improved?
unknown? Should have implementation date
causes
actions only on high for any changes.
RPN's or easy fixes.
Add auto-sensor for B. Carlson Sensor Added,
voltage/current 6/8/99 Software upgraded 5 3 5 75
7/7/99
Establish Forecast and C.S. Soo Auto-ship system
7 2 3 42
Auto-ship w/ supplier 9/2/99 in-place 10/1/99

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Introduction to Control Plans
Process What's Input or Spec. Limits / Measurement Who/What Where Decision Rule/
Sample Size Frequency SOP's
Step Controlled? Output? Requirements Method Measures? Recorded Corrective Action
Coat/Bake Bake Plate Omega T/C Maintenance
X 112 .3 C n/a Weekly ASI Adjust to spec. 9785-123
PMGI Temp. Meter Technician
PMGI 1 wafer/
Y 195 45 nm SP 3 sites/ wafer Operator Oracle None 9785-369
Thickness lot
PMGI 36 sites- all
Y 14 xx m KLA 100% Operator Oracle Rework wafer 9785-411
Width wafers
36 sites- all
Undercut Y 2.0 0.5 m KLA 100% Operator Oracle 9785-615
wafers

A control plan is:


A summary of all of the control activities for the process.
A method of identifying holes in the control system.
A list of control activities yet to be implemented.
An input to the FMEA (mature processes).
An output of the FMEA (new processes).

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001
Exercise
Apply the FMEA to the same process identified in the
mapping & C&E exercises.
Analyze the top three input variables using the FMEA.
Establish the action priorities based on the RPN and other
experience.
Report results on a flip chart, or Excel.
Report on any problems during the team presentation.

Mar 9, 2017, Breakthrough Management Group. Unpublished proprietary work available only under license. All rights reserved. October 23, 2001

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