6Sigma - Failure Modes and Effects Analysis
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Transcript of 6Sigma - Failure Modes and Effects Analysis
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Copyright 2005. Confidential and proprietary property of Sykes Enterprises, Incorporated.
Failure Modes and Effects Analysis (FMEA)
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Optimize &Refine
Solutions
Control Xs
& Monitor Ys
Close & Hand-Off Project
ControlRefine the
Project
Process Maps &Simplification
C&E for Variable
Reduction
ProcessCapability
Measure
Failure Modes &Effects Analysis
ID Variation:
GraphicalAnalysis
Plan for DOE
AnalyzeDesign &
Execute AnExperiment
Define Y=f(x)
RecommendedChanges
ImproveProject Scope &
ProblemValidation
ProblemStatement
Project Metrics
Team Members
Define
MeasurementCapability
ID Variation:StatisticalAnalysis
Objective
Statement(s)Data Collection
Systems
D MAIC Roadmap for Breakthrough
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P rocess Analysis
1) Describe Project O bjective statement Metrics.xls charts Initial validated forecast
2) Apply FMEA3) ID Variation: Graphical Methods
4) ID Variation: Statistical Methods Correlation & Regression Means testing Sigma testing Proportions testing Contingency tables
5) Planning for D O E
6)
Complete Phase Summary Conclusions, Issues, & Next Steps
Failure Modes& EffectsAnalysis
ID Variation:
GraphicalAnalysis
Plan for DOE
Analyze
ID Variation:StatisticalAnalysis
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Background
Failure Modes and Effects Analysis (FMEA) First developed in the 19 50 s Appropriated by NASA in the 19 60 s for the space program Ford Motor Company was the first North American company to widely implement the
use of FMEAs.
T ypes of FMEA S ystem T op-level, early stage analysis of complex systems D esign Systems, subsystems, parts & components early in design stage P rocess Focuses on process flow, sequence, equipment, tooling, gauges, inputs,
outputs, set points, etc
The Process FMEA is the Six Sigma FMEA.
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W ho? W hen?
Who constructs the FMEA? T he Black Belt is the team leader. T he 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
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W hy?
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, AN O VA, D O E
A completed FMEA is a Six Sigma project deliverable.
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6 W P rocess FMEA -- T erminology
FMEA: A systematic analysis of a process used to identify potentialfailures and to prevent their occurrence.Pot en tial F ailur e m od e : T he manner in which the process couldpotentially fail to meet the process requirements.Pot en tial F ailur e Eff ec t : The effects of the failure mode on thecustomer.S eve rity : An assessment of the seriousness of a failure mode.Severity applies to the effects only.C aus e : H ow the failure could occur, described in terms of somethingthat can be corrected or controlled.Occ urr en c e : T he likelihood that a specific failure mode is projectedto occur.
D e t e c tion : T he effectiveness of current process controls to identifythe failure mode (or the failure effect ) prior to occurring, prior torelease to production, or prior to shipment to the customer.R PN -- R isk P riority N umber: T he product of Severity, O ccurrence& Detection
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Initial Assessment Actions and HistoryActions Taken
SEV
CC
DET
RPN
What are the actions for reducing the occurrence, or improving detection, or for identifying the root cause if itis unknown? l e c i s ly i RPN's re sy i es.
Who isresponsible for therecommendedaction?
List the completed actionsthat are included in therecalculated RPN.Include t he implementationdate for any changes.
W h a t i s
t h e n e w
s e v e r i t y ?
W h a t i s
t h e n e w p r o c e s s
c a p a
b i l i t y ?
A r e
t h e
d e t e c t
i o n
l i m i t s
i m p r o v e d
?
R e c o m
k p u t e
R P N a f
t e r
a c t i o n s a r e c o m p l e t e .
0
0
0
0
0
0
A
ion R ul
R o nd dA
ion
R pon ibili
! nd
Co pl
ionD!
The highest value process stepsf romthe C&E
matrix.
In what ways might the process potentially f ail tomeet the processrequirements and/or designintent?
What is the e ff ect o f eachf ailure mode on the outputsand/or customer requirements?The customer could be the nextoperation, subsequentoperations, another division or the end user.
H o w
S e v e r e
i s t h e e f
f e c t
t o t h e c u s o
t m e r
?
How can the f ailure occur?Describe in terms o f somethingthat can be corrected or controlled. Be speci f ic. Tryidenti f y the causes that directlyimpacts the f ailure mode, i.e., rootcauses.
o w o
t e n o e s
t e
c a u s e o r
f a i l u r e m o d e
o c c u r ?
What are the existing controls and procedures (inspection and test) thateither prevent f ailure mode f romoccurring or detect the f ailure shouldit occur? Shouldi nclude an SOPnumber.
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x
O C C x D
E T
0
0
0
0
0
0
RPN
Potential Cause(s)/Mechanism(s) of Failure
OCC
CurrentProcessControls
DET
ProcessFunction Potential Failure Mode
Potential Effectsof Failure
SEV
P arts of the FMEA Form
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 alist of actions to reduce the occurrence or increase the detection.
FMEA & CP Form.xls
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FMEA Examples
Documentation ExampleT he H uman Resources Department for a particular organization maintains official filesfor all personnel. Included is personal data, benefits, current organizational status, andperformance evaluation packages. Many within the organization both contribute and querythese files, relying on their accuracy. Queries from external entities also rely on theiraccuracy. T he H R Department is receiving many complaints both from internal and external
customers regarding the inaccuracy of the information forwarded to them by H R.Service T ime Example
A Customer Service Department for a particular organization handles all customerinquiries, either directly or by channeling cases to other departments as appropriate. Auditsto determine timeliness and completeness of each case is periodically conducted. Resultsfrom the last three month s audits show a trend veering from annual objectives.
In the following examples, a single line from the FMEA is used as anillustration for each of the above examples.
R emember! The purpose of the FMEA is to drive improvement!
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T he Form P art I: Initial Assessment
The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form P rocess Function
The p rocess ste p s to b eanal yz ed in the FME A, should b e the to p three or four that were identified inin the C &E Matri x.
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form P otential Effects of Failure
Effects are theim p act on customer
re q uirements .
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form S everity
Se verit y is a rankin g ona 1 -10 scale , 10 b ein g the most se vere . Low
se verities are those thatare unnoticea b le or
locall y reworka b le . Ver y hi g h se verities areusuall y reser ved for
safet y or lia b ilit y issues .
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form P otential Causes of Failure
To the e xtent p ossi b le , list e ver y concei va b lecause of each failure
mode . Remem b er the6Ms -- man , machine , method , measurement ,
materials , mother nature .
W hat are all of the possible causes for a particular failure?
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o
d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form Occurrence
Occurrence is the likelihoodthat a s p ecific cause will occur
and will result in a s p ecificfailure mode . Rank on a scale
from 1 -10 . If the cause is either unknown or it s fre q uenc y is not
tracked , then the occurrencerefers to the failure mode .
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M ?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form Current P rocess Controls
Controls are methodsthat either p re vent the
failure mode fromoccurrin g or detectthe a failure mode
when it occurs .
W hat happens if this box is blank? W hat is the DET value?
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The highest value process stepsfrom the C&E
matrix.
In what ways mightthe process
potentially fail tomeet the process
requirements and/or design intent?
What is the effect of each failure mode onthe outputs and/or customer
requirements?
o w
e v e r e
s t e e e c
t t o
t h e c u s o
t m e r ?
How can the failureoccur?Describe in terms of something that can be
corrected or controlled.Be specific.
H o w o
t e n d o e s
t h e c a u s e
o r f a i l u r e m o d e o c c u r ?
What are the existingcontrols and procedures(inspection and test) thateither prevent or detect
occurrence?
H o w w e l
l c a n y o u
d e t e c t
c a u s e o r
F M
?
S E V x O
C C x
D E T
Manager completion of change form
Not filled outcorrectly
Outdated employeeinformation incurrent profile
6
No incentive for Manager to complycompletely withrequirement
3
HR checklist for tasksto be completed uponchange in employeestatus
2 36
Communicationfrom CustService toSupporting DeptRepresentative
No directcommunication
Delayed transfer of customer case
9
No formal liaison
4
Customer complaints
8 288
ProcessFunction
Potential FailureMode
Potential Effectsof Failure
SEV
Potential Cause(s)/Mechanism(s) of
Failure
OCC
CurrentProcessControls
DET
RPN
T he Form Risk P riority Number
The risk p riorit y num b er (RPN) is the p roduct of
the se verit y, occurrence ,
and detection . DET OCC SEV RPN vv!
R PNs help to determine Six Sigma project priorities.
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Rating S ummary
Ratin S it f E ff t ik lih d f u n D t t i n Ab ili t10 Hazardou s it out arning Canno t detect
Hazardou s it arningVer y remote chance
of detection
8 Loss of r imar y func tionRemote chance
of detection
7Reduced r imar y
func tion erfor mance
Ver y low chance
of detection6
Loss of secondar yfunc tion erfor mance
Low chance of detection
5Reduced secondar y
func tion erfor mance Modera te chance
of detection
4Minor defec t noticed by most customer s
Modera tely high chance of detection
3 Minor defec t noticed by some customer s High chance of detection
2Minor defec t noticed
by ob servan t customer sVer y high chance
or detection
1 o effec tRemote:
Failure is unli elyAlmost cer tain detection
Low:Relatively few failures
Modera te:Occa sional Failures
Ver y High:Failure is almost inevitable
High:Repea ted Failures
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T he Form P art II: Actions and History
Actions TakenSEV
OCC
DET
RPN
What are the actions for reducing the occurrence,or improving detection,or for identifying the rootcause if it is unknown?Should have actionsonly on high RPN's oreasy fixes.
Who is responsiblefor therecommendedaction?
List the completedactions that areincluded in therecalculated RPN.Include theimplementation datefor any changes.
W h a t i s t h e n e w s e v
W h a t i s t h e n e w p r o
c a p a b
i l i t y ?
r e e e e c o n m
i m p r o v e d ?
e c o m
p u e
a
a c t i o n s a r e c o m p l e t e
Issue delinquencyreport
C.C. Largelist5/1/00
Procedurechanged toincludedelinquencyreport 7/15/00
5 2 3 30
ID Dept liaison for allsupportingDepartments
Slim Pickins8/3/00
Procedurechanged, Deptliaisons identified8/31/00
9 2 4 72
Action ResultsRecommended
Action(s)Responsibilityand Completion
Date
The actions in Part II are directed at solving the project issues.
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Actions TakenSEV
OCC
DET
RPN
What are the actions for reducing the occurrence,or improving detection,or for identifying the rootcause if it is unknown?Should have actionsonly on high RPN's oreasy fixes.
Who is responsiblefor therecommendedaction?
List the completedactions that areincluded in therecalculated RPN.Include theimplementation datefor any changes.
W h a t i s t h e n e w s e v
W h a t i s t h e n e w p r o
c a p a b
i l i t y ?
r e e e e c o n m
i m p r o v e d ?
e c o m
p u e
a
a c t i o n s a r e c o m p l e t e
Issue delinquencyreport
C.C. Largelist5/1/00
Procedurechanged toincludedelinquencyreport 7/15/00
5 2 3 30
ID Dept liaison for allsupportingDepartments
Slim Pickins8/3/00
Procedurechanged, Deptliaisons identified8/31/00
9 2 4 72
Action ResultsRecommended
Action(s)Responsibilityand Completion
Date
T he Form Recommended Actions
Corrective actions are thepoint of the FMEA. If no
actions are generated for aparticular cause this should
be noted. Correctionactions should first bedirected to the highest
priority items.
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Actions TakenSEV
OCC
DET
RPN
What are the actions for reducing the occurrence,or improving detection,or for identifying the rootcause if it is unknown?Should have actionsonly on high RPN's oreasy fixes.
Who is responsiblefor therecommendedaction?
List the completedactions that areincluded in therecalculated RPN.Include theimplementation datefor any changes.
W h a t i s t h e n e w s e v
W h a t i s t h e n e w p r o
c a p a
b i l i t y ?
r e e e e c o n m
i m p r o v e
d ?
e c o m p u e
a
a c t i o n s a r e c o m p l e t e
Issue delinquencyreport
C.C. Largelist5/1/00
Procedurechanged toincludedelinquencyreport 7/15/00
5 2 3 30
ID Dept liaison for allsupportingDepartments
Slim Pickins8/3/00
Procedurechanged, Deptliaisons identified8/31/00
9 2 4 72
Action ResultsRecommended
Action(s)
Responsibilityand Completion
Date
T he Form Actions T aken
Include a brief description of the actual action completed. Manytimes an action changes
during theimplementation. Include
the actual completiondate for the action.
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Actions TakenSEV
OCC
DET
RPN
What are the actions for reducing the occurrence,or improving detection,or for identifying the rootcause if it is unknown?Should have actionsonly on high RPN's oreasy fixes.
Who is responsiblefor therecommendedaction?
List the completedactions that areincluded in therecalculated RPN.Include theimplementation datefor any changes.
W h a t i s t h e n e w s e v
W h a t i s t h e n e w p r o
c a p a b
i l i t y ?
r e e e e c o n m
i m p r o v e
d ?
e c o m
p u e
a
a c t i o n s a r e c o m p l e t e
Issue delinquencyreport
C.C. Largelist5/1/00
Procedurechanged toincludedelinquencyreport 7/15/00
5 2 3 30
ID Dept liaison for allsupportingDepartments
Slim Pickins8/3/00
Procedurechanged, Deptliaisons identified8/31/00
9 2 4 72
Action Results
RecommendedAction(s)
Responsibilityand CompletionDate
T he Form Recalculation
Generate ne w ratings for severity, occurrence anddetection based on the
results of the actions. Thene w values of the RPN w ill
determine if ne w actionsare re q uired for those
causes
Actions should be designed to reduce the occurrence or increase detection.
-
8/6/2019 6Sigma - Failure Modes and Effects Analysis
32/32
Introduction to Control P lans
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 ).
Pro cess"
#
epW
$
a#
's% ontroll e & ?
In p'
t or Out p ut ?
"
pec. Lim its /R eq uir eme nt s
Meas ur eme ntMe thod
S amp le Siz e ( r eq u e n cy Who/ Wh a tMeas ur es
Wh e r e R ec ord e d
Dec is ion Rul e /Corr ec tiv e Ac tion
SOP 's
StatusChangeindicator
X List SelectMgr Review
HR Inspection100% A s Needed
Mgr, HRClerk
HR Checklist Return to Mgr for Correction 9.3 0 12
New Dept Y List Select Mgr ReviewHR Inspection
100% A s Needed Mgr, HRClerk
HR Checklist Return to Mgr for Correction 9.3 0 12
New Grade Y List Select Mgr ReviewHR Inspection
100% A s Needed Mgr, HRClerk
HR Checklist Return to Mgr for Correction 9.3 0 12
New Salary Y rade Guideline Mgr Review 1 00% A s Needed Mgr 9.3 0 12
New Mgr Y Org Chart Mgr Review 1 00% A s Needed Mgr 9.3 0 12
Change
Effect DateY None Mgr Review
HR Inspection100% A s Needed Mgr, HR
ClerkHR Checklist Return to Mgr for Correction 9.3 0 12
) mp lo yee St a tu s
Ch a ng e For m