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How could things go wrong? Where are the biggest risks?

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FMEA Origination The different types FMEA FMEAs Link with Continuous Improvement Our focus is on Process FMEA FMEA Worksheet Why we use FMEA When to use FMEA Potential Applications of FMEA Steps on completing FMEA

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Where does FMEA come from?

Developed by the Aerospace industry in the 1960s Spread to the Automotive industry Now used extensively across all industry sectors Reference SAE J-1739

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Different Types of FMEA


Design
An analytical technique used primarily by Design Responsible Engineer/Team as a means to assure potential failure modes, causes and effects have been addressed for design related characteristics

Process
An analytical technique used primarily by a Manufacturing Engineer/Team as a means to assure potential failure modes, causes and effects have been addressed for process related characteristics

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Link with Continuous Improvement


Component Component Proving Proving Process Process Mistake Mistake Proofing Proofing Techniques Techniques

Continuous Improvement Programs


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Our Focus is on Process FMEA A structured approach to:


Identifying the way in which a process can fail to meet critical customer requirements Estimating the risk of specific causes with regard to these failures Evaluating the current control plan for preventing these failures from occurring Prioritising the actions that should be taken to improve the process

Concept: To identify ways the product or process can fail and then plan
to prevent those failures, utilising mistake proofing tools and techniques.
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Example of an Process FMEA Table


Process Failure M ode and Effects Analysis
Notes:

Problem:
T eam Members: Occurrence: Scores: High No. low No. High No. Low No. High No. Low No. (10) (1) (10) (1) (10) (1) Frequently/with certainty Rarely Dangerous/warranty statistic Not Significant Detection very unlikely Easily detected Recommende d C orre ctive Action

Issued By:

Revision: Date:

RPN= Occ.x Sev.x Det.

Assumptions:

Severity: Detection:

Sort FMEA by Highest RPN Numbers

R e f. P a rt No . No . Na m e Is s ue

Function or Process

Failure Mode

Effect O f Failure

C ause O f Failure

Current C ontrols

C u rre n t S t a t u s

Sev Occ Det

RPN

By

C o m p 'l D a te

C omme nts

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

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Why we use FMEA? rather than cure. Increase probability of DETECTION Identify biggest contributor to failures and eliminate them Reduce probability of failure occurring Build quality into the product & process

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When to use FMEA?


FMEA is most beneficial as a beforethe-event action Design FMEA should be done during initial design of product Process FMEA should be done during design of manufacturing process Process FMEA can be done for legacy product/processes

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Potential Applications for PFMEA


Component Proving Process Outsourcing / Resourcing of product Develop Suppliers to achieve Quality Renaissance / Scorecard Targets Major Process / Equipment / Technology Changes Justification of Fast Track RESA? Cost Reductions New Product / Design Analysis Assist in analysis of a flat pareto chart
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Guide to do Process FMEA


STEP STEP 1 1 STEP STEP 2 2 STEP STEP 3 3 STEP STEP 4 4 STEP STEP 5 5 STEP STEP 6 6 STEP STEP 7 7 STEP STEP 8 8 STEP STEP 9 9 STEP STEP 10 10 Scope Scope Project Project Brainstorm Brainstorm all all potential potential failure failure modes modes Identify Identify potential potential effects effects of of failures failures Determine Determine Severity Severity Rankings Rankings Identify Identify causes causes of of failures failures Determine Determine Occurrence Occurrence Rankings Rankings Define Define current current control control methods methods Determine Determine Detection Detection Rankings Rankings Calculate Calculate Risk Risk Priority Priority Numbers Numbers Prioritise Prioritise corrective corrective actions actions

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Complex Part

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Step 1 - Scope Process


Formulate cross functional team Defining Defining Scope Scope of of Understand customer/process FMEA FMEA is is requirements CRITICAL! CRITICAL! 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
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Process Map Example


Flowchart 10 Issue Material
Rough & Finish cutters. Mistake proof fixture One oven used. Wall clock used. Calibrated thermocouple Operator concerned with fixture - no positive location. Batch scrapped - due to incorrect time in oven

Observations

Quality data
Quality audit - material cert. Not stamped

20

Mill Profile

30

Heat Treatment

40 50

Drill and Tap hole Final Inspect

60

Mark, Pack & Dispatch

Parts not rechecked by inspection

Customer complaint - incorrect part #

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Definition of a failure mode


The way in which a specific process input fails - if not detected and either corrected or removed, will cause an effect to occur. The way in which something goes wrong Surface too rough Shaft not round Radius too large Bent Improper set-up
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Step 2 - Brainstorm all potential failure modes


Utilise process flow chart

- break down each step


Use knowledge of previous and existing parts/processes Review all quality information
-complaints, scrap, rework, turn backs, etc.

Talk to internal and external customers

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Ref. P a rt No . No . Name Is s ue

Function or Process

Failure Mode

Effect O f Failure

Cause O f Failure

Current Controls

C urre nt S ta

Sev Occ Det

OP 10 Issue Mat'l

Ultilizing wrong material

OP 20 Mill outer profile

Failure to meet Profile Tolerance Surface finish

OP 30 Heat treatment

Failure to meet datacard requirements (temp/time)

OP 40 Drill and tap Hole

Incorrect hole size and position

OP 50 Final Inspection

Failure to fully inspect all features

Op 60 Mark, Pack & Release

Incorrect part identification Incorrect # of parts delivered


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Definition Effects of failure -Effects Effect - impact on customer requirements. Generally external customer focus, but can also include downstream processes.
Does not fit Can not load/fasten Poor performance Intermittent operation Erratic operation
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Step 3 - Identify potential effects of failures For each failure mode, identify the effect(s) on the current or next process or customer downstream in the manufacturing/assembly process. Describe the effects of the failure in terms of what the customer might notice or experience
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Step 4 - Determine severity ranking


Ranking the seriousness of the effect of failure.
Severity (SEV) Ranking Criteria
Criteria The minor nature of this type of failure would not have a noticeable effect on the next higher level assembly or overall engine performance. The customer will probably not be able to detect variation in the product. Variation causes only slight customer annoyance. Customer will probably notice only very minor performance degradation, or minor problems at next higher assembly. Customer is likely to be annoyed by the variation in the component. For example, moderate ratings would be given to undesirable attributes such as part adjustment on installation, high forces used in installing the part or visual defects. There will be a high degree of customer dissatisfaction due to the nature of the failure, such as inoperable sub-assembly requiring strip and rebuild. The defect has a severe affect on engine performance. Variation in component feature has a major impact in that it involves potential safety considerations such as in-flight failures leading to loss of engine function. Rating 1 2 3 4 5 6 7 8 9 10

You may need to involve your customer in allocating this number


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P a rt No . Na m e Is s ue OP 1 0

Function or Process

Failure Mode
Ultilizing wro ng m a te ria l

Effect O f Failure

Cause O f Failure

Current Controls

C u rre n t S t a t u s

Sev Occ Det


Is s ue Ma t'l

RPN

Failure to meet Drg. Requirements Safety issue Variant part - Rework/Scrap

0 0 0

OP 2 0

M ill o ute r pro file

F a ilure to m e e t P ro file To le ra nc e S urfa c e finis h

0 0 0 0

OP 3 0

He a t tre a tm e nt

F a ilure to m e e t da ta c a rd re quire m e nts (te m p/tim e )

Failure to meet required mat'l properties

0 0 0

OP 4 0

Drill a nd ta p Ho le

Inc o rre c t ho le s ize a nd po s itio n

Part does not fit at assembly

0 0 0 0

OP 5 0

F ina l Ins pe c tio n

F a ilure to fully ins pe c t a ll fe a ture s

Non-conforming part delivered to customer Safety issue Non-conforming part delivered to customer Traceability Failure to meet P/O requirement

0 0 0

Op 6 0

M a rk, P a c k & R e le a s e

Inc o rre c t pa rt ide ntific a tio n Inc o rre c t # o f pa rts de live re d

3 1

0 0 0

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Definition - Causes Sources of process variation that causes the Failure Mode to occur.
Part not in fixture properly incorrect tool gage inaccurate

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Step 5 - Identify all potential causes of failure


How the failure could occur, described in terms of something that can be corrected or controlled Experiments may have to be conducted to determine causes use Technical Problem Solving There could be more than one cause for each failure

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Step 6 - Determine occurrence ranking


How frequently the failure cause is likely to happen
Occurrence (OCC) Ranking Criteria
Criteria Remote probability of occurrence. Process in control and capable. Low probability of occurrence. Process in statistical control and capable although any increase in variation or process shift could cause problems. Moderate probability of occurrence. Generally associated with processes that have experienced occasional failures, but not in major proportions. Process in statistical control, but is not quite capable. High probability of occurrence. Generally associated with processes that have often failed. Process in statistical control but not capable. Very high probability of occurrence. In the teams view, this failure mode is almost certainly certain to occur. Process out of control and not capable. Rating 1 2 3 4 5 6 7 8 9 10 Process Cpk (if k nown) > 1.3 1.25 1.20 1.10 1.00 0.95 0.85 0.75 0.65 < 0.55

You may need to involve your customer in allocating this number


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P a rt No . Na m e Is s ue OP 1 0

Function or Proce ss

Failure Mode
Ultilizing wro ng m a te ria l

Effect O f Failure
fa ilure to m e e t Drg. R e quire m e nts

Cause O f Failure

C urrent Controls

C u rre n t S t a t u s

Sev Occ Det


Is s ue M a t'l

RPN

Safety issue
F a ilure to m e e t P ro file To le ra nc e S urfa c e finis h Va ria nt pa rt R e wo rk/S c ra p

Incorrect info. on router Material ID incorrectly Incorrect cutter Position of part on fixture Worn tooling

6 6

2 3 2 1 2

0 0 0

OP 2 0

M ill o ute r pro file

3 3 3

0 0 0 0

OP 3 0

He a t tre a tm e nt

F a ilure to m e e t da ta c a rd re quire m e nts (te m p/tim e )

F a ilure to m e e t re quire d m a t'l pro pe rtie s

Incorrect Temp Incorrect Time Incorrect cutter Position of part on fixture Worn tooling

6 6

2 6 2 5 2

0 0 0

OP 4 0

Inc o rre c t ho le s ize Drill a nd ta p Ho le a nd po s itio n

P a rt do e s no t fit a t a s s e m bly

3 3 3

0 0 0 0

OP 5 0

F ina l Ins pe c tio n

F a ilure to fully ins pe c t a ll fe a ture s

No n-c o nfo rm ing pa rt de live re d to c us to m e r S a fe ty is s ue No n-c o nfo rm ing pa rt de live re d to c us to m e r Tra c ibility F a ilure to m e e t P /o re quire m e nt

Inexperience of inspector/incomprehensive checklist Defective gage

6 6

2 1

0 0 0

Op 6 0

M a rk, P a c k & R e le a s e

Inc o rre c t pa rt ide ntific a tio n Inc o rre c t # o f pa rts de live re d

operator error/ unclear instructions Incorrect paperwork operator failed to count

3 3 1

6 2 4

0 0 0

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Definition - current controls?


Systematic methods/devices in place to prevent or detect failure modes or causes (before causing effects) Prevention consists of mistake proofing, automated control and set up verifications Controls consists of audits, inspection, training, etc.

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Step 8 - Determine detection ranking


An assessment of the probability that the current controls will be effective
Detection (DET) Ranking Criteria
Criteria A remote likelihood that the component would be passed on to the next customer containing the defect. The defect is an obvious characteristic that can be readily found. A low likelihood that the component would be passed on to the customer with the defect. The defect is an obvious characteristic that can be readily detected by a subsequent operation (eg. Missing location hole found during assembly) A moderate likelihood that the product will be shipped containing this defect. The defect is an easily identified characteristic examined by inspection checks. Low chances that the current controls will detect the failure mode. A high likelihood that the component will be shipped containing this defect. Practically no chance that the current controls will detect the failure mode. The part will be shipped with the defect as no known controls are in existence for detecting the failure mode. % of failures being detected 99.99 95 90 85 80 75 70 65 60 Nil

Rating 1 2 3 4 5 6 7 8 9 10

Use of SPC and Measurement System Analysis will help


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R e f. P a rt No . No . Na m e Is s ue

Function or Process

Failure Mode

Effect O f Failure

C ause O f Failure

C urrent C ontrols

C u rre n t S t a

Sev Occ Det


Ultilizing wro ng m a te ria l fa ilure to m e e t Drg. R e quire m e nts

OP 1 0

Is s ue M a t'l

Inc o rre c t info . o n ro ute r

Safety issue
F a ilure to m e e t P ro file To le ra nc e S urfa c e finis h

M a te ria l ID inc o rre c tly

Training, audited procedure. Password protected router ID with marker. Operator training

2 4

OP 2 0

M ill o ute r pro file

Va ria nt pa rt R e wo rk/S c ra p

Inc o rre c t c utte r P o s itio n o f pa rt o n fixture

Cutter identified Mistake proof fixture Process control -Change after a fixed # of parts

3 3

2 1

3 1 2

Wo rn to o ling

OP 3 0

F a ilure to m e e t da ta c a rd F a ilure to m e e t re quire m e nts re quire d m a t'l He a t tre a tm e nt (te m p/tim e ) pro pe rtie s

Inc o rre c t Te m p

Inc o rre c t Tim e Inc o rre c t ho le s ize a nd P a rt do e s no t fit po s itio n a t a s s e m bly

Calibrated thermometer Wall clock. Operator training

1 6

OP 4 0

Drill a nd ta p Ho le

Inc o rre c t c utte r P o s itio n o f pa rt o n fixture Wo rn to o ling

Cutter identified Operator skill Operator skill Inspection check list. Training and auditing of inspectors Calibration system. Audited procedure

3 3 3

2 5 2

3 4 4

OP 5 0

F a ilure to fully No n-c o nfo rm ing ins pe c t a ll pa rt de live re d to F ina l Ins pe c tio n fe a ture s c us to m e r

Ine xpe rie nc e o f ins pe c to r/inc o m pre h e ns ive c he c klis t

2 1

S a fe ty is s ue

De fe c tive ga ge

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Step 9 - Calculate the Risk Priority Numbers RPN = Risk Priority Number Multiply severity, occurrence and detection rankings together

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R e f. P a rt No . No . Na m e Is s ue OP 1 0

Function or Proce ss

Failure Mode

Effe ct O f Failure

Cause O f Failure

C urre nt C ontrols
ID with m a rke r. Ope ra to r tra ining Tra ining, a udite d pro c e dure . P a s s wo rd pro te c te d ro ute r

C u rre n t S t a t u s

Sev Occ Det


Is s ue M a t'l fa ilure to m e e t Drg. Ultilizing wro ng m a te ria l R e quire m e nts Inc o rre c t info . o n ro ute r 6 3 4

RPN

72 24 18 12 3

Safety issue
F a ilure to m e e t P ro file To le ra nc e S urfa c e finis h

M a te ria l ID inc o rre c tly

OP 2 0

M ill o ute r pro file

Va ria nt pa rt - R e wo rk/S c ra p Inc o rre c t c utte r P o s itio n o f pa rt o n fixture Wo rn to o ling

C utte r ide ntifie d Ope ra to r s kill M is ta ke pro o f fixture

3 3 3

2 2 1

3 2 1

OP 3 0

He a t tre a tm e nt

F a ilure to m e e t da ta c a rd re quire m e nts (te m p/tim e )

F a ilure to m e e t re quire d m a t'l pro pe rtie s

Inc o rre c t Te m p Inc o rre c t Tim e

Wa ll c lo c k. Ope ra to r tra ining C a libra te d the rm o m e te r

6 6

6 2

6 1

216 12 60 24 18

OP 4 0

Drill a nd ta p Ho le

Inc o rre c t ho le s ize a nd po s itio n

P a rt do e s no t fit a t a s s e m bly

Inc o rre c t c utte r P o s itio n o f pa rt o n fixture Wo rn to o ling

Ope ra to r s kill P ro c e s s c o ntro l -C ha nge a fte r a fixe d # o f pa rts C utte r ide ntifie d

3 3 3

5 2 2

4 4 3

OP 5 0

F ina l Ins pe c tio n

F a ilure to fully ins pe c t a ll fe a ture s

No n-c o nfo rm ing pa rt de live re d to c us to m e r S a fe ty is s ue

Ine xpe rie nc e o f Ins pe c tio n c he c k lis t. ins pe c to r/inc o m pre he ns ive Tra ining a nd a uditing o f c he c klis t ins pe c to rs C a libra tio n s ys te m . Audite d De fe c tive ga ge pro c e dure o pe ra to r e rro r/ unc le a r ins truc tio ns Inc o rre c t pa pe rwo rk o pe ra to r fa ile d to c o unt

6 6

2 1

2 1

24 6 162 12 8

Op 6 0

M a rk, P a c k & R e le a s e

Inc o rre c t pa rt ide ntific a tio n

No n-c o nfo rm ing pa rt de live re d to c us to m e r Tra c ibility F a ilure to m e e t P /o re quire m e nt

No c o ntro ls S igne d a nd re vie we d by DQR Ope ra to r tra ining

3 3 1

6 2 4

9 2 2

Inc o rre c t # o f pa rts de live re d

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Step 10 - Prioritize corrective actions


Tackle highest RPNs first How can we reduce the occurrence? How can we improve the detection? Use process improvement skills Where possible apply mistake proofing techniques. Standardization across all products or processes Introduce any change in a controlled manner. PDSA(traceability and improvement monitor) Note :- Mistake proofing process will result in either lower occurrence or detection rankings
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R e f. P a rt No . No . Na m e Is s ue

Function or Process

Failure Mode

Effe ct O f Failure

Cause O f Failure

C urrent C ontrols

C u rre n t S t a t u s

Re comme nde d C orre ctive Action

Occ Sev Det

RPN

OP 1 0

Is s ue M a t'l

fa ilure to m e e t Drg. Ultilizing wro ng m a te ria l R e quire m e nts

M a te ria l ID inc o rre c tly

ID with m a rke r. Ope ra to r tra ining Tra ining, a udite d pro c e dure . P a s s wo rd pro te c te d ro ute r

72 24 18 12 3

Material stores to have 5's. All mat'l to be identified with labels. Re training. Regular audits

Inc o rre c t info . o n ro ute r F a ilure to m e e t P ro file To le ra nc e

OP 2 0

M ill o ute r pro file

Va ria nt pa rt - R e wo rk/S c ra p Inc o rre c t c utte r Wo rn to o ling P o s itio n o f pa rt o n fixture

C utte r ide ntifie d Ope ra to r s kill F o o lpro o f fixture

3 3 3

2 2 1

3 2 1

OP 3 0

He a t tre a tm e nt

F a ilure to m e e t re quire m a t'l pro prtie s

F a ilure to m e e t re quire d s tre ngth

Inc o rre c t Tim e Inc o rre c t Te m p

Wa ll c lo c k. Ope ra to r tra ining C a libra te d the rm o m e te r

6 6

6 2

6 1

Calibrated clock that is part of the heattreat contol 216 system 12 Mistake proof fixture.Positive location

OP 4 0

Drill a nd ta p Ho le

F a ilure to m e e t drg re quire m e nts

Inc o rre c t ho le s ize & po s itio n

P o s itio n o f pa rt o n fixture Wo rn to o ling Inc o rre c t c utte r

Ope ra to r s kill P ro c e s s c o ntro l -C ha nge a fte r a fixe d # o f pa rts C utte r ide ntifie d Ins pe c tio n c he c k lis t. Tra ining a nd a uditing o f ins pe c to rs C a libra tio n s ys te m . Audite d pro c e dure

3 3 3

5 2 2

4 4 3

60 24 18

OP 5 0

F ina l Ins pe c tio n

Ac c e pta nc e o f no nc o nfo rm ing pa rt

No n-c o nfo rm ing pa rt de live re d to c us to m e r

F a ile d to c he c k a fe a ture De fe c tive ga ge

6 6

2 1

2 1

24 6 Insert a mark part # operation prior to final view plus produce clear work instructions with 162 photos for operator 12 8

Op 6 0

M a rk, P a c k & R e le a s e

De fe c t pa rt re le a s e d to No n-c o nfo rm ing pa rt c us to m e r de live re d to c us to m e r

P a rt # m is -m a rke d Inc o rre c t pa pe rwo rk

No c o ntro ls S igne d a nd re vie we d by DQR Ope ra to r tra ining

3 3 1

6 2 4

9 2 2

Inc o rre c t # o f pa rts de live re d

F a ilure to m e e t P /o re quire m e nt

o pe ra to r fa ile d to c o unt

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Reassess rankings when action completed FMEA must be a live document Review regularly Reassess rankings whenever changes made to product and/or process Add any new defects or potential problems when found
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Web-sites / references with more examples and quality tools:

John Grout's Poka-Yoke Page (web page)


http://www.campbell.berry.edu/faculty/jgrout/pokayoke.shtml

QS9000 FMEA reference manual(SAE J 1739) Free Quality Tools Web Site
Www.freequality.org
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