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FAILURE MODE

AND
EFFECT ANALYSIS

TPM SECRETARIAT - ORAI FACTORY


FAILURE - WHAT DOES IT MEAN TODAY
 99.9 % quality in the USA would mean-
 12 babies given to the wrong parents
 1 hour of unsafe drinking water per day
 16,000 lost pieces of mail per hour
 19,000 newborn babies dropped at birth by doctor every
year
 22,000 checks deducted from wrong account each hour
 291 incorrect pace maker operations per year

CHANGE IN PARADIGM
 SOLUTION TO PROBLEMS PREVENTION OF PROBLEMS
 MONITORING OF WASTE ELIMINATION OF WASTE
 QUANTIFICATION OF RELIA- REDUCTION OF UNRELIABILITY
BILITY

TPM SECRETARIAT - ORAI FACTORY


DEFINITION
FAILURE MODE AND EFFECT ANALYSIS IS A SPECIFIC
METHODOLOGY TO EVALUATE A SYSTEM, DESIGN,
PROCESS, OR SERVICE FOR POSSIBLE WAYS IN WHICH
FAILURES(PROBLEMS, ERRORS,RISKS) CAN OCCUR

 BENEFITS:-
 Improve the quality,reliability and safety of products/service
 Helps select the optimal systems design
 Helps identify diagnostic procedures
 Provides an early prevention system
 Identifies the causes and effects of each failure mode
 Provides for problem follow up and corrective actions
 Help in reduction in risk of failure
 Establishes a priority for design improvement actions
 Helps error identification and prevention
 Helps that all conceivable failures and their effects on potential success have been
considered
 Lists potential failures and identifies relative magnitude of their effect
 Provides historical documentation for future reference to aid in the analysis of field
failures and consideration of design, process and service changes.
TPM SECRETARIAT - ORAI FACTORY
FMEA - WHEN TO USE IT

 When new systems,designs, products,processes or services are designed


 When existing systems, design, products, processes, or services are about
to change regardless of reasons
 When new applications are found for the existing conditions of the
systems, designs, products, processes, or services
 When improvements are considered for the existing systems.

TPM SECRETARIAT - ORAI FACTORY


FAILURE PRIORITY - COMPONENTS
FMEA - IDENTIFY AND PREVENT KNOWN AND POTENTIAL
FAILURES - PRIORITISE FAILURES

 Three components that help define the priority of failures


 OCCURRENCE(O) - Frequency of a failure
 SEVERITY(S) - Seriousness of the failure
 DETECTION(D) - Ability to detect the failure
 RISK PRIORITY NUMBER - The priority of the problem
To rank order and concern system
RPN = (O) x (S) x (D)

 MINOR RISK - NO ACTION IS TAKEN


 MODERATE RISK - SOME ACTION IS TAKEN
 HIGH RISK - DEFINITE ACTION IS TAKEN
 CRITICAL RISK - EXTENSIVE CHANGES ARE REQUIRED

TPM SECRETARIAT - ORAI FACTORY


FMEA - PROCESS
STEP-1 Select team and brainstorm - cross-functional. Brain storm to prioritize the
opportunity for improvement

STEP-2 Prepare Functional Block Diagram and/or Process flow chart. This is required so
that everybody understands the design/process

STEP-3 Prioritize - Which area to attack ?

STEP-4 Collect Data - Collect Data on failures,categorize the failures, and the failure modes.

STEP-5 Analyze the data. Information from this step will be used to fill in the columns of the
FMEA Form in relationships to the effect of the failure, existing controls, estimation
of severity, occurrence, and detection
STEP-6 Based on the analysis, results are derived. The information from this step will be
used to quantify the severity,occurrence, detection and RPN.

STEP-7 After the results have been recorded, it is time to confirm, evaluate, and measure the
success or failure. We need to see whether the situation is better, worse or same as
before.
STEP-8 Review for continuous improvement. The long term goal is to completely eliminate
every single failure

TPM SECRETARIAT - ORAI FACTORY


ACTION - POST FMEA
STEP-1 Review the FMEA. Make sure that all the loose ends have been addresses and
appropriate action has been recommended and/or implemented.

STEP-2 Highlight the high-risk areas. Critically examine the Severity and RPN columns in
the FMEA.

STEP-3 Identify the critical,significant and major characteristics.Great care should be taken
when reviewing the RPN because these numbers will indicate whether or not action
should be taken.
STEP-4 Ensure that a control plan exists and is being followed.

STEP-5 After control plan is in place and statistical controls have been established, a
potential capability or long capability must be performed.

STEP-6 Work on processes which have a CpK less than or equal to 1.33

TPM SECRETARIAT - ORAI FACTORY


TYPES OF FMEA
SYSTEMS DESIGN PROCESS SERVICE

COMPONENTS COMPONENTS MANPOWER COMPONENTS


MACHINES
SUBSYSTEMS SUBSYSTEMS METHODS SUBSYSTEMS
MATERIAL
MAIN MAIN MEASURES MAIN
SYSTEMS SYSTEMS ENVIRON. SYSTEMS

MACHINES HUNAM
RESOURCES

TOOLS TASKS
WORK STATIONS WORK STATIONS
PROD.LINES SERVICE LINES
PROCESSES PERFORMANCES
GAUGES TRAINING
TRAINING

FOCUS FOCUS FOCUS FOCUS


Minimize failure effect on Minimize failure effect of Minimize process failure Minimize service failure
the system the design on the total system on the total organization
OBJECTIVE/GOAL OBJECTIVE/GOAL OBJECTIVE/GOAL OBJECTIVE/GOAL
Maximize systems quality Maximize design quality Maximize the total process Maximize the customer
reliability, cost and reliability, cost and quality, reliability, cost and satisfaction through quality,
maintainability maintainability maintainability reliability, and service

TPM SECRETARIAT - ORAI FACTORY


FMEA - TERMINOLOGY

 FUNCTION
The task that the system,design,process,component,subsystem,service must
perform.
Example - Lubricate,retain,support.- it should be an ACTIVE VERB

 FAILURE
The inability of the system,design,process, service,or subsystems to perform
based on design intent.This inability can be defined as both known and
potential.

 FAILURE MODE
The physical description of the manner in which a failure occurs.
Example - open circuit,leak,corroded,broken,dirty,eccentric,bent,misalign

TPM SECRETARIAT - ORAI FACTORY


SYSTEMS FMEA

TPM SECRETARIAT - ORAI FACTORY


SYSTEM FMEA FORM
1.SYSTEM NAME 5. SUPPLIER INVOLVEMENT 9.FMEA DATE
2.SYSTEM RESPONSIBILITY 6. MODEL 10.FMEA REV.DATE
3.PERSON RESPONSIBILTY 7.ENG.RELEASE DATE
4.TEAM 8.PREPARED BY PAGE 0F PAGES

SYSTEM POTENTIAL POTENTIAL S POTENTIAL O DETECTION D R RECOMMENDED ACTION ACTION ACTION RESULTS
FUNCTION FAILURE EFFECTS OF E CAUSES OF C METHOD E P ACTION PLAN AND TAKEN S O D R
MODE FAILURE V FAILURE C T N TARGET E C E P
DATES V C T N

11 12 13 14 15 16 17 18 19 20 21 22 23 24

The Engineer writes the design intents, purpose goals,


or objective of the systems

For each system function one must list down the corresponding failure
of the function

A potential effect of the failure is the consequence of a systems


failure mode. “What happens or what are the ramifications of this failure

Critical characteristics usually are not associated with systems


FMEA

Severity is a rating indicating the seriousness of the effect of


the potential system failure.
SEE GUIDELINES
The cause of a system failure mode is the system design
deficiency that results in the failure mode.

TPM SECRETARIAT - ORAI FACTORY


DESIGN FMEA FORM
1.SYSTEM NAME 5. SUPPLIER INVOLVEMENT 9.FMEA DATE
2.SYSTEM RESPONSIBILITY 6. MODEL 10.FMEA REV.DATE
3.PERSON RESPONSIBILTY 7.ENG.RELEASE DATE
4.TEAM 8.PREPARED BY PAGE 0F PAGES

SYSTEM POTENTIAL POTENTIAL S POTENTIAL O DETECTION D R RECOMMENDED ACTION ACTION ACTION RESULTS
FUNCTION FAILURE EFFECTS OF E CAUSES OF C METHOD E P ACTION PLAN AND TAKEN S O D R
MODE FAILURE V FAILURE C T N TARGET E C E P
DATES V C T N

11 12 13 14 15 16 17 18 19 20 21 22 23 24

Occurrence is the rating value


corresponding to the The system through which the failure can be
estimated number of failures that discovered, recognized
could occur for
Detection is a rating corresponding to
a given cause over the design life span
the likelihood that the proposed system
of the system
controls will detect a specific rootcause.

Specific actions after the RPN


calculations

PRIORITIZE FAILURE MODES


After the actions are
WITH
incorporated in the system, the • HIGHEST RPN
FMEA team should re - evaluate • HIGEST SEVERITY
the consequences of severity, • HIGHEST OCCURRENCE
occurrence and detection - the
RPN is calculated.

TPM SECRETARIAT - ORAI FACTORY


SEVERITY GUIDELINE -SYSTEMS FMEA
EFFECT RANK CRITERIA

NO 1 NO EFFECT

VERY SLIGHT 2 VERY SLIGHT EFFECT ON PRODUCT OR SYSTEM


PERFORMANCE
SLIGHT 3 SLIGHT EFFECT ON PRODUCT OR SYSTEM PERFORMANCE

MINOR 4 MINOR EFFECT ON PRODUCT OR SYSTEM PERFORMANCE

MODERATE 5 MODEREATE EFFECT ON PRODUCT OR SYSTEM


PERFORMANCE
SIGNIFICANT 6 PRODUCT PERFORMANCE DEGRADED, BUT OPERABLE
AND SAFE. PARTIAL FAILURE
MAJOR 7 PRODUCT PERFORMANCE SEVERELY AFFECTED BUT
FUNCTIOANBLE.SYSTEM IMPARED
EXTREME 8 PRODUCT INOPERABLE BUT SAFE. SYSTEM INOPERABLE

SERIOUS 9 ABLE TO STOP PRODUCT WITHOUT MISHAP – TIME


DEPENDANT FAILURE
HAZARDOUS 10 HAZARDOUS EFFECT. SAFETY RELATED – SUDDEN
FAILURE.
TPM SECRETARIAT - ORAI FACTORY
DETECTION GUIDELINE -SYSTEMS FMEA
EFFECT RANK CRITERIA

ALMOST 1 PROVEN DETECTION METHODS AVAILABLE IN CONCEPT


CERTAIN STAGE
VERY HIGH 2 PROVEN COMPUTER ANALYSIS AVAILABLE IN EARLY
DESIGN STAGE
HIGH 3 SIMULATIONS AND/OR MODELLING IN EARLY STAGE

MODERATELY 4 TESTS ON EARLY PROTOTYPE SYSTEM ELEMENTS


HIGH
MEDIUM 5 TESTS ON PREPRODUCTION SYSTEM COMPONENTS

LOW 6 TESTS ON SIMILAR SYSTEM COMPONENTS

SLIGHT 7 TESTS ON PRODUCT WITH PROTOTYPES WITH SYSTEM


COMPONENTS INSTALLED
VERY SLIGHT 8 PROVING DURABILITY TEST ON PRODUCTS WITH SYTEM
COMPONENETS INSTALLED
REMOTE 9 ONLY UNPROVEN OR UNRELIABLE TECHNIQUES
AVAILABLE
ALMOST 10 NO KNOWN TECHNIQUE AVAILABLE
IMPOSSIBLE

TPM SECRETARIAT - ORAI FACTORY


OCCURENCE GUIDELINE -SYSTEMS FMEA
EFFECT RANK CRITERIA CNF/1000

ALMOST 1 FAILURE UNLIKELY <.00058


NEVER
REMOTE 2 RARE NUMBERS OF FAILURES LIKELY 0.0068

VERY SLIGHT 3 VERY FEW FAILURES LIKELY 0.0063

SLIGHT 4 FEW FAILURES LIKELY 0.46

LOW 5 OCCATIONAL NUMBERS OF FAILURES LIKELY 2.7

MEDIUM 6 MEDIUM NO. OF FAILURES LIKELY 12.4

MODERATEL 7 MODERATELY HIGH NO.OF FAILURES LIKELY 46


Y HIGH
HIGH 8 HIGH NO. OF FAILURES LIKELY 134

VERY HIGH 9 VERY HIGH NUMBERS OF FAILURES LIKELY 316

ALMOST 10 FAILURE ALMOST CERTAIN. >316


CERTAIN

TPM SECRETARIAT - ORAI FACTORY


DESIGN FMEA

DESIGN FMEA IS A DISCIPLINED ANALYSIS/METYHOD


OF IDENTIFYING POTENTIAL OR KNOWN FAILURE
MODES AND PROVIDING FOLOW-UP AND CORRECTIVE
ACTION BEFORE THE FIRST PRODUCTION RUN OCCURS

TPM SECRETARIAT - ORAI FACTORY


DESIGN FMEA FORM
1.SYSTEM NAME 5. SUPPLIER INVOLVEMENT 9.FMEA DATE
2.DESIGN RESPONSIBILITY 6. MODEL 10.FMEA REV.DATE
3.PERSON RESPONSIBILTY 7.ENG.RELEASE DATE
4.TEAM 8.PREPARED BY PAGE 0F PAGES

DESIGN POTENTIAL POTENTIAL S POTENTIAL O DETECTION D R RECOMMENDED ACTION ACTION ACTION RESULTS
FUNCTION FAILURE EFFECTS OF E CAUSES OF C METHOD E P ACTION PLAN AND TAKEN S O D R
MODE FAILURE V FAILURE C T N TARGET E C E P
DATES V C T N

11 12 13 14 15 16 17 18 19 20 21 22 23 24

TPM SECRETARIAT - ORAI FACTORY


SEVERITY GUIDELINE -DESIGN FMEA
EFFECT RANK CRITERIA

NONE 1 NO EFFECT

VERY SLIGHT 2 VERY SLIGHT EFFECT ON PRODUCT PERFORMANCE. NONVITAL


FAULT NOTICED SOMETIMES
SLIGHT 3 SLIGHT EFFECT ON PRODUCT PERFORMANCE. NONVITAL FAULT
NOTICED MOST OF THETIME
MINOR 4 MINOR EFFECT ON PRODUCT PERFORMANCE.FAULT DOESNOT
REQUIRE REPAIR. NONVITAL FAULTS ALWAYS NOTICED
MODERATE 5 MODEREATE EFFECT ON PRODUCT PERFORMANCE.FAULT ON
NONVITAL PART REQUIRES REPAIR.
SIGNIFICANT 6 PRODUCT PERFORMANCE DEGRADED, BUT OPERABLE AND SAFE.
NONVITAL PART INOPERABLE..
MAJOR 7 PRODUCT PERFORMANCE SEVERELY AFFECTED BUT
FUNCTIOANBLE. SUBSYSTEM INOPERABLE.
EXTREME 8 PRODUCT INOPERABLE BUT SAFE. SYSTEM INOPERABLE

SERIOUS 9 ABLE TO STOP PRODUCT WITHOUT MISHAP – TIME DEPENDANT


FAILURE
HAZARDOUS 10 HAZARDOUS EFFECT. SAFETY RELATED – SUDDEN FAILURE.

TPM SECRETARIAT - ORAI FACTORY


DETECTION GUIDELINE -DESIGN FMEA
EFFECT RANK CRITERIA

ALMOST 1 HAS THE HIGHEST EFFECTIVENESS IN EACH APPLICABLE


CERTAIN CATEGORY
VERY HIGH 2 HAS VERY HIGH EFFECTIVENESS

HIGH 3 HAS HIGH EFFECTIVENESS

MODERATELY 4 HAS MODERATELY HIGH EFFECTIVENESS


HIGH
MEDIUM 5 HAS MEDIUM EFFECTIVENESS

LOW 6 HAS LOW EFFECTIVENESS

SLIGHT 7 HAS VERY LOW EFFECTIVENESS

VERY SLIGHT 8 HAS LOWEST EFFECTIVENESS IN EACH APPLICABLE


CATEGORY
REMOTE 9 IS UNPROVEN, OR UNRELIABLE,OR EFFECTIVENESS IS
UNKNOWN
ALMOST 10 NO DEISGN TECHNIQUE AVAILABLE OR KNOWN, AND/OR
IMPOSSIBLE NONE IS PLANNED

TPM SECRETARIAT - ORAI FACTORY


OCCURENCE GUIDELINE -DESIGN FMEA
EFFECT RANK CRITERIA CNF/1000

ALMOST 1 FAILURE UNLIKELY <.00058


IMPOSSIBLE
REMOTE 2 RARE NUMBERS OF FAILURES LIKELY 0.0068

VERY SLIGHT 3 VERY FEW FAILURES LIKELY 0.0063

SLIGHT 4 FEW FAILURES LIKELY 0.46

LOW 5 OCCATIONAL NUMBERS OF FAILURES LIKELY 2.7

MEDIUM 6 MEDIUM NO. OF FAILURES LIKELY 12.4

MODERATEL 7 MODERATELY HIGH NO.OF FAILURES LIKELY 46


Y HIGH
HIGH 8 HIGH NO. OF FAILURES LIKELY 134

VERY HIGH 9 VERY HIGH NUMBERS OF FAILURES LIKELY 316

ALMOST 10 FAILURE ALMOST CERTAIN. >316


CERTAIN

TPM SECRETARIAT - ORAI FACTORY


PROCESS FMEA

TPM SECRETARIAT - ORAI FACTORY


PROCESS FMEA FORM
1.PROCESS NAME 5. SUPPLIER INVOLVEMENT 9.FMEA DATE
2.DESIGN RESPONSIBILITY 6. MODEL 10.FMEA REV.DATE
3.PERSON RESPONSIBILTY 7.ENG.RELEASE DATE
4.TEAM 8.PREPARED BY PAGE 0F PAGES

PROCESS POTENTIAL POTENTIAL S POTENTIAL O DETECTION D R RECOMMENDED ACTION ACTION ACTION RESULTS
FUNCTION FAILURE EFFECTS OF E CAUSES OF C METHOD E P ACTION PLAN AND TAKEN S O D R
MODE FAILURE V FAILURE C T N TARGET E C E P
DATES V C T N

11 12 13 14 15 16 17 18 19 20 21 22 23 24

TPM SECRETARIAT - ORAI FACTORY


SEVERITY GUIDELINE -PROCESS/SERVICE FMEA
RANK RATING PROCESS SERVICE

1 MINOR UNREASONABLE TO EXPECT UNREASONABLE TO EXPECT THAT


THAT THE MINOR NATURE OF THE MINOR NATURE OF THE
THIS FAILURE WOULD CAUSE FAILURE WOULD CAUSE ANY
ANY REAL EFFECT ON THE NOTICEABLE EFFECT ON THE
PRODUCT AND/OR PRODUCT AND/OR THE SERVICE. THE
SERVICE.FAILURE MAY NOT FAILURE IS MOST LIKELY NOT BE
EVEN BE NOTICED NOTICED
2 –3 LOW A SLIGHT DETERIORATION OF A VERY SLIGHT DETERIORATION OF
THE PRODUCT AND/OR THE PRODUCT AND/OR SERVICE IS
SERVICE,A SLIGHT PROBABLY NOTICED
INCONVENIENCE IN THE NEXT
PROCESS,OR A MINOR REWORK
4–6 MODERATE MAY CAUSE THE USE OF SOME DEGRADATION OF
UNSCHEDULED REPAIR AND/OR PERFORMANCE IS NOTICEABLE
DAMAGE TO EQUIPMENT
7–8 HIGH MAY CAUSE DISRUPTION TO HIGH DEGREE OF DISSSATISFACTION
SUBSEQUENT PROCESSES DUE TO THE NATURE OF FAILURE
AND/OR SERVICES
9 - 10 VERY HIGH FAILURE AFFECTS SAFETY SAFETY ISSUES ARE INVOLVED

TPM SECRETARIAT - ORAI FACTORY


OCCURRENCE GUIDELINE -PROCESS/SERVICE FMEA

PROCESS SERVICE
RANK CRITERIA RANK CRITERIA

1 REMOTE PROBABILITY OF 1 FAILURE IS UNLIKELY


OCCURRENCE. CAPABILITY
SHOWS T LEAST X-BAR +/- 3
WITHIN
SPECIFICATIONS(1/10,000)
2–5 LOW PROBABILITY OF 2–5 VERY LOW. ISOLATED FAILURES
OCCURRENCE. PROCESS IN EXISTS
STATISTICAL CONTROL
6–7 MODERATE PROBABILITY OF 6–7 LOW. ISOLATED FAILURES OCCUR
OCCURRENCE. PROCESS IN SOMETIMES
STATISTICAL CONTROL WITH
OCCATIONAL FAILURES, BUT
NOT IN MAJOR PROPORTIONS
8–9 HIGH PROBABILITY OF 8–9 MODERATE. PROCESS IN
OCCURRENCE. PROCESS IN STATISTICAL CONTROL WITH
STATISTICAL CONTROL WITH OCCATIONAL FAILURES BUT NOT IN
FAILURES OFTEN OCCURRING MAJOR PROPORTIONS
10 VERY HIGH PROBABILITY OF 10 HIGH. PROCESS IS NOT STATISTICAL
OCCURRENCE. FAILURE IS CONTROLLED. HAVE FAILURES
ALMOST CERTAIN. OFTEN

TPM SECRETARIAT - ORAI FACTORY


DETECTION GUIDELINE -PROCESS/SERVICE FMEA
PROCESS SERVICE
RANK CRITERIA RANK CRITERIA

1 VERY HIGH. CONTROLS ALMOST 1 REMOTE LIKELIHOOD THAT THE


CERTAINLY WILL DETECT THE PRODUCT OR SERVICE WILL BE
EXISTENCE OF A DEFECT DELIVERED. DETECTION RELIABILITY
AT LEAST 99.99 %
2–5 HIGH. CONTROLS MAY DETECT 2–5 LOW LIKELIHOOD THAT THE PRODUCT
THE EXISTENCE OF A DEFECT WOULD BE DELIVERED WITH THE
DEFECT. DETECTION RELIABILITY AT
LEAST 99.80 %
6–8 MODERATE. CONTROLS MAY 6–8 MODERATE LIKELIHOOD THAT THE
DETECT THE EXISTENCE OF A PRODUCT WILL BE DELIVERED WITH TH
DEFECT DEFECT. DETECTION RELIABILITY AT
LEAST 98%
9 LOW. CONTROLS MORE LIKELY 9 HIGH LIKELIHOOD THAT THE PRODUCT
WILL NOT DETECT THE WOULD BE DELIVERED WITH THE
EXISTENCE OF A DEFECT DEFECT. DETECTION RELIABILITY
GREATER THAN 90%
10 VERY LOW. CONTROLS VERY 10 VERY HIGH LIKELIHOOD THAT THE
LIKELY WILL NOT DETECT THE PRODUCT AND/OR SERVICE WILL BE
EXISTENCE OF A DEFECT DELIVERED WITH THE DEFECT. ITEM IS
USUALLY NOT CHECKED OR NOT
CHECKABLE.

TPM SECRETARIAT - ORAI FACTORY


GUIDELINE - INTERPRETATION OF RPN
90%
• Minor Risk 1-13
• Moderate Risk 14 -52
• Major Risk 53 -125
95%
• Minor Risk 1-6
• Moderate Risk 7 - 24
• Major Risk 25 - 125

99%
• Minor Risk 1-2
• Moderate Risk 3 - 8
• Major Risk 9 - 125 Common Scale
• Minor Risk 1-17
• Moderate Risk 18 -63
• Major Risk 64 -125

TPM SECRETARIAT - ORAI FACTORY


AN EXAMPLE
PROCESS POTENTIAL POTENTIAL S POTENTIAL O DETECTION D R RECOMMENDED ACTION ACTION ACTION RESULTS
FUNCTION FAILURE EFFECTS OF E CAUSES OF C METHOD E P ACTION PLAN AND TAKEN S O D R
MODE FAILURE V FAILURE C T N TARGET E C E P
DATES V C T N

2 10 3 60
DOME MISALIGNED FIELD 1 STATIC 10 10 100
ASSEMBLY DOME FAILURE FLYOUT NONE 100% INSPECT

LUMP IN 2 10 2 40
WRONG 2 WRONG 10 INCOMING 7 140 INCOMING
SHIM OVERLAY MATERIAL INSPECTION SPC

NO OPERATOR
SHIM COSMETIC 2 7 INSPECTION 8 112 KEEP GOOD 2 7 3 42
ERROR PARTS FOR
COMPARISON

REDESIGN
MISREGIS- DOME 2 OPERATOR 10 INSPECTION 5 100 PART FOR 1 1 1 1
TERED SLIP ERROR FOOL PROOF
RETAINER DESIGN

RETUR
RETUR
NN
TPM SECRETARIAT - ORAI FACTORY

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