FAILURE MODES and EFFECTS ANALYSIS

Modelo FMEA / AMEF

ANALISIS DE MODO Y EFECTOS DE LA FALLA

PROBLEMAS

ANALIZARLOS
CORREGIRLOS PREVENIRLOS
MITIGARLOS
RESOLVERLOS

PHVA FMEA
DMAIC
GUIA DE ANALISIS DE FALLOS

http://issuu.com/davidalejandro.aguilera/docs/amef
 Modelo FMEA - AMEF
OBJETIVO

MEJORAR * PROCESOS

• Productividad

• Calidad • PRODUCTOS
• SERVICIOS
• Fiabilidad

• Seguridad * ERRORES HUMANOS

 Why Create an FMEA?

As a means to
management…

RISK!!!
We want to avoid causing failures in the Process.
El AMEF o FMEA es una técnica de
prevención utilizada para detectar por
Anticipado los posibles modos de falla con
el fin de establecer los controles
Adecuados que eviten la ocurrencia de
defectos.

Modo falla. Es la manera en que podría

Presentarse una falla o defecto. Para
Determinarlos cuestionamos..¿ de que forma
Podría fallar la parte o proceso ?
3
 History of FMEA

History of FMEA:

• First used in the 1960’s in the Aerospace industry during

the Apollo missions

• In 1974 the Navy developed MIL-STD-1629 regarding the

use of FMEA

• In the late 1970’s automotive applications driven by

liability costs began to incorporate FMEA into the
management of their processes

• Automotive Industry Action Group (AIAG) now maintains

the FMEA standard for both Design and Process FMEA’s
4
 Purpose of FMEA

FMEA’s:

• Improve the quality, reliability and safety of

products.

• Increase customer satisfaction.

• Reduce product development time and cost.

• Document actions taken to reduce risk and improve

the process.

• ¨Focus on continuous problem prevention not

problem solving ¨.
 Definition of FMEA

Failure Modes Effect Analysis (FMEA) is a structured approach

to:

• Predict failures and prevent their occurrence in manufacturing

and other functional areas that generate defects.
• Identify the ways in which a process ¨can ¨ fail to meet critical
customer requirements.
• Estimate the Severity, Occurrence and Detection (SOD) of
defects
• Evaluate the Control Plan for preventing these failures from
occurring and escaping to the customer.
• Prioritize the actions that ¨should be ¨ taken to improve and
control the process using a Risk Priority Number (RPN).

Give me an “F”, give me an

“M”……
 Modelo FMEA - AMEF
ANALISIS DE MODO Y EFECTO DE FALLO
OBJETIVOS

• Evaluar el riesgo asociado con defectos

• Identificar los modos de falla potenciales y calificar la severidad de su efecto

• Identificar, estimar, establecer, priorizar y Evaluar un riesgo.

• Priorizar las causas sobre las cuales hay que actuar
• Evaluar objetivamente la ocurrencia de causas y la habilidad de los
controles para detectar la cauda cuando ocurre
• Formular hipótesis acerca de la relación entre variables
• Clasifica el orden potencial de deficiencias de producto y proceso

• Establecer prioridades y orientar esfuerzos en la recolección de datos

• Identificar acciones que reduzcan o eliminen las probabilidades de falla.
• Se enfoca hacia la prevención y eliminación de problemas del producto
y proceso
 Modelo FMEA
• FMEA de : DISEÑO. Analiza los componentes de diseño.
se enfoca en los modos de falla asociados con la
funcionalidad de un componente causado por el diseño.

• FMEA de : PROCESO. Analiza los procesos de manufactura y

ensamble. Se enfoca en la incapacidad para producir el
requerimiento que se pretende ¨un defecto ¨. Los modos de
fallo pueden derivar de las causas identificadas en el AMEF
de diseño.
 When to use FMEA
AS EARLY AS POSSIBLE

– When new systems, products and processes are being designed E NT

R EV
P
– When existing designs and processes are being changed

– When carry-over designs or processes will be used in new applications or

environments

– After completing a Problem Solving Study, to prevent recurrence of a problem

– When existing lack of clarity about what the important variables are and how they
impact output quality

– When you need to prioritize data collection effort

DO THE BEST YOU CAN WITH WHAT YOU HAVE

 How to Conduct an FMEA ( Matriz )
Se recomienda que sea un grupo multidisciplinario, el ingeniero responsable del proceso y la participación
De diferentes áreas como mantenimiento, calidad, I&D.,

1. Identify potential failure modes, ways in which the product,

service, or process might fail
2. Identify potential effect of each failure (consequences of that
failure) and rate its severity
3. Identify causes of the effects and rate their likelihood of
occurrence
4. Rate your ability to detect each failure mode
5. Multiply the three numbers together to determine the risk of
each failure mode (RPN = Risk Priority Number)
6. Identify ways to reduce or eliminate risk associated with high
RPNs
How to Conduct an FMEA ( Matriz )

SIPOC

S U B P R O C E S O S
 Modelo FMEA - AMEF
ALGUNOS EJEMPLOS

AMEF ( Modo ) AMEF ( Efecto ) AMEF ( Causa )

• Roto * Deterioro prematuro

* Selección de material
• Flojo
* Tolerancias
• Fracturado * Ruidoso
* Ambiente
• Equivocado
* Aspecto térmico
• Deformado * Operación errática
* Rendimiento
• Agrietado
* Fatiga
• Mal ensamblado * Paros de línea *
 FMEA Worksheet

Total Risk Priority Number (S*O*D) =

La SEVERIDAD antes y después de implementadas las acciones, es la misma.

 Capturing FMEA Information FMEA Analysis Date ___________ (original)
___________ (revised)
Project: _____________________ Team: _____________________

Occurrence

Occurrence
“After”

Detection

Detection
Item or Potential Potential Responsibility

RPN
Severity

Severity

RPN
Process Failure Effect (s) Potential Current Recommended and
Step Mode of Failure Cause(s) Controls Action Target Date Action Taken

Total Risk Priority Number (S*O*D) = “After” Risk Priority Number =

 FMEA Components…Process Step

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes of C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Enter the Name of the Process Function here. The FMEA

should sequentially follow the steps documented in your
Process Map.
Phone
Dial Number
Listen for Ring
Say Hello
Introduce Yourself
Etc.
15
 FMEA Components…Potential Failure Modes

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Functio Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
n Modes Effects V a of Failure C Controls T N Target Date V C T N
(Step) (process (Y's) s (X's)
defects) s

Potential Failure Modes refers to the mode in which the

process could potentially fail.

This information is obtained from Historical Defect Data.

A failure mode is a name for a defect.

At a crossroads?
 Potential Causes of Failure (X’s)

# Process Potential Potential S Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E Causes C Process E P Actions Person & Action E C E P
(Step) Modes Effects V of Failure C Control T N Target Date s V C T N
(process (Y's) (X's) s
defects)

Potential Causes of the Failure refers to how the failure could

occur.
This information should be obtained from the Fishbone Diagram.

17
 FMEA Components…Occurrence “OCC”

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Occurrence refers to how frequently the specified failure is

projected to occur.
This information should be obtained from Capability Studies
or Historical Defect Data - in conjunction with the
predetermined scale.

18
 FMEA Components…Current Process Controls

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Current Process Controls refers to the three types of

controls that are in place to prevent a failure. The 3 types of
controls are:

• SPC - (Statistical Process Control)

• Poke-Yoke – (Mistake Proofing)
• Detection after Failure – (Inspection)

Ask yourself “How do we control this defect?”

19
 FMEA Components…Detection (DET)

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Detection is an assessment of the probability that the

proposed type of control will detect a subsequent Failure
Mode.

This information should be obtained from your Measurement

System Analysis Studies and the Process Map. A rating
should be assign in conjunction with the predetermined
scale.

20
 Risk Priority Number “RPN”

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

The Risk Priority Number is a value that will be used to

rank order the concerns from the process.

The RPN is the product of Severity, Occurrence and Detect

ability as represented here…

RPN = (SEV)*(OCC)*(DET)

21
 FEMA Components…Actions

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Recommended Actions refers to the activity for the

prevention of a defect.

Responsible Person & Date refers to the name of the

group or person responsible for completing the activity and
when they will complete it.

Taken Action refers to the action and effective date after it

has been completed.
 FMEA Components…Adjust RPN

# Process Potential Potential S C Potential O Current D R Recommend Responsible Taken S O D R

Function Failure Failure E l Causes C Process E P Actions Person & Actions E C E P
(Step) Modes Effects V a of Failure C Controls T N Target Date V C T N
(process (Y's) s (X's)
defects) s

Once the Recommended Actions, Responsible Person &

Date, Taken Action have been completed the Severity,
Occurrence and Detection should be adjusted. This will
result in a new RPN rating.

El la FMEA la severidad NO cambia

23
 Sample ¨Severity¨ Rating Scale
• Severity = likely impact of the failure. Para estimar el grado de severidad, se debe tener en cuenta
El efecto de la falla en el cliente

Rating Criteria: A failure could…

10 Efecto peligroso. Seguridad relacionada. Falla repentina, incumplimiento con el

Bad
reglamento del gobierno.
9 Efecto de peligro potencial. Capaz de discontinuer el uso

8 El cliente está muy insatisfecho. Artículo inoperable

7 El cliente está insatisfecho. El desempeño se ve seriamente afectado.

6 El cliente se siente algo inconforme. El desempeño se ve afectado pero es operable.

5 El cliente se siente algo insatisfecho, efecto moderado en el desempeño.

4 El cliente se siente algo insatisfecho. Efecto moderado en el desempeño.

3 El cliente se siente algo molesto. Poco efecto en el desempeño del producto

2 Cliente no molesto. Poco efecto en el desempeño del producto

Good
1 Sin efecto
 Ranking Severity

Effect Criteria: Severity of Effect Defined Ranking

Hazardous: May endanger the operator. Failure mode affects safe vehicle operation and/or 10
Without involves non-compliance with government regulation. Failure will occur WITHOUT
Warning warning.
Hazardous: May endanger the operator. Failure mode affects safe vehicle operation and/or 9
With Warning involves non-compliance with government regulation. Failure will occur WITH
warning.
Very High Major disruption to the production line. 100% of the product may have to be scrapped. 8
Vehicle/item inoperable, loss of primary function. Customers will be very dissatisfied.

High Minor disruption to the production line. The product may have to be sorted and a portion 7
(less than 100%) scrapped. Vehicle operable, but at a reduced level of
performance. Customers will be dissatisfied.
Moderate Minor disruption to the production line. A portion (less than 100%) may have to be 6
scrapped (no sorting). Vehicle/item operable, but some comfort/convenience
item(s) inoperable. Customers will experience discomfort.
Low Minor disruption to the production line. 100% of product may have to be re-worked. 5
Vehicle/item operable, but some comfort/convenience item(s) operable at a
reduced level of performance. Customers will experience some dissatisfaction.
Very Low Minor disruption to the production line. The product may have to be sorted and a 4
portion (less than 100%) re-worked. Fit/finish/squeak/rattle item does not
conform. Most customers will notice the defect.
Minor Minor disruption to the production line. A portion (less than 100%) of the product may 3
have to be re-worked online but out-of-station. Fit/finish/squeak/rattle item
does not conform. Average customers will notice the defect.
Very Minor Minor disruption to the production line. A portion (less than 100%) of the product may 2
have to be re-worked online but in-station. Fit/finish/squeak/rattle item does
not conform. Discriminating customers will notice the defect.
None No effect. 1

* Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, 2002. Pgs 29-45. Chrysler Corporation, Ford Motor Company,
General Motors Corporation.
 Sample Transactional Severities

Effect Criteria: Impact of Effect Defined Ranking

Critical Business May endanger company’s ability to do business. Failure mode affects process
10
Unit-wide operation and / or involves noncompliance with government regulation.

Critical Loss - May endanger relationship with customer. Failure mode affects product delivered
Customer and/or customer relationship due to process failure and/or noncompliance with 9
Specific government regulation.

Major disruption to process/production down situation. Results in near 100%

High 7
rework or an inability to process. Customer very dissatisfied.

Moderate disruption to process. Results in some rework or an inability to process.

Moderate Process is operable, but some work arounds are required. Customers experience 5
dissatisfaction.
Minor disruption to process. Process can be completed with workarounds or
Low rework at the back end. Results in reduced level of performance. Defect is 3
noticed and commented upon by customers.
Minor disruption to process. Process can be completed with workarounds or
Minor rework at the back end. Results in reduced level of performance. Defect noticed 2
internally but not externally.
None No effect. 1

26
 Sample Severity Rating Scale
You will need to define your own criteria…
and be consistent throughout your FMEA

Let’s brainstorm how we might define

the following SEVERITY levels in our
own projects:
1, 5, 10
 Sample ¨Occurrence¨ Rating Scale
ES NECESARIO ESTIMAR EL GRADO DE OCURRENCIA DE LA CAUSA DE LA FALLA POTENCIAL
1 INDICA REMOTA PROBABILIDAD
10 INDICA MUY ALTA PROBABILIDAD

Rating Time Period Probability

10 Muy alta Este proceso o uno similar a fallado a menudo 1 en 3
Bad
9 Muy alta Este proceso o uno similar a fallado a menudo 1 en 6

8 Alta Este proceso o uno similar a fallado a menudo 1 en 15

7 Alta Este proceso o uno similar a fallado a menudo 1 en 50

4 Moderada Este proceso o uno similar con fallas ocasionales 1 en 150

5 Moderada Este proceso o uno similar con fallas ocasionales 1 en 800

6 Moderada Este proceso o uno similar con fallas ocasionales 1 en 4500

3 Poca Fallas aisladas con procesos similares 1 en 30000

Solo fallas aisladas asociadas

2 Muy poca 1 en 150000
con el producto o proceso
Good 1 Remota Falla improbable. No existen fallas asociadas < 1 en 1 millon
con el producto o proceso
 Ranking Occurrence

Probability of Failure Possible Failure Rates Cpk Ranking

Very High: Failure is almost ³ 1 in 2 < 0.33 10

inevitable.
1 in 3 0.33 9
High: Generally associated with
1 in 8 0.51 8
processes similar to previous processes
that have often failed.
1 in 20 0.67 7

Moderate: Generally associated with 1 in 80 0.83 6

processes similar to previous processes
that have experienced occasional 1 in 400 1.00 5
failures but not in major proportions.
1 in 2,000 1.17 4

Low: Isolated failures associated with

1 in 15,000 1.33 3
similar processes.
Very Low: Only isolated failures
associated with almost identical 1 in 150,000 1.5 2
processes.
Remote: Failure is unlikely. No failures
ever associated with almost identical £ 1 in 1,500,000 1.67 1
processes.

Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, 2002. Pg. 35.. Chrysler Corporation, Ford Motor Company, General Motors Corporation.

29
 Sample ¨Detection¨ Rating Scale
Rating Definition
10 Defect caused by failure is not detectable
Bad 9 Occasional items/transactions are checked for defects

8 Items/transactions are systematically sampled and inspected

7 All items/transactions are manually inspected

6 Manual inspection with mistake-proofing modifications

5 Process is monitored and manually inspected

4 Used with an immediate reaction to out of control

conditions

3 100% inspection surrounding out of control conditions

Good 2 All items/transactions are automatically inspected

1 Defect is obvious and can be kept from affecting customer

 Ranking Detection

Criteria: The likelihood that the existence of a defect will

Detection be detected by the test content before the product Ranking
advances to the next or subsequent process
Almost Impossible Test content must detect < 80% of failures 10

Very Remote Test content must detect 80% of failures 9

Remote Test content must detect 82.5% of failures 8

Very Low Test content must detect 85% of failures 7

Low Test content must detect 87.5% of failures 6

Moderate Test content must detect 90% of failures 5

Moderately High Test content must detect 92.5% of failures 4

High Test content must detect 95% of failures 3

Very High Test content must detect 97.5% of failures 2

Almost Certain Test content must detect 99.5% of failures 1

Potential Failure Mode and Effects Analysis (FMEA), AIAG Reference Manual, 2002 Pg. 35. Chrysler Corporation, Ford Motor Company, General Motors
Corporation.

31
 Adjusting FMEA Scales

– The scales for severity, occurrence, and detection

can be adjusted if necessary

– Before you use the standard scales, make sure

that this is in line with what your company uses
FMEA Example
 FMEA Example
• We will conduct an FMEA on the ¨truck stop
coffee¨ example we used to create a
prioritization matrix
• A green belt wants to improve customer
satisfaction with the coffee served at the truck
stop
• The process map and completed prioritization
matrix follow
Truck Stop Coffee Process Map
Truck Stop Coffee Process Map
Step 1: For Each Input, Determine The
Potential Failure Modes
Step 2: For Each Failure Mode, Identify
Effects And Assign Severity
Step 3: Identify Potential Causes Of Each
Failure Mode And Assign Score
Step 4: List Current Detection Controls For
Each Cause And Assign Score
Step 5: Calculate RPNs
Step 6: Develop Recommended Actions, Assign
Responsible Persons, and Note Actions Taken
Step 7: Compare RPN Prioritize and implement
Solutions
 Exercise : In your Project. Planning to
Minimize Failures
• Objective: Practice identifying critical variables using the
FMEA model.

• Instructions: Brainstorm Failure Modes appropriate for a

product, service, or process associated with your project, then
define potential Effects and Causes of those modes. Capture
your work on a flipchart. Be prepared to share your answers
with the class.

• OK Team, The rest of the Class

do the FMEA matrix to project