FMEA Form v3.

FMEA

Process/Product Name: Analisis de Muestras Prepared By: Camilo Varela Vega

Responsible: Analistas de laboratorio FMEA Date (Orig.): 20-Jun (Rev.): 2020--06-20

Potential Failure Potential Failure

OCCURRENCE (1 - 10)

OCCURRENCE (1 - 10)
Process Step/Input Potential Causes Current Controls Action Recommended Resp. Actions Taken

DETECTION (1 - 10)

DETECTION (1 - 10)
Mode Effects

SEVERITY (1 - 10)

SEVERITY (1 - 10)
RPN

RPN
What are the
What is the impact on What causes the step,
What is the process In what ways could What controls exist that recommended actions for Who is responsible for What actions were
the customer if this change or feature to go
step, change or feature the step, change or either prevent or detect reducing the occurrence of making sure the actions completed (and when) with
failure is not prevented wrong? (how could it
under investigation? feature go wrong? the failure? the cause or improving are completed? respect to the RPN?
or corrected? occur?)
detection?

Condiciones Laboratorio con Emision de Averias en los aires Lectura en Mantenimiento Coordinador de Se establecio
ambientales de condiciones resultado de acondicionados termohigrometros. preventivo de los laboratorio programa de
laboratorio ambientales fuera analisis incorrecto 8 7 5 280 aires acondicionados mantenimiento 8 3 5 120
de especificación preventivi
Condiciones Laboratorio con Emision de Equipos de medición Programa de Sistema de alarmas Coordinador de Libro de datos que
ambientales de condiciones resultado de no calibrados calibración de de aviso laboratorio se alimenta con
laboratorio ambientales fuera analisis incorrecto 8 4 equipos 5 160 fechas de calibración 8 1 1 8
de especificación
Condiciones Laboratorio con Emision de Error en la digitación Grafico de Llevar un registro Coordinador de Libro electronico de
ambientales de condiciones resultado de - No corección de correccion digital que laboratorio registro de datos,
laboratorio ambientales fuera analisis incorrecto 8 temperatura 7 3 168 automaticamente formulado con 8 1 1 8
de especificación haga la coreccion de corecciones y
acuerdo al certificado alarmas cuando

0 0

0 0

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 FMEA Form v3.6

FMEA

Process/Product Name: Coffee Process Prepared By: Tracy

Responsible: Servers FMEA Date (Orig.): May 15th (Rev.): May 30th

Potential
Process Potential Potential Current Action Actions
Failure Resp.

OCCURRENCE (1 - 10)

OCCURRENCE (1 - 10)
Step/Input Failure Mode Causes Controls Recommended Taken

DETECTION (1 - 10)

DETECTION (1 - 10)
Effects

SEVERITY (1 - 10)

SEVERITY (1 - 10)
What are the

RPN
What is the Who is
What causes What controls recommended What actions
What is the In what ways impact on the responsible
the step or exist that either actions for reducing were completed
process step or could the step or customer if this for making
feature to go prevent or the occurrence of (and when) with
feature under feature go failure is not sure the
wrong? (how detect the the cause or respect to the
investigation? wrong? prevented or actions are
could it occur?) failure? improving RPN?
corrected? completed?
detection?

Fill carafe Wrong Coffee too Faded level Visual Replace old Mel Carafe
with water amount of strong or 8 marks on 4 Inspection 4 128 carafes replaced 8 1 3
water weak carafe 9/15
Water spilled None Train Flo Trained on
8 from carafe 5 9 360 employees 9/20 8 2 7

Water too Coffee too Faucet not Finger Train Flo Trained on
warm strong 8
allowed to 8 4 256 employees 9/20 8 2 6
run cool
Employee None Train Flo Trained on
unaware of employees 9/20
8 7 7 392 8 1 8
need for cool
water
Unclean Foreign Carafe not Visual Appoint Alice Vera
carafe objects in 10 washed 4 Inspection 4 160 inspector appointed 10 1 4
coffee before storage 9/21
Bad tasting Carafe Training Create storage Alice Bin & visual
coffee 10 stored 7 5 350 & instructions instructions 10 2 3
improperly done 9/25

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 FMEA Form v3.6

FMEA

RPN
24

112

96

64

40

60

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 FMEA Form v3.6

FMEA

Process/Product Name: Food Order Delivery Prepared By: Team Lead

Responsible: Manager FMEA Date (Orig.): May 1st (Rev.): May 5th

Potential
Process Potential Potential Current Action Actions
Failure Resp.

OCCURRENCE (1 - 10)

OCCURRENCE (1 - 10)
Step/Input Failure Mode Causes Controls Recommended Taken

DETECTION (1 - 10)

DETECTION (1 - 10)
Effects

SEVERITY (1 - 10)

SEVERITY (1 - 10)
What are the

RPN
What is the Who is
What causes What controls recommended What actions
What is the In what ways impact on the responsible
the step or exist that either actions for reducing were completed
process step or could the step or customer if this for making
feature to go prevent or the occurrence of (and when) with
feature under feature go failure is not sure the
wrong? (how detect the the cause or respect to the
investigation? wrong? prevented or actions are
could it occur?) failure? improving RPN?
corrected? completed?
detection?

Changing Run out of Unable to Supply chain Won't know Give vendor a Manager Directions
Vendors key food offer issues until delivery 30-day trial created,
products standard copied and
menu items 8 8 10 640 distributed 8 6 10
on May 5th

Delivering to Won't know Have vendor Manager Instituted on

8 others first 8 until delivery 10 640 call to confirm May 5th 8 4 10
quantities
Impose Manager Instituted on
8 8 10 640 penalties for May 6 8 4 10
missed items
Products Customers The vendor Won't know Conduct taste Chef Setup testing
may differ reject the has found until tests on any trials on May
from what's new cheaper customers new brands of 5th
currently products 10 sources 9 taste new 10 900 products - 10 4 10
served product reject as
needed

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 FMEA Form v3.6

Vendor Won't know Have vendor Manager Contact

delivers best until replace any vendor as
10 food to long- 7 customers 10 700 products that needed on 8 4 10
term taste new don't meet May 6
customers product requirements
0
0
0
0
0

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 FMEA Form v3.6

FMEA

RPN
480

320

320

400

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 FMEA Form v3.6

320

0
0
0
0
0

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 FMEA Form v3.6

FMEA

Process/Product Name: Establishing Stocking Levels Prepared By: Team

Responsible: Wesley FMEA Date (Orig.): 25-May (Rev.):

Potential
Process Potential Potential Current Action Actions
Failure Resp.

OCCURRENCE (1 - 10)

OCCURRENCE (1 - 10)
Step/Input Failure Mode Causes Controls Recommended Taken

DETECTION (1 - 10)

DETECTION (1 - 10)
Effects

SEVERITY (1 - 10)

SEVERITY (1 - 10)
What are the

RPN
What is the Who is What are the
What causes What controls recommended
What is the In what ways impact on the responsible completed
the step or exist that either actions for reducing
process step or could the step or customer if this for making action taken
feature to go prevent or the occurrence of
feature under feature go failure is not sure the with the
wrong? (how detect the the cause or
investigation? wrong? prevented or actions are recalculated
could it occur?) failure? improving
corrected? completed? RPN?
detection?

Chef to put Chef gets Delay of all 10 It takes too 10 White Board 4 400 Cross-Train all Scott 27-May 10 7 1
food into backed up food orders much time to showing kitchen staff to
containers with orders package food order handle pick-up
orders timing packaging
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

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 FMEA Form v3.6

0
0
0
0

Copyright 2019 GoLeanSixSigma.com. All Rights Reserved.

 FMEA Form v3.6

FMEA

RPN
70

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

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 FMEA Form v3.6

0
0
0
0
0

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 Severity Scale
Adapt as appropriate

Effect Criteria: Severity of Effect Ranking

Hazardous - May expose client to loss, harm or major disruption -

10
Without Warning failure will occur without warning

Hazardous - May expose client to loss, harm or major disruption -

9
With Warning failure will occur with warning

Major disruption of service involving client interaction, resulting in either

Very High 8
associate re-work or inconvenience to client

Minor disruption of service involving client interaction and resulting in either

High 7
associate re-work or inconvenience to clients

Major disruption of service not involving client interaction and resulting in either
Moderate 6
associate re-work or inconvenience to clients

Minor disruption of service not involving client interaction and resulting in either
Low 5
associate re-work or inconvenience to clients

Minor disruption of service involving client interaction that does not result in
Very Low 4
either associate re-work or inconvenience to clients

Minor disruption of service not involving client interaction and does not result in
Minor 3
either associate re-work or inconvenience to clients

No disruption of service noticed by the client in any capacity and does not result
Very Minor 2
in either associate re-work or inconvenience to clients

None No Effect 1
 Occurrence Scale

Per Item Failure

Probability of Failure Time Period Ranking
Rates

More than once per day >= 1 in 2 10

Very High: Failure is almost inevitable
Once every 3-4 days 1 in 3 9

Once every week 1 in 8 8

High: Generally associated with processes similar to
previous processes that have often failed
Once every month 1in 20 7

Once every 3 months 1 in 80 6

Moderate: Generally associated with processes
similar to previous processes which have
Once every 6 months 1 in 400 5
experienced occasional failures, but not in major
proportions
Once a year 1 in 800 4

Low: Isolated failures associated with similar

Once every 1 - 3 years 1 in 1,500 3
processes

Very Low: Only isolated failures associated with

Once every 3 - 6 years 1 in 3,000 2
almost identical processes

Remote: Failure is unlikely. No failures associated

Once Every 7+ Years 1 in 6000 1
with almost identical processes
 Detection Scale

Criteria: Likelihood the existence of a defect will be detected

Detection by process controls before next or subsequent process, -OR- Ranking
before exposure to a client

Almost Impossible No known controls available to detect failure mode 10

Very remote likelihood current controls will

Very Remote 9
detect failure mode

Remote likelihood current controls will

Remote 8
detect failure mode

Very low likelihood current controls will

Very Low 7
detect failure mode

Low Low likelihood current controls will detect failure mode 6

Moderate likelihood current controls will

Moderate 5
detect failure mode

Moderately high likelihood current controls will

Moderately High 4
detect failure mode

High High likelihood current controls will detect failure mode 3

Very high likelihood current controls will

Very High 2
detect failure mode

Current controls almost certain to detect the failure mode.

Almost Certain Reliable detection controls are known 1
with similar processes.