Professional Documents
Culture Documents
Potential Effect on S O D R S O D
Process Step or Variable Future
Potential Failure Mode Customer Because of E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
or Key Input RPN
Defect V C T N V C T
Detection of cause?
Future Occurance
to the customer?
Future Detection
How probable is
How frequent is
What are the actions for
order concerns
Future Severity
In what ways can the What are the existing What were the actions
What is the impact on the reducing the Occurrence of
Process Step, Variable, or What causes the Key Input controls that either prevent Who's Responsible for the implemented? Include
Key Output Variables the cause, or improving
What is the process step? Key Input go wrong? to go wrong? (How could the failure mode from recommended action? What completion month/year.
(customer requirements) or Detection? Should
(chance of not meeting the failure mode occur?) occurring or detect it should date? (Then recalculate resulting
internal requirements? have actions on high RPN's
requirements) it occur? RPN.)
or Severity of 9 or 10.
proliferación de bacterias y
Cocción y adición Que quede la fruta cruda probabilidad de enfermedad
en el cliente
Concentración y
batido
Enfriado y envasado
Empaque
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Design FMEA
S O D R S O D
Item Potential Effect on Customer Future
Potential Failure Mode E Potential Causes C Current Process Controls E P Actions Recommended Resp.& Target Date Actions Taken E C E
Function Because of Defect RPN
V C T N V C T
Detection of cause?
Future Occurance
to the customer?
Future Detection
How probable is
How frequent is
Future Severity
order concerns
What are the Existing Controls What are the actions for
In what ways can the What is the impact on the Key What were the actions
List every conceivable failure & Procedures (Fail-Safe, Tests, reducing the Occurrence of the Who's Responsible for the
What is the component, Component, Subsystem or Output Variables (customer implemented? Include
and/or failure mechanism for Mathemat.Calcs)that prevent cause, or improving Detection? recommended action? What
function, or feature? System potentially fail to meet requirements) or internal completion month/year. (Then
each failure mode either the cause or the failure Should have actions on high date?
the Design Intent ? requirements? recalculate resulting RPN.)
mode RPN's or EASY FIXES
Plasticos con dimensiones Cliente molesto por recibir la Inspeccion antes de la Luis Reyes
incorrectas. presentacion dañada.
5 Daños fisicos. 1 Inspeccion visual. 2 10 18 / Julio / 2020
5 1 2 10
entrega al cliente.
Mal funcionamiento de las Falta de conocimiento Instalacion incorrecta de las Capacitacion de los Diana Muñoz
8 2 Inspeccion visual. 1 16 8 1 1 8
tablillas electronicas. adecuado del funcionamiento. tablillas. operadores. 18 / Julio / 2020
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Cliente:
Referencia cliente:
Nivel de modificación cliente:
Flujo de proceso Características
Parámetro característica
Nº Fase/operación Máquina/medio de producción proceso producto
Báscula x25fg .. pesado por paquete
individual
Recepción y lavado lavadora Clean master 256 Ciclo fruta sin residuos de jabón
1 completo
de frutas
2 Pre cocción
3 Despulpado
4 Cocción y adición
Concentración y
5
batido
Enfriado y
6
envasado
7 Empaque
PLAN DE CONTROL
PROTOTIPO
LANZAMIENTO
PRODUCCION
característica muestreo
producto Tipo Especificación Técnica de evaluación medida tamaño
sado por paquete *** ± 2% del peso indicado Verificacion contra peso patrón 1
dividual
uta sin residuos de jabón Crítica Max. De jabón 3ml / 100 prueba de laboratorio / Registro de datos 3 muestras
lts. Agua
Código: CP-01-
x25
Edición: 1
Fecha:
03/05/20
Preparado por: Mr. Cobi
Revisado por: Mosito
Aprobado O.T.: Mi esposa
Plan de Reacción
muestreo (Reacción a situación de
frecuencia Método análisis anomalía)
cada lote Control Estadístico llamar a depto de
calibración
FREQUENCY Detection
Cpk
( 1 in … ) Certainty
Customer will not notice the adverse effect or it is Likelihood of occurrence is Sure that the potential failure will be found or prevented
1 insignificant remote 1,000,000 > 1.67 before reaching the next customer 100%
Customer will probably experience slight annoyance Low failure rate with supporting Almost certain that the potential failure will be found or
2 documentation 20,000 1.33 prevented before reaching the next customer 99%
Customer will experience annoyance due to the slight Low failure rate without Low likelihood that the potential failure will reach the
3 degradation of performance supporting documentation 5,000 approx. 1.0 next customer undetected 95
Customer dissatisfaction due to reduced performance Occasional failures Controls may detect or prevent the potential failure from
4 2,000 < 1.0 reaching the next customer 90
Customer is made uncomfortable or their productivity is Relatively moderate failure rate Moderate likelihood that the potential failure will reach
5 reduced by the continued degradation of the effect with supporting documentation 500 the next customer 85
Warranty repair or significant manufacturing or assembly Moderate failure rate without Controls are unlikely to detect or prevent the potential
6 complaint supporting documentation 100 failure from reaching the next customer 80
High degree of customer dissatisfaction due to Relatively high failure rate with Poor likelihood that the potential failure will be detected
7 component failure without complete loss of function. supporting documentation 50 or prevented before reaching the next customer 70
Productivity impacted by high scrap or rework levels.
Very high degree of dissatisfaction due to the loss of High failure rate without Very poor likelihood that the potential failure will be
8 function without a negative impact on safety or supporting documentation 20 detected or prevented before reaching the next 60
governmental regulations customer
Customer endangered due to the adverse effect on safe Failure is almost certain based Current controls probably will not even detect the
system performance with warning before failure or on warranty data or significant potential failure
9 violation of governmental regulations Design Verification* testing 10 50
Customer endangered due to the adverse effect on safe Assured of failure based on Absolute certainty that the current controls will not detect
10 system performance without warning before failure or warranty data or significant 2 the potential failure < 50
violation of governmental regulations Design Verification* testing
*Design Verification Testing (DVT): Test conducted when designing new products/services to verify that the optimal process design performs at the level specified by customer requirements (CTQs).
DVT is a methodical approach used to identify and resolve problems before finalizing the process for new products/services.
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