3 - Management System Excellence

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BIQS

Management System
BPD

BIQS Thinking

BIQS 02
Management
BIQS 05 System’s Excellence
BIQS 08
BIQS 09
BIQS 10
BIQS 12
BIQS 14
BIQS 15
BIQS 16
BIQS 23 Purposes and Values
BIQS 29
MANAGEMENT SYSTEMS´ EXCELLENCE

“Management’s job is to improve the system”


“Quality is everyone’s responsibility”
LPA

Fast
SCM
Response

Bypass/Deviation

Managing Mgt Problem


Process Change Control Change Solving
System
PTR

Feedback /
Alarm &
Feed
Escalation
forward

Andon
LAYERED AUDIT
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Layered Audit Layered Audit is an effective tool to confirm the processes are operating at
standard, and enhance continuous improvement.
Layered audits are in place to assess compliance to Leadership utilizes an audit process by going and seeing on the shop floor to
standardized processes, identify opportunities for continuous check process compliance, employee behavior and knowledge. Leadership
improvement , and provides coaching opportunities. uses Layered Audit as an opportunity for coaching. Recognition is used to
reinforce the right behaviors.
Layered audit process is owned by Management. Audit plan shall
include multiple levels of Management. Ask Leadership how Layered Audit works in the organization, who is involved
BIQS -2 in the layered audit process, what is the frequency of layered audits.
Audits are tracked and their results recorded. Is the layered audit sheet content relevant for the user (have each principle
calibrator review respective part of the audit sheet)? Layered audit questions
Follow up to address non compliance is in place. are reviewed from time to time to focus on the plant weaknesses.

Check that all findings are recorded on the audit sheet and those not solved
within the shift are transferred to countermeasure sheets.

Tip: “if everything is green”, then something is wrong. Either


not looking hard enough or asking wrong questions
BIQS Requirement
Layered audits are in place to assess compliance to standardized processes, identify opportunities
for continuous improvement , and provides coaching opportunities.
(Example)

Assess
compliance to
standardized
process

Provide Coach

(GMM)
 Verify the LPA content. Is it adequate to lead to assess
compliance to standardized processes and provide
coach?

Guidelines
 Layered Audit is an effective tool to confirm the processes are operating at standard, and enhance continuous improvement.
 Leadership utilizes an audit process by going and seeing on the shop floor to check process compliance, employee behavior and knowledge.
Leadership uses Layered Audit as an opportunity for coaching. Recognition is used to reinforce the right behaviors.
 Is the layered audit sheet content relevant for the user (have each principle calibrator review respective part of the audit sheet)?
 Layered audit questions are reviewed from time to time to focus on the plant weaknesses.
A Big Part Of A Leader’s Role Is To Establish Systems
& Then CHECK, CHECK, CHECK!!!

What Should be Checked??? Review processes to identify and


eliminate waste. Make improvements
and review again.
Items such as:
 Safety
 Workplace Organization
 Customer Requirements - Quality
 Process Control
 Standardized Work
Layered Audits is an effective tool that should be used by all levels of the organization to
conduct regular reviews

Reminder: “if everything is green”, then something is wrong. Either not looking hard
enough or asking wrong questions
CHECKLIST AUDITORIA ESCALONADA GRUPO Evaluación
ESTACIÓN
Planta Ensamble - Operaciones
LET Sem 1:

Fecha
. MET: _____________________ Tripulación: ____
LET Sem 2: MET: _____________________ Tripulación: ____
. MET: _____________________ Tripulación: ____
LET Sem 3: MET: _____________________ Tripulación: ____
. MET: _____________________ Tripulación: ____
MET: _____________________ Tripulación: ____
LET Sem 4:

Staff
Tripulación: ____

LGT
LET

LET

LET

LET
MET: _____________________

SL
.
LGT:
Safety VERIFICACIÓN PRIORITARIA (Realizada por TODOS los niveles de la Organización) X ó O

PI
1 - ¿El MET esta usando su EPP requerido como lo indica su MST y su equipo de protección personal de mutilaciones?

Workplace 2 -
¿Se siguen los estándares de Organización del Lugar de Trabajo en la estación de trabajo?
La localización de todos los objetos móviles esta marcada en el piso y se respeta; las herramientas y dispositivos se encuentran en su localización y no hay
objetos personales en los contenedores de material. No hay tornillos, tuercas o partes en el piso.
Organization ¿El Trabajo Estandarizado está siendo realizado como está definido en la Hoja de Trabajo Estándar (HTE)?
3 - Lee los elementos en la HTE, observa 3 ciclos y confirma si el MET esta siguiendo la secuencia correcta de los elementos. Revisa si en la HTE hay elementos
de contenido opcional y valida como se indica y cómo el MET identifica la opción en el Manifiesto.

STD
Standardized 4 -
¿El Trabajo Estandarizado está siendo realizado como está definido en las Hojas de Elemento de Trabajo (HETs)?
Lee las HETs, observa 3 ciclos y confirma si el MET esta siguiendo la secuencia correcta de los Pasos Principales y los Puntos Clave.
Work Verifica la ejecución de Inspecciones Secundarias, ejemplo: Conexiones Eléctricas y Clamps de Mangueras.

5 M
¿Puede el MET explicar la importancia, el significado y la relación de los Símbolos con su Trabajo Estándar?
¿Coinciden los Símbolos de la HTE con los de las HETs? El MET debe hacer referencia a lo que esta documentado en los "porqués" preguntale: ¿Qué, Cómo
LET
Quality y Por qué lo checa?
¿Es capaz el MET de explicar los Estándares de Calidad que aplican en su operación? ¿Están referenciados los Estándares de Calidad en las HETs en

BIQ
Standards 6 M la columna del "porqué"? ¿Cuenta el MET con el Equipo de Inspección Medición y Prueba requerido?
En caso de que no le apliquen estándares de calidad debe hacer referencia a los punto clave del "como" de las HETs.
¿El MET esta realizando las actividades de Limpieza y Atención Básica (LAB) con la frecuencia requerida?
7 M
Pide al MET que explique los requerimientos y en que consiste las actividades. Confirma la revisión del Error Proofing si aplica.
TPM Level 1

CI
¿Está funcionando el sistema del Andon apropiadamente?
8 -
Jala o activa el Andon de la estación y valida el funcionamiento de las luces de la estación, la música del equipo y el tablero de Andon.

Andon Revisa el scrolling o el diagrama de hilos y las gráficas de tiempos de ciclo en la HTE; ¿Existe desperdicio en la HTE revisada? Proporciona asesoría para la LGT

STD
9 M/L
eliminación del desperdicio que hayas identificado.

¿Se encuentra firmada la HTE por los LETs, LGTs y Superintendentes al frente y por los METs que rotan en la estación al reverso? Valida que el
10 L
recuadro de Registro de Cambios este firmado por los LETs, con fecha y descripción de los cambios realizados.

¿Están documentadas las actividades No Cíclicas en la HTE? Valida Hojas de Instrucción de Actividad (HIA)
11 L
En caso de que se requieran herramientas específicas para su ejecución, valida que sean las herramientas correctas.
Staff
STD
¿Las imágenes de las Hojas de Elemento de Trabajo aportan información clara y de valor agregado para el MET?
12 - Revisa que las imágenes de las HETs/HIAs sean claras y muestren el detalle de los Puntos Clave (secuencias, puntos de inicio/fin)
Verifica que existan fotos de Inspecciones Secundarias requeridas, ejemplo: Conexiones Eléctricas y Clamps de Mangueras, etc. Managers
13 L
¿Están documentados los problemas de Seguridad (accidentes e incidentes) y Calidad (todos los problemas en los que se haya emitido una Alerta de
Calidad) al reverso de las Hojas de Elemento de Trabajo?
Directors
Questions should be Valida que el MST este firmado y actualizado. Valida la vigencia del documento: 6 meses.
PI

14 L
Valida que los Químicos utilizados en la operación estén documentados en el MST y el EPP requerido por las HUS del Químico.

revised periodically based Revisa que en la estación ¿todos los materiales tienen definido un Mínimo y Máximo? ¿Qué exista un sistema de re-ordenamiento de material?
SLT

15 L Pregunte al MET ¿Cómo asegura PEPS del material? Valide el PEPS, Min-Max y que el MET re-ordene material a tiempo. En el área de sub-ensambles
verifica que no exista sobreproducción y que se respete el PEPS.

on business need Verifica que en la Estación de Trabajo no haya material sin identificar.
BIQ

16 L
Pide al LET te muestre la Mesa o Góndola de material no conforme y valida que el material se encuentre identificado.

ENFOQUE A CALIDAD - (Todas las verificaciones enfocadas a Calidad debe ser completadas en cada turno) XóO
BIQ

17 L Cumplimiento de registros, acciones y seguimiento de QSA aplicables al área / estación


N/A
Criterio: Cumple todos los Estándares Desviación encontrada No Aplica Total de desviaciones:

VERIFICACIÓN DE PROCESOS (Realizado en las Auditorias de los Superintendentes y Gerentes de Area) XóO

Valida el Plan de Entrenamiento y Plan de Rotación de un Equipo de Trabajo. Verifica la correcta relación de los documentos: JIT, Carta de
PI

18 LGT
Flexibilidad, Plan de Entrenamiento, Plan de Rotación y Registro de Rotación del Equipo en las estaciónes.

Valida en el BPD 4/5: Sí existen 12 semanas en Verde deberán de ser ajustados los objetivos y documentados al reverso del DO semanal. Valida que
19 LGT los objetivos son SMART. Sí existen 6 semanas en Rojo en un periodo de 10 semanas deberán estar emitidos RSPs. Valida que se esten llevando a
cabo las revisiones de BPD 4/5 y que exista evidencia de las revisiones.
CI

Solución Efectiva de Problemas, selecciona un RSP de la matriz de Calidad y verifica la existencia y el correcto llenado: Alerta de Calidad, AMEF
20 LGT
actualizado, PCP, KCC dados de alta en QSA, Error Proofing y QFC. Para fallas de Equipos revisar 15 diamantes.
STD

21 LGT WPO, valida que los Tableros en Group Rooms y Nerve Center se encuentren actualizados

Estaciones de Verificación (VS's), revisa que las Hojas de Respuesta Inmediata esten contestadas efectivamente y los Planes de Acción de Tops
BIQ

22 LGT
semanales y de Causas Comunes esten actualizados
Valida con el LGT la documentación y actualización de contramedidas en los tableros de BPD, Auditorías Escalonadas, CAT, 5F's, Soldadura, GMS,
CI

23 LGT
TIP y ANDON
M=MET L=LET -- = OBSERVAR **Por cada no corregida inmediatamente, documenta y da seguimiento a la hoja de contramedidas

Criterio: Cumple todos los estándares Desviación encontrada No Aplica N/A Total de desviaciones:
BIQS Requirement
Layered audit process is owned by Management. Audit plan shall include multiple levels of Management.
(Example)

Multiple levels of
Management starting
with Team Leader /
Coordinator / Supervisor

Guidelines
 Ask Leadership how Layered Audit works in the organization, who is involved in the layered audit process, what is the frequency of layered
audits.
Lordstown (Example) Orion (Example)
Level Purpose Min Frequency
Team Leader Maintain process and standards 1/ week –
in the team. Coach T/Ms. 1/day - (team quality focused
checks)

Group Leader Maintain process and standards 1/ week


within the group. Coach T/Ls.

Superintendent/Shift leader Verify process is in place and 1/ week


standards are maintained.
Coach/Teach G/Ls & T/Ls

Plant Mgr & Plant Joint High level overview to verify the 1/week
Leadership (may do individual process is working. Coach
or group audits) /Teach lower levels.

GMU Course #33947 (Example) San Luis Potosí (Example)

To define the adequate frequency, take into consideration the following factors: Plant turnaround level, Plant Level of maturity (provided by
data*), Business Result (internal and external) associated with past LPA results. As recommendation, start with daily frequency
(Example
)
Audit Plan –
Multiple Levels

(Example
)
BIQS Requirement
Audits are tracked and their results recorded.
Audits are tracked (Example) Audit Results are recorded

DEPT._________________ LAYERED PROCESS AUDIT RESULTS

100% 47 50
90% 43 43 45
80% 40
70% 35
60% 27 30
24
50% 23 22 25
20 19
40% 20
16 16
14
30% 15
20% 10
10% 5
0% 0
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC

JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
% IN COMPLIANCE: 88% 68% 95% 96% 97% 84% 95% 95% 94% 95% 95% 89%
# OF ITEMS ON ASSESSMENT: 20 15 20 30 20 10 20 25 20 20 20 20
# OF ASSESSMENTS 20 9 28 15 20 10 20 20 20 20 20 20
TOTAL # OF ITEMS ASSESSED: 400 135 560 450 400 100 400 500 400 400 400 400
# OF ITEMS IN COMPLIANCE: 353 92 533 434 386 84 380 477 376 381 378 357
NON CONFORMANCES 47 43 27 16 14 16 20 23 24 19 22 43

NON CONFORMANCES NUMBER OF ITEMS NOT IN COMPLIANCE


Safety 10 8 5 2 1 1 1 1 1 1 1 1
Missed Audits 10 8 3 2 3 4 5 2 1 1 1 10
5S Related 2 7 7 3 2 2 2 2 2 2 3 2
Product 10 4 3 2 1 1 1 1 1 1 1 10
Voice of Customer 6 4 2 2 3 4 4 4 3 2 2 10
Systemic 9 7 1 2 2 2 2 2 2 2 2 2
Gage Calibration 5 6 3 2 2 5 6 7 2 2 2
Poke Yoke 5 7 8 10 6

Guidelines
 Check that all findings are recorded on the audit sheet and those not solved within the shift are transferred to countermeasure sheets.
Interview auditors how they perform audit and compare results with shop floor major findings .
(Example)
BIQS Requirement
Follow up to address non compliance is in place.
(Example)
GM Example
• Team Leader / Supervisor: maximum
time to fill out the countermeasure (5
whys, action, due date and
responsible) is 5 business days
• Layered Audit Countermeasures are
reviewed and addressed during
regularly scheduled BPD reviews
across all shifts.
• Past due countermeasures must be
reviewed and addressed during
layered audits conducted by GL, EGM,
Senior Manager & Site Director

(Example)
Hint: Post the Information in the shop floor (Group/Team Level)
Layered Audit Table

Layered
Audit
Schedul
e and
Status
•Notify the Team Leader / Supervisor about issues
identified
•Countermeasure sheet shall be updated every time that
an open item is closed by Team Leader / Supervisor
Countermeasure
•Countermeasure sheet should be revised in a weekly
basis
•Retention period: maximum 3 months

Monthly
Metrics

LPA
Forms
Annual
Metrics
POSTING/VISUALIZING INFORMATION

R e q u ir eme nts fo r p o s ti n g s c h e dul e s, c o m p l eti o n tr a c ki n g,


a u d it r e s u l ts, a n d c o u n terme asure s a r e :

 C o mmo n l o c a ti o n a n d fo r m at w i th i n th e p l a n t
 Vis ib le w i th i n th e w o r k a r e a ( s h o p fl o o r )
 Mu s t s u p p ort r e g u l ar, fr e q u ent r e vi e w s
 N e a r o r b a c k o f G r o up L e a d e r B u s i n e ss P l a n b o a r d.
 Pla n t J o i n t L e a d e rshi p a n d Sh i ft L e a d e r/Su peri n te nde nt
s c h e dule s s h o u ld b e lo c a te d a t o r n e a r th e ir r e s p ective
BPD b o a r d s.

Near or Back of BPD

Quality Audits G/L & T/L Schedule

Priority Checks/ Countermeasure


Process Checks Sheets
Audits
FAST RESPONSE
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Quality Focused Checks Look for high risk quality focused items from Fast Response, customer
feedback and problem solving to be included in the quality focused section of
High risk items from Critical (Delta) operations have a Quality the layered audit, or other suitable checklist and checked each shift.
Focused check performed each shift.
BIQS -10 Look for high risk quality focused items from Delta C operations to be included
High risk quality focused items from customer feedback and in the quality focused section of the layered audit and checked each shift.
problem solving are included in the Quality Focused audit, or
other suitable checklist, and checked each shift.
AT GM….
1. “Delta C” Operations: Operations with KPC and/or High Risk
priority level. They affect directly fit/function, safety or regulatory NO. DE REGISTRO

requirements C-BIQ-CC-QR-19-2
FECHA DE EMISIÓN
MAYO 2010
FECHA DE REV. JUNIO.
REV. 5 2015

VERIFICACIÓN DEL PROCESO PAGINA : 1 DE: 2

C
FECHAS DEL: AL DEPARTAMENTO: TURNO:

NUMERO DE PARTE : NOMBRE (LGT/LET): FIRMA: ÍTEM OK: ÍTEM NO OK: X


LET MAQUINAS
TIPO DE OPERACIÓN

TIPO DE CARACTERISTICA
ACCIÓN CORRECTIVA
(KCDS: PQC, KPC, AQC, Máquina NOMBRE DE MAQUINA/ Op. ACCIONES A VERIFICAR L M M J V S D PLAN DE REACCION
INMEDIATA
etc.)
(COLOCAR PALABRA
DINAMICA O ESTATICA)

W6, W7, Verificar las Maquinas trabajen conforme a la EP-LI-06, Parar la Maquina y retroalimentar al
N/A
R.S. EP-LI-1 Y EP-LI-11 LGT para definir acciones a tomar.

Verificar que en los block's 859 se encuentran limpios los En caso de detectar block's sucios
W6, W7,
N/A pasos de aceite lado asiento a cabeza, asiento a carter y de los drenes de aceite, regranallar
R.S.
crankcase al salir de la màquina. nuevamente el material.

Si las piezas presentan exceso de


Verificar visualmente que las piezas limpias no presenten limpieza enviar a Scrap.si las piezas
W6, W7,
N/A exceso de limpieza y/o falta de limpieza en los block's presentan falta de limpieza pare la
R.S.
V-8 y L-4, cabezas V-8 y L-4 maquina y notifique al LGT para
tomar acciones correctivas.

En caso de detectar block's con los


Verificar que los block's 859 se encuentran destapados
W6, W7, drenes de aceite tapados no meter
N/A los pasos de aceite lado asiento a cabeza, asiento a
R.S. a proceso de granallado, colocar
carter y crankcase antes de darles la primera vuelta.
tarjeta amarilla y enviar a retrabajo.

2. “Delta Q” Operations: Operations with significant impact W6, W7,


R.S.
N/A
El operador inspecciona como lo marca su HET que el
material casting en negro haya sido vibrado y se
encuentren destapadas todas las zonas de las piezas que
En caso de detectar block's que no
estan vibrados no meter a proceso
de granallado, colocar tarjeta

(internal or external) tracked at Fast Response Meeting contribuyen a liberar residuos internos. amarilla y enviar a retrabajo.

En caso de que la maquina no


El operador revisa el nivel de granalla en tolva de cuente con suficiente granalla para
W6, W7,
N/A acuerdo a lo que marca su HIT, solicitar al operador que limpiar la maquina, pida a seglo traer
R.S.
explique el metodo de revision. granalla para adicionarla en la
maquina.

Q
En caso de que las piezas casting
no se cuelguen como lo indica la
W6, W7, Las piezas casting se cuelgan en los ganchos de la HET. Pare la maquina retroalimente
N/A
R.S. maquina de acuerdo a lo que marca la HET. al operador para que las piezas
sean colgadas como lo indica la
HET.
BIQS Requirement
High risk items from Critical (Delta) operations have a Quality Focused check performed each shift.

Schedule & Status (Example Quality Focused Audit (Example)


Critical operations – identification flow
) QUALITY FOCUSED CHECKS 1560 Team A TL

Start of Week Date: _____________________ Name:_________________________


Complete all shift checks using O/X: O - no deviation found X - deviation found NA-Not Applicable
ALSO RECORD THE JOB / VIN NUMBER OF CAR WHEN THE CHECK WAS COMPLETED
D at e
R easo n U LOC Issued Quality Check Description Mon Tue Wed Thu Fri Sat
ALCOHOL WIPE ONE COMPLETE FASCIA

KPC A
L
L
GCA ALL 01/15/16 EACH STYLE PER DAY - CHECK FOR WELD
IMPERFECTIONS - RECORD RACK NUMBER

GCA ALL 07/23/14 ARE ALL EMBLEMS INSTALLED PROPERLY

#1 KPC C
H
GEN ALL 07/23/14
DO PANELS MATCH RUN SHEET - COLOR

#1 E
C
K GEN ALL 07/23/14
AND STYLE

ARE ALL CHEMICAL BOTTLES AND SAFETY


S CANS LABELED PEOPERLY

A DO MACHINES HAVE PROPER MUTILATION


MUT ALL 07/23/14
R PROTECTION
E
DO OPERATORS HAVE PROPER
MUT ALL 07/23/14
T
MUTILATION PROTECTION
O
CHECK ONE RACK PER DAY FOR SAND
GCA ALL 07/23/14
SCRATCHES ON PANELS
B
E CHECK ONE RACK PER DAY FOR PANEL
MUT ALL 07/23/14
MUTILATIONS
C

KPC O
M
P
FR SW2 07/23/14
CHECK 6 FASCIA'S PER DAY FOR ZIPPER
BRACKET ALIGNMENT- GO/NOGO GAGE

#1 L
E
T
FR SW2 09/08/14
CHECK 6 FASCIA'S PER DAY FOR KEYLOCK
BRACKET ALIGNMENT- GO/NOGO GAGE
CHECK 2 LT4 AND 2 LT1 REAR FASCIA PANELS
E
FR SW2 08/17/15 EVERY 2 HOURS FOR WELD STRENGTH
D
(BONE TEST) RECORD RACK #
CHECK 2 FRONT FASCIA PANELS EVERY 2
D FR SW2 08/17/15 HOURS FOR WELD STRENGTH (BONE TEST)
A
RECORD RACK #
I
L
Y
GEN SW1 08/31/15
CHECK PICK LIGHTS FOR PROPER
OPERATION (Example)
CHECK PICK LIGHTS FOR PROPER
GEN SW2 08/31/15
OPERATION

Reason Legend: W: Warranty; PFA: Process Failure Alert from BG; PQS: Product Quality Standard; PMP: Production Maintenance Partnership; MS: Mandatory Sequence;
GCA: Audit Call; OSO: Operator Sensitive Operation; PQC: Product Quality Characteristics; EL: Electrical (DVT, Static, Etc); H20: Water Leak; MUT: Mutilation; GEN: General;
CO-R: Critical Operation; PCP-R: Process Control Check; FR-R: Fast Response (Required for a minimum of 20 days)
NOTE: "-R" means required check and it cannot be removed

KPC KPC
#1 #1

Guidelines
 Look for high risk quality focused items from Delta C operations included in the quality focused section of the layered audit and checked each
shift.
BIQS Requirement
High risk quality focused items from customer feedback and problem solving are included in the Quality Focused audit, or other
suitable checklist, and checked each shift.
Target Timing, Status, & Date Green
24 H 7D 14 D 34 D 35 D 40 D

Operator Instructions
Corrective Action

Corrective Action

(Institutionalized)
Lessons Learned
Layered Process
Proof/Detection
Containment -

Standard Work
Implemented

PFMEA / CP
Quality Alert
Breakpoint -

Root Cause
Identified

Validated

Updated
Audits
Error
Reason Legend: W: Warranty; PQS: Product Quality Standard;
MS: Mandatory Sequence; GCA: Audit Call; PQC: Product Quality
Characteristics; KPC: Key Product Characteristic; GEN: General;
CO-R: Critical Operation; PCP-R: Process Control Check; FR-R:
Fast Response (Required for a minimum
of 20 days)
NOTE: "-R" means required check and it cannot be removed

Guidelines
 Look for high risk quality focused items from Fast Response, customer feedback and problem solving to be included in the quality focused section
of the layered audit, or other suitable checklist and checked each shift.
Quality Focused: example of questions used in each Problem Solving phase

Target Timing, Status, & Date Green


24 H 7D 14 D 34 D 35 D 40 D

Operator Instructions
Corrective Action

Corrective Action

(Institutionalized)
Lessons Learned
Layered Process
Proof/Detection
Containment -

Standard Work
Implemented

PFMEA / CP
Quality Alert
Breakpoint -

Root Cause
Identified

Validated

Updated
Audits
Error
Containment:
• Quality Alert is posted (VS and operation) Documentation:
• Inspection method clearly defined • Standardized work has been updated
• People are trained and following the • Process Control Plan has been updated
inspection method • PFMEA has been updated
• Approved parts are identified and stored • PTR form has been used (BIQS 14)
properly • Read Across done properly
• Records are up to date (e.g.: I-Chart)

Corrective Action Implemented: Corrective Action Validated:


• Quality Alert is still posted (VS and operation) • Quality Alert is still posted (VS and operation)
At workstation At workstation
• Corrective action is working properly • Corrective action is working properly
• If EP is in place, its verification is being done At VS:
properly • People still are following the inspection method
• The process change procedure has been used • Approved parts are identified and stored
(BIQS 12) properly
At VS: • Records are showing the effectiveness of
• People still are following the inspection method action
• Approved parts are identified and stored
properly
• Records are up to date (e.g.: I-Chart)
FAST RESPONSE
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Fast Response Process Verify that the Fast Response process is used for all significant quality issues
(customer/Visual Inspection station/GP12). Review the board or the log file
Minimum criteria for initiating Fast Response is met. Plant and select 3 closed problem to check how they are closed (Evaluate fast
Manager ensures the applicability and the timely completion of response problems on Pg. 1 of this document).
the items being tracked. Plant Staff level personnel actively
participate in daily meeting. Required documents are reviewed Confirm that the Plant Management ensures the applicability and the timely
(Fast Response Tracking Sheet, Problem Solving Document, completion of the items being tracked.
PFMEA, Process control plan, standardized work, Layered audits
BIQS -8 etc.). Confirm that the plant staff level personnel actively participate in daily meeting
and confirm that natural owner is assigned for FR issues .
Exit criteria with appropriate timing are defined for closing issues.
Verify that the required documents are reviewed and updated (e.g. Fast
There is read across of corrective actions to like operations. Response tracking sheet, problem solving document, PFMEA, Process
control plan, standardized work, layered audits, lessons learned, etc.)

Confirm that there is read across of corrective actions to like operations.


BIQS Requirement BIQS Requirement
Minimum criteria for initiating Fast Response is met. Plant Manager ensures the applicability and the timely
completion of the items being tracked

(Example)

Guidelines
 Verify that the Fast Response process is used for all significant quality issues (customer/Visual Inspection station/GP12).
 Review the board or the log file and select 3 closed problem to check how they are closed (Evaluate fast response problems on Pg. 1 of this
document).
 Confirm that the Plant Management ensures the applicability and the timely completion of the items being tracked.
BIQS Requirement BIQS Requirement
Plant Staff level personnel actively participate in daily meeting. Required documents are reviewed (Fast Response Tracking
Sheet, Problem Solving Document, PFMEA, Process control
(Example) plan, standardized work, Layered audits etc.).

Problem
Solving

PFMEA

Process Control
Plan

Std. Work (SOS &


JES)

Guidelines
 Confirm that the plant staff level personnel actively participate in daily meeting and confirm that natural owner is assigned for FR issues .
 Verify that the required documents are reviewed and updated (e.g. Fast Response tracking sheet, problem solving document, PFMEA, Process
control plan, standardized work, layered audits, lessons learned, etc.)
BIQS Requirement BIQS Requirement
Exit criteria with appropriate timing are defined for closing There is read across of corrective actions to like operations.
issues.
(Example) (Example)
DRILL WIDE MATRIX
Target Timing, Status, & Date Green SUPPLIER:
(Ref. GM 1927-69 Drill Wide Matrix)
SYMBOL & STATUS KEY:

O Original location

24 H 7D 14 D 34 D 35 D 40 D Name:
Location:
X
N/A
Location with similar process
Not Applicable
Duns: Completed & 3rd Party/GM verified

Operator Instructions
Contact Name: Completed & Supplier verified only
Corrective Action

Corrective Action

(Institutionalized)
Lessons Learned
Layered Process
Contact Phone: Not Completed

Proof/Detection
Containment -

Standard Work
E-mail: P Pass Through
Implemented

PFMEA / CP
Quality Alert
Breakpoint -

Root Cause
Identified

Validated
Tiered

Updated
Duns
Supplier

Audits
Error

Classification
Product /
Process

Press 1

Press 2

Press 3
Line 1

Line 2

Line 3

Cell 1

Cell 2

Cell 3

Tier 2

Tier 3

Tier 4
Part Name & EFFECT OF FAILURE N/C or CS DDW Completion
GM Plant FAILURE MODE PRR Number / Issue
Number MODE CPV Status & Verification 1 Champion Symbols
Containment

Corrective Action
Cause of Failure Mode Corrective Action
Prevent Corrective Action
Protect Corrective Action
Predict Corrective Action
Key Findings Corrective Action
Documentation Updated

A Process Failure Alert must be used to “read across” to other facilities and
engineering for preventive measures when a product quality issue (mfg. controllable):
is missed by first line of error detection, a Preventive Action Letter (PAL) letter is
issued, a Process Control Plan not followed has escaped the control of the plant or a
significant process failure occurs(e.g. safety, regulatory, statutory, etc.). A PFA may
also be used to communicate a significant process improvement. The receiving
plant(s) must implement preventive measures communicated through the PFA.

Guidelines
 Confirm that there is read across of corrective actions to like operations.
FAST RESPONSE
FAST RESPONSE PROCESS KEY STEPS

Departments gather significant issues from the past 24 hours.

Daily Fast Response Meeting assigns owner to each issue.


Outside the meeting the owner utilizes the Problem Solving
process to correct and prevent recurrence.

Issues are tracked on the Fast Response Tracking


Board. Owners are required to give periodic updates at
Fast Response meeting.

Owner responsible for completion of all exit criteria


including Lessons Learned. Results of Problem Solving
process communicated. Fast Response Tracking Board
indicates exit criteria is green.

Global Purchasing and Supply Chain


IS THERE ANYTHING WRONG?

ABC Company - Quality Fast Response Tracking Board


EXIT CRITERIA
STATUS KEY
Target Date
R
Missed
Initiated but not
Y
complete
Target Timing, Status, & Date Green G Complete
24 H 7D 14 D 34 D 35 D 40 D N/A Not Applicable

OVERALL STATUS
Actual Closed Date
Operator Instructions

Forecasted Closed
Field Rep Ranking

Open > 40 Days=R


Corrective Action

Corrective Action
Next Report Date

(Institutionalized)
Lessons Learned
Program/Product

Layered Process
Proof/Detection
Who Answered

Containment -

Standard Work
Date Opened

Implemented

PFMEA / CP
Quality Alert
Breakpoint -

Root Cause
Concern # /

By Owner
Customer

Identified

Validated

Updated
ITEM #

Audits
Owner

(RYG)
Name

Error

date
Issue Description Action Plan / Countermeasure

G G G G G G G
1/10 PRR Hood Brkt Material Contaminated F. LaFeve 2/21 Need operator approval and training Y
1/11 1/18 1/24 1/24 1/25 2/13 2/15
1 Mason 312869 24241198 completion for Work Instructions across shifts 2/19
Internal Radio
G G G G G G G
1/15 CAR 08- Spt. Brkt Burrs B. Adam s CLOSED N/A N/A G
1/15 2/16 2/10 2/20 2/10 2/17 2/20
2 Jones 626 15891477 2/24 20-Feb
Hinge
Parts mislocated on G G G G G G
1/21 PRR Assy McIntosh 2/23 N/A PLL Program Logic for Error Prevention device Y
assembly 1/22 1/26 2/1 2/17 2/17 2/18
3 Arnold 313123 21119878 to reprogrammed by 2/21. J. Busch - M.E. 3/2
FORD Seat Brkt
G
1/22 NCR MNOP- Mixed Parts J. McGrath 2/22 Y
1/22
4 Stelzer 4219 13456-AF 3/3
Internal Hinge
Paint dots found on G G R R R G
2/3 CAR 08- Assy J. McGrath 2/23 N/A N/A NA Y
loose & mis-built parts 2/4 2/7 2/8 2/8 2/23 2/20
5 Mehall 632 21119878 3/15
FAST RESPONSE MEETING
Agenda
1) Request update for both late items (Red) and items with due date for the current date
(according to column “Next Report out Date”)
2) Update the table
3) If for any item a response has not been provided, start a escalation process
4) Inform the team about the issues from the last 24 hours (based on entry criteria)
5) Assign natural owner
6) Inform the next report out date
7) After the meeting, review the information related to updates (containment matrix, root cause
analysis, corrective action plan, validation results, documentation updates, lessons learned,
quality focus check, etc.). Are there ok? In case of don’t, start the coaching process
FAST RESPONSE
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Team Problem Solving Process To provide common methods for solving problems that are understood and
used by all.
A well developed, standardized problem solving process exists at
all levels of the organization. A standardized problem solving process exists. A range of problem solving
activities are conducted for different problem types and complexities, including
Formal problem solving activities are initiated according to a single (special) cause, common (repetitive) cause, as well as more complex
specified criteria. multiple-cause problems.

Issues are identified, root causes analyzed and robust actions Ask to talk through some problems with Team Leaders and Supervisors.
completed in a timely manner. Ask how many formal problem solving activities the team has worked on in
BIQS -9 recent months?
Problem solving is driven at the Team level and all Teams are
involved. Leaders are actively involved coaching and guiding the Look for all teams should be involved in problem solving activities.
process. Look for a standardized process that includes: issue description and
definition, containment, probable cause analysis, root cause analysis (5
Whys), countermeasures, implementation plan, verification, approval to close,
and escalation or read across if needed.

Look for Leadership involvement (reviews, coaching, escalation, support, read


across, etc.)
BIQS Requirement
A well developed, standardized problem solving process exists at all levels of the organization.

PPS (Example)

(Example)
PLAN DE ACCIÓN

Date Reference Problem Root Cause - Why? Countermeasure - How? Responsible - Who? Status Support/Comments
Due Date
Root Cause Analysis: Problem Containment:
Problem Description - What?

Why?

Countermeasure Problem Definition: Where? When?


Why?

Why?
Problem Correction:

Why?

Why?
Problem Prevention:
Deviation - How much?

Root Cause (Last Why?):

Rev. y Aprob. LGT:(Aplica para Nivel 5: ETAD`s)______________________

IMMEDIATE RESPONSE ACTION SHEET / ALARM SHEET


Immediate VERIFICATION STATION: Y / N = Yes /No (circle one for each question, #2 - #5) *S=Supplier, A=Assembly/Build issue
VERIFICATION STATIONS RESPOND PRODUCTION RESPONDS

Response (Completed by the Verification Operator) (Completed by the responder)


Corrective Action:
1-Identify Point of Cause Station # ?
Date/ Product Who Was Escalation Immediate Fix 2-Standardized work followed?
*S Who Breakpoint
# Shift Line
Serial# Defect Description / Number
Called
Time
Level 1-5 What was done with the defective 3-Correct Tools / Fixtures / Error Proofing?
A Answered
Time
CSN #
Part? 4-Correct Parts?
5-Parts in spec?
6-What did you do to STOP a REPEAT defect from occurring?
1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
1 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
2 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
3 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
4 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
5 6:

Guidelines
 To provide common methods for solving problems that are understood and used by all.
BIQS Requirement
Formal problem solving activities are initiated according to a specified criteria.
(Example)

Guidelines
 A standardized problem solving process exists.
 A range of problem solving activities are conducted for different problem types and complexities, including single (special) cause, common
(repetitive) cause, as well as more complex multiple-cause problems.
BIQS Requirement
Issues are identified, root causes analyzed and robust actions completed in a timely manner.

PPS Countermeasure
PLAN DE ACCIÓN

Date Reference Problem Root Cause - Why? Countermeasure - How? Responsible - Who? Status Support/Comments
Due Date
Root Cause Analysis: Problem Containment:
Problem Description - What?

2
Why?

Why?

1 2 3
Problem Correction:
Problem Definition: Where? When? Why?

1 Deviation - How much?


Why?

Why?

Root Cause (Last Why?):

Rev. y Aprob. LGT:(Aplica para Nivel 5: ETAD`s)______________________


Problem Prevention:

3 Immediate Response
VERIFICATION STATION:
IMMEDIATE RESPONSE ACTION SHEET / ALARM SHEET

Y / N = Yes /No (circle one for each question, #2 - #5) *S=Supplier, A=Assembly/Build issue
VERIFICATION STATIONS RESPOND PRODUCTION RESPONDS
(Completed by the Verification Operator) (Completed by the responder)
Corrective Action:
1-Identify Point of Cause Station # ?
Immediate Fix 2-Standardized work followed?

2
Date/ Product Who Was Escalation *S Who Breakpoint
# Shift Line
Serial# Defect Description / Number
Called
Time
Level 1-5 What was done with the defective 3-Correct Tools / Fixtures / Error Proofing?
A Answered
Time
CSN #
Part? 4-Correct Parts?
5-Parts in spec?
6-What did you do to STOP a REPEAT defect from occurring?

1
1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
1 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
2 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
3 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
4 6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N

1 – Issues are identified


3
5 6:

2 – Root causes analyzed


3 – Robust actions completed

Guidelines
 Look for a standardized process that includes: issue description and definition, containment, probable cause analysis, root cause analysis (5
Whys), countermeasures, implementation plan, verification, approval to close, and escalation or read across if needed.
BIQS Requirement
Problem solving is driven at the Team level and all Teams are involved. Leaders are actively involved coaching and guiding the
process.

Roles and Responsibility (Example)

Leadership
Engineers
Members

Manager
Leaders

Leaders

Leaders
Group
Team

Team

Plant
Area
Shift
Tasks

P a rtic ipa te in
P ro ble m S o lving
      
Le a d/F o llo w-Up o n
P ro ble m S o lving 
within a Te a m
Le a d/F o llo w-Up o n
P ro ble m S o lving 
within a Gro up

Le a d/F o llo w-Up o n


P ro ble m S o lving  
within a De pa rtm e nt

Le a d/F o llo w-Up o n


P ro ble m S o lving
a c ro s s

De pa rtm e nts

Guidelines
 Ask to talk through some problems with Team Leaders and Supervisors.
 Ask how many formal problem solving activities the team has worked on in recent months?
 Look for all teams should be involved in problem solving activities.
 Look for Leadership involvement (reviews, coaching, escalation, support, read across, etc.)
1. Título del tablero: Debe llevar el título “Proceso
de Solución de Problemas” y en la parte inferior
1 del mismo el nombre del área que corresponda.
2 . Ta b l a d e s e g u i m i e n t o d e s o l u c i ó n d e p r o b l e m a s :
3 4 Colocar el formato de seguimiento a las diferentes
hojas de solución de problemas que estén abiertas
2 ( Ta m a ñ o C a r t a ) .
3. Proceso de Solución de Problemas: Esquema del
Proceso Estandarizado y los Pasos del Proceso de
Solución de Problemas.
4. Criterios de Solución de Problemas: Matriz de
criterios para disparar el proceso de solución de
p r o b l e m a s ( Ta m a ñ o C a r t a ) .
5. Ayudas visuales de estatus: Se colocan ayudas
visuales para identificar tres estatus del proceso,
c i r c u l o v e r d e , d e l t a a m a r i l l a & e q u i s r o j a . ( Ta m a ñ o
Carta).
5 6. Reportes de Solución de Problemas de los
Equipos: En cada columna colocar los formatos de
solución de problemas de los diferentes equipos
agrupados en las tres categorías de estatus, verde
cuando el proceso inicio hace menos de 30 días,
amarillo cuando el proceso tiene de 31 a 60 días y
rojo cuando el proceso tiene más de 60 días y en
cualquiera de los tres casos no ha sido cerrado.
Puede colocarse más de un equipo por columna,
6 siempre y cuando se trate de nivelar la cantidad de
e q u i p o s a s i g n a d o s a c a d a c o l u m n a . ( Ta m a ñ o
Carta).
PROBLEM SOLVING
A GM plant issued a PRR
against of one of its supplier
complaining about lack of weld
nuts

After a carefully
investigation, the company
has found the root cause
using the Drill Deep
Process. See in the next
slide its answer

38
IS THERE ANYTHING WRONG?
Failure Mode? Assembly without nuts

Cause of Failure Mode?


Prevent (Manufacturing System) Mix of material: finish good with WIP material
Error Proofing & Std. Work

Why? Mix of material: finish good with WIP material

Therefore (logical verification)


Why? Put WIP material on the finish good container

Why? It is easy to put WIP material on the finish good container

Why? WIP material and finish good material are close to the corridor

Why? This is the defined location of both material

Root Cause This is the defined location of both material

Countermeasures Locate material far from each other


39
IS THERE ANYTHING WRONG?
Failure Mode? Assembly without nuts

Cause of Failure Mode? Mix of material: finish good with WIP material
Error Detection & Containment
Detection (Quality System)

Why? Mix of material: finish good with WIP material

Therefore (logical verification)


Why? There´s no revision for material inside the container

Why? There´s no requirement about that

Why?

Why?

Root Cause There’s no requirement about that

Countermeasures Install a barrier in the corridor to avoid material mix


40
IS THERE ANYTHING WRONG?
Failure Mode? Assembly without nuts

Cause of Failure Mode? Mix of material: finish good with WIP material
Information content in all doc
Predict (Planning System)

Why? Mix of material: finish good with WIP material

Therefore (logical verification)


Why? There are controls established. However they are
not robust enough to prevent the issue
Why?

Why?

Why?

Root Cause There are controls established. However they are not
robust enough to prevent the issue
Countermeasures Update PFMEA and Process Control Plan
41
CALL FOR HELP
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Alarm and Escalation Verify that nonconforming material has sufficient alarm limits with escalation.

Nonconforming product has sufficient alarms limits with Confirm that alarms are responded to and the response is documented.
BIQS -16 escalation. Alarms are responded to according to the alarm and
escalation process (reaction plan).
BIQS Requirement
Nonconforming product has sufficient alarms limits with escalation. Alarms are responded to according to the alarm and escalation
process (reaction plan).

Alarm limits and Escalation (Example) Documented Response (Example)

Guidelines
 Verify that nonconforming material has sufficient alarm limits with escalation.
 Confirm that alarms are responded to and the response is documented and followed. Reaction plan is followed if alarm reached.
 Check that last gate before delivery to customer has alarm limit of 1. In some cases alarm limit in final gate could be bigger based on
requirements.
Defects Entering the Station Defects Entering the Station
1 2
Alarm and Escalation: Alarm and Escalation:

• Alarm limits are set based on type and number of defect found. SCOPE OF CHANGING ALARM LIMITS
• Alarm limits can be divided into two groups: PR&R type defect and High frequency Alarm limits are changed or reduced when there is:
low severity type defects.
• An intentional, permanent change in the actual process such as
through problem solving, or continuous improvement activity.
Past Customer defects shall always have an alarm of 1.
1 • A special cause variation, where despite our best efforts to
High frequency low severity type. discover the cause we are unable to make the correction and
THIS is an estimate based on the ability to detect. Use problem solving efforts have been escalated.
your judgment.
Variable
3 based on: The Goal for all alarms is ‘1’.
Need, It is best to not to have too many alarm levels so keep it
process, simple. Group the Alarms based on the levels and
No Alarms = No Improvement.
situation Highlight them so it clear as to When to Call for Help. Alarms Set too high increase the risk for an escape!

Defects Entering the Station


3 1st Hour 2nd Hour 3rd Hour 4th Hour 5th Hour 6th Hour 7th Hour 8th Hour
# Defects VS Alarm 6:00-7:00 Trigger
7:00-8:00 8:00-9:00
an Alarm! 9:00-10:00 10:00-11:00 12:00-1:00 1:00-2:00 2:00-3:00 Total
Alarm and Escalation:
Trigger # 4:00-5:00 5:00-6:00 6:00-7:00 7:00-8:00 8:00-9:00 11:00-12:00 12:00-1:00 1:00-2:00
1 Scratches 6 ll l ll 5
2 Bolt Reject 1 l l 2nd Alarm is Escalated! 4
The Tally Sheet:
3 Lash Reject 4 ll l 3
• records the number of each type of problem by the hour. 4 Crank Torque 5 ll lll l 6

• addresses special cause variation.


• alerts operator when alarm limit is reached.
• is located at or near the point of inspection.
Trigger an Alarm
Alarm by shift not hour.
(Example)
CALL FOR HELP
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Andon System Implementation The Andon system enables the Team Member to call for help and supports
the concept of "Do Not Accept, Build or Ship a Defect". Andon calls can be
A well functioning Andon system is implemented in all production radio, pager, stack lights, andon boards, etc.
areas to support the Team Member when abnormal conditions
occur and communicate relevant information. Check that the requirements of an effective Andon system are present in all
production areas.
BIQS -15
All operational areas of the organization are using the Andon
process as intended and this shows tangible results on the shop Take a few operator stations in different areas as an example. Ask Team
floor. Members and Team Leaders how the Andon is working and validate the
effectiveness.
BIQS Requirement
A well functioning Andon system is implemented in all production areas to support the Team Member when abnormal conditions
occur and communicate relevant information.
Call for Help
Assembly Workstation Example Work Cell Example
(Moving Line) Yellow
Workstation
Light 14 Run Stop
Run-Stop Yellow Button
Switch and Light Andon Workstation
Light
Pull Cord
4
R
U
N
STOP
Andon
Push Button

Activation Purpose Where Used Description


Device The Andon system can
• To e m p o w e r o p e r a t i o n s t o p r e v e n t t h e Andon Pull Cord Team Member Help On a workstation in a Connected to a switch with a be activated by a number
occurrence or passing of defects to the next Call moving conveyor line. light and looped along the length
of different methods:
of the conveyor.
process and call for assistance when behind in Andon Push Team Member Help Work Cells, such as a Switch box with a push button is
– pull cords,
work sequence or experiencing problems Button Call Body Shop or Press located in the most convenient
Line, or in a Paint location of the work cell. – buttons, and
• prioritize and init iate t he problem s olving Run Stop Switch Stop the process or
Booth
Installed along the Placed at regular Fixed Position – switches of the
process conveyor conveyor and on all Stops on alternating sides of the Andon system.
immediately for major equipment. line. (Note: Must be in
• drive management and support groups to go safety reasons. accordance to all safety
standards and regulations.)
and see the problems on the floor and take Manipulator Increase level of The limit switch is To prevent manipulators,
action and communicate operational Over-Travel safety on the installed along the articulating arms and assist
Limit Switch workstation by travel of the devices from dangerous over-
information stopping the manipulator. travel conditions to increase
conveyor when an safety on the workstations.
over-travel condition
Guidelines occurs.
 The Andon system enables the Team Member to call for help and supports the concept of "Do Not Accept, Build or Ship a Defect". Andon calls
can be radio, pager, stack lights, Andon boards, etc.
 Check that the requirements of an effective Andon system are present in all production areas.
 Take a few operator stations in different areas as an example. Ask Team Members and Team Leaders how the Andon is working and validate the
effectiveness.
BIQS Requirement
All operational areas of the organization are using the Andon process as intended and this shows tangible results on the shop floor.

 Leaders should use the Andon downtime tracking to (Example)


analyze problem areas and identify waste in the current
process.
 The focus should be on the pulls with the highest
frequencies. It means that the root cause of the problem
has not been addressed. Also it absorbs a lot of the team
leaders time and effort.
 Downtime data should be analyzed after a
predetermined period of time ( weekly, bi-weekly, monthly )
and problem solving process needs to be started.
 During the problem solving we need to recognize the
root cause of the problem, define and implement
countermeasures to tackle the root cause, and then
implement a follow-up process to make sure the root
cause has been eliminated.
Group ANDON Data Analysis (Example)
Shop : - Group : - Dat e : - From _ _ _ _ _ _ _ _ _ To _ _ _ _ _ _ _ _ _ _
50.00
45.00
40.00
35.00
Based on 30.00
Downtime 25.00
20.00
(Min) 15.00
10.00
5.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
0.00

50
45
40
35
30
25
20
Based on 15
10
Count 5
0
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Top 3 ANDON Analysis sheet


Down
Sr.No Target Date
Station Time Count Causes Countmeasure Owner Status

A.

1 B.
(Based on Down time and Frequency)

C.
Top three down stations.

A.

2 B.

C.

A.

3 B.

C.
Frequency
Station
Lowest

1
COMMUNICATION
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Feedback / Feed forward Look for fast feedback / feed forward flow between the Verification Station
(Final Inspection /CARE / GP12) and the manufacturing team leader and
There is fast feedback /feed forward flow between Verification between production teams and shifts.
Station (Final Inspection /CARE / GP12) and the manufacturing
BIQS -23 team leader and between production teams. Confirm that quality alerts are posted at the operation for issues detected
downstream (e.g. Fast Response, Verification Station (Final Inspection
Quality Alerts are posted at the operation for issues detected /CARE / GP12)).
downstream.
BIQS Requirement
There is fast feedback /feed forward flow between Verification Station (Final Inspection /CARE / GP12) and the manufacturing
team leader and between production teams.
Immediate Quality Alert Containment
Feed Response
Part 1
VERIFICATION STATION:
VERIFICATION STATIONS RESPOND
(Completed by the Verification Operator)
Worksheet
DEPARTMENT CONTAINMENT WORKSHEET

DEPARTMENT:

PRODUCT NAME / NUMBER:


PRODUCT NONCONFORMANCE:
DEPARTMENT CONTAINMENT OWNER:
GQP-004b

DATE:
REV: 3/13/01

Information
Date/ Product Who Was Escalation
# Shift Line
Serial# Defect Description / Number
Called
Time
Level 1-5
PRODUCT CONTAINMENT SCOPE
IDENTIFY ALL AREAS WHERE SUSPECT PRODUCT COULD BE LOCATED

POTENTIAL AREA N/C PRODUCT VERIFICATION


LOCATION QTY. VERIFIED ? FOUND? QTY? RESPONSIBILITY

Back 4

VS team fills out the SEGREGATE SUSPECT PRODUCT TO (location, as feasible):

IRAS 1st. part 2. Fast!!!: Make sure


SORT METHOD (eg. visual, gage, mating part):

SORT CRITERIA (clear pass / fail standards):

I.D. METHOD CONFORMING (eg. mark, tag, sign):

I.D. METHOD NONCONFORMING (eg. mark, tag, sign):

VS / CARE / GP- containment is in place!


12

1st. Feedback (Containment)

1. Find it: Identify the problems 4. Feedback (2nd.):


and start the escalation contacting Review data, validate/drive 3. Fix it: Implement
manufacturing leader results, lead and coach countermeasures for the
Immediate problems
Response
Very pretty!
Nice Charts!

Part 2 Y / N = Yes /No (circle one for each question, #2 - #5)


PRODUCTION RESPONDS
(Completed by the responder)
Corrective Action:
*S=Supplier, A=Assembly/Build issue

1-Identify Point of Cause Station # ?


Immediate Fix 2-Standardized work followed?
*S Who Breakpoint
What was done with the defective 3-Correct Tools / Fixtures / Error Proofing? Time
A Answered CSN #
Part? 4-Correct Parts?
5-Parts in spec?
6-What did you do to STOP a REPEAT defect from occurring?
1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

1-Stat #_________ 2- Y / N 3- Y / N 4- Y / N 5- Y / N
6:

Guidelines
 Look for fast feedback / feed forward flow between the Verification Station (Final Inspection /CARE / GP12) and the manufacturing team leader
and between production teams and shifts.
BIQS Requirement
There is fast feedback /feed forward flow between Verification Station (Final Inspection /CARE / GP12) and the manufacturing
team leader and between production teams.

Feed Information Forward


• Internal and external suppliers communicate
known/potential problems and/or problem solving
status to their customers in a timely manner.
• This provides the customer with sufficient lead time
to react to upcoming changes and take appropriate
measures.
Feedforward
• Escaped defects are communicated downstream
• Containment is implemented to ensure defects do not
leave the department
• Supplier visits customer departments to feedforward
any issues and “See” current customer issues

Guidelines
 Look for fast feedback / feed forward flow between the Verification Station (Final Inspection /CARE / GP12) and the manufacturing team leader
and between production teams and shifts.
BIQS Requirement
Quality Alerts are posted at the operation for issues detected downstream.

(Example
)
Quality Alerts posted at the operation for issues
detected downstream

Guidelines
 Confirm that quality alerts are posted at the operation for issues detected downstream (e.g. Fast Response, Verification Station (Final Inspection
/CARE / GP12)).
IS THERE ANYTHING MISSED? ABC Company, INC

QUALITY ALERT Report Date: 1/30/2017


Issue Title: Nut missed (not welded)
Part Number(s): 81234567

INFO
PART
Part Name: Rail
Problem on Vehicle: Part can not be assembled
Problem on Part: Lack of nut

PROBLEM
Part Specification: Nut welded at rail
Deviation from Spec: Nut not welded
Root Cause if Known:
Corrective Action(s) if Determined:
Good Bad

PHOTOS
CUSTOMERS Vehicle/Platform(s) Affected: D2XX
Other GM Facilities Impacted: San Luis Potosi
Other OEMs supplying to GM NA
SPO, CKD, Overseas Destinations: Service Parts
OTHER

Customer Contact Single Point : E. Cuellar


Phone: 52 844 448 4455
Issued by: J. Apple, Quality Engineer
54 Review / Removal date: 3/3/17
MANAGING CHANGE
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Process Change Control Confirm that all plant changes are processed through the plant cross functional
process change approval system.
Plant processes are validated relative to changes in Design,
Man, Machine, Material, Method and Environment. The plant Confirm if PTR is necessary.
follows a documented change control process for customers and Confirm that the plant has regular meetings, including all departments, to
internal changes. The PFMEA is updated to reflect any change, discuss upcoming changes and coordinate PTR's for customers or internal
BIQS -12 as required. The plant has regular meetings, including all changes.
departments, to discuss upcoming changes (product engineering
changes, plant process changes, supplier process changes) and
coordinate PTR
BIQS Requirement
Plant processes are validated relative to changes in Design, Man, Machine, Material, Method and Environment. The plant follows a
documented change control process for customers and internal changes. The PFMEA is updated to reflect any change, as required.

Procedure (Example) PPCR (Example)


Rev. Date: 10/5/07 PLANT PROCESS CHANGE REQUEST PPCR NO. Rev. Date: 10/5/07 PLANT PROCESS CHANGE REQUEST PPCR NO.
SECTION 3: DETERMINE WHICH FUNCTIONAL GROUPS NEED TO RESPOND TO THIS CHANGE
(ALL SHADED AREAS MUST BE COMPLETED)

PFMEA Updated
CONTACT: EXT. 5-5391 CHECK ANY ITEMS THAT MAY BE APPLICABLE / IMPACTED: RESPONSE DUE DATE:
SAFETY: CONTACT: SIGNATURE:
SECTION 1: BACKGROUND INFORMATION EMERGENCY PPCR? YES NO
GUARDING OTHER WORK-FIT INSTRUCTIONS
IF "YES", GIVE COPY TO QUALITY
MANUFACTURING: CONTACT: SIGNATURE:
PART NAME(S) IMPACTED Manufacturing Process Bypassed? MAINTENANCE MANUFACTURING INSTRUCTIONS PRODUCTION MONITORING
IF "YES", COMPLETE Manufacturing Process MANUFACTURING ENGINEERING: CONTACT: SIGNATURE:
Backup Worksheet (in S:\ECO\FORMS) PROCESS ROUTING PROCESS PARAMETERS GAGE (DRAWING, PLAN)
TOOLING AND DRAWINGS PFMEA CMM (DRAWING, FIXTURES)
YES NO PROCESS CONTROL PLAN MACHINE DRAWINGS (MECH/ELECT) FLOAT SHEETS
ERROR PROOFING GAGE CHECK SHEET PROCESS FLOW DIAGRAM
MODEL YEAR AND APPLICATION TOOLING ENGINEERING: CONTACT: SIGNATURE:
PART #(S) IMPACTED
CUTTING TOOLS & DRAWINGS CNC PART PROGRAM TOOL ROUTING
INDUSTRIAL ENGINEERING: CONTACT: SIGNATURE:
DATE INITIATED MFG. DEPT(S) IMPACTED OPERATION
WORKPLACE LAYOUT ENGINE SEQUENCING SYSTEM JOB INSTRUCTIONS (SWC/SOS/STS/JES)
/ STATION # TAKT TIME / LABOR CONTENT CYCLE TIME (PART TO PART) STANDARDIZED WORK VIDEO
DUNNAGE (INTERNAL & EXTERNAL) ERGONOMICS GAGE/TOOL CHG/COMP. FREQ.
(IF EMERGENCY, TIME ALSO PLANNED CHANGE DATE MATERIAL HANDLING JOB DESIGN (METHOD CHANGE) VISUAL CONTROLS
REQUIRED) ANDON SIGNALING SYSTEM
PLANT ENGINEERING: CONTACT: SIGNATURE:
OPPORTUNITY / PROBLEM STATEMENT:
ELECTRICAL/CONTROLS SOFTWARE WASHER PARAMETERS/CHEMICALS
RELOCATION/REARRANGEMENTS INSTALLATION/REMOVAL COOLANTS/FILTRATION

ENVIRONMENTAL ENGINEERING: FOR QUESTIONS ON ASSESSING ENVIRONMENTAL IMPACT, CONTACT ENVIRONMENTAL ENGINEER.

DESCRIPTION OF CHANGE/EMERGENCY REACTION PLAN: CONTACT: SIGNATURE:


IS THERE AN ENVIRONMENTAL IMPACT? YES NO

TRAINING: CONTACT: SIGNATURE:


WORK REFERENCE STATION SYSTEM LEVEL JOB AIDS CHECKLISTS
INTEGRATED TASK PROCEDURES TASK/STATION LEVEL JOB AIDS OTHER
WHAT IS THE AIM OF THIS CHANGE? WHY SHOULD WE WORK ON THIS NOW? OEM / SUPPLIER TRAINING MODULES
PRODUCTION CONTROL & LOGISTICS: CONTACT: SIGNATURE:
BREAK-POINT REQUIRED MATERIAL PULL SYSTEM SUPPLIER DUNNAGE
DELIVERY ROUTES ADDRESS SYSTEM SUPPLIER PACKAGING
MATERIAL PARTS LIST
IS&S:
EXPLAIN THE METHOD BY WHICH PROPER OPERATION WILL BE VERIFIED: CONTACT: SIGNATURE:

IS THERE AN IMPACT ON IS&S? YES NO

QUALITY / RELIABILITY:

GAGES (EQUIPMENT, PROGRAMS) CONTACT: SIGNATURE:


INITIATOR NAME INITIATING DEPARTMENT CMM'S (EQUIPMENT, PROGRAMS) CONTACT: SIGNATURE:
CHANGE LEADER NAME MATERIAL SPECIFICATIONS CONTACT: SIGNATURE:
(if different than initiator) AREA MGR. SIGN. (EMER. ONLY) STATISTICAL VERIFICATION CONTACT: SIGNATURE:
QUALITY SYSTEM CONTACT: SIGNATURE:
SECTION 2: DETERMINE IF CHANGE REQUIRES PDT/CIT-LEVEL OR PPAP REVIEW AND APPROVAL PPAP (PRELIMINARY REVIEW): CONTACT: SIGNATURE:
CHECK ANY OF THE FOLLOWING THAT MAY BE APPLICABLE: CUSTOMER'S EASE OF ASSEMBLY CUSTOMER'S AUDITS/TESTS CUSTOMER'S PROCESS OR TOOLING
ERROR PROOFING AUDIT DUNNAGE/PACKAGING CONTROL PLAN (INSP. METH./FREQ.)
CM, P A NEW PART OR PRODUCT (i.e. A SPECIFIC PART, MATERIAL OR COLOR NOT PREVIOUSLY SUPPLIED TO THE SPECIFIC CUSTOMER). IMPORTANT: 1. THIS SECTION REQUIRES SIGN-OFF IF ANY OF THE ABOVE ITEMS OR IF ANY OF THE "P" ITEMS FROM SECTION 2 APPLY.
2. AFTER CONTACTING THE SQA, FORWARD THIS FORM AND A PPAP WARRANT TO THE SQA, AS APPLICABLE.
CM, P PRODUCT MODIFIED BY AN ENGINEERING CHANGE TO DESIGN RECORDS, SPECIFICATIONS OR MATERIALS. 3. THE SQA IS TO SIGN THIS SECTION AS APPROVAL OF ALL REVIEWED PRE-IMPLEMENTATION PLANS FOR FULFILLING PPAP REQTS.
CM, P USE OF ANOTHER OPTIONAL CONSTRUCTION OR MATERIAL THAN WAS USED IN THE PREVIOUSLY APPROVED PART. ADVISE PRODUCTION OF IMPENDING CHANGE? YES CONTACT:
SECTION 3 REVIEW FOR APPROVAL THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
CM, P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE WHERE, IN THE JUDGEMENT OF TECHNICAL
APPROVED BY: PRINT NAME SIGN DATE
EXPERTS, THE POTENTIAL EXISTS TO IMPACT PRODUCT INTEGRITY (e.g. MATERIAL PROPERTIES, SURFACE FINISH ... ETC.). (LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
SECTION 4: OTHER INSTRUCTIONS / COMMENTS
P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE.
P CORRECTION OF A DISCREPANCY ON A PREVIOUSLY SUBMITTED PART.
P PRODUCTION FROM TOOLING AND EQUIPMENT TRANSFERRED TO A DIFFERENT PLANT LOCATION OR FROM AN ADDITIONAL PLANT LOCATION.
P PRODUCTION FOLLOWING REFURBISHMENT OR REARRANGEMENT OF EXISTING TOOLING OR EQUIPMENT.
SECTION 5A: TO IMPLEMENT PPAP WARRANT APPROVED (IF APPLIC.)
P CHANGE IN SOURCE FOR SUBCONTRACTED PARTS, MATERIALS, DUNNAGE OR SERVICES (e.g. HEAT-TREATING, PLATING, PAINTING, ETC.) THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
PRODUCT RE-RELEASED AFTER TOOLING HAS BEEN INACTIVE FOR VOLUME PRODUCTION FOR TWELVE MONTHS OR MORE. APPROVED BY: PRINT NAME SIGN DATE
P
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
P FOLLOWING A CUSTOMER REQUEST TO SUSPEND SHIPMENT DUE TO A SUPPLIER QUALITY CONCERN. THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
P PRODUCTION FROM NEW OR MODIFIED TOOLS (EXCEPT PERISHABLE TOOLS), DIES, MOLDS, PATTERNS ... ETC., APPROVED BY: PRINT NAME SIGN DATE
(MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
INCLUDING ADDITIONAL OR REPLACEMENT TOOLING.
POST-IMPLEMENTATION SIGNATURE BY CHANGE LEADER
NO ITEMS APPLICABLE CHANGE ALREADY PDT/CIT APPROVED
ACTUAL IMPLEMENTATION DATE BREAKPOINT (IF APPLIC.)
IF YOU CHECKED ANY "CM" ITEM(S): 1) DO NOT CONTINUE TO SECTION 3 UNTIL FURTHER NOTIFIED BY YOUR PDT/CIT LEADER. (USE ENG. # OR DATE)
SECTION 5B: FINAL APPROVAL
2) FORWARD THIS SHEET TO THE MANUFACTURING ENGINEERING CLERK.
THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY

Any change in: IF YOU CHECKED ONLY "P" ITEM(S):

IF YOU CHECKED NO ITEMS:

CORRESPONDING GMPT CMP TRACKING NUMBER


CONTINUE TO SECTION 3. COMPLETE PPAP SECTION (MANDATORY).

CONTINUE TO SECTION 3. COMPLETE PPAP SECTION AS APPLICABLE.


APPROVED BY:

APPROVED BY:
PRINT NAME

PRINT NAME
SIGN
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
SIGN
(MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
DATE

DATE

• Design
• Machine
• Material
• Method
• Environment

Guidelines
 Confirm that all plant changes are processed through the plant cross functional process change approval system.
Process Change Control
Plant Process Change Request Form (Example)
Rev. Date: 10/5/07 PLANT PROCESS CHANGE REQUEST PPCR NO. Rev. Date: 10/5/07 PLANT PROCESS CHANGE REQUEST PPCR NO.
SECTION 3: DETERMINE WHICH FUNCTIONAL GROUPS NEED TO RESPOND TO THIS CHANGE
(ALL SHADED AREAS MUST BE COMPLETED) CONTACT: EXT. 5-5391 CHECK ANY ITEMS THAT MAY BE APPLICABLE / IMPACTED: RESPONSE DUE DATE:

SECTION 1: BACKGROUND INFORMATION EMERGENCY PPCR? YES NO SAFETY: CONTACT: SIGNATURE:


GUARDING OTHER WORK-FIT INSTRUCTIONS
IF "YES", GIVE COPY TO QUALITY
MANUFACTURING: CONTACT: SIGNATURE:
PART NAME(S) IMPACTED Manufacturing Process Bypassed? MAINTENANCE MANUFACTURING INSTRUCTIONS PRODUCTION MONITORING
IF "YES", COMPLETE Manufacturing Process MANUFACTURING ENGINEERING: CONTACT: SIGNATURE:
Backup Worksheet (in S:\ECO\FORMS) PROCESS ROUTING PROCESS PARAMETERS GAGE (DRAWING, PLAN)
TOOLING AND DRAWINGS PFMEA CMM (DRAWING, FIXTURES)
YES NO PROCESS CONTROL PLAN MACHINE DRAWINGS (MECH/ELECT) FLOAT SHEETS
ERROR PROOFING GAGE CHECK SHEET PROCESS FLOW DIAGRAM
MODEL YEAR AND APPLICATION TOOLING ENGINEERING: CONTACT: SIGNATURE:
PART #(S) IMPACTED
CUTTING TOOLS & DRAWINGS CNC PART PROGRAM TOOL ROUTING
DATE INITIATED MFG. DEPT(S) IMPACTED OPERATION INDUSTRIAL ENGINEERING: CONTACT: SIGNATURE:
WORKPLACE LAYOUT ENGINE SEQUENCING SYSTEM JOB INSTRUCTIONS (SWC/SOS/STS/JES)
/ STATION # TAKT TIME / LABOR CONTENT CYCLE TIME (PART TO PART) STANDARDIZED WORK VIDEO
DUNNAGE (INTERNAL & EXTERNAL) ERGONOMICS GAGE/TOOL CHG/COMP. FREQ.
(IF EMERGENCY, TIME ALSO PLANNED CHANGE DATE MATERIAL HANDLING JOB DESIGN (METHOD CHANGE) VISUAL CONTROLS
REQUIRED) ANDON SIGNALING SYSTEM
OPPORTUNITY / PROBLEM STATEMENT: PLANT ENGINEERING: CONTACT: SIGNATURE:
ELECTRICAL/CONTROLS SOFTWARE WASHER PARAMETERS/CHEMICALS
RELOCATION/REARRANGEMENTS INSTALLATION/REMOVAL COOLANTS/FILTRATION

ENVIRONMENTAL ENGINEERING: FOR QUESTIONS ON ASSESSING ENVIRONMENTAL IMPACT, CONTACT ENVIRONMENTAL ENGINEER.

DESCRIPTION OF CHANGE/EMERGENCY REACTION PLAN: CONTACT: SIGNATURE:


IS THERE AN ENVIRONMENTAL IMPACT? YES NO

TRAINING: CONTACT: SIGNATURE:


WORK REFERENCE STATION SYSTEM LEVEL JOB AIDS CHECKLISTS
INTEGRATED TASK PROCEDURES TASK/STATION LEVEL JOB AIDS OTHER
WHAT IS THE AIM OF THIS CHANGE? WHY SHOULD WE WORK ON THIS NOW? OEM / SUPPLIER TRAINING MODULES
PRODUCTION CONTROL & LOGISTICS: CONTACT: SIGNATURE:
BREAK-POINT REQUIRED MATERIAL PULL SYSTEM SUPPLIER DUNNAGE
DELIVERY ROUTES ADDRESS SYSTEM SUPPLIER PACKAGING
MATERIAL PARTS LIST
IS&S:
EXPLAIN THE METHOD BY WHICH PROPER OPERATION WILL BE VERIFIED: CONTACT: SIGNATURE:

IS THERE AN IMPACT ON IS&S? YES NO

QUALITY / RELIABILITY:

GAGES (EQUIPMENT, PROGRAMS) CONTACT: SIGNATURE:


INITIATOR NAME INITIATING DEPARTMENT
CMM'S (EQUIPMENT, PROGRAMS) CONTACT: SIGNATURE:
CHANGE LEADER NAME MATERIAL SPECIFICATIONS CONTACT: SIGNATURE:
(if different than initiator) AREA MGR. SIGN. (EMER. ONLY) STATISTICAL VERIFICATION CONTACT: SIGNATURE:
QUALITY SYSTEM CONTACT: SIGNATURE:
SECTION 2: DETERMINE IF CHANGE REQUIRES PDT/CIT-LEVEL OR PPAP REVIEW AND APPROVAL
PPAP (PRELIMINARY REVIEW): CONTACT: SIGNATURE:
CHECK ANY OF THE FOLLOWING THAT MAY BE APPLICABLE: CUSTOMER'S EASE OF ASSEMBLY CUSTOMER'S AUDITS/TESTS CUSTOMER'S PROCESS OR TOOLING
ERROR PROOFING AUDIT DUNNAGE/PACKAGING CONTROL PLAN (INSP. METH./FREQ.)
CM, P A NEW PART OR PRODUCT (i.e. A SPECIFIC PART, MATERIAL OR COLOR NOT PREVIOUSLY SUPPLIED TO THE SPECIFIC CUSTOMER). IMPORTANT: 1. THIS SECTION REQUIRES SIGN-OFF IF ANY OF THE ABOVE ITEMS OR IF ANY OF THE "P" ITEMS FROM SECTION 2 APPLY.
CM, P PRODUCT MODIFIED BY AN ENGINEERING CHANGE TO DESIGN RECORDS, SPECIFICATIONS OR MATERIALS. 2. AFTER CONTACTING THE SQA, FORWARD THIS FORM AND A PPAP WARRANT TO THE SQA, AS APPLICABLE.
3. THE SQA IS TO SIGN THIS SECTION AS APPROVAL OF ALL REVIEWED PRE-IMPLEMENTATION PLANS FOR FULFILLING PPAP REQTS.
CM, P USE OF ANOTHER OPTIONAL CONSTRUCTION OR MATERIAL THAN WAS USED IN THE PREVIOUSLY APPROVED PART. ADVISE PRODUCTION OF IMPENDING CHANGE? YES CONTACT:
CM, P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE WHERE, IN THE JUDGEMENT OF TECHNICAL SECTION 3 REVIEW FOR APPROVAL THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
EXPERTS, THE POTENTIAL EXISTS TO IMPACT PRODUCT INTEGRITY (e.g. MATERIAL PROPERTIES, SURFACE FINISH ... ETC.). APPROVED BY: PRINT NAME SIGN DATE
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)

P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE. SECTION 4: OTHER INSTRUCTIONS / COMMENTS
P CORRECTION OF A DISCREPANCY ON A PREVIOUSLY SUBMITTED PART.
P PRODUCTION FROM TOOLING AND EQUIPMENT TRANSFERRED TO A DIFFERENT PLANT LOCATION OR FROM AN ADDITIONAL PLANT LOCATION.
P PRODUCTION FOLLOWING REFURBISHMENT OR REARRANGEMENT OF EXISTING TOOLING OR EQUIPMENT.
CHANGE IN SOURCE FOR SUBCONTRACTED PARTS, MATERIALS, DUNNAGE OR SERVICES (e.g. HEAT-TREATING, PLATING, PAINTING, ETC.)
SECTION 5A: TO IMPLEMENT PPAP WARRANT APPROVED (IF APPLIC.)
P THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
P PRODUCT RE-RELEASED AFTER TOOLING HAS BEEN INACTIVE FOR VOLUME PRODUCTION FOR TWELVE MONTHS OR MORE. APPROVED BY: PRINT NAME SIGN DATE
FOLLOWING A CUSTOMER REQUEST TO SUSPEND SHIPMENT DUE TO A SUPPLIER QUALITY CONCERN. (LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
P
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
P PRODUCTION FROM NEW OR MODIFIED TOOLS (EXCEPT PERISHABLE TOOLS), DIES, MOLDS, PATTERNS ... ETC.,
APPROVED BY: PRINT NAME SIGN DATE
INCLUDING ADDITIONAL OR REPLACEMENT TOOLING. (MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)

POST-IMPLEMENTATION SIGNATURE BY CHANGE LEADER


NO ITEMS APPLICABLE CHANGE ALREADY PDT/CIT APPROVED
ACTUAL IMPLEMENTATION DATE BREAKPOINT (IF APPLIC.)
IF YOU CHECKED ANY "CM" ITEM(S): 1) DO NOT CONTINUE TO SECTION 3 UNTIL FURTHER NOTIFIED BY YOUR PDT/CIT LEADER. (USE ENG. # OR DATE)
2) FORWARD THIS SHEET TO THE MANUFACTURING ENGINEERING CLERK. SECTION 5B: FINAL APPROVAL
THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
IF YOU CHECKED ONLY "P" ITEM(S): CONTINUE TO SECTION 3. COMPLETE PPAP SECTION (MANDATORY).
APPROVED BY: PRINT NAME SIGN DATE
IF YOU CHECKED NO ITEMS: CONTINUE TO SECTION 3. COMPLETE PPAP SECTION AS APPLICABLE. (LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
CORRESPONDING GMPT CMP TRACKING NUMBER APPROVED BY: PRINT NAME SIGN DATE
(MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
PPCR
REJECTION.

5 4C 4D. THE CHANGE PROCESS IS STOPPED.


PPCR Process Flow 5. CHANGE LEADER DETERMINES THE APPROPRIATE PERSONS/DEPARTMENTS REQUIRED TO
IMPLEMENT THE CHANGE AND COMPLETES SECTION 3 OF PPCR FORM.XLS.
REJECTED
6 6A 6. IS CHANGE LEADER ABLE TO OBTAIN APPROVAL SIGNATURES FROM EACH DESIGNATED
DEPARTMENT?

APPROVED
6A. IF ANY SIGNATURE CANNOT BE OBTAINED, THE CHANGE PROCESS STOPS. ALL OTHER
1 1. INITIATOR COMPLETES PPCR FORM SECTION 1 AND SELECTS CHANGE LEADER. DEPARTMENTS CONTACTED IN SECTION 3 OF PPCR FORM.XLS MUST BE NOTIFIED OF THE
7 REJECT.
2. CHANGE LEADER COMPLETES SECTION 2. 7. CHANGE LEADER REVIEWS PENDING PROCESS CHANGE WITH HIS/HER GENERAL SUPERVISOR
OR SUPERINTENDENT (SEE SECTION 3 OF PPCR FORM.XLS).

2 3. INITIATOR OBTAINS PPCR TRACKING NUMBER FROM MANUFACTURING


ENGINEERING CLERK 8. DOES THE CHANGE LEADER ACQUIRE WRITTEN DIRECTION TO PROCEED WITH CHANGE
STOP
(OTHER INSTRUCTIONS, SECTION 4 PPCRLOG.XLS) FROM HIS/HER GENERAL SUPERVISOR OR
8 8A SUPERINTENDENT, ALONG WITH SIGNATURE (SIGNATURE BLOCK, SECTION 5A OF PPCR FORM)?
4. IS THE PROPOSED CHANGE TO GO THROUGH CHANGE MANAGEMENT PROCESS
(CMP) SYSTEM OR REMAIN IN PPCR SYSTEM?
8A. IF DIRECTED TO NOT PROCEED, STOP. NOTIFY ALL CONCERNED PARTIES (SECTION 3 OF PPCR
3 4D FORM.XLS) WITH REASON FOR CHANGE REJECTION.
PROCEED
4A. THE PPCR FORM IS REVIEWED WITH MFG. FOCUS TEAM (PDT/CIT). PDT/CIT
WILL GUIDE THE CHANGE THROUGH CMP UNTIL IT IS EITHER ACCEPTED OR 9 9. CHANGE LEADER, ALONG WITH THE PARTIES NAMED IN SECTION 3 OF PPCR FORM.XLS,
REJECTED REJECTED. IMPLEMENTS PROCESS CHANGE

CMP
4 4A 4B 4B. HAS THE PDT/CIT APPROVED OR REJECTED THE CHANGE?
10. CHANGE LEADER RECORDS THE DATE THE PROCESS CHANGE WAS IMPLEMENTED ON THE
10 PPCR FORM (PPCR FORM.XLS) AND ON THE PPCR LOG SHEET (PPCRLOG.XLS, SEE SECTION 5B).
PPCR APPROVED 4C. THE PDT/CIT LEADER NOTIFIES THE CHANGE LEADER OF APPROVAL OR
REJECTION.

5 4C 4D. THE CHANGE PROCESS IS STOPPED.


11. CHANGE LEADER ATTACHES APPLICABLE WORK SHEETS AND FORWARDS COMPLETED PPCR
11 FORM TO GENERAL SUPERVISOR OR SUPERINTENDENT FOR FINAL APPROVAL. SECTION 5B
5. CHANGE LEADER DETERMINES THE APPROPRIATE PERSONS/DEPARTMENTS REQUIRED TO (PPCRLOG.XLS)
IMPLEMENT THE CHANGE AND COMPLETES SECTION 3 OF PPCR FORM.XLS.
REJECTED
6 6A 6. IS CHANGE LEADER ABLE TO OBTAIN APPROVAL SIGNATURES FROM EACH DESIGNATED
DEPARTMENT? 12 12. CHANGE LEADER GIVES ORIGINAL COPY OF FINAL APPROVED PPCR TO MFG ENGINEERING

APPROVED
NOTE Approval is also needed from final customer CLERK.
6A. IF ANY SIGNATURE CANNOT BE OBTAINED, THE CHANGE PROCESS STOPS. ALL OTHER
DEPARTMENTS CONTACTED IN SECTION 3 OF PPCR FORM.XLS MUST BE NOTIFIED OF THE
7 REJECT.
7. CHANGE LEADER REVIEWS PENDING PROCESS CHANGE WITH HIS/HER GENERAL SUPERVISOR
OR SUPERINTENDENT (SEE SECTION 3 OF PPCR FORM.XLS).

8. DOES THE CHANGE LEADER ACQUIRE WRITTEN DIRECTION TO PROCEED WITH CHANGE
STOP
(OTHER INSTRUCTIONS, SECTION 4 PPCRLOG.XLS) FROM HIS/HER GENERAL SUPERVISOR OR
8 8A SUPERINTENDENT, ALONG WITH SIGNATURE (SIGNATURE BLOCK, SECTION 5A OF PPCR FORM)?

8A. IF DIRECTED TO NOT PROCEED, STOP. NOTIFY ALL CONCERNED PARTIES (SECTION 3 OF PPCR
PROCEED FORM.XLS) WITH REASON FOR CHANGE REJECTION.

9 9. CHANGE LEADER, ALONG WITH THE PARTIES NAMED IN SECTION 3 OF PPCR FORM.XLS,
IMPLEMENTS PROCESS CHANGE

10. CHANGE LEADER RECORDS THE DATE THE PROCESS CHANGE WAS IMPLEMENTED ON THE
10 PPCR FORM (PPCR FORM.XLS) AND ON THE PPCR LOG SHEET (PPCRLOG.XLS, SEE SECTION 5B).
BIQS Requirement
The plant has regular meetings, including all departments, to discuss upcoming changes (product engineering changes, plant
process changes, supplier process changes) and coordinate PTR

Regular Meeting: Schedule, Agenda and Planning (Example)


PTR REGULAR MEETINGS - SCHEDULE
M T W T F Invitees:
Wk 1 Quality Engineer
Wk 2 Manufacturing Engineer
Wk 3 Product Engineer
Wk 4 PTR Coordinator
Wk 5 Launch Coordinator
Wk 6 Maintenance Coordinator
Wk 7 Production Leader
Wk 8
Wk 9
Wk 10
* Meetings: every Tuesday (9:00 AM) at Buick Room

AGENDA

Upcoming changes (according to PPCR)


- product engineering changes
- plant process changes
- supplier process changes

PTR PLANNING - ELEMENTS

PTR Date
Standardized Communication and Documentation (PTR form)
Build Readiness Reviews
Quality Reviews before and after the change
Reasonable sample size
Identification
Containment and traceability
Resources needed
Assistance needed (areas)

Guidelines
 Confirm that the plant has regular meetings, including all departments, to discuss upcoming changes and coordinate PTR's for customers or
internal changes.
MANAGING RISK
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Bypass / Deviation Management Look for the plant list of manufacturing processes and error proofing devices
which can be bypassed or placed in deviation. Confirm that Risk Priority
The plant shall identify manufacturing processes and error Number (RPN) for all approved bypass / deviation processes are evaluated
proofing devices which can be bypassed or placed in deviation. and that Standardized Work is available for each bypass/deviation process.
Risk Priority Number (RPN) for all approved Bypass / deviation Supplier locations shall have a written and approved bypass/deviation
processes are evaluated and risks are reviewed. Standard work procedure that includes customer notification. Check how bypass is reviewed
BIQS -5 instructions are available for each Bypass / deviation process. regularly and check if the has a goal to reduce or eliminate bypass .
Implemented Bypass is reviewed regularly and goal is reduce or
eliminate bypass .

ERROR PROOFING
OPERACION
( A PRUEBA
BYPASS
DE ERROR )
BIQS Requirement
The plant shall identify manufacturing processes and error proofing devices which can be bypassed or placed in deviation. Risk
Priority Number (RPN) for all approved Bypass / deviation processes are evaluated and risks are reviewed. Standard work
instructions are available for each Bypass / deviation process.
Bypass Allowed list

t
no

S
JE
or
Processes allowed to be By-passed

up
ss
(Unless approved by Local Plant Manager)

ck
pa
Ba
By
Comments
T5 Engine Ass'y Line - Main 1직
- OP70 EUN check & Piston wrong parts check vision O O
- OP110 Crankshaft wrong parts check vision O O
- OP120 Piston damage check E/P O O
- OP140 Main Bearing caps Fastening
- OP150 Conrod caps Fastening
- OP160 TTT Test (Shork block Torque test)
O
O
O
O
O
O
(Example)
- OP170 Oil seal housing sealing X X Line Stop. Bypass Not Allowed
O O
Bypass/Deviation Std Work (JES)
- OP170 Oil seal housing bolts Fastening
- OP180 Oil seal housing gasket check E/P O O
- OP190 C/Head gasket missing & wrong parts check E/P O O

T5 Engine Ass'y Line - Main 2직


- OP 220 Cyl.head bolts Fastening O O
- OP 230 Camshaft wrong parts check E/P O O
- OP 270 Tappet recheck E/P O O
- OP 310 Cam caps Fastening O O

T5 Engine Ass'y Line - Main 3직


- OP 340 Cam sprocket bolts Fastening(ETC) O O
- OP 360 Timing chain & sprocket wrong parts check vision O O
- OP 370 Frront Cover Sealing X X Line Stop. Bypass Not Allowed

Risk Assessment through Bypass/Deviation FMEA - OP 390 Oil pump ASM bolts Fastening
- OP 410 Oil Pan Sealing
O
X
O
X Line Stop. Bypass Not Allowed
- OP 410 Oil strainer bolts Fastening(ETC) O O
- OP 410 Oil filter Fastening(ETC) O O
- OP 420 Oil pan ASM bolts Fastening O O
- OP 450 Cyl. Head Cover ASM bolts Fastening O O
- OP 460 Spark Plug Fastening O O
- OP 460 Spark Plug wrong parts check vision O O
- OP 480 Water adaptor bolts Fastening(ETC) O O
- OP 500 Cam position senser T/Q wrench E/P O O
- OP 500 Coolant Temp S/W Fastening(ETC) O O

Guidelines
 Look for the plant list of manufacturing processes and error proofing devices which can be bypassed or placed in deviation.
 Confirm that Risk Priority Number (RPN) for all approved bypass / deviation processes are evaluated and that Standardized Work is available for each
bypass/deviation process.
 Supplier locations shall have a written and approved bypass/deviation procedure that includes customer notification.
Authorized Bypass process list (Example)
Product Ref Part Nam e CS. / OPERATION DESC. CHARACTERISTIC ERROR PROOFING ERROR PROOFING RECORD OF CAN VISUAL DOWNSTREAM REACTION PLAN(S) - Refer to BYPASS CRITERIA: Type1 -
ID Sta. IDENTIFICATION & TECHNIQUE VERIFICATION ERROR PROOFING ERRORPROOFING INSPECTION (V) ERROR PROOFING ETQ#: for cannot be bypassed w ithout
DESCRIPTION VERIFICATION BE BYPASSED POSSIBLE? or DETECTION pertinent BYPASS JES(s) PM approval, Type2- Can be
bypassed dow nstream EP
or detection, Type3- Can be
bypassed w ith added
inpsection, no dow nstream
protection.See exact
w ording on EP Logs.

6L50,80,90 Case Sub 10A Install Bar Code Verify readable, format, 2 redundant bar code Verify Correct Tool Area-775-Doc N N Op 470 Scanner Cannot be bypassed. Type 1
location, matches RF tag scanners Primary-441-JES

6L50,80,90 Case Sub 10A Load Case Verify Case Type B,C, or D Non Contact Photosensor Verify Correct Tool Area-775-Doc N Y Can't build on Primary-697-JES. Type 3
Primary-441-JES mainline, excessive (Person to touchpoint that correct
scrap case w as loaded.)
6L50,80,90 Case Sub 10A Install Park Paw l, Spring, and Verify correct installation tool Tool pocket prox sensor Verify Correct Tool Area-775-Doc Y N Op 10B Camera Primary-441-JES. (Remove other Type 2
Shaft Assembly used Primary-441-JES variant tools from job so other tools
can not be used)

(Example) Authorized Bypass process list located at team area board


CYLINDER HEAD ASSEMBLY
No. DE REGISTRO
ASSEMBLY LINE E/P E/D SYSTEMS REGISTRO C-BIQ-MN-QR-05-1
FECHA DE EMISION
BYPASS BYPASS HOJA DE REGISTRO PARA PROCESOS
NOV '2006
BYPASS WITH WITHOUT BYPASS WITH WITHOUT BYPASS DE MANUFACTURA Rev. No. FECHA REV.
7 May-13
OP DESCRIPTION OPERATION NEVER BYPASS PROCEDURE PROCEDURE NEVER BYPASS PROCEDURE PROCEDURE COMMENTS
PAGINA: 1 DE: 1
10 Load Cylinder Head Auto X Bypass at OP 10 per JES
10 Cylinder Head Check - E/D Correct Type Auto X 100% visual inspection required
Modo de falla
Cylinder Head HUN / Cylinder Head 2D Procesos en los que se puede aplicar bypass en Planta Departamento / Estación herramienta Comentarios /Herramienta Bypass
35 Auto X Bypass with Hand Scanner at OP040
Marriage original
40 Load Camshafts / Spark Plugs Manual X Not allowed - shutdown and repair
50 Fasten Spark Plugs Auto X Bypass at OP 55 per procedure
100% visual inspection required / 100%
50 Cam Ring Check - E/D Correct Type Auto X
check with E/D at OP210
55 Spark Plug Colour Check - E/D Correct Type Auto X 100% visual inspection required
60 Untorque and Remove Cam Caps and Bolts Auto X Bypass at OP 65
70 Press Valve Seals Auto X Not allowed - shutdown and repair
70 Lubricate Valve Guides Auto X Not allowed - shutdown and repair
70 Valve Seal Garter Spring Sensor Auto X Bypass Op 70
80 Rollover Cylinder Head Auto X Bypass at OP 85 - two people required
90 Load Valves Manual X Not allowed - shutdown and repair
100 Load Valves Manual X Not allowed - shutdown and repair
106 Valve Type - E/D Correct Type Auto X 100% visual inspection required
107 Install Check Valves Auto X Bypass at OP 109 per procedure
Check Valve Press Force - E/D Correct
107 Auto X 100% Gauging for depth required
Assembly GUO de Calidad Área

__________________________
107 Check Valve Press Force - E/D Correct Depth Auto X 100% Gauging for depth required
GUO de Operaciones
107 Check Valve Probe - E/D Ball is Free Auto X 100% Probing for freeness required
__________________________
110 Rollover Cylinder Head Auto X Bypass at OP 115 - two people required
_____________________________________ __________________________
120 Assemble Valve Springs Auto X Bypass at OP 125
_____________________________________ __________________________

121 Valve Spring Presence Camera Auto X Bypass Instruction Op 121 _____________________________________ __________________________

130 Key-Up Cylinder Head Auto X Not allowed - shutdown and repair _____________________________________ __________________________
131 Key-Up Cylinder Head Auto X Not allowed - shutdown and repair
_____________________________________ __________________________
Station can be bypassed without adding any
GUO de Manufactura/Mantenimiento
140 Run In and Seat Valves Auto X other inspection. Higher leak rate at OP 160
may occur _____________________________________ __________________________

100% visual inspection with touch point _____________________________________ __________________________


Laser Key Check - E/D Correct Valve Key and
150 Auto X marking required + an additional 100% visual Director de Planta
Retainer Assembly
inspection of the touch point mark
_____________________________________ __________________________ Fecha de Actualización: ________________
160 Valve Blow By Leak Test Auto X Not allowed - shutdown and repair
At GM, the Bypass Task Instruction Sheet is located at Operation Certification Folder or Board
(Example)

The Bypass Operation is identified


using the information below
BIQS Requirement
Implemented Bypass is reviewed regularly and goal is reduce or eliminate bypass .

Bypass/Deviation reviewed in daily Leadership Meeting (Example)


Bypass Tracking Sheet
evaluate overall status as a result of the
detailed evaluytion on the right side G: documentation approved and posted Bypass/Deviation Quality Focused
(C)ontinuous failure
Y: documentation nedds update

Standardized Work

Operators trained

RPN orig. process


R: no documentation available
(I)ntermittent or

PFMEA review /
BYPASS QUALITY FOCUSED CHECKSHEET

documentation
Overall Status

Layered Audit
plant internal consecutive number of insert exit date of Bypass, if verification was

Verification
Bypass RPN
conducted w ith OK result

Action Plan
Bypass situation
Advisor Name:____________________________________________________ Shift:_________
Bypass #

Status of
scheduled

Restart
Result
Original Process Bypass restart acc. Bypass Station # being bypassed :__________________________________________ Date: ________
which is bypassed started Action Plan Owner exit date
Station Description:________________________________________________ Dept: ________
G 5 Torque OP 2030 C 6/1/2008 9/13/2008 K. Smith G G G G G G LAYERED
Reason for BYPASS:________________________________________________

Y 9 Conrod mach. OP 240 I 7/12/2008 9/1/2008 J. Peterson G G G Y G Y


1 Failure occurence: (C)ontinuous or (I)ntermittent:
AUDIT *

Restart Verification
1st Hour
Directions: After each step has been completed, please initial. Post form at bypass station. Time
R 15 Cyl. Head Assy OP 1020 I 8/22/2008 T. Johnson G G G R Step BYPASS PREPARATION Initial
1 Verify BYPASS JES approved and posted. (Note: Verify torque is confirmed for all spindles in a bypassed station) Initial

2 Verify operator trained in BYPASS JES.


3 BYPASS process verification method:
Oshawa Bypass Reaction Record
indicate if the failure occurence of the
original process was continuous or
intermittent
insert the planned date for restart of original
process as stated in the individual action Location of verification mark (touch point):________________________________ Time
2nd Hour
Bypass Initiator: John Doe Date of Bypass: May 23/2012 Time Bypass started: 9:00 am
plan G: Verification of restart done, OK result Color (different than normal process):___________________________________ ULOC in Bypass: 2C-76-101A Reason for Bypass: Torque tool cable broken
Y: Verification of original process ongoing Initial
4 Verify tools match BYPASS JES:
R: Verification of restart done, NOK result Bypass Starting Bypass failure modes communicated to
S/L who was notified: Mel Jones

2
G: operators are trained Type of tool:______________________________________________________ CSN or PVI #: 2ga12345678 PFMEA Tech? N Joshi
R: operators are not trained Serial #:_________________________________________________________
(according SOS/JES) G: RPN of Original process in allow able range 3rd Hour T/L Validations of Reactions
Y: RPN too high, process needs optimization Date & Time removed from cabinet:____________________________________ Time
R: RPN not evaluated Bypass Reactions implemented to Contain/Repair/Confirm (Containment present?)
(Initial & record CSN/PVI every 2 hrs.)
Step BYPASS CONFIRMATION & APPROVAL Initial Initial
G: RPN of Bypass process in allow able range G: Layered Audits conducted, results ok
5 Notify lead advisor or superintendent: 1) Record Bypass on Build ticket 1st/2nd hr. 3rd/4th hr. 5th/6th hr. 7th/8th hr.
Y: RPN too high, process needs optimization Y: deviations found in Layered Audit
R: RPN not evaluated R: Layered Audits not conducted Name:_______________________________________ Title:____________________________ T/L Initials JD JD JD
2) 100% Manually Click wrench fastener shown below to XX NM.
4th Hour
G: all actions w ithin due date 6 Lead advisor or superintendent verify "BYPASS PREPARATION" steps 1-4 above completed. Time CSN/PVI # CSN/PVI # CSN/PVI # CSN/PVI #

3
Y: actions behind target date 3) Stamp build ticket to show manual completion/repair
5698 5750 5800
R: no action plan available Step BYPASS IMPLEMENTATION Initial Initial
4) T/L to enter "repair" in GSIP 1st/2nd hr. 3rd/4th hr. 5th/6th hr. 7th/8th hr.
8 Record FIRST unit processed in bypass/backup:
Trace#:_____________________________________ Time:______________________ 5) Downstream IRC to confirm (Visually & GSIP) MK MK MK T/L Initials

9 Is there suspect material? Yes No If yes, initiate containment checksheet. 5th Hour CSN/PVI # CSN/PVI # CSN/PVI # CSN/PVI #
Time
10 Complete Business Team process to notify succeeding shift. 5850 5900 5950
NOTE: Post the original form at bypass station. Forward a copy of this form to Superintendent/Lead Advisor. Initial 1st/2nd hr. 3rd/4th hr. 5th/6th hr. 7th/8th hr.

Implemented bypasses/deviations If station is still in bypass at end of shift, next shift MUST initiate new " BYPASS CHECKLIST AND LAYERED AUDIT " form.
T/L Initials T/L Initials T/L Initials T/L Initials
CSN/PVI # CSN/PVI # CSN/PVI # CSN/PVI #
Step BYPASS EXIT / BREAKPOINT Initial 6th Hour

are reviewed in FR 11 For continuous failure: Verify proper operation of bypassed station (5 parts check minimum).
a Who:________________________________________ Title:_________________________
Time

Initial Bypass Ended Date: May 23/2012


Bypass Ended Bypass Ended
CSN/PVI #: 2ga12345999 S/L notified: Sudesh Kent

1st. Containment (LPA / Std. Work) Signature:____________________________________ Time:________________________


11 For intermittent failure: Verify proper operation of bypassed station. Amount: 100 + _______ part check
b 7th Hour
Error Proofing back on
line and validated by:
Prod. Group or Shift Leader
Signature: Sudesh K ent
Quality Tech/Lead
Signature: Connie Tuck
Both Signature are Mandatory!
Date: May 23/2012

Time

2nd. Verification of Restart Signature:_________________________________ Title:_________________________


Initial
If bypass continues beyond 3 shifts - start next sheet. Form Revision: May 24/2012

12 Verify station placed back into full automatic. Re-evaluated RPN: ______
8th Hour
13 Record LAST unit processed in bypass/backup: Time
Trace#:_____________________________________ Time:______________________
14 Verify tools returned to cabinet: Initial

Who:________________________________________ Title:_________________________
Signature:____________________________________ Time:________________________
9th Hour
15 Approval of Restart of original process Time

Authorized Signature:________________________________ Date & Time: ___________


Initial
NOTE: Remove "BYPASS CHECKLIST AND LAYERED AUDIT" from station & forward to Superintendent/Quality Coordinator.

Step BYPASS PROCESS AUDIT/RECORDED


16 Audit BYPASS process to confirm completed properly. 10th Hour
Time
Quality Manager Signature:_______________________________ Date & Time:___________________
17 "BYPASS CHECKLIST AND LAYERED AUDIT" completed and filed in DCC. Initial

Quality Signature:_________________________________ Date & Time:___________________


Revised: 01SEP12. Record Retention: ADM001, Active +0
* MINIMUM LAYERED AUDIT CONTENT: STEPS 1 TO 4

Guidelines
 Check how bypass is reviewed regularly and check if the has a goal to reduce or eliminate bypass .
No. DE REGISTRO
REGISTRO $ C-BIQ-MN-QR-05-3
FECHA DE EMISION
NOV '2006
HOJA DE REGISTRO PARA PROCESOS
Bypass/Deviation reviewed
Rev. No. FECHA REV.
ACTUALMENTE EN BYPASS PLANTA 5 Enero 2013
PAGINA: 1 DE: 1
TOLUCA

in daily Leadership Meeting Hoja de seguimiento Bypass (Example)

Trabajo Estandarizado
Falla (I)ntermitente o

Auditoria Escalonada
Operador entrenado

Estatus del plan de

RPN proceso orig.


AMEF revisado /

Verificación de
RPN de Bypass
Fecha programada

Resultado de
© Continua
Fecha de

Bypass #

reinicio.
Inicio de para reestablecer

Status

acción
salida de
Proceso Original con bypass Bypass el proceso original Responsable
Bypass
de acuerdo a plan
de acción.

(Example)
No. DE REGISTRO
REGISTRO C-BIQ-MN-QR-05-2
No . DE REGISTRO
(Example) HOJA DE REGISTRO PARA PROCESOS
FECHA DE EMISION
NOV '2006 INSPECCIÓN OPERACIÓN BYPASS (POR HORA) Y/O REINICIO C - B IQ - M N - Q R - 0 5 - 4
BYPASS Y AUDITORIA ESCALONADA Rev. No. FECHA REV.
Descripción de la Operación: FECHA DE EM ISION
8 Mar-15
N O V '2 0 11
PAGINA: 1 DE: 1
# OP. Rev. No . FECHA REV.

HOJA DE REGISTRO PARA PROCESO BYPASS DE MANUFACTURA


(Example) 4
P A GINA : 1
M arzo 2015
DE: 1
Sección1: llenado por el solicitante
Nombre de solicitante: Turno:
Número de estación a la que se aplicará bypass: Fecha: FECHA 2A HRA 4A HRA 6A HRA 8A HRA 10A HRA 12A HRA
Descripción de estación a tener bypass: Departamento: FIRMA
Razón de aplicación del bypass: Sección 2: Verificada por
GUO o designado de
Ocurrencia de falla: (C) Contínua o (I) Intermitente calidad Auditoria
Escalonada
LGT Calidad
8a hora
Firma Hora
Paso Implementación del bypass Responsable
LGT Calidad
8 Registro de primera unidad/pza procesada con bypass
Identificación: Hora: Firma LGT Calidad
9 Existe material sospechoso Sí No
Sí existe iniciar la hoja de contención LGT Calidad
10 Registrar en bitacora de proceso para notificar al siguiente turno 10a hora
Hora
Nota: LGT Calidad
Postear el formato original en la estación de bypass.
Firma LGT Calidad
LGT Calidad

Sección3: llenado por el solicitante Firma


Paso Retorno a proceso original / Punto de quiebre Responsable 12a hora LGT Calidad
Para fallas continuas: Verificar la operación apropiada de la estación original de proceso. (5 piezas verificadas Hora
mínimo)
11 partes verificadas.
LGT Calidad
a Nombre: Puesto:
Firma LGT Calidad
Firma: Hora: LGT Calidad
Para fallas intermitentes: Verificar la operación apropiada de la estación original de proceso. Cantidad 100 +
11 partes verificadas.
b Nombre: Puesto: 14a hora LGT Calidad
Firma: Hora
12 Verificar que la estación original esta trabajando en forma automática RPN Revaluado
13 Registrar la última unidad procesada en el bypass. Firma LGT Calidad
LGT Calidad
Identificación: Hora:
14 Verificar que las herramientas regresen a su ubicación original
Nombre: Puesto: LGT Calidad
Firma: Hora: 16a hora
15 Aprobación de reinicio a proceso original (GUO operaciones o delegado) Hora
Nombre:
Firma: Fecha & Hora: Firma LGT Calidad LGT Calidad

Nota: Remover el formato de bypass de proceso de la estación y enviarlo al GUO o Coordinador de Calidad.
LGT Calidad
Paso Sección 4: Es llenado por calidad Proceso Bypass Auditado / Registrado 18a hora
16 Auditar el proceso Bypass para verificar que se haya completado apropiadamente (GUO de Calidad o delegado) Hora
Firma del GUO de Calidad: Fecha y Hora:
LGT Calidad
17 "CHECKLIST DE BYPASS Y AUDITORIA" Completada y llenada en DCC. Firma LGT Calidad
Firma de Calidad: Fecha y Hora:

20a hora LGT Calidad


Hora

Firma LGT Calidad LGT Calidad


Bypass x Deviation: Requirements’ comparison
Bypass Deviation
Requirement
(Proactive) (Reactive)
The plant shall identify manufacturing processes and error
proofing devices which can be bypassed or placed in X X
deviation.
Risk Priority Number (RPN) for all approved Bypass /
X X
deviation processes are evaluated and risks are reviewed.
Standard work instructions are available for each Bypass /
X X
deviation process.

*Customer Approval (see PPAP Manual) X X


Implemented Bypass is reviewed regularly and goal is reduce
X X
or eliminate bypass
Processes/devices in bypass / deviation must have a quality focused
audits performed. Supplier locations that have a process in
bypass/deviation shall have the bypass/deviation process checked on
X X
the daily LPA.

Restart verification is documented for defined period. It should be


100% checked for all features
X X
MANAGING CHANGE
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Change Control - Production Trial Run (PTR) Look for a reasonable sample size to be used for Production Trial Run, based
on risk.
A reasonable sample size is used for Production Trial Run, Ensure changes are clearly communicated.
based on risk. Changes are clearly communicated and Verify that parts are contained, stored and clearly identified prior to and after
understood at all levels (e.g. team level). the PTR build.

BIQS -14 Parts are contained, stored and clearly identified prior to and Confirm that for changes that require a customer PTR, all customer locations
after the PTR build and PPAP approval. are notified. Look to see that production breakpoints are recorded.
BIQS Requirement
A reasonable sample size is used for Production Trial Run, based on risk.

PTR - Procedure (Example) (Example)

Product/Process Minimum required


Affected
Standards According to Customer
Characteristic schedule
PQC/KPC 100 parts (to define
Characteristic control chart limits and
capability
Constraint/Bottleneck According to GP-9
Process

Guidelines
 Ensure changes are clearly communicated.
 Verify that parts are contained, stored and clearly identified prior to and after the PTR build.
 Confirm that for changes that require a customer PTR, all customer locations are notified. Look to see that production breakpoints are
recorded.
BIQS Requirement BIQS Requirement
Changes are clearly communicated and understood at all levels Parts are contained, stored and clearly identified prior to and
(e.g. team level). after the PTR build and PPAP approval.
Communication: PTR form (Example)
Top half of form Bottom half of form
(Example)

Responsibility -
Rasic

Guidelines
 Ensure changes are clearly communicated.
 Verify that parts are contained, stored and clearly identified prior to and after the PTR build.
 Confirm that for changes that require a customer PTR, all customer locations are notified. Look to see that production breakpoints are
recorded.
TIER SUPPLIER MANAGEMENT
BIQS
BIQS Requirement BIQS Calibrator Guidelines (Look For)
Item #
Supply Management Is there a process at all Tiered suppliers for tracking internal and external
issues?
Tier supplier targets are defined and their performance are Do they mandate a Fast Response process be used?
tracked. Do they review how effective their problem solving process is at each Tiered
BIQS -29
Annual Audits are performed, issues found are tracked until supplier?
closed. Are annual Tiered Audit performed? Do they use BIQS 1-13 at a minimum to
Quality Data is used in the sourcing decision process. audit?
BIQS Requirement BIQS Requirement
Tier supplier targets are defined and their performance are tracked. Quality Data is used in the sourcing decision process.

Performance tracking
(Example)
Bidlist

(Example)

Guidelines
 Is there a process at all Tiered suppliers for tracking internal and external issues?
 Do they mandate a Fast Response process be used?
 Do they review how effective their problem solving process is at each Tiered supplier?
BIQS Requirement
Annual Audits are performed, issues found are tracked until closed..
Performance Tracking (Example)

Annual Audit Plan


Annual Audit Plan (Example)
Score Supplier Location Driver Focus Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Comments
R MNO Pontiac, MI Plant Disruption Manufacturing System Action Plan Review - Jun
Y ACB Detroit, MI Repetitive issues Assembly Process Action Plan Review - Aug

Action Plan Tracking (Example)

Guidelines
 Check that supplier has periodic system audits of their suppliers to improve key tier 2 performance such as first 13 elements of BIQS or
equivalent, with clear plan and follow up to close the gap .
ADDITIONAL INFORMATION: TRAINING,
MATERIAL AND RECOMMENDED READINGS
BIQS QSB+ Material Books / other
Element resources
BIQS 1 2. Control of Nonconforming
Material
BIQS 2 6. Layered Process Audit AIAG CQI – 8

BIQS 3 7. Risk Reduction AIAG FMEA Manual

BIQS 4 7. Risk Reduction AIAG FMEA Manual

BIQS 5 10. Managing Change

BIQS 6 3. Verification Station and AIAG CQI – 18


Error Proofing Verification
BIQS 7 4. Standardized Operations AIAG MSA Manual

BIQS 8 1. Fast Response

BIQS 9 1. Fast Response AIAG CQI – 20 / 21


Toyota Way – Chapters 13
to 17
BIQS 10 6. Layered Process Audit

BIQS 11 4. Standardized Operations Toyota Talent – Chapters 6


to 10
BIQS 12 10. Managing Change AIAG PPAP Manual –
Section 3
BIQS 13 3. Verification Station and
Error Proofing Verification
BIQS QSB+ Material Books / other
Element resources
BIQS 14 10. Managing Change

BIQS 15 1. Fast Response

BIQS 16 3. Verification Station and


Error Proofing Verification
BIQS 17

BIQS 18

BIQS 19 AIAG APQP & Control Plan


Manual
GM 1927-16 (section B)
BIQS 20 AIAG APQP & Control Plan
Manual
GM 1927-16 (section B)
BIQS 21 AIAG SPC Manual
GM 1927-03 (SQ SOR)
BIQS 22 2. Control of Nonconforming
Material
BIQS 23 3. Verification Station and
Error Proofing Verification
BIQS 24 5. Training Toyota Talent – Chapters 11
to 15
BIQS QSB+ Material Books / other
Element resources
BIQS 25 8. Contamination Control

BIQS 26 11. Maintenance

BIQS 27 2. Control of Nonconforming


Material
BIQS 28 2. Control of Nonconforming GM 1738i
Material
BIQS 29 9. Supply Chain AIAG CQI 19
Management
BIQS 30
Global Built-in Quality Supply Based (BIQ-S)
MISSION :
Lead suppliers to achieve operational excellence by developing a Quality Culture through
Built-In Quality (BIQ) manufacturing systems for suppliers.

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