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Quality System Basics Aud

1) The QSB audit is a 'checklist' used to provide objective evidence that satisfies General Motor's Su
Manual .

2) Suppliers are required to keep completed copies of the QSB audit, and accompanying corrective a
be uploaded in GQTS supplier cert tab.

3) Supplier is required to forward an updated self- assessment every 12 months after initial certificati
manager, Quality Manager or Operation Manager) or repeat Quality issue.

4) Not Reviewed is used when immediate focus does not include the strategy. Plan to review in future
Applicable is used if a question does not apply. Question should be given a score of 4 and a note m

5) Self-assessment audits can not and will not be certified without verification by a GM SQE or GM re
GM SQE can input a forecast date by sending self assessment to SQ Cert mailbox with Self asses

6) Overall scoring of 85% or greater without any Red strategies will be certified. High PRR duns locat
certification will only occur after 60 day review period of PRR reduction activites ( see question 1.3

7) A QSB certification is valid for a 3 year period. The certification status will be made available for vi
note that this certification can be revoked at any time during this period if it has been determined t
will spot check several QSB elements at all post certification visits.

8) A List of GM Approved 3rd party providers is available in Supply Power:


https://gmsupplypower.covisint.com/web/portal/document-library?p_p_id=20&p_p_lifecycle=0&p_
%2Fdocument_library%2Fview&_20_folderId=4500875

9) Any Questions about Audit or audit procedure should be addressed to responsible SQE (QSB tool
https://gmweb.gm.com/gpsc/gpsclibrary/supplierquality/Global%20Processes/Forms/AllItems.aspx
%2fGlobal%20Processes%2fGM1927%20SQ%20Manual%20and%20Supporting%20Documents%2f
%20Toolbox&FolderCTID=0x0120001F177ADA3D18CF4EAD316284181CDF67&View=%7b8127FE65

stem Basics Audit

fies General Motor's Supplier Quality Expectations addressed in the Supplier Quality

ompanying corrective action plans, covering the prior 12 months. Latest audit shall

hs after initial certification or 60 days after any key management change (Plant
Plan to review in future. Give future review date in comment box
score of 4 and a note made in comment section

Not

by a GM SQE or GM representative.
mailbox with Self assessment in subject line

d. High PRR duns location will be required to put PRR reduction activites in place ivites ( see question 1.3 ) Min 15% improvement.

be made available for viewing in the 'Certification' module in GQTS. It is important to


has been determined that a supplier's quality performance has deteriorated. SQE's

20&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_20_struts_action=

onsible SQE (QSB toolbox is now accessible by supplier)


es/Forms/AllItems.aspx?RootFolder=%2fgpsc%2fgpsclibrary%2fsupplierquality
ting%20Documents%2fQSB
7&View=%7b8127FE65%2d235A%2d47B9%2dB065%2d4B7B4F092C2F%7d

QSB Audit Acronyms


AIAG (Automotive Industry Action Group)
AIMS (Automated Issues Matrix System)
AP Action Plan
APQP (Advanced Product and Quality Planning)
BIQ (Build-IN-Quality)
CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)
CARE Customer Acceptance Review and Evaluation
CC (Critical Characteristic)
CP (Confirmation Prototype)
Cpk (Process Capability Index)
CPU (Cost Per Unit)
DFMEA (Design Failure Modes & Effects Analysis)
ES (Engineering Specifications)
FIFO First In First Out
FM Failure Mode
FMEA (Failure Mode and Effects Analysis)
FR Fast Response
FRB Fast Response Board
FTQ First Time Quality
GA Gap Analysis
GAGE R&R (Gauge Repeatability & Reproducibility)
HIC (High Impact Characteristic)
JES (Job Element Sheet)
JIT (Just In Time)
KCC (Key Control Characteristic)
KPC (Key Product Characteristic)
LPA Layered Process Audit
LRR (Launch Readiness Review)
MRB Material Review Board
MS (Material Specifications)
MSA (Measurement Systems Analysis)
NA Not Applicable
NR Not Reviewed
PCPA Process Control Plan Audit
PD (Product Development)
PEO (Product Engineering Office)
PFMEA (Process Failure Modes & Effects Analysis)
PM Preventive Maintance
PPAP (Production Part Approval Process)
PPCR (Plant Process Change Request)
PPE Proper Protective Equipment
Ppk (Performance of process)
PQC (Product Quality Characteristic)
PRR (Problem Reporting & Resolution)
PSW (Part Submission Warrant)
PTR Production Trial Run
QSB Quality System Basics
RPN (Risk Priority Number)
SOS (Standardized Operation Sheet)
SPC (Statistical Process Control)
SWI (Standardized Work Instructions)

TPM (Total Productive Maintenance)


WIP Work In Process
WPO Work Place Organization

GPSC Supplier Quality


QUALITY SYSTEMS BASICS AUDIT

GM 1927-30
Version February 20, 2012

SUPPLIER NAME:

AUDIT DATE:

SUPPLIER DUNS NO:

GM AUDITOR NAME:

SUPPLIER LOCATION:

GM AUDITOR EMAIL:

SUPPLIER CONTACT:

AUDIT CONDUCTOR:

SUPPLIER EMAIL:

Expected "Green" Compliance Date:

CURRENT STATUS ISO/TS 16949:

ISO/TS 16949 CERTIFICATION NUMBER:

ISO/TS 16949 EXPIRATION DATE:

AUDIT SUMMARY
KEY STRATEGIES

POTENTIAL
SCORE

AUDIT
SCORE

STATUS

28

28

100%

28

26

93%

20

18

90%

32

31

97%

20

20

100%

12

12

100%

28

28

100%

24

21

88%

24

23

96%

16

16

100%

16

13

81%

1.0 FAST RESPONSE


CONTROL OF NONCONFORMING
2.0
PRODUCT
3.0 VERIFICATION STATIONS
4.0 STANDARDIZED OPERATIONS
5.0 OPERATOR TRAINING
6.0 ERROR PROOFING VERIFICATION
7.0 LAYERED PROCESS AUDITS
8.0 RISK REDUCTION
9.0 CONTAMINATION CONTROL
10.0 SUPPLY CHAIN MANAGEMENT
11.0 MANAGING CHANGE

IS CORRECTIVE ACTION REQUIRED

Audit Status: Status default on RED or NR from each Key Strategy which requires Corrective Actions.
If any of audit line item is scored by 0 or 1 strategy goes to Red

Audit Summary
Total Score:

Audit Summary Total Score:


248

236

95%

1. Green - 85% or greater with No Red elements - Pass


2. Yellow - 75-84% with No Red elements - Follow Up - Fail
3. Red - < 74% or a Red or NR strategy - Workshop - Fail

G
Pts

Element Scoring

Element is not in place and no evidence of plans to implement

1
2
3
4
NR

Element is not in place but a plan to implement is documented


Element is in place but it is not being followed
Element in place but not followed at each job or all the time
Element is in place and it is being followed

Not Reviewed: Key Strategy not audited at this time. (Training Required, Follow-Up Required)

Note: Status and Code entered automatically from audit sheet..


Not Reviewed is used when immediate focus does not include the strategy. Plan to review in future. Give future review date in comment box
Not Applicable is used if a question does not apply. Question should be given a score of 4 and a note made in comment section

This audit corresponds to the current Quality Systems Basics requirements as defined in the QSB presentation revised in January, 2011. A QSB certification is
valid for a 3 year period. The certification status will be made available for viewing in the 'Certification' module in GQTS. It is important to note that this
certification can be revoked at any time during this period if it has been determined that a supplier's quality performance has deteriorated.

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
EVIDENCE REQUIRED
LOOK FOR
#
1.0 FAST RESPONSE: PROBLEM SOLVING, COMMUNICATION and LESSONS LEARNED
Is there a system in place to immediately respond to significant internal and external quality failures?
Daily leadership meeting held with
cross-functional, multilevel attendees to
address significant external and internal
Quality concerns.
To each concern natural owner is
designated, next report out date is
assigned

1.1

Fast Response (FR) meeting is owned


by Manufacturing

1) Prior to the audit check last PRRs if any.


Ask if there are any significant internal issues (e.g.: findings of Verification Station, dock
audit or LPA, supplier issue etc). Prior to the meeting review the board if these issues
addressed.
ON THE SHOP FLOOR:
Attend Fast Response meeting. Observe:
2) Who leads the meeting (owned by manufacturing), if needed back up person designated
Has to be a communication meeting, average duration of 10-20 minutes, check how
3) leader controls the FR meeting (keep timing, focus on subject, not going to the details...)
Cross functional attendees - check for sign-in sheet
Report out process and verify that a Problem Solving report format is used to document
4) & communicate the status of the issue.
5) Natural owners are assigned to problems

COMMENTS

SCORE

R/Y/G

Se tienen juntas de Arranque de Turno donde


se revisan todos los puntos de Produccion,
Calidad.
EVIDENCIA. PIZARRON PCC
En estas reuniones se revisa la informacion de
Dock Audit, Rechazos del Cliente y los
indicadores clave de la linea

6)

G
Fast Response Board to track concerns
1)
Problems are communicated to the
appropriate employees
2)
Exit Criteria, required to close a
concern, follows the problems steps

1.2

Timing for each of the criteria


established

3)
4)
5)

Overall status represents the worst


condition or overall planned timing has
been exceeded

ON THE SHOP FLOOR:


Rechazos de Cliente QuickUpdate, QSYS,
Fast Response board is used for tracking of issues, being updated before FR meeting
Close of Audit, WRQM, Lecciones Aprendidas,
(board could be a dry erase board, laminated poster, Excel sheet projected by beamer
Procedimiento de Quejas de Cliente
etc)
Method of communicating problems to all Key Stake holders (e.g. Quality Alert,
Temporary Work Instructions, By-Pass Procedure etc.)
Exit criteria represents the core 6 "Steps" steps of problem solving including timing for
each of the exit criteria
Check statusing (Red, Yellow, Green), red items have a planned date to go green with
next steps. Problems are not closed until all criteria is met.
Follow an issue from FR Tracking Board through the exit criteria confirming actions are in
place & all documentation has been updated

6 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Fast Response Process performance is
tracked.

1.3

Immediate review and timely response


of all problem resolution reports.
High PRR duns locations (24+ SQ
related PRR's in past 12 months) shall
be required to perform PRR reduction
activities (see item#6 in Instructions
Sheet). Score should be 0 until PRR
reduction activities are in place for at
least 60 days.

LOOK FOR

COMMENTS

ON THE SHOP FLOOR


1) Quality Q or other method to track FR performance is posted and up to date.
Are PRR assigned to a champion for immediate response and corrective actions
2) Are corrective actions robust enough to prevent further defects?
High PRR duns location shall have a special team created to work on PRR reductions performance shall be tracked at FR meeting on open issues list.
3)
4)

SCORE

R/Y/G

Quick Update Ultimo rechazo Marzo.


VERDE.
Revisar todas las *D, QYSYS, Read Across
Lesson Learn, Planes de Control, PFMEAS<
Formatos

G
Is there a defined process for Problem Solving leading to root cause identification and elimination?
A defined process for Problem Solving
including a standard for documenting
the tools used for root cause
identification.

1.4

1) Standard process (PPSR, 8D or equivalent) used with a format that follows the core "6
Steps" of problem solving (1.Define, 2.Contain, 3.Root Cause, 4.Correct, 5.Validate,
6.Institutionalize)
2) Problem Solving forms used across the plant for internal, customer and supplier issues.
Evidence of cross-functional team approach and team members got the necessary
3) trainings
Tools for identifying root cause are applied (7 diamonds, Drill Deep / 3X5 why to correct
4) systemic issues, Fishbone Diagram etc.)

AMARILLO POR DOCK AUDIt


es NECESARIO REVISAR PASO A PASO
CADA DOCK AUDIT.
Alertar a Produccion e Ingenieria sobre la
visita, el documentar correctamente los Dock
Audits y mantener la disciplina

ON THE SHOP FLOOR:


Check last quality issues (customer/internal/supplier) and confirm:
Main root cause found. Try to raise further "whys".
Corrective action implemented for elimination of main root cause, breakpoint identified
Corrective action is verified
Relevant documents updated (PFMEA /see point 8.4/, Control Plan, Working Instruction
etc.)

AMARIllO POR DOCK AUDIt


es NECESARIO REVISAR PASO A PASO
CADA DOCK AUDIT.
Alertar a Produccion e Ingenieria sobre la
visita, el documentar correctamente los Dock
Audits y mantener la disciplina

Problem solving used efficiently,


all the core "6 steps" applied
1)
2)

1.5

3)
4)

4
G

Is there a system in place to capture information that supports continuous improvements to all operations/processes?
A system to capture and institutionalize
lessons learned
A disciplined approach to problem
prevention using lessons learned.

1.6

1) Review Lessons Learned procedure & forms (electronic forms or database), ask people
for examples how are they using Lessons Learned system
Method which assures implementation supported by evidence of review dates,
2) distribution lists, or posted Lessons Learned
Check 6th step of problem solving (Institutionalize) via examples of point 1.5. Check
3) Readacross (Drill Wide) of last PRRs.
Completed Lessons Learned information which is easily retrievable by all who need the
4) information. (e.g. Master FMEA, Read Across, APQP Program check list reviews).

ROJO OBSCURO
NO tenemos institucionalizado como TRW un
proceso de Lesson Learned como
consecuencia de quejas de clientes PRR
read Across si esta implementado

7 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#
1.7

EVIDENCE REQUIRED
Leadership reviews and supports
Lessons Learned process to assure
implementation.

# Corrective Action Required =

LOOK FOR

COMMENTS

1) Continuous improvement team notes and agendas


2) Leadership notes or agenda indicating Lesson Learned system is reviewed such as
through a LPA (e.g.: check Institutionalize for problems) or internal systems audit

NO tenemos institucionalizado como TRW un


proceso de Lesson Learned como
consecuencia de quejas de clientes PRR
read Across si esta implementado

SCORE / POTENTIAL
2.0 CONTROL OF NONCONFORMING MATERIAL
Is there a system in place to ensure products that do not conform to specified requirements are prevented from unintended use?

2.1

A consistent tagging system is used to


identify suspect and nonconforming
product.
(Such us Stoplight visual management:
Red-Yellow-Green)

1) Consistent tagging system is defined on procedure level


ON THE SHOP FLOOR
2) All the parts statuses can be identified based on tagging system
3) Colour coding is applied for identification of scrap containers, hold tags, scrap labels, inprocess tags, travellers, routers, etc
4) If red tags are used for both scrap and suspect material, tag must have disposition.
Suspect tags should have last operation performed.
5)

Verde
Todo en el buzon, todo con etiqueta todo
registrado.
Agregar en la etiqueta la estacion de donde
sale

SCORE

R/Y/G

4
G
28

28

4
G

2.2

2.3

Nonconforming and suspect material


are segregated in properly identified
areas.
Scrap is prevented from unintended
use.

Containment form or nonconforming


material form identifies expected
quantity and locations of suspect
material.
Product in containment properly
identified.

1) Procedure and method for materials/parts designated as scrap to ensure it is properly


identified and kept from being reintroduced back into the normal material flow. (e.g.
destruction, paint, locked container)
ON THE SHOP FLOOR:
2) Segregation areas are identified and/or foot printed.
Scrap bins, rework tables, hold areas, etcare identified/foot printed, scrap boxes size
should match with part size
Quarantine area physically closed, entrance only with authorized access, quantities in
quarantine are controlled
1)
2)
3)
4)

Verde
Todo en el buzon, todo con etiqueta todo
registrado.
Agregar en la etiqueta la estacion de donde
sale

4
G

ON THE SHOP FLOOR:


Sistema Report Management. Se puede
Containment worksheet or equivalent contains all the potential locations
identificar donde y cuantas piezas estan
Containment activity starts with physical counting of suspected batch, including signature sospechosas
for accountability
Containment area is separated from production line
Tagging system is applied for containment

4
G

Is there a nonconformance quality alert and notification procedure that meets customer requirements?

2.4

The organizations nonconformance


alert notification and containment
process includes communication and
action for all stakeholders:
- Customer(s)
- Tier suppliers
- Internal stakeholders

1) Quality Alert is issued for external and internal issues


2) Quality Alert includes:
- defines the problem, the standard and deviation from standard
- tasks, time line,& communication necessary to meet
customer requirements.
3) Internal/external distribution and notification
- Contact list for customer and tier suppliers
- Certified shipment log (to customer, from tier supplier)
ON THE SHOP FLOOR
4) Quality Alert is signed by operator for review and understanding
5) Andon System in shop floor to raise alarm when error is made, if applicable

8 of 38

Amarillo Cada Dock Audit una alerta de


calidad como parte del plan de accin
Sistema de Escalacion por problemas de
calidad

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Product removed from the approved
process flow for repair or rework:
- Has Approved Work Instructions
- Is reworked by approved person

LOOK FOR
1)
2)
3)
4)

2.5
- Is
reintroduced into the process at or
prior to the point of removal
- Is traceable through an identifier
- Is released using a defined process
and authority.

2.6

2.7

COMMENTS

ON THE SHOP FLOOR:


Evidence of reintroduction, at or prior to point of removal.
Reintroduction includes all downstream checks such as error proofing. All control plan
inspections & tests to be performed
If it cannot be reintroduced into the process, verify that an approved (Quality Manager)
documented rework and inspection procedure is followed.
Look for an identifier such as serial number or special marking that can be traced back to
the supplier record to show what was done and when.
Form to release product with authorized signature and approved inspection of product
Define limit for the number of times of repairment, suggested not more than 2 times with
a tracking method.

R/Y/G

Performance metrics and goals should


be established and analyzed for
continuous improvement.

1) Performance metrics and goals such as 6 Panel, Downtime, FTQ, scrap rate etc. are
established to reduce scrap at all levels of the operation.
2) Action plan and its follow up for top issues.

Verde
Indicadores de Scrpa, de Dowtime,

Leadership involvement in internal and


external spill, containment,
communication activities, scrap analysis

1) Periodic summary reports


2) Review for analysis and action taken for metrics
5)

Verde
QIP. Juntas de Staff

# Corrective Action Required =

SCORE

Repasar con los lideres el proceso de Producto


no Conforme.
Se identifica el material, se pone dentro del
buzon, se analiza por el lider si es producto no
conforme se va al SCRAP, si puede ser
sustituido un componente se cambia de
acuerdo a las instrucciones de la linea

4
G

6)

SCORE / POTENTIAL

26

28

3.0 VERIFICATION STATIONS (VS)


Is there at least one Verification Station in the process? (If a GMPT Supplier, C.A.R.E. must be implemented.)
A procedure which focuses on Building
Quality in Station through Feedback
from the process.
Powertrain supplier shall implement
C.A.R.E.

3.1

1) Verification Station strategy is defined on procedure/instruction level:


- Selection of place of Verification Station (high risk, poor FTQ, low capability etc.)
- Necessary documentation to be used
- Guideline for set up of alarm limit
- Definition when a problem needs to be escalated with its escalation route
ON THE SHOP FLOOR
C.A.R.E is implemented and running at Powertrain supplier
Verification station(s) selected efficiently:
2) -Prior to audit review PRRs (any major or repeative issue), Control Shippings, GP12.
3) -Review FTQ results, high RPN items from PFMEA, process capability data.
-Based on data review, evaluate if Verification Station(s) implemented to right place or
there is a need to implement a new one(s).

Process Audit. El PA tiene un plan de reaccin


que esta vinculado al proceso de escalacion
REFORZAR EL PLAN DE REACCION DE LAS
AUDITORIAS DE PROCESO. INGENIEROS
DE CALIDAD Y PRODUCCION
Como se activa el proceso de escalacion
cuando hay fallas??
Inspeccion en cascada en cada estacion de
produccion.
Estaciones de Inspeccion Final.
Graficos de SPC con alertas en puntos fuera
de control. Datos en rojo
Necesitamos revisar los mas altos RPNs y
ver como se controlan. REVISAR CON
INGENIERIA RPNS.
AGREGAR CRITERIOS DE ESCALACION

Y
9 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

3.2

3.3

EVIDENCE REQUIRED

LOOK FOR

Tally Sheet which records the number of


problems by the hour (or batches)
1)
2)
Reaction when alarm limit is reached.
3)
Responses to alarms are documented
4)
Escalation procedure is followed.

COMMENTS

ON THE SHOP FLOOR:


Tally Sheet posted at or near the Verification Station, filled in properly
Alarm limits reasonable (e.g.: 1 for C.A.R.E., GP12, customer complaint; how often alarm
limit reached as no alarm=no improvement)
Escalation kept (when and who to call, who responded and when)
Issues documented and fixed immediate

Reporte de Fallas Inspeccion FinAl lleno


correctamente.
Poner a funcionar el proceso de escalacion en
GM. Mauricio Cossio, Ingenieros de Calidad

SCORE

R/Y/G

4
G

Problem solving process applied for VS


ON THE SHOP FLOOR
findings, corrective actions implemented 1) Assignment of problem solving activities
as a result of Verification Station
2) Corrective actions documented and verified
activities.

Reporte de Fallas lleno correctamente.


Poner a funcionar el proceso de escalacion en
GM. Mauricio Cossio, Ingenieros de Calidad

Feed Back data from downstream


ON THE SHOP FLOOR
customers is documented and
1) Performance Graphic or Q chart showing (i.e. calendar days-red/green) feedback from
performance is tracked at the inspection
downstream customers and details.
point.
2) Graphics or report card showing findings at the station for communication to upstream
processes/suppliers.
3) FTQ or scrap analysis showing improvement trend, reduction of events/defects over
time.

Close off Audit Reporte Clientes


Dock Audits Interno
Scrap Interno
Process Audit

Leadership reviews Verification Stations


activities and results.
Management walk through or meetings
at selected stations.

Revisiones de QIP
Close off Audit

3
Y

3.4

3.5

ON THE SHOP FLOOR


1) Leadership review of verification station review results and follow up of action plan, if
needed read across its results
2) Team reports out minimum weekly and the status is reviewed during the
leadership/support staff walk through.

# Corrective Action Required = 0


4.0 STANDARDIZED OPERATIONS
WORKPLACE ORGANIZATION
Is there a systematic approach to utilize and maintain Workplace Organization?

10 of 38

4
G

SCORE / POTENTIAL

18

20

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Procedures or operator instructions for
safe, clean, and orderly arrangement of
the workplace environment that
eliminate waste, provide a specific
location for everything, contribute to
higher quality, and the opportunity to
standardize and increase efficiency.

4.1

LOOK FOR
1)
2)
3)
4)
5)
6)
7)

COMMENTS

Systematic approach for Workplace Organization (like 5S) is implemented and


maintained:
Defined in procedure level including standard markings
Organization trained
Action plan with timing for implementation
Audit schedule and feedback for maintain
A countermeasure sheet or equivalent includes issue found during audit, owner, action
and date for correction.
ON THE SHOP FLOOR:
Audit performed according to schedule, action addressed to deviations and followed up
Ask a Team Member to explain the 5S process, examples of waste eliminated in their
workplace. Does the 5S process focus on waste elimination?
FIFO kept

SCORE

R/Y/G

Auditorias de 5S, tenerlas al dia. Produccion


Cynthia cursos de 5S
Auditoria de LPA
Auditorias de B2B. Silvia Concha URGE

8)

G
Clean, organized work areas. Items in
areas labelled, foot printed or otherwise
identified.

4.2

ON THE SHOP FLOOR:


1) Display placement (what is to be in a work cell) and identification (how it is to be labelled)
of material, equipment, tools, aisles, hazards, including storage of personal belongings.
Visual aids used to assist in the process flow.
2) Ask if the Production, Maintenance, Quality, Material and office areas have documented
3) workplace organization standards.
Check several working stations that 5S requirements kept
4)

Asegurar que todo el material ete


identificado, en orden las lineas, limpias y
ordenadas.
Ingneira y Produccion

4
G

STANDARDIZED WORK INSTRUCTIONS


Is there a system in place to develop standardized work instruction (methods and sequence) for all operations?

4.3

Standardized Work Instructions


1) Standardized Work Instruction /SWI/ template developed and applied for all operations.
(Standardized Operation Sheet /SOS/ or
SWI contains minimum: Work elements and their sequence, Operator movement with
equivalent) are posted at or near all
2) sketch of work flow, Work elements takt time and work element cycle time.
operations where there are human
ON THE SHOP FLOOR
operators.
SWI posted near or at the operation
Ask operators to explain SWI. Does operator understand it?
3) Check some SWIs if match with workplace, work elements sequence kept within cycle
time.

Hojas de Operacion en cada estacion

Usage of Standardized Work


Instructions (Standardized Operation
Sheet /SOS/ or equivalent)

Reforzar el seguimiento a las hojas de


operacion ty Process Audit MI PRODUCCION

G
4.4

1)
2)
3)
4)

ON THE SHOP FLOOR:


Training for new team members
Analysing job for improvement opportunities
Layered Process Audit
Problem solving (4 diamonds)

4
G

11 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Procedure that requires cross-functional
teams to develop standardized work
instructions. Should be maintained through
the use of the continuous improvement
process.

LOOK FOR
1)
2)
3)

4.5

4)

COMMENTS

ON THE SHOP FLOOR


Procedimiento de Desarrollo de Mis
Ask the Team Member/Leader their level of involvement in developing their standardized
work.
Verify Team Leaders, Team Members, Group Leader original signature is on the
document.
Ask the Team Leader if there is a process (formal or informal) for teams to seek
agreement for job element sequence within the team and across all shifts and crews.
Ensure controls listed in Control Plan added to SWI, efficient time allocated for quality
checks (if cannot be ensured it needs to go back to PFMEA)

SCORE

R/Y/G

G
OPERATOR INSTRUCTIONS
Is there a systematic approach to develop Operator Instructions for all work.
Procedure, instructions or other
documentation that requires
development of operator instructions
(Job Element Sheet, /JES/) for all work.

4.6

1) Operator Instruction template developed and applied for all operations.


Procedimiento de Desarrollo de Mis. HAYDEE
2) Operator Instruction contains Major Steps (What), Key Points (HOW), and Reason
Revision
(WHY) supported with pictures
3) Use Operator Instruction for standardized operator training to ensure that all operators
got the training on same level
ON THE SHOP FLOOR:
4) Operator instructions in or near work areas that are accessible to operators.
Compare instructions to work performed by operators. Observe 3 full cycles of the job in
5) station & verify that the Major Steps, Key Points are followed Reason is understood
Quality checks are included.
Specific tool requirements are listed at the operation.
6) Verify critical items such as torque Customer or Safety requirements are specified in the
7) document.
8)

G
Verify, maintain and update operator instructions as processes/products change.
4.7

Procedure, instructions or other


documentation that requires
implementation and revision of operator
instructions.

ON THE SHOP FLOOR:


Impact mantiene en obsoletos
1) Review revision history of operator instructions.
2) Check to see if it is marked up, signed, and dated around the timing of a recent design or
process change

4
G

Is there a system in place for Gage control.

4.8

Procedure and forms to document


process.
Compliance to customer requirements
(GM 1925) for both internal & external
gage providers.
Gage instructions updated to current
product and process level.

1)
2)
3)
4)
5)
6)
7)

ON THE SHOP FLOOR:


Mauricio, revisar todas las instrucciones de
Documented procedure and gage/fixture use instructions.
calibracion e instrucciones de Process Audit,
Operator gage training to the current gage instruction.
de Inspecciones,
Gage master device.
Ingenieros de Calidad. R&R Variables y
All the gages calibrated.
atributos. R&R Atributos en
Gage certification frequency.
Gage R@R.
Last Part Checked should be held for confirmation of last known good part at a frequency
of at minimum of 1 per shift

Y
# Corrective Action Required =

SCORE / POTENTIAL
12 of 38

31

32

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
EVIDENCE REQUIRED
LOOK FOR
COMMENTS
#
5.0 STANDARD OPERATOR TRAINING
Is there a system to define a standard training method, minimum content and tracking for all operators new to an operation and/or those in need
of refresher training?
A standard operation training method
which ensures that all the trainers are
trained to apply it when teaching
operators

5.1

Records for identification of trainers to


ensure that only certified trainers train

1) Train the trainer process in place, evidence of a graduating step approach such as the 4
Step (Job Instruction Training) process:
1.Prepare, 2.Demonstrate, 3.Try-out performance, 4.Follow-Up.
ON THE SHOP FLOOR:
2) Certified trainer list, a document to show who is certified to train.
3) Check minimum 3 working stations and verify their operators got the training from
certified trainer and ask operators how they were trained (e.g.: according to 4 Step)
Follow up should include monitoring new operators' activities by the trainer at a
4) frequency determined necessary to assure all standards are met and verify productivity

SCORE

R/Y/G

5.2

5.3

Standard operator training records


1) Training record that documents training of procedures and overall job knowledge to:
document specific areas of training such
-Work safely (guards, start-up shut down, lock out)
as safety, quality record keeping,
-Perform proper record keeping (production/quality)
gaging, workplace organization
-Understand work place organization responsibility
responsibilities.
-Quality requirements (containment, red-bins, andon, etc)
Records are available and easily retrieved.
2)
Specific Job instruction training is
documented for each operator showing
all jobs trained on, skill or knowledge
level of the job, who trained them and
when.

1) Individual Job training record with dates and trainer signoff for each job.
2) Record indicates the steps in training & skill/knowledge level achieved for each job:
ON THE SHOP FLOOR:
Verify a new operator (look for minimum 3 cycles) whether follows Standardized Work
Instructions and know the quality and productivity requirements.

4
G

4
G

5.4

5.5

Records reflecting training status of all


1) How is record maintained to track training of operators to the latest work instruction
operators posted at or near the
change level?
operation indicating they are trained to
ON THE SHOP FLOOR:
the current work instruction change level 2) Check minimum 3 working stations and verify their operators training records to the latest
to ensure only trained operators perform
working instruction level
standardized work.
3) Flexibility Chart or equivalent posted at all operations or work area, keep updated and
being used.
4) All operators listed including supplemental employees.
Refreshment training records for:
- supplemental or temporary employees
- employees failed on re-certification
process

1) Documentation, scheduling, and tracking forms for supplemental operator refresher


training if they have not performed that job within the last three months.
Record of re-certification process for operators including re-training if needed

13 of 38

4
G
4

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED

LOOK FOR

COMMENTS

# Corrective Action Required = 0


SCORE / POTENTIAL
6.0 ERROR PROOFING VERIFICATION
Is there a system in place to verify that error proofing/ detection devices used in manufacturing and assembly are functioning properly?

6.1

6.2

Documentation and evidence that


indicates devices are verified at least
once per day.

ON THE SHOP FLOOR:


1) Documentation (verification logs) of device verification at a minimum of once per day &
are easily accessible.
2) Reaction plan includes who is notified and actions to be taken.
3) Containment and corrective action documentation for failures.

Auditorias de Mistake dos veces al turno por


sistema

Error Proofing device locations shall be


documented.

1) Master list of all devices that prevent/detect the manufacture or assembly of


nonconforming product.

Por estacin. Revisar esten todos con Jose


Luis Nieto. Auditorias de Mistake por los inges

Management reviews results of


verification.

1) Each verification failure needs to be escalated to Fast Response Meeting in order to


avoid shipping out parts without containment
2) Review of result of verifications and Layered Audit in order to define necessary step
(increase frequency of verification or LPA, purchase reliable error detection device etc.)

REFORZAR PLAN DE ESCALACION DE


FALLA DE MISTAKES. PRODUCCION

Reaction to failures and corrective


actions are documented.

6.3

SCORE

R/Y/G

20

20

4
G
4

4
G

# Corrective Action Required =

SCORE / POTENTIAL

12

12

7.0 LAYERED PROCESS AUDITS


Is there a system in place to verify the documented manufacturing/assembly process through layered audits?

7.1

A defined Layered Process Audit (LPA)


procedure that is owned by
manufacturing.

All levels of the organization participate


in Layered Process Audits at
established frequencies.

1)
2)
3)
4)

Written Procedure and Layered Audit questionnaire template


Audit and work instructions define what to "Look For"
Counter measure process, reaction plan with real target dates
Owned by Manufacturing
ON THE SHOP FLOOR:
5) Easy access of Layer Audit questionnaire template
1)

2)

7.2

3)
4)

ON THE SHOP FLOOR:


Audit Schedule showing level of participation and frequency.
CEO should be Quarterly, Plant Manager Monthly,
Management Support Staff - Weekly (i.e. Engineering,
Maintenance, Quality) Daily-Team Leaders/team members.
Evidence that all layers of the organization perform regularly scheduled standardized
audits.
Ensure that each station within a working area is audited at minimum once per month
Perform a Layered Audit together with team leader. Compare your results with team
leader.

4
G

14 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

7.3

EVIDENCE REQUIRED

LOOK FOR

COMMENTS

High risk items identified and included in


LPA Audit document, focused checks on
below sections:
Work Station - 5S
Part/Product
Process
System
Voice of Customer
Verify Fast Response Exit Criteria

1) Work Station: 5S, Workplace organization, Safety list of checks, applicable to all work
stations
2) Part-Product: i.e. First Piece Approval, Error Proofing verification, SOS/JES kept,
Operator Training Matrix, Visual Aids, FIFO etc.
3) Process: i.e. Quality Alerts, Tool Set-up, Containment Logs, Control Non Conforming,
Gaging, SPC Compliance, CMM Logs, etc.
4) System: i.e. Shop Floor Management standards, Calibration Compliance, Preventative
Maintenance, Tooling Life Management, etc.
5) Voice of Customer: i.e. Running containment due to quality problem, Fast Response
Matrix, Verification Board, Performance Measurable, Action Plans, etc.. )
Verify Fast Response Exit Criteria: i.e. External & Internal corrective action for closure,
6) Lessons Learned etc.

Internal Process specific audits are


performed (i.e. Process/Commodity
Specific Audit , CQI audits etc.)

1) Layered Process Audit under system specific items, where applicable, Audits for special
processes are performed and monitored.

SCORE

R/Y/G

G
7.4

All non conforming issues are recorded


on the LPA master document.

7.5

Non-conformances cannot be resolved


immediately shall be entered on
Countermeasure Sheet

1)
2)
3)
4)

Audit results are summarized and


reviewed by manufacturing site
leadership.

7.6

ON THE SHOP FLOOR:


Results reviewed with team members & area supervisors
Evidence and documentation of immediate corrective action for nonconformance. (Items
corrected immediately)
Countermeasure list with responsibility and realistic target dates for items that could not
be corrected immediately.
Review of counter measure process at least once per week.

ON THE SHOP FLOOR:


1) Results and Countermeasurment action statuses are reviewed by management
Reports or graphics (i.e LPA Matrix) that are reviewed by management.
2) Continuous Improvement / positive trend for Value added out of the LPA matrix non
3) conformances (i.e. Fast Response, 8D, 5 Why, Drill Deep, Read Across)

4
G

Using LPA findings for problem


prevention

7.7

1) LPA results shall be added to the Lessons Learned database when appropriate
When appropriate nonconformance is added to Fast Response or C.A.R.E. process
2)

4
G

# Corrective Action Required = 0


8.0 RISK REDUCTION
Is there a system in place for reducing the risk of all production processes ?

SCORE / POTENTIAL

15 of 38

28

28

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

8.1

8.2

EVIDENCE REQUIRED

LOOK FOR

COMMENTS

PFMEAs shall be developed and


maintained by cross-functional teams
for all manufacturing processes and
support functions as required by the
AIAG FMEA manual.

1) PFMEA is developed by cross-functional team. Check member of PFMEA team.


PFMEA available for all part numbers and all operations
2) Scoring of Severity/Occurrence/Detection are according to latest AIAG FMEA Reference
3) Manual, ratings are accurate.
Potential cause of failure defined specifically. Ambiguous phrases
4) (e.g., operator error or machine malfunction, etc.) should not be
used.

Las revisiones de PFMEA se hace por parte de


Ingenieria, es necesario agregar a Calidad,
Produccion y Mantenimiento.
Terminar en un 100% las evaluaciones de
Reverse PFMEA en Febrero 2014. Cada
Octubre se realizara la auditoria a todas las
estaciones que hayan sufrido cambio./ Javier
Torres/ Haydee Sylva. Ver plan anexo

Proactive approach for reduction of


1) When Severity is 9 or 10, PFMEA team ensures that the risk is
highest risk items shall be implemented.
addressed through existing design controls or recommended
actions
2) Prioritization based on defined approach (e.g.: combination of Severity, Occurrence and
Detection or Risk Priority Number etc.)
3) Recommended actions documented with responsibility and due date
4) Recommended actions re-evaluated after their verification
Cross-functional teams have periodic
reviews of PFMEA

8.3

1) Cross-functional team agenda or other evidence of risk reduction activities.


Documentation that frequency and prioritization of reviews is based on customer input,
2) process capability, process changes, AIAG guidelines, etc
Review checklists, agendas or equivalent that assure adequate PFMEA review (all
operations/processes (paint, heat treat, material handling, labelling, rework/repair, etc)
3) are included and accurate.
All process controls are included.
Detection ratings are accurate.
Occurrence ratings are analyzed using data (SPC, FTQ, ppm,
scrap data, Verification Station results etc.)

SCORE

R/Y/G

3
Y

4
G
Las revisiones de PFMEA se hace por parte de
Ingenieria, es necesario agregar a Calidad,
Produccion y Mantenimiento.
Terminar en un 100% las evaluaciones de
Reverse PFMEA en Febrero 2014. Cada
Octubre se realizara la auditoria a todas las
estaciones que hayan sufrido cambio./ Javier
Torres/ Haydee Sylva. Ver plan anexo

Y
Evidence of past quality issues and
corrective actions that have been
implemented.

8.4

1)
2)
3)
4)

Check last PRRs or quality issues (example from point 1.5)


Asegurar que todas las fallas Oficiales de los
Revision date of PFMEA linked to past failures.
ultimos 12 meses estan reflejados en los
Recommended action defined with actual target completion dates
PFMEAS
Team validates the new Occurrence and Detection rankings and resultant RPN.
Analysed why PFMEA did not predict failure (Drill Deep). Action implemented to avoid in
future

4
G

There is a Reverse PFMEA-(Pro-active


Error Proofing) process in place verify
the RPN.

8.5

1) Cross-functional team conducts on-station review .


2) Schedule of reverse PFMEA (timing for review with prioritization of operation and its
status /planned-done/).
3) Evidence that the findings driven back into Process Flow, PFMEA, Control Plan, Work
Instructions as applicable.
4) Have Occurrence/Detection numbers been revised.
ON THE SHOP FLOOR
5) Chose one station and perform a quick reverse PFMEA to confirm all current controls
rated properly and all potential failure mode cover (try to create new ones)

16 of 38

Plan de Accion. URGE INICIAR ESTAS


AUDITORIAS, REGISTRO DE REVISION,
PLAN DE ACCION. COORDINA INGENIERIA.
Plan de acciones con avance

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#
8.6

EVIDENCE REQUIRED

LOOK FOR

COMMENTS

Managements support and review of the 1) Management review agenda/minutes


RPN reduction process, training
2) Necessary resources allocated for PFMEA development and review as well as
requirements, and tracking of risk
recommended action implementation in time.
reduction results.
3) Cross-functional team training and individual qualifications reviewed and verified
annually.

# Corrective Action Required =

SCORE

R/Y/G

BCC. Haydee va a imprimir cada una de las


hojas de RPN

4
G
SCORE / POTENTIAL

21

24

9.0 CONTAMINATION CONTROL


Is there a system in place to control contamination when appropriate?
Sediment: Procedures for the
measurement, monitoring and
identifying possible risk areas.

9.1

1) Procedure developed which includes method defining sediment collection and system to
measure cleanliness
2) Are the sediment particle size/particle weight, total weight developed off of the agreedupon, customer approved specification?
3) Is GMW 16037 procedure being used for quantification of sediment with parts?
Application using statistical method to monitor and control? (Include individual parts, sub4) assemblies, full assemblies)
Are results documented and plotted on control chart for management review?
5) Evidence of Site Leadership review of cleanliness results including customer complaint
for compliance and continuous improvement?
6) Contamination failure modes are considered in PFMEA, controls listed in Control Plan.

Cada una de las MI inidica la evaluacion de la


contaminacion del producto
En las Auditorias del pRoceso se tienen
auditorias de contaminacion

7)

G
Sediment reduction strategy for
- Metal Working Fluid System
- Fluid/Air Probes
- Work Station Cleanliness
- Dunnage and Part Storage
- Purchased parts

9.2

1) Procedure to define and maintain method and frequency of checks to ensure metal
working fluid quality and cleanliness
2) Procedure to define and maintain method and frequency of checks to ensure
functionality of fluid/air probe flush station
3) Define purchase parts require sediment monitoring/cleaning. Method and frequency for
cleanliness need to be developed.
ON THE SHOP FLOOR:
Check work stations cleanliness, daily verification to be established (Layered Audit, Tape
test etc.)
Dunnage cleaning process defined and kept
Parts are covered / properly protected
Parts on the assembly lines handled with lint free gloves / towels

Cada una de las MI inidica la evaluacion de la


contaminacion del producto
En las Auditorias del pRoceso se tienen
auditorias de contaminacion

17 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Sediment reduction strategy for
Washers/Debur
Procedures for maintaining integrity of
washer/debur process and control the
affect of sediment or contamination for
part/product

9.3

LOOK FOR

COMMENTS

ON THE SHOP FLOOR:


Revisar con Ingenieria de Manufactura que en
1) Are all wash/debur machine parameters captured and monitored/ documented on a daily cada estacion indique la inspeccion de
basis?
contaminacion en cada instructivo
2) Are Temperature, Pressure, Nozzle Alignment, Fluid Conc., Blow-off/Vacuum monitored
daily and documented
Is wash solution monitored and analyzed (ppm, conductivity, hard particles, soft particles,
particle size etc.) on an ongoing basis?
If applicable - is the air filtered that supplies the drying system? How are air contaminants
controlled?
Are parts covered and protected after wash to prevent foreign material penetration?
Documented PM program for washer and deburring?

SCORE

R/Y/G

9.4

Procedure for controlling or maintaining 1) Methods developed to prevent extra parts or materials that may fall into or stick to
foreign material from contaminating
products (e.g.: evidence that dunnage, fixtures, conveyors, washers and pre-assemblies
parts/product.
etc. are covered to prevent falling material)
2) Methods are verified through error proof verification and/or Layered Process Audits (e.g.:
sensor for masking used)
3) Foreign material as failure mode is considered in PFMEA
4) Monitor findings of extra part to initiate corrective actions
Dirt in Paint or Part
Procedure for maintaining the
processes to control and prevent dirt
contamination.

9.5

9.6

Retained material in Castings.


Procedure to measure, monitor, and
improve retained material.

Cada una de las MI inidica la evaluacion de la


contaminacion del producto
En las Auditorias del proceso se tienen
auditorias de contaminacion

1) Procedure or instruction describes dirt control and prevention for key areas: People,
NA
Process, Facility and Material.
2) Dirt awareness training is held
3) Application of statistical method to monitor and control painting process such us dirt
count (SPC, U-chart), dirt identification (Pareto) etc.
4) There is an active dirt reduction team and action plan defined
ON THE SHOP FLOOR:
5) Entire paint shop has to be a clean area. Check that restrictions (e.g.: no food, no fibrous
material etc.) housekeeping requirement and approved attire are kept.
Self inspection/clean up are implemented on all painting operation
6)
1) Is GMN 11174 applied for Sand Casted Cylinder Blocks and Heads?
2) Methods to measure retained material (i.e. Tunk test) before part reaches the final
machining.
3) Verification that measurements are taken and results are documented.
4) Any non-conformance to standards are documented and corrective actions are
implemented and reviewed by leadership.

# Corrective Action Required =

Is there a systematic process in place to control suppliers?

18 of 38

NA

4
G
SCORE / POTENTIAL

10.0 SUPPLY CHAIN MANAGEMENT

23

24

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Procedures or work instructions to select
and evaluate suppliers.

LOOK FOR
1)

Supplier Quality Statement of Requirement

10.1 (SQ SOR) that contains all customer

COMMENTS

Procedures that require supplier audits (e.g.: Potential Supplier Assessment or PCPA) to According to GSQM initiating with NSA. And
support sourcing decisions, evaluation of their quality systems.
followed by VIN/Score card.
Approved supplier list (e.g.: Bidlist)
SQ SOR or equivalent signed by supplier
Evidence of SQ responsibility (SQ organization chart or SQ training records)

SCORE

requirements, expectations, and processes


for all potential suppliers.

1) Methods to determine ranking of Key suppliers with reviews of supplier performance to


specified goals.
2) Key Supplier list with defined metrics/goals
Measurement and validation system for key 3) Reviews of supplier performance with a defined procedure and actions for poor
10.2 suppliers performance tracking
performing suppliers, such as 6 panel.
4) Method or process in place to communicate problems and track corrective action.
2)
3)
4)
1) Evidence of tiered supplier compliance to AIAG PPAP, APQP, FMEAs, MSA, and SPC
requirements.
2) Evidence of selection and designation of KPCs, PQCs KCCs and PTCs on engineering
drawings, SPC is applied for KPC.
Sub-Supplier APQP, AIAG and customer
3) Process specific audits such as CQI, Sediment ....etc are performed per GM
10.3 specific requirement compliance
requirements
4) Customer specific requirements such as GM1927-03 SQ SOR, GP-9, GP-12, Labelling
etc. implemented at tier supplier as well
Tier I Review their supply base to ensure that:
Monitoring Sub-Supplier Process Control

10.4 / Changes performance

11.1

VIN/Score card

According to GSQM adding customer speccific


requirements as required VIN/PTS/core tools.

Trough VIN/SRC procedure.

1)
2)
Engineering/process changes documented and communicated
3) Demonstrate a systematic and disciplined approach to problem solving (technical root
cause analysis and why the system failed (DD & Wide)

# Corrective Action Required = 0


11.0 MANAGING CHANGE
Is there a systematic process in place to control product, process, or source changes?
A documented procedure for monitoring
and controlling all product, process or
source changes.

R/Y/G

4
G
SCORE / POTENTIAL

1) A change form utilized to document all changes (engineering, process and source
Procedimiento de Cambios de Ingeniria, listado
changes). PPCR form is reference for Powertrain suppliers
Revisar con Javier
2) Change Forms are controlled through a Document Control Process. (e.g. tracking log
sheet, revision numbering system, approval process)
3) Both planned and emergency changes covered by the change procedure.
All changes need to be reviewed and approved by customer. Inform GM SQE in early
4) phase to get approval before kick off.

16

16

4
G

19 of 38

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Procedure to establish a defined
Production Trial Run (PTR) process.

11.2

LOOK FOR

COMMENTS

1) A standardized communication procedure and form to control and monitor all Production REVISAR CON JAVIER
Trial Runs that documents each step of the process & records all approvals and results.
Build readiness reviews required to authorize the start of the trial run production process.
2) Quality reviews documented to release product for PTR shipment and verification
process has returned to normal production.
3)

SCORE

R/Y/G

3
Y

A parts banking strategy/procedure for


identifying, protecting and retrieving long
term storage of parts or materials.

11.3

Procedure to authorize bypassing


processes

11.4

1) Procedure with responsibility for the execution of long term storage of parts or materials, REVISAR CON JAVIER
keep FIFO process
2) Customer approval for safety stock level
3) Established guidelines for protective packaging for parts and material.
4) Quality reviews to established inspection criteria for the authorized release of banked
parts and material prior to internal usage or shipment
5) Weekly Layered Audit to ensure processes followed
1) By-pass process approved by Operations, Engineering and Quality manager,
REVISAR CON JAVIER
Standardized Work and training applied
2) A Worksheet is used to track each process that is in bypass.
3) The bypassed process is frequently audited for compliance (Best Practice is hourly)
Bypass processes are always reviewed by Quality Manager to ensure proper back-up
4) inspections are in place and PFMEA and control plans updated. Customer to be notified
of activites before parts are shipped.

3
Y

3
Y

# Corrective Action Required =

SCORE / POTENTIAL

Pts Element Scoring


0

Element is not in place and no evidence of plans to implement

Element is not in place but a plan to implement is documented

Element is in place but it is not being followed

Element in place but not followed at each job or all the time

Element is in place and it is being followed

NR Not Reviewed: Key Strategy not audited at this time. (Training Required, Follow-Up Required)
Note: Enter appropriate score based on R Y G score criteria and hit enter. Correct color will appear in R/Y/G cell.
Not Reviewed is used when immediate focus does not include the strategy. Plan to review in future. Give future review date in comment box.
Not Applicable: is used if a question does not apply. Question should be given a score of 4 and a note made in comment in box.

20 of 38

13

16

Process Performance
Supplier
Location

0
0

Start Date:

Grad Date:

Commodity

PAGE 21 of 38

SQE 0

12/30/99

Rev. Date:

Duns

Prepared by:

QUALITY SYSTEMS BASIC ACTION PLAN REPORT


SQE Phone & Fax #:
Manager:

12/30/99

Program:

Group:

Creativity Team:

"Color Codes"
G

Green - Task Completed on Time

Yellow - Task May Be Late

Red - Task is Late

White - Task Re-Timed, No Status

Blue - Task Status is Incorrect / Not Updated


No Color - Task on Track

ITEM

ACTION ITEM

ACTION
LEADER

TOTAL

TOTAL

DATE
OPENED

TARGET
ACTUAL
CLOSE DATE CLOSE DATE

STATUS
Oldest

LAST
UPDATE

COUNTER MEASURES

# Corrective Action Required =

Control Non-Conforming Product

# Corrective Action Required =

Verification Stations

# Corrective Action Required =

Standardized Operations

# Corrective Action Required =

Fast Response

Most Recent

STATUS HISTORY

qsb

258205150.xlsx

Rev. 5 10/25/01

Process Performance
Supplier
Location

0
0

Start Date:

Grad Date:

Commodity

PAGE 22 of 38

SQE 0

12/30/99

Rev. Date:

Duns

Prepared by:

QUALITY SYSTEMS BASIC ACTION PLAN REPORT


SQE Phone & Fax #:
Manager:

12/30/99

Program:

Group:

Creativity Team:

"Color Codes"
G

Green - Task Completed on Time

Yellow - Task May Be Late

Red - Task is Late

White - Task Re-Timed, No Status

Blue - Task Status is Incorrect / Not Updated


No Color - Task on Track

ITEM

ACTION ITEM

ACTION
LEADER

TOTAL

TOTAL

DATE
OPENED

TARGET
ACTUAL
CLOSE DATE CLOSE DATE

STATUS
Oldest

LAST
UPDATE

COUNTER MEASURES

Operator Training

# Corrective Action Required =

Error Proof Verification

# Corrective Action Required =

Layered Process Audits

# Corrective Action Required =

258205150.xlsx

Most Recent

STATUS HISTORY

Rev. 5 10/25/01

Process Performance
Supplier
Location

0
0

Start Date:

Grad Date:

Commodity

PAGE 23 of 38

SQE 0

12/30/99

Rev. Date:

Duns

Prepared by:

QUALITY SYSTEMS BASIC ACTION PLAN REPORT


SQE Phone & Fax #:
Manager:

12/30/99

Program:

Group:

Creativity Team:

"Color Codes"
G

Green - Task Completed on Time

Yellow - Task May Be Late

Red - Task is Late

White - Task Re-Timed, No Status

Blue - Task Status is Incorrect / Not Updated


No Color - Task on Track

ITEM

ACTION ITEM

ACTION
LEADER

TOTAL

TOTAL

DATE
OPENED

TARGET
ACTUAL
CLOSE DATE CLOSE DATE

STATUS
Oldest

LAST
UPDATE

COUNTER MEASURES

Risk Reduction

# Corrective Action Required =

Contamination Control

# Corrective Action Required =

Supply Chain Management

# Corrective Action Required =

258205150.xlsx

Most Recent

STATUS HISTORY

Rev. 5 10/25/01

Process Performance
Supplier
Location

0
0

Start Date:

Grad Date:

Commodity

PAGE 24 of 38

SQE 0

12/30/99

Rev. Date:

Duns

Prepared by:

QUALITY SYSTEMS BASIC ACTION PLAN REPORT


SQE Phone & Fax #:
Manager:

12/30/99

Program:

Group:

Creativity Team:

"Color Codes"
G

Green - Task Completed on Time

Yellow - Task May Be Late

Red - Task is Late

White - Task Re-Timed, No Status

Blue - Task Status is Incorrect / Not Updated


No Color - Task on Track

ITEM

ACTION ITEM

ACTION
LEADER

TOTAL

TOTAL

DATE
OPENED

TARGET
ACTUAL
CLOSE DATE CLOSE DATE

STATUS
Oldest

LAST
UPDATE

258205150.xlsx

COUNTER MEASURES

Managing Change

# Corrective Action Required =

Most Recent

STATUS HISTORY

Rev. 5 10/25/01

Process Performance

QUALITY SYSTEMS BASIC ACTION PLAN REPORT

B5:

Person at supplier that prepared the form for the GM SQE. (If applicable)

C16:

ACTION ITEM: The item that requires action to improve the process or quality of the product being produced.

D3:

Graduation Date:
This Date Will Be Determined By GM SQ Directors

D4:

For PDC SQE Only:


Identify which program your supplier is in "IQ' or "SQA".

D16:

ACTION LEADER: The person that leads the team to make the improvements. This should be the suppliers person but may be a GM Management person.

E15:

Formula: DO NOT TYPE IN THIS CELL, UNLESS YOUR ARE MODIFYING THE FORMULA

E16:

START DATE: The date the action item was identified and listed in the action item column

F16:

TARGET CLOSE DATE: The date the supplier will complete the action item.
This date may change. If the date changes, you are required to entry the correct color code in the pass status and present status columns.
A comment on why the change to be entered in the comment field

G15:

Formula: DO NOT TYPE IN THIS CELL, UNLESS YOUR ARE MODIFYING THE FORMULA

G16:

ACTUALCLOSE DATE: The date the action item was closed TO INCLUDE VALIDATION.
The SQE should validate the action item as being closed and RESOLVED.

H16:

LAST UPDATE: The date the SQE reviewed the action item.

I16:

PAST STATUS: The cell is filled in when the status changes. Oldest status to the left
If status is WHITE put a "W" in the cell. Do not leave blank.
Copy the cell for the correct color.

O16:

PAGE 25 of 38

COLOR CODE:
GREEN: Task Completed on Time
YELLOW: Action item is in trouble and may affect target date.
RED: Action item has missed target date.
WHITE: Task Re-Timed, No Status
BLUE: Task Status is incorrect / Not Updated
COUNTER MEASURES:

258205150.xlsx

Rev. 5 10/25/01

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
EVIDENCE REQUIRED
2011
LOOK FOR
#
1.0 FAST RESPONSE: PROBLEM SOLVING, COMMUNICATION and LESSONS LEARNED
Is there a system in place to immediately respond to significant internal and external quality failures?
Daily leadership meeting held with
cross-functional, multilevel attendees to
address significant external and internal
Quality concerns.
To each concern natural owner is
designated, next report out date is
assigned

1.1

Fast Response (FR) meeting is owned


by Manufacturing

Fast Response Board to track concerns


Problems are communicated to the
appropriate employees
Exit Criteria, required to close a
concern, follows the problems steps

1.2

Timing for each of the criteria


established
Overall status represents the worst
condition or overall planned timing has
been exceeded

1.3

Daily leadership meeting


addresses significant Quality concerns.
Owned by Manufacturing
Designates owners.
Assigns report out dates.
Cross-functional, multilevel attendees.

Fast Response Process performance is


tracked
Quality status is posted.
Immediate review and timely response
of all problem resolution reports.
High PRR duns locations (24+PRR's in
past 12 months) shall be required to
perform PRR reduction activities (see
item#6 in Instructions Sheet). Score
should be 0 until PRR reduction
activities are in place for at least 60
days.

Exit Criteria, required to close a


concern, follows the problems steps
Timing for each of the criteria
established,
Problems are communicated to the
appropriate employees.
Overall status represents the worst
condition or overall planned timing has
been exceeded

Fast Response Process performance is


tracked
Quality status is posted.

2011

old

1) Prior to the audit check last PRRs if any.


Ask if there are any significant internal issues (e.g.: findings of Verification
Station, dock audit or LPA, supplier issue etc). Prior to the meeting review
the board if these issues addressed.
ON THE SHOP FLOOR:
Attend Fast Response meeting. Observe:
2) Who leads the meeting (owned by manufacturing), if needed back up
person designated
3) Has to be a communication meeting, average duration of 10-20 minutes,
check how leader controls the FR meeting (keep timing, focus on subject,
not going to the details...)
4) Cross functional attendees - check for sign-in sheet
5) Report out process and verify that a Problem Solving report format is
used to document & communicate the status of the issue.
6) Natural owners are assigned to problems

ON THE SHOP FLOOR:


Prior to the meeting review the board: For report out dates and statusing
to see if any are past due, statues appropriately with detail explaining
missed dates.Ask if there are any new issues, check last PRRs if any
Observe the report out process and verify that the Problem Solving report
format is used to document & communicate the status of the issue.
Sign-in Sheet identifying cross-functional & plant wide support is in
attendance daily.
Natural owners are assigned to problems
Internal issues are included and addressed to the same Fast Response
criteria.(e.g. LPA findings, Verification Station or Dock Audit issues,
Supplier Issues)

ON THE SHOP FLOOR:


1) Fast Response board is used for tracking of issues, being updated before
FR meeting (board could be a dry erase board, laminated poster, Excel
sheet projected by beamer etc)
2) Method of communicating problems to all Key Stake holders (e.g. Quality
Alert, Temporary Work Instructions, By-Pass Procedure etc.)
3) Exit criteria represents the core 6 "Steps" steps of problem solving
including timing for each of the exit criteria
4) Check statusing (Red, Yellow, Green), red items have a planned date to
go green with next steps. Problems are not closed until all criteria is met.
5) Follow an issue from FR Tracking Board through the exit criteria
confirming actions are in place & all documentation has been updated

ON THE SHOP FLOOR:


Exit criteria represents the 6 "Core" steps of problem solving including
Lessons Learned, LPA, Error proofing, updates to Work Instructions,
PFMEA & Control Plan.
Method of communicating problems to all Key Stake holders (e.g.
Quality Alert, Temporary Work Instructions, By-Pass Procedure)
A guideline for timing for each of the exit criteria.
Red items have a planned date to go green, some detail explaining why
and the next step.
Problems are not closed until all criteria is met.

ON THE SHOP FLOOR


1) Quality Q or other method to track FR performance is posted and up to
date.
2) Are PRR assigned to a champion for immediate response and corrective
actions
3) Are corrective actions robust enough to prevent further defects?
4) High PRR duns location shall have a special team created to work on
PRR reductions - performance shall be tracked at FR meeting on open
issues list.

ON THE SHOP FLOOR


Quality Q or other method to track FR performance is posted and up to
date.
Compare Quality "Q" to Fast Response Tracking Form for correlation.
Are all the yellow or red days on FR board?

R/Y/G

NR

BEST PRACTICES:
Who leads the meeting & is there a designated back up person.
Has to be a communication meeting, ask average duration (10-20
minutes), check how leader controls the FR meeting

NR

BEST PRACTICES:
Follow an issue from Fast Response Tracking Board through the exit
criteria confirming corrective action is in place & all documentation has
been updated.

NR

Is there a defined process for Problem Solving leading to root cause identification and elimination?
A defined process for Problem Solving
including a standard for documenting
the tools used for root cause
identification.

A defined process for Problem Solving


including a standard for documenting
the tools used for root cause
identification.

1) Standard process (PPSR, 8D or equivalent) used with a format that


follows the core "6 Steps" of problem solving (1.Define, 2.Contain, 3.Root
Cause, 4.Correct, 5.Validate, 6.Institutionalize)
2) Problem Solving forms used across the plant for internal, customer and
supplier issues.
3) Evidence of cross-functional team approach and team members got the
necessary trainings
4) Tools for identifying root cause are applied (7 diamonds, Drill Deep / 3X5
why to correct systemic issues, Fishbone Diagram etc.)

1.4

Completed Problem Solving forms used across the plant for internal,
customer and supplier issues.
Standard forms (PPSR or equivalent) used with a format that follows the
core '6 Steps' of problem solving
(Define, Contain, Root Cause, Correct, Validate, Institutionalize)
Forms identifying route cause, (8D process to be used to establish root
cause, drill deep / 3X5 why to correct systemic issues)
Changes to PFMEA and Control Plan indicating root cause elimination.
Evidence of cross-functional team approach and team members get the
necessary trainings
ON THE SHOP FLOOR:
Ask Supervisors/Team or Group Leaders and OPERATORS about their
role in Problem Solving
Check last quality issues and confirm the main root causes found

NR

BEST PRACTICES:
Forms completed on shop floor by Supervisors/Team or Group
Leaders (non-engineering staff) with team input.

Problem solving used efficiently,


all the core "6 steps" applied

A system to capture and institutionalize


lessons learned.

1.5

ON THE SHOP FLOOR:


Check last quality issues (customer/internal/supplier) and confirm:
1) Main root cause found. Try to raise further "whys".
2) Corrective action implemented for elimination of main root cause,
breakpoint identified
3) Corrective action is verified
4) Relevant documents updated (PFMEA /see point 8.4/, Control Plan,
Working Instruction etc.)

Review Lessons Learned procedure & forms.


Documented sources that capture lessons learned such as Fast
Response, Problem Solving Documents, Continuous Improvement
Process, APQP, Risk Reduction team checklist, Read-Across, Customer
re-allocations (tool moves).
Completed Lessons Learned information which is easily retrievable by all
who need the information. (e.g. Master FMEA, Read Across, Electronic
forms or database).
Ask how are they using Lessons Learned via examples

NR

Is there a system in place to capture information that supports continuous improvements to all operations/processes?
A system to capture and institutionalize
lessons learned

A disciplined approach to problem


prevention using lessons learned.

A disciplined approach to problem


prevention using lessons learned.

1.6

1.7

Leadership reviews and supports


Lessons Learned process to assure
implementation.

Leadership reviews Lessons Learned


process to assure implementation.

1) Review Lessons Learned procedure & forms (electronic forms or


database), ask people for examples how are they using Lessons Learned
system
2) Method which assures implementation supported by evidence of review
dates, distribution lists, or posted Lessons Learned
3) Check 6th step of problem solving (Institutionalize) via examples of point
1.5. Check Readacross (Drill Wide) of last PRRs.
4) Completed Lessons Learned information which is easily retrievable by all
who need the information. (e.g. Master FMEA, Read Across, APQP
Program check list reviews).

APQP Program check list reviews lessons learned.


Continuous improvement team notes and agendas
Method which assures implementation supported by evidence of review
dates, distribution lists, or posted Lessons Learned.
(e.g. Active Drill Wide, Read-Across tracking)
Check last quality issues and their read across

1) Continuous improvement team notes and agendas


2) Leadership notes or agenda indicating Lesson Learned system is
reviewed such as through a LPA (e.g.: check Institutionalize for problems)
or internal systems audit

Leadership notes or agenda indicating Lesson Learned system is


reviewed such as through a LPA or internal systems audit.
Regularly scheduled reviews documenting steps of institutionalizing
lessons learned. (e.g. Read-Across)

# Corrective Action Required =


0
2.0 CONTROL OF NONCONFORMING MATERIAL
Is there a system in place to ensure products that do not conform to specified requirements are prevented from unintended use?
A consistent tagging system is used to
identify suspect and nonconforming
product.
(Such us Stoplight visual management:
Red-Yellow-Green)

A consistent tagging system is used to


identify suspect and nonconforming
product.

2.1

2.2

Nonconforming and suspect material


are segregated in properly identified
areas.
Scrap is prevented from unintended
use.

Nonconforming and suspect material


are segregated in properly identified
areas. Scrap is prevented from
unintended use.

1) Consistent tagging system is defined on procedure level


ON THE SHOP FLOOR
2) All the parts statuses can be identified based on tagging system
3) Color coding is applied for identification of scrap containers, hold tags,
scrap labels, in-process tags, travellers, routers, etc
4) If red tags are used for both scrap and suspect material, tag must have
disposition.
5) Suspect tags should have last operation performed.

1) Procedure and method for materials/parts designated as scrap to ensure


it is properly identified and kept from being reintroduced back into the
normal material flow. (e.g. destruction, paint, locked container)
ON THE SHOP FLOOR:
2) Segregation areas are identified and/or foot printed.
Scrap bins, rework tables, hold areas, etcare identified/foot printed,
scrap boxes size should match with part size
Quarantine area physically closed, entrance only with authorized access,
quantities in quarantine are controlled

29 of 38

SCORE / POTENTIAL

ON THE SHOP FLOOR


Color coding of scrap containers, hold tags, scrap labels, in-process tags,
travelers, routers, etc
If red tags are used for both scrap and suspect material, tag must have
disposition.
Suspect tags should have last operation performed.

NR

NR
NR

NR

BEST PRACTICE:
System is Stoplight visual management where red indicates scrap or and
yellow indicates suspect product/material. Green or any other color
(except yellow or red) indicates acceptable product.
ON THE SHOP FLOOR:
Segregation areas are identified and/or foot printed.
Scrap bins, rework tables, hold areas, etcare identified/foot printed.
Procedure and method for materials/parts designated as scrap to ensure
it is properly identified and kept from being reintroduced back into the
normal material flow. (e.g. destruction, paint, locked container)

NR

28

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED

2011

LOOK FOR

2011

Containment form or nonconforming


material form identifies expected
quantity and locations of suspect
material.
Product in containment properly
identified.

Containment form or nonconforming


material form identifies expected
quantity and locations of suspect
material.
Product in containment properly
identified.

ON THE SHOP FLOOR:


1) Containment worksheet or equivalent contains all the potential locations
2) Containment activity starts with physical counting of suspected batch,
including signature for accountability
3) Containment area is separated from production line
4) Tagging system is applied for containment

ON THE SHOP FLOOR:


Containment worksheet or equivalent,
Are standards in place for color coding of scrap containers for
containment issues and size should match with product size
Std Containers for W.I.P. and Finished good are not used for sorting and
placement of defective material.
Nonconforming material area and associated documents.

2.3

old

BEST PRACTICES:
Standards for Color Coding of containers for containment issues.
Green = After Breakpoint, Conforming Product Containers.
Yellow = Suspect Product
Red = Non-conforming Product

R/Y/G

NR

Is there a nonconformance quality alert and notification procedure that meets customer requirements?
The organizations nonconformance
alert notification and containment
process includes communication and
action for all stakeholders:
- Customer(s)
- Tier suppliers
- Internal stakeholders

The organizations nonconformance


alert notification and containment
process includes communication and
action for all stakeholders:
- Customer(s)
- Tier-2s, etc.
- Internal stakeholders

1) Quality Alert is issued for external and internal issues


2) Quality Alert includes:
- defines the problem, the standard and deviation from standard
- tasks, time line,& communication necessary to meet
customer requirements.
3) Internal/external distribution and notification
- Contact list for customer and tier suppliers
- Certified shipment log (to customer, from tier supplier)
ON THE SHOP FLOOR
4) Quality Alert is signed by operator for review and understanding
5) Andon System in shop floor to raise alarm when error is made, if
applicable

Documents to ensure communication and follow-up activities occur as


required such as:
An Alert document that is used:
For external and internal issues
To establish tasks, time line,& communication necessary to meet
customer requirements.
Defines the problem & the standard
Andon System in shop floor to raise alarm when error is made
Internal/external distribution and notification
Customer contact list
Certified shipment log
Tiered supplier contacts and certified shipment documents.

Product removed from the approved


process flow for repair or rework:

Product removed from the approved


process flow for repair or rework:

- Has Approved Work Instructions


- Is reworked by approved person

- Has Approved Work Instructions


- Is reworked by approved person

- Is
reintroduced into the process at or
prior to the point of removal
- Is traceable through an identifier
- Is released using a defined process
and authority.

- Is
reintroduced into the process at or
prior to the point of removal
- Is traceable through an identifier
- Is released using a defined process
and authority.

ON THE SHOP FLOOR:


1) Evidence of reintroduction, at or prior to point of removal.
2) Reintroduction includes all downstream checks such as error proofing. All
control plan inspections & tests to be performed
3) If it cannot be reintroduced into the process, verify that an approved
(Quality Manager) documented rework and inspection procedure is
followed.
4) Look for an identifier such as serial number or special marking that can
be traced back to the supplier record to show what was done and when.
Form to release product with authorized signature and approved
inspection of product
Define limit for the number of times of repairment, suggested not more
than 2 times with a tracking method.

ON THE SHOP FLOOR: (if live example is available)


Look for evidence of reintroduction, at or prior to point of removal.
Verify that reintroduction includes all downstream checks such as error
proofing. (All control plan inspections & tests to be performed)
If it cannot be reintroduced into the process, verify that an approved
(Quality Manager) documented rework and inspection procedure is
followed.
Look for an identifier such as serial number or special marking that can
be traced back to the supplier record to show what was done and when.
Form to release product with authorized signature and approved
inspection of product

2.6

Performance metrics and goals should


be established and analyzed for
continuous improvement.

Performance matrices and goals should


be established and analyzed for
continuous improvement.

1) Performance metrics and goals such as 6 Panel, Downtime, FTQ, scrap


rate etc. are established to reduce scrap at all levels of the operation.
2) Action plan and its follow up for top issues.

Performance metrics and goals such as 6 Panels, down time and FTQ
monthly established to reduce scrap at all levels of the operation.
Analysis should be
performed for matrices and action plan are created against top issues.

2.7

Leadership involvement in internal and


external spill, containment,
communication activities, scrap analysis

Leadership involvement in internal and


external spill, containment and
communication activities

1) Periodic summary reports


2) Review for analysis and action taken for metrics

Periodic summary reports


Material Review Board information and signatures.
Review for analysis and action taken for matrices

2.4

2.5

# Corrective Action Required =


0
3.0 VERIFICATION STATIONS (VS)
Is there at least one Verification Station in the process? (If a GMPT Supplier, C.A.R.E. must be implemented.)
A procedure which focuses on Building
Quality in Station through Feedback
from the process.
Powertrain supplier shall implement
C.A.R.E.

A procedure which focuses on Building


Quality in Station through Feedback
from the process.
Procedure that requires selecting
Verification station according to High
risk areas.

3.1

1) Verification Station strategy is defined on procedure/instruction level:


- Selection of place of Verification Station (high risk, poor FTQ, low
capability etc.)
- Necessary documentation to be used
- Guideline for set up of alarm limit
- Definition when a problem needs to be escalated with its escalation
route
ON THE SHOP FLOOR
2) C.A.R.E is implemented and running at Powertrain supplier
3) Verification station(s) selected efficiently:
-Prior to audit review PRRs (any major or repeative issue), Control
Shippings, GP12.
-Review FTQ results, high RPN items from PFMEA, process capability
data.
-Based on data review, evaluate if Verification Station(s) implemented to
right place or there is a need to implement a new one(s).

NR

NR

BEST PRACTICE:
The limit for the number of times repaired is not more than 2 times with a
tracking method.

SCORE / POTENTIAL

NR

NR
NR

28

ON THE SHOP FLOOR


How process information is monitored and captured information is
relayed upstream to those that need to know and react:
Stations staffed for 100% inspection with a defect tally sheet
or hourly count sheet should include listing type of defects and quantity.
Automated testing and list of part characteristic/defect
checks being verified. (fault codes, defect description)
Control chart noting reaction to out-of-control conditions.
When C.A.R.E. is in place, documentation requires identification and
inspection of customer satisfaction items: warranty issues, pass-through
items, PR/R issues, past Quality problems, high RPN items, etc... (i.e.
Powertrain Suppliers are required to support C.A.R.E. process &
procedures.)
BEST PRACTICE:
Look for a minimum of 1 verifcation station at the end of each product
assembly line, or between departments such as molding, machining,
assembly, paint, which provides feedback to upstream operations.

NR

SPC variable charts for each work area , work cell or section CPK
measurment for different areas.
Verification station are set according to high risk items , High RPN , CPK
below 1.33 , or according to faluire found in performance matrix charts

Tally Sheet which records the number of


problems by the hour (or batches)
Reaction when alarm limit is reached.

3.2

Procedure or instructions that require


immediate reaction when alarm limit is
reached. (Past Customer defects shall
always have an Alarm limit of '1'. All
C.A.R.E. items must be '1).

Responses to alarms are documented


Escalation procedure is followed.

ON THE SHOP FLOOR:


1) Tally Sheet posted at or near the Verification Station, filled in properly
2) Alarm limits reasonable (e.g.: 1 for C.A.R.E., GP12, customer complaint;
how often alarm limit reached as no alarm=no improvement)
3) Escalation kept (when and who to call, who responded and when)
4) Issues documented and fixed immediate

Responses to alarms are documented.


Escalation procedure is followed.

3.3

3.4

3.5

ON THE SHOP FLOOR:


When and who to call,
Who responded and when
The immediate fix, corrective action taken and breakpoint.
Document that describes when a problem is to be escalated.
Escalation identifies who is the next person to be called and their contact
information?

NR

BEST PRACTICE:
Alarm & Escalation is applied at each step of the operation where defect
detection exists.

Problem solving process applied for VS


findings, corrective actions implemented
as a result of Verification Station
activities.

Corrective actions implemented as a


result of Verification Station activities.

ON THE SHOP FLOOR


1) Assignment of problem solving activities
2) Corrective actions documented and verified

Feed Back data from downstream


customers is documented and
performance is tracked at the inspection
point.

Feed Back data from downstream


ON THE SHOP FLOOR
customers is documented and
1) Performance Graphic or Q chart showing (i.e. calendar days-red/green)
performance is tracked at the inspection
feedback from downstream customers and details.
point.
2) Graphics or report card showing findings at the station for communication
to upstream processes/suppliers.
3) FTQ or scrap analysis showing improvement trend, reduction of
events/defects over time.

ON THE SHOP FLOOR


Performance Graphic or Q chart showing (i.e. calendar days-red/green)
feedback from downstream customers and details.
Graphpics or report card showing findings at the station for
communication to upstream processes/suppliers.
FTQ or scrap analysis showing improvement trend, reduction of
events/defects over time.

Leadership reviews Verification Stations


activities and results.
Management walk through or meetings
at selected stations.

Leadership reviews Verification Stations


activities and results.
Daily management walk through or
meetings at selected stations.

ON THE SHOP FLOOR


Leadership review of verification station check sheet for information and
attendances

Team reports out weekly and the status


is reviewed during the
leadership/support staff walk through.

ON THE SHOP FLOOR


1) Leadership review of verification station review results and follow up of
action plan, if needed read across its results
2) Team reports out minimum weekly and the status is reviewed during the
leadership/support staff walk through.

# Corrective Action Required =


0
4.0 STANDARDIZED OPERATIONS
WORKPLACE ORGANIZATION
Is there a systematic approach to utilize and maintain Workplace Organization?

ON THE SHOP FLOOR


Assignment of problem solving activities related to station data
Tracking sheet displayed in the area on the shop floor.
Problem solving documentation
Problem Report out Schedule

SCORE / POTENTIAL

30 of 38

NR

NR

NR
NR

20

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED
Procedures or operator instructions for
safe, clean, and orderly arrangement of
the workplace environment that
eliminate waste, provide a specific
location for everything, contribute to
higher quality, and the opportunity to
standardize and increase efficiency.

2011
Procedures or operator instructions for
safe, clean, and orderly arrangement of
the workplace environment that
eliminate waste, provide a specific
location for everything, contribute to
higher quality, and the opportunity to
standardize and increase efficiency.

LOOK FOR
1)
2)
3)
4)
5)
6)
7)

4.1

8)

Clean, organized work areas. Items in


areas labelled, foot printed or otherwise
identified.

Clean, organized work areas. Items in


areas labeled, foot printed or otherwise
identified.

4.2

Systematic approach for Workplace Organization (like 5S) is


implemented and maintained:
Defined in procedure level including standard markings
Organization trained
Action plan with timing for implementation
Audit schedule and feedback for maintain
A countermeasure sheet or equivalent includes issue found during audit,
owner, action and date for correction.
ON THE SHOP FLOOR:
Audit performed according to schedule, action addressed to deviations
and followed up
Ask a Team Member to explain the 5S process, examples of waste
eliminated in their workplace. Does the 5S process focus on waste
elimination.
FIFO kept

ON THE SHOP FLOOR:


1) Display placement (what is to be in a work cell) and identification (how it
is to be labelled) of material, equipment, tools, aisles, hazards, including
storage of personal belongings.
2) Visual aids used to assist in the process flow.
3) Ask if the Production, Maintenance, Quality, Material and office areas
have documented workplace organization standards.
4) Check several working stations that 5S requirements kept

2011
ON THE SHOP FLOOR:
Ask a Team Member to explain the 5S process. Team member participate
in the development, implementation, maintenance and improvement of
existing standards for his/her work area. Team member can provide
examples of waste eliminated in their workplace
Does the 5S process focus on waste elimination? Are Methods and tools
(eg. material layout from work flow diagram, work combination tables,
area layout, and layered audits) utilized to identify additional waste
elimination opportunities within the workplace?
Standards that display placement (what is to be in a work cell) and
identification (how it is to be labeled and guides for label location) of
material, equipment, tools, aisles, hazards, including storage of personal
belongings.
Start-up/Shut down task list, 5S or TPM Check List, identifying frequency,
time, and tools required.
FIFO - Material is staged with oldest material to be used first and newest
to be used last.
Visual aids used to assist in the process flow.
A process for updating workplace organization standards at some
frequency.

ON THE SHOP FLOOR:


Ask if the Production, Maintenance, Quality, Material and office areas
have documented workplace organization standards.
Look for evidence of an established audit frequency and that it is
followed.
A countermeasure sheet or equivalent includes issue found, owner,
action, and date for correction.

old

R/Y/G

NR

NR

STANDARDIZED WORK INSTRUCTIONS


Is there a system in place to develop standardized work instruction (methods and sequence) for all operations?
Standardized Work Instructions
(Standardized Operation Sheet /SOS/ or
equivalent) are posted at or near all
operations where there are human
operators.

4.3

4.4

Usage of Standardized Work


Instructions (Standardized Operation
Sheet /SOS/ or equivalent)

Procedure that requires cross-functional


teams to develop standardized work
instructions. Should be maintained through
the use of the continuous improvement
process.

4.5

Standardized Work Instructions are


1)
posted at or near all operations where
there are human operators. It
2)
establishes the flow of production (what
is needed, when it is needed and
eliminate waste), a repeatable
3)
predictable baseline for continuous
improvement and involves the team
member in both the initial and ongoing
improvements to achieve the highest
levels of safety, quality and productivity.

Standardized Work Instruction /SWI/ template developed and applied for ON THE SHOP FLOOR
all operations.
Does the number of Standardized Work Charts in the cell match the
SWI contains minimum: Work elements and their sequence, Operator
number of operators?
movement with sketch of work flow, Work elements takt time and work
Are the 3 elements (Takt Time - Customer and Actual and Operator Cycle
element cycle time.
Time -, Work Flow Sequence & Standard in-process stock) of
ON THE SHOP FLOOR
Standardized Work represented on the chart?
SWI posted near or at the operation
Is the takt time on each chart correct? Is the work cell running to takt
Ask operators to explain SWI. Does operator understand it?
time?
Check some SWIs if match with workplace, work elements sequence kept Is the number of Standard in-process stock shown on the chart correct?
within cycle time.
Is the number or Standard in-process stock currently in process correct?
(No batching, no gaps, etc.)
Is the Work Flow Sequence shown on the chart correct? Are the
operators adhering to the work sequence as written?
Visuals accurately represent the workstation layout and work sequence.
Is the drawing/layout correct?
Documentation of required PPE, availability and use at the workstation.

All affected operators are trained in the


use of Standardized Work Instructions

ON THE SHOP FLOOR:


Training for new team members
Analysing job for improvement opportunities
Layered Process Audit
Problem solving (4 diamonds)

1)
2)
3)
4)

Procedure that requires cross-functional


ON THE SHOP FLOOR
teams to develop stanardized work
1) Ask the Team Member/Leader their level of involvement in developing
instructions. Should be maintained through
their standardized work.
the use of the continuous improvement
2) Verify Team Leaders, Team Members, Group Leader original signature is
process.
on the document.
3) Ask the Team Leader if there is a process (formal or informal) for teams
to seek agreement for job element sequence within the team and across
all shifts and crews.
4) Ensure controls listed in Control Plan added to SWI, efficient time
allocated for quality checks (if cannot be ensured it needs to go back to
PFMEA)

ON THE SHOP FLOOR:


Evidence that operators are trained in the use of Standardized Work
Instructions.
Ask team member how the Standardized Work Instructions are used.
ON THE SHOP FLOOR
Ask the Team Member/Leader their level of involvement in developing
their standardized work.
Verify Team Leaders, Team Members, Group Leader original signature is
on the document.
Ask if the Group Leader understands their role in the support of
standardized work by acting as a liaison to the support organizations.
Ask the Team Leader if there is a process (formal or informal) for teams
to seek agreement for job element sequence within the team and across
all shifts and crews.

NR

NR

NR

OPERATOR INSTRUCTIONS
Is there a systematic approach to develop Operator Instructions for all work.
Procedure, instructions or other
documentation that requires
development of operator instructions
(Job Element Sheet) for all work.

Procedure, instructions or other


documentation that requires
development of operator instructions for
all work.

4.6

1) Operator Instruction template developed and applied for all operations.


2) Operator Instruction contains Major Steps (What), Key Points (HOW),
and Reason (WHY) supported with pictures
3) Use Operator Instruction for standardized operator training to ensure that
all operators got the training on same level
ON THE SHOP FLOOR:
4) Operator instructions in or near work areas that are accessible to
operators.
5) Compare instructions to work performed by operators. Observe 3 full
cycles of the job in station & verify that the Major Steps, Key Points are
followed Reason is understood
6) Quality checks are included.
7) Specific tool requirements are listed at the operation.
8) Verify critical items such as torque Customer or Safety requirements are
specified in the document.

ON THE SHOP FLOOR:


Operator instructions in or near work areas that are accessible to
operators.
Compare instructions to work performed by operators.
OBSERVE 3 full cycles of the job in station & verify:
That the Major Steps (What), Key Points (HOW),
and Reason (WHY) are followed.
(All key points shall have a reason Why)
Ask the Team Member how they know they have made good part.
Quality checks are included.
Specific tool requirements are listed at the operation.
Verify critical items such as torque or Customer Safety requirements are
specified in the document.

NR

Verify, maintain and update operator instructions as processes/products change.

4.7

Procedure, instructions or other


documentation that requires
implementation and revision of operator
instructions.

Procedure, instructions or other


documentation that requires
implementation and revision of operator
instructions.

ON THE SHOP FLOOR:


1) Review revision history of operator instructions.
2) Check to see if it is marked up, signed, and dated around the timing of a
recent design or process change

ON THE SHOP FLOOR:


Review revision history of operator instructions.
Compare revision levels of operator instructions with PFMEA or Control
Plan revision levels.
Check to see if it is marked up, signed, and dated around the timing of a
recent customer problem or contaiment action.
Evidence of appropriate operator training records when revisions were
made.

NR

Is there a system in place for Gage control.

4.8

Procedure and forms to document


process.
Compliance to customer requirements
(GM 1925) for both internal & external
gage providers.

Procedure and forms to document


process.
Compliance to customer requirements
(GM 1925) for both internal & external
gage providers.

Gage instructions updated to current


product and process level.

Gage instructions updated to current


product and process level.

1)
2)
3)
4)
5)
6)
7)

ON THE SHOP FLOOR:


Documented procedure and gage/fixture use instructions.
Operator gage training to the current gage instruction.
Gage master device.
All the gages calibrated.
Gage certification frequency.
Gage R@R.
Last Part Checked should be held for confirmation of last known good
part at a frequency of at minimum of 1 per shift

ON THE SHOP FLOOR:


Documented procedure and gage/fixture use instructions.
Operator gage training to the current gage instruction.
Gage master device.
Calibration sticker.
Gage certification frequency.
Gage R@R.
BEST PRACTICE:
Retain hourly samples for each inspection, retained for the entire shift or
previous 8 hours. Last Part checked should be held for confirmation of
last known good part at a frequency of at minimum of 1 per shift.

# Corrective Action Required =


0
SCORE / POTENTIAL
5.0 STANDARD OPERATOR TRAINING
Is there a system to define a standard training method, minimum content and tracking for all operators new to an operation and/or those in need of refresher training?
A standard operation training method
which ensures that all the trainers are
trained to apply it when teaching
operators

5.1

Records for identification of trainers to


ensure that only certified trainers train

A standard operation training method 1) Train the trainer process in place, evidence of a graduating step approach ON THE SHOP FLOOR:
to ensure that all the trainers are
such as the 4 Step (Job Instruction Training) process:
Evidence of a graduating step approach such as the 4 Step (Job
trained to apply it when teaching
1.Prepare, 2.Demonstrate, 3.Try-out performance, 4.Follow-Up.
Instruction Training) process:
operators
ON THE SHOP FLOOR:
Prepare, Demonstrate, Try-out performance, Follow-Up.
2) Certified trainer list, a document to show who is certified to train.
Follow up should include monitoring new operators' activities by the
Records for identification of trainers to
3) Check minimum 3 working stations and verify their operators got the
trainer at a frequency determined necessary to assure all standards are
ensure that only certified trainers train
training from certified trainer and ask operators how they were trained
met and verify productivity
(e.g.: according to 4 Step)
Documentation to show who is certified to train.
4) Follow up should include monitoring new operators' activities by the
Ask operators how they were trained.
trainer at a frequency determined necessary to assure all standards are Check minimum 3 working stations and verify their operators got the
met and verify productivity
training from certified trainer

31 of 38

NR

NR

NR

32

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

5.2

EVIDENCE REQUIRED

2011

LOOK FOR

Standard operator training records


document specific areas of training such
as safety, quality record keeping,
gaging, workplace organization
responsibilities.

Standard operator training records


1) Training record that documents training of procedures and overall job
document specific areas of training such
knowledge to:
as safety, quality record keeping,
Work safely (guards, start-up shut down, lock out)
gaging, workplace organization
Perform proper record keeping (production/quality)
responsibilities.
Understand work place organization responsibility
Quality requirements (containment, red-bins, andon, etc)
2) Records are available and easily retrieved.

Specific Job instruction training is


documented for each operator showing
all jobs trained on, skill or knowledge
level of the job, who trained them and
when.

Specific Job instruction training is


documented for each operator showing
all jobs trained on, skill or knowledge
level of the job, who trained them and
when.

5.3

Records reflecting training status of all


operators posted at or near the
operation indicating they are trained to
the current work instruction change level
to ensure only trained operators perform
standardized work.

5.4

1) Individual Job training record with dates and trainer signoff for each job.
2) Record indicates the steps in training & skill/knowledge level achieved for
each job:
ON THE SHOP FLOOR:
Verify a new operator (look for minimum 3 cycles) whether follows
Standardized Work Instructions and know the quality and productivity
requirements.

Records reflecting training status of all


1) How is record maintained to track training of operators to the latest work
operators posted at or near the
instruction change level?
operation indicating they are trained to
ON THE SHOP FLOOR:
the current work instruction change level 2) Check minimum 3 working stations and verify their operators training
to ensure only trained operators perform
records to the latest working instruction level
standardized work.
3) Flexibility Chart or equivalent posted at all operations or work area, keep
updated and being used.
4) All operators listed including supplemental employees.

2011

old

Training record that documents training of procedures and overall job


knowledge to:
Work safely (guards, start-up shut down, lock out)
Perform proper record keeping (production/quality)
Understand work place organization responsibility
Quality requirements (containment, red-bins, andon, etc)
Records are available and easily retrieved.

R/Y/G

NR

Individual Job training record with dates and trainer signoff for each job.
Record indicates the steps in training & skill/knowledge level achieved for
each job:
ON THE SHOP FLOOR:
Verify a new operator is following Standardized Work Instructions and
look for minimum 3 cycles & know the quality and productivity
requirements.

NR

How is record maintained to track training of operators to the latest work


instruction change level?
ON THE SHOP FLOOR:
Check minimum 3 working stations and verify their operators training
records to the latest working instruction level
Operator Tracking Sheets or equivalent posted at all operations or work
area, keep updated and being used.
All operators listed including supplemental employees.

NR

BEST PRACTICE:
Chart showing cross training/certification level in a cell such as a flexibility
chart, job rotation plan or log.

Refreshment training records for:


- supplemental or temporary employees
- employees failed on re-certification
process

5.5

Training records for supplemental or


temporary employees that document
refresher training if they have not
performed that job within the last three
months.

1) Documentation, scheduling, and tracking forms for supplemental operator


refresher training if they have not performed that job within the last three
months.
Record of re-certification process for operators including re-training if
needed

Documentation, scheduling, and tracking forms for supplemental


operator refresher training.
Record of re-certification process for operators including re-training if
needed

# Corrective Action Required =


0
6.0 ERROR PROOFING VERIFICATION
Is there a system in place to verify that error proofing/ detection devices used in manufacturing and assembly are functioning properly?

6.1

6.2

Documentation and evidence that


indicates devices are verified at least
once per shift.

Reaction to failures and corrective


actions are documented.

Reaction to failures and corrective


actions are documented.

Error Proofing device locations shall be


documented.

Error Proofing device locations shall be


documented.

1) Master list of all devices that prevent/detect the manufacture or assembly Master list of all devices that prevent/detect the manufacture or assembly
of nonconforming product.
of nonconforming product.

NR

Management reviews results of


verification.

Management periodically reviews


results of verification.

1) Each verification failure needs to be escalated to Fast Response Meeting Verification failures on Fast Response Tracking Sheets, Layered Audit,
in order to avoid shipping out parts without containment
Management Review agenda, Verification tracking forms available.
2) Review of result of verifications and Layered Audit in order to define
necessary step (increase frequency of verification or LPA, purchase
reliable error detection device etc.)

NR

# Corrective Action Required =


0
7.0 LAYERED PROCESS AUDITS
Is there a system in place to verify the documented manufacturing/assembly process through layered audits?
A defined Layered Process Audit (LPA)
procedure that is owned by
manufacturing.

A defined Layered Process Audit


procedure that is owned by
manufacturing.

7.1

1)
2)
3)
4)

Written Procedure and Layered Audit questionnaire template


Audit and work instructions define what to "Look For"
Counter measure process, reaction plan with real target dates
Owned by Manufacturing
ON THE SHOP FLOOR:
5) Easy access of Layer Audit questionnaire template

ON THE SHOP FLOOR:


Documentation (verification logs) of device verification at a minimum of
once per shift & are easily accessible.
Reaction plan includes who is notified and actions to be taken.
Containment and corrective action documentation for failures.

NR

Documentation and evidence that


indicates devices are verified at least
once per day.

6.3

ON THE SHOP FLOOR:


1) Documentation (verification logs) of device verification at a minimum of
once per day & are easily accessible.
2) Reaction plan includes who is notified and actions to be taken.
3) Containment and corrective action documentation for failures.

SCORE / POTENTIAL

NR

SCORE / POTENTIAL

Written Procedure
Audit & work instructions to define what to "Look For"
Counter measure process, reaction plan with real target dates
Owned by Manufacturing- Evidence that Team Members, Team Leaders,
are all involved in performing audits

NR

NR

NR

BEST PRACTICE:
Reference how their ISO/TS 16949 Certifcation LPA Process &
Procedure
All levels of the organization participate
in Layered Process Audits at
established frequencies.

All levels of the organization participate


in Layered Process Audits at
established frequencies.

7.2

7.3

7.4

ON THE SHOP FLOOR:


1) Audit Schedule showing level of participation and frequency.
CEO should be Quarterly, Plant Manager Monthly,
Management Support Staff - Weekly (i.e. Engineering,
Maintenance, Quality) Daily-Team Leaders/team members.
2) Evidence that all layers of the organization perform regularly scheduled
standardized audits.
3) Ensure that each station within a working area is audited at minimum
once per month
4) Perform a Layered Audit together with team leader. Compare your results
with team leader.

ON THE SHOP FLOOR:


Audit Schedule showing level of participation and frequency.
CEO should be Quartely, Plant Manager Monthly,
Management Support Staff - Weekly (i.e. Engineering,
Maintenance,Quality) Daily-Team Leaders/team members.
Evidence that ALL layers of the organization perform regularly scheduled
standardized audits.

1) Work Station: 5S, Workplace organization, Safety list of checks,


applicable to all work stations
2) Part-Product: i.e. First Piece Approval, Error Proofing verification,
SOS/JES kept, Operator Training Matrix, Visual Aids, FIFO etc.
3) Process: i.e. Quality Alerts, Tool Set-up, Containment Logs, Control Non
Conforming, Gaging, SPC Compliance, CMM Logs, etc.
4) System: i.e. Shop Floor Management standards, Calibration Compliance,
Preventative Maintenance, Tooling Life Management, etc.
5) Voice of Customer: i.e. Running containment due to quality problem, Fast
Response Matrix, Verification Board, Performance Measurable, Action
Plans, etc.. )
6) Verify Fast Response Exit Criteria: i.e. External & Internal corrective
action for closure, Lessons Learned etc.

Procedure to include:
Focused checks on Part-Product (i.e. First Piece Approval, Error
Proofing, SOS/JES, Opertator Training Matrix, Visual Aids, FIFO, etc...)
Focused checks on Process (i.e. Quality Alerts, Tool Set-up,
Containment Logs, Control Non Conforming, Gaging, SPC Compliance,
CMM Logs, etc)
Focused checks on System (i.e. Shop Floor Management standards,
QA TWI, Calibration Compliance, Preventative Maintenance, Tooling Life
Management, etc...)
Focused checks on Voice of Customer (i.e. Fast Response Matrix,
Verification Board, Performance Measurables, Action Plans, etc.. )
Focused checks on Verify Fast Response Exit Criteria (i.e. External &
Internal corrective action for closure, Lessons Learned etc...)

LPA Audit document includes:


5S, Part/Product, Process, System,
Voice of Customer, Verfiy Fast
Response Exit Criteria

Internal Process specific audits are


performed (i.e. Process/Commodity
Specific Audit , CQI audits etc.)

Internal Process specific audits are


1) Layered Process Audit under system specific items, where applicable,
performed (i.e. Part Process Specific
Audits for special processes are performed and monitored.
Audit , CQI 9, 11, 12, Weld Audit,
Chrome Audit, Paint Process Audit, etc.)

Layered Process Audit under system specific items, where applicable,


Audits for special processes are performed and monitored.

All non conforming issues are recorded


on the LPA master document.

All non conforming issues are recorded


on the LPA master document which is
reviewed at least once a week.

ON THE SHOP FLOOR:


Results reviewed with team members & area supervisors
Evidence and documentation of immediate corrective action for
nonconformance. (Items corrected immediately)
Countermeasure list with responsibility and realistic target dates for items
that could not be corrected immediately.
Review of counter measure process at least once per week.
When appropriate nonconformance is added to Fast Response or
C.A.R.E. process

Non-conformances cannot be resolved


immediately shall be entered on
Countermeasure Sheet

7.5

ON THE SHOP FLOOR:


1) Results reviewed with team members & area supervisors
2) Evidence and documentation of immediate corrective action for
nonconformance. (Items corrected immediately)
3) Countermeasure list with responsibility and realistic target dates for items
that could not be corrected immediately.
4) Review of counter measure process at least once per week.

NR

BEST PRACTICE:
Schedule Matrix showing every Build of Process/cell is evaluated on a
regular basis (ie.. 3 shift operation with 80 cells @ 21 LPA's a week - plan
showing entire plant is audited 100% every month.)

High risk items identified and included in


LPA Audit document, focused checks on
below sections:
Work Station - 5S
Part/Product
Process
System
Voice of Customer
Verify Fast Response Exit Criteria

NR

NR

NR

BEST PRACTICE:
Check that the Audits are verified by the next level.
2)
Audit results are summarized and
reviewed by manufacturing site
leadership.

7.6

Audit results are summarized and


reviewed by manufacturing site
leadership.

ON THE SHOP FLOOR:


1) Results and Countermeasurment action statuses are reviewed by
management
2) Reports or graphics (i.e LPA Matrix) that are reviewed by management.
3) Continuous Improvement / positive trend for Value added out of the LPA
matrix non conformances (i.e Fast Response, 8D, 5 Why, Drill Deep,
Read Across)

32 of 38

ON THE SHOP FLOOR:


Reports or graphics (i.e LPA Matrix) that are reviewed by management.
Continuous Improvement / positive trend for Value added out of the LPA
matrix non conformances (i.e Fast Response, 8D, 5 Why, Drill Deep,
Read Across)

20

NR

12

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#
7.7

EVIDENCE REQUIRED
Using LPA findings for problem
prevention

2011
Addition of Layered Process Audit
issues to the Lessons Learned system.

LOOK FOR
1) LPA results shall be added to the Lessons Learned database when
appropriate
2) When appropriate nonconformance is added to Fast Response or
C.A.R.E. process

2011

PFMEAs shall be developed and


maintained by cross-functional teams
for all manufacturing processes and
support functions as required by the
AIAG manual.

1) PFMEA is developed by cross-functional team. Check member of PFMEA


team.
2) PFMEA available for all part numbers and all operations
3) Scoring of Severity/Occurrence/Detection are according to latest AIAG
FMEA Reference Manual, ratings are accurate.
4) Potential cause of failure defined specifically. Ambiguous phrases
(e.g., operator error or machine malfunction, etc.) should not be
used.

PFMEA available for all part numbers and all operations, especially high
risk such as labeling and rework.
Accurate Severity/Occurrence/Detection Ratings with Valid RPN numbers
and revision dates with some correlation to known problems (PRRs,
etc).
Are updated on a regular basis (at least once per month or as quality
items are eliminated).

Proactive approach for reduction of


highest risk items shall be implemented.

Proactive approach to reduction of


highest RPN values has been
implemented. Top RPN list with action
plans.

1) When Severity is 9 or 10, PFMEA team ensures that the risk is


addressed through existing design controls or recommended
actions
2) Prioritization based on defined approach (e.g.: combination of Severity,
Occurrence and Detection or Risk Priority Number etc.)
3) Recommended actions documented with responsibility and due date
4) Recommended actions re-evaluated after their verification

Top RPN list,


Tracking charts
Cross-functional team minutes noting improvement actions and
completion details.

1) Cross-functional team agenda or other evidence of risk reduction


activities.
2) Documentation that frequency and prioritization of reviews is based on
customer input, process capability, process changes, AIAG guidelines,
etc
3) Review checklists, agendas or equivalent that assure adequate PFMEA
review (all operations/processes (paint, heat treat, material handling,
labelling, rework/repair, etc) are included and accurate.
All process controls are included.
Detection ratings are accurate.
Occurrence ratings are analyzed using data (SPC, FTQ, ppm,
scrap data, Verification Station results etc.)

Cross-functional team agenda or other evidence of RPN reduction


activities.
Documentation that frequency and prioritization of reviews is based on
customer input, process capability, process changes, AIAG guidelines,
etc
Review checklists, agendas or equivalent that assure adequate PFMEA
review (all operations/processes (paint, heat treat, material handling,
labeling, rework/repair, etc) are included and accurate.
All process controls are included.
Detection ratings are accurate.
Occurrence ratings are analyzed using data (SPC, FTQ,
Quality Gate, C.A.R.E.*, Scrap, Layered Process
Audits* results)

Check last PRRs or quality issues (example from point 1.5)


1) Revision date of PFMEA linked to past failures.
2) Recommended action defined with actual target completion dates
3) Team validates the new Occurrence and Detection rankings and resultant
RPN.
4) Analysed why PFMEA did not predict failure (Drill Deep). Action
implemented to avoid in future

Revision date of PFMEA to address error proofing and verification of


past failures.
Action plans with actual target completion dates
Team validates the new Occurrence and Detection rankings and resultant
RPN.
Error proofing is verified per the Error Proofing Verification* process.

1) Cross-functional team conducts on-station review .


2) Schedule of reverse PFMEA (timing for review with prioritization of
operation and its status /planned-done/).
3) Evidence that the findings driven back into Process Flow, PFMEA,
Control Plan, Work Instructions as applicable.
4) Have Occurrence/Detection numbers been revised.
ON THE SHOP FLOOR
5) Chose one station and perform a quick reverse PFMEA to confirm all
current controls rated properly and all potential failure mode cover (try to
create new ones)

Cross-functional team conducts a process walk through audit .


Action Plan and target dates
Does this cover all High Risk Parts and PRRs
Are the findings driven back into Process Flow, PFMEA, Control Plan,
Work Instructions as applicable.
Have Occurrence/Detection numbers been revised.

Cross-functional teams have periodic


reviews of PFMEA

Cross-functional teams have periodic


reviews of PFMEA and coordinate RPN
reduction activities?

8.3

Evidence of past quality issues and


corrective actions that have been
implemented.

Evidence of past quality issues and


corrective actions that have been
implemented.

8.4

There is a Reverse PFMEA-(Pro-active


Error Proofing) process in place verify
the RPN.

There is a Reverse PFMEA-(Pro-active


Error Proofing) process in place verify
the RPN.

8.5

8.6

Managements support and review of the


RPN reduction process, training
requirements, and tracking of risk
reduction results.

Managements support and review of the 1) Management review agenda/minutes


RPN reduction process, training
2) Necessary resources allocated for PFMEA development and review as
requirements, and tracking of RPN
well as recommended action implementation on time.
reduction results.
3) Cross-functional team training and individual qualifications reviewed and
verified annually.

# Corrective Action Required =


0
9.0 CONTAMINATION CONTROL
Is there a system in place to control contamination when appropriate?
Sediment: Procedures for the
measurement, monitoring and
identifying possible risk areas.

Sediment: Procedures for the


measurement, monitoring and
identifying possible risk areas.

9.5

Sediment reduction strategy for


- Metal Working Fluid System
- Fluid/Air Probes
- Work Station Cleanliness
- Dunnage and Part Storage
- Purchased parts

Procedure for maintaining the


processes to control the affect of
contamination or sediment issues.

9.4

Sediment reduction strategy for


Washers/Debur
Procedures for maintaining integrity of
washer/debur process and control the
affect of sediment or contamination for
part/product

9.6

Procedure for controlling or maintaining


foreign material from contaminating
parts/product.

9.1

SCORE / POTENTIAL

PFMEAs shall be developed and


maintained by cross-functional teams
for all manufacturing processes and
support functions as required by the
AIAG FMEA manual.

8.2

Washers/Debur: Procedures for


maintaining integrity of washer/debur
process and control the affect of
sediment or contamination for
part/product

Management review agenda/minutes


Cross-functional team training and individual qualifications reviewed and
verified annually.
Evidence of documentation to track improvements. (Trend Chart,
Process change validation, Layered Process Audit)

SCORE / POTENTIAL

Procedure to include:
Has a baseline been established to montiored on an ongoing basis?
(This to include individual parts, sub-assemblies, full assemblies)
Is there an agreed upon document (drwg/tech spec) that is customer
approved and defines the acceptable level of contamination?
Are the sediment particle size/particle weight, total weight developed off
of the agreed-upon, customer approved specification?
Process defining part collection/frequency?
Is GMW 16037 procedure being used for quantification of sediment with
parts?
Application using statistical method to monitor and control?
Are results documented and plotted on control chart for management
review?
Is there evidence of Site Leadership review of results for compliance and
continuous improvement?
1) Procedure to define and maintain method and frequency of checks to
ON Shop Floor:
ensure metal working fluid quality and cleanliness
Review customer complaint history for contamination related complaints.
2) Procedure to define and maintain method and frequency of checks to
Corrective Actions for contamination or sediment findings with actual
ensure functionality of fluid/air probe flush station
target dates
3) Define purchase parts require sediment monitoring/cleaning. Method and Verify complaints are reviewed at Fast Response, have documented
frequency for cleanliness need to be developed.
problem solving, and corrective actions have been implemented.
ON THE SHOP FLOOR:
Contamination issue and corrective actions are added to Layered
Check work stations cleanliness, daily verification to be established
Process Audits.
(Layered Audit, Tape test etc.)
PFMEA should be reviewed as result of contamination issues
Dunnage cleaning process defined and kept
Parts are covered / properly protected
Parts on the assembly lines handled with lint free gloves / towels

ON THE SHOP FLOOR:


1) Are all wash/debur machine parameters captured and monitored/
documented on a daily basis?
Are Temperature, Pressure, Nozzle Alignment, Fluid Conc., Blowoff/Vacuum monitored daily and documented
Is wash solution monitored and analyzed (ppm, conductivity, hard
particles, soft particles, particle size etc.) on an ongoing basis?
If applicable - is the air filtered that supplies the drying system? How are
air contaminants controlled?
Are parts covered and protected after wash to prevent foreign material
penetration?
Documented PM program for washer and deburring?

Procedure for controlling or maintaining 1)


foreign material from contaminating
parts/product.
2)
3)
4)

On Shop Floor:
Are all wash/debur machine parameters captured on the Control Plan
and monitored/documented on a daily basis?
Are Temperature, Pressure, Nozzle Alignment, Fluid Conc., Blowoff/Vacuum monitored daily and documented
Is there evidence of standardized work instruction/ washer set-up
procedures on the shop floor?
Is chemical titration conducted to monitor the washing solution and
documented?
Is wash solution analyzed (ppm, conductivity, hard particles, soft
particles, particle size etc.) on an ongoing basis?
If applicable - is the air filtered that supplies the drying system? How are
air contaminants controlled?
Are parts covered and protected after wash to prevent foreign material
penetration?
Are washer pipes, hoses, gages, nozzles, filters & solution on a
Methods developed to prevent extra parts or materials that may fall into or On Shop Floor:
documented PM system? (check for evidence)
stick to products (e.g.: evidence that dunnage, fixtures, conveyors,
Is there evidence that dunnage, fixtures, conveyors & washers are
If main wash system becomes inoperable - Is there a PPAP approved
washers and pre-assemblies etc. are covered to prevent falling material) covered to prevent falling material or unauthorized material from
alternate wash system? Is there an alternate GM approved bypass
Methods are verified through error proof verification and/or Layered
contaminating product?
procedure?
Process Audits (e.g.: sensor for masking used)
Are pallets, dunnage, fixtures, conveyors, part racks & teardown bench
Foreign material as failure mode is considered in PFMEA
cleaned and documented on an ongoing basis? 5-S procedures
Monitor findings of extra part to initiate corrective actions
implemented?
Evidence that 5-S procedures are being followed?
Evidence and procedures developed to prevent extra parts or materials
that may fall into or stick to products?
Methods are verified through error proof verification and/or Layered
Process Audits.

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28

NR

NR

BEST PRACTICE:
GM 1927-21 RPN Risk Reduction Summary

1) Procedure developed which includes method defining sediment collection


and system to measure cleanliness
2) Are the sediment particle size/particle weight, total weight developed off
of the agreed-upon, customer approved specification?
3) Is GMW 16037 procedure being used for quantification of sediment with
parts?
4) Application using statistical method to monitor and control? (Include
individual parts, sub-assemblies, full assemblies)
5) Are results documented and plotted on control chart for management
review?
6) Evidence of Site Leadership review of cleanliness results including
customer complaint for compliance and continuous improvement?
7) Contamination failure modes are considered in PFMEA, controls listed in
Control Plan.

2)

R/Y/G

NR

# Corrective Action Required =


0
8.0 RISK REDUCTION
Is there a system in place for reducing the risk of all production processes by reducing the highest RPN values?

8.1

old

Lessons Learned system, documentation.

NR

NR

NR

NR
NR

NR

NR

NR

NR

24

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED

2011

Dirt in Paint or Part


Procedure for maintaining the
processes to control and prevent dirt
contamination.

Process and Procedures for Part


Handling and Storage:

9.2

Retained material in Castings.


Procedure to measure, monitor, and
improve retained material.

Process to retained material in Part:


Procedure to measure, monitor, and
improve material.

LOOK FOR

2011

old

1) Procedure or instruction describes dirt control and prevention for key


areas: People, Process, Facility and Material.
2) Dirt awareness training are held
3) Application of statistical method to monitor and control painting process
such us dirt count (SPC, U-chart), dirt identification (Pareto) etc.
4) There is an active dirt reduction team and action plan defined
ON THE SHOP FLOOR:
5) Entire paint shop has to be a clean area. Check that restrictions (e.g.: no
food, no fibrous material etc.) housekeeping requirement and approved
attire are kept.
6) Self inspection/clean up are implemented on all painting operation

Procedure to include:
There is a process in place to remove damaged dunnage and replace?
There is a process for parts to be covered / protected during down
periods?
On Shop Floor:
Are parts loaded into finished racks in order of conductive to reduced
sediments levels? (Load -Top to bottom) (Unload - Bottom to Top?)
Are parts on the assembly lines handled with lint free gloves / towels?
Verification that in-process dunnage is not used for finished parts?
Are teardown parts removed from the normal flow of production and
reintroduced through standard production wash process prior to moving
to assembly?

1) Is GMN 11174 applied for Sand Casted Cylinder Blocks and Heads?
2) Methods to measure retained material (i.e. Tunk test) before part reaches
the final machining.
3) Verification that measurements are taken and results are documented.
4) Any non-conformance to standards are documented and corrective
actions are implemented and reviewed by leadership.

Procedure to include:
Methods to measure retained material (i.e. Tunk test)
Verification that measurements are taken and results are
documented.
Any non-conformance to standards are documented and
corrective actions are implemented.
Processes/Equipment are verified through error proof
verification, preventative/predictive maintenance, and Layered
Process Audits.
Site leadership review of results for compliance and continuous
improvement
Has a GM Sediment Audit Completed: (i.e. Powertrain Suppliers
required to complete)

9.3

# Corrective Action Required =


10.0 SUPPLY CHAIN MANAGEMENT

SCORE / POTENTIAL

R/Y/G

NR

NR

NR

24

Is there a systematic process in place to control suppliers?


Procedures or work instructions to select
and evaluate suppliers.

Procedures and work instructions to


select and evaluate suppliers.

1)

Procedures that require supplier audits (e.g.: Potential Supplier


Assessment or PCPA) to support sourcing decisions, evaluation of their
quality systems.
Approved supplier list (e.g.: Bidlist)
SQ SOR or equivalent signed by supplier.

Supplier Quality Statement of Requirement


(SQ SOR) that contains all customer
requirements, expectations, and processes

Procedures that require supplier audits to support sourcing decisions,


quality systems, special processes, and product/process specific
evaluations.

BEST PRACTICE:
Potential supplier assessments including Manufacturing,Quality
Quality Systems Basics audit or equalivent audit
Evidence of SQ responsibility (SQ organization Special Process audits - such as Heat Treat, Welding, Plating and
chart or SQ training records)
Coating.
Labeling PFMEA/Control Plan

10.1 for all potential suppliers.

Procedure for evaluating compliance to


customer specifications and
requirements
Measurement and validation system for key
10.2 suppliers performance tracking

Measurement and validation system for


key suppliers performance
Sub-Supplier APQP, AIAG and customer

10.3 specific requirement compliance

1) Methods to determine ranking of Key suppliers with reviews of supplier


Procedure to include:
performance to specified goals.
Compliance to Customer specific requirements such as GM1927-03 SQ
2) Key Supplier list with defined metrics/goals
SOR, GP-9, GP-12, etc.
3) Reviews of supplier performance with a defined procedure and actions for Process Control Plan Audits
poor performing suppliers, such as 6 panel.
Gaging Audits
4) Method or process in place to communicate problems and track
Problem Solving with disciplined method for root cause analysis such as
corrective action.
5-Why.
1) Evidence of tiered supplier compliance to AIAG PPAP, APQP, FMEAs,
MSA, and SPC requirements.
2) Evidence of selection and designation of KPCs, KCCs, PQCs, and PTCs
on engineering drawings, SPC is applied for KPC.
3) Process specific audits such as CQI, Sediment ....etc are performed per
GM requirements
4) Customer specific requirements such as GM1927-03 SQ SOR, GP-9,
GP-12, Labelling etc. implemented at tier supplier as well

Methods to determine ranking of Key suppliers with reviews of supplier


performance to specified goals.
Key Supplier list with defined metrics/goals
Reviews of supplier performance with a defined procedure and actions
for poor performing suppliers, such as 6 panel.
Method or process in place to communicate problems and track
corrective action.

NR

NR

NR

Tier I Review their supply base to ensure that:


1)
2)
3) Engineering/process changes documented and communicated
Demonstrate a systematic and disciplined approach to problem solving
(technical root cause analysis and why the system failed (Drill Deep &
4) Wide)
Perform regular audits at key suppliers

Monitoring Sub-Supplier Process Control

10.4 / Changes performance

# Corrective Action Required =


0
11.0 MANAGING CHANGE
Is there a systematic process in place to control product, process, or source changes?
A documented procedure for monitoring
and controlling all product, process or
source changes.

A documented procedure for monitoring


and controlling all product, process or
source changes.

11.1

NR

SCORE / POTENTIAL

1) A change form utilized to document all changes (engineering, process


and source changes). PPCR form is reference for Powertrain suppliers
2) Change Forms are controlled through a Document Control Process. (e.g.
tracking log sheet, revision numbering system, approval process)
3) Both planned and emergency changes covered by the change procedure.
All changes need to be reviewed and approved by customer. Inform
4) GM SQE in early phase to get approval before kick off.

Procedure to include:
A plant process change form utilized to document all changes.
Change Forms are controlled through a Document Control Process. (e.g.
tracking log sheet, revision numbering system, approval process)
Both planned and emergency changes covered by the change
procedure. All changes need to be reviewed and approved by customer
BEST PRACTICE:
All changes need to be reviewed and approved by your GM SQE.
(Powertrain Suppliers - Reference SPCR Process)

Procedure to establish a defined


Production Trial Run (PTR) process.

Procedure to establish a defined


Production Trial Run (PTR) process.

11.2

A parts banking strategy/procedure for


identifying, protecting and retrieving long
term storage of parts or materials.

11.3

Procedure to authorize bypassing


processes

11.4

# Corrective Action Required =

A parts banking strategy/procedure for


identifying, protecting and retrieving long
term storage of parts or materials.

1) A standardized communication procedure and form to control and monitor Procedure to include:
all Production Trial Runs that documents each step of the process &
A standardized communication procedure and form to control and
records all approvals and results.
monitor all Production Trial Runs that documents each step of the
2) Build readiness reviews required to authorize the start of the trial run
process & records all approvals and results.
production process.
Build readiness reviews required to authorize the start of the trial run
3) Quality reviews documented to release product for PTR shipment and
production process.
verification process has returned to normal production.
Quality reviews documented to release product for PTR shipment and
verification process has returned to normal production.
1) Procedure with responsibility for the execution of long term storage of
parts or materials, keep FIFO process
2) Customer approval for safety stock level
3) Established guidelines for protective packaging for parts and material.
4) Quality reviews to established inspection criteria for the authorized
release of banked parts and material prior to internal usage or shipment
5) Weekly Layered Audit to ensure processes followed

On the Shop Floor:


Review procedure and responsibility for the execution of long term
storage of parts or materials?
Established guidelines for protective packaging for parts and material.
Quality reviews to established inspection criteria for the authorized
release of banked parts and material.
Start Up/Shutdown Audits

1) By-pass process approved by Operations, Engineering and Quality


manager, Standardized Work and training applied
2) A Worksheet is used to track each process that is in bypass.
3) The bypassed process is frequently audited for compliance (Best Practice
is hourly)
4) Bypass processes are always reviewed by Quality Manager to ensure
proper back-up inspections are in place and PFMEA and control plans
updated.

Procedure to include:
A Worksheet is used to track each process that is in bypass.
The bypassed process is frequently audited for compliance (Best
Practice is hourly)
Bypassed processes are documented in PFMEA and Control Plan

BEST PRACTICE:
Product quality standards are maintained
Method for proper authorization to enter and exit the process
Defines when the process is initiated and returned to normal
Standardized work and operator training are documented

SCORE / POTENTIAL

34 of 38

16

NR

NR

NR

NR

NR

16

QUALITY SYSTEMS BASICS AUDIT


Read through QSB Presentation (GM 1927-36) before filling audit form in
#

EVIDENCE REQUIRED

2011

LOOK FOR

Pts Element Scoring


0

Element is not in place and no evidence of plans to implement

Element is not in place but a plan to implement is documented

Element is in place but it is not being followed

Element in place but not followed at each job or all the time

Element is in place and it is being followed

NR Not Reviewed: Key Strategy not audited at this time. (Training Required, Follow-Up Required)
Note: Enter appropriate score based on R Y G score criteria and hit enter. Correct color will appear in R/Y/G cell.
Not Reviewed is used when immediate focus does not include the strategy. Plan to review in future. Give future review date in comment box.
Not Applicable: is used if a question does not apply. Question should be given a score of 4 and a note made in comment in box.

35 of 38

2011

old

R/Y/G

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