Nonconformity Report / Supplementary Report

numbers: 1 to 6

CN: 01 111 044492 Client: Dana de Mxico Corporacin, S. de R.L.

Order number: 175764 Audit type: de C.V. Divisin Cardanes
Applicable standar ISO/TS 16949:2009 Site: Quertaro, Qro., Acceso III No. 7 Puerta 1
Audit date: 15/08/2016 - 18/08/2016 Fracc. Industrial
Auditee representatiAlfonso Ochoa Benito Jurez
Lead Auditor QM Bulmaro Auditor(s): Apolinar Mendoza [e]
Zempoaltecatl [e]

18.08.2016
Date

Lead Auditor QM Auditor(s) QM

Auditee Representative QM

Correction(s) has (have) been verified and classified as closed including documents
possibly submitted later.
Major nonconformities and nonconformities that
are considered as "100% resolved" are
mandatory subject to an onsite verification prior
to the next scheduled audit. Furthermore major
nonconformities require an action plan of the
client latest 20 days after the last audit day.

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 An on-site
verification was
performed
Date processing auditor QM QMR or Client Represent
Applicable standard/Standard

Consideration of the
impact of the

Minor nonconformity
Major nonconformity
nonconformity onto
chapter

Root Cause Analysis Systemic Corrective

Correction to the similiar processes and
No.

Systemic deviation Objective evidence (including method Action to the

nonconformity products and onto
used and results) nonconformity
other sites of a
Corporate Scheme
respectively

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 COR1.1 The PFMEA # Analysis of 5 WHYs CA1.1* Update Check Replicate the approved
3 was corrected on Constantino H, Cesar S, List 8D format action plan as
08/18/2016, Added Noel F, Alfonso O, Luis FCQUA00022 / 1 to appropriate to other
Failure mode (Glue over T, Juan N, Rocio A. include review of Dana production sites.
label), update of date Identifying the root PFMEA in D4, and add When: 14/10/2016
last revision, of PFMEA cause to the list of approvers to Responsable: Floyd
and Control plan, the coordinators and McNiece, Specialist
controls of detection and Why happened? manager involved in the Technical - Supplier
NPR califcation, The FMEA is not taken update PFMEA, before Quality,
8 D report, date
according to costumer into account from the sending the 8D to
28/03/2016. With NCT
complaint CC-93 of beginning of the problem customer approval. (CA-
No. 16601792, date
FCA. reported PR-0063/8 FMEA
24/3/2016, P/N
(Constantino Hernndez process, CA-PR-0058/4
52123042AC from FCA
Rico, Manufacturing The meetings for the Control Plan, CA-PR-
client. During the
Engineer) analysis of problem 0017/6 Corrective Action
analysis and definition
In specific the process solving are not effective with customers) With
of the solving problem
to review and updating signature of
was not updated te
7.3.1.1

the PFMEA is not COR1.2 Validate Because it not multidisciplinary team

FMEA # 3, Rev.
1

effective._x000D_ update FMEA, control considered the FMEA (Production Manager /

01/15/2016, Op.
_x000D_ Plan, process Sheets VS during root cause Manufacturing,
40._x000D_
actions defined in the 8D analysis Manufacturing
. Other 4 CARs were
issued for claims of Engineer / quality,
reviewed and checked
customer, of January to Because only taken the Production Coordinator /
and found to be
current date, In that FMEA as a more Manufacturing / Quality,
updated the FMEAs.
period they were corrective actions and Maintenance Supervisor,
Other 4 PFMEAps were
received 5 of Navistar, 2 not as a participant of Costumer Service, Team
checked anf found that
FCA, 2 Nissan, 1 Dina the solution Leader) in the check list
udpating were done.
and 1 Kenworth. FCQUA00022/2
(Manufacturing Because no parallel (Quality Engineer Luis
Engineer Constantino meetings to process 8D Tarrios 30 / Sept / 2016)
Hernandez, Quality and FMEA are
Engineer Luis Tarrios, performed. CA1.2* Include in
Manufacturing Engineer procedure (CA-PR-
Johnatan Ugalde 0063/8 FMEA process,
(09/20/2016). Why do not was CA-PR-0058/4 Control
detected? Plan, CA-PR-0017/6
x

The PFMEA information Corrective Action with

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 Implementation of a A 3-legged 5-Why Change of procedure Replicate the approved
review of Cardanes' analysis was performed CA-PR-0067 "Statistical action plan as
twelve customers' CSR by a team of Quality Techniques" to include appropriate to other
to identify other possible Engineers, Quality the tool selection matrix Dana production sites.
omissions in order to Customer Service, SQA, shown in VDA 4 (1. When: 14/10/2016
produce an action plan PLM Instructor and QMS Methods Overview), as Responsable: Floyd
to implement them that Engineer: it's a synopsis of the McNiece, Specialist
will be documented as analytical tools Technical - Supplier
an Open Issues Status WHY OCURRED? described in this manual. Quality,
Report (form W1: Why we did not (QMS Engineer, 2016-
FCQUA00006). (Quality show evidence of review, 09-20)
The CSRs from Ford
Engineering Coordinator, identification and
Client requires the VDA
Quality Engineers application of the Deployment by training
4.1 manual. However
(Driveshafts), PLM requirements defined in of change to CA-PR-
the organization did
Instructor, Quality the VDA 4.1 manual? 0067 "Statistical
not show evidence of
Customer Service, SQA, Because we didn't give it Techniques" to Quality
review, identification
The process to review, QMS Engineer, importance, as it's listed and Manufacturing
and applciation of the
document and 09/07/2016) as "as appropriate" in Engineers, as these two
7.2.1

requirement defined in
2

communicate the Ford's CSR. positions participate

the VDA 4.1 manual.
CSRs is not effective.
Other 3 CRSs were
checked and found are
identified, documented
and implemented. Ford
be included in Cardanes'
also has approved all
PPAPs.
x
Review of VDA 4.1 by W2: Why didn't we and/or support the
the QMS Engineer in evaluate if it was processes COP
order to identify appropriate? Because Development, COP
requirements pendig to the VDA site didn't list Production, and SOP
VDA 4.1 "Quality Auditing and Monitoring.
QMS, and update the Assurance prior to Serial (QMS Engineer, 2016-
"Requirements vs CSR Application", only VDA 4 09-27).
Relation Matrix" "Quality Assurance in
(FCQUA00004) and the Process Modification of
other documents as Landscape". WIQUA00002
appropriate. (QMS W3: Why the VDA 4.1 "Identification and
Engineer, 09/07/2016) was no longer listed in Deployment of CSR" to
the VDA site? Because include:
Deployment by training all VDA 4.x were unified Name the positions
of the contents of VDA to form VDA 4. that are the
4.1 and how it's being W4: Why didn't we used "touchpoints" with the
implemented in the latest version, VDA customers and might

Cardanes' QMS to 4? Because at that time detect new or changed

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The client
subcontracts with DHL
the raw material
income, the respective
Warehousing and the
delivering of them to
the production lines.
The performance of
DHL includes the
shutdown production
line with target zero,
but there was an
incident in May 2016,
The process to identify
revising the respective
8.5.2
the root cause analysis
3
action plan, there was
is not effective.
no evidence the root
cause (s) was
identified._x000D_
_x000D_
This is minor; DHL
showed an action plan
with corrective actions
which are obtaining no
repetition of the failure.
For the incident in April
2016, the root cause
was identified using 5
whys methodology.
x
Request to DHL to A 3-legged 5-Why 1) Modify procedure CA- Replicate the approved
perform an 8D Report analysis was performed PR-0009 "Control of action plan as
for the production line by a team of Personnel Contractors and Service appropriate to other
shutdown on July 14th, Development Specialist, Suppliers" to include the Dana production sites.
2016 in order to identify Quality Customer management of When: 14/10/2016
if additional actions are Service, SQA, and QMS corrective actions from Responsable: Floyd
required to prevent Engineer, identifying the outsourced processes McNiece, Specialist
recurrence. (Warehouse root causes: by requesting an 8D Technical - Supplier
Coordinator and DHL when nonconforming Quality,
Site Coordinator, 2016- WHY OCCURRED: products or services are
09-07) W1: Cardanes only delivered and/or when
requested an action planned results are not
Refreshment by the plan. achieved. (QMS
Quality Manager to the W2: It's not indicated in Engineer, 2016-10-14)
Materials Manager, Dana Suppliers Quality
Warehouse Coordinator, and Development 2) Deployment of the
DHL Site Coordinator, Manual, except for change to CA-PR-0009
Quality Engineers, suppliers of production "Control of Contractors
Customer Service, and materials. and Service Suppliers"
SQA on the W3: Each site assumes to representatives of the
requirements of clauses the responsibility of the organizations that
8.5.2 to 8.5.3 and 4.1 to control of services perform services that
4.1.1 with the purpose suppliers. might affect quality, in
that they know, W4: While the SQA and order that they know and
understand and the Incoming Quality apply it. (QMS Engineer,
effectively apply its Coordinator are focused 2016-10-07)
requirements. (Quality on suppliers of
Manager, 2016-09-07) production materials, the 3) Elaborate a document
Quality Manual names that shows the default
specific roles as the purchasing information /
responsibles for supplier selection criteria
monitoring outsourced to apply by commodity,
processes and states as a guidance to
that procedure CA-PR- Purchasing. This
0009 "Control of document will establish
Contractors and Service 8D as a requirement for
Suppliers" describes outsourced services
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 1) Review and correction The packaging process 1) Review packaging Replicate the approved
of CA-WI-0240. Review was outlined to instructions form to action plan as
packaging instructions understand it, and an include the minimum appropriate to other
form to include the Ishikawa Diagram was characteristics to be Dana production sites.
minimum characteristics made and rated with the specified. (Customer When: 14/10/2016
At the Warehousing of
to be specified. collaboration of service and Shipping Responsable: Floyd
finished products
(Customer service and Cardanes' Customer coordinator, 09/08/2016) McNiece, Specialist
managed by DHL, the
shipping coordinator, Service personnel, The minimum of Technical - Supplier
Packaging and
09/07/2016) Shipping Supervisors characteristics are the Quality,
labeling-Inter Dana
The minimum of and Materials Manager, following, according CA-
Plants Work
characteristics are the and DHL's site WI-0240/6:
Instruction CA-WI-0240
following, according CA- representatives, instructions for the
rev. 4, does not include
WI-0240/6: identifying the root strapping
the standard pack of
instructions for the causes: instructions for the
the P. N. 2-2-329, Full
strapping stacking
Round Flange Yoke;
instructions for the Lack of availability of heat treated wooden
The process to define the instructions for the
stacking documentation for pallet
the packaging strapping and the
heat treated wooden shipping personnel in number of strips
7.5.5

requirements to stacking are

4

pallet the railroad spur number of and labels.

preserve the product is missed._x000D_
number of strips shipping area, 2) Put a controlled
not fully effective _x000D_
number of and labels. particularily DHL's copies binder in the
This is minor; in the
Because the packaging railroad spur shipping
revision of other 5 P.N.,
2) Put a controlled training was done area to assure the
the respective work
copies binder in the person to person without packaging instructions
instruction are
railroad spur shipping using the work and the label color code
completed regarding
area to assure the instruction (CA-WI- are available to
the packaging
packaging instructions 0240 / 4, Empaque y personnel in the area.
conditions, such as,
and the label color code Etiquetado - (Customer service and
heat treated wooden
are available to Componentes Clientes shipping coordinator,
pallet, cardboard box,
personnel in the area. internos Dana). 09/08/2016).
number of strips and
(Customer service and
labels._x000D_
shipping coordinator, Outdated work The purpose to have the
09/07/2016). instruction. labels colors code is to
The purpose to have the Because the work interpret customer
labels colors code is to instruction was not destination , We put a
interpret customer updated on time information folder in site.
x

destination , We put a (annually) and the new Labels are generated in

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 All production lines were Why Ocurred? 1) develop an action Replicate the approved
swept and 31 plan* to include all the action plan as
equipments were found W1. It was not effective equipments that appropriate to other
without MSA from 5000. in the case of MSA currently dont have MSA Dana production sites.
(08/28/2016, Quality studies to no replicable studies, in the gagetrak When: 14/10/2016
Coordinator Manuel Neri equipments. program (MSA following Responsable: Floyd
/Quality Engineering W2. No studies to no up). McNiece, Specialist
Manuel Pia/ Thecnician replicable equipments "the studies will be Technical - Supplier
Metrology Alejandro were done. performed according to Quality,
Mandujano) W3. They were not the chapter IV manual
contemplated in the MSA"
It was provided a annual program of MSA * Activities to be
refreshment training by studies developed:
the quality manager W4. The section of No Verify that all the
about the requeriments replicable tests (Chapter equipments recorded in
Load Cell CODE CEXT- of the clause 7.6.1 to the 4, MSA) was not being the Control Plan have
001-31 in Line 2 Ford: next positions: Quality applied. MSA studies.
The system for the
assembly used for the Engineer, Manufacturing W5. Non replicable Verify that all the
7.6.1

MSA studies are not

5

destructive testing, Engineer, Gages equipments were equipments recorded in

effective.
was not showed the Technicians and controlled by an external the Control Plan
MSA study Metrology Technicians, calibration. uploaded in the
with the objective, they Gagetrak.
know, understand and Why not detected? Include all the
apply the MSA studies W1. It wAas not listed equipment wish have a
effectively. into the annual plan of calibration or msa date
08/30/16 Quality MSA studies. expired in the Gagetrk
Coordinator Manuel Neri W2. The annual plan program tracking.
/Quality Engineering considered only the 09/09/16
Manuel Pia/ Thecnician replicable equipments. Quality Coordinator
Metrology Alejandro W3. A calibration was Manuel Neri /Quality
Mandujano used to validate the No Engineering Manuel
replicable equipment. Pia/ Thecnician
It was obtained W4. The necesary Metrology Alejandro
counseling by Engineer elements to make MSA Mandujano
Francisco Hernandez, studies to No replicable
Metrolab's consultant, equipments were not 2) Updating our work
x

according to 4th edition considered at th e instruction WIQUA00008

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 The course of analysis Was made the three 1. Develop plan to Replicate the approved
and problem solving was legged 5 whys with include in Cpro job action plan as
implemented for the the collaboration of profiles to reinforce appropriate to other
supervisor producccion Cardanes' Quality staff, compliance and Dana production sites.
When. 06/09/2016 Personnel Development document control When: 14/10/2016
Responsable: R. Specialist and QMS permits modification and Responsable: Floyd
AndradePersonal Engineer, identifying the approval to have the job McNiece, Specialist
Development l root causes: evaluation by direct Technical - Supplier
/F.Torres Production head having the Quality,
Cordinator) Why made? validation and objectivity
The Job position for
in the review to identify
the production
Include in the annual 1. There is no evidence discrepancies in current
supervisor from Nissan
training program 2016 in for the production profiles.
Line requires the
the course of analysis supervisor course of When. 30/09/2016
course of the solving
and problem solving analysis and problem Responsable: L.
problems. However
production supervisors solving Campos Organizational
during the last
to comply with this 2.Because at the time Development / R.
In specific the training detection done in
competition. of the training program Andrade Personal
6.2.2

necessities detection January 2016 was not

6

When. 06/09/2016 the DNC was omitted DEvelopment /J.

system is not effective. identified this course
Responsable: from the production area Briones HRBP)
for this position. Other
Coordinadores de "
5 positions were
produccion (F.Torres / 3.Because the job 2. Up to Cpro job
checked and found
A.Gutierrez/ Gregorio description is not descriptions adding
that all positions were
Sanchez / M.Cordero consider for the those responsible for
identified the courses
/R.Ocampo) R.Andrade realization of the DNC review and validation
according of their job
Personal Development 4.Because the job (Head, manager and
positions.
description production staff ranks)
Request managers area supervisor was not When. 30/09/2016
(quality, manufacturing, validated by the Responsable: L.
production, HR, corresponding area Campos Organizational
comptroller general 5.Because there is no Development / R.
management, plan for verification of Andrade Personal
maintenance) through the job description. Development /J.
an email by the Head of Briones HRBP)
HR the review of the
DNC made to identify Why was not detected? 3. Generate an internal
x

courses that were not 1.The training plan and audit process for

Dates and time limits: Agreed date:

for major nonconformities: submission of the action plan to the Leadauditor until latest 9/7/2016

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