Omnex 2018 Navigator Newsletter

Omnex • 315 E. Eisenhower Pkwy, Suite 214 • Ann Arbor, MI 48108 • USA • 734.761.4940 • info@omnex.com
Rough Transition to IATF 16949
The Final Draft International Standard (FDIS) for ISO 45001,
formerly OHSAS 18001, has been approved. It is time to
start planning on implementing ISO 45001 if you are already
OHSAS 18001 certified. Additionally, in October 2017, the IATF
published Sanctioned Interpretations 1-9 for IATF 16949. These
interpretations were based on common misunderstandings of of
IATF 16949 leading to non-conformances. Learn more on page 2.
Aerospace Standards Update
New OHS – ISO Standard is Finally Approved &
An Update to IATF 16949
Globally, there are over 68,000 organizations certified to
ISO/TS 16949:2009 that will need to undergo a transition audit to
IATF 16949:2016. As of April 2017, 181 of these audits have been
completed this year, resulting in an average of 5.3 nonconformities
and nearly one major nonconformity (0.73) per audit. There is a lot
wecananalyzeandlearnfromtheseaudits.Whatareasarereceiving
nonconformities? Learnmoreonpage3.
As with 75% of the automotive supply base, spreadsheets and
silo client-server applications with lack of standardization was
hindering the global growth objectives of this customer.
TheirgoalwastolocateaglobalpartnerwhounderstandsAPQP
andcanimplementasingle-windowsoftwaresolutionforallthe
APQP / PPAP documentation and also provide implementation
and training services worldwide. This problem’s solution must
beeasy-to-use,easy-to-configure,centrallycontrolled,andhave
the ability to be shared across all their facilities worldwide. Read
more on the solution in the case study on Page 7.
by Chad Kymal by Chad Kymal
by Omnex Systems
See full article on pg 6 CONTINUED on pg 7
See full article on pg 2 Continued on pg 3
2018
Visibility On “APQP/PPAP Documentation”
Update to ISO 45001 & IATF 16949
Rough Transition to IATF 16949
OMNEX NEWS: New innovation Assessment,
Magna Award and more…
PAGE 3
PAGE 9
PAGE 2
PAGE 7
PAGE 6
Omnex attended the IAQG meeting in October to provide an
update on the following Aerospace standards, see page 6:
AS9100D Quality Systems – Aerospace – Model for Quality
AssuranceinDesign,Development,Production,Installationand
Servicing, AS9110C Quality Maintenance Systems – Aerospace
Requirements for Maintenance Organizations, AS9120B –
Quality Management Systems Aerospace Requirements for
Stockist Distributors, AS9145 Aerospace Series Requirements
for Advanced Product Quality Planning and Production Part
Approval Process.
Reduce New Product Development Lead Times
Case Study From A Major Tier 1 Supplier
by Roland Kelly
IATF 16949, Automotive SPICE, ISO 17025:2017,
AIAG/VDA FMEA & E-Learning Training Courses
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Update on ISO 45001
The ISO 45001 FDIS was released in
November2017andachievedapproval
as the new ISO Occupational Health &
Safety Management System Standard
in January 2018. The US TAG had
overwhelmingly voted in favor of the
DIS2 when they met in September
2017. Many European members of
ISO/PC 283 had a few more issues and
some were philosophically against the
standard in the first place.
If you recall the history of the ISO
45001 or OHSAS 18001, it was voted
down twice by the ISO body. This
effort to make it a DIS and an FDIS was
also fraught with issues. For those of
you who attended Omnex’s webinar
“Update to Status of New Standards,”
you may recall that the ILO had a turf
war with ISO over who is responsible
for Health and Safety standards. It is
now good to know that these issues
are behind us. The DIS was then voted
down and the DIS2 took some time to
make it out of committees. The DIS2
meetings in the US TAG in September
were thorough and very democratic.
Multiplekeyissueswereboileddownto
threeshowstopperswhichwecovered
in our webinar “ISO 45001 (Former
OHSAS 18001) Released as a Final
Draft International Standard (FDIS),”
write us for access to the recording at
webinars@omnex.com
Not only was the DIS2 for ISO 45001
voted on quite positively by the ISO/
PC TAG 283, but the FDIS was also
accepted with a large majority. After
theDIS2wasaccepted,therewereonly
two options for the FDIS, you either
accept it as is or you vote it down. The
US TAG accepted it as is with editorial
comments. There is a general feeling
thatthisisagoodstandardandwillhelp
organizationsimplementandtransition
from the OHSAS 18001 to ISO 45001.
It is also felt that due to the high level
structure,thestandardwillattractmany
newentrants.TheISO45001standard
isexpectedtobecomeanInternational
Standard in March 2018.
It is time to start planning on
implementing ISO 45001 if you are
already OHSAS 18001 certified. If
you are ISO 9001 certified or have
implemented a derivative standard
like AS9100, IATF 16949, and/or ISO
14001, write Omnex to find out why
ISO45001maybethestandardforyou.
Update on IATF 16949
ThetransitiontoIATF16949wasreported
in September 2017 as 5% completed.
The Ford IATF members commented
that as per their calculations, there
were just enough resources for IATF
16949 if all went well. The top minor
and major nonconformities resulting
from181auditscanbeseeninFigure1.
There are an average of 5.44 non-
conformances and .78 majors found
in each audit. Registrars do not seem
to be shy about giving multiple majors
to organizations that they feel are not
deserving of IATF 16949. Omnex has
performed several gap analyses for
some of these organizations that have
failed their initial IATF 16949 audits.
In October 2017, the IATF published
SanctionedInterpretations1-9forIATF
16949. These interpretations were
basedoncommonmisunderstandings
of suppliers that resulting in minor or
even major nonconformities. One of
the key areas is Customer Specific
Requirements.
All Omnex customers who we
have helped either via training or
implementation are getting certified.
Not only are we working with many
customers who are systematically
working on getting certified, we are
also working with a few who have
failed their initial IATF transition audit
and approached Omnex for help and
support.
PleasecontactOmnexforawebinaron
the latest information on IATF 16949
includingSanctionedInterpretationsor
a free audit tool for those conducting
gap analysis or internal audits.
Figure 1:
Update to ISO 45001 & IATF 16949
Clause No.
And Name
Number
of NC
Percentage
of Total NC
Cumulative %
of Total NC
8.5.1.5 Total
Productive
Maintenance
48 4.9 4.90%
8.5.1.1
Control Plan
38 3.9 8.80%
6.1.2.3
Contingency
Plans
37 3.8 12.60%
8.5.1 Control of
Production and
Service Provision
26 2.7 15.30%
7.2.3 Internal
Auditor
Competency
23 2.4 17.60%
8.3.5.2
Manufacturing
Process Design
Output
23 2.4 20.00%
8.5.1.2
Standardized
Work- Operator
Instructions and
Visual Standards
23 2.4 22.40%
8.5.1.3
Verification of
Job Set-ups
23 2.4 24.70%
8.5.1.6
Management
of Production
Tooling and
Manufacturing,
Test, Inspection
Tooling and
Equipment
20 2.1 26.80%
7.1.5.1.1
Measurement
Systems Analysis
19 1.9 28.70%

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Rough Transition to IATF 16949 3rd Party Audit Findings, Conclusions, and Recommendations
(continued from page 1)
What surprises lie in these
nonconformities? What are 3rd party
auditors finding/not finding? The list
of nonconformities can be used as
a preventive measure to ensure key
registrarnonconformitiesareaddressed
before your transition audit. Omnex
has performed a large number of gap
analysis audits for our customers and
will compare our findings to the list of
registrar nonconformities. What were
Omnex’s top findings? How many of
themstillremain?Whyarecompanies
still receiving major nonconformities
for“AuditorCompetencies”and“CSRs”
when that was one of the top findings
inOmnex’sgapanalyses?Thesearejust
some of the questions we will explore.
TOP FIVE NONCONFORMITIES
The top five nonconformities overall
are “Total Productive Maintenance”
(48),“ControlPlan”(38),“Contingency
Plans” (37), “Control of Production
Service Provision” (26), and “Internal
AuditorCompetency”(23).See Figure1
Thetwobiggestsurprisesshowninthis
list are Total Productive Maintenance
(TPM) and Control of Production and
Service Provision. The requirements
for Total Productive Maintenance
(8.5.1.5 of IATF 16949) have increased
significantlyfromthoseofISO/TS16949.
We can infer that when organizations
are implementing IATF 16949, they
have so much to update in other
areas that maintenance is not getting
the attention it needs. Despite the
many additional requirements found
in IATF 16949, the 3rd Party auditors
are not overlooking the expanded
requirements for Total Productive
Maintenance. Total Productive
Maintenance has also made it to the
top five list of major nonconformities,
showing that it is indeed an area
that needs the attention of the IATF
16949 implementation champion.
Similarly, Control of Production
and Service Provision (8.5.1 of IATF
16949) has requirements for “special
processes” and “implementation
of actions to prevent human error.”
Control of Production and Service
Provision is showing the fourth most
nonconformitiesofallareasinIATF16949.
Based on the IAOB data, the top five
major nonconformities are Customer-
Specific Requirements (CSRs) (7),
Internal Auditor Competency (7),
Quality Management System Audit
(7), Total Productive Maintenance
(6), and Management Review Inputs
(6). Omnex gap analyses are also
finding major nonconformities in
CSRs, Internal Auditor Competency,
Quality Management System Audits
and Management Review Inputs.
Management Review Inputs have
not changed drastically enough
in IATF 16949 to be resulting in
so many major nonconformities.
Omnex gap analyses have found
many of the majors are the result
of a variety of issues with the ISO/
TS 16949 management reviews.
Top 5 - Total Non-Conformance Clauses
Clause No. And Name
Number of Non
Conformances
Percentage of
Total Non
Conformances
Cummulative
Percentage of
Total Non
Conformances
8.5.1.5 Total Productive
Maintenance
48 4.9 4.9
8.5.1.1 Control Plan 38 3.9 8.8
6.1.2.3 Contingency Plans 37 3.8 12.6
8.5.1 Control of Production and
Service Provision
26 2.7 15.3
7.2.3 Internal Auditor Competency 23 2.4 17.6
Figure 1
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T h e i s s u e s i nvo l ve d i n t h e
n o n c o n f o r m i t i e s a n d t h e
implementationoftheserequirements
in a manner that reduces the risk of
being issued a nonconformity have
been discussed in many of our IATF
16949 webinars available at Omnex.
com. These webinars also cover many
key preventive issues, in addition to
other issues that have not yet been
added to the list of 3rd party auditor
nonconformities. Omnex’s goal is to
provide professional insights to assist
youinachievingasuccessfulIATF16949
implementationinyourorganization.If
youhaveanyquestionsonhow Omnex
canhelpyourorganziationwithyourIATF
transition,writeusatinfo@omnex.com
Chad Kymal is the CTO and founder of
Omnex Inc., an international consulting
and training organization headquartered
intheUnitedStates.Aftergraduatingfrom
theGeneralMotorsInstitute,Chadspenta
numberofyearsworkingatGeneralMotors
and KPMG before founding Omnex Inc. in
1986.OverthecourseofChad’ssuccessful
career, he has served on the Malcolm
Baldrige Board of Examiners and has
received numerous quality achievement
awards,includingtheQualityProfessionalof
theYearawardbytheAmericanSocietyfor
Quality(ASQ)AutomotiveDivisionin2005.
In addition to his bachelor’s degree from
GMI, Chad holds both a master’s degree
in industrial and operations engineering
from the University of Michigan and an
MBA Cum Laude from the University of
Michigan. He is a member of Tau Beta Pi.
Chad both developed and teaches auditor
trainingforISO9001,ISO14001,andOHSAS
18001/ISO45001,aswellasanIntegrated
Management Systems Lead Auditor
training course where all three standards
are combined in a single audit. Chad is the
founder of AQSR, a global registrar that
routinely provided integrated audits in
QMS,EMS,andOHSMS.Chadisalsoonthe
ISO/TC176,ISO/TC207,PC283committees
forISO9001:2015(QualityManagement),
ISO 14001:2015 (Environmental
Management) and ISO 45001 (Health
and Safety Management Systems.
OmnexhasbeenworkingintheAutomotive
industryfor30yearsandOmnexprincipals
beenactiveinwritingdifferentautomotive
standards including QS 9000, ISO/TS
16949,SemiconductorSupplement,APQP,
FMEA and Core Tools. Chad conducted
the first world-wide witness audit for
QS 9000 a predecessor to IATF 16949.
He is the author of seven books and
more than 100 papers including several
on integrated management systems.
Chad is currently working on books for ISO
14001 and IATF 16949.
Rough Transition to IATF 16949 3rd Party Audit Findings, Conclusions, and Recommendations
(continued from page 3)
Figure 2
Top 5 - Major Non Conformance Clauses
Clause No. And Name
Number of Non
Conformances
Majors
Majors
%
Cumulative
Majors %
4.3.2 Customer-Specific Requirements 24.5 7.0 5.3 5.3
7.2.3 Internal Auditor Competency 38 7.0 5.3 10.5
6.1.2.3 Contingency Plans 37 7.0 5.3 15.8
8.5.1 Control of Production and
Service Provision
26 6.0 4.5 20.3
7.2.3 Internal Auditor Competency 23 6.0 4.5 24.8

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Continued from page 1
AS9100D Quality Systems – Aerospace –
Model for Quality Assurance in Design,
Development, Production, Installation
and Servicing
This revised version of the Aerospace
Quality Management System
encompasses ISO 9001:2015 and adds
specific QMS requirements for aerospace
and defense industries (approx. 105
additional requirements).
Major changes in these revisions are
listed below:
AS9100D is based on the ISO 9001:2015
standard, therefore it follows the Annex
SL high level structure.
• New clauses are taken from ISO 9001 –
context of the organization, interested
parties, risk based thinking, top
management involvement
• Annexes from ISO 9001:2015 remain,
but AS9100D have added notes to help
clarify them
• ISO 9001:2015 doesn’t mandate a
quality manual, but AS9100D suggests
that a manual may be a prudent
document to maintain
• Several new clauses added or enhanced
including
o Product safety
o Prevention of counterfeit
parts
o Human factors
o Configuration management
o Management representative
requirement (yes they have
added it back in)
• The number of “shalls” has increased
from 53 to 66
• While Preventive Action has been
formally removed, the emphasis on risk
based thinking adequately replaces and
enhances it.
When comparing AS9100C and
AS9100D, the changes in the additional
aerospace requirements are not that
significant, the biggest change is in the
base ISO 9001:2015 standard. Improved
integration with other business activities,
enhancement of the process approach
and PDCA cycle, greater involvement of
top management in QMS monitoring
are the primary benefits of the ISO
9001:2015 changes.
Note: Interestingly, if you have both ISO
9001 and AS9100D certification, if you
move your ISO 9001 system over to the
2015 revision you may run the risk of not
fulfilling the requirements of AS9100C.
AS9110C Quality Maintenance
Systems – Aerospace Requirements for
Maintenance Organizations
AS9110C defines the quality system
requirements and offers additional
comprehensive requirements/criteria for
overhaul facilities and the maintenance
repair for the aircraft industry at all levels
of the MRO (Maintenance, Repair &
Overhaul) process.
• It is tailored for organizations with
national airworthiness authority
(NAA) repair station certification, but
is also suitable for non-certificated
organizations including those that
provide maintenance, repair, and
overhaul services for military aviation
products. Companies whose primary
business is providing maintenance,
repair, and overhaul services for aviation
sector products should comply with this
standard.
•
It is also intended to be used by
organizations with maintenance, repair,
and overhaul operations that operate
autonomously, or that are substantially
different from their manufacturing
operations.
• PAMA members (Professional Aviation
Maintenance Association)
• FAA 145 certified repair stations
• Companies seeking Parts Manufacturing
Approval (PMA) from the FAA to
manufacture aircraft parts and
components
AS9120B – Quality Management
Systems Aerospace Requirements for
Stockist Distributors
AS9120B defines the quality system
requirements and offers additional
comprehensive requirements/criteria for
stockists and distributors for the aircraft
industry at all levels
Following a similar format to AS9100D
andAS9110Cin10clauses,thesignificant
additional requirements include
• Emphasis on product safety and
unapproved parts, updated controls on
counterfeit parts
• Awarenessofcontributiontocompliance
and product safety
• Control of product obsolescence
• Prevention of use of counterfeit parts at
all steps
• Process to validate test reports for raw
materials when associated risks are
identified
• Product identification and traceability
for splitting of lots
• Emphasis on performance indicator
review during Internal Audits
• Consideration to human factors in non-
conformity resolution and correction/
corrective action.
AS9145 Aerospace Series Requirements
for Advanced Product Quality Planning
and Production Part Approval Process
AS9145 establishes requirements for
performing and documenting APQP
and PPAP. APQP begins with conceptual
product needs and extends through
product definition, production planning,
product and process validation (i.e.,
PPAP), product use, and post-delivery
service. This standard integrates and
collaborates with the requirements
of the AS9100, AS9102, AS9103, and
AS9110 standards.
This standard was created to
• Define the aviation, space, and defense
process requirements for Advanced
Product Quality Planning (APQP) and
ProductionPartApprovalProcess(PPAP).
• Detail a methodology to ensure that
the product development processes
deployed throughout the aviation,
space, and defense industries are fully
integrated phased processes that extend
from concept and design through
manufacturing process planning and
execution and that it is extended to
product use, service, and customer
feedback.
• Ensure PPAP documentation produced
by the APQP process is adequate to
prove that the production process has
demonstrated the potential to produce
products that consistently fulfill all
requirements at the customer demand
rate.
SAE manages these standards which are
regulated by the IAQG (International
Aerospace Quality Group).
www.sae.org/iaqg/

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CUSTOMER PROFILE:
A leading Tier 1 Automotive Supplier
for Lighting/Visibility Solutions
INDUSTRY: Automotive
LOCATION: Headquarters in France,
with 155 global sites.
EMPLOYEES:Approximately 91,000+
The Customer:
A leading Tier-1 Automotive Supplier
focusedonVisibilitySolutionsandpart-
neredwithallmajorOEMs.Thissupplier
operates in 32 countries and has 155
production facilities across the globe
withmultiplebusinessunits,including
thermal & powertrain solutions.
The Problem:
As with 75% of the automotive supply
base,spreadsheetsandsiloclient-serv-
erapplicationswithlackofstandardiza-
tion was hindering the global growth
objectives of this customer.
Theirgoalwastolocateaglobalpartner
whounderstandsAPQPandcanimple-
mentasingle-windowsoftwaresolution
for all the APQP / PPAP documenta-
tion and also provide implementation
and training services worldwide. This
problem’ssolutionmustbeeasy-to-use,
easy-to-configure,centrallycontrolled,
andhavetheabilitytobesharedacross
all their facilities worldwide.
The Solution:
Aftercarefullyevaluatingthemanyso-
lutionsinthemarket,thisclientchose
Omnexashavingthemostqualifiedand
comprehensivesolution.Omnexbegan
the partnership in 2012 with a pilot
project at one of their largest Design
& Development centers in Spain. The
Omnex APQP / PPAP Documentation
solution, which is part of our Enter-
prise APQP Suite, was a perfect fit for
this.TheOmnexconceptofdeveloping
Design&Processdocumentsaslibraries
andgroupingthemasFamily-Partswas
met with great relief for the Engineer-
ing&Processteams.Thesoftwarewas
implemented and utilized for 2 years
beforelargergoalsweretobereached.
Being a market leader in Visibility So-
lutions, APQP / PPAP documentation
was not only a mere document for
our customer but was the life line of
NewProductDevelopment.Inorderto
retain market leadership, they raised
the bar for APQP / PPAP Documenta-
tion so high that our out-of-the-box
solutionneededcustomizationforthe
enhanced performance.
Asalways,Omnexwasreadyforthese
challenges. Customer Leadership
Team, Omnex Subject Matter Experts
&ProductDevelopmentTeamsjoined
together to create an innovative solu-
tion that was tailored to fit customer
needs.ProjectKick-Offcommittedboth
Technical&ITresourcesfromboththe
customer & Omnex. Our weekly and
monthly Project Review meetings as-
sisted in tracking & monitoring the
Design&Developmentofthesolution.
Omnex’sunderlyingplatformwasvery
flexibleandgenericenoughtoallowthe
scaling up of customer requirements.
Thecustomizedsolutionwasdeveloped
in less than 5 months and made avail-
able for business users in 2016.
TheOmneximplementation&roll-out
journey started in the Winter of 2016.
Omnexglobalpresencegreatlyassisted
inthesoftwareimplementationinmany
countriesincludingEurope,theAmeri-
cas, Asia and more.
This software is now being used in all
major Development Centers across
the globe.
The Benefits:
• 65% reduction in New Product
Launch Lead time using existing
Design & Process Libraries.
• 30%reductioninreuseofinforma-
tion between Family-Parts.
• 35% savings on tracking and con-
trolling Special Characteristics.
• 30%savingsinStandardizationand
Change Management.
• 20% reduction in Communication
ManagementonInformationAvail-
ability & Accessibility.
• 50%savingsinKnowledgeManage-
ment across the Enterprise.
Focus On “APQP/PPAP Documentation”
Continued from page 1
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N E W S F R O M O M N E X A R O U N D T H E W O R L D
US NEWS
• In December, Omnex held an annual
internal training session at their Ann
Arbor Headquarters. More than 50
consultants, auditors and sales team
members attended these sessions
covering IATF 16949, AS9100, AIAG
VDA FMEA and much more.
•
•
• OmnexreleasednewExemplarcertified
E-Learning+Classroomseriestoreduce
theamountofclassroomtrainingtime
in everyone’s busy schedules
• Omnex released IATF 16949 Supplier
Auditor and Manufacturing Process
Auditor in response to requirements
in IATF 16949
• To correlate with the OEM Customer
SpecificRequirements,Omnexreleased
training for:
• CQI 9: Heat Treat System Asmnt.
• CQI 11: Plating System Asmnt.
• CQI 12: Coating System Asmnt.
• CQI14:UnderstandWarrantyMgmt.
• CQI 15: Welding System Asmnt.
• CQI 17: Soldering System Asmnt.
• CQI 19: Subtier Supplier Mgmt.
• CQI 23: Molding System Asmnt.
• More new and updated trainings
available from Omnex:
• IATF 16949 E-Learning
• AS9100D E-Learning
• AIAG VDA Process FMEA
• AIAG VDA Product FMEA
• ISO 17025:2017
• ISO 45001:2018
• FSSC 22000
• AS9145
• In October, Omnex attended and was
an exhibitor at the IAQG Meeting in
Cleveland, Ohio.
• InSeptember,OmnexCTO,ChadKymal
attendedtheAIAGQualitySummitheld
in Novi, Michigan.
• Other events Omnex participated in
recently include:
• Quality 4.0 Summit
• FSSC 22000 Harmonization
Conference
• IMDS & Product Chemical
Compliance Conference
• AAQG / G-14 AAQSC Meetings
• TAG 176 Quality Management
Meetings
• TAG 207 Environmental Mgmt
Meetings
• TAG 283 OH&S Mgmt Meetings
OMNEX CHINA NEWS
In July, Omnex Wuhan provided IATF 16949
training for numerous well-known automotive
suppliers.Thefactoriesoftheenterprisesunder
this training are world-class in manufacturing
and standardized production.
The instructor was a senior instructor with
Omnexwithover10yearsofforeignenterprise
managementexperience.Healsopossessesrich
experience in management regarding HRM,
enterprise integrated management and can
connect the course closely with customers’
practical problems.
There were 70 automotive suppliers that
participated in this training. After class, the
students’ feedback indicated that Omnex’s
training was informative, professional, and
provided personal experiences to solve their
automotive problems.
Omnex Guangzhou provided CQI-9, CQI-11,
andCQI-12trainingforworld-classmicromotor
enterprisesonMarch6th-9th.Thefacilitiesthat
received this training are engaged in electric
machine,automotivecomponents,mechanical
equipment, instruments and hardware
manufacturing.Theyareallnew andhigh-tech
facilitiesspecializedinmanufacturingandselling
micro motors.
TheOmnexinstructorforthistraininghasover
20yearsofrichexperienceinon-siteoperations.
Hehaspracticalexperienceinheatingtreatment,
coating, and welding special technology and is
knowledgeable of special technology quality
and process management. He has successfully
trainedandassistedmanywell-knownEuropean
and American manufacturing customers and
builtcontrolmanagementsystemstomeettheir
special requirements in CQI.
Intheclass,theinstructorusedAIAGmethods
and tools to help improve electroplating, heat
treatment,paintingspraysystem,andhelpthe
enterpriserecognizeandfulfillcustomers’special
requirements.
OnSeptember18th-19thOmnexprovidedISO/
IEC17025laboratorystandardsunderstanding
and practical standards for a nuclear power
company in Huizhou.
Thiscoursefocusedontheapprovedlaboratory
validation, measuring and testing standards;
building the laboratory QS to meet ISO/
IEC 17025, and how to provide third party
independent audit in laboratory capability.
The instructor for this training was a senior
trainer in Omnex, who is responsible for Six
Sigma GB/BB promotion in manufacturing in
Europe and America, has worked in quality
control and program management for over 16
years,andhasrichexperienceinmanagement,
trainingandconsultinginvehiclemanagement,
component manufacturing.

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OMNEX EUROPE NEWS
• Omnex has been able to help Suzlon
to update its 9001 management
system in Germany to the latest
revision in 2015. From gap analysis
to implementation assistance and
international harmonization, a cross-
functional team analyzed and setup
activities to improve the Suzlon BOS
• OMNEX helped Magna in Germany,
Hungary, Italy and Bulgaria with
technical trainings to roll out their
APQP initiative in Europe. To achieve
thisgoalthemethodsFMEA,MSA,SPC,
PPAP, GD&T and Blueprint Reading
were trained
• OMNEX has helped ZF TRW to
successfully complete its IATF
16949:2016 recertification. Services
were provided from GAP analysis to
theidentificationofcorrectiveactions
• We are pleased to announce that the
medical technology sector is being
expanded. The first open training
course for lead auditors according to
ISO 13485 will be offered at the end
of November. In the first quarter of
2018,newcoursesinriskmanagement
and usability engineering will be
implemented.Thesecomplementthe
range of products and services for the
medical technology market, which is
very present in and around Berlin
OMNEX INDIA NEWS
• Assisted over 52 organizations
currently in their implementation of
IATF 16949:2016
• Completedtrainingformorethan5000
people on IATF 16949 tools
•
Completed more than 122 Lean Six
Sigma projects for clients in 2017
• EightcompanieshaveselectedOmnex
astheirtrainingpartnerforalltraining
workshops
• PresentedattheQAConferenceofTata
Steel on Managing Non-Conforming
Products and Services
•
Omnex worked with three leading
manufacturers of automotive wheels
in their pursuit to Business Systems
certification on ISO 9001 and ISO
14001. We are working with them on
a project to improve Design concepts
and Manufacturability
•
Working with leading Truck
Manufacturers to improve employee
capability on Quality Systems, Core
Tools and Supply chain
•
Completed14implementationprojects
for various clients in India
•
Omnex wins the Contract for QMS
Strengthening from Maharashtra
Pollution Control Board (MPCB)
•
Completed training of over 300
Engineers of a leading Truck
Manufacturer
•
Omnex has completed training
for AS9100 for several premier
Government Defense and Space
companies
• LeadingUSAutomotiveOEMworkswith
Omnex for Design for Manufacturing
and Assembly for new programs
OmnexreceivedMagnaCosmaappreciation
award for implementing Manufacturing
Excellence program
OMNEX MIDDLE EAST NEWS
• Omnex Middle East completes Lead
Auditor workshop on Lead Auditing
ISO 17025, Lead Auditor for AS9100
and IATF 16949
• Morethan180peoplehavesuccessfully
completedtheirimprovementtraining
programs with Omnex
• Kick starts 5 IATF 16949 consulting
programs in Middle East
• Working with a leading company on
theirqualityimprovementassessments
• SuccessfullycompletedamajorLSSdrive
for1majorOil/NaturalGascompanies,
one in Kuwait and one in Dubai
ContinuingthetrendofpromotingQualityand
Business Excellence culture in the Middle East
region,Mr.AndrewWeichmann,Mr.Ravikumar
and Mrs. Aysha Habeeb of the Omnex Dubai
Office have completed the UAE Innovation
AwardAssessorTrainingthatwasdevelopedasa
collaborationbetweenDubaiQualityGroupand
Dr.KasimKanakriofTeamPowerInternational.
As part of the team of assessors for the first
cycle of this prestigious award, Omnex has
positioned itself as a leader in the region
for understanding and recognizing the best
practicesoforganizationsthathavesuccessfully
implemented a systematic process for driving
continual innovation, and will cooperate with
Team Power International to provide further
trainings on the concept of innovation in the
future. We are proud to be associated with
Dubai Quality Group for this endeavor, and
we look forward to being a part of the UAE’s
continuing strategy of supporting innovative
organizations in the Middle East region.
OMNEX THAILAND NEWS
• OmnexThailandkickstartstheEnterprise
Quality Software implementation
programs for Abatech and Delta
Electronics
• SuccessfullycompletedEWQIMSproject
forPandoraJewelryandkickstartsthe
implementation for plant 2
• Omnex Thailand has completed
training more than 200 people on CQI
workshops, 26 participants for Lead
Auditor IATF 16949.
• Completedtrainingfor morethan900
people on IATF 16949
• Completed CQI pgm requirements for
Delta Electronics
• Leading American Automotive
OEM contracts Omnex for supplier
development programs
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Aerospace and Defense
AS9100D Internal Auditor Training
(Exemplar Global-certified training provider)
AS9100D Lead Auditor Training
Understanding and Documenting
AS9100D Quality Management
Systems
AS9110C Internal Auditor Training
AS9110C Lead Auditor Training
AS9110C Quality Management
Systems
AS9120B Internal Auditor Training
AS9120B Lead Auditor Training
AS9120B Quality Management
Systems
AS9115A Internal Auditor Training
AS9115A Lead Auditor Training
AS9115A Quality Management
Systems
Understanding AS9145 — APQP
and PPAP for Aviation, Space and
Defense Organization
Aerospace Product
Realization (APQP
& PPAP) Risk
Management Series
Understanding AS9145-APQP
and PPAP for Aviation, Space and
Defense Organizations
Design Tools Including SFMEA /
DFMEA and Associated Tools
Process Tools Including Process
Flow, PFMEA, Control Plans and
Work Instructions
Risk Assessment, Characteristics
Designation and Flow Down
Team Leader Facilitation
Setting Up for Process Capability
and MSA
Planning and Conducting the
Enhanced FAI (Production Trial
Run)
Reviewing the Enhanced FAI
Statistical Process Control (SPC)
Capability Analysis and Advanced
SPC
Automotive &
Production/Manuf.
Core Tools
Core Tools Understanding (APQP
& PPAP, DFMEA & DVP&R, PFMEA
& Control Plan, SPC, MSA)
AIAG VDA Process FMEA Overview
AIAG VDA Product FMEA
Overview
CQI
Understanding Heat Treat System
Assessments (CQI-9)
Understanding Plating System
Assessments (CQI-11)
Understanding Coating System
Understanding Warranty
Management (CQI-14)
Understanding Welding System
Understanding Soldering System
Understanding AIAG Sub-tier
Supplier Management (CQI-19)
Understanding Molding System
VDA 6.3
Understanding VDA 6.3
Conducting Process Audits to VDA
6.3
Food Industry
Quality Standards
FSSC 22000 Internal Auditor
Training
(FSSC 22000 Licensed Training Organization)
FSSC 22000 Lead Auditor Training
(FSSC 22000 Licensed Training Organization)
FSSC 22000
Energy Management
(ISO 50001)
ISO 50001:2011 Internal Auditor
Training
ISO 50001:2011 Lead Auditor
Training
ISO 50001:2011
Environmental
Management
(ISO 14001) Series
ISO 14001:2015 Transition Training
Training
Training
ISO 14001:2015
Automotive SPICE
Understanding Automotive SPICE
and Integration with ISO 26262
and IATF 16949
Conducting Internal and Supplier
(Second Party) Audits to
Automotive SPICE
ISO 26262 for
Functional Safety
Understanding ISO 26262
ISO 26262 Executive Overview
2018
OMNEX
OMNEX 2015
2018
NORTH AMERICA TRAINING COURSES
visit omnex.com/training to access our full training schedule

navigator
ISO 9001:2015
ISO 9001:2015 Transition Training
Training for Manufacturing or
Service.
Training for Manufacturing or
Service
ISO 9001:2015
Risk and Implementing Risk
Strategies for ISO Management
Systems
BOS: Aligning Objectives – Risk in
Planning including Context and
Interested Party Expectations
ISO 13485:2016
Medical Devices
ISO 13485:2016 Role of Top
Management
Transitioning to ISO 13485:2016
Training
Training
ISO 13485:2016
IATF 16949:2016
IATF 16949 Executive Overview
IATF 16949 Transition Training
IATF 16949:2016 Manufacturing
Process Auditor Training for
Automotive Quality Management
Systems
IATF 16949:2016 Product Auditor
Training for Automotive Quality
Management Systems
IATF 16949:2016 Second Party
(Supplier Auditor) Training for
Automotive Quality Management
Systems
IATF 16949:2016 Internal Auditor
Training for the Automotive
Quality Management Systems
IATF 16949:2016 Lead Auditor
Training for the Automotive
Quality Management Systems
IATF 16949:2016
Understanding, Documenting and
Implementing IATF 16949:2016
ISO 45001
OHSAS 18001:2007 Internal
Auditor Training
OHSAS 18001:2007 Lead Auditor
Training
OHSAS 18001:2007 Understanding
and Documenting
Teams and Problem
Solving Series
Effective Problem Solving
Problem Solving - Employing the
8S Methodology
R&D Series
Design for Manufacturing and
Assembly
Design of Experiments (DOE)
Geometric Dimensioning &
Tolerence(GD&T) - Blueprint
Reading
Geometric Dimensioning and
Tolerancing (GD&T) Fundamentals
Tolerance Stack-Up Analysis
(GD&T Application)
Geometric Dimensioning &
Tolerence(GD&T) Gage Design
E-Learning +
Classroom Training
ISO 9001:2015
ISO 14001:2015
Public Training
Locations
OMNEX USA
Ann Arbor, MI
Huntsville, AL
Seattle, WA
Chicago, IL
Greenville, SC
Houston, TX
Irvine, CA
Minneapolis, MN
Nashville, TN
Los Angeles, CA
San Jose, CA
CANADA
Mississauga, ON
MEXICO
Mexico City, MX
2018
OMNEX
OMNEX 2015
2018
visit omnex.com/training to access our full training schedule
11

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Who in the world is OMNEX?
ISO 9001 & IATF 16949 | AS9100D | ISO 26262 | ISO 14001 | ISO 45001
ISO 50001 | FSSC 22000 | ISO 13485 | APQP | Risk Management | Lean Enterprise
Our global clients will tell you. We’ve implemented
management systems for many of the world’s top companies.
OMNEX INC
Global Headquarters
315 E. Eisenhower Parkway
Suite 214, Ann Arbor, MI 48108, USA
Phone: (734) 761-4940
Fax: (734) 761-4966
Email: info@omnex.com
Web: www.omnex.com
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