OHSAS 45001 DOES NOT MOVE FORWARD PAGE 2 ISO 9001 AND ISO ... · ohsas 45001 does not move forward iso 9001 and iso 14001 move from dis to fdis page 2 ... iso 9001 and iso 14001 move

Omnex • 325 E. Eisenhower Pkwy, Suite 4 • Ann Arbor, MI 48108 • USA • 734.761.4940 • [email protected]

Enterprise Quality Software

back to their core competencies. Globalization has brought a new level of complexity for every organization. Requirements are constantly changing for existing standards, such as CQI-19, VDA 6.3, and ISO 9001:2015. Companies are outsourcing auditing, inspection, FMEA facilitation, PPAP/FAI reviews and Supply Chain management.

A severe shortage in the supply of engineers and the increased complexity in advanced technology will require organizations like Plantech Omnex to provide much needed engineering talent.

PlanTech Inc., a Division of Omnex, Inc., recently revamped its service offerings. These changes originate from customer demands and market trends, indicating a desire for organizations to get

ISO 45001 Does Not Move ForwardISO 9001 and ISO 14001 mOve frOm dIS tO fdIS

Connected Center of Excellence 40% of Fortune 500 companies are forecasted to go out of business due to disruptive technology

WINTER

OHSAS 45001 DOES NOT MOVE FORWARDISO 9001 AND ISO 14001 MOVE FROM DIS TO FDIS

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VALUE STREAM MAPPING WITH THEORY OF CONSTRAINTS YIELD IMMEDIATE RESULTS – CASE STUDY

ENABLING HAPTICS FOR TECHNICAL TRAINING

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NEWS FROM OMNEX AROUND THE WORLD PAGE 8

2015

PLANTECH-OMNEX REVAMPS SERVICE OFFERINGS PAGE 5

conventional industry sectors and service delivery on its ear.Since its rise into the mainstream during the 1990s, the Internet (of Things) has revolutionized how business is conducted, and in the near future Disruptive Technologies will impact all of us in new and very profound ways.

by Chad Kymal and R. Dan Reid

PlanTech Omnex

EwIMS links customers and supplier problems to an FMEA database. The software allows an organization to manage its entire supply base’s PPAPs/FAIs. “Many New Features such as Inspection Control, Layered Process Audits, Linkage between problem solving and FMEA and much more..”

This year gets bigger and better with Omnex Systems, the award-winning leader in Enterprise Quality and Integrated Management Systems Software, announcing the release of the 4.x Series. The Service Pack 4 Series includes a variety of product improvements.

Japan, Canada and a few other Western Countries. The ISO/TC 176 can consider moving the DIS to an IS and bypassing the FDIS, thus bringing out the standard earlier than planned. The ISO 9001:2015 DIS represented major changes and includes some significant value adds by incorporating the “Needs and Expectations of Interested Parties” and the “Context” of the business in setting goals and objectives.

The ISO 9001:2015 passed the vote to proceed from a DIS to an FDIS in October, 2014. The votes were 79% in favor with dissenting votes from the US,

There is a convergence of advanced technology called Disruptive Technologies that is imminent and promises to turn traditional manufacturing principles,

by Bill Mitchell, Director PlanTech-Omnex Services Enterprise Quality

Connected Center of Excellence COnTinuED On Pg 2 SEE full aRTiClE On Pg 6

SEE full aRTiClE On Pg 5 SEE full aRTiClE On Pg 11

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The biggest changes may be the inclusion of risk throughout the standard.

A SUMMARY OF THE MAJOR CHANGES ARE INCLUDED BELOW:

•4.1UnderstandingtheOrganizationandits Context – new

•4.2 understanding the needs and ExpectationsofInterestedParties-New

•4.3 Scope - removal of exclusions

•5.1 leadership and its Commitment - tying together quality policy and objectives with strategic direction and context of organization

•6.1 actions to address Risks and Opportunities - running change and additionofriskinmultiplelocations

•6.2 Quality Objectives and Planning to AchieveThem-Clarifications

•7.1.4EnvironmentfortheOperationofProcesses (and not work environment) - Clarifications

•6.3 Planning of Changes and 8.5.6 Control of Changes - new Manage the Change Process

•7.1.6OrganizationalKnowledge-New

•7.5DocumentedInformation-New

•8.1 Operational Control - removal of statisticaltechniques

•8.3 Design and Development of Products and Services - removal of sub clauses Design VerificationandDesignValidation

•RemovalofPreventiveAction

HIGH LEVEL STRUCTURE CHANGE (HLS):

i S O 9 0 0 1 : 2 0 1 5 , i S O 1 4 0 0 1 : 2 0 1 5 a n d iSO 45001:2016 and al l new or revised management system standards going forward will consist of the same 10 Clauses as shown below. This HlS change in the standards will help organizations implement integrated Management Systems more easily.

1. Scope

2.NormativeReferences

3.TermsandDefinitions

4.ContextoftheOrganization

5. leadership

6. Planning

7. Support

8.OperationalPlanningandControl

9.PerformanceEvaluation

10. improvement

This mandated structure also has common text that must be used with some of these elements. Newelements,suchascontextoftheorganization,and new terms, such as “documented informa-tion,”“innovation,”“risk-basedthinking,”“contextoftheorganization,”“organizationalknowledge,”and“contingencyactions”willlikelydrivetheneedforadditionalprocessesandtrainingformanycur-rently-certifiedorganizations.Otherrequirementsalready common across the key MSSs have been deleted,suchasamanagementrepresentative,anMSSmanual,preventiveactionand“exclusions”.

ISO 14001 - ENVIRONMENTAL MANAGEMENT SYSTEM (EMS) REQUIREMENTS:

iSO 14001 was also reviewed and is being revised atthistime.ItisalsotargetedforreleasenextJuly.The number of clauses in the new iSO 14001:2015 will increase from four to the 10 mandated by annex Sl. The length will also increase considerably from the2004edition,e.g.DraftInternationalStandard(DiS) increased from 23 to 35 pages.

The biggest change reflected in iSO 14001 is the new environmental context represented by climate change and carbon reduction. This changeisevidentinthesectioncalledBackgroundwheretheTC2017identifiesthethreereasons why EMS is required:

•Balance between three pi l lars of environmental, social and economic (triplebottomline)

•Meet the needs of the present without compromising the ability of the future generations(definitionofsustainabilityby the Bructland commission)

•Societal expectations for sustainable development, transparency, and accountability have evolved … management ofwaste,climatechange,degradationofeco-systems and bio diversity

Theinclusionofenvironmentalprotectionisnotbeing mandated but is requested in the Environ-mentalPolicyalongwithPollutionPrevention.

There currently is not an element in iSO 14001 for top management, but there will be in the revision. The revision will also include a requirement for value chain control - whether goods are procured fromanoutsidesupplieroraffiliatedlocation.Thecontextoftheorganizationisnewforallcurrentmanagement system standards including iSO 14001.TherearealsoimplicationsforISO14001-related standards, such as OHSaS 18001/anSi Z10, Responsible Care 14001.9

Other changes in iSO 14001 includes new terminologysuchas“EnvironmentalPerformance”in many places in the standard and lifecycle Thinking(6.1.2SignificantEnvironmentalAspectsand8.1OperationalPlanningandControl).Itisclear that iSO 14001 is maturing and asking for performance in the management system and also using current lifecycle thinking in decision making. lifecycle thinkinglooksattheentirelifecycleofaproductfrom start to end of life including its eventual decommission and disposal.

OHSAS 18001 / ISO 45001 - OCCUPATIONAL HEALTH & SAFETY MANAGEMENT SYSTEM REQUIREMENTS

InMarchof2013,theBritishStandardsInstitution(BSI)submittedaproposalforanewinternationalstandard that would specify requirements for an Occupational Health and Safety (OH&S) Management System. according to the proposal,thestandardwoulddefinerequirementsfor an OH&S System, with the goal of providing


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organizationswithincreasedcontroloverOH&Srisks and providing for improved performance in this area. The standard would not establish specificperformancecriteriaforOH&SnorprovidedetailedspecificationsforthedesignofanOH&S management system. it is expected that the standardwouldbeapplicabletoanyorganizationseeking to establish, maintain, or improve an OH&S management system. it would not address product safety, environmental impacts, or other health and safety-related subjects.

iSO/Project Committee (PC) number 283 was establishedinJune2013bytheISOTechnicalManagement Board to develop this standard. iSO has advised that the future standard will be iSO 45001 as the number 18001 has already beenassignedtoadifferentstandard.Someofthe key issues the PC has to resolve within the standardconcern:theapplicationof“risk”;“people”underthecontrolofthemanagementsystem;the understandingofwhatconstitutesthe“workplace”;participationinthesettingofpoliciesandobjectives. ACommitteeDraft(CD)wasreleasedinJulyofthis year with iSO member body comments due in October.Omnexsaidinourlastreview“Thedraftreflectstheimmaturitytypicalofafirstdraft.Itisrather wordy and has a lot of requirements that will not be easy to audit. it is likely that there willbeseveralmoredraftspriortorelease.”The last CD was voted down with 64% Yes and 36% no, and as such, the revision will move to CD 2 before going to a DiS standard. The target

release date stays the same at October 2016. The new iSO 9001, iSO 14001 and iSO 45001 are scheduled for release soon. iSO 9001 could be released as soon as March 2015 if the TC 176 elects not to do an fDiS. The iSO 14001 willbecomingout inJuly2015.Withthesechanges coming, organizations would do well to prepare for integrated management systems.

What Can we do Now?Omnex suggests that organizations ready themselves for implementing integrated Management Systems that allow them to integrate all three standards. Omnex defines integrationasa)integratedprocesses,b)integratedrisk and c) integrated audits. note: Mr. Chad Kymal, Mr. Dan Reid and Mr. gregory gruska’s book on integrated Management Systems is planned for releaseinfirstquarter2015.

The most important part of an integrated management system is the process map of the organization.ThisiswhereintegrationofQMS,

EMS and OHSMS takes place. Companies should review their process map and ensure that it truly reflectstheorganization.

Thesecondrecommendationisfororganizationsto examine and adopt Enterprise Management SystemssuchasOmnex’sEwIMSsoftware.Thisis the right time to implement portions of an Enterprise Management System standard such as documentmanagement.WerecommendfivemodulesandfunctionalitiesinanEnterpriseIntegrated ManagementSystemSoftware:

1. Document Management for integrated Processes

2. Risk Management for integrated Risk

3. audit Management for integrated audits

4. CorrectiveActionforIntegratedProblemSolving

5. PerformanceManagementSoftwareforNeedsandExpectationsandIntegratedPerformance Management

The changes to iSO 9001, iSO 14001, and iSO 45001 represent some of the biggest changes and opportunitiesofthenextdecade.ThecommonHlS change combined with the needs and expecta-tions,context,andobjectivesettingineachofthetopics of Quality, Environmental, and Health and Safety represent major change and opportunity for integrated Management Sytems (iMS). Companies adoptingabusinessmanagementandtechnologyapproachwillbenefitthemostfromthesechanges.

R. Dan Reid is director of consulting at Omnex Engineering and Management in Ann Arbor,

MI. He is the first delegation leader of the International Automotive Task Force, an

author of ISO Technical Specification 16949, QS-9000/QSA, ISO 9001:2000, the first ISO International Workshop Agreement, and its replacement, Automotive Industry Action Group’s Business Operating Systems for

Healthcare Organizations (HF-2). Reid is an ASQ fellow and certified quality engineer.

Only ISO 45001 Does Not Move Forward. ISO 9001 and ISO 14001 Move from DIS to FDIS COnTInuED FROM pAGE 2

www.omnex.com/about/news/10th-annual-fmea-forum-in-osnabrueck-omnex-inc.aspx

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Operational Excellence or Business Excellence initiatives like Six Sigma have been extensively used to reduce the cost and hence improve profitability. Similarly, excellence initiatives like lean Manufacturing have been used to reduce inventory and hence working capital. These tools, thoughefficientandeffective,arenotaguaranteedfixforthemanyissuesfacedbyclients.

at Omnex, we cater to these types of projects as our StrategicImprovementconsultingvertical,Typicallyover a period of 18-26 weeks, we help companies notjustdiagnose,butalsodesignanactionplan.The tools and techniques used vary from case to case andareusedinaseriesofinterventionsthatresultinultimatelymeetingthedefinedgoal.Ofcourse,

someoftheprojectsexecutedareoflongerdurationand have a capability-building module designed to enabletheorganization’scross-functionalteamtotaketheinitiativesfurtherandimproveperformance.

Inthecasestudypresentedbelow,acombinationof lean Value Stream Mapping (VSM) and Theory of Constraints (TOC) were used to improve the Return on Capital Employed (ROCE) by increasing the productivity of assets and avoiding capital expenditure.

Client: a large chemical processing company. in the chemical industry that is highly capital-intensive, one repeatedly hears - “these initiatives are for part manufacturing industries and not for chemical processes,”todesignanddevelopcapabilitytoensureproject success was a big challenge.

The company was making chemicals used for adhesiveapplications.Themanufacturingwasabatch process with 3 steps - Reaction, Blending, Packingandused2vessels-oneforreactionandanother for blending and packing.

The setup was producing one batch per day (Cycle time24hrs)ofeightdifferentchemicalformulations.ThecalculationofTaktTimeshowedthatjustforthisproductfamily,acycletimeofapprox16hrswas required. The company was taking losses and hadnocapitaltosetupadditionalfacility.(TaktTimeistheavailableproductiontimedividedbycustomer demand).

A CAREFUL EVALUATION OF “CURRENT VA L U E S T R E A M ” Y I E L D E D T H E FOLLOWING OBSERVATIONS FOR THE REACTION VESSEL.

On the other hand while the blending itself took only 4 hrs, the vessel was occupied with charging and cleaningfor2-3hrs.Itwasinterestingtonotethatthe packaging itself took 12 hrs as the chemical was pouredintobarrelsrestingonaloadcell.Duringthistime,theblendingvesselwasoccupiedandcreateda blockage for the next batch to be taken.

WiththesupportoftheCOO,theopportunityforimprovementwasmadecleartotheentireteam.The“BusinessValueAdded”activityofpackingwasholdingupthe“CustomerValueAdded”activityofreaction.AtacostofUS$100andatimeframeofjust two days, a manifold was created to allow two barrelstobefilledsimultaneouslyandthepackingtimewasreducedfrom12to6hrs.

By taking waste out of charging, discharging and cleaningtimes,thecyclecouldnowbecompletedin16hrs.Furtherprojectswereinitiatedtostabilizequality. SMED principles were used to further reduce cleaningtimetobringthecycletimedownto12hrs.

Value Stream Mapping with Theory of Constraints Yield Immediate Results - Case Study

1. The standard reaction time for the product family varied from 6-8 hrs for different products and 8-12 hrs from batchtobatch.Thisincludedthetimetaken for quality checks and adjustments.

2. in addition to the reaction time, the reaction vessel was occupied for an additional4hrsduringchargingofrawmaterials and discharging of product.

3. Anadditional8hrswasbeingusedforcleaning of the vessel while changing the product chemistry. a large part of this timewasspentwaitingfortherequiredauthorizationsandpermitsbothbeforeandafterthecleaning.Nobodyseemedto mind this as the vessel was already waiting for the blending vessel to be emptied.

4. Ineffectthecycletimewas18-22hrsandto maintain an even planning cycle, the productionplanwastochargeonceaday.

What is noteworthy is that structured thinking using excellence tools avoided a cost of a few thousand dollars, improving the return on capital. All this in a matter of two weeks and at a cost of $100. Now that is Excellence!

To learn more about Omnex strategy consulting projects and how we can be of help to your company, contact: [email protected]

World over, the financial community is increasingly getting inclined to measure the Economic Value Added (EVA). EVA is the profit earned by the enterprise minus the cost of financing the firm's capital. (EVA = Net Operating Profit after Tax - Cost of Capital). The idea is that value is created when the return on the firm's economic capital employed is greater than the cost of that capital. In effect, EVA can be improved by increasing profitability or by reducing cost of capital.

- The author is Nitin Dixit, Director - Strategy Projects, Asia.

EVA = Operating Profit - (Weighted Averagecost of capital X Capital Employed)


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APPLICATION OF HAPTIC TECHNOLOGY:

Untilrecently,theuseofHapticshasbeenlimitedtoafewapplicationsinthemedical,mobiletelephoneand gaming industries. ammachi labs is one of the pioneersindevelopingHapticapplicationsimulatorsfor other uses including milling, drilling, and plumbing using a device called aPTa. in fact, it was applied in order to to train female plumbers in a social developmentprogramthatreceivedUNattention.

WiththesuccessofAPTA,OmnexandAmmachilabs are working to apply it to a wide variety of applications.Anyapplicationthatincludestrainingwhere the equipment or the work product or tool usage is cost-prohibitive, such as die making or welding,aregoodapplicationsforHaptics.Hapticscan also be used in jobs where worker safety or

safety of others can be compromised during training.

AgoodcasestudyofaHaptic-enabledapplicationisacurrentprojectwhereHapticsisbeingusedinalargeConstructioncompanyfortrainingandcertifyingtrainees. The cost of the materials and the learning timearethereasonswhyHapticswereused.Barbending, plumbing, carpentry, welding, and masonry aresomeofthetradeswherethisapplicationhasbeen deployed.

a great use of aPTa is in community colleges where students are being trained. The cost of the product is about half the cost of a milling or drilling machine, but it can be used for a half dozen applications such as milling, drilling, machining, plumbing and other trades.

Enabling Haptics for Technical Training

PlanTech-Omnex Revamps Service Offerings

PlanTech inc., a Division of Omnex, inc., recently revampeditsserviceofferings.Thesechangesoriginated from customer demands and market trends,indicatingadesirefororganizationstogetbacktotheircorecompetencies.Globalizationhas brought a new level of complexity for every organization. Requirements are constantly changing for existing standards, such as CQi-19, VDa 6.3, and iSO 9001:2015.

Companies are outsourcing auditing, inspection, FMEA facilitation, PPAP/FAI reviews and Supply Chain management. A severe shortage in the supply of engineers and the increased complexity in advanced technology will require organizations like Plantech Omnex to provide much needed engineering talent.

Through outsourcing non-core processes such as Quality, Supplier Management, and aPQP/FMEAtospecialistslikePlanTech,organizationshave the opportunity to reduce cost, while improving their Projects, Products, and

Performance. Withourglobalpresence,PlanTech-Omnex has the ability to support youroperationsonagloballevel.Ourextensiveoperationsinhigh-opportunitylabormarketslike india, SE asia, and China, have opened up a whole new avenue for companies to achieve a competitive advantage. By utilizing this approach,organizationsareabletosignificantlyreducecostsandatthesametimeguaranteeasupply of talented engineers.

PLANTECH-OMNEX SERVICES:

AuditingServicesSelection:

• internal audits

• integrated internal audits

•VDa 6.3 Phase audits

Supplier Services:

•global Sourcing

•Supplier Development

•Supplier assessments

global Sourcing Services:

•PPaP/fai Support and/or Package Reviews

•aPQP Support

•Resident Engineers

•Electrical Engineers

•fQE

•SQE

•fMEa Support

•Program Managers

419-252-0004

[email protected]

To discuss how PlanTech-Omnex can assist yourorganization,pleasecontact:

Bill Mitchell, Director, PlanTech-Omnex Services

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There is a convergence of advanced technology calledDisruptiveTechnologiesthatisimminentandpromisestoturntraditionalmanufacturingprinciples,conventionalindustrysectorsandservicedeliveryon its ear.

Since its rise into the mainstream during the 1990s,theInternet(ofThings)hasrevolutionizedhow business is conducted, and in the near future DisruptiveTechnologieswillimpactallofusinnewand very profound ways.

Today the internet of Things is interwoven with everybusiness,servicesector,productapplicationand device produced for the marketplace, and is promising to replace 40 percent of today’s fortune 500 firms with companies called Exponential Organizations(ExOs),accordingtoDr.JanuszBryzek,President and CEO of the TSensors Summit, inc.

JustastheInternetofThingswillbewhollyintegratedinto our homes, our social lives, our schools, our factories and our economies, manufacturing and service centers in the future will adopt these advancedtechnologiesgivingthemasubstantialcompetitiveedge.

Omnex describes these centers as Connected Center of Excellence (CCoE). The Connected Center will use Smart Tags and Smart Scheduling to plan and trace

productflow.Workcenterswillbeautomatedandproduct will flow with automatic measurement and source inspection of product and process characteristics. The entire process is designed to prevent defects, self-test and self-check key parameters using intelligent process monitoring methods and smart sensors. RfiD, mobile communications, and intelligent Processing will be the norm for tomorrow’s Connected Center of Excellence.

The CCoE will employ visual electronic andon displays thatrevolutionizehowmanufacturingisplannedandultimatelycontrolled.Processandproductdata(BIGData)isautomaticallygatheredandrecorded(analyzed and reported) thereby reducing non-value added tasks for operators.

IntheCCoE,optimizationoftheworkflowtakesplace at the site level and enterprise level, between all the sites involved in product or service delivery.

INNOVATION AND THE CONCEPT OF ZERO

The responsibility for the design of CCoE rests with senior leadership. Staked value streams, management systems, methodologies and best practices need to be implemented including

integrated Management Systems that seek conformance to quality, environmental, health and safety, sustainability and social standards.

leadership must ensure that the CCoE embraces the cultureofZeroorperfectionwhichwerepresentwith the 10 Zeros in figure 2.

The CCoE incorporates lean Six Sigma methodology

with Enterprise Stacked Value Streams as shown

in figure 3. The CCoE design and planning start

early, up to two years before breaking ground on a

greenfieldsite.Whetherthesiteisagreenfieldoran

existingone,theproductdesign,manufacturing

process design, and human factors are key

considerationsiftheCCoEistobeasuccessfulone.

SUMMARY

There will be new organizations that grow rapidly (Exponential Organizations) and today’s giants will become tomorrow’s failures. large and small organizations need to be flexible and adapt. in many ways, when technologies change, large organizations are especially handicapped with their present technology and market success and are not able to adopt the new technologies as highlighted by Clayton M.

Connected Center of Excellence Exciting changes related to Disruptive Technologies, the Internet of Things (IoT), Smart tag traceability (RFID), and analytics of Big Data.

Seven Concepts for the CCOE

1

2

3

5

6

7

4

Connected Supply Chain Management

Cradle to Cradle product traceability

with RFID

Smart scheduling for operations

and Flow

Integrated machines and advanced

robotic work centers

Virtual Factory monitoring and flow

optimization

Intelligent Process Monitoring

and Analytics

Enterprise optimization with Big Data

Industrial Ethernet

!

6 Intelligent Process

Monitoring QC Analytics

7Enterprise

Optimizationwith Big

(process) Data

3 & 5 Smart Scheduling

and VFMO

4Integerated Machines

&Advanced Robotics

1 & 2 Connected Supply

Chain Management using RFID


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Christensen in his book, the “innovator’s Dilemma - WhenNewTechnologiesCauseGreatFirmstoFail”.

ProductandservicedeliverywilldramaticallychangewithDisruptiveTechnologies.However,technologywill fail if it is built on products and processes that arepoorlydesigned,defective,withhighdowntime,oraworkflowthatispoorlyplannedandimproperlylaid out.

The Connected Center of Excellence needs an innovativenewproductlaunchprocessconnectedto the social network using rapid prototyping and virtual factory design that is able to introduce products in just a few months rather than years. This is the second piece of the puzzle that Omnex is trying to solve.

Wewould like to invite people to join our linkedin groups Connected Center of Excellence andProductLaunch15XReduction.Ifyouhaveaninterest in this area or have something to contribute in any of the technologies please join us.

POSTSCRIPT CREATING INTEGRATED VALUE (CIV)

a select group of experienced consultants are working withCTOChadKymalinputtingtogetherOmnex’svision for the factory of the future (Connected Center of Excellence).

IntheCCoE,processesandmachineswillbefittedwithadvancediagnosticstoallowtheorganizationto take processes off line when preventive maintenance is planned. Modular machining cells

or assembly work centers can immediately go inline to take their place.

Zero PPM, Zero accidents and Zero Missed CustomerCommitmentsarenotenough;thisCCoEgoes further by fully embracing net Zero Energy, ZeroCarbon,ZeroWater,ZeroWaste,ZeroHumanRights, Zero labor infringements, and Zero Corruption metricsfortoday’sWorldClassFactory.

The concept of Zero is being heralded by Omnex’s CIVmethodology(createdbyWayneVisser,Directorof Sustainability and Chad Kymal, CTO).

TheFactoryoftheFuturewillembracetheCreatingintegrated Value methodology that ushers in Corporate Responsibility (CR) and Sustainability(S) withintheorganization.Aswehavementioned,Corporate Responsibility and Sustainability are key components of the new Quality System.

WorldClassCompaniesandCCoEswilladoptCIVand the Zero Concept.

Download the paper on CiV by Dr.WayneVisser and Chad Kymal at: www.omnex.com/docs/civ

Zero Defects

Zero Accidents

Zero Missed Customer

Commitments

Zero Energy

Zero Carbon

Zero Water

zero Waste

Zero Human

Rights Violations

Zero Labor

Infringements

Zero Corruption

Figure 2

2.0 RiskAssessment &

Mitigation

6.0 Internal Audit & Management

Review

1.0 StakeholderMateriality Analysis

CREATING INTEGRATED VALUEThe CIV Implementation Framework

3.1 Governance &strategic planning

3.2 Product/servicedevelopment

3.3 Product/servicedelivery

3.4 Supply chainmanagement

3.5 Customer chainmanagement

3.6 Other CriticalProcesses

Copyright © 2014 Wayne Visser & Chad Kymal

3.0 Critical ProcessIdentification

4.0 Innovation & Value Creation

5.0 Business Process Transformation

figure 3 – CiV framework

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US NEWS

•Omnex has signed global Training agreements with lear, gKn and Key Safety Systems.

•Omnexhasbeenconductingtrainingfor a number of major aerospace organizations.

•a standing factory of the future group is researching methodologies and technologies that factories of the future will employ, including methods to incorporate mobility, the internet of Things, and big data into this vision. for moreinformation,seethearticleonpage6inthisnewsletter.

•a number of training courses including integrated Risk, interested Party and SettingObjectivesandISO9001:2015are in the planning stages for the launch of the updated iSO 9001 standard. Omnexhasrevampedtheentireline-upofitscorecoursesfromInternalAuditingtoAPQPandisupdatingitglobally.

•Omnex is working with genzyme to implement iSO 50001 into their five uS sites.

•O m n e x c o m p l e t e d t h e P h a s e i i m p l e m e n t a t i o n p lan and i s in the process of implementinganIntgratedManagement SystemintoSmartrac’sglobalfacilities. Smartrac, a global RfiD leader, will integrate and standardize their QMS, EMS, and OHSMS management systems. They will implement customer focused key measurablesintheirExecutivemanage- mentreviews,includingimplementing fMEas for new product development.

CHAD’S VISIT TO CHINA

Chad Kymal (CTO), Michael Xu (Country Manager China),andJudyFei(OperationsDirectorChina)visitedOmnex’smainofficeinShanghaiandthebranchofficesinWuhan,Guanzhou,andChengdu. in each of the offices Chad Kymal

conducted training on the Omnex 2020 plan.Omnex conducted training on “Changes to iSO 9001,ISO14001andOHSAS18001”inWuhan,guangzhou and Chengdu with over 400 students from300companiesattendingtheseminars.

CHENGDU OFFICE

•Omnex China established its fourth Office-OmnexChengdu.

•OmnexChinalaunchedtheApplicationSeminar of product reliability method for the manufacturing industry.

•Omnex Wuhan s u c c e s s f u l l yimplemented a period of two days of “TotalProductiveMaintenance”trainingfor an auto parts company.

•OmnexWuhansuccessfullyheldthreedays of “advanced Product Quality Planning”trainingforalargesteelenterpriseWuhanSteelMillsinChina.

•Omnex Shanghai held two days of “american / European geometric Dimensioning and Tolerancing (gD&T) advancedtraining”forthelargestcommercial aircraft manufacturer (COMaC) in China.

CHENGDU GOVERNMENT OFFICE

On friday, Oct 23, the management team visited aChinesegovernmentofficeinChengduthatmanages local area business and met Director

Mr.XieCunliangandGeneralManagerJackJi (featured below on the steps of the government office).Mr.XieCunliangmanagesastaffof300who provide business licenses, insurance and otheramenitiestobusinesses.Asanenterprisingsenior manager, he takes great pride in leading the quality improvement activities of the

bureau. He gave us a two hour tour of the improvementactivitiestheyhaveconductedincluding iSO 9001 certification, customer satisfactionsurveys,centralizationofforms,and many other improvements. He has been selectedbyBeijingasamodelofficeforothersin China to emulate.

OmnexconsultantVivianWuhasbeenworking with them for the last two years as well. She is going to be helping them next year with further improvementactivitiesincludingupgradingtheirISO9001certification.

OMNEX SHANGHAI OFFICEThe last stop of the trip was on Oct. 26th at the OmnexShanghaioffice.Thisoffice,whichwas established 15 years ago, has grown over

Left – (from left to right) Mr Arun Kumar, Vp of Omnex Asia, Michael Xu, General Manager of Omnex China, Chad Kymal, CTO, Omnex Inc. and Bill Zhang, General Manager of Omnex Wuhan

October 24, OMnEX CTO Mr. Chad Kymal and management team to the Wuhou administrative approval office visit.

Chad Kymal and Michael Xu with Mr. Xie Cunliang, the Director of the Bureau in Chengdu


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20%inthelastfiveyearsfromitsoriginalsize.featured in the picture are consultants and administrativestaff.

OMNEX ACADEMY NEWS

•Omnex academy completed 2014 withafifthbatchofCertifiedQualityProfessional (CQP) programs for fresh graduate engineers from over a dozen Engineering colleges.

•Asanewinitiative,OmnexAcademyconducted training workshops on CQP atKochi,Kerala,inassociationwiththeKeralaInstituteforEntrepreneurshipDevelopment (KiED). KiED is an autonomous institute under the industries Department, government of Kerala.

•Underthenewbusinessverticals,OmnexAcademyhasbegunimplementinganddeveloping new e-learning courses.

•Omnex academy announced the new R2RE (Raw to Ready Engineer) coursemodulesincollaborationwithIndustryleadersfromtheAutomotivea n d M a n u fa c t u r i n g i n d u st r y. Courses commence Jan 2015 for the following :

- Certified Quality Engineers (CQE) for Quality functions. - Certified production Engineers (CpE – II) for production engineering functions.

- Certified production Engineers (CpE – I) for production functions. - Certified Maintenance Engineers (CME) for Maintenance functions.

OMNEX INDIA NEWS

•Omnex india conducted more than 500 training and/or workshop programs in 2014.

- More than 12,000 people have been trained in India this year.

- Omnex Bangalore office completes 2nd batch of AS9100 Lead Auditor program.

- Completes training of more than 750 Sup- plier Quality Engineers of TATA Motors on customized SQE qualification curriculum.

- Continues work with Force Motors for the third successive year for the Competency Development program for employees. More than 150 employees are being trained and developed every month.

- Working with SETCO Automotive on the Employee Competency Development program covering 1000 employees.

- For fourth successive year, MATE group has selected Omnex as their training partner for various training programs across all the plants of mate in india.

- Chrysler Automotive India, JSW completed Lead Auditor Training on ISO/TS 16949:2009 for employees with Omnex.

- Continues customized FORD SQE training and qualification for FORD India in Chennai and ford Sanand.

- Michelin selects Omnex for project Management training workshops.

- Magna takes Six Sigma Green Belt, Design FMEA training & implementation and GD&T.

- Other clients include Epcos Bawal, Kalyani and nasik plants, Daebu Automotive Seat India, Turbo Energy, GATES unita, etc... - Omnex completes the implementation for more than 50 dealerships of Skoda Automotive.

- Omnex pune office successfully completes Quality Management System and Safety

Management systems implementation across all labs of Maharashtra pollution Control Board. - TATA STEEL signs up with Omnex for implementation of Quality Management System based on ISO/TS16949.

- Steel Strips Wheels Limited - Chennai plant signs up with Omnex for training and implementation of TpM.

- Vishay precision starts their quest for Lean Manufacturing and Operational Excellence with Omnex.

- HVCC Chennai starts Operational Excellence Implementation with Omnex. This is the third factory of HVCC that Omnex is assisting with OpEX implementation.

- Visteon India starts Lean systems implementation for Green Field site with Omnex.

- Omnex assists Dutch Lady/ Friesland Campina Malaysia in completing all the Lean Six Sigma projects taken for Business Excellence in 2014.

•D a i m l e r i n d i a a d o p t s O m n ex EwIMSSoftware.

•Omnex was invited to speak during the VOlVO Bus Supplier conference in December 2014. arun Kumar, Director andVPforAsiaPacificspoketoaround100participantsonimportanceofnewproduct development process and PPaP during the event. Omnex has been working closely with VOlVO group for many years now inAsiaPacificregion.

Arun Kumar, Director and Vp for Asia pacific

In the front row second from left is Lynn Lin Training Manager, Andy Yu, GD&T Consultant, Mr. Michael Xu, Chad Kymal, Gregory Gruska, Senior Omnex uS Consultant and distinguished member of the writing commit-tees that created the MSA, SpC, and FMEA AIAG Standards, Judy Fei and Wilson Gu

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navigatorN 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 DN 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

OMNEX THAILAND

•Omnex Thailand successfully completes SMED implementation project for Visteon Thailand.

•Omnex Thailand extends training assistance for fORD THailanD on SQE Qualification.

•TRWThailandjoinshandswithOQAThailand for their training requirements.

•Thai Summit signs up with Omnex for CustomerSpectificworkshopsforFord.More than 100 training days have been completed thus far.

OMNEX MIDDLE EAST/ GCC

•O m n ex s i g n s p a c t w i t h E ra m InternationaltosetupajointventureinSaudiArabia.TheAl-KhobarofficewillbetheGCCHeadquarters.Withover15employeesstationedinSaudi,Qatar, Kuwait and Bahrain, the Eram-Omnex venture has already bagged a fewprestigiousprojects.

•Omnex has started a 3 year lean Six Sigma transformation program with Kuwait Oil Company, Kuwait.

•Omnex Dubai works with EPPCO in SixSigmaimplementationprocessforBusiness Excellence.

•OmnexDubaicompletesthecertificationproject at noor islamic Bank, Dubai.

•Omnex Dubai launches iSO 50001 workshops under the auspicious of Dubai Quality group.

•Omnex Dubai completes food Safety improvement program for Barakat Quality Plus, a leading juice producer in uaE.

•Omnex Dubai conducts iSO 9001:2008 lead auditor training for Ethihad Rail.

•Dunes Oman completes integrated Management Systems workshop with Omnex.

•nBTC Kuwait signs Omnex for training workshops.

•King abdul aziz city for Sciences & Technology (KaCST), Riyadh, signs training workshops with Omnex.

LEAD AUDITOR WORKSHOP FOR KACST

Omnex Saudi Conducted lead auditor workshops for King abdulaziz City for Science and Technology, Saudi arabia for their PV lab & Solar Manufacturing unit.

www.omnexsystems.com


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ThisyeargetsbiggerandbetterwithOmnexSystems, the award-winning leader in Enterprise Quality and integrated Management Systems Software, announcing the release of the 4.x Series. The Service Pack 4 Series includes a variety of product improvements.

EwiMS links customers and supplier problems toanFMEAdatabase.Thesoftwareallowsanorganizationtomanageitsentiresupplybase’sPPaPs/fais.

HIGHLIGHTS:

8DandFMEALinkagesimplified:

You definitely know fMEa and 8D are complementary tools. now we made it more simple and seamless for you to share “data collectedandbrainstormed”duringan8DProcess into the fMEa for future new Product/Process Quality.

Initiatean8DfromyourFMEAifyouarenotsure of the root causes.

in all these linkages you don’t just update the fMEa but you also determine if these failures and causes are part of the family/Sub-families/Parts.

APQP/PPAP PROJECT PLANS & APQP DOCUMENT LINKAGES:

SetupyourentireAPQP/PPAPProjectPlanwithaPQP document templates, procedures, work instructions,checklistsandguidelinedocuments.Create live links to Process flows, D/P fMEa and Control Plans and other documents in our AquaProsoftware.Templatizewithallapprovalroutes and transform the lessons learned from one launch to all the future Product launches.

APQP /PPAP PROJECT PLANS & SUPPLIERS:

Suppliers can now be linked to your aPQP/PPaP Project Plans. Bring in your Tier 1 and Tier 2 suppliers as part of your aPQP /PPaP Project Management.Definethedeliverablesforthesesuppliers and allow the system to manage the aPQP/PPaP Project for you.

AEROSPACE DOCUMENTS IN AQUA PRO :

aqua Pro is now not just PPaP-Compliant but also fai-Compliant. all fai forms are now available in aqua Pro.

Document Viewer:

it can get quite challenging to look for the aPQP/PPaP document deliverables through yourWBSProjectstructure.Wemadeiteasierwith a document viewer interface, including an interface to list only the deliverables that have documentattachmentswithAdvanceSearchCapabilities.

ABILITY TO CATCH REPEAT PROBLEMS:

Tim O’Reilly, founder of O’Reilly Media said “We’reenteringanewworldinwhichdatamaybemoreimportantthanthesoftware.”WesimplifiedyourConcernManagementtotrackrepeatproblems.Thesoftwareautomatically

Enterprise Quality Sizzles with EwIMS Quality Springs

Modules with Major Enhancements in SP 4.x SeriesModules with Major Enhancements in SP 4.x Series

Aqua Pro Document Pro APQP PPAP Manager Problem Solver Audit Pro

Aqua Pro Document Pro APQP PPAP Manager Problem Solver Audit Pro

Concerns/Problems

8D FMEA

Update your FMEA automatically after completing the 8D (or other problem solving tool) for one part, series of parts or the entire part family

8DFMEA

FailuresCausesRecommended Actions

Failures

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navigatorrunsanOrganization-widesearch,processesand serves you with similar problems and lets your concerns tie with the existing 8Ds.

INTEGRATED MANAGEMENT SYSTEMS:

Jugglingmultiplestandardsisnotaseasyasit initially appears. Duplicated Documents, ImplementationCosts,andInternalandExternalaudit Costs will drain resources and dollars within the Enterprise. Omnex integrated Management System provides both a methodology and softwaretocomplementIMSimplementation.Thesoftwareprovidesanintegratedapproachfor managing documentation for a variey of standards,integratingauditsandintegratingorganizationRiskManagement.

•Document Pro allows you to manage multiple management systems sharing common documents between management systems and sites. a technique important enough for an applied patent.

•OmnexAQuAProhelpsorganizationsconduct integrated risk analysis in multiple formats sharing risk and mitigation tools between Quality, Environmental and Health and Safety.

NESTED 8D:are you sandwiched between your Customers and Suppliers in Problem Solving? is it challenging to manage your Suppliers to resolve your internal problems?Weheardyoushout“YES”!ThishasbeenoneofthebiggestchallengestodayintheGlobalmarketplace.Wejust“Simplified”itforyouwiththe“Nested8DApproach”.YoucannowtakeanyInternal/ExternalProblemsandinvolvebothyourCustomersandSupplierstojointlyconductProblem Solving.

CustomersConcern Reported Initiate

Problem Solving

Supplier

Internal

Update Customer withNested 8D

Highlight of SP 5x Series:

We have not rested, we are developing the new 5x Series to help yousimplify Enterprise quality with many bells and whistles

Changes in User Experience and interfaces.

Inspection Control Software (**New Module)

Upgraded KPI / QOS Management Software

Upgraded Training & Competency Management Software and more…….

EwIMS – Simplicity personified.

WATCH FOR OUR SUMMER NEWSLETTER


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VISIT THE OMNEX RESOURCE CENTER ONLINE!The Omnex Resource Center provides you with valuable information on business management systems and quality initiatives. You will find timely articles, presentations, whitepapers, archived Navigators, and Quality Reference Links.

visit: www.omnex.comRESOURCE

CENTER13


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Aerospace and Defense

AS9100C Internal Auditor Training (Exemplar Global-certified training provider)

huntsville, alMay 04-06

AS9100C Lead Auditor Training (Exemplar Global-certified training provider)


Understanding and Documenting AS9100C Quality Management Systems (Exemplar Global-certified training provider)

ann arbor, miaugust 11-12, December 1-2

seattle, Wa august 11-12, September 29-30

Understanding and Documenting AS9110C Quality Management Systems (Exemplar Global-certified training provider)


Automotive and Production/Manufacturing Core Tools

Core Tools Training Module 1 - APQP & DFMEA ann arbor, mi

Mar 9

Core Tools Training Module 2 - FMEA/Control Plan

ann arbor, miMar 10

Core Tools Training Module 3 - Production Part Approval Process (PPAP)

ann arbor, miMar 11

Core Tools Training Module 4 - Statistical Process Control (SPC)

ann arbor, miMar 12

Core Tools Training Module 5 - Measurement Systems Analysis (MSA) 4th Edition

ann arbor, miMar 13

Core Tools Understanding (CTU) (APQP & DFMEA, FMEA/Control Plan, PPAP, SPC, MSA)

ann arbor, miMar 09-13

Understanding AIAG Sub-tier Supplier Management (CQI-19)

ann arbor, miMar 16-17, May 18-19

Energy Management (ISO 50001) Series

ISO 50001:2011 Internal Auditor Training

ann arbor, mifeb 23-25, May 11-13

ISO 50001:2011 Lead Auditor Training


Understanding and Documenting ISO 50001:2011


Environmental Management (ISO 14001) Series

ISO 14001:2004 Internal Auditor Training (Exemplar Global-certified training provider)

ann arbor, miapr 13-15

ISO 14001:2004 Lead Auditor Training (Exemplar Global-certified training provider)


Understanding and Documenting ISO 14001:2004 (Exemplar Global-certified training provider)


Food Industry Quality Standards Series

FSSC 22000 Internal Auditor Training (Exemplar Global-certified training provider) (FSSC 22000 Licensed Training Organization)

ann arbor, mi

Mar 30-apr 01

FSSC 22000 Lead Auditor Training (Exemplar Global-certified training provider) (FSSC 22000 Licensed Training Organization)

ann arbor, miMar 30-apr 03

Understanding and Documenting FSSC 22000

ann arbor, miMar 30-31

Integrated Management Systems Series

Integrated Management Systems for the Automotive Sector - Lead Auditor Training (ISO/TS 16949:2009, ISO 14001:2004 and OHSAS 18001:2007) (Exemplar Global-certified training provider)

ann arbor, mifeb 23-27

Integrated Management Systems Lead Auditor Training (OHSAS 18001, ISO 14001 and ISO 9001)(Exemplar Global-certified training provider)


2014OMNEXOMNEX 20152015NORTH AMERICA TRAINING COURSE SCHEDULENORTH AMERICA TRAINING COURSE SCHEDULE

`

Omnex is an Exemplar Global-certified Training Provider for the Understanding

and Documenting, Internal Auditor and Lead Auditor courses as noted.


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ISO 13485:2003 Series

ISO 13485:2003 Internal Auditor Training (Exemplar Global-certified training provider)


ISO 13485:2003 Lead Auditor Training. (Exemplar Global-certified training provider)


Understanding and Documenting ISO 13485:2003. (Exemplar Global-certified training provider)


ISO 9001:2008 Series

ISO 9001:2008 Internal Auditor Training for Manufacturing or Service. (Exemplar Global-certified training provider)

dallas, txapr 27-29

ISO 9001:2008 Lead Auditor Training for Manufacturing or Service (Exemplar Global-certified training provider)

dallas, txapr 27-May 01

Understanding and Documenting ISO 9001:2008 (Exemplar Global-certified training provider)

dallas, txapr 27-28

ISO/IEC 17025:2005 Series

Internal Auditor Training for ISO/IEC 17025:2005


ISO/TS 16949:2009 Series

Customer Specific Requirements and Core Tools - Effect on Process Approach To Auditing.

ann arbor, miMar 03, May 28

ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009). (Exemplar Global-certified training provider)

dallas, txapr 27-29

ISO 9001:2008 Lead Auditor Training for the Automotive Sector (ISO/TS 16949:2009) (Exemplar Global-certified training provider)

dallas, txapr 27-May 01

Understanding and Documenting ISO/TS 16949:2009 (Exemplar Global-certified training provider)

dallas, txapr 27-28

OHSAS 18001:2007 Series

OHSAS 18001:2007 Internal Auditor Training (Exemplar Global-certified training provider)


OHSAS 18001:2007 Lead Auditor Training (Exemplar Global-certified training provider)


OHSAS 18001:2007 Understanding and Documenting (Exemplar Global-certified training provider)


QOS/BOS Series

Quality System Basics Plus (QSB+)


R&D Series

Geometric Dimensioning & Tolerence(GD&T) Gage Design


Social Responsibility/Sustainability (ISO 26000) Series

ISO 26000 Internal Auditor


ISO 26000 Lead Auditor

ann arbor, mifeb 23-27, apr 20-24

Understanding and Documenting ISO 26000

ann arbor, mifeb 23-24, apr 20-21

Teams and Problem Solving Series

Effective Problem Solving


VDA Series

Conducting Process Audits to VDA 6.3

ann arbor, miapr 29-May 01

2014OMNEXOMNEX 20152015NORTH AMERICA TRAINING COURSE SCHEDULENORTH AMERICA TRAINING COURSE SCHEDULE

15

Who in the world is OMNEX?

ISO 9001 & ISO / TS16949 | AS9100 | ISO 26262 | ISO 14001 | OHSAS 18001ISO 50001 | FSSC 22000 | ISO 13485 | APQP | Risk Management | Lean Enterprise

Our global clients will tell you. We’ve implementedmanagement systems for many of the world’s top companies.

OMNEX INC

Global Headquarters325 E. Eisenhower ParkwaySuite 4, Ann Arbor, MI 48108, USAPhone: (734) 761-4940Fax: (734) 761-4966Email: [email protected]: www.omnex.com