The Automotive Electronic Council (AEC) is working on aligning the QS-9000 SemiconductorSupplement to ISO/TS 16949. The council has met twice and could complete the document as early as March when ISO/TS 16949:2002 is expected to be launched. The document will be straightforward with minor changes expected. "There should be no surprises,” said Chad Kymal, CEO of Omnex. OMNEX NavigatorSEMICONDUCTORAND ELECTRONICS ISSUE B U I L D I N G S U C C E S S W O R L D W I D E W I N T E R 2002 Inside 3 Biggest Challenge for IG QS-9000 Companies in a Nutshell Omnex News4 5 Silicon Valley Training Schedule Thailand Training 6 7 Malaysia SemiconductorTraining Ann Arbor Headquarters Training 8 Enterprise-wide Quality 10 Systems: The Hitachi Cable Story TS 16949:2002 Approved: The Vote n December 14th, the P-members of TC 176 voted to approve the balloting draft of ISO Technical Standard 16949:2002 (Second Edition) by 79% (30 votes of approval, 8 votes of disapproval and 9 abstentions). Germany was the only other P-member that has a large domestic automotive sector that joined the US in voting against the TS. O The roa d to approv al was bumpie r tha n expected. continued on page 3 Page 1 of 20
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The Automotive Electronic Council(AEC) is working on aligning theQS-9000 Semiconductor Supplement to ISO/TS 16949. The
council has met twice and couldcomplete the document as early asMarch when ISO/TS 16949:2002 isexpected to be launched.
The document will bestraightforward with minor changesexpected. "There should be nosurprises,” said Chad Kymal, CEOof Omnex.
OMNEX
Navigator SEMICONDUCTOR AND ELECTRONICS
ISSUE
B U I L D I N G S U C C E S S W O R L D W I D E W I N T E R 2 0 0
Inside
3 Biggest Challenge for IG
QS-9000 Companies in aNutshell
Omnex News 4
5 Silicon Valley Training
Schedule
Thailand Training6
7 Malaysia Semiconductor
Training
Ann Arbor Headquarters Training8
Enterprise-wide Quality 10Systems: The Hitachi Cable
Story
TS 16949:2002Approved: The
Voten December 14th, theP-members of TC 176voted to approve the
balloting draft of ISO Technical Standard16949:2002 (Second Edition)by 79% (30 votes of approval,8 votes of disapproval and 9abstentions). Germany was theonly other P-member that hasa large domestic automotivesector that joined the US invoting against the TS.
personnel in the process. Document the productealization process in your process map. Identify all theupport processes that affect the development and
delivery of your product. Next, decide whether theQuality Management System will support onlycustomers or whether it will satisfy the requirements of all the “interested parties” of your organization. Thismay result in incorporating many more processes toyour process map. Lastly, check to see whether theprocess map includes every TS-16949:2002 process.See Figure 1 Process Map below.)
2. Conduct Gap Analysisof the Existing System Now, examine the
documentation structurebehind your organization’sQMS. Do you have theeven procedures required
by TS-16949:2002?Typically, QS-9000companies will already havehese procedures. Next
verify whether you havedocuments needed by the
organization to ensure theeffective planning,
operation, and control of itsprocesses” and determine if both the operation and
control of these processesare effective.” The processmap is a good place to startevaluating yourdocumentation needs.Taking these steps shouldesult in the clarification of
your organization’s
documentation needs for satisfying customers and/ointerested parties. Once you have taken the stepsabove, it is now time to conduct an audit or gapanalysis to prepare for revision of your QS-9000-registered quality system to conform with TS16949:2002’s draft requirements. Implementing TS16949 requires two methodologies: Business OperaSystem (BOS) process, and the Process ReviewMethodology (PRM).
3. Implement BOS The first step in implementing BOS involves identifyingcustomer and interested party expectations. In workingwith our clients, our organization uses a process bywhich we list group and rate expectations using Post-Itnotes. Through these groupings into CustomerExpectations Categories, we are able to better align thecustomers’ or interested parties’ expectations withprocesses and metrics. Another key step in this
methodology is the use of alignment charts to link eachexpectation category to the key processes and processmeasurables that need to be measured and monitored.To effectively satisfy Subclause 5.4.1, Planning—QualityObjectives, of ISO 9001:2000, the organization shoulduse benchmarking to determine what its short- andong-term objectives should be. With BOS, theorganization will be on its way to achieving bothenterprise improvement and breakthrough processmprovement.
4. Implement PRM
PRM is a method of documenting and controlling QMSprocesses. It takes the processes in the process mapand your organization’s documentation and appliesProcess Flows (PFs), Process Failure Mode and EffectsAnalyses (PFMEAs) and Control Plans to ensure thedocumentation your organization has is effective andhat its QMS processes are under control. This
document links the BOS process measurables and thePRM approach.
5. Implement TS 16949:2002 One of the greatest challenges—and benefits—of
mplementing TS 16949:2002 is that it will require QS-9000-registered organizations to become customer-ocused as well as process-focused. Becomingcustomer-focused requires an organization tomplement a methodology like the BOS process,however, it also requires an organizational culturechange. Most important, implementing methodologieso become customer-focused and process-oriented do
not require any standards to initiate the process, so youhould start your organization’s change to the newequirements now, because they make business sensen an increasingly competitive marketplace.
An Alternative: The Minimalist ApproachMake No Change: This is the approach someorganizations may take. The inputs and outputsbetween two processes need to be carefully defined..
Organizations and auditors need to be careful not to
The US TAG voted to disapprove thedraft, which came down to three keyobjections:1. 7.4.1.2 requires an organization that isactively pursuing registration to TS16949:2002 to use only suppliers that areregistered to ISO 9001:2000 and thenhave a plan for evaluating those suppliersand helping them achieve conformity
with TS 16949:2002.
2. The US TAG and TG 18 leadership feltthat the addition of 7.5.2.1 to Subclause7.5.2 of ISO 9001:2000, Validation of Processes for Production and ServiceProvision, would be a hardship fororganizations registered to TS16949:2002 and their suppliers. Theywould have to comply with this“expanded” requirement in TS, which
would not have a clearly definedendpoint.
Transition (continued)rap of the minimalist approach. In effect, no improvementwill be evident in such a system. More important, theorganization will not make any movement forward inbecoming customer- or process-focused, which could be
detrimental in the long term.
Chad Kymal is CEO of Omnex, Inc., and a muchsought-after international consultant and trainer. He
was on the Malcolm Baldrige Board of Examiners and has a BSME
from General Motors Institute and an MS degree inIndustrial Operations Engineering and MBA from theUniversity of Michigan.
For the complete article, go towww.omnex.com/news/news.html
The Biggest Challenge for QS-9000Organizations In a NutshellThe Final Draft International Standard (FDIS) of the ISO/TS 16949:2002 is finallyavailable. Though the circulation is limited to a small circle, it is a sign that it will beeleased to the larger public. What is still missing is the Customer-Specific
document (GM, Ford and DaimlerChrysler) accompanying the ISO/TS 16949:2002tandard.
n a nutshell, the ISO/TS-16949:2002 is more influenced by the ISO 9001:2000Standard than any new automotive-related change. For the most part, the ISO/TS16949:1999 has now been faithfully mapped into the ISO 9001:2000 to create theSO/TS 16949:2002. Elements influenced by ISO 9001:2000 include 4.1 GeneralRequirements, 5.2 Customer Focus, 5.4.1 Quality Objectives, 5.5.3 Internal Communication, 5.6 Management Revie6.1 Provision of Resources, 6.2 Human Resources, 6.2.2.3 Training on the Job, 6.2.2.4 Employee Motivation andEmpowerment, 7.0 Product Realization, 8.2.1 Customer Satisfaction, 8.2.3 Monitoring and Measurement of Processeand 8.4 Analysis of Data. (See the Omnex website for two articles on this topic which were published inThe Informed Outlook.)
The biggest challenge for QS-9000-registered companies is the customer focus and process focus represented by thtandard. (See the Omnex website or next month’s Informed Outlook for more information and a table
on the subject.)
TS 16949:2002 Approved: TheVote… (continued)
t is suspected thatSEMATECH, a consortiumof 13 semiconductormanufacturers in the USand six other countries,
may have had annfluence on the ballotingby several P-members,ncluding the UnitedStates. Evidence of thiss found when onecompares the US positionpaper with a SEMATECHwhitepaper. But why wouldSEMATECH oppose the
new version of TS 16949 Jim Mroz of The InformeOutlook explains that mhave been the perceivedinability of an organizat
to self-declareconformance with thesecond edition which wathe issue. SEMATECHincludes several companthat have previously raisthe banner for self-declaration instead of registration.
Chad Kymal, Omnex CEO, says, “Theemiconductor industry has alreadyncorporated many TS elements already, so thenew TS 16949:2002 shouldn’t pose a significantchallenge.” In many cases, semiconductorcompanies adopted excellence standardsoutside the QS-9000 or ISO 9001 systems. TS16949:2002 privides an excellent opportunityor semiconductor companies to integrate their
Business Management System with their Quality
Management System. And as Jim Mroz says, “Idon’t expect that TS 16949 will have aignificant impact on the processesemiconductor manufacturers follow. However, the
ormal incorporation of those processes into a QMS and into
ocumented procedures may be an implementation burden for the
ector. It also depends on whether amanufacturer is a Tier 1 supplier to an OEM or aupplier to a Tier 1
upplier, since only Tier 1s will be required toegister to the TS, while Tier 2s and below will
be required to register to ISO 9001:2000 andpursue compliance with the TS.” 7.4Purchasing, with the requirement for productand service suppliers to become ISO 9001:2000
could indeed prove challenging to allorganizations, not just the semiconductormanufacturer.
The drafters of the second edition of ISO/TS16949 agreed to pursue their objectives throughhe proper procedures provided by ISO, whichnvolves review and addressing of commentsubmitted in balloting. There were 63 pages of
comments submitted with the balloting, andhese comments have been considered inewording of ISO/TS 16949 second edition.
The IATF is already working on a version thataddresses the comments provided in theballoting process. Jim Mroz notes, “Therewording is not very important unless it leadto changes in the requirements, which I do no
expect to change significantly. Most of thecomments come down to requests forrestrictions on ISO 9001:2000 to be modified removed from the TS, and the options in ISO9001:2000 are not likely to be of much use toproduction and service parts manufacturersanyway.” After that, we will have to see if thAutomotive Task Group that drafted ISO/TS16949:2002 will pursue development of theautomotive QMS requirements as a full ISOstandard by the time the TS is to be revised iMarch 2005.
Omnex News
News from AsiaIndia
TELCO, India’s biggest OE manufacturer of heavy vehicles, has selected Omnex for a largeupplier training initiative. Omnex will beraining around 300 suppliers of TELCO. Omnexndia recently partnered with Visteon India for
heir Six Sigma initiatives. ZF Steering Gear haspurchased and implemented the EwQMS OmnexSystems Suite through Omnex India. Also, thendia office is working with ZF Steering Gearndia and Asian PPG Industries Ltd. for TS16949:2002 (Second Edition) implementation.Omnex and TUV Rheinland India haveannounced joint training programs on qualitymprovement to the Indian industry.
Thailand Our Thailand office has recently signed twoconsulting projects for ISO/TS 16949:2002
Second Edition). It also completed its first ISO17025 implementation and an ISO 9001:2000mplementation for BASF’s regional chemicaloperations.
Ford Asks Omnex to Present on Ford Q1Omnex has been asked to participate in a seriesof Q1 for Service roll-out presentationsponsored by the Ford Global Facilities,
Materials and Services Purchasing group.
Participants include targeted suppliers from t Transportation, Construction, Machinery &Equipment, Industrial Materials, and Serviceindustries.
New Software Releases from Omnex SystemsOmnex Systems recently released new versionsof Audit Pro and Document Pro. In addition, thendustry has taken notice of the full Enterprise-wide Quality Management System (EwQMS TM).Omnex Systems has implemented several suitesn the US and abroad. Already, the suite thatdoes it all is doing it worldwide. (See below, and he article about the EwQMS Suite on page 7.)
AQuA was written up in the October issue of Quality Digest in the “Newsoftware” section. Acreenshot was shown, and a description told
about how it links with the rest of the EwQMSSuite.
Omnex to Provide Training at National Manufacturing Week ConferenceFor the first time, National Manufacturing Wowill partner with Omnex to provide publictraining seminars. The conference takes placat McCormick Place, Chicago, March 18-22,2002. Omnex’s courses during the 5 dayconference will include Understanding the ISO9001:2000 International QMS Standard, SixSigma: An Executive Overview and
Understanding the ISO-14001 International EStandard.
Online Training Omnex is offering its first online courses incollaboration with a leader in web conferencing,
Virtual WorkshopsTM. Currently Omnex is teaching
the Understanding ISO 9001:2000 course found in our
Training Schedule is subject to course load requirements; dates may vary. Please contact Omnex forthe most current information and a copy of our catalog, outlining our full course offering.
SAN JOSE, CAUnderstanding,
Documenting andImplementing ISO 14000
Dates: February 18-20, 2002
Course description:rovides an understanding of the ISO 14000 requirements
nd a basic overview of how they apply to the design of a
unctional and effective Environment Management System
EMS). All of the ISO 14001 elements are reviewed
omprehensive approach to implementing Best-In-Class
ystems and understanding the intent of ISO 14000
ertification; Participants learn how to improve their
urrent environmental systems and document an ISO 14000
ystem; 3-Day Seminar.
Measurement SystemsAnalysis (MSA)
Dates: February 25-26, 2002
Course description:his two-day seminar is designed to provide participants
ith an understanding of the importance of MSA in
ontrolling and improving the production process and to
ive students a practical knowledge of using statistical
methods in analyzing the measurement system.
Understanding Documentingand Implementing ISO/TS
16949, Second EditionDates: March 11-13, 2002
Course description:his two-day seminar provides a comprehensive approach
understanding, documenting, and implementing Best-In-
lass Quality Management Systems to the requirements of
SO 9001:2000 and ISO/TS 16949:2002. The presentation
nd hands on exercises focus on the semiconductor sector
pecific approaches in ISO/TS 16949:2002, as well as
pecific strategies for making the transition from QS-000/TS-16949 1st Edition
ISO/IEC 17025 LABDates: June 13-14, 2002
Course description:his new standard replaces lessons learned from
mplementation of the ISO/IEC Guide 25:1990 and EN
5001: 1989 and contains all the requirements that testing
nd calibration laboratories should have.
Internal Auditor for ISO9001:2000 with Specific
Reference to ISO/TS16949:2002
Dates: June 10-12, 2002
Course description:This three-day seminar explains ISO 9001:2000, ISO/TS
16949:2002 and their impact on audit systems, the auditing
process and audit instruments. Participants will learn the
documentation process, how to conduct an audit, write the
audit report, and take corrective action. The Omnex
Internal Auditor training provides one day of ISO
9001:2000 and ISO/TS 16949:2002 audit trails and
guidance on each element of ISO 9001:2000 and ISO/TS
16949:2002. The class is built around a case study, which
includes auditing PFMEA, Control Plans, Work
Instructions, and Management Review. Also included are
case studies to develop skills for identifying
nonconformances.
Lead Auditor Training for ISO 9001:2000
with Specific Reference toISO/TS 16949:2002
Dates: April 22-26, 2002
Course description:This seminar fully integrates RAB-accredited Lead Auditor
ISO 9001:2000 requirements with reference to ISO/TS
16949:2002 throughout the entire five-day seminar.
Presentation materials are supported with real-world
examples and exercises for the semiconductor industry
ISO 9001:2000 -Understanding and
ImplementingDates: February 21-22, 2002
Course description:This class teaches the intent, content, and objective
evidence required to implement the ISO 9001:2000
standard. The Best-in-Class implementation methodology
for each clause of the standard is covered. The class covers
the standard and introduces two methodologies that can be
used with ISO 9001: QOS, and Process Review. QOS
starts with customer expectations, goals and objectives, and
then drives toward key processes and process measurables.
Process Review is the methodology that conducts a process
flow, PFMEA, and Control Plan for administrative
processes.
ISO 9001:2000 Lead AudiTraining
Dates: April 15-19, 2002
Course description:
This seminar fully integrates ISO 9001:2000 requirem
throughout the entire five-day seminar. Presentation
materials are supported with real-world examples an
exercises for the semi-conductor industry.
ISO 14000 Internal AuditDates: May 20-22, 2002
Course description:This three-day seminar explains ISO 14001 series of
Environmental Management System (EMS) Standard
how to audit them from an internal auditor perspectiv
This course is organized around the unique aspects o
Omnex ISO 14000 audit trails. Topics include the au
process and audit instruments such as checklists, aud
forms and records. Participants will learn EMS
documentation, how to audit each element, conduct a
audit, write audit reports and approve corrective actio
ISO 14000 Lead Audito
Dates: June 17-21, 2002
Course description:This five-day seminar fully integrates ISO 14000
requirements. This course is designed to satisfy the tr
requirements for auditors seeking EMS auditor
certification. This course is also directly applicable to
first party, second party, and third party auditors, as w
personnel involved in the implementation of environm
management systems. Presentation materials are supp
with real-world Environmental Management System
(EMS) examples and exercises.
ISO 9001:2000 InternalAuditing
Dates: March 25-27, 2002Course description:This course teaches both service and manufacturing
examples. This course provides and understanding o
to audit ISO 9001:2000, along with audit trails and
sampling. Conducting an audit, writing non conform
ISO 14000 SO 14000 LeadAuditorNovember 12-16, 2001an 28-Feb 1, 2002March 18-22, 2002May 20-24, 2002uly 22-26, 2002
SO 14000 InternalAuditoranuary 14-16, 2002
March 11-13, 2002May 13-15, 2002uly 15-17, 2002
Understanding,Documenting andmplementing ISO
14000anuary 7-9, 2002March 4-6, 2002
May 6-8, 2002 July 8-10, 2002
ISO 9001:2000 NOW RAB-ACCREDITED!
ISO 9001:2000Lead Auditor
November 26-30, 2001December 10-14, 2001Feb 25-March 1, 2002April 22-26, 2002
June 17-21, 2002
Understanding andImplementing ISO9001:2000
December 3-4, 2001February 4-5, 2002April 1-2, 2002
June 3-4, 2002
CaliforniaTraining
Omnex is offering courses on theWest Coast. Many of the coursesyou see here are also offered withthe Semiconductor Supplement included. Call Jim Hooper at 408-
683-2710 or visit www.omnex.comto obtain a schedule for San Jose.
Omnex…A World
of Knowledge
ISO 9001:2000
Internal Auditor
December 5-7, 2001February 11-13, 2002April 8-10, 2002
June 10-12, 2002
How to Audit ISO9001:2000–
An Auditor’s Guid
This is your last chanceorder the best technique
value-addedimplementation,
interpretation, anddocumentation of ISO
9001:2000 from OmneChad Kymal’s book is goto be printed by Paton Pr
An intensive two day auditor transition training course for auditors who have passed aninternal or lead auditor course.This two day course will teach ISO 9001:2000 audit trails, scopeselection, and audit planning.Breakouts and graded exerciseswill test your skills in the new ISO 9001:2000 requirements for documentation, management review and customer expectations,etc.
November 15-16, 2001December 3-4, 2001February 14-15, 2002May 9-10, 2002
Six Sigma Taught by a Master Black
Belt who led Allied SignalSafety Systems in their SixSigma implementation. TheOmnex Six Sigma traininginstructor will show you thehands-on techniques used inthe successful deployment of Six Sigma from an insider’sview.
With our Black Belt training,you’ll be able to save$500,000 - $750,000 per
Black Belt. And sign uptoday for Omnex’sChampion Training in SixSigma!
Call Omnex for more informationon our Six Sigma OpenEnrollment and onsite training being offered now.
The Hitachi Cable Storynterprise-wide software solutions are juststarting to come out on the market. TheOmnex Systems EwQMS TM Suite may be the
answer to what companies are looking for – onepackage for all of their quality managementneeds. Companies today are tired of addressing
heir documentation, auditing and measurementystems analysis needs by stringing several
packages together.. And organizations who haveocations around the world are looking for Internet-based solutions like EwQMS TM.
E
The EwQMS TM solution allows the organizationalentity and the supply chain to act as a cohesivewhole. How does this work? Read the Hitachi CableStory below.Though thismplementations
in its infancy,he potential is
huge.
Savings withAQuA
Hitachi workedwith Omnexbecause of thearge savingshey got while
using Omnex
Systems’ AQuA software. Hitachi Cable had beenusing AQuA software since May, 2000. Greg Walts,Quality Manager at HCI, found AQuA “user friendlyand powerful” to use. By the end of 2000, Greghad documented over $200,000 in savings usingAQuA. (Go to www.omnexsystems.com todownload a presentation from HCI on thesavings it got from AQuA.)
Hitachi QMS Strategy
Hitachi Cable Indiana along with other HitachiCable companies were looking for a system to 1)bring standardization to their quality systemsworldwide, 2) allow communications betweenompanies concerning quality matters by usinghe Internet, and 3) help information travel more
easily. Also, 4) Hitachi management was seekingan efficient means of obtaining criticalperformance measurements for each operatingunit.
Due to their experience with AQuA, it seemednatural for HCI to expand their involvement withOmnex Systems by implementing its EwQMS
software. What surprised them was the relativeease with which Omnex Systems got theirimplementation going. While most of the time ittakes weeks or months to install new software aconvert existing systems, Omnex Systems toldGreg that the web installation would take one dand that Audit Pro and Document Pro would takday each to get up and running. So in a matter three days the core of the EwQMS suite would bfunctional.
Omnex Systems purchased the server andconfigured the system for Hitachi. Next we carrthe software and hardware to Hitachi and instait that day. In two more days, we uploaded theexisting documentation to Document Pro and gAudit Pro up and running.
Omnex delivered on its promise. Greg says, “Wfound thesoftware to bevery userfriendly, with
so-called “bugin the softwar
The softwarerequired verylittle additionaprogrammingmeet ourcompany’sspecificrequirementsBasically, thesoftware can
loaded “off the shelf” and it becomes functionaimmediately.”
Chad Kymal, Omnex Systems President, says, “run against competitors that give quotes wherethe set-up and implementation costs for thesoftware are much larger than the quote for thesoftware itself. On the other hand, OmnexSystems can typically get a company up andrunning and the documents converted in a day.top of that, we don’t need to customize theprograms. Why? Quality and quality systems arOmnex’s business already. The flexibility is buil
to accommodate most organizations’ qualitysystems. We not only accomplished it at HCI, w
just did it again in a Lear Seating plant last wee
At HCI Omnex’s web-based solution has been amajor boon. Greg Walts says, “Document Pro anAudit Pro are both web-based software packageOur desire to use the Internet for globalcommunications will make it much easier toachieve our inter-company goals. We envision audit program that will be used by all of the
atellite companies at one time.” HCI is still in theprocess of implementing Doc Pro, Audit Pro, andBOSS to their fullest potential. Theirmplementation of the AQuA software helped themo realize a savings of $225,000. The initial
estimation of the savings for the suite will
definitely be at least that much, if not more.
For the complete text of Greg Walt’s interview, go
o www.omnexsystems.com/news/news.html.
Take a guided tour of Document Pro and Audit Pro online, right at your desk. Call 734.761.4940.