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Statistical Tolerance Design with Simulation New Omnex Southeast Office in Atlanta, GA News from Omnex Around the World Moving from FMEA 3rd Edition to 4th Edition Omnex 2009 US Training Schedule

November 2008

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ISO 9001:2008
DIsTrACTIoN or oPPorTuNITy?
David Watkins Vice President, Omnex hen ISO 9001:2000 ness practices) to a customer arrived, replacing ISO focused system of interacting 9001:1994 and build- processes implemented in a ing on the process approach in management driven architecISO 14000, it ture aligning ushered in Customer ISO 9001:2008 an era of Expectareleased Nov. 14th! radically tions, re-thinking Processes, the concepts, apOutputs/Results, proaches, and methodologies while requiring the managed employed in Quality Manage- continual improvement of proment Systems. In fact, its impact cesses, products, and customer has been so great that it has sig- satisfaction. nificantly changed thinking and In contrast, the 2008 release of practices about management ISO 9001 seems to be arriving systems and like Carl Sandbergs fog, on little principles in cat feet with little notice or atgeneral. It tention. This is because the intromarked the duction of circulated drafts (the evolutionfrom latest being the FDIS, expected a list of ele- to be officially published as an m e n t s Amendment to the standard in ( b a s i c November) has accurately emg o o d phasized that the Amendment b u s i - incorporates no new require-

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In the Eye of the OEM

How your CusTomer Is CHANgINg
Jim Mourafetis General Manager, Southeast Region our customer is constant- centers around customer satly asking you to change, isfaction. To keep quality stanbut why? Its a competi- dards high, automakers are tive market as more products forced to continuously elimiare offered, consumers can be nate waste and improve their pickier. To succeed, you need systems. This means building to identify the real factors that perfect quality, in-station, efare driving changes in customer ficiently, while maintaining demand and understand how minimal inventory throughout they impact the demands on the entire supply chain. The your organization. This article first 90 days of Initial Quality takes a look at how Quality, is considered the scorecard for Productivity, Cost, and Logis- assembly plant quality perfortics impact the future of your mance, and GM Plant Oshawa company. #2 awarded JD Powers 2006 Gold Plant Quality Award Quality for North America was also the most producConsumers have zero toltive, at 15.68hrs per erance for poor quality. vehicle. Initial Quality is one of the most important Productivity metrics for ranking a production plants Productivity of an performance, assembly plant and this all is measured

cont. on David Watkinsp4

cont. on p3

Jim Mourafetis

cont. on p9

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Statistical Tolerance Design with Simulation

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Jaran Sabseree - Master Black Belt Consultant, Omnex Thailand Worst Case Tolerance In this example, the tolerances are set according to the worst-case scenario: A = 10.1 0.05 mm B = 9.9 0.05 mm These figures are for samples generated for A and B assuming triangular distribution (other distributions, such as normal or uniform, may be assumed as appropriate). This simulation can be done by using a statistics software package such as mINITAB. Simulated data can be selected in pairs to simulate the resultant gaps in the assembly. The process capability of the simulated gaps can then be calculated as in Figure 2. With this tolerance (0.7mm), the Cpk is 0.85, indicating that a stricter tolerance is needed to achieve the customers Cpk specification. Let the tolerance of A and B are as follows: A = 10.1 0.06 mm B = 9.9 0.06 mm After simulating the data again, the Cpk of the gap as seen in Figure 3 has increased to 1.01, thus satisfying the target, so these are appropriate tolerances for this gap requirement. As these tolerances are wider than the worst case tolerance, the desired quality target is still achieved while simultaneously minimizing manufacturing costs associated with lower tolerance.
mr. Jaran sabseree, an omnex Thailand master Black Belt Consultant, received the Best Paper Award, presented by quality guru Prof. Dr. Kano at the 2008 ANQ Congress in Bangkok, Thailand for his paper, Fusion Six Sigma: Methodology and Case Studies. Photo on p7.

ngineering and quality design often require tolerances for products or processes to satisfy customer requirements. In Figure 1, part B is installed into part A. One of the customers requirements for this assembly is the size of the gap in the installation. In order to achieve the desired quality characteristics, the gap must be 0.2mm 0.1mm with Cpk = 1. The problem is then this: what are appropriate tolerances

With this method, so long as A and B are each within their tolerances the gap will conform the requirement. However, this method has one disadvantage this worst-case tolerance is usually too tight, leading to higher Gap specication: 0.2mm 0.1mm; Targeted Cpk = 1 manufacturing cost. Tolerance Design

Since the worst case scenario is unlikely, the tolerance can be B = 9.9mm ? improved by evaluating the probability distribution for the dimensions of parts A and B. This data can be simulated and A = 10.1mm ? the process capability of the gap can be Figure 1 calculated in order to for A (10.1 ?) and B (9.9 ?) that will satisfy evaluate the suitability of various tolerances the gap requirement. If the tolerance is too for A and B. tight, the manufacturing cost is usually increased. On the other hand, if the tolerance In this case, we may first try to simulate this is too loose, the variation in the product in- condition: creases, leading to poor quality. This article A = 10.1 0.07 mm discusses a technique for determining ap B = 9.9 0.07 mm propriate tolerances.
Process Capability of Gap No.1
LSL
P rocess Data LS L 0.1 Target * USL 0.3 S ample M ean 0.199901 S ample N 1000 S tDev (Within) 0.0392679 S tDev (O v erall) 0.0392581

Process Capability of Gap after Tolerance Adjustment

LSL USL Within Ov erall
P otential (Within) C apability Cp 1.07 C P L 1.01 C P U 1.13 C pk 1.01 O v erall C apability Pp PPL PPU P pk C pm 1.07 1.01 1.13 1.01 *

USL W ithin Ov erall

P otential (Within) C apability Cp 0.85 C P L 0.85 C P U 0.85 C pk 0.85 O v erall C apability Pp PPL PPU P pk C pm 0.85 0.85 0.85 0.85 *
P rocess D ata LS L 0.1 Target * USL 0.3 S ample M ean 0.194377 S ample N 1000 S tDev (Within) 0.031209 S tDev (O v erall) 0.0312012

0.08
O bserv ed P erformance P P M < LS L 1000.00 P P M > U S L 3000.00 P P M Total 4000.00

0.12

0.16

0.20

0.24

0.28

0.32
O bserv ed P erformance P P M < LS L 1000.00 PPM > USL 0.00 P P M Total 1000.00

0.09 0.12 0.15 0.18

E xp. Within P erformance P P M < LS L 1247.19 PPM > USL 356.70 P P M Total 1603.89

0.21 0.24 0.27 0.30

E xp. Within P erformance P P M < LS L 5478.11 PPM > USL 5399.62 P P M Total 10877.73

E xp. O v erall P erformance P P M < LS L 5468.14 P P M > U SL 5389.75 P P M Total 10857.88

E xp. O v erall P erformance P P M < LS L 1244.08 PPM > USL 355.60 P P M Total 1599.67

Figure 2

Figure 3

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ISO 9001:2008

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David Watkins Vice President, Omnex after publication of the 2008 Amendment. However, 12 months after publication of the 2008 Amendment, certificates to the 2000 standard will no longer be issued. Wheres the Beef? Changes in emphasis and Focus First, there are interesting indications of changes in emphasis starting with 0.1, where language is added noting that design and implementation of a Qms is influenced by Business environment, changes in that environment, or risks associated with that environment. This speaks directly to the issue of enterprise sustainability. specifically, this language suggests the need to factor in an awareness of these types of external changes when: 1) adopting or changing policies 2) determining objectives 3) establishing and monitoring key performance indicators 4) managing continual improvement in areas critical to long term sustainability (Interestingly, the Iso/CD 9004 that has been circulated places enormous emphasis on an organizations processes and approaches to capturing, analyzing, and addressing these areas of external focus within the Qms.) Increased emphasis on the impact Processes have on Outcomes appears in language added in 0.2, paragraph 3: to produce the desired outcome, and 1.1 Note 1, which adds: intended output resulting from the product realization processes. While these are not radical, they do suggest the need to attend to process outputs, rather than inputs, as the objective focus of the Qms.

ments and no changes to existing requirements from 2000 but without pointing out the opportunities the Amendment offers in terms of improvement and enhanced impact for Quality Management Systems. As characterized in a statement by the Conformity Advisory Liaison group (CALg), subsequently endorsed by TC 176, the intent of the 2008 Amendment is threefold: Introduce clarifications to the existing requirements of ISO 9001:2000 Improve compatibility with ISO 14001:2004 Employ added or expanded notes as a way of enhancing understanding and overall QMS effectiveness The 2008 Amendment is not considered an upgrade, so certifications to either 2000 or 2008 will have equivalent status until 2000 is fully supplanted 24 months

10 Key Elements of an Effective QMS

1. Quality Policy is consistent with the organizations commercial purpose, customer-centric, externally focused, and based on having effectively captured, analyzed, and understood customer values and requirements while expressing a real commitment to continual improvement in products, processes, and the QMS. 2. Quality Objectives are quantifiable, aligned with elements in the organizations Quality Policy, consistent with customer expectations and requirements, benchmarked to ensure competitive advantage, and integrated into the organizations business plan. 3. Key Result Measurables, aligned with Quality Objectives, are employed by the Management Team to monitor performance and determine business planning process initiatives to continually improve performance. 4. Process Measurables have been determined and implemented to monitor variation in products, processes, and the effectiveness of the QMS, as well as support analysis and continual improvement planning. Process Measures from business processes are aligned with Key Result Measurables to see the impact these processes have on Quality Objectives and Customer Satisfaction. 5. Management Review is focused on operational performance, employing analysis of Key Measurables, Process Measurables, and Customer Inputs, as well as effectively implementing a continual improvement process to achieve Quality and Business Objectives. Management Review is conducted frequently enough to be effective and sustainable. 6. All of the processes of the QMS and their interactions have been determined, defined, and documented to manage essential knowledge within the organization. Appropriate monitoring and measurement is employed to help identify and understand variation in the efficiency and effectiveness of these processes in order to ensure their effective control and improvement. 7. Program Management and the best practices of Advanced Quality Planning (AQP) such as Robust Design Linkages, FMEA, Control Plans, SPC, and MSA are incorporated into the realization processes. 8. There is an effective, documented process for Verification and Validation of Product and Process Design; accordingly, the Process Design process is robust and fully integrated with the Product Design process. 9. Corrective and Preventive Action processes are actively employed to resolve and prevent failures in all of the processes of the QMS; the organization creates and maintains a problem solving culture. 10. Internal audit is used to assess effectiveness as well as conformity and therefore provides significant input into operating management review to enable greater understanding of the effectiveness of the system along with opportunities for improvement.

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ISO 9001:2008

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David Watkins Vice President, Omnex recognizes that conformity is both definable and determinable, and is consistent with ISO 9000:2005. As the old saw goes: If you cant define it, you cant measure it. If you cant measure it, you cant understand it. If you cant understand it, you cant control it, etc. so while Customer satisfaction is subjective in the sense that it involves perception, that perception must be, in part, based on the determination of conformity to requirements and continual improvement. Clarification that Interprets Its in the Notes! Our reading of the FDIS of the Amendment indicates that the committee has consciously elected to employ notes not only to enhance understanding and effectiveness but also, in some instances, to suggest different meanings, scope, and implications for some requirements. some significant examples: 1.1, Note 1 adds to Product: any intended output resulting from the product realization processes. Now presumably this would include as product: communicated information, data, documents, eDI and ImDs information, invoices, labels, instructions, packaging anything produced by elements of, or activities related to, the product realization process. 4.1, Note explicitly includes analysis and improvement as processes that are needed for the quality management system described in 4.1. In many Qmss these activities (analysis and improvement) are not explicitly addressed either as processes or as documented procedures in a manner likely to significantly enhance the effectiveness of the Qms. This note addresses this specifically as an omission to be corrected. 4.1, Note 2 expands the meaning of outsourced process by referring to an outsourced process as one needed for the organizations quality management system that is performed by an external organization. many companies outsource processes (e.g. Customer Service, Payroll, Purchas-

Not really new, but nonetheless important. There is a word change repeated throughout, changing from identify or list to determine (e.g. in 0.2 determine and manage linked activities, in 4.1 determine the processes needed, in 4.2.1 & 4.2.3 determinedto be necessary). what is the significance of this? The difference is that determine is active, in the sense that determining something requires investigation, assessment, and understanding, as compared to simply identifying something, which is a passive activity that requires no investigation or understanding. I.e., we know there is something called Purchasing, which we can list or identify, but determining what Purchasing is requires investigation, assessment, and understanding. Throughout the Amendment, the phrase Product Quality and related expressions are replaced with variations on the phrase conformity to product requirements. Some may read this as a change to little q, but its more significant than that. This rewording

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ISO 9001:2008

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David Watkins Vice President, Omnex tion are being used to push Qms effectiveness by addressing the monitoring of Customer satisfaction through a much broader, more meaningful scope of activities and approaches. 8.2.3 Note discusses monitoring and measurement of processes based on a determination regarding their impact on the conformity to product requirements and on the effectiveness of the Quality Management System. It seems that, in the context of the P-D-C-A cycle and management of Continual Improvement, this was always the intent of the entire clause. However, this note recognizes that this has not ostensibly been the practice of many companies. The implications of this note involve rethinking and realigning objectives, Key measures, Processes, and in particular, Process measures to focus on and drive Continual Improvement. Conclusions The combination of the apparent changes in emphasis and focus cited above, coupled with the changes in wording and clarifying Notes intended to enhance the effectiveness of the QMS together provide an opportunity to rethink, restructure, realign, and refocus your companys QMS. Improvements obtained through this effort will not only enhance effectiveness of the Qms, but they will help make it more relevant and empowered to determine and achieve business objectives that are strategically critical to the long term competitiveness and sustainability of the company.
Dave watkins is executive VP, Director of International operations, and a senior consultant and trainer for Omnex. With a wide range of international experience across a variety of manufacturing and service industries, his activities are focused on enhancing the ability of organizations to create value for their customers and stockholders by developing and integrating management and operating systems in order to achieve and sustain customer satisfaction and a competitive advantage.

Omnex Southeast Office

OMNEx OFFICE OPENS Doors IN ATLANTA, gA

ing, Invoicing and Payables, Contract staffing, Training, etc.) that, while not part of the value stream, are arguably essential to the effectiveness of the Qms (and thus the company), and because they are outside of the primary realization process, they are often ignored in the context of this clause. In the companion notes it is clear that outsourced processes and their controls must be part of the Qms. This is reinforced in the Note to 6.2, below: 6.2, Note 1 adds Conformity to product requirements can be affected directly or indirectly by personnel performing any task in the QMS (including, presumably, any tasks and processes which are outsourcedsee 4.1 Note 2, above). This note specifically refers to competencies, and directly suggests the need to assess and manage competencies in any task identified in the Qms and its processes. While this is a note and not a requirement, it has significant implications regarding how a company determines and manages competencies throughout its operations. 6.4 Note characterizes work environment as conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather). While this clearly constitutes clarification, it also suggests that companies have frequently chosen to address this clause with a narrow scope, rather than attempting to effectively determine (theres that word again) and manage the many elements of environment which affect work both in the value stream as well as in other processes and activities to the detriment of the overall effectiveness of the QMS. 8.2.1 Note indicates that monitoring customer perception can includesurveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, [and] dealer reports. while this answers questions elicited by the wording of the original clause, it again seems that explanation and clarifica-

James Mourafetis General Manager, Southeast Region

iven the significant demand for Omnex services, we are excited to announce our expansion into the southeast region of the united states with the opening of our Atlanta, GA regional office. within the first two months, Omnex Southeast has already begun operations in manufacturing, aerospace, and automotive sectors within Tennessee, Alabama, Georgia, South Carolina, and Texas. Services our full service consulting and training portfolio has received a warm welcome in the Southeast, despite the economic conditions in our country. we have been able to continue offering a high volume of both general as well as niche services, including: PPAP preparations and reviews, improving aerospace organizations APQP process, software solutions for managing APQP documents, Iso 9001 and Ts 16949 gap analysis and implementation, and six-sigma green Belt and Core Tools workshops. How Omnex can Help By freeing up time and resources, omnex enables organizations to be nimble and flexible in order to meet fluctuating market and economic demands, companies are seeing a real benefit from our full range of capabilities. To see how omnex southeast can help you, please contact: Julie McColgan Director of Business Development Phone: 800-310-4129 E-mai: jmccolgan@omnex.com

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Omnex China omnex China has been strongly supporting the strategy of providing high level consulting and training service to global clients in a broad range of sectors including automotive, chemical, electronic, aerospace, and service. In accordance with this strategy, Omnex China has just signed a coperation contract with sKF China, which extends the collaboration between omnex and sKF across the entire Asia Pacific region. Omnex China will be providing a wide range of professional consulting and training services to sKF China, especially on Ts 16949 Qms and automotive core tools, such as APQP, FmeA, and PPAP support. The sKF group is a leading global suppliers of products, solutions, and services in rolling bearings, seals, mechatronics, and lubrication systems. SKF has 110 manufacturing sites distributed all over the world and sales entities in 70 countries. sKF has 9 manufacturing sites in China and more than 3,000 employees with a headquarters located in Shanghai.

news from omnex Around the world

Officials from Dubai Metro at Omnexs Integrated Management Systems training with active plans for Ims, IT security, and Lean six sigma projects, Omnex Middle East is on the fast track towards unprecedented levels of growth. Omnex India omnex India launched automotive tool training programs soon after AIAgs FmeA 4th edition and APQP 2nd edition guidelines were released and has provided training on these processes for major Indian automotive companies including Ford India, Tata motors, Volvo India, and maruti suzuki. The India office recently contracted a Qms Improvement Training project with Integral Coach Factory (ICF). This training covers 50% of the supervisors / officers at ICT and is being conducted throughout october and November in Chennai. Other major clients from 2008 include Delphi Automotive Bangalore, ICICI Bank mumbai, Jaihind Inustries, goyal Knitfab, saint gobain Abrasives, and the National Thermal Power Corporation (NTPC). Through omnexs strategy Consulting vertical, omnex is conducting several workshops to help organizations cut cost and improve operational efficiency. workshops such as Value stream mapping (Vsm) and Breakaway Lean have helped many companies to achieve 50% improvement in the throughput, 50% reduction in inventory, and 20% decrease in operating expenses within six months.

Michael Xu General manager of Omnex China, Jiang Yaoping Vice Minister of MOC, and the AIAG delegation at the 2008 AIAG Auto Parts Purchasing Leadership and Supplier Forum in Beijing omnex China, in conjunction with greg gruska, VP of omnex systems, has just completed a very successful seminar on FmeA 4th edition, with 80 participants representing over 40 companies. Omnex Middle East omnex middle-east has had an eventful year in 2008 with both projects and on-site training being managed simultaneously from our Dubai office. As part of omnexs association with Dubai metro rail Agency, we are developing their Integrated management system documentation and management. omnex is assisting Axiom Telecom in redesigning their processes, development, and documentation. Omnex has also conducted Integrated Management Systems and Iso/ IeC 17025: 2005 Laboratory Quality management systems training for saudi Forensic Labs and saudi ArAmCos ras Tanura refinery Laboratory.

ICF Engineer B.M. Prasod speaks at the ICF inauguration, with ICF gen. mgr. Mrs. Sabita Gopal, Omnex Asia VP Arun Kumar and Omnex regional manager Manoj Radhakrishnan

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Omnex Thailand The omnex Thailand office has experienced good growth this quarter. we were awarded a contract with Delta electronics Thailand for Lean six sigma training and implementation, currently underway. The Thailand office has also started Lean manufacturing training and implementation for saint gobain sekurit Thailand, a TQm workshop for essilor Thailand, and a Process Improvement workshop for ANCA Thailand. on the consulting front, omnex Thailand is working with NrB Bearings, Hanill steel for the implementation of Integrated management systems. Transition optical is another company that is using Omnex for their training and workshop needs of Six Sigma Green Belt training. Other customers for the quarter include Robert Bosch Automotive, NHK springs, Calsonic Kansei, epson Toyocom, siam Nippon steel Pipe, mercedes Benz Thailand, enkei Thailand. mr. Jaran sabseree omnexs senior Consultant in Thailand won the Best Paper Presented Award from respected Prof. Dr. Kano during the Asian Network for Qualitys 2008 congress, conducted at Swissotel, Thailand.

news from omnex Around the world

Jaran Sabsaree receives the ANQ Congress 2008 Best Paper Award from renowned quality guru Prof. Dr. Kano for his paper: Fusion Six Sigma: Methodology and Case Studies Omnex Mexico Omnex Mexico has recently been focusing on advising companies such as Kenworth to achieve Ts compliance, as well as offering Core Tools courses and Ts training for DNV (an international registrar), Carplastic, Benteler, Linamar, Visteon reynosa, Cassa seating systems, Delphi matamoros, Hayes-Lemmerz, Continental, radar stamping Technologies, Ice Industries, sumidenso mediatech, Delphi Sabinas, and Interplex Industries de Mexico. we have also been working with Troqueladora Beasville de mexico on implementing the ewQms suite at the Queretaro facility. Omnex North America omnex Canada has been exporting its automotive expertise into expanding industries (Medical Devices, Consumer Goods, & Healthcare) using ewQms to successfully support this endeavour. Recently, Omnex Canada assisted in the development and preparation of the Quality management system for Iso 9001 certification and helped with Iso 17025 lab accreditation at two sites for Sierra Wireless. omnex helped Boart Longyear with a product launch including 200 parts at different suppliers throughout North America. The program was a major success with First Article / PPAP performed for all supplier parts. The program was implemented with little or no launch-related problems. Boart Longyear, working with Omnex, has expanded this program world-wide. omnex launched a major Lean / six sigma program for Letica, a plastics injection molder. with 14 green Belt six sigma and Lean programs were launched, savings of over 1.5 million dollars was achieved. Letica and omnex will further broaden these programs in 2009.

Omnex Thailand country manager Praveen Patiyasevi with the Robert Bosch Quality team Omnex Sri Lanka omnex has finalized its partnership agreement with one of the most respected consulting companies in sri Lanka m/s somaratna Consultants (P) Ltd. under the agreement, omnex will provide Lean, six sigma, and Lead Auditor training and implementation services to the sri Lankan business community. The launch ceremony is planned for November 17th and will be presided over by Dr. Sarath Amunugama, Hon. Minister of Enterprise Development and Investment Promotion, and mr. David watkins, executive Vice President of omnexs International operations.

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Moving from FMEA 3rd Edition to 4th Edition

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only for PPAP approval.

Greg Gruska Vice President, Omnex Systems analysis and improvement efforts Deflation of the RPN to obtain an arbitrarily set threshold Sole reliance on the RPN in the evaluation of risk priorities and improvement actions Focusing only on the completion of the FMEA form and not on the knowledge contained therein Lack of understanding of the role of the FMEA process throughout the APQP process i.e. looking at the FMEA as a static document necessary

ome November 1st, 2008, the Chrysler, Ford, and gm Failure mode effects Analysis Reference Manual, 4th edition available from AIAg will supersede the 3rd edition. The 4th edition of the FmeA reference manual expands on the efforts of the 3rd edition by focusing on the FMEA as a process rather than just a set of forms in order to minimize the improper use of the FMEA, including: Column shifting: placing information in the wrong columns thus hindering

The 4th edition also contains discussion which will allow organizations with a mature FmeA process to go beyond the basic implementation and not be subject to non-conformances by auditors who sometimes have a cursory knowledge of the FmeA process or attempt to audit to the manual as a standard.
greg gruska, Vice President of omnex systems, is a Fellow in the American Society for Quality, a Six Sigma Black Belt, and Omnexs principal consultant in performance excellence. He is also a member of the AIAg writing committee for the MSA, SPC, and FMEA reference manuals.

Overview of Changes from 3rd to 4th Edition

3rd edition Focus APQP relationships FmeA Dev. Process Prereq. Activities Documentation Documentation s, o, D rankings rPN Analysis rPN Thresholds Linkages examples How to fill out a standard DFMEA and PFMEA form Not addressed Not addressed Not addressed Oriented towards a single form. DFMEA and PFMEA elements inconsistent. Consistent with current sAe J-1739 Only risk analysis metric discussed No discussion on thresholds Not addressed Single example for DFMEA and PFMEA 4th edition How to develop and document a FMEA with emphasis on DFMEA and PFMEA Addressed Addressed Addressed minimal elements to be documented identified (carry over from 3rd edition form). Alternate forms allowed and examples given. DFMEA and PFMEA element discussions made consistent with uniqueness identified. Consistent with new sAe J-1739 being developed. Default risk analysis metric is RPN, but alternate analysis acceptable. Exclusive use of rPN to determine action priority is not recommended. The use of an rPN threshold is not considered an acceptable practice for determining the need for recommended actions. Addressed multiple examples and graphics used to communicate concepts.

To see a complete listing of the changes with commentary, please visit the omnex resource Center at www.omnex.com.

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Process Function PC ID
PC Description Preventive Potential Potential Potential Failure Effects of Sev Causes of Occ Controls Detective Controls Mode Failure Failure

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OP #

Tool

Process Function

PC ID

PC Description
Process Product

Control Methods

Gage

Sample
E/M-T

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+++

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In the Eye of the OEM

by Capacity utilization and assembly Hours/ Vehicle (HPV), and these measures have a strong impact on an organizations plant cost performance. The more productive an assembly plant is, the higher the First Time Quality. In order to improve productivity, emphasis is increasingly placed on implementing Poka-yoke (error-proofing devices) that either prevent defects or immediately notify line operators of a defect in-station, so that lost productivity time resulting from defects and defect detection can be minimized. given the flood of a variety of models by both domestic and foreign automakers into the North American Market, OEMs need to be flexible in their production capabilities. Assembly plant flexibility is critical for this, and an investment in equipment and infrastructure will allow an OEM to offer a greater portfolio of platforms, models, and chassis configurations to be assembled on one production line. This allows the oem greater flexibility to scale production to meet shifts in customer demand, and it also empowers the OEM to support greater demand in foreign markets. Logistics Foreign automakers are finding it necessary to build in local markets. Transplants from Asia and Europe are growing in North America at an outstanding rate. Honda and Toyota have a half dozen North American plants each. Volkswagen, Bmw, mercedes, Nissan, Mitsubishi, and Hyundai all have assembly plants in North America. Kia has just begun construction in the us, and Chinese automakers are in planning to build American assembly plants. going along with this localization trend is inventory reduction oems have rebalanced production operations to optimize takt time and have taken significant steps to remove non-valued added processing steps. They

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Jim Mourafetis General Manager, Southeast Region change from their previous vertical orientation to a significantly flatter structure. This structure emphasizes team-work, participation with suppliers, self-scheduling through pull systems, problem solving skills, participation in continuous improvement groups, direct communication with senior plant management, zone budget responsibilities, supervisor and administration roles, creation and support of standardized work, improvement in safety and ergonomics, and a greater awareness and sense of urgency focused on satisfying the Customer. How Omnex Can Help These four critical measures are driving your oems approach to your organization. James mourafetis general manager of the new southeastern us regional omnex office has pioneered a method to benchmark OEMs and suppliers based on JD Powers and Harbor results. With this method, Omnex is currently transitioning suppliers and establishing internal audit programs linked to JD Powers and Harbor scores. Business Management system scorecards are modified to reflect these metrics and objectives to meet oem required improvements. Once the scorecards have been revised to meet OEM objectives, omnex develops the key process metrics to support an organization in achieving their newly revised objectives. omnex then creates an audit program to ensure that Quality, Productivity, Logistics, and Cost drive the organizations internal audit process.
James mourafetis has a strong entrepreneurial spirit, and he knows how to continuously reinvent organizations. His successful approaches have produced positive organizational impact at both the system and process level, providing solutions that have resulted in significantly improved results for all stakeholders of the organization.

have also reduced overall WIP vehicle inventory levels within their assembly plants. A solid example of this is Hondas Lincoln, Alabama plant, wherein total material inventory never exceeds four hours worth of production materials, with a maximum of two hours at the workstations. Cost when it comes down to it, the bottom line is paramount, and as it turns out, cost is the driving factor behind all three of these other factors that are affecting oems. It is imperative to keep quality standards high, as returns and defects are extremely expensive problems that additionally drive customers away from your company. Having flexible assembly plants in order to be able to quickly match shifting demand in production saves

Quality, Productivity, Logistics, and Cost drive OEMs approach to your organization.
vast amounts of money by avoiding unnecessary overproduction and allowing a smaller number of assembly plants to accommodate a broad range of models. Assembly plant localization and inventory reduction also reduce costs by minimizing shipping, stock, storage, and maintenance overhead costs. The basic formula for profit is the difference between OEM cost and market-driven price, and the significant variable the oem can control is cost, so any measures that effectively reduce cost consequently increase profit. Restructuring Pressures from these factors have all led automakers to develop production systems that require high levels of communication, skill, and empowerment at the operator level to make quality, cost, and delivery decisions, as well as active involvement in and commitment to continuous improvement activities. These actions have led stamping and assembly plant organization charts to significantly

omnex 315 e. eisenhower Pkwy, suite 110 Ann Arbor, mI 48108 usA 734.761.4940 info@omnex.com

US Training Course Schedule

Order Early for Discounts!
Training schedule subject to enrollment requirements. Dates may vary; to confirm, call us at (734) 761.4940. All courses are offered in Ann Arbor, mI.

2009

OMNEX

navigator

To register, visit our website: www.omnex.com

september 14-16, 2009 November 2-4, 2009

training
July 6-8, 2009 August 3-5, 2009 september 14-16, 2009 october 5-7, 2009 November 9-11, 2009 December 7-9, 2009 January 22, 2009 February 5, 2009 March 19, 2009 April 9, 2009 may 7, 2009 June 11, 2009 July 9, 2009 August 6, 2009 september 17, 2009 October 8, 2009 November 12, 2009 December 10, 2009

classes are offered through AIAg. Call us at (734) 761.4940 or see www.aiag.org to register.

Omnexs Lean & Six Sigma

> ISO Training

ISO 9001:2008
for the Service Sector

Lead Auditor Training for ISO 14001:2004

February 16-20, 2009 April 13-17, 2009 June 15-19, 2009 August 17-21, 2009 october 12-16, 2009 November 30 - December 4, 2009

Internal Auditor Training for ISO 9001:2008

January 19-21, 2009 February 2-4, 2009 march 16-18, 2009 April 6-8, 2009 may 4-6, 2009 June 8-10, 2009 July 6-8, 2009 August 3-5, 2009 september 14-16, 2009 october 5-7, 2009 November 9-11, 2009 December 7-9, 2009

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

ISO 17025
for Laboratories

Internal Auditor Training for ISO 17025:2005

January 19-21, 2009 April 27-29, 2009 July 13-15, 2009 August 10-12, 2009 November 2-4, 2009

Lead Auditor Training for ISO 9001:2008

January 26-30, 2009 February 16-20, 2009 march 2-6, 2009 April 20-24, 2009 May 18-22, 2009 June 8-12, 2009 July 20-24, 2009 August 24-28, 2009 september 21-25, 2009 october 12-16, 2009 November 16-20, 2009 November 30 - December 4, 2009

ISO 13485

for Medical Devices

Internal Auditor Training for ISO 13485:2003

February 2-4, 2009 April 6-8, 2009 June 1-3, 2009 August 10-12, 2009 November 2-4, 2009

ISO 9001:2000 Lead Auditor Training for the Automotive Sector (ISO/TS 16949:2002)
January 26-30, 2009 February 16-20, 2009 march 2-6, 2009 April 20-24, 2009 May 18-22, 2009 June 8-12, 2009 July 20-24, 2009 August 24-28, 2009 september 21-25, 2009 october 12-16, 2009 November 16-20, 2009 November 30 - December 4, 2009

ISO/TS 16949:2002

for Automotive and High Tech Industries

ISO 14001:2004
January 19-21, 2009 March 2-4, 2009 may 4-6, 2009 July 13-15, 2009

for Environmental Management

ISO 9001:2000 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2002)
January 19-21, 2009 February 2-4, 2009 march 16-18, 2009 April 6-8, 2009 may 4-6, 2009 June 8-10, 2009

Internal Auditor Training for ISO 14001:2004

10

omnex 315 e. eisenhower Pkwy, suite 110 Ann Arbor, mI 48108 usA 734.761.4940 info@omnex.com

US Training Course Schedule

Order Early for Discounts!
Training schedule subject to enrollment requirements. Dates may vary; to confirm, call us at (734) 761.4940. All courses are offered in Ann Arbor, mI.

2009

OMNEX

navigator

To register, visit our website: www.omnex.com

9001, ISO 14001, OHSAS 18001)
January 26-30, 2009 February 9-13, 2009 march 9-13, 2009 April 13-17, 2009 may 11-15, 2009 June 22-26, 2009 July 20-24, 2009 August 10-14, 2009 September 28 - October 2, 2009 october 19-23, 2009 November 9-13, 2009 December 14-18, 2009

training
Team Problem Solving (Global 8D)

classes are offered through AIAg. Call us at (734) 761.4940 or see www.aiag.org to register.
July 27-31, 2009 September 28 - October 2, 2009 December 7-11, 2009

Omnexs Lean & Six Sigma

> Special Courses

Auditor Training
February 9-11, 2009 April 6-8, 2009 August 17-19, 2009 october 26-28, 2009

Advanced Auditor Workshop

OHSAS 18001 Lead Auditor with Additional Materials for ISO 9001 & ISO 14001 Integration
January 26-30, 2009 February 9-13, 2009 march 9-13, 2009 April 13-17, 2009 may 11-15, 2009 June 22-26, 2009 July 20-24, 2009 August 10-14, 2009 September 28 - October 2, 2009 october 19-23, 2009 November 9-13, 2009 December 14-18, 2009

march 16-17, 2009 June 1-2, 2009 August 24-25, 2009 october 5-6, 2009 November 30 - December 1, 2009

Zero Defects using Layered Process Audits

March 18-19, 2009 June 3-4, 2009 August 26-27, 2009 october 7-8, 2009 December 2-3, 2009

Other Special Training

Core Tools Training Five Daily Modules:
APQP & DFMEA FMEA Control Plan PPAP SPC MSA February 16-20, 2009 may 11-15, 2009
(May be taken in whole or by module see our website at www.omnex.com for daily schedule)

International Material Data System (IMDS) Reporting

January 12, 2009 March 9, 2009 May 29, 2009 July 13, 2009 September 28, 2009 November 23, 2009

Integrated Management System Lead Auditor (ISO

The ISO/TS 16949:2002 Auditor Handbook:

Process Approach Auditing for the Automotive Industry by Chad Kymal In straightforward language, The ISO/TS 16949 Auditor Handbook explains the automotive standards requirements and outlines the most effective auditing techniques for organizations registered to Iso/Ts 16949. The automotive process approach to auditing is presented in manageable sections that follow a logical step-by-step format. Auditors are walked through a typical audit from start to finish; flowcharts, ready-to-use forms, and annotated templates are included. This essential handbook will help auditors improve and prioritize their audits based on customer requirements and business performance. Available now from Paton Press: www.patonpress.com Contact omnex at 734-761-4940 to place your order now! omnex 315 e. eisenhower Pkwy, suite 110 Ann Arbor, mI 48108 usA 734.761.4940 info@omnex.com

11

Who in the world is Omnex?

Panasonic Siemens Hitachi Fujitsu Philips Sony Ford TRW 3M NEC Bosch Mazda Delphi Suzuki Henkel Toyota Visteon Lucent / Agere General Motors Daimler Chrysler Texas Instruments

Our global clients will tell you.

Weve implemented Management Systems for many of the worlds top companies.

ISO/TS 16949 QOS ISO 14000 Ford Q1 APQP Lean Enterprise

OMNEX

Driving worlDwiDe Business excellence

315 E. Eisenhower Pkwy Suite 110 Ann Arbor, MI 48108 Phone: 734.761.4940 Fax: 734.761.4966 E-mail: info@omnex.com

www.omnex.com