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ISO/TS 16949:2009 Whats Changed? News from Omnex Around the World Paper to Pixels - Using Document pro Omnex 2009 US Training Schedule New Training offerings coming in 2010

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ISO 9001:2008 Surprises
DOEs NO ChANGEs MEAN My QMs Is sAfE?

OMNEX

Chad Kymal - CTO and Founder, Omnex

sO 9001:2008 was released gave companies 24 months to Nov. 14, 2008, followed by upgrade their systems and 12 a communiqu from the months for new companies to International Organization for become certified. standardization (IsO) and t h e The IsO 9001:2008 International Acrelease was creditation a c co m Wondering about f o r u m p a ISO/TS 16949:2009? (IAf). The See page 3 nied key point from with a this communiqu was host of other accoman announcement that there panying guidance documents are no changes to IsO 9001:2008. from the IsO Technical CommitThey also tee 176 on Quality Management p ro v i d e d and Quality Assurance (IsO/Ts overall 176) including guidance on the deadapplication, documentation, lines for implementation, outsourced impleprocesses, and the process apmentaproach of IsO 9001:2008. The tion that Implementation Guidance for IsO 9001:2008 (IsO/ TC 176/sC 2N 836) asked organizations to conduct a review of Chad Kymal
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Applying the Quality Improvement Techniques of Manufacturing Industries to Medical Practices

ExCErpT Of A CAsE sTuDy puBLIshED By ThE COMMONwEALTh fuND, rEprINTED wITh pErMIssION Sarah Klein - The Commonwealth Fund and thus, waste. But, with the help of consultants from both Omnex and AIAG, a large ophthalmology practice proved it could be done. Organization and Leadership Lansing Ophthalmology has 14 physicians and seven optometrists, and a staff of 144 employees who provide clinical and administrative support. The East Lansing office a 35,000-squarefoot facility where clinicians conduct eye exams, perform surgery, and dispense eyewear sees around 63,000 patients per year.
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ix Sigma and Lean manufacturing have been used to identify and reduce defects in production methods for more than two decades. Though commonly used in the automobile and manufacturing industries to reduce costs and increase profits and efficiency, these methodologies have only recently been used to identify and reduce variance in care processes within physician offices. Part of the reason is that medical professionals tend to believe that the complexity of health care routines defies the type of categorization necessary to eliminate process variation

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ISO 9001:2008 Surprises

their QMs against the IsO 9001:2008 standard and to make the necessary changes when their interpretation of IsO 9001 was different from that which is in IsO 9001:2008. what do you think? Does this sound a little confusing? No changes have been made, therefore anything you perceive as a change is the result of an incorrect interpretation of the standard? Lately, we have been receiving calls from customers regarding nonconformities that they had received. One company received a major nonconformity from their 3rd party auditor for not training their auditors. In fact, we conducted a Spanish version of our training to train all of their auditors in Mexico. Another organization we have been in contact with for a few years told us that they received many suggestions for needed changes from their third party auditor during their annual surveillance audit. The auditor also told them that they would be turned into nonconformities if not addressed by the next audit. Interesting!!! so what is going on and what should you do? Before that we need to understand the changes and review some in detail so we can discern a plan of action. Overall, there are 67 changes, but only 26 can really impact a

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Chad Kymal CTO and Founder, Omnex to auditors, they ask auditors to take this interpretation into account for service provision. In fact, you may notice that IrCA has identified 24 items that they want 3rd party auditors focus on in the new IsO 9001:2008. IrCA has also provided an outline highlighting what 3rd party auditors should know in terms of learning objectives: understanding the underlying philosophy and the principles, concepts and requirements of the ISO 9001:2008 standard, and how to apply them within an audit context. understand the key differences between the revised series of standards and the 2000 & 2008 version, and understand the implications of these differences for effective auditing against the revised standard.

mentations. One small change has been made to 4.2.4 Control of records where the standard requires Records established to quality management system shall be controlled. The key word in this change is controlled; there is a greater burden that records need to be restrained or regulated. Omnex, along with other commentators on the standard, interprets this to mean that

Others, who are oblivious to the implications of ISO 9001:2008 changes, are possibly facing a nasty surprise in the form of nonconformities
records need to be available only to those who are responsible and that the content of these records cannot be changed. A small change, but the idea records need to be controlled is something new. I am not sure we can say the control of records is a matter of understanding or interpretation when compared to IsO 9001:2000. The second change is also something small, this time in 7.3.3 Design and Development Outputs. A new Note has been added that Information for production and service provision can include details for preservation of product. This note goes hand in hand with the requirements of 7.3.3 that the output of design has to be compared to many different things, including in 7.3.3 b production

Summary of Changes in ISO 9001:2008 As Defined By Various Organizations

ISO 9001:2008 Clauses Affected Number of changes guidance for auditors 16/23 70% 67 16 24 IRCA NSF

QMs. Lets look at three of those 26 changes - two that are minor and one that may have a major implication to most IsO 9001 imple-

and service provision. since this entire Note is new and notes are only recommendations, do we need to do anything? plain and simple, IrCA, the largest body of 3rd party Auditors, says we do. In their Briefing Note

The third change, which is quite significant in both length and impact, is the redefinition of Outsourcing and the discussion of how outsourced products should be managed and controlled. In a nutshell, IsO 9001:2008 states that An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party (ref 4.1 , Note 2). This definition tends to make me wonder Omnex Training if that includes any and all processes outside of the products we purchase. If we make widgets 26 and a widget lid is made by both ourselves and an external party, technically the widget lid that is purchased would be an outsourced process. On the other end of spectrum, organizations conducting training could be considered outsourced processes too. Most organiza-

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Chad Kymal CTO and Founder, Omnex

ISO/TS 16949:2009 - Whats New?

Other than the changes made to IsO 9001:2008, there is nothing new in IsO /Ts 16949:2009 beyond the inclusion of word statutory wherever regulatory in the standard. The IATf website had the following to say on the IsO/Ts 16949:2009, IsO/Ts 16949:2009 introduces no new or changed requirements. IsO 9001:2008 is based on clarifications or amendments to the existing requirements of IsO 9001:2000 and those that are intended to improve consistency with IsO 14001:2004. however, the IATf further states, Certification Bodies and Organizations are expected to understand and apply the amendments to IsO/Ts 16949:2009. Application of the clarifications related to IsO 9001:2008requirements in the boxed text of IsO/Ts 16949:2009 is effective not later than 120 days after the release of IsO/Ts 16949:2009. for the implications of the changes to IsO 9001:2008, read this article. you may be surprised. we also have webinars to assist you in your transition. see the details listed below. tions that have implemented IsO 9001 will probably need to update their outsourced process list. furthermore, the key addition to outsourced process is the need to ensure that all necessary processes are in place to meet all regulatory, mandatory and customer requirements, (ref. IrCA Briefing Note on IsO 9001:2008 Changes). There is much more that can be said about this topic but is beyond the scope of this article. In conclusion, if we have done a good job taking a sample of the 26 changes, we could conclude that not all changes are just simply interpretations and clarifications, but that some of them are actual changes to the ISO 9001:2000 standard. some and/or many of these changes will require organizations to make related changes to their documentation and their QMs implementation. The deadline to transition to IsO 9001:2008 is Nov. 14, 2010, which isnt as much time as you may think. Many organizations are not aware of the impact of these changes to IsO 9001:2008 well, the IsO/IAf communiqu did say that there were no changes, right? Conducting the necessary document review, training of auditors, and internal audit will take time -- we estimate at least six months. Also, it is a good idea to have your Third party Audit conducted by June of 2010 at the latest. (why? If you fail, you still have time to recover before the deadline.) so there Is still time to get started, but just barely. As a starter, most organizations may want not to get training because it is viewed as unnecessary. Others, who are oblivious to the implications of IsO 9001:2008 changes, are possibly facing a nasty surprise in the form of nonconformities. This is... if your third party auditor is actually tuned in to the changes in the system. The deadline for IsO/Ts 16949:2009 is more severe. The IATf provided only 4 months for automotive organizations to apply changes to the standard. As such, since IsO/ Ts 16949:2009 was released on June 15, 2009, IsO/Ts 16949-certified organizations have very little time left to transition to IsO 9001:2008. Omnex offers a number of webinars that are scheduled monthly to assist you with IsO 9001:2008 and/or IsO/Ts 16949:2009, incluidng the IsO 9001:2008 (or IsO/Ts 16949:2009) Transition Training for Auditors that meets both the IrCA and rABQsA requirements, as well as additional webinars with a focus on implementation. These 3-hour webinars are highly recommended for all first, second and third party auditors as well as those responsible for the implementation of their organizations QMs as the following topics are covered: IsO 9001:2008 - philosophy, principles, Concepts and how to Apply to a QMs Key differences between IsO 9001:2000 and IsO 9001:2008 - Implications of the differences practical examples of these differences in an audit Conducting a Document review for IsO 9001:2008 rABQsA, IrCA and IsO/TC 176 requirements for an auditor Transition deadlines and selected registrars requirements Question and Answer session upon successful completion of a short exam, attendees receive an IsO 9001:2008 Transition Training certificate, which can be used as evidence of Continual professional Development If youre still not convinced that IsO 9001:2008 will have a bigger impact on your QMs than you were lead to believe, there is a free webinar available to view in the Omnex resource Center titled IsO 9001:2008 Might Be More significant Than you realize.
Chad Kymal is the founder and CTO of Omnex Inc., a global, business management consulting organization with hundreds of consultants and several offices worldwide. In addition to founding Omnex, Chad owned an international registrar office and conducted the first world-wide witness audit to Qs-9000. he has published a number of books through paton press including his latest, The IsO/Ts 16949 Auditor handbook: process Approach Auditing for the Automotive Industry. Chads interests include working with large corporations in designing effective Business Management systems and getting value from implementing effective business strategies. he has served on the Malcolm Baldrige Board of Examiners and as an rABQsA-certified Lead Auditor. he has a Bachelors degree in Mechanical Engineering from General Motors Institute, a Masters degree in Industrial and Operations Engineering from the university of Michigan, and an MBA from the university of Michigan. Over Chads successful career, he has received numerous quality achievement awards, including the Quality professional of the year award by the American society of Quality Automotive Division in 2005.

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Charles Dobis, CMpE, has been executive director of the practice for more than 20 years. Teresa prior, r.N., who has been the practices clinical director for almost eight years, oversaw the project. The practice relied on the consulting advice of David Lalain, director of life sciences for the Automotive Action Industry Group (AIAG), and David watkins, executive vice president and director of international operations for Omnex. In early 2007, Lansing Ophthalmology volunteered to take part in a pilot project sponsored by AIAG, which aimed to demonstrate the value of applying Lean production and six sigma techniques to the health care industry. The administrative leaders at Lansing Ophthalmology hoped to use these methodologies to streamline the flow of patients through its main clinic. At the time, patients were waiting as long as 90 minutes to see a doctor; they tended to bunch outside the physicians offices, putting additional pressure on doctors (see figure 1). The group had tried without success to find its own solution to the problem.

ister the patient, gather a history, perform a refraction, and provide other services. The chart also captured how long patients waited between these care processes. Before project leaders began gathering data, they held meetings to gain the cooperation and support of the practices physicians and staff. That was the most difficult part, Dobis says. Although the clinicians and staff agreed patient flow was a problem, they were reluctant to change the existing system, which allowed physicians great latitude in how they prioritized patients and managed their time. No one wanted to give up control of his or her own schedule, he says. It wasnt strictly self-interest. There was also a prevailing sense that wait times might increase. They thought things might get worse; that instead of seeing improvement, things might degenerate further, Dobis says. Such resistance to change is common among professionals such as lawyers, engineers, and doctors, watkins says. They say, There is no such thing as a process. what we do is an art form. That was the case at Lansing as well. They were adamant there were no processes, Lalain says. The data would show

the patient flow problem was a longstanding one, which the practice had not previously been able to solve. In essence, prior argued: Now we have experts. we have to try it. The collected data showed that 241 patients or 19.6 percent of those measured had spent more than one hour waiting during their visit. The data also showed that, while there were some 149 exam combinations required by patients, nearly 50 percent followed one of five set patterns. The 242 patients who came for a history, a refraction, dilation, and an exam with the doctor spent an average of 79 minutes in the office, of which 45 minutes was spent waiting. The consultants found great variability in the time taken to perform various procedures. The number of patients seen by doctors per hour ranged from less than two to nearly six (see figure 3). The practice made a decision not to try and alter that variation at the outset. In some cases, there were good reasons for the variability: some physicians were performing more complex procedures or seeing long-term patients who required more face time with doctors. Eventually they are going to get pulled into the process, Lalain says. But not at first. Once they are sold on eliminating variation with techniciains and everything else, then they might swallow the pill that says they are part of the problem, Lalain says.

Drawing on six sigma methods, the consultants recommended collecting patient flow data for a period of seven business days, measuring how long it took patients to advance through every step of the process. Clinic staff kept a separate time sheet for each person, noting how long it took to reg-

otherwise, but until they could collect it, Dobis and Prior had to convince the physicians and staff they needed outside help. The two stressed that

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Among the technicians, there was also great variability in the time taken to gather histories from patients and perform refractions. histories took from five to 16 minutes, while EpIC exams (a refraction to measure the degree of a patients nearsightedness or farsightedness, if any) took from five to 21 minutes, depending on the technician. That variation made it difficult to present a patient to the doctor at the appropriate time. Another problem revealed by the data was the variation in patient arrival times. some were as much as an hour early and others were up to 45 minutes late. Because the clinic had a policy of seeing patients when they arrived, patients were inadvertently encouraged to game the schedule, which had tremendous downstream consequences for staff trying to predict the flow of patients and manage their care appropriately. The data also confirmed what physicians had complained about: patients were bunching outside doctors offices in large numbers. The problem, consultants pointed out, was caused by the fact that patients were being moved through the system without any recognition for the pace at which doctors were seeing those patients. To reduce variation in the patient-flow process, the practice: formalized its training for technicians to reduce the variation in exam times. Created a queuing system that limited the number of patients entering the doctors waiting area. restructured the scheduling system to anticipate the time needed to complete vision tests before meeting with doctors.

The data collection process focused on three measures, as defined below: Technician time: The goal is 10 minutes for each exam (the previous range was five to 21 minutes). Everyone is hitting it except for some new people, says prior. The consultants determined that if the clinic could train the technicians to complete both the history and the refraction in eight minutes each, they could save the equivalent of one and one-half staff positions per year (figure 4). prior says that, because the clinic is growing, it would not lay off staff but would use any extra staff to meet the needs of new physicians.

managers or patient coordinator tries to assign patients to different doctors to smooth out the flow. The goal is to pull patients through the system at the pace at which doctors can see them, rather than push them through without regard for such timing. Applicability to Other Practices Its easier to implement such programs in specialties that compete for patients, such as ophthalmology and plastic surgery, as well as practices where the provided services are more routine. Its not impossible to make the same improvements in a primary care practice, says watkins. Even in an apparently unpredictable system, theres predictability, he says. Because of employee resistance to change, its important to have a highly motivated person shepherding the project. This leader also needs reinforcement. when prior was frustrated, for example, she could turn to one of the consultants, who would remind her that the things she was experiencing were typical.
This is an excerpt of the case study Applying the Quality Improvement Techniques of Manufacturing Industries to Medical practice ioriginally published in the september/October 2008 edition of Quality Matters by The Commonwealth fund. This case study can be viewed in its entireity at: http://www.commonwealthfund. org/Content/Newsletters/Quality-Matters/2008/ September-October.aspx Copyright 2008 The Commonwealth fund The Commonwealth fund 1 East 75th street New york, Ny 10021 phon: 212.606.3800 fax: 212.606.3500 E-mail: commonwealth@cmwf.rog web: www.commonwealthfund.org

wait times: we met the benchmark for a complete eye exam, which is one hour and 16 minutes, says prior. The average prior to implementation was three minutes more. The clinic expects to see greater time savings when it fully implements the new scheduling system. Bunching: Doctors only see one or two patients waiting for their visit at any given time. That doesnt mean more patients arent waiting, as there can still be clusters of patients after 11 am or 4 pm. In those cases, the clinic

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Omnex China Omnex China has launched a program conducting six sigma Green Belt training for Autoliv Electronics, a fortune 500 company who is the market leader in vehicle safety. Autoliv operates 80 companies in 28 countries, developing and supplying safety systems and products to automotive manufacturers around the world, including major Chinese brands such as Chery, Geely, Brilliance, and many others. Autoliv joins a long list of well-known companies to use Omnex China for six sigma projects, including Chery, Vishay, and saint-Gobain. Omnex China also had the opportunity to assist 2 large companies in their r&D by conducting DfMEA training for Zhongtong Bus & holding Co., and robust Design training for the key engineers of fAw-wV Automobile Co., Ltd. As a standardized joint-stock company, Zhongtong Bus & holding Co., Ltd. has a long history of manufacturing large- and medium-sized buses for nearly 40 years and is one of the first listed bus OEMs in China. The Company mainly manufactures 350 sets of equipment through its internationally advanced production line incorporating the complete bus manufacturing technology from Dutch BOVA Company, with an annual production capacity of more than 10,000 medium- and high-end luxury buses. fAw-Vw Automobile Co., Ltd. is a major passenger sedan joint-venture of fAw Group Corporation and Volkswagen AG, Audi AG and Volkswagen Automobile (China) Investment Co., Ltd. It is Chinas first modern passenger sedan industrial base of considerable economic scale. Omnex Middle East Omnex Middle-East has had an eventful year with an increasing number of projects and training programs being managed simultaneously from the Dubai office. As part of Omnexs association with Dubai Customs, we are developing and implementing an IsO/IEC 20000-1:2005 IT service Management system, as well as providing understanding and Lead Auditor training for the same as part of the implementation. Omnex has also conducted an in-house Lead Auditor training program in Occupational health & safety Management systems (OhsAs 18001:2007) for Canpack Dubai, a leading can manufacturing company. Omnex also has another set of projects for implementation of valueadded systems and Integrated Management systems (Integrating IsO 9001:2008 and IsO 14001:2004) for some of the major suppliers of Burj Dubai (the worlds tallest tower) in Dubai, u.A.E. The planned growth of Omnex Middle East is continuing through the successful ongoing project of IsO/IEC 17025:2005 practical training for ADwEA. Ravikumar General Manager of Omnex Middle East, with the Canpack Dubai team. Omnex India Omnex India, through the Bangalore office, has signed the largest green field site IsO/Ts 16949:2009 implementation contract. The real challenge for this implementation lies in incorporating a large number of critical processes into the system. The project also needs to address the need for a scope for integrating with their present system while simultaneously working on cost-benefit projects. The implementation of value-added IsO 9001 was recently completed for one of Indias largest banks, ICICI Bank, Mumbai. since 2008, Omnex has been working with General Motors India on the implementation of IsO 9001 and IsO 14001 certification, in addition to integrating GMp. This project has ended with GMI successfully obtaining certification. Omnex India has also been busy in the field of Lean six sigma. A Lean six sigma implementation project has recently been started with Castrol India and the second phase of Lean six sigma implementation projects for Intimate fashions, a leading garment manufacturing company in India, has recently been completed. Omnex launched our money saver implementation programs for sMEs, with many companies improving their bottom line using Lean and six sigma projects. The implementations, with a time span of 2-4 months, results in large savings to organizations. Earlier, most of the companies were dependent on their headquarters for all support, which incurs huge costs. utilizing Omnex Indias regional offices and worldwide support, companies are able to finish projects within a lower, more affordable budget.

News from Omnex Around the World

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Omnex Thailand Omnex Thailand extended our partnership with Essilor Manufacturing by conducting Team problem solving (8D) workshops for the CI-Asias Management at Essilor. Attendees included members from france, India, China, Taiwan and the phillipines. Omnex Thailand is currently working with several other companies in their implementation efforts towards various standards.

News from Omnex Around the World

training and IsO 9001:2008 & IsO/Ts 16949:2009 Transition training. These webinars have been well-received and over 100 companies have already enrolled students for these web-based training. The Transition training in particular has been heavily praised for the convenience a web-based class provides and the quality of the training itself. As one recent student commented, Not only was the information designed to meet the requirements of the official bodies, but was also presented in a format and at a depth beyond my expectations. Often, students are surprised by how effective the webinar format is as a training tool. In fact, sal Casas of rio Tinto, who recently hosted a webinar for its employees in Mexico, told the presenter that they did not expect as much as they received from the training. watch for more web-based training from Omnex in 2010! with the As9100 series of standards - including As9110, As9120 and As9101 - either having been updated are in the process of being updated, Omnex has been hard at work updating our existing Aerospace-related training or creating new training as necessary. The upcoming rewrite to As9101 Quality Management system Assessment is adopting a process-oriented and performance analysis-based approach to auditing, and therefore offers significant training opportunities. As9100C Quality Management systems - requirements for Aviation, space and Defense Organizations was released earlier this year and incorporates the latest version of IsO 9001:2008 in addition to other significant changes. The current release includes project management and risk management incorporated into sales, design, engineering, purchasing and manufacturing. Beyond risk, there is a linkage created between special, Critical and Key Characteristics. Look for a new training series of Aerosapce Industry standards from Omnex within the next few months. Omnexs Enterprise Management system software underwent a major release in June of this year. significant features were added to Omnexs state-of-the-art ApQp software (AQuA pro Integrated DfMEA/pfMEA/Control plan/work Instructions) and the Document Management system software (Document pro). for example, AQuA Pro - which enables the use of families of products and processes for the manufacturing side - has been extended to design; where design risk and test programs conducted for functions, bills of materials, or features can now re-use this information, saving much time and cost during product launch. similarly, the ApQp project management software (project planner) has addedd risk Assessment as a feature. Omnex has also added a brand new module: problem solver for Corrective and preventive Actions, as well as a new CrM package. Overall, 16 major features - including two new software modules - were added to the EwIMs suite. find out more about the EwIMs software suite by contacting us, or visiting www.omnexsystems.com.

Praveen Patiyasevi with the Essilor team during the 8D workshop.

Omnex North America Chad Kymal, CTO of Omnex, was invited to speak at NOshCON, the largest health, safety and Environmental risk Conference in Africa, held by NOsA in Central Drakensberg, south Africa on August 25-28. Chad presented an important paper on Integrated risk Analysis for Quality, Environmental and Occupational health & safety (IsO 9001, IsO 14001, OhsAs 18001). Integrated risk Analysis is the ability of companies to integrate various risk assesments using one common tool and format (i.e., fMEA). Chad co-wrote this paper with Greg Gruska, Vice president of Technology for Omnex Inc., who is also a member of the writiing committe of the fMEA 4th Edition Manual published by AIAG. This paper discusses how the use of a common format and standardized risk tables leads to providing management a risk assessment number that is common and consistent in rating and prioritizing Quality, Environmental, and health & safety risks. The paper further extends the calculation of risk to common departments, processes and products based on identifying process and product families. It is also addresses using Enterprise software to accomplish this task. for more information on this important topic, check the Omnex resource Center or join our free webinar on september 24, 2009. Detals are available on our website. Omnex has expanded its selection of web-based training with the successful launch of a series of webinars in Automotive Core Tools

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Paper to Pixels
usING DOCuMENT prO fOr DOCuMENT MANAGEMENT
The Customer The Murugappa Group, headquartered in India, is a $3 billion conglomerate with interests in engineering, abrasives, fertilizers, finance, bio-products and plantations. It has over 25 companies under its roof, of which more than five are listed and actively traded on the National stock Exchange (NsE) and the India stock Exchange (BsE).CuMI is one of the group companies that manufactures abrasives in India and caters to the global market. The Challenge Despite state-of-the-art IT systems and sophisticated business processes, the volume of paper that assaults the typical enterprise is overwhelming. Not surprisingly, the perils of paper have exacted a toll on CuMI as well. Manual searching for a particular documentor associated documentsdevoured even more time. records management brought its own set of problems.

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Anthony John, AGM - Operations ments to each employee across different entities and plants during a procedure/work Instructions. so, in addition to the pure bulk of paper, there was an organizational requirement that needed to be addressed. CuMIs main criteria for selecting a solution provider was an international company with wide expertise and implementation of Quality Management systems and, ease of use of the software for their employees; given this, it wasnt difficult selecting Omnex as a possible provider. Omnex took a consulting approach and recommended Document Pro as a solution. Omnex presented a live demonstration of Document pro that seemed to address CuMIs business issues. what finally put Document Pro ahead of the pack were our outstanding and credible Customer

The post-implementation review of ROI from Document Pro validated a reduction of 20% of the time spent tracking, searching and waiting for documents
The Solution It all started when the team from TpM, QA and IT saw the value in implementing a Document Management system in their Quality department and progressively including additional departments throughout the enterprise. It wasnt just the 20,000 pieces of paper that drove CuMI to seek a solution, but also the challenge of distributing docu-

Documents a mess? Omnex can help.

For more on document management, log in to the Omnex website Resource Center to see the video of our webinar:
Document Pro is your complete document control solution. Web-based Single or Multi-site Configuration User Defined Folder Structure Automated Approval Routing Revision Control Related Documents Function Document Drafts Action Items List

Managing Documents in the Global Environment of the 21st Century

WWW.OmNex.cOm

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references. Our customers highly recommended Document pro and attest to the advantage it provides to the enterprise. with such great features and strong client references, CuMI decided to implement Document Pro for four of their abrasives units. At Omnex, we typically believe in aligning the clients business process to the software, however, in this case, we decided to align Document pro to suit CuMIs operational needs. The original installation took less than a day and the CuMI training center was arranged to provide intensive software training, data input workshops and realtime case studies. The post-implementation review of rOI from Document pro validated a reduction of 20% of the time spent on tracking, searching

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Anthony John, AGM - Operations provided for all new recruits. The Future CuMI is actively working with Omnex to extend the Document Pro to other divisions of Murugappa Group, such as Ceramics. Document Pro has also been extended to the Legal cell of CuMI corporate. Omnex has also custom-developed a statutory Compliance Management system for CuMI, which will be used by all the plants across India. for more information on Document pro and EwQMs, please visit the Omnex systems website at http://www.omnexsystems.com or contact us for product information or to schedule a product demo.

Documents can be accessed by the intended users from any location of the divsion at any time. No need to maintain a separate Amendment summary as it is built-in during each revision activity. - sundravadivelu GM, TPM & QA
and waiting for documents. This, in turn, has increased productivity and ushered in a new discipline across the plants, thereby increasing their savings on investment. CuMI has included the Document Pro training as part of their hr Induction process for all new recruits. A printed handout on the Document Management system is distributed with the New Employee Induction kit and training is

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Lead Auditor Training for ISO 14001:2004
October 12-16, 2009 November 30 - December 4, 2009

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classes are offered through AIAG. Call us at (734) 761.4940 or see www.aiag.org to register. Web-based ISO/TS 16949:2009 Auditor Transition Training - satisfying RABQSA and IRCA requirements for ISO 9001:2008

Omnexs Lean & Six Sigma

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Internal Auditor Training for ISO 9001:2008

september 14-16, 2009 October 5-7, 2009 November 9-11, 2009 December 7-9, 2009

ISO 17025
for Laboratories

Internal Auditor Training for ISO 17025:2005

November 2-4, 2009

Lead Auditor Training for ISO 9001:2008

september 21-25, 2009 October 12-16, 2009 November 16-20, 2009 November 30 - December 4, 2009

ISO 13485

Web-based ISO/TS 16949:2009 Transition Training With a Focus on Implementation

september 29, 2009 October 30, 2009 November 20, 2009 December 18, 2009

for Medical Devices

Internal Auditor Training for ISO 13485:2003

November 2-4, 2009

Web-based ISO 9001:2008 Auditor Transition Training - satisfying RABQSA and IRCA requirements
september 28, 2009 October 29, 2009 November 19, 2009 December 17, 2009

ISO/TS 16949:2002

for Automotive and High Tech Industries

ISO 9001:2000 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2002)
september 14-16, 2009 October 5-7, 2009 November 9-11, 2009 December 7-9, 2009

> Special Courses

Auditor Training
October 26-28, 2009

Advanced Auditor Workshop OHSAS 18001 Lead Auditor with Additional Materials for ISO 9001 & ISO 14001 Integration
JAugust 10-14, 2009 september 28 - October 2, 2009 October 19-23, 2009 November 9-13, 2009 December 14-18, 2009

Web-based ISO 9001:2008 Transition Training With a Focus on Implementation

september 28, 2009 October 29, 2009 November 19, 2009 December 17, 2009

Customer Specific Requirements and Core Tools - Effect on Process Approach to Auditing
september 17, 2009 October 8, 2009 November 12, 2009 December 10, 2009

ISO 14001:2004
september 14-16, 2009 November 2-4, 2009

for Environmental Management

Internal Auditor Training for ISO 14001:2004

ISO 9001:2000 Lead Auditor Training for the Automotive Sector (ISO/TS 16949:2002)
september 21-25, 2009 October 12-16, 2009 November 16-20, 2009 November 30 - December 4, 2009

Integrated Management System Lead Auditor (ISO 9001, ISO 14001, OHSAS 18001)
Jseptember 28 - October 2, 2009 October 19-23, 2009 November 9-13, 2009 December 14-18, 2009

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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. Courses offered in Ann Arbor, MI except where noted

2009

OMNEX

navigator

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

DFMEA and PFMEA PPAP SPC MSA september 28 - October 2, 2009 December 7-11, 2009

training
November 19, 2009 December 17, 2009 september 29, 2009 October 30, 2009 November 20, 2009 December 18, 2009

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

Omnexs Lean & Six Sigma

Other Special Training

Team Problem Solving (Global 8D)
October 5-6, 2009 November 30 - December 1, 2009

Zero Defects using Layered Process Audits

October 7-8, 2009 December 2-3, 2009

Web-based ISO/TS 16949:2009 Auditor Transition Training - satisfying RABQSA and IRCA requirements for ISO 9001:2008

Web-based ISO 9001:2008 Auditor Transition Training - satisfying RABQSA and IRCA requirements
september 28, 2009 October 29, 2009 November 19, 2009 December 17, 2009

> Web-based Training

Core Tools Training Five Daily Modules:
APQP & Control Plans
(May be taken in whole or by module see our website at www.omnex.com for daily schedule)

Web-based ISO/TS 16949:2009 Transition Training With a Focus on Implementation

september 29, 2009 October 30, 2009 November 20, 2009 December 18, 2009

Web-based ISO 9001:2008 Transition Training With a Focus on Implementation

september 28, 2009 October 29, 2009

New Training Offerings Coming in 2010!

Omnex is expanding our training catalog in 2010 in response to the needs and changes of the global marketplace. Look for new training offerings in the upcoming months in the areas of Aerospace, food safety and healthcare. In order to prepare you for these new offerings, we are presenting a number of free webinars to give you a taste of whats coming:

Aerospace
As9100C introduces major changes in the product Development process with the addition of project Management, risk Assessment and flow-Through Characteristics. The auditing standard will move from a checklist audit to a Process Approach audit including a performance-oriented audit, putting a bigger emphasis on the process Approach and the process Definition of organizations.

Other GFSI Standards

October 27, 2009

Healthcare
focusing on patient safety and improved outcomes, health care providerswhether hospitals, clinics, physician offices or labs are struggling in their efforts to reduce errors and improve care in their facilities. In fact, the industry as a whole is promoting an error prevention culture and adopting CI tools that are currently used in other industries, including healthcare fMEA (hfMEA) and root Cause Analysis (rCA). hfMEA and rCA have recently become Joint Commission requirements, so it is important to understand and be able to effectively employ these tools to reduce risk.

AS9100, AS9110, AS9120 and AS9101 Key Changes

October 6, 2009

Food Safety
what are the sQf, fsCC 22200 and other GfsI standards? how do they compare? how do you benefit from implementing them? what are hACCp standards for food safety and how does it compare to hACCp for Quality as required by sQf?

Reduce Sentinel error risk and improve patient safety through best practices
November 12, 2009

SQF, FSCC 22000, ISO 22000 and

Omnex 315 E. Eisenhower pkwy, suite 110 Ann Arbor, MI 48108 usA 734.761.4940 info@omnex.com

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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

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