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ISO/TS 16949:2009 - What’s Changed?

News from Omnex Around the World

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Six Sigma and Lean manu-facturing 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 pro-cesses 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 –

and thus, waste. But, with the help of consultants from both Omnex and AIAG, a large oph-thalmology practice proved it could be done.

Organization and Leadership

Lansing Ophthalmology has 14 physicians and seven optom-etrists, and a staff of 144 em-ployees who provide clinical and administrative support. The East Lansing office – a 35,000-square-foot facility where clinicians conduct eye exams, perform surgery, and dispense eyewear – sees around 63,000 patients per year.

ISO 9001:2008 SurprisesDOEs “NO ChANGEs” MEAN My QMs Is sAfE?

Chad Kymal - CTO and Founder, Omnex

Applying the Quality Improvement Techniques of Manufacturing Industries to Medical PracticesExCErpT Of A CAsE sTuDy puBLIshED By ThE

COMMONwEALTh fuND, rEprINTED wITh pErMIssION

Sarah Klein - The Commonwealth Fund

I sO 9001:2008 was released Nov. 14, 2009, followed by a communiqué from the

International Organization for standardization (IsO) and t h e International Ac-creditat ion f o r u m (IAf). The key point from this communiqué was an announcement that “there are no changes to IsO 9001:2008”. They also provided o v e r a l l d e a d -lines for i m p l e -m e n t a -tion that

gave companies 24 months to upgrade their systems and 12 months for new companies to become certified.

T h e IsO 9001:2008 release was

accom-p a -

n i e d with a

host of other accom-panying guidance documents from the IsO Technical Commit-tee 176 on Quality Management and Quality Assurance (IsO/Ts 176) including guidance on the application, documentation, implementation, outsourced processes, and the process ap-proach of IsO 9001:2008. The

Implementation Guidance for IsO 9001:2008 (IsO/TC 176/sC 2N 836) asked organizations to conduct a review of

Chad Kymal

Wondering about ISO/TS 16949:2009?

See page 3

September 2009

Omnex • 315 E. Eisenhower pkwy, suite 110 • Ann Arbor, MI • 48108 • usA • 734.761.4940 • [email protected] 1

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their QMs against the IsO 9001:2008 stan-dard 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 re-garding nonconformities that they had received. One company received a major nonconformity from their 3rd party auditor for not train-ing their auditors. In fact, we conducted a Spanish version of our training to train all of their auditors in Mexico. Another orga-nization 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 sur-veillance audit. The auditor also told them that they would be turned into nonconfor-mities 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

QMs.

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

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

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 pro-vision 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 differ-ent things, including in 7.3.3 b “production

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

to auditors, they ask auditors to take this in-terpretation into account for service provi-sion. 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 highlight-ing what 3rd party auditors should know in terms of learning objectives:

• understanding the underlying phi-l o s o p h y and the principles, c o n c e p t s and re-quirements of the ISO 9001:2008

standard, and how to apply them within an audit context.

• understand the key differences between the revised series of stan-dards and the 2000 & 2008 version, and understand the implications of these differences for effective audit-ing against the revised standard.

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 if that includes any and all processes outside of the prod-ucts we purchase. If we make widgets and a widget lid is made by both our-selves and an exter-

nal 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-

Summary of Changes in ISO 9001:2008 - As Defined By Various OrganizationsISO 9001:2008 IRCA NSF Omnex Training

Clauses Affected 16/2370%

Number of changes 67

guidance for auditors 16 24 26

ISO 9001:2008 Surprises (cont from cover)Chad Kymal – CTO and Founder, Omnex

Others, who are oblivious to the implications of ISO 9001:2008 changes, are possibly facing a nasty surprise in the form of nonconformities

Omnex • 315 E. Eisenhower pkwy, suite 110 • Ann Arbor, MI • 48108 • usA • 734.761.4940 • [email protected]

navigator ISO 9001:2008 Surprises (cont from pg 2)

Chad Kymal – CTO and Founder, Omnex

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 custom-er 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 documenta-tion and their QMs implementation.

The deadline to transition to IsO 9001:2008 is Nov. 14, 2010, which isn’t 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 commu-niqué 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 Audi-tors that meets both the IrCA and rABQsA requirements, as well as additional webi-nars 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 imple-mentation of their organization’s QMs as the following topics are covered:

• IsO 9001:2008 - philosophy, princi-ples, Concepts and how to Apply to a QMs

• Key differences between IsO 9001:2000 and IsO 9001:2008 - Im-plications of the differences

• practical examples of these differenc-es in an audit

• Conducting a Document review for IsO 9001:2008

• rABQsA, IrCA and IsO/TC 176 re-quirements for an auditor

• Transition deadlines and selected registrar’s requirements

• Question and Answer session• upon successful completion of a

short exam, attendees receive an IsO 9001:2008 Transition Training certifi-cate, which can be used as evidence of Continual professional Develop-ment

If you’re 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 found-ing 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. Chad’s interests include working with large cor-porations in designing effective Business Manage-ment systems and getting value from implement-ing effective business strategies. he has served on the Malcolm Baldrige Board of Examiners and as an rABQsA-certified Lead Auditor. he has a Bach-elor’s degree in Mechanical Engineering from General Motors Institute, a Master’s degree in Industrial and Operations Engineering from the university of Michigan, and an MBA from the uni-versity of Michigan. Over Chad’s successful career, he has received numerous quality achievement awards, including the Quality professional of the year award by the American society of Quality Au-tomotive Division in 2005.

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 intro-duces 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 clarifica-tions 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.

ISO/TS 16949:2009 - What’s New?


navigatorApplying the Quality Improvement Techniques... (cont from cover)

Charles Dobis, CMpE, has been executive di-rector of the practice for more than 20 years. Teresa prior, r.N., who has been the prac-tice’s clinical director for almost eight years, oversaw the project. The practice relied on the consulting advice of David Lalain, direc-tor of life sciences for the Automotive Action Industry Group (AIAG), and David watkins, executive vice president and director of in-ternational operations for Omnex.

In early 2007, Lansing Ophthalmology volun-teered to take part in a pilot project spon-sored by AIAG, which aimed to demonstrate the value of applying Lean production and six sigma techniques to the health care in-dustry. The administrative leaders at Lansing Ophthalmology hoped to use these meth-odologies 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 pres-sure on doctors (see figure 1). The group had tried without success to find its own so-lution to the problem.

Drawing on six sigma methods, the consul-tants 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-

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 practice’s physicians and staff. “That was the most difficult part,” Dobis says. Although the clinicians and staff agreed patient flow was a problem, they were re-luctant 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 wasn’t strictly self-interest. There was also a pre-vailing 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

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

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 fol-lowed one of five set patterns. The 242 pa-tients 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 de-cision 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. “Eventu-ally 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.


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Among the technicians, there was also great variability in the time taken to gather histo-ries from patients and perform refractions. histories took from five to 16 minutes, while EpIC exams (a refraction to measure the degree of a patient’s 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 en-couraged 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 con-firmed what physi-cians 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 techni-cians 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 com-plete vision tests before meeting with doctors.

Key Measures

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). “Every-one 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.

• 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 doesn’t mean more patients aren’t waiting, as there can still be clusters of patients after 11 am or 4 pm. In those cases, the clinic

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

It’s easier to implement such programs in specialties that compete for patients, such as ophthalmology and plastic surgery, as well as practices where the provided ser-vices are more routine. It’s not impossible to make the same improvements in a primary care practice, says watkins. “Even in an ap-parently unpredictable system, there’s pre-dictability,” he says.

Because of employee resistance to change, it’s 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 Manufactur-ing Industries to Medical practice” ioriginally published in the september/October 2008 edition of Quality Matters by The Common-wealth 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: [email protected]

web: www.commonwealthfund.org

Applying the Quality Improvement Techniques... (cont from pg 4)


navigatorNews from Omnex Around the World中国 भारतไทย

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 Auto-mobile 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 in-ternationally 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 Volkswa-gen Automobile (China) Investment Co., Ltd. It is China’s 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 simulta-neously from the Dubai office. As part of Omnex’s 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 manufactur-ing company.

Omnex also has another set of projects for implementation of value-added systems and Integrated Management systems (Integrating IsO 9001:2008 and IsO 14001:2004) for some of the major suppliers of Burj Dubai (the world’s 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.

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 complet-ed for one of India’s 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 ad-dition to integrating GMp. This project has ended with GMI success-fully 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 imple-mentation projects for Intimate fashions, a leading garment manu-facturing 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 India’s regional offices and worldwide support, companies are able to finish projects within a lower, more affordable budget.

Ravikumar – General Manager of Omnex Middle East, with the Canpack Dubai team.


navigatorNews from Omnex Around the World中国 भारतไทย

Omnex Thailand

Omnex Thailand extended our partnership with Essilor Manufac-turing by conducting Team problem solving (8D) workshops for the CI-Asia’s 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.

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 depart-ments, 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 sep-tember 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

training and IsO 9001:2008 & IsO/Ts 16949:2009 Transition train-ing. These webinars have been well-received and over 100 compa-nies 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 train-ing itself. As one recent student commented, “Not only was the in-formation designed to meet the requirements of the official bodies, but was also presented in a format and at a depth beyond my expec-tations.” Often, students are surprised by how effective the webinar format is as a training tool. In fact, sal Casas of rio Tinto, who re-cently hosted a webinar for its employees in Mexico, told the pre-senter 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 Aero-space-related training or creating new training as necessary. The up-coming rewrite to As9101 Quality Management system Assessment is adopting a process-oriented and performance analysis-based ap-proach to auditing, and therefore offers significant training oppor-tunities.

As9100C Quality Management systems - requirements for Avia-tion, 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.

Omnex’s Enterprise Management system software underwent a major release in June of this year. significant features were added to Omnex’s 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 mate-rials, or features can now re-use this information, saving much time and cost during product launch. similarly, the ApQp project man-agement 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.omnexsys-tems.com.

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


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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:

Managing Documents in theGlobal Environment of the 21st Century

WWW.OmNex.cOm

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

Paper to Pixels usING DOCuMENT prO fOr DOCuMENT MANAGEMENT

Anthony Peter John Maria - Sr. Mgr., Operations, CPC

The Customer

The Murugappa Group, headquartered in India, is a $3 billion conglomerate with in-terests 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 Ex-change (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 so-phisticated business processes, the volume of paper that assaults the typical enter-prise is overwhelming. Not surprisingly, the

perils of paper have exacted a toll on CuMI as well. Manual searching for a particular document—or associated documents—de-voured even more time. records manage-ment brought its own set of problems.

The Solution

It all started when the team from TpM, QA and IT saw the value in implementing a Doc-ument Management system in their Quality department and progressively including ad-ditional departments throughout the en-terprise. It wasn’t just the 20,000 pieces of paper that drove CuMI to seek a solution, but also the challenge of distributing docu-

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 re-quirement that needed to be addressed.

CuMI’s main crite-ria for selecting a solution provider was an international company with wide expertise and imple-mentation of Quality Management systems and, ease of use of

the software for their employees; given this, it wasn’t difficult selecting Omnex as a pos-sible provider. Omnex took a consulting ap-proach and recommended Document Pro as a solution. Omnex presented a live dem-onstration of Document pro that seemed to address CuMI’s business issues. what finally put Document Pro ahead of the pack were our outstanding and credible Customer ref-

The post-implementation review of ROI from Doc-ument Pro validated a reduction of 20% of the time spent tracking, searching and waiting for

documents


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erences. Our customers highly recommend-ed Document pro and attest to the advan-tage it provides to the enterprise. with such great features and strong client references, CuMI decided to implement Docu-ment Pro for four of their abrasives units.

At Omnex, we typically believe in aligning the client’s business process to the software, however, in this case, we decided to align Document pro to suit CuMI’s 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 real- time case studies.

The post-implementation review of rOI

from Document pro validated a reduction of 20% of the time spent on tracking, searching and waiting for documents. This, in turn, has increased productivity and ushered in a new

discipline across the plants, thereby increas-ing their savings on investment. CuMI has included the Document Pro training as part of their hr Induction process for all new re-cruits. A printed handout on the Document Management system is distributed with the New Employee Induction kit and training is provided for all new recruits.

The Future

CuMI is actively working with Omnex to extend the Document Pro to other divi-sions of Murugappa Group, such as Ceram-

ics. Document Pro has also been ex-tended to the Legal cell of CuMI corpo-rate. 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.

Paper to Pixels usING DOCuMENT prO fOr DOCuMENT MANAGEMENT

Anthony Peter John Maria - Sr. Mgr., Operations, CPC

Initial setup is simple, but care has to be taken for defining the levels and user groups. After the initial

setup system runs seamlessly and smoothly. - Nayajiv V – Document Pro Administrator


navigator

> ISO TrainingISO 9001:2008for the Service Sector

Internal Auditor Training for ISO 9001:2008september 14-16, 2009October 5-7, 2009November 9-11, 2009December 7-9, 2009

Lead Auditor Training for ISO 9001:2008september 21-25, 2009October 12-16, 2009November 16-20, 2009November 30 - December 4, 2009

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

Web-based ISO 9001:2008 Transition Training With a Focus on Implementationseptember 28, 2009October 29, 2009November 19, 2009December 17, 2009

ISO 14001:2004for Environmental Management

Internal Auditor Training for ISO 14001:2004september 14-16, 2009November 2-4, 2009

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

ISO 17025for Laboratories

Internal Auditor Training for ISO 17025:2005November 2-4, 2009

ISO 13485for Medical Devices

Internal Auditor Training for ISO 13485:2003November 2-4, 2009

ISO/TS 16949:2002for Automotive and High Tech Industries

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

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

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

Web-based ISO/TS 16949:2009 Auditor Transition Training - satisfying RABQSA and IRCA requirements for ISO 9001:2008september 29, 2009October 30, 2009November 20, 2009December 18, 2009

Web-based ISO/TS 16949:2009 Transition Training With a Focus on Implementationseptember 29, 2009October 30, 2009November 20, 2009December 18, 2009

> Special CoursesAuditor TrainingAdvanced Auditor WorkshopOctober 26-28, 2009

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

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

OMNEX2009US Training

Course Schedule trainingOrder 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

To register, visit our website:

www.omnex.com

Omnex’s Lean & Six Sigmaclasses are offered through AIAG. Call us at (734) 761.4940 or see

www.aiag.org to register.


navigator

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

Zero Defects using Layered Process AuditsOctober 7-8, 2009December 2-3, 2009

> Web-based TrainingCore Tools TrainingFive Daily Modules:

(May be taken in whole or by module — see our website at www.omnex.com for daily schedule)

· APQP & Control Plans

· DFMEA and PFMEA· PPAP· SPC· MSAseptember 28 - October 2, 2009December 7-11, 2009

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

Web-based ISO 9001:2008 Transition Training With a Focus on Implementationseptember 28, 2009October 29, 2009

November 19, 2009December 17, 2009

Web-based ISO/TS 16949:2009 Auditor Transition Training - satisfying RABQSA and IRCA requirements for ISO 9001:2008september 29, 2009October 30, 2009November 20, 2009December 18, 2009

Web-based ISO/TS 16949:2009 Transition Training With a Focus on Implementationseptember 29, 2009October 30, 2009November 20, 2009December 18, 2009

OMNEX

training2009

US TrainingCourse 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

To register, visit our website:

www.omnex.com

Omnex’s Lean & Six Sigmaclasses are offered through AIAG. Call us at (734) 761.4940 or see

www.aiag.org to register.


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 what’s coming:

AerospaceAs9100C introduces major changes in the product Development process with the addition of project Management, risk Assess-ment 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.

AS9100, AS9110, AS9120 and AS9101 Key ChangesOctober 6, 2009

Food Safetywhat 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?

SQF, FSCC 22000, ISO 22000 and

Other GFSI StandardsOctober 27, 2009

Healthcarefocusing on patient safety and improved outcomes, health care providers—whether 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.

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

❇ 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

Who in the world is Omnex?

Our globalclients will

tell you.We’ve implemented

Management Systemsfor many of the world’s

top companies.

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

OMNEX315 E. Eisenhower PkwySuite 110Ann Arbor, MI 48108Phone: 734.761.4940Fax: 734.761.4966E-mail: [email protected]

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