Blog Archives

Interested in volunteer opportunities in reliability engineering?

Interested in volunteer opportunities in reliability engineering?

Our ASQ division is very active in engineering education, conferences and publications both in the US and abroad.

If you are interested in learning more about our group and how to get involved, I invite you to join our yearly planning meeting via WebEx.

Our meeting will be held on 1 October and you can volunteer from any geographic region.

Please email me (marc@asqrd.org) if you are interested!

Please also have a look on our website to learn more.

www.asqrd.org

asqrd-at-rams

Posted in General

Keynote Speakers on ASTR 2016

This year on ASTR:  Dr. William Meeker Dr. Andre Kleyner and Dr. Elisabetta Jerome are the key speakers.

They are know for many thinks, but certainly as co-authors of “Statistical Methods for Reliability Data”, “Statistical Intervals” and “Practical Reliability Engineering”

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Afbeeldingsresultaat voor Statistical Intervals with Gerald Hahn

Posted in General

ARS North America 2016 Award Winners

TUCSON, AZ (July 20, 2016) – ReliaSoft announced the winners of the Excellent Presentation Awards of the International Applied Reliability Symposium (ARS) North America 2016. The peer-selected winners were revealed at a hosted awards dinner that closed out the 3-day event in San Diego, California, which ran June 21 – 23. Winners were recognized with certificates and cash prizes.

Congratulations to the Excellent Presentation Award Winners at ARS North America 2016:

  • Gold – Vishal Mhaske of Tesla Motors
    Tailoring the DFMEA Process to Fit a Fast Paced Company Culture
  • Silver – Rachel Stanford of Schlumberger
    Reliability Centered Maintenance: Applying an Aviation Philosophy to Oil & Gas
  • Bronze – Ray Gibson of Philips – Respironics Sleep Therapy Product Group
    Combining Reliability Tools in the Pursuit of Root Cause from Field Data

More than 160 reliability and maintainability professionals from over 100 cities attended this year’s event. Both new and experienced presenters contributed to the diverse range of topics discussed, from FMEA and safety & risk analysis to maintenance strategy and design for reliability.

ReliaSoft VP of Business Development Adamantios Mettas said, “On behalf of ReliaSoft, I want to thank all the presenters who led the conversations at ARS by sharing their experiences, challenges and solutions to the reliability and maintainability engineering community. We invite past presenters to continue enriching the community, as well as new presenters to bring their unique voice to the forum. We look forward to next year’s event.”

For more details about the about ARS North America 2016 event, visit http://www.arsymposium.org/2016/index.htm

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About ReliaSoft Corporation

ReliaSoft Corporation is the industry leader in reliability engineering software, training and services that combine the latest theoretical advances with essential tools for the practitioner in the field. Founded in 1992, ReliaSoft has evolved into a total reliability solutions company, offering software and expertise focused primarily on the reliability engineering and quality needs of product manufacturers and maintenance organizations. For more information, visit www.reliasoft.com.

For More Information

To view event details on ARS North America 2016, visit http://www.arsymposium.org/2016/index.htm. To purchase digital copies of the ARS proceedings, visit the ReliaSoft Online Store at https://store.reliasoft.com/store/home.php?cat=29. To view pictures from the event, visit http://www.arsymposium.org/2016/pictures/.

For questions, please contact Nikki Helms, Marketing Specialist at nikki.helms@hbmprenscia.com.

Posted in General

ASTR Conference 2016, 28-30 September,

“Finding the Balance between Testing, Modeling and Analysis to ensure Product Reliability and Safety”

Panelists:

  • Dr. William Meeker – Distinguished Professor, Iowa State University
  • Dr. Andre Kleyner – Global Reliability Engineering Leader, Delphi
  • Dr. Elisabetta Jerome – Technical Advisor, Armament & Weapons Test and Evaluation, United States Air Force (USAF)

Exceeding customer expectations and designing highly reliable products and systems is a complex task that should balance modeling and testing. Failure modes must be identified, modeled and mitigated in order to reduce risk while growing reliability.

  • However, what type of testing should be conducted?
  • When should modeling be used instead or in conjunction with testing?
  • How much testing should be performed?
  • What type of evidence should vendors provide in order to ensure reliability requirements?

These are tough questions engineers, analysts and managers face during the design and manufacturing process.

The ASTR 2016 panelists will discuss these important questions.

http://www.ieee-astr.org/

Have a question for the panel? Submit it today to marc@asqrd.org!

Keynote Speaker

Dr. William Meeker Dr. William Meeker | Professor of Liberal Arts and Sciences, Iowa University
Dr. William Meeker is Professor of Statistics and Distinguished Professor of Liberal Arts and Sciences at Iowa State University. He is a Fellow of the American Statistical Association (ASA) the American Society for Quality (ASQ), and the American Association for the Advancement of Science, and a past Editor of Technometrics. He is co-author of the books Statistical Methods for Reliability Data with Luis Escobar (1998), and Statistical Intervals with Gerald Hahn (1991), 14 book chapters, and of numerous publications in the engineering and statistical literature. He has won the ASQ Youden prize five times and the ASQ Wilcoxon Prize three times. He was recognized by the ASA with their Best Practical Application Award in 2001 and by the ASQ Statistics Division’s with their W.G. Hunter Award in 2003. In 2007 he was awarded the ASQ Shewhart medal. He won the 2012 Jerome Sacks Award for Cross-Disciplinary Research and the 2014 ASQ Brumbaugh Award. He has done research and consulted extensively on problems in reliability data analysis, warranty analysis, accelerated testing, nondestructive evaluation, and statistical computing.

Featured Speakers

Dr. Elisabetta Jerome Dr. Elisabetta Jerome | Technical Advisor, Armament and Weapons Test and Evaluation, Eglin Air Force, Florida
Dr. Elisabetta L. “Betta” Jerome, a member of the Senior Executive Service, is Technical Advisor, Armament and Weapons Test and Evaluation, Eglin Air Force, Florida. She is the senior technical advisor to the Air Force Test Center Commander and serves as the senior Air Force technical advisor and national/international authority in armament and weapons test and evaluation. Dr Jerome also has responsibility for providing technical advice and guidance to the highest levels of the Air Force, the DoD, as well as nationally-important conventional weapon system development efforts with regard to test infrastructure, test capabilities and best practices, modeling and simulation, and interpretation of test results. Dr. Jerome holds a Doctor of Philosophy in Aerospace Engineering from the University of Florida, Master of Science degree in Mechanical Engineering and Bachelor of Science degree in Mechanical Engineering from Ohio State University.
Dr. Elisabetta Jerome Dr. Andre Kleyner | Global Reliability Engineering Leader, Delphi Electronics & Safety
Andre Kleyner has 30 years of engineering, research, consulting, and managerial experience specializing in reliability of electronic and mechanical systems designed to operate in severe environments. He received the doctorate in Mechanical Engineering from University of Maryland, and Master of Business Administration from Ball State University. Dr. Kleyner is a Global Reliability Engineering Leader with Delphi Electronics & Safety and an adjunct professor at Purdue University. He is a Fellow of the American Society for Quality (ASQ), a Certified Reliability Engineer, Certified Quality Engineer, and a Six Sigma Black Belt. He also holds several US and foreign patents and authored multiple professional publications including three books on the topics of reliability, statistics, warranty management, and lifecycle cost analysis. Andre Kleyner is also the editor of the Wiley Series in Quality and Reliability Engineering (John Wiley & Sons). For more information please visit www.andre-kleyner.com.

 

 

Posted in General

Risk-Based Approaches To Establishing Sample Sizes For Process Validation

By Mark Durivage, ASQ Fellow

Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements. Figure 1 shows the relationship between risk and sample size — as level of risk increases, the sample size increases accordingly.

Working with companies in FDA-regulated industries, I frequently see validations with inadequate sample sizes or otherwise without satisfactory statistical justification. This is due, in part, to engineers being thrown into the quality function without proper training or being told that “this is the way we have always done it”. This article is intended to provide background and guidance for people writing, executing, and summarizing validation protocols and reports.

risk_v_sample_size

 

Rooted in the Regulations and Standards

The importance of validating using accepted statistical techniques with rationale for sample sizes is readily apparent in FDA and ISO requirements.

The definition of process validation, according to 21 CFR 820, the FDA’s Quality System Regulation (QSR) for medical devices, is “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” The QSR requires that:

Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.

The QSR also requires that:

Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics. Sampling plans, when used, shall be written and based on a valid statistical rationale.

In the pharmaceutical world, 21 CFR 211, FDA’s Good Manufacturing Practices (GMP), requires that “appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes.” As you may have noticed, 21 CFR 211 is “silent” in regard to sample size justification for process validation, but it uses wording such as “application of suitable statistical procedures where appropriate” in reference to product release and stability programs. However, experience has shown there is an expectation of using valid statistical and rationale for all aspects of pharmaceutical process validation.

ISO 13485:2016, the standard for medical device quality system requirements, has similar language requiring the organization to “validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.” — using, “as appropriate, statistical techniques with rationale for sample sizes.”

The ISO 9001:2015 quality management system requirements stipulate that an organization “implement production and service provision under controlled conditions.” Controlled conditions shall include, as applicable, “the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.”

Statistical Methods for Determining Sample Size

Deciding which statistical techniques to use is dependent on the type of data for which validation is required. There are two types of data: variable and attribute. Variable data is those aspects measured using a continuous scale, such as weight, length, strength, etc. Attribute data has two different outcomes — for example, good/bad or pass/fail — or discrete counts. Due to the specific nature of variable data, it yields much more information than attribute data.

Risk is defined as combination of the probability of occurrence of harm and the severity of that harm. It is essential that risk levels be defined and applied uniformly throughout the organization. Table 1 shows an example of risk level definitions with accompanying defect classifications. These definitions can and will vary based upon the product(s) produced and their intended and unintended uses.

Risk-Based Approaches To Establishing Sample Sizes For Process Validation - Google Chrome_2

So how exactly is confidence and reliability related to attribute data? Confidence is defined as the amount of uncertainty about this estimate of probability, whereas reliability is the probability that a product will be functional at specified conditions for a specified amount of time. Confidence can be increased by increasing the sample size. In other words, the larger the sample, the more is actually known regarding the confidence of the reliability of the process.

Confidence and reliability have slightly different, yet similar, meanings when referring to variable data. In this context, confidence is the degree of certainty that the interval contains a certain percentage of each individual measurement in the population. Reliability is the fraction of the population the interval contains. The use of confidence and reliability for variable data assumes normality of the data. Other methods are also available that utilize non-parametric for data that is not normally distributed.

Table 2 depicts example confidence and reliability levels based upon risk. Of course, different confidence and reliability levels can and should be utilized based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.

Risk-Based Approaches To Establishing Sample Sizes For Process Validation - Google Chrome_3

There is also a third method for determining statistically valid techniques and rationale for sample sizes. This method uses sampling tables with an appropriate AQL. According to ANSI/ASQ Z1.4-2008, the AQL is “the maximum defective percent … that, for purpose of sampling inspection, can be considered satisfactory as a process average.” This method relies on assigning AQLs based upon risk acceptance.

Table 3 depicts example AQL levels based upon risk. Different AQL levels can and should be utilized based upon the organizations risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements. A note of caution when using this method: Lot sizes used for validation activities should be consistent with the lot sizes anticipated for production.

Risk-Based Approaches To Establishing Sample Sizes For Process Validation - Google Chrome_4

Regardless of the method used to determine the statistically valid sample size and appropriate rational (confidence, reliability, or AQL), the method should be based on predefined definitions of risk associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing and consistently applied.

Subsequent articles in this series will provide how-to advice on applying these techniques in your organization.

About the Author

Mark Allen Durivage is the managing principal consultant at Quality Systems Compliance LLC and an author of several quality-related books. He earned a B.A.S. in computer aided machining from Siena Heights University and an M.S. in quality management from Eastern Michigan University. Durivage is an ASQ Fellow and holds several ASQ certifications including; CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, and CSSBB. He also is a Certified Tissue Bank Specialist (CTBS) and holds a Global Regulatory Affairs Certification (RAC). Durivage resides in Lambertville, Michigan. Please feel free to email him at mark.durivage@qscompliance.com with any questions or comments, or connect with him on LinkedIn.
References:

  1. Durivage, M.A., 2014, Practical Engineering, Process, and Reliability Statistics, Milwaukee, ASQ Quality Press
  2. Durivage, M.A. and Mehta B., 2016, Practical Process Validation, Milwaukee, ASQ Quality Press
  3. Durivage, M.A., 2016, The Certified Pharmaceutical GMP Professional Handbook, 2nd Ed., Milwaukee, ASQ Quality Press.
  4. ISO 9001:2015 Quality management systems—Requirements
  5. ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes
  6. United States Code of Federal Regulations 21 CFR:
    1. Part 211 Current good manufacturing practice for finished pharmaceuticals
    2. Part 820 Quality system regulation
  7. ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes

Link: http://www.outsourcedpharma.com/doc/risk-based-approaches-to-establishing-sample-sizes-for-process-validation-0001

Posted in General

Tesla Motors to Deliver Keynote Address at ARS North America 2016

TUCSON, AZ (June 6, 2016) – ReliaSoft Corporation announced a special event for their 13th International Applied Reliability Symposium (ARS) North America: akeynote address from Georgios Sarakakis, Senior Manager of Reliability Engineering at Tesla Motors. The Symposium will offer 4 tutorials and 30 presentations where fellow practitioners share applications, success stories and lessons learned in reliability and maintainability engineering; Sarakakis’s presentation will bring the event to a close.

ARS North America 2016 will be held June 21 – 23 in San Diego at the Coronado Island Marriott Resort & Spa. During those three days, ARS attendees will have opportunities to explore solutions from sponsors and exhibitors, network with industry professionals and gain insights from results-oriented presentations and tutorials.

The hosted awards dinner on the last night will feature a keynote address from Sarakakis on The First Two Billion All-Electric Miles: Enabling Reliability of Disruptive Technologies. The Symposium’s other tutorials and presentations will be given by a variety of organizations ranging from technology and automotive to aerospace industries.

ReliaSoft VP, Product Management Adamantios Mettas said, “ARS 2016 in San Diego will give reliability and maintainability professionals the ability to make connections with others in their field and hopefully generate new ideas for their work. ARS is where innovative ideas in reliability and maintainability originate – from discussions between experts and across industries. Each year we welcome a diverse group of attendees, presenters, sponsors and exhibitors, and this year we are excited to see what contributions these experts bring.”

Learn more about ARS North America 2016 and register today: http://www.arsymposium.org/northamerica/index.htm

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About ReliaSoft

ReliaSoft Corporation is the industry leader in reliability engineering software, training and services that combine the latest theoretical advances with essential tools for the practitioner in the field. Founded in 1992, ReliaSoft has evolved into a total reliability solutions company, offering software and expertise focused primarily on the reliability engineering and quality needs of product manufacturers and maintenance organizations.

For More Information

Find more information on ARS at http://www.arsymposium.org. To register for the ARS North America 2016 event in San Diego, visit http://www.arsymposium.org/register.htm.

For questions, please contact Nikki Helms, Marketing Specialist, Energy & Technology at nikki.helms@hbmprenscia.com.

Posted in General

ReliaSoft and nCode Unite Processes as HBM Prenscia

ReliaSoft and nCode Unite Processes as HBM Prenscia

TUCSON, AZ (May 25, 2016) – As part of the company’s future vision and growth strategy, HBM is pleased to announce the creation of a new strategic segment to their business: HBM Prenscia.

HBM Prenscia joins nCode and ReliaSoft software products, training and consulting to offer solutions in the disciplines of durability, data analysis and reliability. This shared product portfolio provides a unique and exciting opportunity, allowing engineers across the globe to benefit from both nCode—the world’s leading provider of fatigue, durability and data analysis solutions—and ReliaSoft—the global leader in reliability engineering solutions.

HBM Prenscia unites the nCode and ReliaSoft complementary software offerings throughPrenscia Access, a new token-based licensing system. Prenscia Access allows an unlimited number of users to run any configuration of nCode and ReliaSoft desktop applications, empowering organizations to streamline their engineering analysis processes. With Prenscia Access, users will always receive the most recent software version upgrades and desktop applications—at a fraction of the cost of individual licenses.

HBM Prenscia’s President, Brian Dabell, commented on the new opportunity, “For many years now, we have seen a growing demand within the software simulation world for our existing nCode products and capabilities. It was this demand that inspired us to acquire ReliaSoft early in 2015 and go on to enjoy further exciting growth. Unifying the complementary product ranges of nCode and ReliaSoft under HBM Prenscia is a logical evolution that will help leverage existing legacy and reputation, whilst at the same time develop new and innovative joint solutions in the future. The introduction of Prenscia Access provides unparalleled entry to the most up-to-date engineering software for durability, data processing and reliability—improving the way that organizations operate.”

For more information on how a combined approach to durability, test, measurement, data analysis, signal processing, availability, maintainability and reliability can deliver tangible advantages to your business, please visit www.hbmprenscia.com.

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About HBM Prenscia

HBM Prenscia leverages nCode and ReliaSoft software, training and consulting to deliver solutions that empower the engineering community. We are committed to the development of innovative concepts for improving reliability, availability, maintainability, safety and durability, while reducing risk across a broad range of applications.

For More Information

Find more information on HBM Prenscia and Prenscia Access at www.hbmprenscia.com.

For questions, please contactNikki Helms, Marketing Specialist, Energy & Technology.

 

Posted in General

2016 Accelerated Stress Testing and Reliability (ASTR) Conference – call for abstracts

Exceeding Customer Expectations through Accelerated Reliability Testing

September 28 – 30, 2016

Hilton, Pensacola Beach Florida

The 2016 Accelerated Stress Testing and Reliability (ASTR) Conference is focused on highlighting cutting-edge methods to deliver maximum cost-benefits from accelerated reliability testing. ASTR 2016 is relevant to product development, test and manufacturers involved in the aerospace, automotive, consumer electronics, defense, medical, telecommunications and other cutting edge industries where reliability is a key driver of operational and business success. If your company needs to improve accelerated product testing, improve field reliability, reduce warranty costs, improve profits, gain market share, and become more competitive, then the 2016 ASTR Conference can help you. Participate in the practical papers, attend tutorials, talk to equipment exhibitors and learn proven methods. ASTR 2016 will present detailed case studies, best practices, lessons learned, and clear insight on how to best apply and integrate accelerated testing tools and methods.

CALL FOR PRESENTATIONS

Presentation abstracts are invited now with a 150 words summary due by March 15.  Paper selection announcements by April 15 with draft paper and presentation due by May 15 and finals due July 15. The 2016 focus will include:

  • The science of test acceleration: integration of design modeling, analysis and accelerated testing
  • Leveraging testing when total system failure is not an option: assuring product-life from degradation test approaches
  • Focusing and streamlining test effort: achieving better results with less effort
  • Discover ways to better understand vibration testing

Complete submission details are available at www.ieee-astr.org.  Presenters selected will follow a strict time line for papers and receive discounted registration.

Become part of this active, growing conference sponsored by both the ASQ-Reliability Division and the IEEE- Reliability Society. The hotel has special rates for this conference of $159 a night.

There are many reasons to attend this conference! Make this your Fall destination:

  • Visit a local technology company
  • Visit Eglin AFB nearby
  • See the Naval Aviation Museum nearby
  • Visit the Air Force Research Lab
  • See the National Flight Academy
  • Catch the Blue Angels
  • Visit Historic Fort Pickens
  • Enjoy the Pensacola Sea Food Festival Sept. 30

General ASTR conference contact: Jim McLinn at jmrel2@aol.com

For Program related questions: Marc Banghart at marc@asqrd.org

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Posted in General

Amanda Gillespie, Mark Monaghan, and Yuan Chen, win ASQ Best Paper Award at 2012 RAMS

Congratulations to Amanda Gillespie, Mark Monaghan, and Yuan Chen. Their paper, “Comparison Modeling of System Reliability for Future NASA Projects,” won the award for the best paper by an ASQ Reliability Division member at the 2012 Reliability and Maintainability Symposium in January. Gillespie and Monaghan are a Reliability Engineers with SAIC at NASA Kennedy Space Center in Florida; Chen is a senior member of technical staff with the Electronic Systems Branch, NASA Langley Research Center in Hampton, Virginia. The paper presented a methodology combining reliability block diagram analysis, cut set analysis, comparison modeling, and Fussell-Vesely importance measures to better understand and compare the vulnerabilities of future NASA launch vehicle architectures under possible application scenarios. This approach allowed the design team to address the deficiencies in the design architectures more efficiently, while balancing the need to design for optimum weight and space allocations. The paper was presented at RAMS by Amanda Gillespie. The award, which will be presented annually, was initiated last year by the RD Executive committee to recognize the contributions of RD members to RAMS and to encourage more RD members to submit papers to RAMS. The selection committee, appointed by the executive committee, reviewed all of the papers submitted to RAMS by ASQ-RD members, selected five finalist papers, attended the presentations of those papers at RAMS, and selected the winner based on both the content and quality of the written text and the presentation. John Bowles, chair of the selection committee said “We were pleased with the quality of the papers submitted and look forward to having even more next year.” The award has two parts: a $500 honorarium distributed to the winners and a plaque to be presented at the ASQ-RD dinner at the 2013 RAMS.

Posted in General

Amari wins ASQ Best Paper Award at 2013 RAMS

tolerant systems subject to imperfect fault coverage and resource constraints. Amari said the system model is flexible and can accurately model a wide range of fault-tolerant systems used in safety critical applications. It assumes the system consists of several subsystems in series and each subsystem contains multiple redundant components. Integer programming is used to select the optimal design configuration, types of components, and types of fault tolerant mechanisms from the available choices.

The ASQ RAMS Best Paper award is presented annually to recognize significant contributions of RD members to RAMS and to encourage more RD members to submit papers to RAMS. The selection committee, appointed by the RD executive committee, reviewed all of the papers submitted to RAMS by ASQ-RD members to select the winner. John Bowles, chair of the selection committee said “We were pleased to have many high quality papers submitted by RD members this year. We anticipate having even more next year.” The award has two parts: a $500 honorarium distributed to the winners and a plaque that will be presented to the winners at the ASQ-RD dinner at the 2014 RAMS.

 

Posted in General
Webinar Categories
Recent Webinars
  • In-situ Mems Inertial Sensor Health Prognostic Method Based On Micro Vibrator (基于微振动台的MEMS惯性传感器原位健康状态监测方法)
    April 9, 2017
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  • Reliability Calculation for Dormant k-out-of-n Systems with Periodic Maintenance
    April 13, 2017
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  • Design and Analysis of Experiments in MINITAB
    May 11, 2017
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Provide a global forum for networking among practitioners of reliability engineering, management and related topics.

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Training

Sponsor, present and promote reliability, maintainability, and related training materials for courses, symposia, and conferences.