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Sustaining Edge Solutions, Inc. Newsletter |
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| Performance Improvement Solutions for Your Business Needs |
August 2008 |
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In this issue
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Greetings!
Welcome to Sustaining Edge Solutions E- Newsletter
Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.
If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.
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International Energy Management Standard |
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ISO has approved the creation of a project committee to develop an international standard on energy management. The standard will provide all types of organizations a practical and widely recognized approach to increase energy efficiency, reduce costs, and improve environmental performance.
The standard is intended to be broadly applicable to various sectors of national economies, including utility, manufacturing, commercial building, general commerce, and transportation sectors. As a result, the standard could have an influence on as much as 60 percent of the world's energy demand.
ISO Secretary-General Alan Bryden commented: "The urgency to reduce GHG emissions, the reality of higher prices from reduced availability of fossil fuels, and the need to promote efficiency and the use of renewable energy sources, provide a strong rationale for developing this new standard building on the most advanced good practices and existing national or regional standards".
Following the successful examples of the ISO 9000 series on quality management and the ISO 14000 series on environmental management, the project committee ISO/PC 242, Energy Management, will consider the development of a standard that provides management system requirements together with guidance for use, implementation, measurement, and metrics. The standard will be based on the continual improvement and Plan-Do-Check-Act approach utilized in ISO 9001 and ISO 14001 to provide compatibility and integration opportunities.
Among the main benefits of the future standard are that it will:
- provide organizations with a well-recognized framework for integrating energy efficiency into their management practices
- provide a logical and consistent methodology for identifying and implementing improvements that may contribute to a continual increase in energy efficiency across facilities
- offer guidance on benchmarking, measuring, documenting, and reporting energy intensity improvements and their projected impact on reductions in GHG emissions
- provide a framework for organizations to encourage suppliers to better manage their energy, thus promoting energy efficiency throughout the supply chain
The US TAG for PC 242 will consist of experts and practitioners in the field of energy management. The selected delegates will participate in the activities of ISO/PC 242, including the development of the ISO standard on energy management and others that will be approved in the future. Participation in the US TAG 242 provides an opportunity for representatives of all affected U.S. constituencies (industry, commerce, NGO, education, government, etc.) to influence the development of international energy standards.
The TAG is a mechanism for identifying issues and developing national consensus regarding energy management. The TAG's primary purpose is to develop and transmit to the International Organization for Standardization (ISO), via ANSI, the US position on activities and ballots of their ISO Project Committee.
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OEMs to Suppliers: 'FMEA Implementation is Expected' |
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The FMEA fourth edition was released July 2008 and is scheduled to replace the previous edition effective November 1. Nearly 400 suppliers from across the United States attended the AIAG-sponsored FMEA/APQP Rollout to learn about new revisions to the reference manual and obtain clearer guidelines for developing, implementing and maintaining failure mode effects analysis. The purpose of FMEA is to address risk mitigation for the organization's products and processes.
At the FMEA/APQP Rollout, held July 22 in Novi, Mich., representatives from OEMs, IAOB and AIAG emphasized the importance of FMEA implementation and summarized the changes within the newest editions of the FMEA and APQP reference manuals.
The rollout sessions reinforced the critical importance of supplier FMEA implementation to satisfy IAOB compliance, OEM expectations, and ultimately, cost- effectiveness and consumer atisfaction. 'Performance is proof that your quality system is working,' said Mike Brennan, managing director for the IAOB. 'Audit compliance is just part of the reason why you're here.'
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Predictive Maintenance |
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Jonathan Katz begins his Industry Week article with the statement, "Plant floor machines have so much to say." He goes on to explain that trapped inside every machine is a wealth of information that can tell maintenance technicians if small hiccups might develop into large problems.
Tapping into this machine information is becoming easier with predictive maintenance tools. Machine maintenance is evolving from prescheduled routine tasks to the use of more precise indicators that increase maintenance efficiency.
Scheduled maintenance is an effective way to reduce machine downtime and prevent costly repairs. However, it doesn't take into account the ever- changing plant floor environment.
Technologies have been developed that use embedded machine sensors and remote monitoring to identify and prevent maintenance issues. These sensors collect data on variables such as temperature, vibration, and motor current.
With this information, you can gain insight into the rate of machine degradation and historical data can be used to predict future problems.
To read the full article, see Maintenance Seers at the Industry Week website.
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Webinars on Software Best Practices |
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The CAI's IT Metrics and Productivity Institute is hosting a series of Free Weekly Webinars on software best practices. Each webinar will feature an expert speaker who has extensively researched, and successfully applied, best practice principles to the development and maintenance of software.
For example, the webinars in August 2008 are:
- 8/14/08 - Essential Measurements for Software Projects
- 8/19/08 - ITIL Early Adoptors: Initial Results
- 8/20/08 - IT Silver Bullets - Tools and Techniques
- 8/21/08 - Top 10 Pitfalls in Agile Software Development
- 8/26/08 - Best Practices for Determining Project Requirements
For detailed information on each webinar, including registration information, go to ITMPI Website.
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ISO 13485 and GMDCAS |
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GMDCAS stands for "Global Medical Device Conformity Assessment System", a program initiated by the International Accreditation Forum (IAF).
As many as 150 countries have no medical device regulations. Several of these countries are considering establishing their own, unique regulatory requirements, with more countries to follow. As a result, there is a strong need to develop a third party accreditation program that can be used by all countries.
Since these countries rely heavily on imported medical devices, their development of national QMS accreditation requirements could cause a serious adverse impact on that country's local healthcare system. Why? Because most medical device manufacturers cannot justify making special accommodations for a single, small market. In addition, many certification bodies might find it economically infeasible to apply for a separate accreditation for just a few clients.
Without a globally accredited QMS certification program for medical devices, the unintended consequence for these developing countries may be to lose their current access to healthcare technologies.
The IAF has established a Working Group for the ISO 13485 GMDCAS program. This group includes representatives from the United States, Canada, European Union, Australia, Japan, and China. It also includes industry experts in medical device regulations and standards.
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