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.
Aviation safety is a very critical issue. For millions of people to fly safely every day around the world, a very large and complex network of business and regulatory agencies have to operate flawlessly, delivering defect- free, on-time parts and hardware to all corners of the globe.
An article written by Sidney Vianna, a representative of the Americas Aerospace Quality Group (AAQG) explains how more than 10,000 organizations have implemented the AS9100 standard and attained certification through the IAQG Industry Controlled Other Party (ICOP) scheme; a program where industry stakeholders engage with accreditation and certification bodies to enhance the credibility, trustworthiness, and confidence of certificates issued in the sector.
A much less known, but no less critical standard is the AS9110 document, the subject of this article, which prescribes requirements for a quality management system for organizations whose primary business is providing maintenance, repair, and overhaul services (MRO) for commercial and military aviation products.
Surprisingly to some, neither the civil nor the military aviation maintenance industry have awakened yet to the potential benefits of embracing and deploying the AS9110 standard through its supply chain, including reliance on the associated ICOP certification scheme. While in the OEM world more than 10,000 organizations have been certified to the AS9100 standard, less than 250 organizations have attained certification to the AS9110 model.
This development caught the attention of the IAQG, which recently launched the Maintenance, Repair, and Overhaul Relationship Growth Strategy Team to address this disparity.
While industry wide adoption of AS9110 is a potential answer to this challenge, it is critical to realize that the aviation maintenance industry is marked by a co-existence of certificated and noncertificated repair stations. Certificated, in this context, means that the repair station has been assessed by a national aviation authority, such as the Federal Aviation Administration (FAA).
Noncertificated repair stations fall outside the regulatory oversight of the aviation authorities and are subject to monitoring only by their customers, e.g., airlines. It has been noted, that the monitoring of noncertificated repair stations is not as vigorous as many stakeholders would like to see. Certification of this industry segment to AS9110 would be a welcome layer of control and risk mitigation. A solid quality management system, such as AS9110, would definitely boost the performance of noncertificated repair stations.
For those not familiar with the AS9110 standard, be informed that the document is based on the world- acclaimed ISO 9001 and supplemented by applicable AS9100 aviation, space, and defense industry requirements.
Some of the enhancements, new requirements, and areas of emphasis in the revised AS9110 standard include:
Counterfeit and suspect unapproved parts. Addresses the need for systems to detect and prevent the introduction of counterfeit parts and components that might not have been or are suspected of not having been produced in accordance with applicable laws and regulations.
Human factors. Recognizing that workers are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction, communication, and attitudes, AS9110 includes requirements associated with human factors.
Safety management systems. Aviation maintenance organizations will be required to introduce safety management system within their business practices. The AS9110 standard introduces some initial components required for a safety management system (i.e., establishment and maintenance of a safety policy and safety objectives), with the primary concern being product safety.
Technical data. The availability of technical data necessary to ensure that the aircraft or component can be maintained for serviceability and airworthiness, and related operational and emergency equipment is assured.
Project management. The revisions to AS9110 contain new requirements for planning and managing product overhaul, repair, and maintenance in a structured and controlled manner.
Risk management. The way aviation maintenance organization’s address risk management is critical. Therefore, it only seems appropriate to introduce a new requirement for the development, implementation, and maintenance of a risk management process applicable to the organization’s products and services provided, with well-defined process responsibilities, criteria, mitigation, and acceptance.
The IAQG believes that a well-coordinated promotion of the AS9110 standard and the intelligent and responsible use of the ICOP certification scheme can assist with risk mitigation and performance improvements in the aviation maintenance sector. A concerted effort is under way to engage with industry stakeholders for a larger scale embrace of the standard in the aviation MRO community.
For more information or assistance with AS9110, contact us. Read Sidney Vianna’s complete article.
According to The Automotive Industry Action Group (AIAG) and Michigan Biosciences Industry Association (MichBio) they have partnered to assist the automotive supply chain in diversifying into medical device manufacturing.
In recent months, considerable effort has been made by the state of Michigan to assist manufacturers who are looking to shore up business lost from the automotive industry and diversify into the exploding medical devices market. While the automotive market has been on a decline, the medical device industry is seeing growth due to an aging demographic, increased awareness and expectations for medical care from patients, and advances in medical technologies. While many synergies exist, some retooling will most likely be required.
However, medical device manufacturing is a complementary vertical for suppliers that have mastered strict quality certification systems in the automotive industry, which can be readily transitioned into other manufacturing industries. “We are committed to providing our member organizations with the tools and resources they need to manage the economic recovery. Given the current financial condition of the automotive industry, it is imperative that we collaborate with organizations like MichBio to help our members diversify as well as take best practices for quality improvement and apply them in other industries” said J. Scot Sharland, executive director, AIAG.
Members of both organizations will benefit from shared tools and resources bringing together the best of both manufacturing industries. Through this cooperative relationship, AIAG and MichBio have agreed to pursue areas of collaboration where appropriate, share information on initiatives and projects where there is common interest.
A method to extend this collaboration is being enhanced through The MichBio Expo and Conference on November 3-4, 2009. The MichBio Expo is the largest single gathering of biosciences professionals in the state, attracting more than 500 biosciences professionals and service providers, and more than 60 exhibitors last year.
(ASQ: Milwaukee) — Business, industry, and nongovernmental organization leaders addressed quality opportunities and crises in the 21st century in a dialogue, hosted by American Society for Quality (ASQ) and the Baldrige National Quality Program at the National Institute of Standards and Technology in Gaithersburg, Maryland.
Participants, from organizations such as Best Buy, Google, Hewlett- Packard, IBM, and Pfizer identified priority areas where quality and performance improvement can achieve the greatest effect and foster positive change.
“The impact of quality and organizational performance excellence on the future of businesses, industry, health care, and education is a critical area for discussion and action,” says Paul Borawski, ASQ executive director and chief strategic officer. “The outcomes of the Future of Quality Dialogue will help ASQ shape strategic direction and priorities for our members now and in the years ahead.”
The four priority areas include:
A full report of the event is now available at ASQ’s website.
The American Society for Quality (ASQ) is holding its First Annual HealthCare of the Future Conference, October 13, 2009 in Tucson, Arizona.
The American Society for Quality (ASQ) Audit Division is holding its Audit Division Conference on October 15-16, 2009 in Tucson, Arizona. The theme: Audit Revolution, focuses on the auditor’s role in achieving and reporting effective audit results to provide management with accurate data to make informed decisions.
We are a sponsor and are exhibiting at the Audit Division Conference. Visit our booth and try your luck with our free prizes raffle!
Arizona Technology Council “Lunch and Learn” November 3, 2009 Phoenix, AZ. Walter Tighe, President of Sustaining Edge Solutions, Inc. is conducting a workshop “Improving Operational Performance in Troubled Times.” Arizona Technology Council members are free; non-members, $10.00. 11:30 AM TO 1:00 PM. Lunch is included. Workshop will be conducted at HVVi Semiconductors, Inc. a client of ours.
We are now offering Web-Based Training Courses!
Benefits of training include:
The courses are offered through our Virtual University. View our current courses and demos including new courses starting in October.
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.
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- AS9100D:2016 Aviation, Space and Defense April 17, 2016
- Effectiveness Versus Documented Information April 1, 2016
- ISO 13485:2016 Medical Devices Standard Published March 13, 2016
- Standards Transition Current Update March 1, 2016
- ISO 9001:2015 Guidelines for Application February 10, 2016
- International Certification Database February 3, 2016
- Deming Documentary: If Japan Can…Why Can’t We? January 7, 2016
- Business Strategies for New Year January 3, 2016
- Future Standards in Transition December 1, 2015
- Anxiety Issues With ISO 9001:2015 November 9, 2015
- Celebrate World Quality Month November 4, 2015
- ISO 9001:2015 Published and Released October 1, 2015
- ISO 9001:2015 Standard Now Official September 24, 2015
- ASQ 24th Annual Internal Audit Conference September 16, 2015
- ISO 9001:2015 Risk Approach September 2, 2015
- Annex SL – Changes for ISO Standards August 18, 2015
- ISO 9001:2015 Content Review August 1, 2015
- ISO 9001 Moves to Final Draft International Standard (FDIS) July 14, 2015
- Current State of Quality View July 1, 2015
- The IATF Wants to Hear From You! June 12, 2015
- ISO 9001:2015 Begins With Leadership June 1, 2015
- AS9100:2016 – What’s Ahead? May 14, 2015
- Executive Leadership Engagement May 3, 2015
- Have you found the root cause yet? April 13, 2015
- Risk-Based Thinking April 2, 2015
- Where is Risk Addressed in ISO 9001:2015? March 15, 2015
- Profit Improvement Approach March 5, 2015
- ISO 14001 EMS Revision to Final Stage February 22, 2015
- Holistic Performance Excellence February 1, 2015
- Key Manufacturing Trends for 2015 January 22, 2015
- True Culture of Quality January 4, 2015
- Outsourcing Boom Drives New Standard December 14, 2014
- The Next Level of Performance December 2, 2014
- ISO 9001:2015 DIS Receives Approval Moves to FDIS November 10, 2014
- Strategy Deployment November 3, 2014
- ISO Standards Still A Worldwide Priority October 14, 2014
- Quality Standards and Conformance October 2, 2014
- Celebrate World Quality Month September 17, 2014
- Future of Management Systems September 2, 2014
- ISO 14001 Environmental Management System Revision August 13, 2014
- Visual Controls August 1, 2014
- Manufacturing Metrics that Really Matter July 17, 2014
- Global Manufacturing View July 2, 2014
- Call for Public Comments on ISO/DIS 9001:2015 June 19, 2014
- Lean Improvement Methods June 2, 2014
Archive for October, 2009