Archive for 2009

New Edition of ISO 9004 – Path to Sustained Success

Tuesday, December 1st, 2009
Performance Improvement Solutions for Your Business Needs December 2009

In this issue

  • New Edition of ISO 9004 – Path to Sustained Success
  • New ISO Standard for Effective Management of Risk
  • CMMI Versus ISO 9001
  • In the News
  • Training Courses
  • Greetings!

    Welcome to Sustaining Edge Solutions E-
    Newsletter

    Our newsletters provide guidance on
    operational and quality systems ISO 9001, AS9100,
    ISO/TS 16949, ISO 27001, ISO 13485, ISO 14001, and
    others.
    This includes process improvement methods Six
    Sigma, Lean Enterprise, and other topics of interest
    to our readers.

    We want your input for
    2010!
    If
    you have any
    questions about the articles appearing in this issue,
    or you want to Suggest Topics for 2010 issues,

    please let us know and tell us how we are doing.
    Happy Holidays!!



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    New Edition of ISO 9004 – Path to Sustained Success

    The just-published new edition of ISO
    9004 provides organizations with a model for
    sustained success in today’s complex, demanding,
    and ever-changing environment. ISO 9004:2009-
    “Managing for the sustained success of an
    organization-A quality management approach,”
    is
    the third edition of the standard first published in
    1987. It is intended to support the achievement of
    sustained success by any organization, regardless of
    size, type, or activity, using a quality management
    approach.

    “While the goal is initially to ensure the production
    of ‘good’ products and services, leading to the
    achievement of customer satisfaction, the longer-term
    purpose is to ensure the economic survival of the
    organization. The new edition gives guidance on how
    an organization should adopt a systematic approach
    to achieve this,” says Bob Alisic, leader of the task
    group responsible for the ISO 9004:2009.

    ISO 9004:2009 provides guidance for
    the continual improvement of an organization’s overall
    performance, efficiency, and effectiveness based on a
    process-based approach. It focuses on meeting the
    needs and expectations of customers and other
    relevant parties over the long term, and in a balanced
    way.

    Compared to ISO 9001:2008, which ensures
    quality management of products and services while
    enhancing customer satisfaction, ISO 9004:2009
    provides a broader perspective of quality
    management, particularly for performance
    improvement. It will prove useful to organizations
    whose top management wishes to move beyond ISO
    9001 in pursuit of ongoing improvement, measured
    through the satisfaction of customers and other
    stakeholders.

    ISO 9004:2009 allows organizations to enhance the
    quality of product and service delivery to their
    customers by promoting self-assessment as
    an
    important tool to enable organizations to:

    • Benchmark their level of maturity, covering
      leadership, strategy, management system, resources,
      and processes
    • Identify their strengths and weaknesses
    • Identify opportunities for either improvements or
      innovation, or both.

    The self-assessment tool may
    become a
    key element during the strategic planning processes
    in any organization.

    “The objectives of
    customer satisfaction and product quality are
    extended in ISO 9004:2009 to include the satisfaction
    of interested parties and the performance of the
    organization. The combination of ISO 9001 and ISO
    9004 will allow you to get the most of your quality
    system,” says Jose Dominguez, a leader of the ISO
    9001 task group.

    ISO 9004:2009 replaces ISO 9004:2000. It
    makes substantial changes to the structure and
    contents of the earlier edition based on eight years’
    experience of implementing the standard worldwide,
    and introduces changes intended to improve
    consistency with ISO 9001 and other management
    system standards. An example of an important
    change (maybe the most important one) in the
    structure of ISO 9004, is that the “body” of the standard
    starts with the chapter giving guidance on how to
    manage an organization aiming for sustained
    success and not how to build a quality management
    system.

    Although ISO 9004:2009
    complements ISO 9001:2008 (and vice versa), it can
    also be used independently. It is not intended for
    third-party certification, regulatory, or contractual use,
    nor as a guide to the implementation of ISO
    9001:2008
    . To help users get the best out of the
    standard, an annex gives a clause-by-clause
    correspondence between ISO 9001:2008 and ISO
    9004:2009.

    Purchase ISO 9004:2009 at the


    ANSI E-Store for $149.00
    or at the ASQ
    Store for $76.00, member price
    for a backorder
    issue.

    New ISO Standard for Effective Management of Risk

    A new International Standard, ISO 31000:2009,
    Risk management – Principles and guidelines
    ,
    will help organizations of all types and sizes to
    manage risk effectively. ISO 31000 provides
    principles, framework and a process for managing
    any form of risk in a transparent, systematic and
    credible manner within any scope or
    context.

    At the same time, ISO is publishing

    ISO Guide 73:2009, Risk management
    vocabulary
    , which complements ISO 31000 by
    providing a collection of terms and definitions relating
    to the management of risk.

    Kevin W. Knight,
    Chair of
    the ISO working group that developed the standard
    explains, “All organizations, no matter how big or
    small, face internal and external factors that create
    uncertainty on whether they will be able to achieve
    their objectives. The effect of this uncertainty is ‘risk’
    and it is inherent in all activities.” “In fact,” he
    continued “it can be argued that the global financial
    crisis resulted from the failure of boards and executive
    management to effectively manage risk. ISO 31000 is
    expected to help industry and commerce, public and
    private, to confidently emerge from the crisis.”

    The standard recommends that organizations
    develop, implement and continuously improve a risk
    management framework as an integral component of
    their management system.

    “ISO 31000 is a
    practical document that seeks to assist organizations
    in developing their own approach to the management
    of risk. But this is not a standard that organizations
    can seek certification to
    . By implementing ISO
    31000,
    organizations can compare their risk management
    practices with an internationally recognized
    benchmark, providing sound principles for effective
    management. ISO Guide 73 will further ensure that all
    organizations are on the same page when talking
    about risk,” said Mr. Knight.

    ISO 31000 is designed to help organizations:

    • Be aware of the need to identify and treat risk
      throughout the organization
    • Improve the identification of opportunities and
      threats
    • Improve stakeholder confidence and trust
    • Establish a reliable basis for decision making and
      planning
    • Effectively allocate and use resources for risk
      treatment
    • Enhance health and safety performance, as well
      as environmental protection

    ISO 31000 and ISO Guide 73 can be applied to any
    public, private or community enterprise, association,
    group or individual. The documents will be useful to:

    • Those responsible for implementing risk
      management within their organizations
    • Those who need to ensure that an organization
      manages risk
    • Those needing to evaluate an organization’
      practices in managing risk
    • Developers of standards, guides procedures and
      codes of practice relating to the management of risk.

    CMMI Versus ISO 9001

    The Software Engineering Institute (SEI) published a
    report earlier this year, CMU/SEI-2009-SR-005, that
    compares CMMI-Development, v1.2, to the ISO
    9001:2000 international quality standard. Note:
    Since the more recent ISO 9001:2008 edition didn’t
    add any new requirements or clause numbering to
    ISO 9001:2000, the SEI comparison remains valid.

    The report is meant for anyone with
    knowledge of either the Capability Maturity Model
    Integration (CMMI ) Product Suite or the International
    Organization for Standardization (ISO) 9000 family of
    standards, that is interested in learning more about
    the other process standard.

    The CMMI-DEV, v1.2, comparison to ISO 9001:2000
    notes their similarities and differences. The report
    points out that it is not intended to be an exhaustive or
    authoritative comparison, nor does it provide specific
    guidance for deciding which model or standard to
    adopt.

    Organizations that are implementing
    both ISO 9001 and the CMMI Development model will
    benefit from understanding the areas that are covered
    fully by both bodies of knowledge, as well as, areas
    not covered by both. While the two bodies of
    knowledge were developed independently and for
    different purposes, they have important connections
    and are largely consistent with each
    other.

    The report is organized into four
    sections. The first
    section provides a brief overview of the report’s focus
    and organization. The next two sections describe the
    two bodies of knowledge, i.e., the world of ISO 9000
    and the world of CMMI-DEV. The final section provides
    a comparative analysis of the two bodies of
    knowledge. Finally, the appendices identify the report
    contributors, acronyms, terminology differences,
    resources, and references.

    Download the 70 page Free Report in PDF format
    from SEI web page.

    In the News

    The American Society for Quality (ASQ) invites
    business professionals to register for a Free
    Webinar

    that spotlights how service quality measurement, data
    analysis, and planning can positively affect your
    business. The webinar, “Intro to Service Quality
    Measurement,” will be available on demand via the ASQ web site.

    Manufacturers Struggle to Hire High-Skilled
    Workers Despite Double-digit Unemployment
    .

    As
    employers across the country continue to shed
    hundreds of thousands of jobs, many manufacturers
    are facing an ironic dilemma. As they eliminate
    positions-mainly repetitive, assembly type jobs-they
    still have unfilled job openings for high-skilled
    workers. According to a recent survey conducted by
    Deloitte, The Manufacturing Institute, and
    Oracle, “almost one-third of responding companies
    report some level of shortages today.”

    These
    shortages of high-skilled workers are particularly
    acute within “the most profitable companies,
    aerospace and defense, and life science sectors,”
    and among “skilled production workers, scientists,
    and engineers.” “This is certainly an employer’s
    market, but not as much with manufacturers,” says
    Mark C. Tomlinson, executive director and general
    manager of the Society of Manufacturing Engineers.

    The survey also shows that many
    manufacturers are “not acting” on finding these types
    of workers or are depending on largely
    ineffective “traditional approaches to managing and
    developing their employees,” like current performance,
    rather than on the latest “talent management trends”
    such as “lean and industry-recognized skills
    credentials.”

    Respondents to this survey also
    reported dissatisfaction with the skills of their cur­rent
    employees. Nearly half indicated many workers have
    inadequate basic employability skills, such as
    attendance, timeliness, and work ethic, while 46
    percent reported inadequate problem-solving skills,
    and 36 percent indicated insufficient reading, writing,
    and communication skills.

    Baldrige Program Calls for
    Examiners

    Each year the Baldrige
    Program recruits experts from business, education
    organizations, health care providers, nonprofit
    organizations, and other groups to serve on the Board
    of Examiners for the Malcolm Baldrige National Quality
    Award. Examiners evaluate applications for the award
    and prepare feedback reports to applicants that cite
    strengths and opportunities for
    improvement.

    The application form for the
    2010 Board of Examiners is now available online.

    Applications must be submitted electronically; the
    deadline is 2 p.m. EST on Jan. 7, 2010.

    ASQ Lean and Six Sigma Conference

    ASQ Lean and Six Sigma
    Conference
    - 10th Anniversary March 8-9th, 2010
    Phoenix, Arizona. Learn from proven firsthand
    applications, technical applications, and best
    practices.

    Training Courses

    training

    To see the course description, schedule, and
    on-line
    registration click on the course title below. View all our Courses.

    We now offer web-based courses.


    Understanding and Implementing
    ISO9001:2008

    ISO
    9001:2008 Process Based Internal Auditor

    Documenting Your Quality Management System


    Understanding and Implementing AS9100C:2009
    Aerospace-NEW

    AS9100C
    Process Based Internal Auditor-NEW



    Documenting Your Quality Management System


    Understanding and Implementing
    ISO/TS16949:2009 Automotive-
    NEW


    ISO/TS16949:2009 Process Based Internal
    Auditor-NEW


    Documenting Your Quality Management System


    Understanding and Implementing
    ISO14001:2004 Environmental


    ISO14001:2004 Process Based Internal Auditor


    The Five Pillars of a Lean Workplace
    Organization

    Continuous Process
    Improvement

    Lean Six Sigma
    8 Disciplines (8D) of
    Problem Solving-NEW


    Understanding and Implementing ISO 13485:2003
    Medical Devices

    ISO
    13485 Process Based Internal Auditor


    Understanding and Implementing ISO 27001:2005
    Information Security

    ISO
    27001 Process Based Internal Auditor

    All courses can be delivered at your company.
    Don’t
    see a course, location, or date that fits
    your needs?


    Contact Us

    Quick Links

    phone:
    888-572-9642 Toll Free

    Published New Edition of ISO 9004 – Path to Sustained Success

    Wednesday, November 25th, 2009
    The just-published new edition of ISO 9004:2009 provides organizations with a model for sustained success in today’s complex, demanding, and ever-changing environment.

    ISO 9004:2009- “Managing for the sustained success of an organization-A quality management approach,” is the third edition of the standard first published in 1987.It is intended to support the achievement of sustained success by any organization, regardless of size, type, or activity, using a quality management approach.

    Compared to ISO 9001:2008, which ensures quality management of products and services while enhancing customer satisfaction, ISO 9004:2009 provides a broader perspective of quality management, particularly for performance improvement. It will prove useful to organizations whose top management wishes to move beyond ISO 9001 in pursuit of ongoing improvement, measured through the satisfaction of customers and other stakeholders.

    Although ISO 9004:2009 complements ISO 9001:2008 and vice versa), it can also be used independently. It is not intended for third-party certification,regulatory, or contractual use, nor as a guide to the implementation of ISO 9001:2008

    To help users get the best out of the standard, an annex gives a clause-by-clause correspondence between ISO 9001:2008 and ISO 9004:2009.

    ISO 9004:2009 allows organizations to enhance the quality of product and service delivery to their customers by promoting self-assessment as an important tool to enable organizations to: Benchmark their level of maturity, covering leadership, strategy, management system, resources, and processes. This includes identify their strengths and weaknesses, identify opportunities for either improvements or innovation, or both.

    The self-assessment tool may become a key element during the strategic planning processes in any organization.”The objectives of customer satisfaction and product quality are extended in ISO 9004:2009 to include the satisfaction of interested parties and the performance of the organization. The combination of ISO 9001 and ISO 9004 will allow you to get the most of your quality system,” says Jose Dominguez, a leader of the ISO 9001 task group.

    Purchase ISO 9004:2009 at the ANSI E-Store for $149.00
    or at the ASQ Store for $76.00, member price.

    Share your thoughts on this new edition with the Quality Guru and our readers!

    Auditors Can Apply Journalistic Techniques

    Sunday, November 1st, 2009
    Performance Improvement Solutions for Your Business Needs November 2009
    In this issue

    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.

    Newsletter Sign-up

     

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    Auditors Can Apply Journalistic Techniques
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    In the October 2009 issue of Quality Progress Magazine you will find an excellent article written by Natalia Scriabina, and team titled ” Ask, and Ye Shall Receive -Auditors can take a page from journalists to get the answers they need.”

    The article discusses how auditors can be technically proficient, but struggle with the more human side of the auditing process, and journalistic techniques can help during interviews and make the auditee more comfortable. The following is a synopsis of the article.

    “The interview is more than a simple process of asking questions. It’s a relationship, however brief, between two people.”

    The relationship starts the moment that you, the auditor or assessor, enter the room. There is never a second chance to make a good first impression: Did you enter with an expression of interest or suspicion? How confident did you appear? Did you introduce yourself or wait to be introduced? Did you take on the role of host or guest? Did you display enthusiasm? Your answers form the baseline of the interview relationship, and they determine the quality of the information you will obtain.

    Let’s outline five underlying principles and techniques journalists use to conduct productive interviews:

    1. Establish two- way trust: Work from the assumption the interviewee wants to share information and wants to make a valuable contribution to your audit or assessment results. Be professional, open and non-judgmental; try to establish that you share a common goal. While your subject may have his or her own agenda, set aside your concerns about that for the moment and try to put the person at ease. People need to feel confident you value what they offer and believe what they say-and that they can trust you.

    2. Create a comfort zone: An interview should be relaxed and conversational. Social psychologists suggest we feel more comfortable around people who appear similar to us, with whom we feel familiar, who appear to like us and whose personalities are inherently attractive. If we try to conform to these ideas, there can be a real improvement in the quality of the interview.

    By nature, people are unlikely to be open to complete strangers, so share a bit about who you are from the outset. Be prepared. Before you meet your interviewees, try to learn about their work and achievements. If you have the opportunity to meet them in their surroundings, look carefully around their offices and note photos, plaques or other memorabilia.

    3. Pay attention: Ken Metzler, in his book Creative Interviewing, suggests that people who make eye contact while speaking are judged to be friendly, self-confident, mature and sincere, while non-lookers are judged as cold, pessimistic, defensive, evasive and immature. Journalist Sally Adams frames it this way: “How much you look at your interviewee matters vitally-look, please do not stare. Whether you realize or not, it affects how much they will tell you.”

    In some instances, people look away when they are being evasive, but sometimes your subject may break the visual connection because he or she is thinking in a more introspective manner. To reestablish eye contact, lean forward as you ask your next question, arrange your face in a quizzical manner or make a hand gesture to draw the person’s attention back to you.

    4. Paraphrase: During the interview, you might include an interviewee’s words and phrases in your questions. By paraphrasing, you indicate to your subject that you are listening and following. This technique creates empathy, suggests you are free of preconceptions and clarifies information for others who might be involved in the interview, such as representatives of partners, customers or suppliers. When you paraphrase, you speak the other person’s language, and it helps to convey shared meaning clearly.

    5. Downplay yourself: The purpose of an interview is to gather information, not to talk about yourself. The best interviewers “concentrate on their interviewees so much that they almost become invisible,” Adams suggests. “One sign of a good interviewer is that he or she is forgotten.” Adams also recommends mirroring body language to establish rapport. “If they sit back relaxed, you sit back relaxed. If they lean forward, you lean forward. it needs to be subtly done.”

    The best interviews do not just happen. They are the result of careful and conscientious preparation by the interviewer. Auditors must spend a great deal of time learning about the organization, the employees and the processes involved before asking the first question.

    The best way to improve your interview skills is to practice-the more opportunities you have to ask questions, the better you will become at procuring the information you seek.

    Read the complete article.

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    Study: Managers Make Recession Worse By Ignoring Workers
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    According to a new study by Leadership IQ, 66 percent of employees say that they have too little interaction with their boss. In an indication that this could be driven by the recession, this number is up from 53 percent in May 2008, the last time this study was conducted.

    However, employees don’t just want warm-and-fuzzy interactions. While 67 percent of employees say they get too little positive feedback, 51 percent also say they get too little constructive criticism from their boss. Perhaps most troubling is that employees who said they didn’t get enough feedback were 43 percent less likely to recommend their company to others as a great organization in which to work.

    These are the results compiled by Leadership IQ, a leadership training and research company headquartered in Washington, D.C., after surveying 3,611 workers from 291 business and health care organizations in the United States and Canada. Employees were asked 21 questions about their relationship with their direct boss, their personal effectiveness, work-force issues, and overall management effectiveness. The surveys were delivered to Leadership IQ subscribers, with 93 percent of respondents submitting their responses electronically, 5 percent via paper, and 2 percent by telephone. Leadership IQ statisticians reviewed the data for accuracy and consistency, and analyzed the valid submissions.

    It is not just the quantity of the feedback that is lacking. Of the surveyed employees, 53 percent say that when they do receive praise for performance excellence, their supervisors neglect to provide enough useful information to help them repeat it; and 65 percent say that when they receive negative feedback for poor performance, their supervisors don’t provide enough constructive criticism to help them correct the issue.

    “Managers are neglecting one of the most fundamental aspects of their job-providing feedback. Especially in these stressful times, employees are desperate for feedback and interaction with their boss. And when they don’t get it, their job performance suffers. But perhaps worse than the lack of interaction, is the finding that when managers actually do give feedback, more than half of employees say that the feedback is useless. The whole point of feedback is to improve poor performance or reinforce great performance. And this study shows that it’s just not happening,” says Mark Murphy, chairman of Leadership IQ.

    What can managers do to fix this?

    “First, focus on giving a lot more feedback,” recommends Murphy. “Managers should double their efforts to interact with, and provide feedback to, their employees. Second, managers must be sure that when they give feedback, it’s actually useful. If the feedback doesn’t help employees improve poor performance or repeat great performance, then it’s not worth the breath it took to utter it.”

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    Quality Objectives are Business Objectives
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    Are you having a difficult time identifying quality objectives for your organization? Think about your business.

    According to ISO 9000:2005, 3.2.5, a quality objective is something sought or aimed for, related to quality. ISO 9001:2008, 5.4.1, states your quality objectives must be measurable and consistent with the quality policy.

    Clause 5.3 of ISO 9001:2008 says your quality policy is a framework for establishing quality objectives. It also says that the policy must include a commitment to 1) comply with requirements and 2) continually improve the effectiveness of the quality management system. Using the quality policy as a framework, you would have a quality objective to measure the degree to which requirements are being met, as well as, a quality objective that measures the results of the quality management system.

    If your quality policy identifies other important areas, for example, product reliability, you would be expected to have another measurable target for product reliability. ISO 9001:2008, clause 8.2.1, says a required performance measure is for customer satisfaction.

    Remember, goals are conditions to be achieved in the future. They should be defined consistent with your vision and mission. Goals are established to guide your decisions and actions. They don’t change as much as objectives. Your objectives must involve measurable results to achieve your goals.

    Objectives are focused on critical issues and milestones. They describe the activities and targets to achieve your goals. They even identify the dates for completing the activities. They are measurable in terms of being achieved, or not. For example, a general goal might be to reduce waste. The related, specific objective might be to reduce rework from 10% to 5% by the end of 2009.

    Depending on your industry, you might consider quality objectives such as:

    • Scrap Rate = Product Rejects / Products Produced
    • Return Rate = Products Returned / Products Shipped
    • Complaint Rate = Received Complaints /Total Customers
    • Design Stability = Change Requests / Product Releases
    • Service Quality = Defective Transactions / Total Transactions

    Be careful how you set these objectives and how you communicate them. You might find people actually manipulating processes to achieve the desired results, especially if the numbers are used to evaluate employee performance. When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be optimized at the expense of overall system performance.

    If a target is perceived as arbitrary, and set beyond the capability of the process, it may lead to employee frustration, reduced morale, and even lower performance. Individuals must feel they have some control over the outcome for an objective to actually promote improvement. The objectives should help monitor and control the processes, not the people.

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    In the News
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    IPC Lean Sigma Conference for Electronics Manufacturing will be held Nov. 17-19, in Phoenix, Arizona. Designed to benefit all operations managers, including manufacturing, field application, market development, and inventory control engineers, the event offers insight into ways to immediately implement the lean Six Sigma methodology and reduce cycle times, inventory levels, and costs, while improving quality.

    2009 Aerospace Nadcap Supplier Survey Preliminary Results. The fourth biennial Global Aerospace Nadcap Supplier Survey was conducted by the Performance Review Institute (PRI) in 2009. The preliminary results were announced at the Nadcap meeting in Pittsburgh, last month. Nadcap is part of PRI’s Customer Solutions and Support, which aims to identify and respond to customer need in all areas of business relating to quality.

    The Panel of Judges for the Malcolm Baldrige National Quality Award, the nation’s highest recognition for organizational performance excellence, has selected 15 organizations for the final review stage for the 2009 Award. Starting last September, teams of business, education, health care and nonprofit experts will make site visits to two organizations in the manufacturing category, two in small business, one in education, eight in health care and two nonprofits. There were no organizations chosen for site visits in the service category.

    Free Webinar: “What is ISO 14001 and Should I Care?” DNV Certification is offering a free webinar on Nov. 10, “What is ISO 14001 and Should I Care?” Time: 2pm Eastern / 1pm Central / 11am Pacific Duration: 1 hour Description and registration.

    Contact us for assistance with your future 14001 EMS.

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    Training Courses
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            training

    To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.

    View all our Courses.

     

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    Understanding and Implementing ISO9001:2008

    ISO 9001:2008 Process Based Internal Auditor

    Documenting Your Quality Management System

    Understanding and Implementing AS9100C:2009 Aerospace – NEW

    AS9100C Process Based Internal Auditor-NEW

    Documenting Your Quality Management System

    Understanding and Implementing ISO/TS16949:2009 Automotive – NEW

    ISO/TS16949:2009 Process Based Internal Auditor-NEW

    Documenting Your Quality Management System

    Understanding and Implementing ISO14001:2004 Environmental

    ISO14001:2004 Process Based Internal Auditor

    The Five Pillars of a Lean Workplace Organization

    Continuous Process Improvement

    Lean Six Sigma

    8 Disciplines (8D) of Problem Solving – NEW

    Understanding and Implementing ISO 13485:2003 Medical Devices

    ISO 13485 Process Based Internal Auditor

    Understanding and Implementing ISO 27001:2005 Information Security

    ISO 27001 Process Based Internal Auditor

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    FORWARD TO A FRIEND!

    Aerospace Standard Improves Safety

    Thursday, October 1st, 2009
    Performance Improvement Solutions for Your Business Needs October 2009
    In this issue

    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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    Aerospace Standard Improves Safety
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    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.

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    Medical Devices Auto Industry’s Next Frontier?
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    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.

    Click here for more information on this event.

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    Future of Quality Report Released
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    (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:

    1. Emphasize strategic relevance and contribution to long-term sustainability: Ensure that performance excellence and quality systems stay relevant to an organization and move it toward long-term sustainability.
    2. Further, quality and organizational performance excellence should move from the past and current information technologies to active engagement technologies for greater awareness, acceptance, relevance, and impact.
    3. Connect with innovation: For businesses and society, the relationship between innovation and quality is unclear; it must be understood and leveraged.
    4. Increase public awareness and brand value: The need to significantly boost public awareness through branding of quality and performance excellence exists. This is achieved when the consumers understand the importance of quality and how quality has an impact in what they buy, as well as through social media and through quality professionals becoming involved outside the quality community.
    5. Utilize information technology and the movement to engagement technology and tools: From the work force to the customer, use information technology and the explosion of engagement tools as multidirectional, multiple sources of information and transferable knowledge. Share data, strategies, and practices that are successful, and that change mind-sets and behavior.

    A full report of the event is now available at ASQ’s website.

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    In the News
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    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.

    Click here for more information and to register

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    Web-Based Training
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    We are now offering Web-Based Training Courses!

    Benefits of training include:

    1. Maximize Your Budget – More affordable with no travel.
    2. Minimize Time from the Office – Training is self- paced.
    3. Higher Retention of Content – Increased material understanding.

    The courses are offered through our Virtual University. View our current courses and demos including new courses starting in October.

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    Training Courses
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            training

    To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.

    Understanding and Implementing ISO9001:2008

    ISO 9001:2008 Process Based Internal Auditor

    Documenting Your Quality Management System

    Understanding and Implementing AS9100C:2009 Aerospace – NEW

    AS9100C Process Based Internal Auditor-NEW

    Documenting Your Quality Management System

    Understanding and Implementing ISO/TS16949:2009 Automotive – NEW

    ISO/TS16949:2009 Process Based Internal Auditor-NEW

    Documenting Your Quality Management System

    Understanding and Implementing ISO14001:2004 Environmental

    ISO14001:2004 Process Based Internal Auditor

    The Five Pillars of a Lean Workplace Organization

    Continuous Process Improvement

    Lean Six Sigma

    8 Disciplines (8D) of Problem Solving – NEW

    Understanding and Implementing ISO 13485:2003 Medical Devices

    ISO 13485 Process Based Internal Auditor

    Understanding and Implementing ISO 27001:2005 Information Security

    ISO 27001 Process Based Internal Auditor

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    Quick Links
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    FORWARD TO A FRIEND!