Archive for 2006

2007 Training Course Schedule

Friday, December 1st, 2006
Performance Improvement Solutions for Your Business Needs December 2006
In this issue

  • 2007 Training Course Schedule
  • How Lean is Your Management System?
  • How to Audit Continual Improvement
  • How to Audit Preventive Action
  • Healthcare Standard & Hospital Quality Programs
  • 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.

    Send an Email

    Happy Holidays and Thanks for your Support!

    2007 Training Course Schedule

    We are pleased to inform you that our 2007 1st Qtr courses are now posted on our website.

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

    Understand & Implement ISO9001:2000
    ISO 9001:2000 Process Based Internal Auditor
    ISO 9001:2000 Lead Auditor
    Documenting Your Quality Management System

    Understand and Implement AS9100B:2004
    AS9100B:2004 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understand & Implement ISO/TS 16949:2002
    ISO/TS16949:2002 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understand & Implement ISO 14001:2004
    ISO14001:2004 Process Based Internal Auditor
    Documenting Your Quality Management System

    5S Five Pillars of a Lean Workplace Organization
    Continuous Process Improvement
    Lean Six Sigma

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

    Contact Us

    How Lean is Your Management System?

    November Quality Digest Survey:

    If your company is registered to ISO 9001 or a similar quality management system standard, does top management set an expectation of adherence to the standard for the purposes of improving quality, or just enough adherence to get a good audit report from your registrar?

    • Top management expects just enough adherence to quality standards to get a good audit report. 48.4%
    • Top management sets an expectation of adherence to quality standards in order to improve quality. 46%
    • We are not registered to any quality management system standard. 5.6%

    Forty Eight Percent adherence to get a good audit report! We agree that many organizations today are still focused on the CB report for validation of an effective management system. We find organizations that use their documented operational and quality system in order to improve quality(survey says 46%) take the time to streamline, improve, and inquire internally as to “Does this work and can we make it better?”

    How to Audit Continual Improvement

    How do you audit the conformity of an organization to the continual improvement requirements of ISO 9001:2000? First, lets review the definition of continual improvement, “The recurring activity to increase the ability to fulfill requirements.”

    Clause 8.5.3 requires continual improvement of a quality management system through the use of:

    • Quality Policy
    • Quality Objectives
    • Audit Results
    • Data Analysis
    • Corrective Action
    • Preventive Action
    • Management Review

    In addition, clause 5.3 requires the Quality Policy to include a commitment to the continual improvement of the effectiveness of the quality management system. Both these clauses refer to continually improving the “effectivessness” of the system. To fully understand continual improvement, we need to know that the term effectiveness means, “the extent to which planned activities are realized and planned results are achieved.”

    Continual improvement is more than just corrective action (based on a detected nonconformity) or preventive action (based on a potential nonconformity). An organization may identify a unique improvement activity based on their desire to become better and faster at what they do, instead of just reacting to actual or future nonconformities. See if they are identifying specific improvement activities, especially at Management Review. And, how were the target rates of improvement determined? Are the plans being approved, resources being allocated, and progress being tracked?

    Are the improvement projects keyed to increasing the level of conformity to requirements and better satisfying customers? See if performance trends indicate a continual improvement in results. Remember, if they aren’t meeting an improvement target, that doesn’t make it a nonconformity … they may have set an aggressive objective. However, if not met, they should be understanding why not and revising their plan.

    How to Audit Preventive Action

    One of the difficulties in auditing a preventive action program is that some organizations don’t understand well the differences between corrective actions and preventive actions.

    A Corrective Action is taken on a detected nonconformity to prevent it from happening again. An organization will first correct or contain the problem, and then determine its root cause so they can take corrective action to prevent its recurrence.

    When we act to “prevent” a repeat of a detected nonconformity, that is full and complete corrective action, not preventive action.

    Preventive Action is when we anticipate a potential problem and take action to eliminate the possible causes and prevent the occurrence of the nonconformity.

    Auditing a preventive action program begins with a review of the preventive action procedure required by ISO 9001:2000. Of course, an organization may choose to have corrective actions and preventive actions covered in the same documented procedure. This is acceptable as long as the requirements in both clause 8.5.2 and 8.5.3 are adequately addressed.

    The best time to take preventive actions is early in the product cycle, e.g., performing Failure Mode Effects Analysis and conducting Design Reviews. However, these actions are integral to the process and won’t necessarily be captured on preventive action forms.

    When auditing a preventive action program, find out how potential nonconformities are identified. If they aren’t analyzing trends and looking for warning signs, they may be ignoring possible problems that could be avoided if only they were considered.

    Examine the preventive action records to see if the organization is following their procedure. Find out how they identify causes and determine the appropriate actions. Review the results to see if their actions were effective in preventing the problems.

    Healthcare Standard & Hospital Quality Programs

    The new Automotive Industry Action Group (AIAG) voluntary standard for healthcare delivery is now in its second review, with an anticipated launch no later than 2008.

    Medical errors in the United States are well documented. There is growing evidence of the applicability of automotive process methodlogy to healthcare. The Institute of Medicine (IOM) has indicated that the first critical step to effect change in healthcare delivery is the application of engineering principles used in other industries.

    The IOM reports that between 15 and 25 common chronic conditions account for the majority of the health servcies delivered. These would lend themselves to standardization of common sets of services, which is another of the engineering principles mentioned in the report.

    According to a study by the Center for Studying Health System Change The large number of hospital quality reporting programs and the lack of coordination among them means hospitals are scrambling to fulfill their many various requirements.

    According to the study, hospitals have devoted additional resources and staff to quality measurement and improvement, but inadequate IT systems have made the reporting a burden to staff.

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    ISO 17021:2006 for Certification Bodies

    Wednesday, November 1st, 2006
    Performance Improvement Solutions for Your Business Needs November 2006
    In this issue

  • ISO 17021:2006 for Certification Bodies
  • What are Layered Audits?
  • ISO/TS16949 Customer Specific Requirements
  • TL9000 Handbook
  • Tips for Selecting a Certification Body
  • 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 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.

    Thanks for your support!

    ISO 17021:2006 for Certification Bodies

    The recently released ISO 17021:2006 standard is expected to increase confidence in management system certification.

    Hundreds of thousands of organizations worldwide, their customers, consumers, and regulatory authorities stand to benefit from ISO 17021, Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems. The new standard places rigorous requirements for competence and impartiality on the bodies that offer audits and certification to standards like ISO 9001:2000 (quality management) and ISO 14001:2004 (environmental management).

    ISO 17021 has a huge potential impact since some 888,000 organizations in 161 countries are independently certified to ISO 9001:2000 and/or ISO 14001:2004.

    ISO 17021 has been designed as the single source of internationally harmonized requirements for certification bodies and their activities, not only in relation to ISO 9001:2000 and ISO 14001:2004, but also to new management standards for food safety (ISO 22000), information security (ISO 27001), and supply chain security (ISO 28000), as well as, to others that may be developed.

    Replacing and improving on two ISO Guides (62 and 66), ISO 17021 distills an international consensus on the latest in good practice. In addition, it incorporates guidance developed by the International Accreditation Forum (IAF), an international association of accreditation bodies.

    Requirements for impartiality include the following: demonstration by the top management of certification bodies of the need to avoid conflicts of interest between certification and consultancy, training and internal auditing services; the marketing of certification services; and the subcontracting of audits.

    The certification body is required to set up a committee for safeguarding impartiality. The standard envisages that such a committee could include representatives of clients of the certification body, customers of these clients, trade associations, regulatory bodies, governmental and nongovernmental organizations, and consumer associations.

    Additionally, the certification body is required to implement a management system to ensure its conformity to ISO 17021:2006.

    This standard is now available from the ANSI eStandards Store

    What are Layered Audits?

    What are layered audits? They are a system of audits performed by multiple levels of management, from supervisors up to top management. The intent is to frequently audit key process characteristics to verify process conformity.

    Layered audits have proved so valuable, DaimlerChrysler requires their suppliers of production parts and components to conduct these audits on all manufacturing and assembly lines. The purpose is to ensure ongoing conformity, thereby improving process stability and first-time through capability.

    There are two types of layered audits: 1) Process Control audits and 2) Error and Mistake Proofing Verification audits. Supervisors conduct process control audits once per shift. Plant management performs process control audits once per week. Delegation of this responsibility is not acceptable except in unusual circumstances.

    Error and mistake proofing verification audits are conducted once per shift by qualified employees. Set- up and maintenance personnel, as well as, quality auditors, are typically viewed as qualified. Layered audits consider multiple topics, for example documentation, process parameters, product quality, safety, and housekeeping. And, it is expected that people audit their own work and that their managers audit that work.

    For more information on DaimlerChrysler’s requirements for Layered Audits, Contact Us.

    ISO/TS16949 Customer Specific Requirements

    Organizations seeking or maintaining ISO/TS 16949 certification are required to comply with the Customer Specific Requirements (CSR) for all of their customers that subscribe to ISO/TS 16949.

    A central repository for ISO/TS 16949-related CSR is being set up on the Automotive Industry Action Group (AIAG) web site. The AIAG web page will be a resource for subscribing organizations to post links to their customer specific requirements for ISO/TS 16949. Using this newly established repository will ensure the current revision is available and communicated to suppliers and auditiors.

    To date, Delphi, Visteon, and Timken have established links on the AIAG web site for their ISO/TS 16949 customer specific requirements. To view the repository, go to the AIAG web page and look at the links within the ISO/TS 16949 section.

    TL9000 Handbook

    The new TL 9000 Quality Management System (QMS) Requirements Handbook, Release 4.0, must be used for all audits after June 30, 2007. Auditors must have delta training before conducting a third party audit to R4.0.

    Summary of Changes

    • ISO 9001:2000 Base Remains Unchanged
    • 30% of Adders Remain Unchanged
    • 30% of Adders have Minor Changes
    • 40% of Adders have Major Changes or are New

    These requirements designed to:

    • Ensure intended results instead of specifying methods of doing
    • Emphasize design process quality measurements
    • Add required testing (regression, document verification, stress, abnormal condition, and system), and
    • Broaden the scope of certain requirements, e.g., from software only to common or, hardware and software

    A companion document is the TL 9000 Measurements Handbook (Release 3.5). It is a comprehensive guide to measurements processing, usage, responsibilities, and requirements. This book defines the minimum set of performance measurements to assess progress and evaluate results of quality management system implementation. It identifies performance measurements that are key in the telecom industry which are Common Measurements, Outage Measurements, Hardware Measurements, Software Measurements, and Service Quality Measurements.

    Order the Handbook

    Tips for Selecting a Certification Body

    Did you notice the title of this article refers to “Certification Body” instead of “Registrar”? The new ANAB web site uses Certification Bodies (CBs) like the rest of the world, not Registrars as previously used by the RAB. This terminology change took place when the ANSI-RAB National Accreditation Board became the ANSI-ASQ National Accreditation Board (ANAB).

    As with most of life’s major purchases, it pays to shop around for an ISO 9001 or ISO 14001 certification body (CB). Investigate, ask for and check references, and request the resumes of the CB’s proposed audit team. You’re the customer and the CB provides a service to you. Make sure you get what you pay for, but don’t let price alone be the deciding factor. Look for added value.

    Things to consider when selecting a CB:

    • Accreditation by a reputable body
    • Industry experience, background, and expertise
    • For ISO 9001 CBs, approval to work in the appropriate scope category
    • Recommendations from your clients or customers
    • References provided by the CB
    • Scheduling issues and ability to meet your time frame
    • All aspects of the CB’s fee schedule
    • Your comfort level in establishing a long term relationship with a CB

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  • The Process Approach to Auditing

    Sunday, October 1st, 2006
    Performance Improvement Solutions for Your Business Needs October 2006
    In this issue

  • The Process Approach to Auditing
  • Documents of External Origin
  • Quantitative Results from ISO 9001:2000
  • Reluctant to use a Quality Tool?
  • News and Events
  • 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 14001, and others. This includes process improvement methods as 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.

    Thanks for your support!

    The Process Approach to Auditing

    Are you confused about the process approach to auditing? Let us begin with one definition of a process: a set of interrelated or interacting activities which transform inputs into outputs.
    As a result, a process audit is an objective evaluation of a process to determine the extent to which the process is meeting its requirements. Using the process definition, the process audit includes an examination of process inputs, activities, outputs, and outcomes.
    However, a process is part of a larger set of processes (a system) that define an operational and quality management system. Therefore, a process audit must also consider the linkage and interaction of a process with these other processes.

    A process approach methodology helps illustrate the process elements to be audited.

    1. PROCESS (Identify the Process)
    2. INPUTS: (What Received, When, and from Who)
    3. WHAT – Resources: (Equipment, Tools, and Software)
    4. WHO – Resources: (People, Skills, and Experience)
    5. METHODS: (Procedures, Instructions, and Controls)
    6. MEASURES: (Performance Results and Objectives)

    Want to move your auditing program from boring to brilliant and learn more on how to use this approach to developing effective audit checklists and sustained results?

    Process Based Internal Auditing Training

    Documents of External Origin

    Many organizations have a difficult time or are unclear as to these types of documents.
    Let’s clarify: A document of external origin is explicitly one that originates from outside the organization and contains specific information that the organization needs to fulfill customer requirements, maintain their quality management system (QMS) or comply with statutes, for example.

    These documents have their own category because they’re handled differently from those created by the organization. Because of their origins, they carry restrictions. An organization may use them, but it cannot change them, because the authorization for revisions, approvals, withdrawals, etc., resides with those who authored the document. Examples of documents of external origin include:

    Examples of documents of external origin:

      • National/international standards (e.g., ISO 9001, ISO/TS 16949, ISO 17025, etc.)
      • Customer specifications (e.g., drawings, schematics, bills of material, contractual requirements, etc.)
      • Industry and product standards (e.g., clean room standards, National Electrical Manufacturers Association codes)
      • Statutory and regulatory requirements (e.g., OSHA, Environmental Protection Agency, Child Safety Protection Act, Food and Drug Administration, et al.)
      • Operating and repair manuals (i.e., manuals needed to use or maintain equipment)
    • The typical problem that arises with this category is because they aren’t created by the organization, individuals don’t perceive these documents as part of the QMS documentation. If it defines requirements you need to make your organization run or bring product to market, it’s a document that must be controlled.

      Quantitative Results from ISO 9001:2000

      Did you know that the ISO 9001:2000 operational and quality system standard has spread across industry and service – and that implementing the standard results in bottom-line benefits?

      ISO 10014:2006 provides guidelines for realizing financial and economic benefits from the application of the ISO 9000 quality management principles.

      ISO 10014:2006 is directed to top management of an organization and complements ISO 9004 for performance improvements. It provides examples of achievable benefits and identifies management methods and tools that are available to assist with the achievement of those benefits.

      See how our client realized the financial benefits of ISO 9001:2000 application. “Moved from a tier 4 (customer audit failure) to tier 1 supplier and a signed 10 year contract.”

      Reluctant to use a Quality Tool?

      Quality Digest asked its readers:
      “Is your Company Reluctant to use a Quality Tool?”
      Top 5 responses:

      1. Six Sigma 35.3%
      2. ISO 9001 25.7%
      3. Statistical process control 25.1%
      4. FMEA 22.2%
      5. Kaizen 18.6%

      What Quality Tool(s) is your company reluctant to use? Send us an e-mail with your input and we will publish the results anonymously in our November issue.

      News and Events

      Preview our October events and training opportunities

      Read on…

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    Adding Value & How’s Your Customer Support System?

    Tuesday, September 5th, 2006

    What do we mean by “Adding Value?”

    We hear so much about the importance of “adding value” to our processes and during quality management system audits. In principle, each of us contributes in some manner or form adding value, but this is not always the case. Occasionally, it is unclear whether an event adds value. Here are three useful tests:
    • Does the event physically transform the product in some way? If so, it probably adds value.
    • If the customer observed the event, would he balk at paying its cost? If so, the event probably does not add value.
    • If the event were eliminated, would the customer know the difference? If not, the event is probably non value added.

    There are several dictionary definitions of “value” but all focus on the concept of something being useful. “Adding Value” therefore means to make something more useful. Some organizations have used ISO 9001:2000 to develop a quality and operational system that is integrated into the way they do business, and is useful in helping them achieve the strategic objectives of the business. Conversely, other organizations have created a bureaucratic set of procedures and records that do not reflect the way the organization actually functions and simply adds costs, without being useful. This does not add value. Let’s look at two different approaches:
    • A non-value added approach asks, “What procedures do we have to write to get the ISO9001:2000 certification?”
    • A value added approach asks, “How can we use our ISO 9001:2000 based quality management system to help us to improve our business and enhance customer satisfaction?”

    Our experience has shown that the approach an organization takes to “adding value” is likely a function of the level of maturity of the organization’s quality culture and the maturity of its quality management system in respect to the requirements of the ISO 9001:2000 Standard. It is important to define that in this context:

    The Quality Guru refers to “Quality culture” as to the degree of awareness, management commitment, and overall collective behavior of the organization with regard to its quality and operational performance success.

    What do you and/or your organization use to identify a “Quality Culture” Let me know and I will post your comments in our October Newsletter.

    How’s Your Customer Support System?

    In a recent issue of “Quality Insider” readers were asked: “Most of us have to call a customer support number at some time. Usually, that number connects to an automated attendant that steps you through a phone tree before connecting you to an actual humanoid. How often do you find yourself either lost in the phone tree or connected to the wrong customer support department?” Here are the results:

    •0 percent of the time (I never have problems with automated attendants.)4.4%
    •25 percent of the time 35.6%
    •50 percent of the time 33.7%
    •75 percent of the time 21.6%
    •100 percent of the time (I always have problems with automated attendants.)4.7%

    Are you losing customers based upon your customer support system? Let us know what your customers would say!

    Next ISO 9001 Edition Delayed to 2009

    Friday, September 1st, 2006
    Performance Improvement Solutions for Your Business Needs September 2006
    In this issue

  • Next ISO 9001 Edition Delayed to 2009
  • Auditing Organizational Legal Requirements
  • Linkage of Business and Quality Objectives
  • The Academy of Quality Awards
  • News and Events
  • Greetings!

    Industry Magazine Feature Article
    Read how the management team of Ascentec and Sustaining Edge Solutions improved operational and quality performance. “If you pick a good ISO consultant, he or she will pay for themselves ten-fold.” Read on…

    Partners in Performance Improvements

    Next ISO 9001 Edition Delayed to 2009

    The planned publication date for the next revision of ISO 9001 and ISO 9004 was to be third quarter of 2008. Since the working drafts for these standards were not approved for elevation to committee drafts at the recent ISO/TC 176/SC2 meeting, the new projected date for their publication is mid 2009. The next ISO 9001 is being referred to as an Amendment and the next ISO 9004 as a Revision. Although not formal ISO terms, they are being used to convey the level of expected changes to the standards. The ISO 9001 amendment will be limited to clarifications. The document is expected to retain all the clause numbers and titles from the 2000 edition. The ISO 9004 revision is expected to include more substantive changes to encourage more usage.

    Auditing Organizational Legal Requirements

    Part of audit planning is determining the audit criteria, in other words, the policies, procedures, and requirements used as the reference for comparing audit evidence. The primary types of requirements are:

    • Customer, as expressed in orders and contracts;
    • Company, as found in policies and procedures;
    • Standard, such as ISO 9001:2000;
    • Legal, as defined in statutes and regulations.

    Unfortunately, legal requirements are often ignored during internal audits. And that omission would be a nonconformity. ISO 9001:2000, clause 7.2.1.c states that organizations must determine statutory and regulatory requirements for their products. In addition, clause 7.3.2.b requires design inputs to include applicable statutory and regulatory requirements.

    According to clause 5.1.a, top management must communicate the importance of meeting customer, as well as, statutory and regulatory requirements. The legal requirements in this context are quality and product-related, not health, safety, or environment- related. Auditors must first identify the applicable legal requirements for the area to be audited. Ask the legal staff, contract group, and audited area itself about any process or product legal requirements. According to ISO 9001:2000, the requirements should have been identified.

    For the organization to meet the legal requirements, they must have access to the statutes and regulations. Ensure they are available for reference. If the applicable legal requirements have been determined by the organization, see how they monitor for any new or changed legal requirements. Then ask for evidence that the organization is conforming to the requirements. If there is proof legal requirements are not being considered, then issue a nonconformity report. Or, if there is evidence that the organization is in violation of a legal requirement, then issue a nonconformity report.

    Linkage of Business and Quality Objectives

    QualityInsider surveyed readers on how their company communicates quality objectives. Here are the results:

    • Bulletin boards 39.2%
    • Company meetings 29.7%
    • My company doesn’t publish quality objectives. 15%
    • Web site 7.2%
    • E-mail or intranet broadcasts 5.1%
    • Company newsletter 3.8%

    Our clients ask “Is their a difference between quality objectives and business objectives”? How does a company ensure that objectives are relevant, measurable, communicated, and understood by employees? The best organizations understand that the two are fully integrated.

    The Academy of Quality Awards

    The annual Quality Progress listing identifies national, international, government, and state quality related awards. Check out if your state quality award is listed. Information on how to include your state award in future listings is included.

    News and Events

    Preview our future events and training opportunities

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  • Which Process Improvement Tools Are You Using?

    Tuesday, August 1st, 2006
    Performance Improvement Solutions for Your Business Needs August 2006
    In this issue

    • Which Process Improvement Tools Are You Using?
    • U.S. Companies Lag in Social Responsibility
    • Changing Times



    Welcome to Our New Newsletter Format! Our goal is to deliver you information on performance improvement methods, techniques, and current news.

    If you have a subject matter in mind you would like to learn more about, please let us know. Thank you very much for your support!

    Walter Tighe, President

    Which Process Improvement Tools Are You Using?


    Quality Digest Magazine last month asked their readers: Which three tools have given you the biggest savings? The Top 10…

    • Brainstorming 41.5%
    • Pareto Charts 38.5%
    • Cause and Effect 34.1%
    • Flow Charts 31.9%
    • Control charts 24.4%
    • Design of Experiment (DOE) 23.7%
    • Failure modes and effects analysis (FMEA) 23.0%
    • Poka Yoke 15.6%
    • Histograms 11.9%
    • Checksheets 10.4%


    The fact is that these process improvement tools have been around for decades long before Six Sigma and Lean became part of the quality landscape methodologies. With a structured process the top 5 tools alone will provide your organization a system for identifying system and process inputs, key characteristics, measures and outputs. This list of tools are the basic fundamental building blocks to process improvement results and when used effectively help identify the seven types of deadly process waste, promote employee involvement, and drive results.




    U.S. Companies Lag in Social Responsibility


    A poll performed by the American Society for Quality found that while 96 percent of respondents indicated that their companies’ corporate stance toward social responsibility will greatly affect the United States’ economic future, more than 40 percent of them don’t have a social responsibility policy in place. In what may be the “Enron effect,” of those that did have such a policy in place, 70 percent of them reported doing so since 2001. The poll also reveals that two-thirds of the business leaders would implement a social responsibility policy primarily to maintain their brand image, enhance employee morale and reduce legal liability.

    ASQ conducted the poll in preparation for its development of a global standard for social responsibility. In the wake of corporate scandals, environmental disasters, child-labor violations and dangerous work environments, the voluntary standard will provide consistent principles and direction for an organization’s commitment to social responsibility. Experts from the public and private sectors are invited to join the team that will develop the standard. “It’s clear that the choices we make today to ensure a more ethical work and living environment will certainly have a major impact tomorrow,” says Paul Borawski, ASQ executive director and chief strategic officer. “There could not be a more timely opportunity for organizations to join together and make their voices heard about the issue of social responsibility.”



    Changing Times


    Bob Dylan was right. The times, they are a-changin’. A recently released study found that most U.S. multinational companies have undergone–and are currently undergoing– great changes. The typical company is using an average of five change- management strategies. Quality management techniques have become an important part of managing change, with 56 percent and 41 percent of respondents reporting that Six Sigma and total quality management (TQM), respectively, were their preferred methodologies. Predictably, the vast majority of respondents reported that growth and cost reduction are the major reasons for their organizations’ changes. Growth was the most-cited reason for change, with 88 percent reporting it as an “important” source, and 42 percent citing it as an “extremely important” source of change. Cost reduction was second on the list, with 76 percent reporting it as an “important” reason for change, and 35 percent citing it as “extremely important.”

    Not surprisingly, companies that see change as necessary for growth are the faster growers,” notes Karen Vander Linde, leader of change-management practice at PricewaterhouseCoopers, which performed the research. “Implementing change for cost reduction ensures that their growth will be profitable.” Other often-cited reasons for organizational change were domestic competition, new regulations, risk- management programs, energy costs and quality improvement programs. PricewaterhouseCoopers interviewed 133 top executives from major U.S.-based companies. Almost all respondents–98 percent–reported that senior management’s support of change activities is essential to success. Other critical success factors included employee involvement (95%), training programs (82%) and team-building exercises (77%). For more information, visit and view “U.S. Multinationals Have Much at Stake in Change Management, PricewaterhouseCoopers Finds.”


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    What Do YOU Think About This?

    Wednesday, May 10th, 2006

    Quality Digest Survey Results:

    Can Six Sigma be overused?

    • Yes 72.3%

    • It depends 15.8%

    • No 11.9%

    Does Six Sigma lead to tunnel vision?

    • Yes 43.8%

    • It depends 35.5%

    • No 20.7%

    Other comments included:

    • "It depends on the individual, not Six Sigma tools or methodology."

    • "It depends on the ultimate understanding that the movers and shakers for Six Sigma have within the company. One must always look at the whole picture and not just the immediate incident/report."

    • "Users need to be careful not to focus too heavily on cost reduction and lose site of product quality. A certain amount of common sense and good judgement have to be applied to all projects."

    • "We can get hung up on the financial returns projects and ignore the just-do-it projects."

    • "Overused? No. Wrongly applied? Yes. Not every problem needs or lends itself to a DMAIC project. And tunnel vision, like beauty, is in the eye of the beholder."



    Reasons Why You Know You Need A Formal Process Improvement Structure

    Tuesday, April 18th, 2006

    1. Fragmented processes causing delays and defects: Firefighting versus Fire Prevention. The focus must be preventing defects, errors, and mistakes.

    2. Customer Complaints: For every customer that complains about your product or service, there are 16 more that won’t tell you directly. Word of mouth can kill you!

    3. Supplier Complaints: Do your suppliers complain about the last minute delays imposed on them?

    4. Employee’s Whining: What’s stopping your employees from doing a good job? “I could do my job better if ____”.

    5. Blaming People: The problems are in your processes, not your people. Six Sigma is process focused.

    6. Knee jerk Reactions: Managing by Gut feelings. “We’ve always done it this way”. Data driven methods create improvements.

    7. Margins are low, expenses are high, and our growth is stalled: Defects and delays eat away at profits, and lack of a strategic focus inflates expenses.

    8. Field failures: How many customer service personnel do you have? How large is your warranty and repair efforts?

    9. Too many inspectors: You cannot inspect quality in, but you can build it in.

    10. Absenteeism and turnover: Employees don’t want to do a bad job. Are your internal systems preventing your employees from doing a good job?

    Who was the ORIGINAL Quality Guru?

    Tuesday, April 11th, 2006


    W. Edwards Deming

    Dr. Deming is the ultimate of the quality gurus. He developed, implemented, and made work many of the ideas that we currently use in quality. The story of his going to Japan and teaching the Japanese about quality has become legend. But, what did he teach? What are the nuggets of information we should remember?

    The first of his teachings is the fourteen points of quality management:

    1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs.

    2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge must learn their responsibilities, and take on leadership for change.

    3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.

    4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.

    5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.

    6. Institute training on the job.

    7. Institute leadership. The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.

    8. Drive out fear, so that everyone may work effectively for the company.

    9. Break down barriers between departments.

    10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.

    11. a. Eliminate work standards on the factory floor. b. Eliminate management by objective.

    12. a. Remove barriers that rob the hourly worker ofhis right to pride of workmanship. b. Remove barriers that rob people in management and in engineering of their right to pride of workmanship.

    13. Institute a vigorous program of education and self-improvement.

    14. Put everybody in the company to work to accomplish the transformation. The transformation is everyone’s job one

    The second of his nuggets of information is his seven deadly diseases:

    1. Lack of constancy of purpose to plan product and service that will have a market and keep the company in business, and provide jobs.

    2. Emphasis on short term profits.

    3. Evaluation of performance, merit rating, or annual review.

    4. Mobility of management; job hopping.

    5. Management by use only of visible figures, with little or no consideration of figures that are unknown or unknowable.

    6. Excessive medical costs.

    7. Excessive costs of liability.

    A Ten Step Method To Continuous Improvement

    Tuesday, April 11th, 2006

    A Ten Step Method To Continuous Improvement

    Continual improvement is a type of change that is focused on increasing the effectiveness and/or efficiency of an organization to fulfill its policies and objectives. It is not limited to quality initiatives. Improvement in business strategy, business results, and customer, employee, and supplier business relationships can be subject to continual improvement. Putting it simply, it means getting better all the time’. Continual improvement should focus on enablers such as leadership, communication, resources, organization structure, people, and processes – in other words, everything in the organization, in all functions at all levels. Continual improvement should also lead to better results, such as, price, cost, productivity, time to market, delivery, responsiveness, profit, and customer and employee satisfaction. There has been a tendency in total quality management programs to focus on departmental improvements which do not improve business results overall. Departmental improvements may merely move the constraints or problem somewhere else in the process chain.

    What continual improvement is not:
    Improvement is not about using a set of tools and techniques. Improvement is not going through the motions of organizing improvement teams and training people. Improvement is a result, so it can only be claimed after there has been a beneficial change in an organization’s performance.

    Gradual, incremental, or breakthrough?
    Continuous improvement is gradual never-ending change, whereas continual improvement is incremental change. Both types of improvements are what the Japanese call Kaizen. In the United States, Lean and Six Sigma improvement is common place. Breakthroughs are improvements, but in one giant leap – a step change. However, the method of achievement is the same, but breakthroughs tend to arise out of chance discoveries and could take years before being made.

    When should continual improvement be started?
    All managerial activity is directed either at control or at improvement. Managers are either devoting their efforts at maintaining performance, preventing change, or creating change, breakthrough, or improvement. If businesses stand still, they will lose their competitive edge, so improvements must be made to keep pace and stay in business. Every system, program, or project should provide for an improvement cycle. Therefore, when an objective has been achieved, work should commence on identifying what is meeting the requirements of the process, and what better ways of doing it.
    There is no improvement without measurement. An organization must establish current performance before embarking on any improvement. If it does not, it will have no baseline from which to determine efforts.

    There are ten steps to undertaking continual improvement:
    1. Determine current performance.
    2. Establish a need to improve.
    3. Obtain commitment and define the improvement objective.
    4. Organize the diagnostic resources.
    5. Carry out research and analysis to discover the cause of current performance.
    6. Define and test solutions that will accomplish the improvement objective.
    7. Produce improvement plans which specify how and by whom the changes will be implemented.
    8. Identify and overcome any resistance to the change.
    9. Implement the change.
    10. Put in place controls to hold new levels of performance, and repeat step one.

    Where do the ideas come from?
    If the organization has identified its critical success factors (that handful of things at which it must be supremely good in order to succeed), then focusing the attention of the continual improvement process onto one or more of these for a defined period might give rise to major improvements. No one in the organization, from top to bottom, is exempt from the responsibility for improvement. It is a normal component of all employees’ jobs to search out ways of improving performance. Furthermore, no one in the organization can be expected to do this without help and the necessary support.

    What tools should be used?
    The portfolio of tools used for continual improvement should be those which enable an organization to execute the ten steps above. These can include:

    • Ishikawa fishbone diagram to examine cause and effect
    • Failure mode and effects analysis to predict failure and prevent its occurrence
    • Pareto analysis to identify the few influences on a situation which have the biggest impact
    • Force field diagram to display the forces for and against change
    • Charting techniques to demonstrate whether improvement is being achieved

    Continual improvement is far more than a set of techniques.
    For many organizations, it involves a radical change in attitudes. The defense of the status quo, and resistance to innovation, cannot be treated as normal management behavior. A fear of reprisals for reporting problems has to be replaced by congratulating people for identifying an opportunity to improve. Hoarding of good ideas within departmental walls must be a thing of the past as people share their knowledge and experience in the search for greater collective success. The importance of commitment
    Continual improvement is about the entire organization and everything it does. It has to be a prime concern of executive management and its success depends upon commitment from the top. The commitment must also be highly visible. It is not enough to have a quality policy signed by the chief executive. If executive management does not demonstrate its commitment by doing what it says it will do, they cannot expect others to be committed.

    Reward success !
    The encouragement of people who have initiated improvements, however small, is an important component. This can be done in many ways, from displays on special improvement notice boards to the awarding of prizes. This is an area in which the culture and style of the organization has to be considered. The sudden introduction of a show business style into a staid environment may lead to cynicism rather than effective promotion of success.