Six Sigma

What is Six Sigma?

Six Sigma is a quality philosophy that uses customer-focused goals and measurements to drive continuous improvement at all levels in any enterprise. The goal is processes that are so robust that defects are measured at levels of only a few parts per million. Six Sigma implementation requires top management leadership, since the concept must be embraced throughout the organization.

We survey customers regularly and they're happy; what can Six Sigma do for us?

If your customers are "happy," but not checking the "top box" on those surveys, Six Sigma can help by raising their perceptions of you. Remember-they may be happy now, but customers are also fickle. They will jump to anyone that promises (and delivers) better value in the marketplace. It has been estimated that customers who rate you as "good" are six times more likely to change suppliers as those who rate you as "excellent."

Is Six Sigma "zero defects"?

Six Sigma considers a mall, but finite, number of defects. The number is so small that it is perceived as "virtual perfection." The fact that it is not zero (albeit small) allows people to "buy into" Six Sigma intellectually. Most people have a problem with "zero" because they are human and cannot believe in "zero." They will, however, be willing to strive for only three parts per million because it is a finite number. They're then willing to try for it, which is really all you need to get started.

Will Six Sigma improve the bottom line?

When you look at all the "re" words in our vocabulary (rework, retest, reedit, redo, reprocess, recheck, rewrite, etc.), you get a feel for the amount of waste in our operations. Six Sigma focuses on reducing that waste, and the results fall to the bottom line. Most organizations run costs-of-poor-quality at anywhere from 10 to 25% of their sales figures. Imagine those numbers dropping to the bottom line-what a loud sound!

We're a service organization; how does Six Sigma apply to us?

Whether you're service or manufacturing, you do your work in "processes." These processes are what Six Sigma strives to improve. Whether a process generates a lot of wasted effort in a service transaction or scrap material in manufacturing, it makes little difference to an unhappy customer. Service processes probably have more potential to improve than manufacturing, since industrial engineers have rarely concentrated on service processes, but have looked at manufacturing since the days of Frederick Taylor.

Why do we need Six Sigma if we already have a quality system in place?

Six Sigma is a set of continual improvement tools that move quality forward and reduce costs. If your organization is not improving, it is probably falling behind.

We're in the process of getting through ISO 9000 registration. Will Six Sigma enhance or detract from our efforts?

ISO 9000 and its derivatives (QS-9000, TL 9000, AS 9100, etc.) give you a basic management system for quality and a foundation in "process" thinking. To become world class requires a lot more than a basic quality system. To delight your customer requires a much deeper commitment to quality; Six Sigma can generate that higher level of focus. Systems based on ISO 9000 support Six Sigma improvements with the documentation and audits of the quality system. Note also that ISO 9001:2000 requires continual improvement. Six Sigma is designed to drive continual improvement throughout your enterprise.

Is Six Sigma similar to the Malcolm Baldrige criteria?

Both the Baldrige criteria and Six Sigma are built on continual improvement. The difference is that Baldrige is an assessment vehicle-a way of measuring the effectiveness of your quality system and its business results. Six Sigma is a way of raising that effectiveness and improving your business results.

How do we handle measuring what we have now versus what we should measure?

You may already be measuring the right things. If the measurements are from the customer's view, you're already there. If you're not, then the Six Sigma measurements are what you should have been measuring. Discard those that drive you away from the customer.

Is Six Sigma like SPC (statistical process control)?

Six Sigma is a philosophy of belief in perfection and customer delight. SPC is one of the tools used to support the Six Sigma philosophy. All the classical quality tools that you've learned, like Pareto charts, fishbone diagrams, control charts, or statistics in general support Six Sigma.

What does "defects per unit (DPU)" mean? What is a "unit"?

First of all, a unit is a measure of the work you do-it can be a report, a gadget, a contract, a phone call, or anything else that describes the product you produce (yes, even in a service organization there are "products"). "Defects per unit" only describes what "percentage" of your units will have defects that pass on to the "customer" (who may be the person performing the next step in the process). A base of one million is generally used instead of one hundred, as you do in percentages, because the numbers are usually small. Hence, in Six Sigma we commonly speak of defects per million opportunities (DPMO).

What examples exist of real savings and benefits from other companies that have used Six Sigma?

There are many stories of savings and improvements in Motorola, Citibank, General Electric, AlliedSignal, Texas Instruments, and others that are almost legendary. If you look at some of their annual reports, you will see success stories of all kinds attributed to Six Sigma. The key is to have the commitment and understanding to realize that there is something here that can work in your enterprise, if it's properly supported and implemented.

I understand Six Sigma. What are some of the advanced tools that I can consider?

There are many other customer-focused tools that enhance Six Sigma. Quality function deployment (QFD), Taguchi methods, etc., are just a few. All of the traditional and new tools that work in your operation can be used and understood.

I've heard and read about "Black Belts." What does this term mean?

The term "Black Belt" was coined at Motorola to designate an expert in the application of Six Sigma tools, much as the traditional definition of a "Black Belt" describes an expert in the martial arts. However, "Black Belts" aren't the only ones that can use Six Sigma tools because most of them are not that complicated. We also train "Green Belts," who have the skills to assist as members of project teams. Click here for more information on Black Belt training or on Six Sigma in general.

How long does it take to implement Six Sigma?

It took the originators of Six Sigma, Motorola, anywhere from 5 to 10 years to really apply the concept. The purpose of Six Sigma training, education, senior management commitment, and these FAQs is to do it faster, with fewer mistakes and false starts.

How much will it cost to implement Six Sigma?

A good training program, in useful tools, at the proper time is an "investment" rather than a cost. The initial outlay is in the form of training in Six Sigma basics and dedicating trained personnel, full-time, to eliminating non-value-added costs. In reality, the training and deployment focus people on doing a better job of what they should be doing anyway.

Who should be trained to use Six Sigma tools?

This answer is simple-just about everyone at all levels. When the entire organization is committed to and understands the Six Sigma philosophy, the greatest gains can be made. However, most organizations start the process with the senior executive staff and then begin to identify and train team leaders.

What do "processes" mean and why are they important in implementing Six Sigma?

A process is the way we work. It's the methodology used to deliver the goods and services we provide. By focusing on "processes" we see ways to improve and provide more and better products and services at lower cost, and keep our customer happy.

How many people are required for Six Sigma implementation?

You can start with any number, however, the real strength of the Six Sigma philosophy comes when everyone in the operation is applying this training-management and workers. The common language, the common goals, and the common methods all help reinforce the effectiveness of the concept.

ISO 9000

What's ISO 9000?

ISO 9000 is an international family of generic quality standards, originally published by ISO (International Organization for Standardization) in 1987 and updated in 1994 and again in 2000. It has currently been adopted by over 100 nations. It has been adopted by the European Union and by the U.S. as ANSI/ASQC Q9000, has been accepted by the U.S. Department of Defense and NASA, and has been incorporated into FDA and NATO standards. It is also the foundation for many industry-specific standards such as QS-9000 for the automotive industry. This international standard specifies elements necessary for the foundation of a quality management system, but does not specify how the requirements are to be implemented. It does not replace product safety or regulatory standards or requirements.

What are the significant changes in ISO 9001:2000?

The ISO 9001:2000 changes include: focus on a process approach, including a process model; more consistent terminology; enhanced compatibility with ISO 14000; continual improvement of the quality management system; and significant emphasis on achieving customer satisfaction by meeting customer requirements.

How do I get started implementing ISO 9001?

Successful companies start an ISO 9001 implementation process with management commitment. A typical schedule for implementation ranges from 12 to 15 months. For information on our complete 14-step process, click here.

What are the benefits of ISO 9001 registration?

ISO 9001 helps meet customer requirements, enhances your company's image, reduces multiple audits, and provides a basis for quality improvement. If you export to Europe, registration will help you comply with European Union directives.

What's the role of the registrar?

A registrar is an impartial independent auditing body, who evaluates your company against a given quality standard, for example, ISO 9001. Registrars are the only accredited body capable of providing a company with ISO 9001 registration. A list of registrars is available from ASQ by calling 1-800-248-1946.

What's the difference between a lead and an internal auditor?

Lead auditors and auditors are trained to audit both suppliers and facilities outside their own organizations (also known as second- and third-party audits) as well as elements within their own organization. Internal auditors are trained to audit their company's internal systems only (first-party audits).

How does ISO 9000 compare with the FDA's Medical Device Quality System Regulation?

FDA's Medical Device Quality System Regulation includes elements from ISO 9000 as well as other international standards. The Medical Device Quality System Regulation is mandatory as stated by the FDA, while ISO 9001 is a voluntary quality management system. Click here for more information on training programs for FDA-regulated industries.

How does ISO 9000 compare with QS-9000, AS 9100, and TL 9000?

All of the elements of ISO 9001 are contained in QS-9000, AS 9100, and TL 9000; however, QS-9000 also contains additional elements specific to the automotive industry, AS 9100 has specific aerospace requirements, and TL 9000 is customized for the telecommunications industry. Also, QS-9000 is built around ISO 9001:1994, and there are no plans to update it, since eventually it will be replaced by ISO/TS 16949, which incorporates several European automotive standards. Click here for more information about QS-9000 and ISO/TS 16949. Click here for more information on TL 9000. Click here for more information on AS 9100.

What's the difference between CQA (certified quality auditor) and registered lead auditor status?

If you have completed CQA training and passed ASQ's CQA exam, you will be certified by the ASQ as a quality auditor. To be a registered lead auditor, you must first take a five-day approved training program, pass the necessary exam, and then apply to the RAB or IRCA for certification as a registered lead auditor. NOTE: To attain registration as a lead auditor, you must pass the written final exam, earn a passing grade in the course's continuous assessments, and meet prescribed professional requirements, which include conducting a number of actual audits. To become an auditor for an automotive registrar, additional training is required.

What's the difference between ISO 9000 and business process improvement?

The difference is that business process improvement deals with the overall business systems of an organization, and can include an ISO 9001 quality management system. Business process improvement or Six Sigma is a natural next step after ISO 9001 implementation.

ISO 14000

What is ISO 14000?

ISO 14000 is a series of international standards that deal with environmental issues. Some key standards in the series are ISO 14001, which deals with environmental management systems, and ISO 14010, which covers environmental auditing.

What's an Environmental Management System (EMS)?

According to ISO 14001, it's the part of an organization's overall management system that deals with developing, implementing, achieving, reviewing, and maintaining the organization's environmental policy. It includes the organizational structure, planning activities, responsibilities, practices, procedures, processes, and resources.

Why is it important?

Environmental concerns are at the forefront of corporate issues today. Having a documented environmental management system helps ensure that your policies are effectively understood and implemented, and that your environmental management system is an integral part of your overall management system.

Who enforces ISO 14000?

Is it mandatory? Like other international standards (such as ISO 9000), ISO 14000 standards are voluntary standards adopted by consensus of the world's standards organizations. Third-party registration by an accredited agency certifies that your organization's management system meets ISO 14000 criteria.

What are the differences between ISO 9000 and ISO 14000?

With ISO 14001 an organization may elect to implement its ISO 14000 system as part of an existing management system such as ISO 9000 or QS-9000, and the standard includes a table of comparisons between ISO 14001 and ISO 9001. Both include policy, management responsibility, training, document and data control, records, corrective and preventive action, and an internal audit program.

Can we integrate any ISO 9000-based system with an ISO 14000 system?

Yes. Although subtle differences do exist, it is possible to integrate an ISO 14001 EMS with your compliant management system. The year 2000 revision to the ISO 9000 standards has greatly enhanced their compatibility with the ISO 14000 standards.

Are companies becoming registered to ISO 14001 in the same way they are for ISO 9001 and QS-9000?

Yes. Many registrars are certifying companies to ISO 14001. There are, however, different requirements for being registered to ISO 14001, including environmental aspects and impacts.

What types of companies are getting registered to ISO 14001?

A variety of companies are focusing their attention on ISO 14000 environmental management systems, primarily manufacturers in automotive, chemicals, pharmaceuticals, and electronics, as well as utilities, printing, metalworking, and assorted manufacturing companies. In addition, the Department of Defense and many other government agencies are showing an active interest in ISO 14000.

Can I become a registered lead auditor/internal auditor to ISO 14000?

Yes. Attending a five-day registered lead auditor training program will satisfy the basic training requirements for applying for registered lead auditor status. Other requirements apply; please check directly with the RAB for specific requirements. To contact RAB, call 1-800-248-1946.

If I'm an ISO 9000 registered lead auditor/internal auditor, what do I need to do to become an ISO 14000 registered lead auditor?

You must still take the five-day training to become a registered lead auditor to ISO 14000.

Automotive

What is ISO/TS 16949:1999?

ISO/TS 16949:1999 was prepared by the International Automotive Task Force and representatives from ISO/TC 176: Quality management and quality assurance. The technical specification aligns existing automotive quality system requirements within the global automotive industry. It has been issued for provisional application in the automotive sector so that information and experience in its application may be gathered. ISO/Technical Specifications are reviewed every three years to decide whether they can be transformed into an international standard. The goal of ISO/TS 16949:1999 is the development of quality systems that provide continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

What is QS-9000?

QS-9000 is the U.S. automotive industry quality system standard and is modeled after the ISO 9001 Standard. QS-9000 encompasses all of ISO 9001 plus additional automotive-specific requirements, as well as customer-specific requirements.

If my company is QS-9000 certified, are we also ISO 9001 registered?

When your company is registered (compliant) to QS-9000, you are also registered to ISO 9001:1994, depending on the business.

Why get certified to QS-9000?

If you are a supplier directly to the Big Three automotive manufacturers, or are considering expanding your business to that industry, QS-9000 registration (or compliance) is necessary. General Motors and DaimlerChrysler have already mandated that their Tier 1 suppliers be registered to QS-9000 and Ford Motor Company is requiring that their supplier base be in compliance with QS-9000.

Is QS-9000 a North American certification only?

Not at all. QS-9000 is a worldwide automotive requirement for Tier 1 suppliers to the OEMs.

How do I go from ISO 9000 to QS-9000?

Since QS-9000 incorporates the elements of ISO 9001:1994, there will be some overlapping areas where additional elements are required. For example, ISO 9001:1994 has 20 elements; QS-9000 has the 20 elements of ISO 9001:1994, but some of them are expanded, plus three specific industry sectors. And while there are 158 "shalls" in ISO 9001:1994, there are 260 "shalls" in QS-9000.

Does QS-9000 certification require a third-party audit?

Yes. As with ISO 9001, the company requesting certification is responsible for selecting and paying for the registrar. There are only about 12 accredited registrars for QS-9000. For a list of certified registrars, please call ASQ at 800-248-1946.

What are the phases in getting started with QS-9000 certification?

There are five major phases toward implementation for certification. Please call our Detroit office at 248-680-4673.

How long does it take to get QS-9000 certification?

Once we assess the current status of your quality system, we will be able to determine the length of time needed for implementation and certification. We suggest allowing 12-18 months.

What is the TE Supplement?

The Quality System Requirement TE Supplement, developed under the guidance of the Chrysler/Ford/General Motors Supplier Quality Requirements Task Force, specifies requirements in addition to QS-9000. These additional requirements apply to suppliers of machinery or any component thereof (e.g., spare parts). The intent of the TE Supplement is to provide to the producers of Tooling and Equipment (i.e., machinery) and selected suppliers of nonproduction materials (e.g., coolants) focus in the application of process-driven quality systems to promote effective use of the principles of reliability and maintainability, and through implementation of the requirements add value at each stage of the tooling and equipment product's life cycle.

What has been changed in the 2002 edition of ISO/TS 16949?

The revised version of ISO/TS 16949 has been aligned with ISO 9001:2000 and was developed and released under the sanction of ISO/TC 176, the ISO technical committee responsible for developing the ISO 9000 series of standards and guidance documents. ISO/TS 16949:2002 is organized along the same eight-element structure as ISO 9001:2000, with a clear emphasis on customer requirements.

What is the deadline for transition/registration to ISO/TS 16949:2002?

Suppliers certified to ISO/TS 16949:1999 will need to upgrade to ISO 16949:2002 by December 14, 2003; however, QS-9000 will be valid until December 14, 2006.

What is the automotive industry's reaction to ISO/TS 16949:2002?

The Supplier Quality Requirements Task Force (SQRTF), in an August 2002 letter, stated that "As a result of harmonization efforts worldwide, the Chrysler Group, Ford Motor Company, and General Motors Corporation, as part of the International Automotive Task Force (IATF), have each decided to adopt the new ISO/TS 16949:2002 standard." In addition, ISO/TS 16949:2002 compliance is being encouraged by BMW, Fiat Auto, Nissan Motor, PSA (Peugeot-Citroen), Renault, and Volkswagen.

What are the benefits of ISO/TS 16949:2002?

Some of the cited benefits of ISO/TS 16949:2002 include:

• Global harmonization with other automotive manufacturers to provide improved quality products to automotive customers worldwide
• Common IATF third-party registration scheme to ensure consistency worldwide
• Improved product and process quality
• Additional confidence for global sourcing
• Reassignment of supplier resources to quality improvement
• Common quality system approach in the supply chain for supplier/subcontractor development and consistency
• Reduction in multiple third-party registrations, thereby reducing cost
• Reduction of variation and increased efficiency
• Reduction in second-party system audits
• Common language to improve understanding of quality requirements
• One audit to satisfy requirements of previous international standards (e.g., QS-9000, VDA 6.1, AVSQ, EAQF)

TL 9000

What is TL 9000?

TL 9000 is the telecommunications industry's set of two handbooks: TL 9000 Quality Management System Requirements and TL 9000 Quality Management System Measurements. The Requirements volume includes all of the requirements of ISO 9001:2000, plus industry-specific requirements for hardware, software, and services. The goal of these added requirements is continual improvement in the telecommunications industry, resulting in potential cost savings for suppliers and service providers, and improved service to end users of telecommunications services.

What is the purpose of TL 9000?

The purpose of TL 9000 is to define the telecommunications quality management system requirements for the design, development, production, delivery, installation, and maintenance of products and services. Included in TL 9000 are performance and cost-based measurements for reliability and quality performance of products and services.

What makes TL 9000 unique and separates it from other quality standards?

The unique feature of TL 9000 is the requirement for quality measurements, which differentiates this quality requirement from all others. Each TL 9000-registered company reports only those measurements that apply to its operations.

What are the benefits of implementing TL 9000?

Telecommunications service providers, their subscribers, and their suppliers will all benefit as a result of implementing TL 9000:

• Continual improvement of service to subscribers
• Enhanced customer/supplier relationships
• Standardization of quality system requirements, worldwide
• Uniform performance and cost-based measurements
• Efficient management of external audits and site visits
• Creation of a platform for improvement initiatives

What relationship does this new set of requirements have with current industry standards?

The various standards used within the industry have produced significant benefits and contain elements that will become important parts of the new requirements. ISO 9001 forms the basis of the effort, augmented by various Telcordia (Bellcore) and other quality management system requirements. TL 9000 consolidates the various quality system requirements currently used within the industry. It creates a telecommunications-specific set of requirements built upon an ISO 9000 framework.

What is included in the TL 9000 Quality Management System Requirements and the TL 9000 Quality System Measurements handbooks?

TL 9000 addresses all elements of quality management that pertain to hardware, software, and services. In addition to ISO 9001, it includes appropriate parts from industry standards and current proprietary standards, such as Telcordia's GR1252-CORE, Quality System Generic Requirements for Hardware. The TL 9000 requirements are constructed to harmonize existing standards and include new sections as appropriate. TL 9000 also includes a commonly applied set of performance measurements to be used to evaluate quality for different classes of products.

What is the QuEST Forum?

The Quality Excellence for Suppliers of Telecommunications (QuEST) Forum is a unique partnership of telecommunications suppliers and service providers.

What is the primary mission of the QuEST Forum?

The QuEST Forum's mission is to foster continued improvements to the quality and reliability of telecommunications service. It is committed to developing and maintaining a common set of quality system requirements for the telecommunications industry, worldwide, including reportable performance and cost-based measurements for the industry.

How does the QuEST Forum monitor the requirements?

Representatives from participating QuEST Forum service providers and suppliers have formed work groups that meet regularly to evaluate the requirements.

What are other responsibilities of the QuEST Forum?

The QuEST Forum is responsible for maintaining the TL 9000 quality requirements and for assuring compatibility with other sets of requirements and standards. Currently, it represents the telecommunications industry on the ISO 9001 Technical Committee (TC 176). For more information, visit the Forum web site: www.questforum.org.

How does an organization become a member of the QuEST Forum?

Telecommunications companies interested in joining may complete the on-line membership application (http://questforum.asq.org) or may download and fax an MS Word document to 414-765-8665. For additional information on joining, please contact the QuEST Forum Program Manager at 414-765-8672 or e-mail admin@questforum.org.

How is compliance to TL 9000 determined, and by whom?

Conformance to TL 9000 is determined by a third-party registration audit from an accredited TL 9000 registrar.

How are registration entities accredited?

The QuEST Forum established guidelines for accreditation bodies to qualify registrars, and defined requirements that registrars must satisfy to carry out TL 9000 registration. Methods for TL 9000 training and registrar accreditation were also established by the QuEST Forum. The accreditation of registrars is the responsibility of accreditation bodies recognized by the QuEST Forum.

What are the registrar's responsibilities?

Registrars are responsible for verifying that those with whom they contract to provide TL 9000 registration have, in fact, implemented a quality management system that complies with TL 9000. In carrying out this responsibility, registrars must comply with their own procedures, the requirements of their contracted registrar accreditation bodies, and the QuEST Forum's Code of Practice for Quality System Registrars.

Does a company need to be a QuEST Forum member to become TL 9000 registered?

No, companies do not need to be members, but there are a lot of advantages to membership in the QuEST Forum. As a member you have voting rights, you can be part of the development team that creates and reviews the TL 9000 documents, and you will have viewing privileges of the TL 9000 measurements summary reports.

Will the scope of registration allow for multiple sites and/or multiple product lines?

Yes, the scope of a registration may apply to hardware, software, services, or any combination thereof. The TL 9000 registration may include an entire company, an organizational unit, a facility(s), or a limited, defined product line as mutually agreed upon by the supplier and the registrar.

The scope of TL 9000 registration will be clearly defined within the certificate. TL 9000 supports three distinct certifications:

• TL 9000-HW -------------Hardware
• TL 9000-SW -------------Software
• TL 9000-SC --------------Services

A company may request registration to any of the above specialty areas or any combination thereof.

Can a company that produces both hardware and software be registered separately?

Yes, as mentioned above, a company can register for TL 9000-HW, TL 9000-SW, or both.

If your company is registered to ISO 9001 or 9002, must you start from the beginning?

No. Companies currently registered to ISO 9001or 9002 will be assessed only on the added requirements of TL 9000. Similar migration paths are available to companies registered to QS-9000 and to various telecommunications industry standards.