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By Lorri Hunt, Denise Robitaille, and Craig Williams
Editors note: The following is an excerpt of The Insiders’ Guide to ISO 9001:2008 , which was published November 1 by Paton Professional.
As users get their first glimpse of ISO 9001:2008, the question on everyone’s mind is, “What, if anything, will our organization need to do differently?” ISO 9001:2008 focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. It should not result in an extensive change to existing quality management systems (QMS). The changes are minor in nature and address such issues as the need for clarification, greater consistency, resolution of perceived ambiguities, and improved compatibility with ISO 14001, which relates to environmental management systems ( EMS).
What does this mean for users? Requirements in the standard are frequently referred to as “shalls.” For the purpose of this amendment, ISO 9001:2008 provides improvements for users without adding to or removing any of the “shalls.”
Quality improvement is a tough undertaking for even the savviest organization. There’s no need to go it alone, however. Quality system consultants and trainers can help keep you and your organization on the right path, and ensure that you’re current in your knowledge of best practices.
On the following pages, you’ll find our Consulting and Training buyers guide. This guide include hundreds of companies that employ experts in the Malcolm Baldrige National Quality Award program, statistical process control, Six Sigma, leadership training, quality system development, and certification, among others.
These directories are not meant to endorse or exclude any particular organization. Rather, they should be used as the starting point in the data-gathering process. Readers are encouraged to contact the companies directly for more information and to ask for—and check—references. Further information, including company descriptions (if provided to us) can be found on our web site at www.qualitydigest.com/content/buyers-guides.
The current economic downturn may have reduced a company’s business, but it has not reduced the requirements associated with doing business. This is particularly true for the numerous activities associated with technical data interpretation and application. For example, although the quantity of parts to be produced may be significantly less than last year, everything associated with the technical data package must still be addressed. This includes reviewing the constituent documents to determine accuracy and completeness, setting up first article inspections, generating manufacturing process plans, and so on.
In this period of reduced resources, there is even less margin for error. This means that those companies that get it right the first time have a distinct competitive advantage over those that can’t. The former are more productive, more cost-efficient, better able to meet schedules, and more valuable to their customers who are being whipsawed by rapidly changing economic conditions.
This is how our readers define quality. (Note: these definitions are straight from our database and have not been edited.)
"Quality itself has been defined as fundamentally relational: 'Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.'
"Even those quality definitions which are not expressly relational have an implicit relational character. Why do we try to do the right thing right, on time, every time? To build and sustain relationships. Why do we seek zero defects and conformance to requirements (or their modern counterpart, six sigma)? To build and sustain relationships. Why do we seek to structure features or characteristics of a product or service that bear on their ability to satisfy stated and implied needs? (ANSI/ASQC.) To build and sustain relationships. The focus of continuous improvement is, likewise, the building and sustaining of relationships. It would be difficult to find a realistic definition of quality that did not have, implicit within the definition, a fundamental express or implied focus of building and sustaining relationships."
Making sure that measuring instruments are properly calibrated is critical to quality manufacturing operations. A gauge that doesn't read accurately and repeatably can compromise the integrity of quality control and quality assurance documentation, and destroy confidence in measuring results. At their worst, inaccurate gauges can result in the production of nonconforming parts.
Gauge calibration represents an important, if not fully appreciated, manufacturing discipline. It should be viewed as an investment. Gauge calibration is the foundation upon which a quality program can be built.
More than simple adjustment
Gauge calibration determines the deviation from the true value of the indication supplied by a measuring instrument. The results of the calibration process can be used for gauge adjustment. Calibration goes beyond simple adjustment, however. A calibrated gauge can be traced back to a master source. Traceability provides the value added to the calibration process.
In its optimum form, Six Sigma is anything but simple or practical. Given its considerable upfront cost and ongoing complexity, it’s best viewed as a results-driven expedition of Homeric scope, one where the final destination is 3.4 defects per million opportunities. It’s not a journey for the faint-hearted. You must be seriously committed to pursuing it for the long term, or you’ll never recoup your sizable upfront investment, let alone enjoy a net return.
In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations.
ISO 13485--”Medical devices--Quality management systems--Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization ( www.iso.org/iso/survey2006.pdf ), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States, compared to only 6 to 7 percent of all ISO 9001 and ISO 14001 registrations. According to the survey, the 2006 total represents an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel.
Welcome to Quality Digest’s 2008 Flowchart/Process Simulation Software Directory. The companies in this buyers guide create or distribute software whose primary function is to aid in analyzing a company’s existing designs or operations to create important process-improvements and cost-savings opportunities. Functions include the flowchart, as in a schematic representation of a process used to help the user visualize the content or to find the flaws in the process; and process simulation, such as viewing a computer simulation that mimics a company’s operations to determine optimal conditions, bottlenecks, or sensitivity to process changes.
Included in this buyers guide are company names, addresses, telephone and fax numbers, and web addresses. Further information that has been provided to us, such as descriptions of the software modules/suites, is available online at www.qualitydigest.com/content/buyers-guides.
Tough economic times are upon us. The leaders of the Big Three automakers have to stoop to driving their own cars, our nation’s leaders have to separate themselves into two parties, and the people affected by the layoffs have to go home and lead their families through troubled times. Which do you think is the toughest job and requires more leadership?
We all accept the role as leaders of our families, churches, the neighborhood association, or perhaps the local school board. Those roles are more important to us as individuals than the roles played by Congress or the car manufacturers’ officers. It is a choice that we make personally, and this decision requires us to question not only our time commitment, but also the alignment of our personal belief system with that of the organization.
As more companies embrace Six Sigma, the need to
hire and train employees in the methodology grows. One issue facing beleaguered
managers and human resource departments is how to determine whether an applicant
truly possesses the Six Sigma skills required by the company. If he or she has a
certificate, does it have any value? If not, how does your organization verify
employees' Six Sigma skills? Once you get beyond the marketing hype of Six
Sigma, what will really help your organization eliminate or even prevent
problems?
These questions and many more based on your particular needs should be
addressed as you review what you and your organization will accept as qualified
certification.
This article presents commentary on important items that apply to the value
(or lack thereof) of Six Sigma certification in your organization.
Understand your needs
Whether you decide to grow your own Six Sigma
practitioners or hire from the outside, management must understand the role that
it wants Six Sigma to play in the organization. Just stating in a job posting
that a person must be Six Sigma-certified is meaningless unless the organization
knows what it really wants.
