All Features
Tim Burke
For years, customers and auditors have been preaching to suppliers the need for the FMEA (failure mode and effects analysis) to be a “living” document. There are probably several interpretations of what it means to have a living FMEA, but one thing is for sure—the FMEA must be updated whenever real…
Mark Crossley
When we discuss or mention Six Sigma, we almost always hear about getting defect rates down to 3.4 ppm. Consider a light bulb. How would you like to have a defect rate of 3.4 ppm only to find out that the bulb lasted just 20 hours before it burned out? This isn’t good, even though the Cpk was 1.50…
For years, many companies have expended countless dollars and painful hours to comply with the various requirements of ISO 9001. Now, some of these companies are being asked to meet the provisions of Carnegie Mellon’s Capability Maturity Model Integration (CMMi). In its former guise as CMM,…
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005
Denise Robitaille
I was channel surfing the other day, looking for some local news that would tell me why I had woken up to a power outage that had lasted the better part of the morning. I don’t usually watch TV during the day, so I had no idea what stations carried noon time news broadcasts. As I was flipping…
David Parlagreco
The concept of establishing goals and flowing them throughout an organization isn’t new in business or in quality management system standards. In ISO 9001:1994, the establishment of goals was done via the quality policy, following a review of effectiveness in meeting these management goals. QS-9000…
Praveen Gupta
After launching a corporatewide Six Sigma initiative, leadership must consider how to get Six Sigma institutionalized in the supply chain. After implementing Six Sigma at an organization, its managers must think about continuing the improvement rate through implementing Six Sigma in its supply…
William A. Levinson
“Then the Husaria broke into a wild g allop and the heavy mass of men and horses cascaded over the Turkish ranks, bowling over the first, slicing through the second… The Grand Vizir leapt onto a horse and made his own escape moments before the winged riders thundered up to the tent and the banner…
Sarah Fister Gale
In a lean environment, training is the last part of the production process to be transformed by the new approach to efficiency. While smaller work groups are streamlining steps and multitasking to eliminate waste and improve output, individuals continue to be linked to single skills or production…
Robert Kozak
Adding value by auditing using the process- and metric-driven approach requires new methods and an increased focus on supplier performance metrics (i.e., scorecards). A change in how auditors work the process approach is evolving, with more sophisticated techniques, more rigorous testing and…
Denise Robitaille
Good morning, everyone. On behalf of Galactic Registrars Interstellar Network (GRIN), I’d like to express our appreciation to your organization for selecting us as your ISO 9001 registrar. Before we begin the audit, there are a few items we need to cover. This is standard auditing protocol. Certain…
Praveen Gupta
Six Sigma was first practiced in product development and manufacturing environments to improve customer satisfaction. There, significant improvements were achieved and sizable savings realized. After successfully implementing Six Sigma in manufacturing, Motorola applied Six Sigma in support…
Denise Robitaille
I was recently asked to write about the ISO 9001:2000 requirements that are still giving folks a hard time. Recent audits that I’ve conducted have led me to conclude that there are several clauses that continue to give us heartburn.
The issue that seems to come up most frequently relates to…
Praveen Gupta
In simple terms, Six Sigma means quick improvement in a short period of time. Incremental improvement will save a lot of time and money for a company. Breakthrough improvement, therefore, is synonymous with Six Sigma. Breaking rules through innovation is a way to achieve breakthrough improvement.…
Paul Mullenhour
Six Sigma is a powerful tool for effecting change within an organization. Since its development in the late 1980s, it’s helped companies dramatically improve business processes, increase customer satisfaction to new levels and save hundreds of millions of dollars. To say it has the ability to…
Denise Robitaille
I’ve long been frustrated, both as an auditor and as a consultant, by the unique exemption most organizations extend to distributors. It’s a common practice for purchasing personnel to excuse distributors from the vendor qualification requirements they apply to most of the other companies they do…
Praveen Gupta
Six Sigma is implemented to affect the bottom line. In a corporation, Six Sigma starts in operations then moves into design and finally supporting areas. Finance and accounting (F/A) functions are involved to monitor the financials, however, they aren’t involved in practicing Six Sigma. At Motorola…
The maintenance problem Too many times, in lean manufacturing and other lean environments, 10- to 40-year-old equipment is re-deployed, moved and organized into lean cells without adequate concern or attention to maintenance reliability. In a lean cell, unscheduled equipment downtime usually costs…
Barbara A. Cleary
Donald Trump’s dramatic, “You’re fired!” on the reality show “The Apprentice” is just entertainment to most people. To teams of summer interns at PQ Systems Inc. in Dayton, Ohio, however, it meant a challenge for the ensuing work week. The young interns, faced with the tedious task of contacting…
Denise Robitaille
Perhaps the single most pervasive reason top management resists the implementation of a quality management system relates to our failure, as quality professionals, to demonstrate the return on investment. We do a less-than-stellar job of demonstrating to executives the financial value implicit in…
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How did your quality system get so complex and redundant? Many companies established their quality systems after having purchased a software program with a “canned” quality manual and procedures. Software companies try to subliminally sell you the concept “more is better.” Purchasing companies…
Praveen Gupta
Six Sigma has been well applied in manufacturing through improving processes that use the DMAIC methodology. Some larger corporations have integrated Six Sigma so well into the corporate culture that it can be considered the DNA of the company. However, even in such companies, the human resources…
Shellye Archambeau
"Quality is never an accident, it is always the result of an intelligent effort"—John Ruskin (1819-1900)
A manufacturing company had annual sales of $250 million. Its quality department calculated the total cost of repair, rework, scrap, service calls, warranty claims and write-offs from obsolete…
Robert Nix
My first experience with the word “culture” comes from my high school science class. We grew a living organism on a nutrient base, which the teacher called a culture. The girls in class described it using the medical term, “Eeewwwww!” Years later, in the business world, I find top…
Chuck Doyle
Many organizations need answers to some key questions about lean and quality management: Is there a difference between quality and value? Should we have two teams, one for continuous improvement and one for lean? What roles would each have? What are the differences? The source for this…