All Features
Praveen Gupta
Companies often have numerous Six Sigma projects in the pipeline, and Six Sigma belts are busy working on projects. However, statistical thinking suggests that not all projects will be equally successful. In fact, the amount of improvement could vary significantly from one project to another. In an…
Scott Paton’s "The Chinese are Coming! The Chinese are Coming!" (Quality Digest, February 2005) describes how China’s Chery Automobile Co. plans to undercut American automakers’ prices by up to 30 percent. The article professes that neither tariffs nor layoffs are the solution to the hemorrhage of…
Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles…
Praveen Gupta
The Six Sigma initiative starts with an executive’s idea of achieving excellence and superior results. Whether the initiation is based on hearsay or the strategic move, it starts with communication among the executives—or employees. Likewise, throughout the implementation of Six Sigma, constant…
Rick Hudgell
As industry standards increase, so too does the demand for flexibility in specialized gaging procedures. Because there’s no room for error, choosing the right contact point or styli is paramount in conforming to the organization’s high quality standards. Accuracy can be jeopardized by any number of…
Paula Esty
This article reviews management review in the latest ISO 14001 standard revision, including the management review requirement update and system recommendations for ISO 14001:2004 compliance. The updated ISO 14001 environmental management system (EMS) standard includes a clarification to the…
Denise Robitaille
The Abbott and Costello routine “Who’s on First?” is one of the greatest comic treasures of our time. Bud Abbott begins listing the improbable names of his team players: Who, What and I Don’t Know (the three basemen), while a befuddled and increasingly frustrated Lou Costello tries to nail down the…
As quality professionals, we frequently report such facts as proportions (percentages), process capability indices, averages and standard deviations as if we know what we’re talking about. But what’s our actual level of confidence? All of our observations and our understanding are based upon data…
”Cause and effect, Chain of events, All of this chaos makes perfect sense” —Joe Diffe Third Rock From the Sun In my recent article, "How to Lead with Six Sigma: What are you solving for?" I discussed the need for leaders to clearly identify just what they’re…
Laura Smith
In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for…
“When, therefore, a man absorbed in the effect which is seen has not yet learned to discern those which are not seen, he gives way to fatal habits, not only by inclination, but by calculation.”
—Frederic Bastiat”That Which is Seen, and That Which is Not Seen,” 1850
“In the South Seas there is a…
Many customers come to Hobson & Motzer seeking a solution for what others have claimed is impossible. Established in 1912 and based in Durham, Connecticut, Hobson & Motzer engineers manufacturing processes and designs tooling to produce seemingly impossible parts for companies worldwide.…
Denise Robitaille
It’s logical to expect the purchasing process to fall under the purview of the purchasing department. However, the reality is that in most organizations there are people from different departments who generate purchase orders and sign contracts. Not all procurement is done by the purchasing…
Craig Cochran
Training is profoundly strategic. It’s a process aimed at improving the single most important resource in the organization: people. Nothing affects customer loyalty more than the behaviors and competencies of employees.
Training is the most effective way to communicate the correct behaviors and…
Praveen Gupta
If you’re considering opportunities for business improvement, dynamic growth and profitability, “plan,” “do,” “check” and “act” (PDCA) is a leading option. Walter A. Shewhart developed the PDCA cycle in the 1920s and W. Edwards Deming made it famous in the 1980s, even though he modified the PDCA…
Tamar June
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
Tom Pyzdek
The headlines screamed, “Local Hospital Leads the State in C-Sections!” The gist of the story was that this hospital had more cesarean section births than any other hospital in the state. Indeed, it had led the entire Southwestern region for five years running. It’s well-established that C-…
Quality Digest
Shortwave infrared (SWIR) imaging is quietly earning a growing place in industrial machine vision for quality inspection. SWIR imagers, sometimes also referred to as NIR imagers, can see objects and events that vision and thermal cameras cannot. Moreover, they’re’ smaller and lighter than all…
Test and measurement equipment (T&ME) must be periodically calibrated to ensure it’s operating within its specified parameters. Of course, the uncertainty of the system used to calibrate the equipment shouldn’t add appreciable error to this process.Test and measurement equipment (T&ME) must…
Denise Robitaille
Occasionally, when I’m waiting for a flight, the small talk with fellow travelers will meander into discussions about the purpose of our respective trips. When I tell them that I’m on my way to conduct an audit, they immediately jump to the conclusion that I’m a certified public accountant (CPA)…
Praveen Gupta
In layman’s language, Six Sigma means great and fast improvement, which leads to virtual perfection. Another indicator of a successful application of the Six Sigma methodology is the degree of breakthrough. Sometimes, when customers demand zero defects at any cost, suppliers are forced to add an…
BSI
More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world.…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
A steel mill had a quality problem in the manufacture of cold-rolled steel for use in applications such as automobile hoods. Several hot-rolled coils were welded end-to-end to form a long continuous band. The band included the welds that were made to join the original coils together. Unfortunately…