All Features
”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-…
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…
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…
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…
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…
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005
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,…
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…
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…
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…