All Features
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…
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-…
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…
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…
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…
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
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…
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…
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…