Davis Balestracci’s picture

By: Davis Balestracci

During the late 1970s, quality began to evolve from its historically Neanderthal, passive inspection approach to its current Cro-Magnon state, where its more proactive, project-based approach is bolted on to the operational status quo. Joseph Juran was a pioneer in such efforts. Various subsequent adaptations such as Six Sigma and lean evolved it further, but over time, it has become comfortably stuck in a misguided focus on tactical improvements at the expense of strategic improvements—i.e., doing things right as opposed to doing the right things right.

In 2011 Jim Liker, a professor of industrial and operations engineering at the University of Michigan, wrote the following to leadership expert Jim Clemmer (emphasis mine):

Clifton B. Parker’s picture

By: Clifton B. Parker

An underlying theme emerged from the Stanford Institute for Human-Centered Artificial Intelligence’s fall conference: Artificial intelligence (AI) must be truly beneficial for humanity and not undermine people in a cold calculus of efficiency.

Titled “AI Ethics, Policy, and Governance,” the event brought together more than 900 people from academia, industry, civil society, and government to discuss the future of AI (or automated computer systems able to perform tasks that normally require human intelligence).

Discussions at the conference highlighted how companies, governments, and people around the world are grappling with AI’s ethical, policy, and governance implications.

Ryan E. Day’s picture

By: Ryan E. Day

Headquartered in Grand Rapids, Michigan, Plasan North America (PNA) manufactures metal, composite, and ceramic-composite components for defense and commercial applications. PNA brings decades of process experience to bear in creating the world’s most advanced armor, metal components, and fabrications.

Challenge

PNA has a vision to become the global leader in armor solutions based on innovation and quality. This vision spurs growth that regularly challenges the company’s quality team to grow right along with production. Accelerating product development forced PNA’s quality department to reassess the capability of its current inspection equipment.

“We were facing some pretty aggressive timelines on launch activity,” explains Tony Bellitto, quality manager at Plasan North America. “We were scheduled to launch 140 new part numbers, and most of them included GD&T [geometric dimensioning and tolerancing], not just basic measurements.”

Some of the parts PNA manufactures are of considerable size and weight, which posed further challenges.

“Some of these products are up to eight feet across,” says Christine Foley, senior quality engineer at PNA. “One of the underbelly parts we produce for tactical vehicles weighs about 2,500 pounds.”

Gleb Tsipursky’s picture

By: Gleb Tsipursky

When was the last time you as a quality professional saw a major failure in implementing decisions? What about in project or process management? Such disasters can have devastating consequences for high-flying careers and successful companies. Yet they happen all too often, with little effort taken to prevent failure.

For example, many leaders stake their reputations on key projects such as successful product launches. However, research shows that most product launches fail. Nike’s FuelBand, launched with much fanfare in 2012, flopped on arrival. By 2014, Nike fired most of the team behind FuelBand, discontinuing this product.

David Hart’s picture

By: David Hart

Climate plans are the order of the day in the presidential primary campaign because carbon pollution is a global threat of unique proportions. But it’s worth asking whether candidates’ plans are based in the reality of the climate, the economy, and the election.

All three dimensions must come together for any climate plan to achieve its goals—and this is especially true when the subject is electric vehicles (EVs). There is no point in putting forward an EV plan that is so aggressive that it cannot be implemented even under the most auspicious economic circumstances. Nor is there a point in advancing an EV plan that would not yield significant climate benefits. And, if such a plan might hurt a candidate’s chances in the election, it would be worse than pointless.

Following the lead of Governor Jay Inslee, who dropped out of the race earlier this fall, Senators Cory Booker, Bernie Sanders, and Elizabeth Warren said they would require all passenger cars sold in the United States to be zero-emissions by 2030, while Senator Kamala Harris and Mayor Pete Buttigieg set a 2035 deadline.

Thomas R. Cutler’s picture

By: Thomas R. Cutler

Quality control and inventory control are equally important to the ongoing success of all manufacturing businesses. Both form the basis of an efficient organization that operates at high productivity levels, minimizes waste, and delivers quality products to meet or exceed consumers’ expectations.

Until a about decade ago, there were layers of quality assurance and quality control steps before products reached the end user. Along with production controls, these steps included quality controls related to warehouse operations, logistics, and inventory verification at retail stores, in order to double-check product quality and order fulfilment accuracy.

Today, more than a million small manufacturers worldwide have forgone any retail sales in favor of a D2C (direct to consumer) model, cutting out warehouse operations and retail stores. The reason is simple: margins. A jewelry manufacturer, for example, selling a bracelet for $20 online, with hard costs of $2, can realize huge profit margins by eliminating the wholesale middleman. That same bracelet would have wholesaled to retailers for $8. But now, while product quality is still a customer expectation, consumers also expect quality delivery and customer service.

Pawel Korzynski’s picture

By: Pawel Korzynski

Dell is doing it. MasterCard, too. Even universities, not exactly bastions of social media influence, are embracing it. Employee advocacy in social media is gaining currency as an effective way to promote an organization by the very people who work in it. Rather than creating ads or hiring social media influencers to boost a brand, companies like Vodafone and Starbucks to schools like Oslo Metropolitan University (OsloMet) are tapping staff members at all levels to become brand ambassadors, with arguably improved conviction and results.

The QA Pharm’s picture

By: The QA Pharm

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

 

Dustin Poppendieck’s picture

By: Dustin Poppendieck

On August 29, 2005, I was starting my first semester teaching freshman environmental engineering majors at Humboldt State University in Arcata, California. At the exact same time, Hurricane Katrina hit Louisiana and Mississippi with 190 kph (120 mph) winds and a storm surge in excess of 6 meters (20 feet). Levees failed, flooding more than 80 percent of New Orleans and many surrounding areas. This tragedy left more than 1,800 people dead, many of whom had been trapped in their own homes. It took nearly six weeks for the water to recede, exposing more than 130,000 destroyed housing units.

I spent the rest of the semester (and subsequent ones) discussing with my students the lessons that environmental engineers should learn from Katrina and its aftermath (levees, water treatment, mold, air testing, planning for disasters, and more). Little did I know I would still be dealing with some of the issues revealed by Hurricane Katrina nearly 15 years later as a scientist at the National Institute of Standards and Technology (NIST).

Heather Thompson’s picture

By: Heather Thompson

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

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