All Features
Adam Zewe
Identifying one faulty turbine in a wind farm, which can involve looking at hundreds of signals and millions of data points, is akin to finding a needle in a haystack.
Engineers often streamline this complex problem using deep-learning models that can detect anomalies in measurements taken…
NIST
‘There is a tremendous opportunity for women to influence the manufacturing industry in a positive way,” says Lisa Dach, strategic business advisor at the Northwest Industrial Resource Center (NWIRC), part of the Pennsylvania MEP and the MEP National Network. “Women in leadership improve the…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
William A. Levinson
Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model. This is in contrast to the traditional goalpost model, where anything inside the specification limits is good, and anything outside them…
Mike Figliuolo
Susan Strayer, a friend of mine, posed a question on social media the other day: “Can you sum up your expertise in 140 characters or less?” Great question. A few people took her up on the challenge. Being an overachiever, I did it in three words. Before I dive in, let me provide some context.
For…
Gleb Tsipursky
As businesses navigate the complexities of remote and hybrid work policies, leaders often face questions regarding the perceived fairness of these arrangements. Employees performing similar tasks may have different levels of flexibility, which can lead to concerns about favoritism and inequity.…
Donald J. Wheeler
The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective. If you improve the efficiency of a support process, or even a portion of the core process, but at the same time lower the efficiency of the overall process,…
Automated Precision Inc.
In the highly competitive automotive industry, quality control is paramount to ensuring the reliability, safety, and performance of vehicles. Metrology, the science of measurement, plays a crucial role in achieving these high standards at every stage of automotive production and testing. Let’s…
Akhilesh Gulati
Maria took a moment to reflect on how much had changed in just over a year since she first explored ChatGPT with her informal innovation group. Back then it was more of a novelty, a fun challenge to see whether artificial intelligence could answer their mundane questions correctly. Sometimes it…
Harish Jose
Recently, I wrote about the process capability index and tolerance interval. Here, I’m writing about the relationship between the process capability index and sigma. The sigma number here relates to how many standard deviations the process window can hold.
A +/– 3 sigma contains 99.73% of the…
Mike Figliuolo
I hate the use of the word just in front of anyone’s title, as in, “He’s just an analyst,” or, “She’s just a cafeteria worker,” or, “I’m just an administrative assistant.”
No one is just anything. The word is demeaning and pejorative. We’re all people—we happen to have different responsibilities.…
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
Stanislav Shekshnia, Sergey Vorobiev
In the complex, uncertain, and fast-changing world we live in, success and even survival require intensive collaboration among individuals, organizations, and countries. The outcomes of such collaboration can be breathtaking: Consider the growth of Netflix and Amazon, the rebirth of Microsoft and…
Mike Figliuolo
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Del Williams
In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment. However, when not designed or installed properly, bulk discharge systems can become a production bottleneck.
Complicating the issue…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
Henrik Bresman
Traditional productivity metrics are used by many companies to assess the value that employees bring to the organization. These tangible, quantifiable, results-based measurements include work quality and output, efficiency, and the number of projects completed on time and on budget. Some managers…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
Mike Figliuolo
We take ourselves too seriously, and in doing so we become boring and no fun. Sometimes it’s OK to let loose, act silly, and have a good time. It’s energizing.
So often we while away the days being the consummate professional. We read professional journals. We write professional messages. We hold…
Jennifer King
At a time when virtual meetings, video conferences, and online work calls are the norm, there’s good news for those who see a unique value in in-person networking. A survey conducted by Harvard Business Review has found that 95% of professionals believe face-to-face meetings are crucial to…
Mike King
Historically, the sensitive nature of personal and company proprietary information held in life sciences quality management systems (QMS) has been a factor for quality management teams’ reluctance to adopt AI. Add to that the complex global regulatory environment and the penalties of noncompliance…
Josh Leath
As the transition to a more sustainable future continues, more Americans are discovering the advantages of electric vehicles (EVs). From limited maintenance to incredible torque, acceleration, the ability to fuel from home, and attractive rebates, EVs are no longer just a “green” vehicle option but…
Yushiro Kato
These days, incessant pings and buzzes from your workspace’s preferred team management software may seem like a fact of life. But not too long ago, the idea of having software beyond emailing to manage teams was beyond imagination. Then one of the market’s leaders stumbled into creating the perfect…
Alexander Gelfand
All publicly traded companies in the United States are legally required to have their financial statements vetted by independent auditors. And plenty of other firms hire external auditors to enhance their credibility in the eyes of investors and other stakeholders. But what about the ESG reports…
