All Features
Stephanie Ojeda
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open before…
Donald J. Wheeler
Over the past two months we’ve considered the properties of lognormal and gamma probability models. Both of these families contain the normal distribution as a limit. To complete our survey of widely used probability models, this column will look at Weibull distributions, a family that doesn’t…
Jamie Bihary
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
Mike Figliuolo
Many people proclaim they are gurus, ninjas, and other silly titles. Giving yourself such a title can cause people to lose respect for you, and it can cost you credibility.
Titles matter. A lot. So do email addresses and signature blocks. As unfortunate and as shallow as it is, people make a first…
Matthew Greenwood
The next frontier for industrial digitization and automation is the convergence of artificial intelligence (AI) and machine vision.
AI-powered machine vision promises to transform the way industrial manufacturers conduct their business, according to experts at a recent webinar hosted by the…
Gleb Tsipursky
As companies continue to navigate the new normal of remote and hybrid work, it’s crucial that they establish clear expectations and guidelines for their employees. And unlike Disney and Twitter, it’s very important that they don’t change their minds randomly when the leadership changes.
However, a…
Joe Judge
I once had to give an employee constructive feedback about being too impatient, irritable, and unmotivated at work. He shrugged, apparently unwilling to acknowledge the problem.
In response, I asked, “How does this character flaw manifest with your kids at home?” That question got his attention…
Stephanie Ojeda
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
Shiela Mie Legaspi
As remote workers, we have more freedom than ever before. This means we must learn how to make personal accountability in virtual teams work for us. We must understand what drives our success, and use that knowledge to drive our own growth. Simple self-accountability techniques can empower you with…
Mike Figliuolo
Managers who establish clear expectations and rules that are communicated to team members find it easier to deal with employees when they violate those rules.
What follows is an excerpt from my book One Piece of Paper: The Simple Approach to Powerful, Personal Leadership (Jossey-Bass, 2011).
“…
Melissa Burant, Marc Schneider
As a manufacturer, you understand that supply chain disruptions happen all the time. What you don’t know is when or how they will affect your operation and business. But assessing your supply chain risks and implementing good supply chain management practices can be daunting. This is especially…
Denise Robitaille
ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.
Equally important but with considerably less…
Scott Ginsberg
The manufacturing sector has always played a crucial role in the economy. But our industry has been grappling with a notable shortage of labor in recent years.
This scarcity of skilled workers is a pressing concern for industry leaders, who recognize the potential consequences for production…
Gleb Tsipursky
Have you seen the headlines about the new study in Nature that “conclusively proves” remote work harms innovation and creativity? That study matches previous anecdotes by leaders like Sallie Krawcheck, CEO of Ellevest, when she claimed remote work made her employees more productive but less…
Andy J. Yap
Mergers have become the norm in the telco sector recently: Far EasTone and Asia Pacific Telecom in Taiwan in 2022, True and DTAC in Thailand, as well as Celcom and Digi in Malaysia both in 2023. These represent a global shift toward an era of two or three players in each market, especially in Asia…
Gene Russell
Without a basic grasp of financial concepts at the C-suite (executive) level, small and medium-sized manufacturers (SMMs) may be limited in their ability to compete in an increasingly crowded marketplace. This is why financial literacy is near and dear to my heart.
As a former manufacturer myself…
Michael King
In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.
Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them to elevate…
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Mike Figliuolo
Is the customer really always right? We throw that comment around haphazardly without truly considering the ramifications of such an approach. I’d submit that they’re not. There are plenty of times the customer is wrong (and sometimes, very much so).
First, let’s explore the implications of a “…
Donald J. Wheeler
Clear thinking and simplicity of analysis require concise, clear, and correct notions about probability models and how to use them. Here, we’ll examine the basic properties of the family of gamma and chi-square distributions that play major roles in the development of statistical techniques. An…
Susan Robertson
When you think of famous visionary leaders, you often think that they have something, know something, or do something that the rest of us don’t have, don’t know, or can’t do. The truth is, they don’t. The only thing they have is an intuitive understanding of how to open their minds and consider new…
Michael Mills
Superficially, ISO 9001 and climate change sound different: ISO 9001 is about how to do things well so your organization satisfies its customers; climate change is about physical and chemical interactions in the atmosphere, and the consequences for our lives in the future.
But ISO is adding…
Miron Shtiglitz
The main benefit of deploying artificial intelligence (AI) for quality inspection is a significant improvement in defect detection. However, the data generated and stored by inspection systems have the potential to deliver additional benefits, including major improvements in yield.
Anyone working…
Matthew Bidwell
Nano Tools for Leaders—a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management—are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success and the engagement and…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
