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William A. Levinson
In his Quality Digest article published in February 2023, Michael Mills1 reported that the next version of ISO 9001 will add to clause 4.1, “Understanding the organization and its context” the words, “the organization shall determine whether climate change is a relevant issue.”
Although nothing in…
James Chan
Tracking work orders is an essential aspect of work order management, and it becomes immensely more efficient with the help of tracking software.
Work orders are the centerpiece of an effective maintenance program. Once a work order request is initiated, it triggers a set of tasks and workflows…
Audrey Kim
Emails that drone on and on. Meetings that could have been Slack messages. Memos loaded with empty jargon. We’re all familiar with friction, or what Robert I. Sutton and Huggy Rao describe as “forces that make it harder, slower, more complicated, or downright impossible to get things done.”
In…
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…
Peter Manin
Global trends and data-driven development in different industries dictate the need for permanent change and finding ways to be more effective for stakeholders and project participants. This is reflected in many types of business through new technologies, new collaboration processes, new org charts…
Grant Ramaley
When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance. Our trust forms the backbone of what we expect from our food, cars, planes, medical devices, and protection of the…
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…
James Chan
Reactive maintenance is a form of physical asset management in which maintenance is only performed on equipment or machinery when it malfunctions or fails entirely. Sometimes referred to as run-to-failure maintenance or breakdown maintenance, reactive maintenance strategies provide the most basic…
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…
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…
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…
Jamie Fernandes-ETQ
Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use.
In…
James Chan
In manufacturing industries, calculating overall equipment effectiveness (OEE) offers deep insights into the performance of production processes and enables data-driven improvements.
Determining OEE is a standard method for assessing the productivity of production lines compared to their…
Mark Rosenthal
Continuing on the theme of value stream mapping (and process mapping in general) from my article “Where is your value stream map?”, I outlined the typical scenario: The map is built by the continuous improvement team, and they are the ones primarily engaged in the conversations about how to close…
Erin Vogen
Utility companies play an essential role in our communities, supporting our well-being and quality of life. But providing always-on services that rely heavily on machinery, technology, and other assets can pose a challenge. In the dynamic and demanding world of utilities, mastering the art of asset…
Matthew Barsalou
The FMEA (failure modes and effects analysis) turned 75 years old in 2024. However, a look at the literature may paint a different picture. Both the origin year of FMEAs and the name of the organization that developed FMEAs seem to vary among authors. Much of the literature on FMEAs is inconsistent…
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…
Pierre-Nicolas Disser
With concerns for an economic downturn constantly looming, the global manufacturing industry finds itself navigating through a sensitive time. Once bustling factories, go-to for the world’s largest brands, are experiencing an unexpected lull attributed to multiple factors, including inflation and…
Jennifer King
In the hustling world of manufacturing, where machines hum and productivity is king, there’s a human element that’s sometimes overlooked: the well-being of the workers themselves. That’s where employee wellness programs come in, adding a jolt of energy and care into the mix. These programs aren’t…
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…
Phanish Puranam, Asher Lawson, Miguel Sousa Lobo
Just two months after its launch in late 2022, ChatGPT reached 100 million monthly active users. Along with other advanced language models, it quickly began encroaching on territory traditionally exempt from automation, such as tasks requiring creativity, intuition, and decision-making.
So, what…
Del Williams
An experienced conveyor supplier can advise food processors on the ideal options for resolving common challenges associated with conveying powdered food products, such as caking, packing, and hazardous dust emissions.
Almost every industry has a powdered version of products or ingredients that…
Jones Loflin
By now you will have already broken one or more of your resolutions for the new year. You didn’t mean to; it was just so hard to keep that major commitment. While I do believe in setting worthwhile and measurable goals for a new year, I prefer identifying small changes I can sustain throughout the…
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…