Operations Article

Huw Thomas’s picture

By: Huw Thomas

In what has been called the “biggest moment for workers’ rights in a quarter of a century,” the International Labour Organization (ILO) adopted a safe and healthy work environment as one of its five fundamental principles and rights at work for all at its June 2022 international conference. This is the first extension of workers’ human rights in almost 25 years, and it means governments must now commit to respecting and promoting the right to a safe and healthy working environment.

Tom Rish’s picture

By: Tom Rish

Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the design control process during product development. It’s also proof that your medical device was developed according to the design plan.

FDA inspectors are guaranteed to look through it during an inspection, and even a single missing signature can get you written up.

With so much riding on it, you need a plan in place to store and manage all of the documentation that goes into your DHF. It may feel like an overwhelming task to keep your design history file audit-ready at all times, but there are a few basic steps you can take to keep it organized and ready for inspection at any time.

ISO’s picture


Standards are not for just the minority of businesses with thousands of employees. According to the World Bank, micro, small, and medium-sized enterprises (MSMEs) make up more than 90 percent of all companies and account for up to 70 percent of total employment. In developing countries, small businesses are key to economic growth and job creation. Inclusive GDP growth is particularly influenced by female-led companies.

MSMEs stand to benefit hugely by aligning with International Standards, which help cut costs, bolster credibility and confidence, and compete with larger businesses in the international market.

engineering.com’s picture

By: engineering.com

Unlike a biological or identical twin, a digital twin does not have a universally accepted definition. In application, a digital twin will mean different things to different industries. On an assembly line, a digital twin of a robot may look identical to the physical robot, especially if it is photo-realistically rendered. The digital twin can mimic the physical robot’s movement, for example. The digital twin may not pass a close inspection for similarity, however. It cannot have the internal minutiae and complexity nature routinely provides. A robot’s digital twin may lack fastener threads, weld details, etc. found on the physical robot.

But unlike nature’s twins, digital twins need not replicate every bit, part, and function of their physical counterparts to be effective. If the digital twin can determine the reach of the assembly line robot and prevent interference with the production line or other robots, then the digital twin can consider itself complete enough for that particular mission.

Del Williams’s picture

By: Del Williams

The use of membrane technology as a processing and separation method in the food industry is gaining wide application for demineralization, desalination, stabilization, separation, deacidification, purification, and reducing microbial load.

Perhaps the most obvious application for membrane filtration is reducing dissolved or suspended solids from process water or liquid ingredients. However, membrane filtration can be used to remove microorganisms to prolong shelf life and provide a healthier option than utilizing additives and preservatives.

Membrane separation can also be combined with cold pasteurization and sterilization techniques to create products and ingredients with favorable characteristics. Since membrane separation eliminates the need for heat temperature treatment of products, it can preserve the natural taste of food products and the nutritional value of heat-sensitive components. Also, less energy is required.

Membrane processing plays a key role in wastewater treatment, as well. Wastewater derived from food production varies depending on the type of food (animal processors/rendering plants, fruit/vegetable washers, or edible oil refiners). By implementing membranes, the separated substances and clean water are recoverable.

Angie Basiouny’s picture

By: Angie Basiouny

Walter Orthmann has worked for the same textile manufacturer in Brazil for more than 84 years, setting the Guinness World Record last month for longest career at a single company.

It’s a remarkable stretch, considering American workers now spend a median of 4.1 years with their employers, according to federal data collected just before the Covid-19 pandemic disrupted a spectrum of industries and spurred the so-called Great Resignation.

The record high quit rate—more than 40 million last year—has led to the tightest U.S. labor market in decades, with employees using that leverage to call the shots and find better jobs. They’re renegotiating everything, from their salaries and shifts to remote or hybrid work, and forcing employers to be more flexible.

Prashant Yadav’s picture

By: Prashant Yadav

During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives. 

However, these developments haven’t benefited everyone equally. Although more than 67 percent of the global population has received at least one dose of the Covid-19 vaccine, disparities between higher and lower income countries are wide. As of May 2022, 72 percent of people in high-income countries have received one dose, compared to 18 percent in low-income countries, according to the United Nations Development Programme’s Global Dashboard for Vaccine Equity.

Richard Harpster’s picture

By: Richard Harpster

On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which require the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the reverse FMEA requirement reads: “Organizations are required to have a process in place that ensures all new launches complete an RFMEA event once the equipment is installed and running.”

As one might expect, multiple webinars are offered by RFMEA training providers, as well as two-day RFMEA classes ranging in price from $795 to $995. My guess is that it won’t be long before RFMEA software is available for purchase.

Having spent six years as a Ford plant and equipment design engineer, and an additional 32 years afterward helping companies manage new tooling risk, I see significant problems with the RFMEA processes being proposed by RFMEA training providers. Ford’s objective in requiring companies to use the RFMEA is to ensure that their suppliers effectively manage tooling risk.

Adam Zewe’s picture

By: Adam Zewe

Malicious agents can use machine learning to launch powerful attacks that steal information in ways that are tough to prevent and often even more difficult to study.

Attackers can capture data that “leak” between software programs running on the same computer. They then use machine-learning algorithms to decode those signals, which enables them to obtain passwords or other private information. These are called “side-channel attacks” because information is acquired through a channel not meant for communication.

Researchers at MIT have shown that machine learning-assisted side-channel attacks are both extremely robust and poorly understood. The use of machine-learning algorithms, which are often impossible to fully comprehend due to their complexity, is a particular challenge. In a new paper, the team studied a documented attack that was thought to work by capturing signals leaked when a computer accesses memory. They found that the mechanisms behind this attack were misidentified, which would prevent researchers from crafting effective defenses.

Multiple Authors
By: Constance Noonan Hadley, Mark Mortensen

Most white-collar employees have spent the bulk of their career working in teams. However, the rise of hybrid work environments is changing work paradigms in ways that make us wonder whether we still need teams. We’re not saying this lightly: Between the two of us, we’ve spent more than 40 years examining the ins and outs of teams in organizations.

Our recent conversations with employees at all levels have made something clear: While concern about work-life balance, burnout, employee disconnection, and turnover is common, those who seem to worry the most are those leading or working in teams.

It’s good to take a step back and remember that teamwork—to the extent that it’s used now—is relatively new. Enabled by technological advances, teamwork only became the norm for knowledge work during the early 1980s, in response to globalization.

The world fell in love with teams because when they work, they really work. Great teams can generate creative solutions to complex problems. They can provide camaraderie and the right level of challenge for employees. Indeed, high-performing teams don’t just produce great results; they also underpin some of the most desirable organizational cultures out there.

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