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Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
Hari Abburi
If there’s one thing the global business community is learning from the Covid-19 pandemic, it’s the outright imperative for companies to be agile “from top to bottom.” This lesson continues to ebb, flow, and unfold daily, wreaking having on bottom lines in every corner of the world.
In fact,…
Corey Brown
Many industrial businesses have heard of the dangers of relying on tribal knowledge. But what exactly does tribal knowledge mean? How does tribal knowledge impact an organization? How do you capture tribal knowledge?
Organizations spend substantial time and resources developing the knowledge and…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…
Tom Taormina
Each article in this series presents new tools for increasing return on investment, enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system. They will help implementers evolve quality management to overall business…
Jon Speer
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971,…
Greg Hoeting
Nuclear power has long been a clean, dependable source of energy throughout the world. However, as power plants age, concerns grow about their continued reliability. Many components make up the infrastructure of a nuclear power plant with the design intent to reduce radiation and contamination…
Ryan E. Day
As shelter-in-place orders make work-from-home (WFH) the new normal, some organizations are struggling with the transition to working as a remote team. But there are companies that have been doing so for quite some time, and we can benefit from their experience.
Covid-19 is forcing thousands of…
Knowledge at Wharton
Long stretches of empty supermarket shelves and shortages of essential supplies are only the visible impacts to consumers of the global supply-chain disruption caused by the Covid-19 pandemic. Unseen are the production stoppages in locations across China and other countries and the shortages of raw…
Alan Rudolph, Raymond Goodrich
We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.
This process is used for the treatment of blood products such as plasma, platelets, and…
Jason Chester
Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify quality…
Cheryl Carleton
The labor market is changing rapidly with the onset of the coronavirus pandemic.
Many organizations are laying off almost all of their workers, while others are considering which workers to lay off, which to furlough, and which to keep. Alternatively, some are expanding their labor forces.
When…
Michael Dehoyos
The amount of risk that one is exposed to when running a business is vast. Some risks may result in severe legal or financial trouble or cause the business to shut down. Mitigating these risks is a major aspect of successfully running a business.
Every aspect of a business has certain risk factors…
Julius DeSilva
ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have…
Bruce Hamilton
Most lean folks use 5 Whys daily to problem solve, but relatively few are familiar with a clever problem-solving device developed 30 years ago by Deming Prize winner Ryuji Fukuda, called the why-not diagram.
Because objection is a natural human response to new ideas, Fukuda created the why-not…
Kathleen Wybourn
Business continuity is a relatively simple idea. Plan ahead so you can keep your business successful during times of difficulty. Key management transitions, loss of a major customer, the impact of a lawsuit, perhaps a fire or an earthquake. But what if that “difficulty” is a global public health…
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
Stanislav Shekshnia
Corporate boards across Europe are reacting to the coronavirus pandemic in three ways. For some, it’s business as usual. “Crisis is the business of the CEO; the board does not need to adjust its workings,” the chair of one such board told me. Other boards are going in the opposite direction,…
William A. Levinson
The phrase “flatten the curve” means to slow the transmission of the coronavirus (Covid-19) in order to spread the total number of cases out over a longer period of time. This will avoid overwhelming the healthcare system.1 The model is accurate as presented throughout the internet, but it also…
David Dubois, Joanna Teoh
From AI-enabled chatbots to ads based on individuals’ search or social media activities, digital data offer novel ways to connect with customers. These connections can develop into intimate customer relationships that boost satisfaction, engagement, and ultimately, loyalty. Consider Netflix’s…
Knowledge at Wharton
When the Mosaic browser, with its consumer-friendly interface, was released to the world in 1993, most had no idea how radically this first foray into the internet era would transform our lives, both personally and professionally. As humans, we are generally poor at detecting and acting on early…
Norm Friesen
As the Covid-19 pandemic forces many U.S. colleges and universities to move their courses online, connecting online via video is now having its moment.
Family, friends, neighbors, and even TV talk-show hosts are now meeting and broadcasting from home. Meanwhile, Microsoft, Google, and Zoom are…
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.
Companies conducting layered process audits (LPAs) can help get the United States get…
Jason Chester
The Covid-19 pandemic has hit every industry with a barrage of challenges. The impacts on the manufacturing sector are already extending far beyond factory walls. And for now, the depth of those impacts and the expectation for recovery are unknown.
Fortunately, manufacturers are a highly adaptable…
Lee Seok Hwai
In the trenches of the battle against Covid-19, critical defensive gear and medical equipment are in short supply. Doctors and nurses fighting the nonstop onslaught of the highly contagious coronavirus desperately need more ventilators, test kits, surgical masks, shields, and gowns.
In Spain,…
