All Features
Todd Hawkins
Most companies face the challenge of managing the documentation they generate—those that are developed to control their business and processes (e.g., standard operating procedures—SOPs) and the associated records as evidence of compliance with those procedures. This may go a step further if the…
Etienne Nichols
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.
The drafted guidance is…
Tom Taormina
The quality profession has been evolving since the Industrial Revolution. I’ve lived part of this journey since the 1970s and have experienced its effect. ASQ and other organizations have continually pushed the envelope in creating training and certifications in the skill sets we’ve developed over…
William A. Levinson
Environmental, social, and governance (ESG) is growing in popularity as a metric to guide investment decisions. What does ESG have to do with productivity, quality, or stakeholders, aka relevant interested parties? The answer is—with the exception of generally accepted practices for workplace…
Alonso Diaz, Maria DiBari
A company’s quality management system should have a formal, effective, and efficient corrective action and preventive action (CAPA) program so management can stay informed and correct existing business problems. The data output and corrective actions from a CAPA program can help prevent recurring…
Liza Dzhezhora
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.
The trend is not fading away…
Rupa Mahanti
Data are an organization’s most valuable asset. However, too much data are inaccurate, incomplete, irrelevant, obsolete, not well defined, or otherwise not fit for use. Bad quality data can lead to operational inefficiencies, poor decision making, non-compliance issues, and lost revenue.
According…
Gorur N. Sridhar
Obsessive-compulsive disorder (OCD) is an anxiety condition characterized by intrusive thoughts that produce uneasiness, apprehension, fear, or worry (collectively termed obsessions), along with repetitive behaviors (or compulsions) aimed at reducing the associated anxiety.
For team members in…
Jake Mazulewicz
Do you lead your team to learn primarily from successes, or from failures? Many leaders argue that their teams are just too busy to spend time discussing why a successful project went well. They just wrap up fast, then dive into the next project. So, the unspoken insights and unwritten lessons…
Shabnam Azimi
Consumers who have a personality that scores high in terms of openness—such as being open to new adventures and intellectually curious—have better success at spotting fake reviews than other personality types, according to our recently published research. Extroverted people, on the other hand, tend…
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of Fires…
Scott Trevino
Nearly a quarter of surveyed healthcare cyberattack victims experienced increased mortality rates following a data breach, and more than half reported poorer patient outcomes due to longer hospital stays and delayed procedures. Healthcare has faced the highest average data breach cost—more than $10…
Gleb Tsipursky
One of the key stakeholders in stakeholder capitalism is the employee. You could argue that the employee is the key stakeholder, because without employees you’d have no stakeholders at all. This is why employers need to stay aware of today’s health environment and its effect on their employees.…
Matthew Barsalou
A root case analysis is performed to identify “what, how, and why something happened, thus preventing reoccurrence” (“Root Cause Analysis for Beginners.” Rooney, J. J. and Vanden Heuvel, L. N. Quality Progress 37, 2004, p. 45). This can be difficult when the problem being investigated is both…
Sue Via
Research shows that during times of economic uncertainty, companies that find a balance between reducing the resources they need to survive and investing in key areas for growth will fare better through a recession and beyond. It’s a nuanced approach that involves playing offense and defense at the…
Harry Hertz
Yes, I have a wicked dream. No, not that definition of wicked—I mean wicked in the sense meant by scientists when they discuss “wicked problems.” Wicked problems are those that typically involve a combination of technical, social, and economic challenges. Wicked problems are daunting. They’re…
Brian Brooks
Manufacturers spend too much on quality issues. Some issues they are blind to, some are due to poor detection, and some are the costs incurred when issues escape to a customer.
It seems like in recent years the challenges have been great in both magnitude and quantity—supply chain turmoil, global…
William A. Levinson
Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it. This includes not only its traditional role as a response to defects, nonconformances, customer complaints, and audit findings, but also outputs…
Ann Brady
Few of us today are unaware of the significance of cybersecurity and the threat of cyberattacks on our computers, smartphones, and other devices. We’re constantly reminded never to disclose passwords and to be on the lookout for spam and phishing emails that attempt to manipulate us into divulging…
Gleb Tsipursky
What’s your decision-making philosophy? Do you toss a coin, or do you consider all the risks of your decisions? As a quality professional, you've probably developed a well-thought-out approach to decision making and risk management. But have you considered how other people’s decision-making…
Joshua Sadlock
Yup, that’s me in the photo. You’re probably wondering how I ended up hanging under a bridge over the Mississippi River. I’m a certified bridge safety inspector.
If you have questions after seeing people hanging under a bridge, in a basket suspended from the long arm of a truck, or have seen…
Stephanie Ojeda
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial to continuous improvement.
It’s also a focus of…
Bryan Christiansen
Every day, manufacturers rely on a large number of tools, machinery, and infrastructure to produce their goods. And while all of those assets help you generate profit, they are a significant expenditure—both in terms of the purchase cost and ongoing maintenance costs.
When deciding which…
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes…
Gleb Tsipursky
Why do companies bury their heads in the sand instead of facing dangerous facts, whether about quality problems or other issues? It happens more often than you might think—most recently with Adidas. It usually boils down to companies falling for three cognitive biases.
“Adidas does not tolerate…
