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OCD in the Quality Department
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…
How You Can Build Trust and Expertise With After-Action Reviews
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…
Consumers Often Can’t Detect Fake Reviews
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…
Data Governance: Establishing and Maintaining Trust in Information
Peter Bilello
In our ongoing series of CIMdata articles on engineering.com, we’ve focused primarily on the digital (aka “virtual”) and physical aspects of digital transformation. Our discussion of these digital and physical elements has centered on what needs to be done with (and to) information as competitive…
Going Beyond Dust Hazard Analysis
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…
Don’t Wait for Laws to Protect Medical Devices
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…
The Business Case for Promoting the New Boosters
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.…
Ten Tips for Root Cause Analysis
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…
Use Lean Tools to Break Out of Risk-Averse Stagnation
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…
I Have a Wicked Dream
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…
Three Ways Quality Affects Reliable Outcomes in Construction Projects
Craig Matthews
Producing quality work is imperative in every field, particularly in the construction industry. A well-built structure, whether it’s an educational facility, hospital, or a commercial establishment, provides shelter, safety, and stability, which is why quality should always be a top priority. As…
European Commission Grants More Time to Certify Medical Devices
In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices…
Is Bad Quality Adding to Your Margin Pressures?
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…
CAPA, FMEA, and the Process Approach
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…
Incorporate Cyber Resilience in Your Business
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…
FTX: The Harmful Consequence of No Oversight and Poor Risk Management
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…
Hanging by a Thread: The Life of a Bridge Inspector
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…
European Commission Proposes Extending MDR Deadlines
Dirk Dusharme
Updated 12/12/22 At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On…
Eight CAPA KPIs You Should Be Measuring Now
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…
How to Conduct Level of Repair Analysis (LORA)
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…
How to Prioritize Cybersecurity Risks in Medical Devices
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…
Why Did Adidas Wait So Long to Drop Kanye West?
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…
Equipment Calibration: The What’s, Why’s, and How’s
Bryan Christiansen
An important part of production is to carefully monitor and control temperature, speed, volume, weight, or mass. To ensure these measurements are always accurate, manufacturers need to calibrate their equipment and instruments regularly. Devising a proper equipment calibration schedule can be a…
Protect Against Food Recalls With the Right Conveyor System
Del Williams
With the threat of contamination from harmful pathogens such as salmonella, listeria, and e. coli a continual concern, food processors are seeking to protect not only the public but also their companies’ bottom lines from the massive costs, reputational damage, and greater regulatory scrutiny…
Should Companies Allow Returns of Customized Goods?
Anton Ovchinnikov
In the age of mass production, the demand for customization is increasing. Customers prefer products catered to their individual needs and preferences over standard items—albeit at a cost. Fortunately, recent advances in information technology, logistics, and advanced manufacturing processes such…

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