All Features
Quality Digest, Donald J. Wheeler
Dr. Donald J. Wheeler has been one of Quality Digest’s most highly read authors for decades. His teaching on the use of control charts in industrial settings has long been considered the gold standard. He has conducted more than 1,100 seminars in 17 countries on six continents, and his books have…
Michael Mills
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Saurabh Joshi Shripad
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…
Creaform
Quality control (QC) teams need reliable results they can trust to make informed decisions and address manufacturing challenges. This is why they rely on the coordinate measuring machines (CMMs). However, a CMM’s speed is often a limitation, making the idea that routine quality control can be…
Ben Eidlisz
A safe work environment will foster productivity, reduce hazards, and enhance overall work morale. Keeping your team and assets safe requires implementing the right policies, medical necessities, vigilant oversight, ongoing assessments, and proper training.
As the COO of DUSAW, making smart locks…
Sergey Sukhovey
The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection nationwide…
Saili Sonawane
In a growing business milieu, ISO quality management system compliance ensures that organizations meet global standards for quality, safety, and efficiency. However, maintaining compliance with ISO frameworks such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO…
Peter Beaucage
Every time you squeeze toothpaste onto your toothbrush, spray perfume on your skin, or swallow a pill, you’re using the result of a carefully crafted recipe made in a lab. These are called formulations.
Formulations aren’t just simple mixtures—they’re complex arrangements of ingredients designed…
Steven Garner
In the ever-changing landscape of business management, the concept of quality has undergone significant transformations. What began as a focus on maintaining standards such as ISO 9001 and AS9100 is evolving into a more holistic approach encompassing organizational excellence. Tom Taormina’s book…
Wayne Labs
A September 2024 Gallup poll revealed that nearly 30% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Considering recent recalls, is it any wonder? What good is a quality control program if it doesn’t include food safety?
Boar’s Head’s Jarratt,…
Ben P. Stein
NIST is unique as the national measurement science institute. We are the U.S. agency responsible for maintaining measurement standards, from the second to the kilogram.
We help ensure that these units of measure are consistent across our watches and our grocery scales. But this isn’t as…
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Rachel Byfleet
In an eco-friendly plot twist that would make Captain Planet proud, the European Union has rolled out the Corporate Sustainability Reporting Directive (CSRD), a blueprint that’s got big companies talking about more than just profits. Imagine a world where every major company’s reports don’t just…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
Akhilesh Gulati
In the ever-changing world of quality management, the intersection of innovation and standardization offers both exciting opportunities and tough challenges. Maria, a dedicated and certified quality professional, struggled with the concept of “standardizing innovation”—something that seemed like an…
Chris Rush
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.
By issuing this…
Anthony Hardy
In a competitive manufacturing industry, meeting high standards is crucial to quality, sustainability, and safety. While it can be challenging to earn customer trust and establish a positive brand reputation, third-party certifications to standards such as IATF 16949: Automotive Quality Management…
ISO
The clock is ticking. Our planet is heating up, and with every passing day the stakes rise. Wildfires, floods, and storms are no longer distant headlines; they’re unfolding right on our doorstep. Humanity stands at a crucial turning point. But amidst the climate crisis, a powerful ally emerges from…
Gabriel Popkin
Time: We all have a sense of it, an innate feel for it. We see it and use it every day. If you’re like me, the first thing you do in the morning is check the time on your phone to see if you need to get out of bed or if you can close your eyes and catch a few more z’s.
Once you’re up and moving,…
Gleb Tsipursky
The 2024 U.S. presidential election is shaping up to be one of the closest in recent history, with Kamala Harris and Donald Trump locked in a dead heat in many polls. This razor-thin margin amplifies the effect of even small demographic changes, such as those driven by the recent surge in remote…
Michael Mills
You’ve finally gotten ISO 9001 certification. Congratulations! You’ve built your quality management system, written your procedures, trained your staff, sweated through internal and external audits, and your registrar sent you a certificate suitable for framing. Now, at long last, all of your…
Scott Crow
W ithin the utility industry, regional entities increasingly focus on internal controls as a measuring stick for overall compliance performance.
Developing and executing rock-solid internal controls with an automated compliance management software solution can help maintain compliance, not only…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
