Standards
Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.
In the highly regulated life sciences industry, quality management system (QMS)…
In the wake of Covid-19 and widespread wildfires, demand skyrocketed for air cleaners, machines that could remove potentially harmful particles from the air in a home. Manufacturers responded by producing a wider variety of air cleaner devices designed for single rooms.
The main…
Plan a route, grab some snacks, and fuel up. Engineers and scientists have been sending massive magnets from U.S. Department of Energy (DOE) national labs on cross-country road trips.
Magnets are at the heart of many scientific instruments at the DOE’s Brookhaven National…
Today, manufacturing is largely shaped by supply chain volatility, complex labor dynamics, and—like most global industries—the rise of AI. Adopting AI technologies on the shop floor can help manufacturers minimize operational costs, mitigate risk, and optimize processes, which drives efficiency…
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.
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What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?
It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet.…
Sarah, a marketing director at a Fortune 500 company, recently celebrated her team’s 40% productivity increase after implementing AI-powered content generation tools. Her seasoned copywriters now produce campaigns in hours rather than days, while AI handles routine social media posts and email…
In July 2024, CrowdStrike rolled out a software update that crashed more than 8 million Windows systems worldwide. The faulty release disrupted hospitals, grounded flights, halted banking operations, and affected government services. Comparable to a major cyberattack, the incident caused more…
A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…
Productivity looks good on paper. It’s measurable, visible, and in many organizations, it’s worshipped. But here’s the problem: Productivity isn’t the same as progress.
Many cultures confuse motion with momentum. Leaders celebrate packed calendars, rapid responses, and efficiency…
Karbonius Composites specializes in manufacturing precision molds and composite components across various sectors, including automotive restoration and high-performance customization. Founded in 2008 and based in La Coruña, Spain, the company’s production capabilities cover every step needed to…
Companies that adopt industrial artificial intelligence see productivity losses before longer-term gains, according to new research.
Organizations have long viewed artificial intelligence as a way to achieve productivity gains. But recent research about AI adoption at U.S.…
Based in Tampa, Florida, Starr Creations, a powerhouse in fiberglass design and fabrication, is known for turning ambitious automotive visions into reality. Jesse Starr, creative director and 3D designer, founded the company with a passion for racing and innovation.
Starr…
They may seem simple, but SOPs (standard operating procedures) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?
In reality, there are a lot of requirements for writing a good SOP, and…
In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance. Because direct part marking plays a key role in ensuring traceability and unique device identification (UDI) conformity, it’s…
Since its founding in 1974, Intercontrôle has been a leader in France’s nuclear energy sector, ensuring the safety of reactor components through automated nondestructive testing (NDT).
As part of the Framatome group, the company develops its own inspection equipment, oversees…
A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…
The Bott Group designs vehicle and operating equipment as well as workplace systems. From its headquarters in Gaildorf, Germany, and two production sites in Bude, England, and Tárnazsadány, Hungary, Bott Group designs and manufactures work environments for mobile and stationary manual work…
Ateam of scientists across several U.S. Department of Energy national laboratories has unraveled how light and a previously unknown form of certain nickel-based catalysts together unlock and preserve reactivity. This research, described in the journal Nature Communications, could potentially…
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices…
A new security screener that people can simply walk past may soon be coming to an airport near you. Last year, U.S. airports nationwide began adopting HEXWAVE, a commercialized system based on microwave imaging technology developed at MIT Lincoln Laboratory. HEXWAVE addresses a new…
Known for building rugged telehandler equipment that delivers reliable performance in the most demanding environments, Xtreme Manufacturing places a strong emphasis on quality in every stage of production.
To uphold its commitment to quality when inspecting large weldments, Xtreme…
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device…
From April 10 through July 3, 2025, ISO (International Organization for Standardization) had the opportunity to vote on a draft update to the global standard ISO 9000 “Quality management—Fundamentals and vocabulary.” ISO 9000 is the companion document to the more widely known ISO 9001. It…
The European Union has taken a leading role in shaping a variety of data and AI regulations. One of its most recent initiatives, the Ecodesign for Sustainable Products Regulation (ESPR), extends this regulatory momentum into the manufacturing sector. Under this new regulation, manufacturers and…
Brosius GmbH is a trusted partner in metal processing for a wide range of companies in the mechanical and plant engineering industries, offering comprehensive services under one roof. Brosius ensures that every part it manufactures in its 10,000 m² state-of-the-art production hall meets or…
The 2025 Major League Baseball season certainly started with a bang—at least for the New York Yankees. At Yankee Stadium against the Milwaukee Brewers, the Bronx Bombers blasted an MLB-record 15 home runs in the first three games, including nine homers in a 20-9 bludgeoning of the Brewers in the…
Stronger than steel and lighter than aluminum, carbon fiber is a staple in aerospace and high-performance vehicles. Now, scientists at the U.S. Department of Energy’s Oak Ridge National Laboratory have found a way to make it even stronger.
ORNL researchers simulated 5 million…
Nano Tools for Leaders—a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management—are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success and the engagement…
For quality heads, compliance officers, auditors, and engineering leaders, audits have been a time-consuming, resource-intensive process, yet necessary to build resilient operations, prevent costly failures, and maintain competitive advantage.
The question isn’t whether to audit,…
Streamlining the transition from scan-to-CAD involves selecting the right tool set for reverse engineering. However, many software platforms force product designers to switch between multiple tools, disrupting their workflow and increasing the risk of errors. Furthermore, some advanced scan-to-…
A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…
Ready for that long-awaited summer vacation? First, you’ll need to pack all items required for your trip into a suitcase, making sure everything fits securely without crushing anything fragile.
Because humans possess strong visual and geometric reasoning skills, this is usually a…
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators…
Hearing aids, mouth guards, dental implants, and other highly tailored structures are often products of 3D printing. These structures are typically made via vat photopolymerization—a form of 3D printing that uses patterns of light to shape and solidify a resin, one layer at a time.
…
Chatbots are everywhere. A fast-growing communication channel for brands, AI-powered chatbots are being deployed by companies to handle everything from booking travel to refunding purchases to helping shoppers choose the right outfit.
When done right, they can drive sales and…
Ålö Agricultural Machinery (Ningbo) Co. Ltd., a wholly owned subsidiary of Ålö, is a leading manufacturer of loaders and implements for agricultural tractors.
With production facilities in four countries, and customers in more than 50, Ålö holds approximately 30% of the world…
A team from MIT Lincoln Laboratory has built and demonstrated wide-band selective propagation radar (WiSPR), a system capable of seeing out various distances at millimeter-wave (mmWave or MMW) frequencies. Typically, these high frequencies, which range from 30 to 300 gigahertz (GHz), are…
To meet the precise requirements associated with semiconductor manufacturing, integrated circuit (IC) packaging and assembly providers must navigate complex quality certification processes, such as those for the well-known ISO 9001 and ISO 13485 standards. Another important certification for…
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their…
A little enjoyment is always important. I recently read a blog post titled 15 Facts That Will Make You Laugh.
A few of those facts were:
• There is a Welsh town with a 58-letter name:
Llanfairpwllgwyngyllgogerychwyrndrobwllllantysiliogogogoch.
• You used to be able…
Imagine what life would be like without GPS, something you use all the time without thinking about where it came from.
NIST’s atomic clock research helped bring us GPS, which has had more than $1 trillion dollars in economic impact.
This is just one of the many scientific…
A common lithium salt has revealed new possibilities for manufacturing cheaper, longer-lasting battery materials.
The discovery centers on sublimation, a commonly known process whereby, under the right conditions, a solid turns directly into a vapor. Sublimation is what creates…
For more than a decade through a collaboration managed by MIT.nano, MIT and Tecnológico de Monterrey (Tec), one of the largest universities in Latin America, have worked together to develop innovative academic and research initiatives with a particular focus on nanoscience, nanotechnology, and,…
Hawthorne High School of Manufacturing & Engineering in Los Angeles is not your typical high school program. Led by program coordinator Lucas Pacheco, it’s a hub where young minds are immersed in advanced manufacturing and engineering design courses. With a hands-on curriculum covering multi…
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…
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…
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…
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…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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.
…
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…
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…
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…
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…
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…
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…
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…
ISO and the United Nations Development Program (UNDP) have unveiled the world’s first international guidelines to help businesses and organizations expedite their contributions to the U.N.’s sustainable development goals (SDGs).
New guidelines for urgent actionThe ISO/UNDP…
Practically everything you use in your everyday life works because of measurement science. Without precise measurements, your car wouldn’t run, your phone wouldn’t work, hospitals couldn’t function, and the ATM would fail.
The National Institute of Standards and Technology (NIST)…
Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups,…
Electronic temperature compensation in gaging has become a valuable tool in improving the accuracy and gage repeatability and reproducibility (GR&R) of gages in harsh manufacturing environments.
The need for temperature compensation comes into play when the expected errors…
In a world where change is the only constant, organizations can no longer afford to be complacent. Keeping up with the pace of technological change is tough, and all business leaders must learn to adapt. It’s no longer enough to react to disruption. To get ahead of the competition, organizations…
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the…
Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model. This is in contrast to the traditional goalpost model, where anything inside the specification limits is good, and anything outside…
Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.
The requirement for medical device companies to use design controls is established in 21 CFR Part 820, as well as ISO…
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of…
The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective. If you improve the efficiency of a support process, or even a portion of the core process, but at the same time lower the efficiency of the overall process,…
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle…
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation…
In 2018, the world agreed to redefine the kilogram. Instead of being pegged to the mass of a physical object in a vault in France, the kilogram is now defined by a few fundamental constants in nature.
This means researchers no longer have to worry about a physical object that can…
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices…
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…
Disclaimer: This isn’t meant to be a car review. This is an article on brand authenticity.
Back in 2021, when Ford was promoting the Mustang Mach-E GT, its high-performance electric vehicle, the company found a way to appeal to potential buyers who somehow missed the sensory…
When it comes to aircraft, poorly documented dents can lead to more significant problems, potentially compromising structural integrity or performance. Dents can trap moisture and lead to corrosion. The stress they generate can initiate fatigue cracks. Their effects on the structure can also…
For any manufacturer, ensuring well-run, successful processes and protocols is the backbone of a successful and profitable operation. Yet, despite the most well-laid plans, circumstances can change and manufacturers may sidestep best practices in the race to meet demand. Still, ensuring quality…
Preventive maintenance (PM) is a proactive maintenance strategy built on calendar-based maintenance tasks, regular inspection, and preemptive repair of physical assets. Physical assets may refer to equipment, production machinery, and operational facilities. Preventive maintenance tasks are…
QIMA, previously called AsiaInspection, is known for not only making inspection and certifications easier, but also increasing accessibility via a convenient digital platform and strong focus on compliance. Both SMEs and e-commerce businesses have benefited from this increase in affordability…
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality that endures over time…
American manufacturing is associated with high-quality standards that are meant to ensure both the reliability and longevity of the products produced. Manufacturers across all industries are looking for technological solutions and enhancements to continue to meet these high-bar standards and to…
In manufacturing, selecting the right cleaning fluids is a critical determinant of product quality, reliability, and environmental impact. As industries increasingly prioritize sustainability, the transition to environmentally friendly cleaning fluids is imperative. This article delves into…
One hundred years ago this month, Walter Shewhart wrote a memo that contained the first process behavior chart. In recognition of this centennial, this column reviews four different applications of the techniques that grew out of that memo.
The first principle for interpreting…
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I,…
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management…
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave. At the heart of this precision lies the unassuming yet critical load cell, a device whose reliability is foundational…
The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…
Trust makes the world go ’round. Without it, democracies crumble and relationships suffer. The same goes for organizations and businesses: Without the trust of their customer base, they simply can’t succeed.
Trust, however, is never a given. Like respect, it must be won. In an…
In less than two months we will celebrate the 100th anniversary of the invention of the control chart, a tool most often associated with statistical process control (SPC). Considering SPC from our modern perspective made us ask, “Is SPC still relevant?”
It’s a question asked…
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard. So, what’s up?
…
In his Quality Digest article published in February 2023, Michael Mills1 reported that the next version of ISO 9001 will add to clause 4.1, “Understanding the organization and its context” the words, “the organization shall determine whether climate change is a relevant issue.”
…
ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.
Equally important but with considerably…
The FMEA (failure modes and effects analysis) turned 75 years old in 2024. However, a look at the literature may paint a different picture. Both the origin year of FMEAs and the name of the organization that developed FMEAs seem to vary among authors. Much of the literature on FMEAs is…
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Superficially, ISO 9001 and climate change sound different: ISO 9001 is about how to do things well so your organization satisfies its customers; climate change is about physical and chemical interactions in the atmosphere, and the consequences for our lives in the future.
But ISO is…
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-…
Calibration is essential in almost every facet of industrial processes. The calibration process verifies test instrument accuracy by comparison with recognized standards, and measurement validity hinges on one crucial concept: traceability.
Traceability adherence ensures a continuous…
At one point in my career, after managing design controls and risk management documentation, I decided to move on.
When the day came to put in my two-week notice, I walked over to another engineer’s cubicle with the news. “From now on,” I said, “design controls are yours.”
I’ll…
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s…
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management.…
As the manufacturing world pushes toward the goal of zero-defect production, part inspection is critical. Sheet metal’s thinness, coupled with its susceptibility to warping, demands precision inspection—even the most minor deviations have significant implications down the line. This underscores…
If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are necessary to bring needed medical products to market and monitor them to protect consumers and…
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need…
Artificial intelligence (AI) is everywhere—and that’s something to marvel at. AI is powering everything from advanced web searches to social media recommendations and video game design. But it could do infinitely more.
AI has the potential to revolutionize our societies and economies.…
Implementing a computerized maintenance management system (CMMS) isn’t just a monetary investment. If you want to see real results, you’ll need to put in the effort to make sure the system is properly implemented and adopted. It isn’t as simple as flipping a switch.
It takes planning,…
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this…
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Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety.
There are also huge risks to companies themselves…
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In everyday life, the most common conversation about artificial intelligence (AI) goes along the lines of, “I used ChatGPT, and it did x.” Corporate leaders, governments, and international organizations, however, are having a very different conversation. Theirs is…
In the era of the industrial internet of things (IIoT), assets of both information technology (IT) and operational technology (OT) are becoming more sophisticated—and they both generate and use more data. As a result, it’s increasingly important for manufacturers to mesh the IT and OT sides of…
I’ve observed that ISO management system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011. Auditors are still using clause-based auditing, despite ISO 19011:2018’s direction to take a risk-based approach.
…
Static force, such as the weight of a person standing motionless on a bathroom scale or the force that an office full of equipment exerts on a high-rise floor, can be easily determined using scales, balances, load cells, and the like because static force doesn’t change over time. It’s…
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (…
It’s been a long and arduous road, but you’re almost ready for that first production run. You made it through supplier selection, your designs and production processes have been finalized, preproduction is finished, and now there’s just one more hurdle to clear: first article inspection (FAI).…
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.
1.…
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything…
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring degrees of improvement, increases in profit, or low turnover rates, it can’t tell you that your…
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link…
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages. Failing to act swiftly and decisively risks catastrophic climate change…
Supply chain quality control is a demanding job. Ensuring that products meet specific standards and expectations for safety and customer satisfaction by monitoring and managing the entire supply chain, from raw materials to finished products, must be accomplished consistently and reliably.…
‘I have a cellphone that doesn’t behave like a phone: It behaves like a computer that makes calls. Computers are becoming an integral part of daily life. And if people don’t start designing them to be more user-friendly, then an even larger part of the population is going to be left out of even…
Despite rigorous vehicle safety testing, current evaluations fail to adequately protect women in the case of an accident. In 2021, a study published by the Insurance Institute of Highway Safety found that women have a mortality rate 20% to 28% higher than men during road accidents. Women are…
I’m looking at a topic in statistics. I’ve had a lot of feedback on one of my earlier posts on OC curves and how one can use them to generate a reliability/confidence statement based on sample size (n), and rejects (c). I provided an Excel spreadsheet that calculates the reliability/confidence…
It’s no secret that there are no universally applicable organization designs. What works in one context may not work in another because each organization has a different history, culture, and cast of characters. And yet there is a thriving segment of the management consulting business that…
At last year’s Masters Summit, MasterControl’s chief strategy officer, Matt Lowe, chatted with Quality Digest’s CEO, Jeff Dewar, about the challenges and rewards of his work and the many titles he’s held over the years. Lowe, who has worked at MasterControl for more than 15 years, has a lot to…
Economic practices need to change. The environmental and social consequences of unsustainable growth strategies are becoming increasingly obvious. A circular economy offers a way to counteract the climate crisis, strengthen our adaptive capacity, and make society more sustainable and resilient.…
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…
Data are an enterprise asset, and data governance (DG) is about establishing policies, processes, rules, standards, and controls around data to improve the quality of data and ensure data security and privacy.1
However, organizations struggle to implement data governance and, as a result…
According to “The 2022 State of Employee Safety Report,” 79 percent of employees say they’re concerned about their health and safety at work. Workplace safety policies along with various technologies can be effective tools for preventing injuries and increasing employee productivity. Overlooking…
The business challenges of the past few years—labor shortages, supply chain disruptions, and inflation—have accelerated the long-term trend toward automated packaging operations. All types of manufacturers and distributors, including food and beverage, pharmaceuticals, automotive, and e-…
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…
In a brightly lit subterranean lab at the National Institute of Standards and Technology (NIST) sits a room-sized electromechanical machine called the NIST-4 Kibble balance.
The instrument can already measure the mass of objects of roughly 1 kilogram, about as heavy as a quart of milk,…
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…
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…
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…
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…
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…
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 (…
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…
Despite the important and ever-increasing role of artificial intelligence in many parts of modern society, there is very little policy or regulation governing the development and use of AI systems in the United States. Tech companies have largely been left to regulate themselves in this arena,…
An improvement to a Nobel Prize-winning technology called a frequency comb enables it to measure light pulse arrival times with greater sensitivity than previously possible—potentially improving measurements of distance along with applications such as precision timing and atmospheric sensing.…
In late spring 2022, the U.S. Securities and Exchange Commission (SEC) charged an elite investment adviser for “misstatements and omissions” about environmental, social, and governance (ESG) considerations related to its managed mutual funds. This same financial firm has also faced myriad…
This is the fourth installment of a five-part series.
As detailed in our third installment, ASQE is a new legal entity connected to the ASQ we all know and love. It’s a trade organization to which organizations, rather than individuals, can belong. Current membership is about 180…
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…
In 1982, when asked about the state of the company’s Xenix operating system, a Microsoft engineer reportedly called it “vaporware“ to indicate that the operating system had really not yet materialized. Unfortunately, the term stuck for this and many other premature software launches.
It’…
‘Anyone can hit a home run if they try,” said the great Ty Cobb at the end of the deadball era as Babe Ruth rose to fame in the 1920s. Cobb was unimpressed by Ruth, the Sultan of Swat. “It’s a brute way to approach the game.”
In 2019, Major League Baseball (MLB) seemed to prove Cobb’s…
Y
ou need to measure length accurately to do things like make a dress, build a house, survey a plot of land, or determine if the home team made a first down on the football field. These length measurements and many others are often made with the help of a measuring tape. The major companies…
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…
One of the unexpected rewards of working at NIST has been the opportunity to see other disciplines through the NIST prism of measurement science and standards. By working with NASA scientists, astronomers, oceanographers and geologists, I’ve had the opportunity to witness the lives of scientists…
‘Firefighters are heroes.” We hear it all the time, from children, the media, and young people looking for a rewarding career. It’s probably something you’ve said or thought yourself at one time or another. These brave men and women put their own safety on the line every day to protect their…
Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s world is how to achieve this. Global food systems, already under pressure before the pandemic, are…
It’s hard to miss the flashing lights of fire engines, ambulances, and police cars ahead of you when you’re driving down the road. But in at least 11 cases from January 2018 to July 2021, Tesla’s Autopilot advanced driver-assistance system did just that. This led to 11 accidents in which Teslas…
Since the 1940s, engineers have used a common design language—a set of definitions, symbols, and practices—to draft engineering drawings that can serve as clear manufacturing blueprints or inspection checklists.
Although this system still works well for many traditional manufacturing…
In our connected, digital world, cryptographic algorithms are implemented in every device and applied to every link to protect information in transmission and in storage. During the past 50 years, the use of cryptographic tools has expanded dramatically, from limited environments like ATM…
In an open letter, Bob Fangmeyer, director of the Baldrige Performance Excellence Program, wrote that the Baldridge Award process would be suspended this year. The reasons and future plans are outlined in the letter shown below.
Dear Friend of Baldrige,
I am writing today to…
Smart sensors play a critical role in smart grids, supporting bidirectional flows of energy. Such sensors are needed for real-time monitoring of energy flow; controlling power generation, transmission, and distribution to customers; and protecting the overall power systems.
However, the…
As the war in Ukraine rages, finance professionals on Wall Street and in Europe recently attracted outrage by suggesting that investing in arms manufacturers should be treated as ethical investing. In the fight against tyranny, they argued that such an investment “preserves peace and global…
After lengthy wrangling, the 2021 COP26 climate summit ended with 197 parties agreeing to the new Glasgow Climate Pact. It will get countries to strengthen their CO2 emissions-cutting targets for 2030 by the end of next year, and formally recognize the need to reduce global greenhouse gas…
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.
…
Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…
Harran blinks in the sunlight, adjusting his eyes. He’s an inquisitive child, enthusiastic for all things new, yet still he struggles to understand what he’s looking at. A man is pressing marks—triangles or wedges—into a piece of clay, explaining that in this way he can speak to people, even…
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
It’s hard to fathom that Quality Digest, a little Northern California media company respected by all and beloved by many, turned 40 in November 2021. For a human being, 40 may be the new 30, but it’s still just creeping up on middle age. For a small business, on the other hand, 40 years is…
Although ISO 19011—“Guidelines for auditing management systems” has included language about remote quality management system (QMS) auditing since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns that ensued. Many of us have…
Artificial intelligence (AI) promises that organizations will be 40-percent more efficient by 2035, unlocking an estimated $14 trillion in new economic value to global GDP by 2030, according to PwC. This makes it the biggest commercial opportunity in today’s fast-changing business climate, all…
‘We didn’t get here on our own,” said Brian Dieter, president and CEO of Baldrige Award-recipient Mary Greeley Medical Center (MGMC), speaking at the 32nd Baldrige Quest for Excellence Conference. “We think we are very much better as a result of having learned from [other Baldrige Award…
High-power laser pulses focused to small spots to reach incredible intensities enable a variety of applications, ranging from scientific research to industry and medicine. At the Berkeley Lab Laser Accelerator (BELLA) Center, for instance, intensity is key to building particle accelerators…
Electric vehicles (EVs) are becoming more popular. The consumers interested in buying them generally want to know answers to questions such as: Is the car’s battery an explosion or fire risk? Will its useful life match or exceed the vehicle’s? Will the battery charge as fast as promised? Can it…
The International Organization for Standardization (ISO) is an independent, nongovernmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. As technology continues to rapidly develop, new standards are drafted…
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create…
In April 2018, the U.S. Food and Drug Administration (FDA) permitted the marketing of the first medical device to use artificial intelligence (AI). The device, called IDx-DR, is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the…
Better buying power, greater efficiencies, and more innovative ideas are not just for big businesses. The publication of ISO 44003 is helping smaller players flex their collective muscle by making the most of strategic partnerships.
How many of us cooped up at home during the lockdowns…
Remember the days when large paper maps filled the car, and holidays were booked by a travel agent? Neither do most people. Technology had already revolutionized the world of travel before Covid-19, and the trend has been catapulted as many more things move to digital. From virtual-reality tours…
Ever since people could tie logs together to form rafts and use them to transport goods by water, seaborne trade has flourished and grown. Historians believe that the first international trade routes were developed 5,000 years ago between the Arabian Peninsula and Pakistan, while by the 18th…
Innovation is the fuel that drives a successful business. Organizations that give their managers and employees the tools to respond to and make the most of opportunities, both internal and external, are well placed to grow profits, improve the health and well-being of their employees, and…
For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.
Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for…
There’s more than one path to service management. It refers to all the activities, policies, and processes that organizations use for deploying, managing, and improving IT service provision. In today’s technology-driven corporate landscape, the two leading methodologies come from the world of…
When it comes to ongoing certification of your quality management system (QMS), whether it’s certified to ISO 9001, ISO 13485, IATF 16949, or AS9100, how many times have you found yourself “preparing for an external audit?”
Picture the scene: You’ve got the dates set on the calendar…
In 2020, MESA, a small business in Oklahoma, became to date the first and only three-time Baldrige Award recipient.
From a one-person consulting firm founded in 1979, MESA has grown to support a workforce of more than 250 people. The largest privately owned company in its market, it is a…
Alot has changed at the National Institute of Standards and Technology (NIST) during the past 120 years. For one thing, we were known as the National Bureau of Standards for the first 87 years of our existence. Then, in 1988, we became the National Institute of Standards and Technology (NIST),…
Does your organization want to aggregate and analyze data to learn trends, but in a way that protects privacy? Or perhaps you are already using differential privacy tools, but want to expand (or share) your knowledge? In either case, NIST’s blog series on differential privacy is for you.
…
It’s been about a year since the Covid-19 pandemic turned our world upside down, and that includes the world in which we work. Certainty has hung up its hat, normality looks unlikely to return, and unpredictability is here to stay for the long term. How can organizations manage in this context,…
Each year during national Weights and Measures Week (March 1 to 7), we celebrate the contributions made by the weights and measures community to ensure accuracy and fair competition in commercial transactions based on weight or measure. This year’s theme, “Measuring Up to the New Normal,” was…
There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.
Although current food safety management system (FSMS) certification schemes around the world are highly…
New employees at the National Institute of Standards and Technology (NIST) are often surprised to learn that our agency is part of the U.S. Department of Commerce. How could this be? On the surface it seems that the missions of the two organizations couldn’t be more different. The Department of…
Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.
Whether a laboratory develops its own…
What do first responders do? It’s an easy question, and I used to think I knew the answer. Firefighters put out fires; police officers enforce the law; emergency medical system (EMS) workers treat injuries; 911 operators answer 911 calls and dispatch first responders to the scene. Simple, right…
As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS) certificates in an attempt to fool governments into buying personal protective equipment (PPE),…
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s…
Remote auditing (RA) has become a norm during the Covid-19 pandemic. Remote auditing is one of the audit methods prescribed in ISO 19011:2018—“Guidelines for Auditing Management Systems.” Although RA has surged due to pandemic constraints, this method of operation will surely gain ground as a…
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the…
Since the days of painting on cave walls, people have been representing information through figures and images. Nowadays, data visualization experts know that presenting information visually helps people better understand complicated data. The problem is that data visualizations can also leave…
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.
Under section 120302 the…
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in…
In this article series, we explain some of the successful strategies and programs shared by Baldrige Award recipients to highlight categories of the Baldrige Criteria and how your organization might consider using them as inspiration.
Part of the purpose of the Malcolm Baldrige National…
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.
But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually…
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…
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…
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,…
Sometimes I see people chasing their tails when trying to troubleshoot a process. This usually (though not always) follows a complaint or rejection of some kind.
A few years ago I posted “Organize, Standardize, Stabilize, Optimize” and talked in general terms about the sequence of…
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…
With the emergence of the coronavirus (Covid-19), many organizations are doing their part to prevent the spread of infection by practicing social distancing. Some organizations have implemented no-visitor policies, which helps prevent the spread of the disease, but is not so good when it comes…
The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally…
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…
In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share a set of tools that help evolve quality management into business management.
These tools…
In 1989, I was handed a copy of ISO 9001:1987 by my employer with the direction to find out what it was all about. Our company was headquartered in Europe, and we would be compelled to implement the standard straightaway.
My first reaction was that I wished it had been published 20 years…
As today’s industries and operations become increasingly more global, an effective management system is rapidly becoming an essential part of a sustainable business strategy. A management system defines how work is done, the desired results, and the controls imposed to ensure those outcomes.…
The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances over FMEA as practiced 15 or 20 years ago.1 The publication is definitely worth buying because the…
After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired. There was no apparent external influence such as poor…
If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations. RCA and corrective actions are some of the most useful tools for continual…
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and…
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!
This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.
Also, each…
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.
…
As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever. In the international standardization arena, much work is being undertaken by ISO/IEC’s joint…
With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists? How do we imagine the future of documented management systems?
…
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every…
How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions? Quality Digest editor in chief Dirk Dusharme and Mike Richman, principal at Richman Business Media Consulting, point out that most manufacturers already recognize that waste, including waste of…
Much has been written about the challenges associated with AI-based decisions. Some documented failures include gender and race biases in recruiting and credit approval software; chatbots that turned racist, and driverless cars that fail to recognize stop signs due to adversarial attacks;…
When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges, missions, and leaderboards, they achieved a 37-percent increase in participation.
And when Ford…
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device…
In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization. But when you have multiple, disparate plants around the country or the globe, standardization can…
The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and…
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and…
Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published.
Innovation is an…
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR…
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the…
During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late…
A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “…
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the…
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
…
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have…
In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this article, we’ll outline four points that can help your organization integrate standards into your…
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk…
Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.
American women earn almost 20 percent less per hour than their male peers, in part because women disproportionately take responsibility for…
Throughout my career, I have been a member of several trade organizations. I believe that standards have meaning, in every field. When I become a member of an organization, I endeavor to learn as much as possible.
For example, I belong to ASQ (American Society for Quality). I enjoy…
According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the issue, the International Organization for Standardization (ISO) has developed a standard, ISO…
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a…
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that these hacks are what come to mind when we think about information security.
The…
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven…
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble…
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and…
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is…
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “too much to do and not enough time to do it…
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.
“The Gift of Being Small”
This article by Quality Digest’s Taran March…
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…
A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years. For the first time, all measurement units will be defined by natural phenomena rather than by…
The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm. A presidential-level honor, the award recognizes exemplary U.S. organizations and…
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.
“GE’s Lessons Won’t Determine Whether You Succeed or Fail”
Does the success or failure of GE’s CEO really matter that much when it…
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest…
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products…
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an…
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the second article, the process control properties of MIL-STD-105 c>0 sampling plans were…
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the…
Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases. The automotive industry was making deep reductions in…
Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook. The new…
IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason…
During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early…
ISO 31000 defines risk as “the effect of uncertainty on outcomes.” Identifying risks and determining ways to respond to them help you learn about your processes, your organization, and the environment you’re operating within. It also raises your awareness of how any of these things might change…
ISO 9001:2015, clause 6.1 requires an organization to identify its risks and take actions to address identified risks. It is very tempting to start with a huge list of potential risks for the organization, but is the organization focusing on the actual risks that have an effect on its operations…
Requirements are the information that best communicates to an engineer what to build, and to a quality-assurance manager what to test.
A requirement has three functions:
• Defines what you are planning to create
• Identifies what a product needs to do and what it…
Load cells are a combination of metal, strain gauges, glue, and more. Over time, fatigue ensures that there will be some instability in the system. Load cell stability or drift is usually assumed to be the amount of change in the entire cell system from one calibration cycle to the next. It is…
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10…
There is a proliferation of management system standards and requirements globally. These management system standards are either customer or industry mandated. Many standards are becoming a requirement for doing business.
For example, ISO 9001 is a quality management system (QMS)…
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.
A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in…
According to the Verdantix global survey of 382 EHS decision-makers, 57 percent expect to use mobile apps in 2018 either widely across all their facilities, at multiple facilities, or as a pilot project at one facility. Mobile has become a game changer for modern quality management systems (QMS…
Story update 7/13/2018: This story was updated with a link to the released version of standard E3125–17.
Large-volume 3D laser scanners play an essential role in manufacturing large products (e.g., airplane wings), making measurements for large-scale construction (e.g., bridges),…
In our June 15, 2018, episode of QDL, we get a field report from the HxGN LIVE user conference, examine the “story of quality,” and consider the importance of experience.
HxGN Live recap
Mike Richman went to HxGN LIVE... but I didn’t. I relive it vicariously through…
Quality management systems (QMS) have become strategic components that touch more and more of the business today. With new versions of QMS standards, and the enrollment of all people in the quality management effort, the need for cohesion from one system to the next is becoming critical.
…
Augmenting its efforts to protect the nation’s critical assets from cybersecurity threats as well as protect individuals’ privacy, the National Institute of Standards and Technology (NIST) has issued a draft update to its Risk Management Framework (RMF) to help organizations more easily meet…
A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001.
The concept…
Markets and manufacturing practices continue to evolve, and companies now outsource to an increasing number of global manufacturing and supply partners. As companies have pursued this broadened supply chain strategy, the ability to manage both business and quality risks has become more…
On the May 4 episode of QDL, we discovered that love is a key component to winning a Baldrige Award, learned how to be more efficient at work, and discussed how great art helps us to really see our processes. Here is an up-close look:
“Undersecretary of Commerce and NIST Director Walter…
The new automotive quality management system (QMS), IATF 16949:2016, was released in October 2016, and it officially went into effect on Jan. 1, 2017, along with revisions to IATF Rules for Achieving and Maintaining IATF Recognition, Fifth Edition. Starting Oct. 1, 2017, all automotive QMS…
Organizations worldwide recognize the need to provide a safe and healthy working environment, reduce the likelihood of accidents, and demonstrate they are actively managing risks. ISO 45001 will provide an internationally accepted framework that will help protect employees as well as protect the…
The greatest challenge I have each year when I return from the Baldrige Program’s annual Quest for Excellence Conference is prioritizing the most important messages for me and my organization, whether that is my work organization, volunteer organization, or—yes—my family (this one might be…
Grace Swanson, vice president of human capital at Accumold, a leading micro-molding plastics injection company located just outside Des Moines, Iowa, knows the field of standards well. Her company has certifications in ISO 9001 for quality management, ISO 14001 for environmental management, and…
The AIAG-VDA FMEA Handbook committee and everyone who responded to the request for comment on the proposed AIAG-VDA failure mode and effects analysis (FMEA) manual must be applauded for their efforts. Harmonizing the VDA and AIAG FMEA methods is not an easy task. According to industry sources,…
During this past Friday’s episode of QDL, we presented two great interviews, both revolving around standards and certification, plus a piece about analytics, and a lively off-script about the responsibilities of media companies like Facebook when it comes to protecting user data. Here’s a closer…
As I’m sure many of you know, the ISO 13485 standard for medical devices was updated in 2016, which means the time to transition your quality management system (QMS) is now. Most auditing organizations have either cut off ISO 13485:2003 recertifications or will be doing so very soon.…
In our March 16, 2018, episode of QDL, we looked at universal basic income, management status quo, ISO 10018, and how a community college is teaching cutting-edge metrology skills.
“Public Split on Basic Income for Workers Replaced by Robots”
Gallup asks Americans if they…
If you had your AS9100 transition audit tomorrow, could you say right now whether you would pass? More important, do you know where the gaps are in your processes that could trigger nonconformities?
AS9100 is the leading standard for aerospace management systems, required by…
Imagine going to work, motivated to meet all your goals and deadlines, only to find you need a different computer for each of the applications you use: Microsoft Word on the laptop in your office; the customer database solution on the tower PC in the conference room; and email on the…
Many quality professionals remain unaware that a systematic approach to human resources is now a requirement in ISO 9001:2015. These new requirements are based on the principles considered by the International Organization for Standardization (ISO) to be essential to quality management success…
In just a few short months, the European Union’s General Data Protection Regulation (GDPR) will take effect. The regulation, which replaces the EU’s 20-year-old Data Protection Directive, imposes new and more rigorous requirements on any entity that collects or maintains personal…
Ageing wastewater systems are under threat from growing populations, urbanization, pollution. and climate change, not to mention human behavior. However, despite these challenges and fears for health and safety, the new ISO 24516 series is playing a key role in turning what many consider…
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be…
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer…
Workplace safety is a vital concern for every organization. According to the U.S. Bureau of Labor Statistics, 2.9 million nonfatal workplace injuries and illnesses were reported by private industry employers in 2016, costing employers tens of billions of dollars.
In March of this…
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Impatient With Colleges, Employers Design Their Own Courses”
Microsoft, Amazon, and others are teaming up with third-party online…
Frequented by more deer than people, the NIST stone test wall lives a fairly isolated existence. Out among the trees and the grass on the south end of the Gaithersburg, Maryland, campus, it cuts an imposing and visually bizarre figure. Set in the mortar of its technicolor face are more…
The concept of risk-based thinking has been implicit in previous editions of ISO 9001 through requirements planning, review, and improvement. But ISO 9001:2015 requires companies to use risk-based thinking to manage their business.
If you want to implement an ISO 9001:2015…
Last Friday’s episode of QDL was our final show of the year, and we’re leaving 2017 on a high note! We brought you two great interviews and a terrific Tech Corner, not to mention some advice on increasing your productivity in 2018. Let’s take a look:
“AIAG and VDA Release…
The Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry, or VDA (Verband der Automobilindustrie), have been cooperating in automotive quality management systems since the advent of the second edition of ISO/TS 16949 in 2002. The integration work…
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Smart Manufacturing Trends in 2017”
The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds,…
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines.
Readmissions…
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To be competitive on both a national and a global level, organizations must adopt a forward-thinking approach in developing their management strategies. One of the foundations of a successful strategy is the management system, which…
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:
“World Toilet Day”
ISO truly has a standard (or at least a standard in…
A new version of ISO 31000:2009—“Risk management” is due to be unveiled early next year. As the threat of risks grows for governments, organizations, and the public alike, how can the new, streamlined standard help to make our future more secure?
Ten years ago, the…
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:
“What Really Causes Workplace Stress”
A multidisciplinary team of researchers…
Reflecting a greater focus on achieving organizational success through people, the first certification program for ISO 10018, “Quality management—Guidelines on people involvement and competence” is now available for organizations committed to quality people management. This standard was…
Never-before-seen growth has turned the aviation, space, and defense industries into lucrative markets. Demand for increased efficiency, security, quality, and durability has taken off in recent years, resulting in high margins and operating profits. With exponential growth potential and…
During the Nov. 3, 2017, episode of QDL, we (figuratively) traveled the globe to bring you quality information. Let’s take a closer look:
“‘Made in Japan’ Falls from Grace Amid Scandals, Systematic Flaws in Manufacturing Industry”
Kobe Steel is the latest Japanese…
General Motors (GM) recently published updated customer-specific requirements for IATF 16949 compliance. The new requirements take effect Nov. 1, 2017, and cover layered process audit (LPA) requirements in greater depth than previous versions.
LPAs use a series of frequent…
Companies purchase lots of things. They purchase tangible goods, like raw materials and equipment, or intangible services, like calibration and transportation. And most companies have basic criteria that they use to qualify and select suppliers.
Many companies require…
We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:
“Energy Harvested from Evaporation Could Power Much of U.S., Says Study”
…
Our Oct. 13, 2017, episode of Quality Digest Live looked at edge computing for natural disasters, medical records, and zero defects.
“New Research May Improve Communications During Natural Disasters”
Could edge computing help communications during disasters?
…
When Philip Crosby announced zero defects as a philosophy during the 1970s, it was met with incredulity. There were already many articles written on the fallacy of such a strategy and the enormous costs of moving toward zero defects. Fast forward 40+ years, and zero defects has become a…
Certificates, certifications, badges, and licenses: What are they worth to the workforce? The last decade has seen huge growth in the number and variety of credentials, and this explosion has fueled a great deal of confusion among students, workers, job seekers, employers, and others.…
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Restriction of hazardous substances (RoHS) regulations help protect the public from dangerous or toxic materials in consumer products and electronics. Beyond public health and safety concerns, noncompliance represents significant…
In my October 2013 column, “Standardize to Improve,” I dealt with business process mapping in detail. Business process management systems (BPMS) comprise the entire gamut of documenting process steps, assigning…
True to my profession as an engineer, I am a total geek at heart and proud of it. Spending time in automobile museums always fascinates me. It excites me to see a prescient innovator from the past come up with an idea like headlights. The first ones were Limelight carbide models that had…
ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental, IT security) and enables us to start looking at integration of these systems.…
As of Sept. 14, 2018, ISO/TS 16949 certificates are longer valid, which means automotive suppliers must certify to the new version, IATF 16949. Transition audits are underway and will continue into next year, but many companies still have a long way to go to prepare.
Let’s…
Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.
“A Better Way to…
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A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem…
On Friday, Sept. 1, 2017, QDL included news about the disaster in Texas and no apocalypse in retail, an interview covering a different approach to failure modes and effects analyses, a feature article on consumer views about for-profit social-benefit enterprises, and a great new Tech…
As discussed in my previous article, the Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under section 501(c)3. However, the IRS isn’t the only one monitoring your tax-exempt hospital. Other organizations have started policing…
There was a lot of ground to cover on this week’s show… fortunately we had drones (I mean, unmanned aircraft systems) to help us cover it all. Here’s a quick flyby:
“Girl Scouts Offer New Badges for Science, Technology, Engineering and Math”
The Girl Scouts of the…
Globally, there are more than 68,000 organizations certified to ISO/TS 16949:2009 that will need to undergo a transition audit to the International Automotive Task Force (IATF) international automotive quality standard, IATF 16949:2016. As of April 2017, 181 of these audits have been…
What do cocoa, socks, and smartphones have in common? If you guessed risk of slavery in the manufacturing supply chain, you are correct. Does your organization have an international supply chain? Then it’s at risk. What are you doing to address the risks associated with modern slavery in your…
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling Steps”
These stairs actually help you go up.
“The Curious Case…
Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated process management system lies the unsung yet essential electronic form. You can avoid quality…
The dog days of summer are here, but the Aug. 4, 2017, episode of QDL offered lots of cool content. Let’s take a closer look:
“What Went Wrong With the F-35?”
One expert calls the Lockheed Martin’s F-35 fighter jet an “inherently terrible airplane.” So why does the Air Force…
Bribery and corruption are a $1 trillion drain on the global economy and a door-shutting event for companies unable to prevent rogue acts from destroying a company’s entire reputation. If you think about it, managing bribery is a bit of an oxymoron. How do you manage something that hasn’…
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actionsAn FDA investigation was conducted from January to…
Change is nothing new. Nobel laureate Bob Dylan sang that “the times they are a-changin’” back in 1964. The difference today is the pace of change. In his book, Thank You for Being Late: An Optimist’s Guide to Thriving in the Age of Accelerations (Farrar Straus & Giroux, 2016),…
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies…
Every company is in business to take risks.
Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be…
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business:…
In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations.
“Demand-Driven Education to Close Skills Gap”
Speaking at the National Association of Manufacturers Summit in Washington, D.C., Secretary of Labor…
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (…
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
The biggest question often asked is, “I’m aware my company needs to pay great attention to…
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As widely useful and broadly applicable as it may be, the ISO 9001 standard covering general requirements for quality management systems (QMS) cannot address all stakeholder needs in every sector. Component functions and operations of…
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For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations; and AS9120 for aerospace warehouse and distribution…
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Organizations that build, supply, design, or maintain products, parts, or services for the aerospace industry generally must be certified to the AS9100 family of standards (including AS9110, which is specifically for aerospace…
To meet the 2018 deadline for becoming certified to ISO 9001:2015, organizations are scrambling to overhaul their quality management systems. One major revision to ISO 9001 is the requirement to identify, evaluate, and address risks. Unfortunately, a tool most appropriate for these…
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when…
In the 1990s, Omnex worked with Ford Motor Co. to develop the Ford quality operating system methodology, which with maturity and broad experience has evolved into Omnex’s business operating system (BOS) process.
The quality operating system promised and has delivered the following:…
In a similar vein to Donald Wheeler’s excellent article on process capability confusion I would like to submit the following example of thinking that you are doing the math right and getting an answer that can get you into real trouble.
Consider the following capability…
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it…
While Hank Matousek Sr. was perfectly content in his position as quality control manager at a bearing company during the late 1960s and early 1970s, he had no idea that his employer’s growing financial woes and a pending layoff would become his surprise catalysts to found Grind All Inc.…
The internet of things (IoT), robotics, augmented reality, 3D printing... look at megatrends, and despite their unique attributes and myriad differences, you’ll find that they all have one thing in common: time—or more precisely, the fact that there’s always less of it.
No matter…
Certifications often drive the implementation of a system approach, based on ISO standards. The primary implementation demand is for ISO 9001. Certifications do have initial costs and then recurring costs for surveillance and recertification visits. This is a responsive approach to…
Whenever the term “nonconformance report” (NCR) comes into project home offices or construction and fabrication sites, it is often seen as a negative, and personnel are typically reluctant to accept it as a positive and powerful tool to improve. Perhaps, the “non” in nonconformance is…
Depression and mental health conditions are on the rise globally. Affecting more than 300 million people of all ages across the world, depression causes immense suffering to people and their families, as well as placing a great economic cost on society. Its consequences and solutions…
In our latest episode of QDL from this past Fri., April 21, 2017, we examined the importance of the various steps in the plan-do-check-act (PDCA) cycle, considered what United Airlines could have done differently to avoid its latest public relations fiasco, and conversed with Mike McLean of ISO’…
In last week’s Quality Digest Live: Enterprise quality management vs. integrated quality management. Our deteriorating U.S. infrastructure. Stress testing composites. The Fowler Precision Mobile Tech Center.
“Save Costs When Implementing Enterprise Quality Systems”
An integrated…
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the loosely regulated wilds of global competition. Quality control now requires a sense of how…
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment. Why is this a good idea? Because it saves money.
Figure 1 illustrates how…
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My wife and I purchased a new car this year. The employee handling the closing paperwork gave a compelling presentation concerning the extended warranty, which we also purchased. His presentation included a litany of…
The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap:
“Winners Selected for the 2017 InVenture Prize”
Colloquially known as “American Idol for Nerds,” the…
“You should prioritize agility, but find ways to take risks without sacrificing sound execution that can jeopardize both customer satisfaction and, more importantly, safety.”
—PWC “2016 Auto Industry Trends”
Perhaps no sector is so thoroughly…
The September 2018 certification deadline for ISO 9001:2015 is looming. The updated standard promises to further streamline mission-critical tasks and information flows as well as better align quality management with overall business management. But to earn certification, organizations…
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always…
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st…
Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with dancing.) The university holds the “You Said... We Did” sessions each January to demonstrate…
More than a million organizations around the world embrace the ISO 9001 quality management system (QMS) standard to guide their businesses and operate in the most efficient manner possible. The International Organization for Standardization (ISO) has recently updated ISO 9001 from its…
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
What the standard saysWhen making sense of Clause 4.1—“Understanding the…
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For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and proper documentation for…
According the International Organization of Standardization (ISO), there are more than 300,000 certifications to ISO 14001 in 171 countries around the world, making it the most relied-upon symbol of environmental stewardship and sustainable business practice. True to its core tenant of…
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a…
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from…
They say opposites attract. Although my husband and I have many important things in common, we are complete opposites in one area. He’s a “risk taker,” and I’m... well, not so much. Rather than being labeled as “risk averse,” I prefer the term “caution giver.”
I’m a federal…
According to the ISO/IEC Guide 99—“International vocabulary of metrology—Basic and general concepts and associated terms (VIM),” the traceability of a measurement result is demonstrated through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty…
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If your organization has yet to make the transition from ISO 9001:2008 to ISO 9001:2015, you’re not alone. It’s estimated that less than 20 percent of the more than one million organizations certified globally have made the…
(ACSI: Colorado Springs, CO) -- Customer satisfaction with banks is up, according to the American Customer Satisfaction Index (ACSI). Its recent report covers the finance and insurance sector, which includes retail banks, credit unions, health insurance, property and casualty insurance,…
The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to…
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the…
Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the underlying requirements are not particularly…
The U.S. Commerce Secretary, Penny Pritzker, has named four organizations as the 2016 recipients of the Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for sustainable excellence through visionary leadership, organizational alignment, systemic improvement…
A production part approval process (PPAP) is used by companies to establish confidence and rules in a production process. In a sense, it gives customers a view into their suppliers’ manufacturing capabilities.
A PPAP is required when there is a new part, engineering changes,…
Until recently, if a company wanted the best measurements in the world for the physical dimensions of one of its dimensional standards, it had to book time on the NIST Physical Measurement Laboratory’s (PML) Moore M48 coordinate measuring machine (CMM). Operating at NIST since 2000, this…
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—…
Changes to the global economy during the last two decades have dramatically altered the landscape of business and industry. Globalization has enabled an ever-lengthening supply chain, which confers greater complexity and risk to every step of the process, whether for material goods or…
Should an organization embrace risk or spend millions of dollars a year to avoid it? How do you know when a particular strategy is best?
Considerations for such thinking are covered in the Baldrige Excellence Framework, and the topic was recently explored by Brennan McEachran in…
An integrated management system (IMS) combines multiple management system standards to which an organization is registered. The management systems are developed, implemented, and maintained via one system with processes that cover each standard’s requirements.
For…
Electronic temperature compensation has been successfully applied to shop-floor gauges for more than 25 years. It’s become a mature technology and proven to be one of the most easily cost-justified means to achieve gauge correlation and eliminate the most common cause of high-resolution…
This month, the International Automotive Task Force (IATF) published IATF 16949, the standard for automotive quality management systems. In this article I’ll provide background on the origins of this important industry standard, summarize the key changes from its predecessor, ISO/TS…
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false.
If you have…
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why…
For companies that are registered to more than one management system, integrating them makes a lot of sense. Combining your management systems provides greater benefit than running separate management systems in parallel. An integrated management system (IMS) can help reduce duplication…
Every year a new cohort of Baldrige Executive Fellows gains intensive knowledge about leading organizations to excellence through cross-sector, peer-to-peer learning hosted at the sites of Baldrige Award recipients. Every Baldrige Fellow completes a capstone project as part of the…
Deadlines for ISO 9001:2015 and ISO 14001:2015 registration have appeared on the horizon. Although we have 24 months to get registered to these new standards, some related timelines are looming even closer, notably scheduling a recertification or surveillance audit.
Some…
If you’ve ever used a device that picks up signals over the air, you know that sometimes you just can’t get the signal to come in clearly. You point the device every which way, move it all around the room, do a little dance, but nothing seems to work. There doesn’t seem to be any…
Public schools across the country are facing significant challenges. Lisa Muller, assistant superintendent for Baldrige Award recipient Jenks Public Schools, says schools are dealing with an increase in student needs, while at the same time managing declining revenues and attempting to…
Current management regulations and standards stress the importance of making quality management a higher priority throughout all areas of operation. At Verse Solutions, we wanted to find out how quality managers are adjusting to that new mindset, and how they are using quality-based…
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Y our product or service is only as good as the management system that supports it. Certification by an independent third-party certification body, such as Intertek, confirms that your management system complies with…
NIST scientists have devised and modeled a unique optical method of sorting microscopic and nanoscopic particles by size, with a resolution as fine as 1 nm for particles of similar composition.
A stream of particles of various sizes enters the system at a single point, but…
Mandatory reporting requirements for regulations such as Europe’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) legislation have increased the focus on environmental compliance and ethical sourcing across the…
What do you feel when you imagine your next regulatory audit? Stress? Anxiety? Overwhelming dread? The average recall can cost a manufacturer as much as $10 million, making compliance important to your brand as well as your bottom line.
As you manage the daily ins and outs…
Creating a new material has long been either an accident or a matter of trial and error. Steel, for instance, was developed over hundreds of years by people who didn’t know why what they were doing worked (or didn’t work). Generations of blacksmiths observed that iron forged in charcoal…
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error.
The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent…
A new publication from the National Institute of Standards and Technology (NIST) provides a basic model aimed at helping researchers better understand the internet of things (IoT) and its security challenges.
Examples of IoT systems include a smart electric grid, a home…
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs.
Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded…
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA).
As an…
Whether they’re made of leather or metal, tape measures have been used by people for a long time. The first spring-loaded metal tape measure was invented and patented in England in 1829. Alvin Fellows of New Haven, Connecticut, made improvements to that design, including the locking…
In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their…
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and…
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential…
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is…
A high-tech version of an old-fashioned balance scale at the National Institute of Standards and Technology (NIST) has just brought scientists a critical step closer toward a new and improved definition of the kilogram. The scale, called the NIST-4 watt balance, has conducted its first…
I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science.
As a fire researcher, or more colloquially, a dragon wrangler, my job is to help protect people and property from fire’s…
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed…
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million…
Anyone who has ever covered a wall with sticky notes to clearly map all of the steps in a process knows how valuable that exercise can be. It can streamline workflow, increase efficiency, and improve the overall quality of the end result. Now, a public-private team led by the National…
The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. Many of us close to the standard expected it to be released in May 2016 after the April International Aerospace Quality Group (IAQG) meeting in Singapore. However, this was not the case; the…
For as long as we have had automobiles, we have had traffic accidents. Even the vehicles that we depend on to take care of us in the event of an accident—ambulances—get into accidents nearly every day. Because ambulances are basically a small emergency room on wheels, the occupants in…
Depending on whom you ask, May (or August or April—it would be great if someone were to standardize this, but we’re going with May) is National Inventor’s Month. Lots of people have dreams of being a famous inventor. Even I’ve had “ideas” for inventions before.
For instance,…
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that…
Put your hands together. Now move them back and forth to rub them against each other. Feel that heat? That’s from friction. No matter if it’s between siblings or the gears of an engine, we usually think of friction as a bad thing, and often it is. Friction can cause things to heat up,…
When a team of researchers at the National Institute of Standards and Technology (NIST) Physical Measurement Laboratory (PML) first tested a new kind of pressure sensor two years ago, initial results showed it was faster and had higher resolution than the centuries-old mercury-based…
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There are many paths for organizations to become good, sustainable, low-footprint citizens of the business world. Production processes can be redesigned to be more efficient, corporate campuses can be located so as to reduce…
Recently on the Taking Measure blog, we asked Tara Lovestead, a recipient of the 2016 Presidential Early Career Award for Scientists and Engineers (PECASE), a few questions about her life and work. She was recognized for her extensive application of new methods to rapidly and…
An upcoming audit can be one of the more stressful times of the year for a quality team. Whether you are pursuing a new certification or retaining your current one, audit preparation can be a daunting challenge to even the most diligent organization. Although standards such as ISO/IEC…
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to…
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize…
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render…
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or…
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices…
The nefarious Major Uncertainty has kidnapped Monsieur Kilogram, putting the world’s measurements of mass in jeopardy. As the world spirals into “Mass Hysteria,” the remaining SI Superheroes, champions of the metric system, leap into action to save the day, and hopefully Monsieur…
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.
When…
Let’s say you’re a biotechnologist working to develop new medicines or a better test for forensic analysis. You might find yourself frequently using absorbance spectroscopy, a technique that allows researchers to identify even small amounts of a substance (such as DNA) or an antibody…
Walking the snowy streets of the small Swiss town of Davos, it was impressive to know that 40 heads of state and 2,500 leaders from business and society were there to talk about some of the most important global challenges facing us today.
In the main congress hall, I saw and met…
ISO 9001:2015, ISO 14001:2015, and ISO 45001:2015 establish clear expectations for top management. Not only are executives accountable for the effectiveness of these respective systems, they also have specific tasks ranging from establishing objectives to supporting relevant managers in…
Although the most common method of metal 3D printing is growing exponentially, moving forward from producing prototypes to manufacturing critical parts will be possible only by reaching a fundamental understanding of the complex physics behind the process, according to a new paper…
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member…
Flu season typically peaks between December and February, but by the time the winter holidays roll around, many of us will have already waited in line at area clinics, grocery stores, and pharmacies to get our annual flu shot. The Centers for Disease Control reports that U.S. vaccination…
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Company managers have a lot on their plates. It’s a tall order to handle daily operations, inventory, staffing needs, training, deadline and quota expectations, and a bevy of other duties. The best managers know enough to…
The auditing profession is changing. Auditors are getting older. Technology is changing the way auditors work. Companies now work 24/7 around the globe, speaking different languages and integrating different cultures, forcing auditors to adapt to a new work reality. How is all this…
ISO 9001 might be the most confusing document in business history. I first became aware of the standard in the late 1980s when my manager handed it to me and said, “See if you can figure this thing out. Our plant has to get certified.”
I took the document back to my desk and attempted…
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In 1996, the International Organization for Standardization (ISO) first released the ISO 14000 family of standards, which provided tools for organizations wanting to manage their environmental responsibilities. In the years since, ISO…
As we near the end of 2015, the pilot phase of the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) is approaching its third and final year. In this article, we’ll provide a review of the pilot study’s progress since its inception two…
With more than one million certifications issued, ISO 9001 is the world’s most widely adopted framework for quality management systems, helping companies achieve conformity of products and services to meet customer expectations and regulatory compliance. The ISO 9001 standard has become…
In a world of incessant change, some things have to stay the same. One is the set of values for the fundamental physical constants—such as the speed of light or the charge of the electron—that underlie precision measurements in industry, science, and medicine worldwide.
Yet even…
A meaningful, systematic approach to environmental management has made IBM one of the world’s most environmentally conscious companies. The globally integrated IT company leverages ISO 14001 for a comprehensive corporate policy on environmental affairs.
In a recent interview for…
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Relationships between an organization and its suppliers have traditionally been characterized by adversarial activities and posturing in which at least one, and often both, parties lose. Rather than working…
In early 1989, Michael Whisman, MBA, MBB, was trained by his then-employer, Baxter Healthcare, to be an examiner within the company’s newly announced Baxter Quality Award. To determine award winners for the performance recognition program, the company was using the first edition of the…
The outward focus of an organization comes from defining the context, mission, vision, policies, and interested-party expectations. A company’s goals and objectives provide the lens through which this outward focus can be seen (figure 1).
…
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We’ve all heard it before: Change is the only constant. This isn’t just cliché but a truth that all companies will come to recognize. Change is the driving force behind improvement. And all of the changes that take place within an…
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One of the most common misconceptions about ISO 9001 certification is that it’s only for big businesses. This couldn’t be further from the truth. The standards set forth by…
The European Cooperation for Accreditation (EA), an association of national accreditation bodies in Europe, has implemented the accreditation requirements of the International Accreditation Forum (IAF) and has signed up for the IAF Multilateral Recognition Arrangement (MLA) extension to…
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With the ISO 9001:2015 revision currently dominating standards conversations, it's easy to pass over the humble energy standard from Geneva—ISO 50001. You might not even know what it is, let alone the benefits…
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Risk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition…
Story update 8/6/2015: Paragraph 14 of this article stated "many organizations are ill-equipped to develop an effective risk management assessment process," implying, to some, that a risk management system is required, which as stated in paragraph 8 of this article, it is not (nor was that the…
The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration…
With quality the driving force behind innovation and operational improvements in the vast majority of organizations, it’s no surprise that every industry sector has embraced it, from manufacturing to the service. For some sectors, however, quality improvements can be the difference…
During the recent leadership plenary of the Baldrige Program’s Quest for Excellence Conference, senior leaders of the 2014 Baldrige Award recipients shared their insights and lessons learned.
Scott McIntyre, the U.S. leader of PricewaterhouseCoopers’ (PwC) Public Sector Practice…
A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the…
Management systems programs such as ISO 9001 and ISO 14001 were originally implemented to help organizations gain market access, satisfy mandatory customer requirements, streamline processes, manage growth, drive continual improvement, and generally keep up with the competition.
…
I am grateful for the opportunity to work for the Baldrige Program. We’re blessed with an engaged community of Baldrige practitioners—folks who have served as examiners at all levels, across the country. These practitioners not only understand but have often mastered how to use the…
In part one of this two-part article, I began an evaluation of Deming’s 14 points, and how they influenced the final draft international standard (FDIS) version of ISO 9001:2015. Part one provided an overview of Deming’s first seven points; in this continuation we explore points eight…
The U.S. Department of Labor estimates that 2.2 million workers worldwide lose their lives each year due to workplace-related accidents, injuries, and diseases, and that another 4.1 million workers in the United States suffer serious work-related illnesses or injury. These and other…
The ISO 9001:2015 standard may still be in draft form, not quite set to replace the existing standard until the end of 2015, but it’s important to keep apprised of these changes and what they will mean for you when complying with the new standard. So what changes lie ahead? In this…
In the years since ISO 9001 and ISO 14001 were first published, many organizations have followed the models of these standards in designing their own management systems. However, many of those systems haven’t been utilized to effectively manage risk. Many have been minimally developed to meet…
ISO 9001 continues to wend its way through the revision process, and as it does so there have been lots of discussions and prognostications over the impending changes. All the wringing of hands and ongoing debate will not hurry the process or change the outcome.
The…
The international standard for quality management systems, known as ISO 9001, is currently being revised and is scheduled for release in late 2015. Are you ready for the changes? How do the changes affect you?
NQA, a globally recognized certification body, is preparing,…
In late October, longtime Baldrige examiner Miriam Kmetzo traveled to Suzhou, China, to attend and speak at the 6th Quality Forum for Academics and Innovation.
Kmetzo gave a presentation at a session that featured four quality award programs in the international arena: the…
The ISO 9001 standard is currently under revision. The decision to do so wasn’t driven by one dramatic event happening in the marketplace, but rather by due diligence of the International Organization for Standardization (ISO) committees and working groups that perform systematic reviews…
When auto manufacturers set out to create award-winning vehicles, much consideration is given to interior sound quality. Ironically, the manufacturers have been so successful in mitigating road noise they have inadvertently caused a new problem for themselves: Apparently, the cars are…
Penny Pritzker, the U.S. commerce secretary, has announced that four U.S. organizations are recipients of the 2014 Malcolm Baldrige National Quality Award, the nation’s highest presidential honor for performance excellence through innovation, improvement, and visionary leadership.
…Publically announced breaches of secured information are so common today that they almost seem routine. Last year, in the United States alone, financial companies like JPMorgan Chase and retailers such as Target and Home Depot were victimized by information system hackers that allegedly…
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
The rapid…
In October 2001, an international team led by Lockheed Martin was awarded the contract to build the next-generation Joint Strike Fighter (JSF) aircraft, which resulted in the development of the F-35 Lightning. The requirements for the new aircraft were complex, demanding new heights of…
Organizations pursue registration to international standards for a variety of reasons, but in the broadest possible sense most agree that the goal is to improve business operations and reap financial rewards, either by saving money through increased efficiencies or in making money by…
At the new NIST Center for Automotive Lightweighting (NCAL), workloads are fraught with stress and strain—all to help the auto industry take a heavy load off future cars and light trucks.
To meet proposed federal fuel-efficiency standards—54.5 miles per gallon by 2025, or nearly…
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an…
Recent experiments have confirmed that a technique developed several years ago at the National Institute of Standards and Technology (NIST) can enable optical microscopes to measure the 3D shape of objects at nanometer-scale resolution—far below the normal resolution limit for optical…
The International Labour Organization estimates that more than 2 million deaths every year can be attributed to work activities. This single statistic clearly indicates the pressing need for occupational health and safety regulations, and the importance of a single standard to help…
For decades now, the measurement systems analysis (MSA) approach has been the predominant method for evaluating measurement systems capability. Although this method is widely considered to be an acceptable and comprehensive approach throughout most of the world, a growing number of…
Arecent client satisfaction survey conducted by our company, the British Assessment Bureau (BAB), a UK-based certification body, highlighted the benefits of achieving certification to ISO 9001. Here is a summary of the results.
As our client base has increased over the…
ISO standards help make the world a safer and more efficient place and help tackle a myriad of societal issues. They also touch almost everything we do. The sparked interest in the new ISO 9001:2015 revision is significant, given that the draft has notable changes vs. the current 2008…
Particles of soot floating through the air and comets hurtling through space have at least one thing in common: 0.36. That, reports a research group at the National Institute of Standards and Technology (NIST), is the measure of how dense they will get under normal conditions, and it’s a…
ISO 14001 is the world’s best-known environmental management system standard, and it provides a systematic framework to help organizations protect the environment through balanced socio-economic means.
In conjunction with an updated ISO 9001, a new version of ISO 14001 is…
Story update 6/18/2014: In an earlier version of this article the editors changed ISO/DIS 9001:2014 to ISO/DIS 9001:2015. The error was ours, not the author's. The correct name of the document is ISO/DIS 9001:2014, as now shown.
The publication of the draft international standard…
Your quality management system (QMS) documents for AS9100, ISO 9001 or any other standard for that matter, do not have to be complicated. Why create volumes of wordy procedures that employees will probably never read? And even if they do, they certainly won’t understand.
…
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food…
ISO 9001 has been the quality management standard, with almost a million businesses certified around the world. It has been through many revisions, in 1994, 2000, and 2008, but the 2015 revision has an added element to consider—risk.
ISO international standards help to ensure…
Governments—local or otherwise—are under increasing pressure around the world to provide results that matter to the public, often within severe resource constraints. Now they are taking pointers from the private sector by using ISO 9001 for quality management to provide efficient and…
The 2015 version of ISO 9001 is still more than a year away from publication, but ISO/TC 176, the technical committee responsible for the standard, has been hard at work on the revision since 2012. Registrants to the current version, ISO 9001:2008, are wondering about changes to the…
When listening to people new to ISO 9001, one of the main stumbling blocks preventing them from starting is the belief that they simply don’t have the time. With so much on their plates, they argue, how could they possibly take on something as fundamental as ISO 9001?
At…
JILA researchers have engineered a short, flexible, reusable probe for the atomic force microscope (AFM) that enables state-of-the-art precision and stability in picoscale force measurements. Shorter, softer, and more agile than standard and recently enhanced AFM probes, the JILA tips…
When you consider rising energy costs, the uncertain nature of foreign fuel sources (regardless of the country in which you operate), and the environmental impact associated with many fuels, then any system that helps you wisely manage your energy consumption and improve your energy…
Story update 4/24/2014: We bumped up the cost of accreditation based on comments that the original article was on the low side. We also added references to ILAC as well as additional accreditation bodies that operate in the United States (ACLASS, NVLAP, L.A.B.)
Getting calibration…
On April 6, 2014, U.S. Secretary of Commerce Penny Pritzker presented two U.S. organizations with the Malcolm Baldrige National Quality Award, the nation’s highest honor for organizational innovation and performance excellence.
The 2013 award recipients…
Management systems are sometimes misunderstood as nothing more than a heavy administrative burden providing limited business benefit. In fact, many organizations with management systems in place haven’t effectively defined the processes they actually employ at all. Perhaps it’s because…
During the first six months in their special, new, four-bedroom home in suburban Maryland, the Nisters, a prototypical family of four, earned about $40 by exporting 328 kilowatt hours of electricity into the local grid, while meeting all of their varied energy needs.
Furthermore…
MassMEP’s ISO 9001:2008 Collaborative was conceived as a way to make the certification process more accessible to small and medium-sized manufacturers. The project brings four to eight companies together in a collaborative setting to help share costs and ideas.
The program…
How can governments increase efficiency, prevent errors, and improve customer service? Answer: ISO 9001.
ISO 9001 is by far the world's most established quality framework, currently being used by more than 1.5 million organizations in 191 countries. Those are some impressive…
The Boy Scouts of America have a timeless motto: “Be prepared.” These are words to live by. In the wilderness, if an individual has a pocket knife, a length of string, and some matches, he can deal with most emergencies that may arise. In business, however, a Swiss Army knife is going to…
O ne reason why ISO’s management standards are so highly regarded is that in order to claim ongoing certification, organizations must be audited continually to ensure they still meet the requirements of their chosen standard. This independent verification gives clients and other…
This past November, three winners of the 2013 Malcolm Baldrige National Quality awards were announced, one in education and two in healthcare. Quality Digest Daily is fortunate that one of the winners, Sutter Davis Hospital (SDH) is practically in our back yard. This gave us an…
The produce industry is moving to implement a systematic, industrywide approach to closely track where fresh produce comes from and where it goes. One of the great challenges in this effort is the automatic recognition of a wide range of different package designs and hand stamps…
Last month in Missouri, the Governor’s Conference on Baldrige in Education kicked off a large-scale improvement initiative that has the backing of key education groups in the state. With a mission to “facilitate school districts’ deployment of the leadership and management principles…
International standards ISO 6892 and JIS Z2241 for tensile testing of metallic materials have been revised with the addition of another test item: strain rate control.
When strain is measured with an extensometer, strain rate control has been added as a test item to the current…
According to a report from the London-based Centre for Economics and Business Research, a dollar invested in improving an organization’s approach to quality management results in a six-fold return in increased revenues, and a 16-fold reduction in expenses. The promise of dramatic…
Companies with mature management systems often feel a decrease in value and an increase in cost over time due to third-party audits. Advanced Surveillance and Recertification Procedures (ASRP) is a solution that shows demonstrated cost reductions in external audit frequency, but has also…
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately…
When it comes to detectors for dangerous chemicals, toxins, or nefarious germs, smaller and faster is better. But size and speed must still allow for accuracy, especially when measurements by different instruments must give the same result.
The recent publication of a new…
As ISO/FDIS 55001—“Asset management—Management systems—Requirements” (now in the final draft international standard stage) moves toward its formal publication around the end of this year, organizations that use and depend on a wide range of assets would benefit from spending some time…
Some of the [ISO 9001: 2015] requirements are relatively clear; others are more “euphemisms,” and you don’t know how to react…
—James Lamprecht, author of ISO 9000: Preparing for Certification (CRC Press, 1992) and former member of ISO/TC 176
During an Aug, 16…
As ISO 9001 wends its way through the revision process, there have been dozens of articles, webinars, forums, and discussions anticipating what the final product will look like. Pundits and experts, consultants and gurus are all weighing in on what’s going to happen. The prognosticators…
There are many reasons why organizations decide to register or certify themselves to the various standards and specifications in industry; all are important, but not all are vital. Standards registration in support of sales, marketing, and PR efforts certainly helps companies grow, for…
Asset management is not a new practice. Managing assets to meet organizational or social objectives has existed since humans first began building infrastructures, whether private or public. The effort and resources involved inevitably generated the need to preserve and maintain such…
The words “risk” or “risks” have been sprinkled throughout the 2015 revision of ISO 9001, the quality management system standard from the International Organization for Standardization (ISO).
Although some “requirements” will be easy to satisfy using well-established…
Scientists at the National Institute of Standards and Technology (NIST) have developed a new standard reference material (SRM), the first such measurement tool to enable hospitals to link important tissue density measurements made by CAT scans to international standards.
Computed…
What’s Happening With ISO 9001?
Stakeholders have offered suggestions for the upcoming revision
Committee Draft of ISO 9001 Is Out
Changes include genuine improvement; some will make implementation more difficult
Approximately half of the 704 employers participating in a survey by The Chronicle of Higher Education and American Public Media’s Marketplace said they have trouble finding qualified college graduates to fill their companies’ positions. Yet, 68 percent of the survey’s manufacturers said…
For me, a quality professional with 20 years experience in manufacturing—producing everything from garbage bags to luxury ski boats—my transition to the service industry was a shocking experience to say the least. It was not without challenges, I must confess.
When I was…
Editor’s note: Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She will be reporting on the revision progress to ISO 9001, which will be completed in 2015. Read other articles in the series here.
By now…
ISO 9001 is much more than a standard. It should be part of a company’s strategic plan rather than something to get certified to because customers require it. The guidelines and quality principles in ISO 9001 are just good business practices.
Throughout my career in quality, I’ve…
This article is about accreditation of conformity assessment bodies. Before proceeding further, however, it is important to provide some definitions in order for all of us to have the same understanding of key terms.
The first term is “conformity assessment body” (CAB).…
With new treatments for disease, test suites that safeguard computers, and even expertise to rescue miners trapped thousands of feet underground, federal laboratories have a wealth of technologies and know-how that can give U.S. companies a competitive edge and improve quality of life.
…
There are several programs on the market that provide information to consumers about energy efficiency. However, the ENERGY STAR program, a joint effort of the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Energy (DOE), is likely…
During a recent ribbon-cutting ceremony, the U.S. Commerce Department’s National Institute of Standards and Technology (NIST) unveiled a new laboratory designed to demonstrate that a typical suburban home for a family of four can generate as much energy as it uses in a year. Following an initial…
The United States already has one of the highest direct fire loss rates among developed nations, and progress in reducing this tremendous burden is slowing.
Fires claim more than 3,000 lives a year, injure more than 90,000 firefighters and civilians, and impose costs and losses totaling…
T he International Organization for Standardization (ISO) develops and publishes more than 19,200 voluntary international standards that bring benefits for businesses, governments, and society. But how do the standards contribute to the economic returns of countries and companies? What is the…
A new versatile measurement system devised by researchers at the National Institute of Standards and Technology (NIST) accurately and quickly measures the electric power output of solar energy devices, capabilities useful to researchers and manufacturers working to develop and make next-…
Editor's note: The following interview with ANSI CEO, Joe Bhatia, first appeared in the June 2012 edition of ISO Focus+ magazine and is reproduced with the kind permission of ISO Central Secretariat.
On Sept. 17–22, 2012, the United States will play host to the world’s standardization…
Editor’s notes: The HSF Mark was inadvertently truncated on the issue of Quality Digest Daily released on Tuesday, June 12th, 2012. The full and complete logo can be found below. Author Stan Salot will be the guest this week on Quality Digest Live, airing Friday, June 15, at 11 a.m. Pacific.…
The volume of oil and oil products moving through America’s pipelines, waterways, roads, and rails borders on the unimaginable.
“Look at it this way,” says John Wright, a project leader in the National Institute of Standards and Technology (NIST) Physical Measurement Laboratory’s (PML)…
Two new advanced laboratory buildings for high-precision science and measurements have officially opened in Boulder, Colorado, providing upgraded facilities to support technology innovation and economic growth as well as the training of future scientists.
Federal, state, and local…
March 15, 2012, marked the 25th anniversary of the ISO 9000 series standards. Since the standards were released in 1987, they have gone through three revisions: 1994, 2000, and 2008. According to the International Organization for Standardization (ISO), as of 2009, the total number of…
Everyone in the quality profession has heard the term “NIST traceable.” Having calibration traceability to the National Institute of Standards and Technology (NIST) is desirable for most measurement devices. It is also enshrined as a requirement in some regulatory documents. Unfortunately, NIST…
(NIST: Gaithersburg, MD) -- The National Institute of Standards and Technology (NIST) is hosting a free public workshop on best practices in federal conformity-assessment activities Wed., April 11, 2012, at NIST’s Gaithersburg, Maryland, site. Conformity assessment determines whether a process,…
The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets. For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who…
Editor's note: Lisa Greenleaf will be appearing on the May 4, 2012, episode of Quality Digest Live at 11 a.m. Pacific, 2 p.m. Eastern. That episode will be available on-demand beginning Monday, May 7, 2012.
For as long as cargo has been transported via road, there has been cargo theft.…
The great artist and inventor Leonardo da Vinci once said, “Simplicity is the ultimate sophistication.” National Institute of Standards and Technology (NIST) research engineer Javier Atencia certainly believes in the wisdom of what da Vinci preached; he has a reputation for creating novel…
BusinessAssurance.com, the world’s first online management systems community, which is sponsored by Lloyd’s Register Quality Assurance Inc., brings to you an interview with Mike Toffel, a leading management systems expert and an associate professor of business administration at Harvard Business…
There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.
This article explains the philosophy behind the major changes in the standard, how these changes…
An advance in sensor design by researchers at the National Institute of Standards and Technology (NIST) and the University of Waterloo’s Institute of Quantum Computing (IQC) could unshackle a powerful, yet high-maintenance technique for exploring materials. The achievement could expand the…
On Nov. 18, 2011, President Obama signed into law the Consolidated and Further Continuing Appropriations Act of 2012 (P.L. 112-55), which provides fiscal year (FY) 2012 funding for a number of government agencies, including the National Institute of Standards and Technology (NIST).
…
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization.
The survey results also show that…
The latest edition of “The ISO Survey of Certifications—2010,” from the International Organization for Standardization (ISO) underlines the global market relevance of ISO’s management system standards for quality, environment, medical devices, food safety, and information security. The survey…
The Property and Emergency Communications Divisions of the Houston Police Department (HPD) achieved certification to ISO 9001 in September 2011. The HPD pursued certification to this international standard from the International Organization for Standardization (ISO) in part because it…
The U.S. Environmental Protection Agency (EPA) introduced the ENERGY STAR program in 1992 to encourage the production and use of energy-efficient devices in more than 60 different product categories. Program results have been dramatic—a desktop computer that once consumed 30 watts in sleep…
Evidence that publication of ISO 50001 was eagerly awaited is borne out by the number of organizations worldwide claiming to be the first in their country or sector to have adopted the new ISO international standard on energy management. What’s more, several are already reporting significant…
A selection of center-page spreads from ISO Focus+, the magazine of the International Organization for Standardization (ISO), filled with colorful graphic art conveying the benefits of international standards, provides the theme for the ISO 2012 calendar. Topics covered include motor vehicle…
In the wake of recent failures in corporate governance, two new standards from the International Organization for Standardization (ISO) will help organizations to disclose corporate information quickly and effectively. Increased pressure by industry regulators obliges companies to provide…
National Institute of Standards and Technology (NIST) colleagues of Dan Shechtman, Ph.D., joined others in the scientific community in congratulating him on winning the 2011 Nobel Prize in Chemistry. Shechtman made his astonishing discovery of a quasicrystal—an arrangement of atoms thought to…
American National Standards Institute (ANSI) president and CEO, S. Joe Bhatia, has advice for U.S. companies on a topic we don’t often see in the news. Streamlining standards and conformance procedures is becoming increasingly essential in an increasingly complex global economy, and is…
A series of groundbreaking case studies by the International Organization for Standardization (ISO) and partner organizations shows that implementing standards can provide economic benefits from between 0.5 and 4 percent of companies’ annual sales revenues. The studies are based on the…
Manufacturing and metrology leaders have announced a new certification body establishing performance standards for service providers and equipment manufacturers in the rapidly expanding digital metrology industry.
The American Association of Advanced Metrology (AAAM) “encourages and…
Six Sigma, a data-driven method for improving business and quality performance, has been published as a two-part standard from the International Organization for Standardization (ISO).
Six Sigma was originally developed by Motorola in 1986 to ameliorate manufacturing processes with the…
The electromagnetic force has gotten a little stronger, gravity a little weaker, and the size of the smallest “quantum” of energy is now known a little better. The National Institute of Standards and Technology (NIST) has posted the latest internationally recommended values of the fundamental…
You’ve heard about “measuring training effectiveness” but aren’t quite sure how to do it. You’ve been filling out training attendance sheets for as long as you can recall, and they have served the purpose. So why is training effectiveness all of the sudden a topic of discussion, and what exactly…
The aerospace standard, AS9100C—“Quality management systems—Requirements for aviation, space and defense organizations,” (aka AS9100:2009 Revision C) has been released for some time now, and the early results are in. For the most part, our customers, those of National Quality Assurance (NQA),…
According to data from The British Assessment Bureau’s (BAB) independent 2011 Client Satisfaction Survey, 44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001, the quality management system standard from the International…
The National Institute of Standards and Technology (NIST) has released a suite of green tea reference materials to help manufacturers evaluate the composition of their products and assure researchers of the accuracy of analytical methods for studying the human health effects of this popular…
The headline’s question seemed a bit far-fetched to me when it was originally posed. The answer provided another delightful illustration of the myriad analogies we find in our everyday lives that relate so effortlessly to our work as quality professionals. The comparison demonstrated the…
How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…
Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…
In my March 24th column, I discussed how you should handle audits that point out a minor or "Mickey Mouse" nonconformance. In this column, I am going to look at this from the auditor’s point of view, when it’s obvious that the auditee did not take a nonconformance seriously and didn’t bother to…
Read this. It won’t be a waste of time.
Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of…
Have you ever been audited and felt like the auditor’s findings were almost irrelevant in the context of your organization’s major challenges and goals? Did you sometimes feel like you've been handed a Mickey Mouse nonconformity given the issues your organization is confronting? But what is…
Have you ever been audited and felt like the auditor’s findings were almost irrelevant in the context of your organization’s major challenges and goals? Did you sometimes feel like you've been handed a Mickey Mouse nonconformity given the issues your organization is confronting? But what is…
(ANSI: Washington) -- The Internet as we know it is about to max out. Within the next 12 to 18 months, every one of the 4.3 billion internet protocol (IP) addresses will have been exhausted.
When the Internet was created more than 30 years ago, 4.3 billion unique addresses…
Protecting the health and well-being of consumers and the world at large is the quality industry’s highest calling. During the past several decades, as the manufacture of electronics and consumer goods has shifted away from North America and Europe, the need to confirm and ensure the safety…
A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.
With this in mind, the…
Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…
My definition of “specification” is rather simple: It’s a promise.
Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is…
Looking for a new factory to work with in China can be daunting. With pressures from poor rice production on the rise and labor throughout China unstable, more China-based manufacturers are closing shop every day.
For these reasons I think it’s an opportune time to review the key aspects…
If you have ever wondered what the difference was between a gap analysis, an internal audit, or a pre-assessment, you might not be alone. When trying to figure out whether your company meets the requirements of a standard, such as one the International Organization for…
Finally, the long and arduous process that appears to be a requisite phase in the development of an international quality management system standard appears to be nearing an end. Though the AS9100:2009 and AS9101:2009 (checklist) have been available for quite some time, the aerospace industry…
The status of nuclear power in the United States is finally changing. As of last month, there were 18 proposals under review by the Nuclear Regulatory Commission (NRC) for 28 new units in 14 states. This renewed interest in building nuclear power plants can be attributed in large part to the…
Industrial organizations face numerous compliance regulations such as management system certification, information security, corporate social responsibility compliance, and limiting the content of hazardous substances in products. Now they can add carbon management to the list. This task is one…
In Part I, “Savvy Compliance Strategy Can Improve GMP,” we took a high-level look at a process for automating regulatory compliance management. The closed-loop process starts with documenting your processes, followed by monitoring or checking that the processes are being followed. Next, you…
The Bre-X gold scandal that rocked the Toronto Stock Exchange (TSX) during the late 1990s forever changed the Canadian mining sector. When millions in pension dollars were lost due to fraudulent and falsified test data, investors around the world were outraged.
It remains one of the…
There is no shortage of standards. There are standards that define how something should be made vs. those related to processes, such as ISO 9001. According to the International Organization for Standardization (ISO), standards that provide requirements or give guidance on good management…
Almost two years ago, the management team of the Indiana Toll Road (ITR Concession Co. LLC) and the Chicago Skyway Bridge (Skyway Concession Co. LLC) decided that implementing a quality management system compliant with ISO 9001 would be a useful tool for driving continual improvement. The…
The following is a profile of one of the 2009 Malcolm Baldrige National Quality Award Winners. The Baldrige Award is the nation’s highest award for quality and is administered by the Department of Commerce through the National Institute of Standards and Technology.
AtlantiCare, a…
Courtesy of another controversy surrounding hazardous substances in children’s toys, China’s massive manufacturing sector is reliving a public relations disaster.
Four years ago, a nationwide recall on children’s toys containing lead paint—and manufactured in China—cast a pall on the…
Ok, men. Leave the room.
Today, I want to discuss fulfilling customer requirements as they relate to one particular product: The bra. For those men who’ve not heeded the warning to leave, you may, by the end of this article have discovered, one of the perennial reasons for your…
The AS9100C standard (also referred to as AS9100:2009 and AS9100 Rev C) has been published since January 2009. You are not alone if you are confused about the delay in being audited to this standard. Like you, most companies seeking registration to AS9100 are in the process of trying to figure…
(NSAI: Nashua, New Hampshire) — Even though no firm action was taken during the 2009 Climate Conference in Copenhagen, the U.S. administration has still pledged that the country will tighten carbon emission regulations. The most plausible possibility is what is referred to as a “cap and trade”…
One of the key additions to the R5 version of the telecommunications quality management system standard, TL 9000, is the addition of a risk management requirement. While the requirement is only a single sentence, it is followed by a bulleted note that adds guidance as to the intent. Managing…
Printed circuite board (PCB) manufacturing is moving rapidly up the technology ladder. Keeping internal processes current (and compliant) with new requirements, without disrupting existing customer demands, presents ongoing risks. To minimize potential failures, it is necessary to identify and…
The first thing you need to do when you are evaluating a potential supplier based on their ISO 9001 certificate is request that they provide you with a copy of the certificate itself. If the company is indeed certified, they shouldn't have a problem providing you with a copy of their certificate…
Quality and IT executives alike face increasing pressure to implement technological solutions that allow the highest level of holistic control and oversight concerning the quality of their operations. This pressure is compounded by the current economic climate in which companies face constant…
You just finished your audit, and your registrar has handed you a brand-new certificate. Now, what do you do to make sure everyone knows about it? Most likely you’ll send an e-mail out to the entire company, prepare a press release, post an announcement on your web site, and so on. But…
With security breaches on the rise, protecting your organization’s confidential and valuable information assets is one of the most important safety measures your organization can take. The issues surrounding information security involve more than just hackers and malicious software; they can…
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--Editors
“The consumer’s concept of quality will no longer be measured by only the physical attributes of the product—it will extend to the process of how the product is made, including product safety, environmental compliance, and social responsibility compliance.”
—Victor Fang, chairman of Li…
All organizations—regardless of industry sector—must begin today to inventory their greenhouse gas emissions (GHG) to prepare for an incoming regulatory wave, according to an expert from BSI Americas.
Wilhelm Wang, BSI product manager for sustainability, has followed the development…
Product certifications have exploded in recent years. Products ranging from pine lumber to children’s toys carry some sort of certification, and the organizations issuing certifications are as diverse as the products themselves. What are the practical values of these certifications? What are…
Aviation safety is a very critical issue. For millions of people to fly safely every day around the world, a very large and complex network of business and regulatory agencies have to operate flawlessly, delivering defect-free, on-time parts and hardware to all corners of the globe.
…
Wireless communications have well and truly arrived in the industrial arena and considerable effort is now being put into integration and the writing of standards. In this article, the author considers the many benefits and a few drawbacks of this cost effective technology.
…
The ISO 9001 standard’s requirements with regard to suppliers are very short and concise but carry a lot of punch. These requirements can be very deceiving and in fact are often misinterpreted and carried out poorly or partially. By implementing the clause correctly, an organization will get…
Even after many years of hearing the words ISO 9000 and seeing many organizations achieve registration to ISO 9001, there are still companies who are skeptical when it comes to going for ISO 9001 registration. For some, a misconception about the objectives of the ISO 9001 standard or a lack of…
To come to the brow of a hill and see on the horizon a line of giant wind turbines, their arms turning majestically, never fails to take one’s breath away. These are awesome structures, imposing in their size, their grandeur—and their simplicity.
World wind power capacityWind…
Story update 8/21/2009: We corrected an error regarding the function of the accreditation body.
I’ve worked with several companies over the years and dealt with different individuals, different processes, and different levels of ISO 9001 understanding. However, when an…
Madico, the world’s preeminent manufacturer of metalized, coated, and laminated films, has been producing high quality manufactured film systems since 1903. Located in Woburn, Massachusetts, the hi-tech ISO 9001-certified firm has more than 170 employees.
A quality and compliance…
Mario Angeles was stuck. His family-operated machine shop, Angeles Precision Engineering LLC, was busy enough with work farmed out to it by larger shops, but Angeles had been repeatedly rebuffed in his attempts to secure a long-term contract on his own; especially one from the “Big Four”…
Formatting constraints prevent us from formatting this article in a way that might make it easier for the reader to understand. If you have problems understanding the web version of this article, download a pdf by clicking here.
--Editor
In March 2009 the ASME…
Well, a simple answer is no, you don’t need a consultant to achieve ISO 9001 certification. In fact, many companies achieve ISO 9001 on their own, by appointing key employees to the task. The implications, however, of trying to implement a system on your own can be a set back to your business if…
Joyalukkas Jewellery is one of the world’s favorite jewelers, with a retail chain of more than 70 showrooms across the Middle East, India, and Europe. The company has grown over the past two decades to become a household name for the wide range of contemporary, ethnic, and traditional jewelry…
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS)…
There’s a new wave of environmental consciousness rolling across the landscape of U.S. business. In certification circles, we refer to it as the Green Wave. But companies are discovering that going green isn’t easy, and getting green certified is even tougher. Research data from the American…
Twitter is the latest new thing. Want to follow John McCain or Al Gore throughout their day? Easy. Just sign up to receive their tweets. While their tweets may provide insights, or just entertainment (Ashton Kutcher and 50 Cent also tweet), does Twitter have value for business management…
When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were…
Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was awarded first place for his paper by the American National Standards Institute (ANSI) for describing the importants of quality standards and accreditation.
--Editor…
The moment for action in the United States on climate change has arrived in earnest. With the election of President Obama and increased majorities of Democrats in Congress, there is unprecedented momentum to pass comprehensive climate legislation that caps the aggregate amount of greenhouse…
Whenever the economic climate freezes assets and sends investors scurrying for cover, businesses must find new ways to grow and stand out from the competition. Cost-cutting is the obvious, and usual, course of action. But in troubled times, isn’t it better to do something proactive and positive…
At the beginning of this year, the International Aerospace Quality Group (IAQG) released revision C to AS9100, the quality management system (QMS) standard for the aviation, space, and defense industries. Unlike the recent release of ISO 9001:2008 (which was more of an amended version), AS9100:…
Many of us in the aerospace community have come to know the value of data in the Online Aerospace Supplier Information System (OASIS), a reliable resource for aerospace supplier certification and registration data housed and maintained by SAE International. The OASIS database is available to…
Abiding by strict environmental rules can at times seem as much like a religion as a lifestyle. It’s often difficult and even conflicting to balance the intention to live “green” with the attractions of modern convenience. Moving into igloos or pit houses made of mud, is sustainable, yes, but…
The approach of using a Wiki to document a quality management system (QMS) may seem overwhelmingly obvious in a year or so, yet we are far from that today. Chances are you've used Wikipedia on the web, but you may not appreciate the power that a Wiki can bring to virtually every facet of…
Story update 6/03/2011: The first two paragraphs following the subhead "ISO 22000 users" were changed.
Regulatory and standards compliance is a requirement that meets with regular resistance from CFOs and CEOs who must justify the expense. Brand protection from recalls and costly…
Story update 6/03/2011: The first two paragraphs following the subhead "ISO 22000 users" were changed.
Regulatory and standards compliance is a requirement that meets with regular resistance from CFOs and CEOs who must justify the expense. Brand protection from recalls and costly…
Today’s manufacturers must develop products quickly and inexpensively to meet the demands of a competitive marketplace. Rigorous testing to meet North American product certification requirements may prove to be a time-intensive process. If not properly planned, third-party approvals can…
With all of the quality lingo over the years, “right-the-first-time,” “prevention vs. detection,” “total quality,” “Six Sigma,” “ kaizen, ” and “continuous improvement,” Intermec Media, a label converter in Fairfield, Ohio, has taken this to another level and applied these concepts to their own…
Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the…
The processes followed by most small- and medium-sized companies to prepare for or maintain an ISO 9001 registration have been largely manual rather than computerized. Employees are expected to key in or type the required quality documents, physically draw process diagrams, and spend hours…
The ISO 9001 series of standards is the most widely used in the world and specifies requirements for an organization’s quality management system (QMS). The standard is designed to enable the organization to have a customer orientation, a people (staff) orientation, and a business orientation.…
For 20 years, I have worked with many companies to achieve a variety of registrations. As a sales manager, auditor, consultant and trainer, I have noticed that a number of companies haven’t realized the benefits that they expected from standards registration. Some of them have actually become…
For years, many companies have expended countless dollars and painful hours to comply with the various requirements of ISO 9001. Now, some of these companies are being asked to meet the provisions of Carnegie Mellon’s Capability Maturity Model Integration (CMMi). In its former guise as CMM,…
Adding value by auditing using the process- and metric-driven approach requires new methods and an increased focus on supplier performance metrics (i.e., scorecards). A change in how auditors work the process approach is evolving, with more sophisticated techniques, more rigorous testing and…
How did your quality system get so complex and redundant?
Many companies established their quality systems after having purchased a software program with a “canned” quality manual and procedures. Software companies try to subliminally sell you the concept “more is better.” Purchasing…
ISO 10006:2003, guidelines for quality management projects, was released in the fall of 2003. This standard is creating the next wave in our understanding of project managing processes. But how does ISO 10006 compare to the Project Management Institute’s Project Management Body of…
Lean means doing the most with what you have. It’s efficiency and intelligence. In the modern economy, lean is a fact of life. Management systems must absolutely be lean, or they will be abandoned as impractical dinosaurs. In the October 2003 issue of Quality Digest, we began…
After undergoing an often costly and usually painful process to achieve ISO 9001:2000 registration, organizations invariably ask, "What do we do now to ensure that we maintain our registration and gain maximum benefit?" Under ISO 9001:1994, the old answer was fairly straightforward: Continue…
Supplier management is one of the most troublesome disciplines within a management system. There’s nothing inherently difficult about it, though. Companies make it difficult by instilling the process with lots of unwieldy bureaucracy. The trick is to strip the process down to its essential…
Under QS-9000, suppliers relied on the Supplier Quality Requirements Task Force for guidance and direction in dealing with questions related to the standard’s requirements. With the global application of ISO/TS 16949:2002, a globalized group was needed to offer the same direction that was given…
Editor’s story update 6/15/2017: This article was originally published on our site in 2004. Although it references ISO 9001:2000 rather than the current version of the quality management standard, Cochran’s 10 questions remain useful for organizations preparing for an audit.
All…
What roles do quality and quality management systems play in a business sector facing revolution? The term isn’t too strong for what’s currently underway in the telecommunications industry. Competitive pressures and customer demands are driving the sector to introduce next-generation network…
Contrary to what alarmists with an interest in fueling controversy might say, ISO 9001 is still on the rise-and with good reason. The standard is capable of producing the desired results (i.e., consistent quality in goods and services globally), and its full potential is yet to be realized.…
Many Americans feel like the winds of change have blown away from them. They turn out on Election Day to provide a gust that blows back to local, state and federal power centers, where the clashing breezes become tornadoes. Consequently, many citizens are left with a sticky, humid feeling of…