All Features
Stefanie Koperniak
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,…
Creaform
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-…
Quality Digest, Donald J. Wheeler
Dr. Donald J. Wheeler has been one of Quality Digest’s most highly read authors for decades. His teaching on the use of control charts in industrial settings has long been considered the gold standard. He has conducted more than 1,100 seminars in 17 countries on six continents, and his books have…
Michael Mills
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Saurabh Joshi Shripad
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…
Creaform
Quality control (QC) teams need reliable results they can trust to make informed decisions and address manufacturing challenges. This is why they rely on the coordinate measuring machines (CMMs). However, a CMM’s speed is often a limitation, making the idea that routine quality control can be…
Ben Eidlisz
A safe work environment will foster productivity, reduce hazards, and enhance overall work morale. Keeping your team and assets safe requires implementing the right policies, medical necessities, vigilant oversight, ongoing assessments, and proper training.
As the COO of DUSAW, making smart locks…
Sergey Sukhovey
The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection nationwide…
Saili Sonawane
In a growing business milieu, ISO quality management system compliance ensures that organizations meet global standards for quality, safety, and efficiency. However, maintaining compliance with ISO frameworks such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO…
Peter Beaucage
Every time you squeeze toothpaste onto your toothbrush, spray perfume on your skin, or swallow a pill, you’re using the result of a carefully crafted recipe made in a lab. These are called formulations.
Formulations aren’t just simple mixtures—they’re complex arrangements of ingredients designed…
Steven Garner
In the ever-changing landscape of business management, the concept of quality has undergone significant transformations. What began as a focus on maintaining standards such as ISO 9001 and AS9100 is evolving into a more holistic approach encompassing organizational excellence. Tom Taormina’s book…
Wayne Labs
A September 2024 Gallup poll revealed that nearly 30% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Considering recent recalls, is it any wonder? What good is a quality control program if it doesn’t include food safety?
Boar’s Head’s Jarratt,…
Ben P. Stein
NIST is unique as the national measurement science institute. We are the U.S. agency responsible for maintaining measurement standards, from the second to the kilogram.
We help ensure that these units of measure are consistent across our watches and our grocery scales. But this isn’t as…
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Rachel Byfleet
In an eco-friendly plot twist that would make Captain Planet proud, the European Union has rolled out the Corporate Sustainability Reporting Directive (CSRD), a blueprint that’s got big companies talking about more than just profits. Imagine a world where every major company’s reports don’t just…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
Akhilesh Gulati
In the ever-changing world of quality management, the intersection of innovation and standardization offers both exciting opportunities and tough challenges. Maria, a dedicated and certified quality professional, struggled with the concept of “standardizing innovation”—something that seemed like an…
Chris Rush
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.
By issuing this…
Anthony Hardy
In a competitive manufacturing industry, meeting high standards is crucial to quality, sustainability, and safety. While it can be challenging to earn customer trust and establish a positive brand reputation, third-party certifications to standards such as IATF 16949: Automotive Quality Management…
ISO
The clock is ticking. Our planet is heating up, and with every passing day the stakes rise. Wildfires, floods, and storms are no longer distant headlines; they’re unfolding right on our doorstep. Humanity stands at a crucial turning point. But amidst the climate crisis, a powerful ally emerges from…
Gabriel Popkin
Time: We all have a sense of it, an innate feel for it. We see it and use it every day. If you’re like me, the first thing you do in the morning is check the time on your phone to see if you need to get out of bed or if you can close your eyes and catch a few more z’s.
Once you’re up and moving,…
Gleb Tsipursky
The 2024 U.S. presidential election is shaping up to be one of the closest in recent history, with Kamala Harris and Donald Trump locked in a dead heat in many polls. This razor-thin margin amplifies the effect of even small demographic changes, such as those driven by the recent surge in remote…
Michael Mills
You’ve finally gotten ISO 9001 certification. Congratulations! You’ve built your quality management system, written your procedures, trained your staff, sweated through internal and external audits, and your registrar sent you a certificate suitable for framing. Now, at long last, all of your…
Scott Crow
W ithin the utility industry, regional entities increasingly focus on internal controls as a measuring stick for overall compliance performance.
Developing and executing rock-solid internal controls with an automated compliance management software solution can help maintain compliance, not only…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
ISO
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 action
The ISO/UNDP guidelines for…
James Olthoff
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) is the national…
Saurabh Joshi Shripad
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, recognized…
George Schuetz
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 from temperature…
ISO
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…
James Chan
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 businesses…
William A. Levinson
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 them…
Etienne Nichols
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 13485:2016.
The…
Jennifer King
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 researchers at Stanford…
Donald J. Wheeler
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,…
Robyn Coward, Brian Brooks
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.”…
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
Etienne Nichols
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 (QSR) with the…
Megan King
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 decay or change…
Chris Rush
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…
ISO
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…
Andrey Solin
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 appeal of gasoline-…
Creaform
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 affect…
David Isaacson
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,…
William A. Levinson
The International Accreditation Forum (IAF) and ISO have published a joint communiqué to require organizations to “consider” climate change in the context of risks and opportunities relevant to the management system.
Although this is pursuant to the London Declaration, which has goals for…
James Chan
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…
Pierre-Nicolas Disser, Megan Wallin-Kerth
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 and…
ISO
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.…
Michael Sharp
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…
Elizabeth Norwood
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…
Donald J. Wheeler
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 data is that no data…
Etienne Nichols
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, Class II, and Class…
Stephanie Ojeda
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 software. The…
Morehouse Instrument Co.
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 to…
Dawn Bailey
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…
ISO
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 ever-evolving…
Douglas C. Fair, Scott A. Hindle
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 within the purview of…
Denise Robitaille
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?
It’s worth…
William A. Levinson
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.”
Although nothing in…
Grant Ramaley
When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance. Our trust forms the backbone of what we expect from our food, cars, planes, medical devices, and protection of the…
Denise Robitaille
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 less…
Matthew Barsalou
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 inconsistent…
Meg Sinclair
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…
Michael Mills
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 adding…
Alonso Diaz, Maria DiBari
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-pandemic…
Master Gage and Tool Co.
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 link between…
Etienne Nichols
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 never forget the…
Jón Bergsteinsson
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 a guide to…
Stephanie Ojeda
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. With…
Aymen Saidane
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 the…
Steve Thompson
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 patients…
ISO
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 for…
Wael William Diab
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. Discussions…
James Chan
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, time, and…
Stephanie Hinton
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 as one of…
Stephanie Ojeda
Untitled Document
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, which face…
Kobi Leins, ISO
Untitled Document
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 about how the…
engineering.com
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…
Jeffrey Lewis
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.…
NIST
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…
Etienne Nichols
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 (QSR…
Ian Wright
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).…
Stephanie Ojeda
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics manufacturer that introduces a new product model with updated features and components. This new model requires…
Etienne Nichols
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. Start by learning about your…
Etienne Nichols
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 that…
Megan Wallin-Kerth
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 company…
Stephanie Ojeda
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 between…
ISO
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,…
Sébastien Breteau
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.
At any…
Ian Wright
‘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…
Jessie MacAlpine
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 also…
Harish Jose
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…
Phanish Puranam
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…
William A. Levinson
I wrote previously1 that environmental, social, and governance (ESG) metrics are often dysfunctional because they prioritize the wrong things and thus deliver the wrong results.
The recent failure of Silicon Valley Bank (SVB) despite SVB Financial Group’s “medium” (at the time) ESG risk rating…
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely on ISO 13485 to provide critical support to world…
Megan Wallin-Kerth
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 say…
ISO
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.…
Todd Hawkins
Most companies face the challenge of managing the documentation they generate—those that are developed to control their business and processes (e.g., standard operating procedures—SOPs) and the associated records as evidence of compliance with those procedures. This may go a step further if the…
Rupa Mahanti
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, face a…
Bryan Christiansen
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 or…
Chip Reavley
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-commerce…
Alonso Diaz, Maria DiBari
A company’s quality management system should have a formal, effective, and efficient corrective action and preventive action (CAPA) program so management can stay informed and correct existing business problems. The data output and corrective actions from a CAPA program can help prevent recurring…
Jennifer Lauren Lee
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, as…
Peter Bilello
In our ongoing series of CIMdata articles on engineering.com, we’ve focused primarily on the digital (aka “virtual”) and physical aspects of digital transformation. Our discussion of these digital and physical elements has centered on what needs to be done with (and to) information as competitive…
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of Fires…
Craig Matthews
Producing quality work is imperative in every field, particularly in the construction industry. A well-built structure, whether it’s an educational facility, hospital, or a commercial establishment, provides shelter, safety, and stability, which is why quality should always be a top priority. As…
In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices…
William A. Levinson
Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it. This includes not only its traditional role as a response to defects, nonconformances, customer complaints, and audit findings, but also outputs…
Dirk Dusharme @ Quality Digest
Updated 12/12/22
At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On…
Bryan Christiansen
An important part of production is to carefully monitor and control temperature, speed, volume, weight, or mass. To ensure these measurements are always accurate, manufacturers need to calibrate their equipment and instruments regularly.
Devising a proper equipment calibration schedule can be a…
Christopher Dancy
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,…
NIST
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.
The…
Leeza Garber, Allison Jegla
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…
Jeff Dewar
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 organizations,…
Dirk Dusharme @ Quality Digest
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…
David Isaacson
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’s not only…
Mark Hembree
‘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 point as big…
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.
But by 2003, ISO 13485 had changed so significantly that the FDA…
NIST
You 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 that…
ISO
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…
Steven Brown
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 in…
Kath Lockett
‘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…
Ann Brady
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 now…
Hayder Radha
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…
Jonathan Griffin
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 methods, it…
Lily Chen, Matthew Scholl
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 provide an important…
NIST
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…
Marc Lepere
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…
ISO
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 emissions…
Wade Schroeder
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.
Given that…
NIST
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…
Barnaby Lewis
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 when…
Bill Marler
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…
Mike Richman
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…
Steven Severt
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 been…
Roxanne Oclarino
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…
Dawn Bailey
‘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 recipients…
UC Berkeley NewsCenter
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…
Emily Newton
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…
Eliot Dratch
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 and…
Taran March @ Quality Digest
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 a…
Rajesh Talpade
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 Topcon…
Ann Brady
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 and travel…
Clare Naden
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 to…
Rick Gould
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…
Ann Brady
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 thereby,…
Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen
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 healthcare…
ISO
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…
Steven Severt
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 months in…
Corey Brown
Getting inside the mind of an ISO 9001 auditor is crucial to a successful ISO audit. Think of it like a gift: Even the best of presents can be unappealing when wrapped in crumpled, messy newspaper and duct tape.
Understanding the background and motivating factors for ISO auditors will help you…
Dawn Bailey
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…
Clare Naden
We all know that like attracts like, but when it comes to the workplace, differences can be a very good thing. Numerous studies have shown that workplace diversity and inclusion can drive innovation and lead to new markets and financial benefits.
There is also evidence that when employees feel…
Mark Esser
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), to…
Joseph Near, David Darais, Kaitlin Boeckl
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.
Why are…
Clare Naden
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, and…
Elizabeth Benham
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…
Esteve Garriga
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 effective, I…
Catherine Cooksey
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…
Clare Naden
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 test…
Shaneé Dawkins
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?
I…
Sheronda Jeffries
Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.
Industry and governmental organizations including the Therapeutic Goods…
Grant Ramaley
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),…
Natalie Weber
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 every…
Steven Stein
Recently there have been a number of articles whose authors discuss conducting assessments remotely because of the pandemic. This article will discuss my experience with an actual assessment conducted remotely, how the plan changed in response to the pandemic, lessons learned, and some of my…
Suneel Kumar
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…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Tom Taormina
After more than 50 years as a quality control engineer and having worked with more than 700 companies, it is my observation that the vast majority of quality professionals hold their prime directive to be reducing defects to the lowest acceptable level by minimizing process variability. Most of us…
Tom Taormina
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…
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
Del Williams
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 nation’s…
Carson MacPherson-Krutsky
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 you…
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case?
In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Tom Taormina
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…
William A. Levinson
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 legislation says…
Tom Taormina
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…
Mary Rowzee
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 their…
Dawn Bailey
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 Quality…
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after hospitals and first responders began reporting massive shortages of N95 masks, latex gloves, and surgical…
Quality Digest
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 polypropylene,…
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…
Tom Taormina
Each article in this series presents new tools for increasing return on investment, enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system. They will help implementers evolve quality management to overall business…
Julius DeSilva
ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have…
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
Mark Rosenthal
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 thinking that…
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.
Companies conducting layered process audits (LPAs) can help get the United States get…
Tom Taormina
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…
Oscar Combs
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 to…
Anjalika Singh
The toughest part of being in a relationship is finding a perfect gift for your loved one. Gifting is an essential part of any relationship. You gift your better half for every reason and every season. Gift as a form of bribery in love is a time-tried tool.
Being a system believer, I use the…
Inderjit Arora
ISO 9001 lead-auditor training should enable auditors to focus on the requirements when auditing and to stay away from the pitfall of guidelines.
Take the case of ISO 9001 or, for that matter, any management system standard. The standard has notes to explain the clauses. ISO 9001’s clause 4.1, for…
Sean Spence
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.…
Tom Taormina
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…
Sheng Lin-Gibson, Vijay Srinivasan
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,…
Tom Taormina
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 include…
Gwendolyn Galsworth
Two of my articles (the first regarding standards, standardization, and standard work; and the second on visual standards) drew a lot of response. Readers were kind enough to share their thoughts and definitions. Some offered new terms to include in the mix: standardized work and visual standard…
Tom Taormina
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 earlier…
Calin Moldovean
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.
Your…
William A. Levinson
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 new…
Michael Lueck
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 weather.…
Miriam Boudreaux
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 improvement…
Dirk Dusharme @ Quality Digest
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
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 this…
The QA Pharm
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 quiz will have one…
Heather Thompson
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.
Medical device…
ISO
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…
Chad Kymal
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?
For…
Dileep Thatte
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 12…
William A. Levinson
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 energy…
Kartik Hosanagar
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;…
Frances Brunelle
Just as baby boomers on the manufacturing plant floor are getting ready to retire, so are the owners. More than 5,000 small manufacturing operations (with annual revenues between $2 and $20 million) will either close their doors or find new owners during the next five years.
Some of these owners…
Anjalika Singh
Management system implementation reminds me of the advice my gym instructor gave when I first enrolled at my local health club: “Losing weight doesn’t happen in one day and with crash diets,” he said. “You gotta work out, gotta sleep the right amount, have a little fun in life. Yes, food is the…
Inderjit Arora
Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The International Organization for Standardization (ISO) publishes management system standards that, when…
Paul Foster
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 Canada…
Jon Speer
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 quality…
Eric Weisbrod
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…
William A. Levinson
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 opportunities…
Jennifer Lopez
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 Drug…
ISO
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 increasingly…
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 permitted…
Grant Ramaley
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 region…
Chad Kymal, Gregory F. Gruska
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…
Jyoti Madhusoodanan, Knowable Magazine
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 “sustainable…
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 Gates …
Jon Speer
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.
If your…
James J. Kline
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…
Ryan E. Day
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…
Ronda Culbertson
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…
Harry Hertz
Recently I’ve seen some startling statistics from Gallup and Glassdoor about employee and customer engagement. I hope those statistics do not represent data from any organization you or I associate with. The actions of senior leaders, as well as setting the right focus on employees, can prevent…
Alexandra Killewald, Xiaolin Zhuo
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 raising…
Brian S. Smith
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 having…
Ryan E. Day
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 45001…
Tom Taormina
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 case…
Chad Kymal
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 table below shows…
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.
Because of…
Ryan E. Day
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 U.…
Donald J. Wheeler
Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon having a good capability or performance index. But a good index by itself does not tell the whole…
William A. Levinson
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…
Laurel Thoennes @ Quality Digest
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 ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme @ Quality Digest
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 to make…
Graham Freeman
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…
Wendy White
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…
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Dirk Dusharme @ Quality Digest
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 wonderfully illustrates how we…
Bretta Kelly
Back in January 2009, I wrote an article for Quality Digest titled “ISO 9001 Documentation Is Like a Box of Chocolates.” Here we are, almost 10 years later, all of the ISO 9001 and related standards have been updated, yet companies still misunderstand what to document, how to document, or why to…
William A. Levinson
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…
NIST
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…
NIST
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…
Dirk Dusharme @ Quality Digest
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 comes to how most…
Ryan E. Day
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…
Taran March @ Quality Digest
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 has…
Dirk Dusharme @ 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…
Mike Richman
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…
Ryan E. Day
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,…
Matthew M. Lowe
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…
William A. Levinson
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…
Anthony Chirico
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…
Andreas Engelhardt
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…
Anthony Chirico
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 inspection does not provide twice the consumer…
Chad Kymal
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 its…
Anthony Chirico
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…
Mike Richman
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 of…
Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485…
Richard Pazdur
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…
Nicole Radziwill
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 in…
Oscar Combs
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?…
Jama Software
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 should look like • Describes the…
Henry Zumbrun
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 the…
Mike Richman
‘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,…
William A. Levinson
ISO 9004:2018—“Quality of an organization—Guidance to achieve sustained success” expands considerably on the former (2009) revision. It introduces the important concept of “quality of an organization” (Clause 4.1), which makes excellent sense. If the organization’s processes are of high quality, we…
Chad Kymal
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) standard with…
Vanessa Burrows, Suzanne Junod, John Swann
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 fact…
Richard Wilson
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).…
NIST
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), and other…
Dirk Dusharme @ Quality Digest
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 Mike’s field report.
“A…
Tim Lozier
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.
Let’s…
NIST
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 these…
William A. Levinson
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 can be carried even…
Tom Middleton
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 challenging…
Mike Richman
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 Copan…
Ryan E. Day
Unily is a leading digital workplace platform designed by BrightStarr to improve engagement, productivity, and efficiency for global enterprises. Unily is also a SaaS solution. That is, it’s served up via the cloud. Meaning that—with more than a million users, including the likes of Shell, Hershey’…
Terry Onica
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 audits…
BSI
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…
Harry Hertz
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 stealth…
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….”
That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars…
Sal Lucido
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Policies are dynamic and require a system to manage their creation, documentation, distribution, and management. Here’s…
Bruce Bolger
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 ISO…
Richard Harpster
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,…
Mike Richman
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…
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a…
Karl Kleinkauf
If you’ve been thinking about software as a service (SaaS) for your quality management system (QMS) and trying to justify the “why,” here’s a quick case supporting SaaS. Although not for everyone, it certainly makes more sense than it used to. There will always be the detractors who are not…
Kyle Rose
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.
I was…
Dirk Dusharme @ Quality Digest
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 would support a universal…
Eric Stoop
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 original equipment…
Violet Masoud
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 desktop in…
Bruce Bolger
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.…
Harry Hertz
The Baldrige Excellence Framework encourages organizations to create an environment for innovation by pursuing intelligent risks. How do you know whether a new idea is an intelligent risk, and therefore worth pursuing? How do you know if the resulting change is an innovation? An experience from my…
Martin R. Voelk
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 consumer data,…
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
ISO
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 a burden…
Eric Cooper
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 obvious, right…
Bruce Bolger
HighlightsThe New Focus on People Overview of ISO 9001:2015 Standards and the ISO 10018 Certification How This Microsite Helps Quality Management, Auditors, and Solution Providers Articles ResourcesOther Articles In This Series
This Month's Featured ArticleAccumold Starts With the Why
Can the…
Mike Richman
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 look…
Miriam Boudreaux
If you are a manufacturing company or a service provider, there is a good chance that you have heard about standards such as ISO 9001. In fact, you may already be certified. But whether you are certified or not, read on for some of the expected trends in the world of standards and certification…
Ismael Belmarez
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 year, the leading…
Dirk Dusharme @ Quality Digest
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 courseware providers to…
Jason Stoughton
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 than 2,000…
Richard Harpster
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-compliant quality…
Mike Richman
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 Draft of Harmonized FMEA…
Chad Kymal, Gregory F. Gruska
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 that…
Dirk Dusharme @ Quality Digest
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, and is spurred on by…
Patrick Horine
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 cost hospitals $…
Jorge A. Correa
Sponsored Content
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 may be well-defined and documented, or consist…
Mike Richman
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 development) for everything. World Toilet…
ISO
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 boardrooms of banks and…
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
Mike Richman
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 at the University of Southern…
ICEE
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 created in…
Gene Morrison
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 a long-…
Mike Richman
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 manufacturer to admit to…
Eric Stoop
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 audits to check high-…
Sheronda Jeffries, Carmine Reda
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 their suppliers to obtain…
Mike Richman
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” Renewal sources of energy like solar…
Dirk Dusharme @ Quality Digest
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?
“How Health Care Leaders Should…
Chad Kymal
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 reality.…
Therese Graff
Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well.
What is project risk management?
The Guide to the Project Management Body of Knowledge (Project Management Institute,…
Roy Swift
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.
Job seekers…
Olympus
Sponsored Content
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 potential costs, including fines, product recalls…
William A. Levinson
Some ISO 9001 users complain that the standard does not improve performance or deliver bottom-line results, while others are delighted by the standard as a framework for effective quality management systems. I pointed out previously that ISO 9001:2015 does not address, at least not explicitly, the…
Arun Hariharan
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 ownership to process owners, and often, process-compliance audits to check whether you…
Mary McAtee
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 a nasty…
Peter Merrill
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. There is a…
Joe Bollard
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 look at some of the…
Dirk Dusharme @ Quality Digest
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 Design Clinical Trials”
A…
DNV GL
Sponsored Content
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 to be nonstop efforts by corporations to harden…
Mike Richman
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 Corner demo.…
Amie Whittington
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 these…
Mike Richman
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 USA are now offering their…
John Flaig
Independence is an important issue in statistics, so I found the article, “Ethics, Auditing and Enron,” by Denis Arter and J. P. Russell, in the October 2003 issue of Quality Progress quite interesting.
In the second section of the article the QP editor asks, “Must auditors be independent?” to…
Chad Kymal
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 completed,…
Ryan E. Day
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…
Dirk Dusharme @ Quality Digest
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 of the Fidget Cube”
How a product…
William A. Levinson
Joseph Juran once warned1 that ISO 9001 standardizes mediocrity, and users often discover that it does not deliver outstanding or world-class results. This is not because of any inherent problems with the standard, but rather the manner in which organizations use it. If their goal is solely to “…
Sal Lucido
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 management…
Mike Richman
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 consider it warfighter…
DNV GL
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’t happened…
AssurX
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 actions
An FDA investigation was conducted from January to February 2017 at…
Elizabeth Gasiorowski Denis
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), Thomas Friedman…
Scott Gottlieb
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. By…
Pam Bethune
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 understood. Whether it’s…
Claire McCluskie
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: computer…
Dirk Dusharme @ Quality Digest
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 Alexander Acosta and…
Amie Whittington
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 (dual status). The…
Tim Lozier
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 the detail of risk, but…
Intertek
Sponsored Content
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 discrete industries often require additional…
Intertek
Sponsored Content
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 operations—is a necessity for doing business.…
Intertek
Sponsored Content
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 maintenance, repair, and overhaul [MRO] organizations…
Michael Ray Fincher
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 actions has…
William A. Levinson
‘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 all…
Chad Kymal
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: • Cross-…
Mike Richman
The June 16, 2017, episode of QDL included my hot take on Hexagon’s ginormous user conference as well as interviews with two of our favorite guests, Chad Kymal of Omnex and Kelly Graves of Internal Business Solutions. Take a look:
“Field Report: Hexagon Live 2017”
I and more than 3,000 of my…
John Flaig, Jack Ren
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 assessment problem. The…
AssurX
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 assesses a…
Ellen Kominars
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. Not…
DNV GL
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 how long your…
Mark Bartholomew
Ethics lawyers and historians have argued that Donald Trump has blurred the line between his public office and private business interests in an unprecedented fashion. In another sense, it’s part of a much larger social trend.
Commercial entreaties, whether in the form of magazine ads, radio…
Inderjit Arora
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 business…
Shobhendu Prabhakar
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 the reason…
Sandrine Tranchard
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 were…
Barbara A. Cleary
Complying to requirements and standards is sufficient to meet the objectives of injury and accident prevention, and ensure the health and safety of all employees—right?
In his article, “We’re blinded by compliance bias,” health and safety consultant Dan Markiewicz says no, citing data indicating…
William A. Levinson
Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and interaction of these processes, noting that handoffs between processes often create risks; and identify the…
Mike Richman
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’s…
Laurie Locascio
Like a lot of scientists, I am very goal-oriented, so after I got my Ph.D. in toxicology, I set out to become a leader in my field by the time I was 40. To get there, I knew I had to be acknowledged by the top researchers in my field, get invited to speak at important conferences, organize…
Dirk Dusharme @ Quality Digest
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 quality management…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Taran March @ Quality Digest
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 different…
Chad Kymal
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 enterprise quality takes…
Ryan E. Day
Sponsored Content
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 high-tech components and even higher-tech systems that could…
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have found that the best tool available to enable price and value comparison is unit pricing—you know,…
Inderjit Arora
Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check, act (PDCA) cycle, risk now appears in the “plan” phase and at each stage thereafter. This change formalizes…
Mike Richman
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 InVenture Prize offered by…
Joseph Aldy
President Trump jettisoned more than 30 years of bipartisan regulatory policy on Jan. 30, 2017, when he issued an executive order on “Reducing Regulation and Controlling Regulatory Costs.” The order requires that whenever a new regulation is enacted by any federal agency, regulators must eliminate…
DNV GL
“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 driven to balance innovation and safety as is the…
Mika Javanainen
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 must first…
Bert Coursey
Marie Curie is perhaps the most famous woman of 20th-century science. Major films and best-selling biographies have chronicled her discovery of the radioactive elements polonium and radium, for which she shared the Nobel Prize in physics in 1903 and then received a second Nobel Prize, this time in…
Tom Middleton
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 seen…
AssurX
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 Century Cures Act. If all…
Christine Schaefer
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 its…
DNV GL
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 2008 version…
Pam Bethune
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 says
When making sense of Clause 4.1—“Understanding the organization and its context…
Mary McAtee
Sponsored Content
Technical and commercial media sources are constantly discussing how design safety and security has not kept pace with quickly evolving technologies. Pundits are pointing to issues with everything from self-driving cars to new holiday toys that latch on to your home Wi-Fi and…
Tim Lozier
Sponsored Content
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 addressing and correcting issues.
In fact, 72 percent of quality…
DNV GL
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 continual…
Katherine Watts
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 challenge we…
Dara Corrigan
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 the…
Pat Toth
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 employee. I come from…
Joe Schlecht
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. This…
Mark Whitworth
For 17 years, ISO/TS 16949 was the leading standard for quality system requirements in the automotive industry. The technical specification was jointly developed by the International Automotive Task Force (IATF) and the International Organization for Standardization (ISO) in 1999. In October 2016…
Timothy Woodcome
Sponsored Content
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 transition to the latest version of the standard (as of…
American Customer Satisfaction Index ACSI
(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, life…
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 consider human…
Suzanne Schwartz
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 safety of…
William A. Levinson
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…
NIST
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 and…
Mike Richman
Hard as it may be to believe, a close analysis of our extensive trove of behavioral data on the Quality Digest user group indicates that more than a handful of you don’t regularly watch our regular weekly web TV show, Quality Digest Live, which broadcasts from our studio in Northern California…
Cole Cooper
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, tooling changes,…
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
NIST
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 CMM—…
Michael Causey
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—will be…
Paula Oddy
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 for services…
Dawn Bailey
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 Innovation…
Timothy Woodcome
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 example, the processes required…
Harry Hertz
Yes, it’s time for the Oxford English Dictionary (OED) to pay attention! Having recently seen an article in The Guardian about the new additions to the OED, it seemed a good time to take a somewhat tongue-in-cheek look at the 10 words I would propose for inclusion in that venerable reference 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 gauge…
Karleen Bacoccini
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 16949, and…
Christine Schaefer
To entertain you, to grab your attention, and (of course) to advance your understanding of the Baldrige Excellence Framework, staff members who contribute to this blog have occasionally written some odd posts—or, at least, given them curious titles.
In case you’ve missed one or more of these, I’m…
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Kade Moody
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 already started…
Peter Bussey
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 and how…
NQA
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 and…
Christine Schaefer
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 executive…
Chad Kymal
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 organizations have…
Kate Remley
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 explanation.…
Dawn Bailey
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 prepare…
Timothy Lozier
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 technology to…
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
Daniel Desilets
Sponsored content
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 the respective international standards for quality,…
NIST
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 the particles exit the…
Swapnil Srivastav
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 globe.…
InfinityQS
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 of your quality…
James Warren
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 was…
British Assessment Bureau BAB
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 of the breaches…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
NIST
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 controlled by sensors,…
Jennifer Huergo
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 in the shaft and…
Jesseca Lyons
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 engineer, there’s a good…
Dan Sawyer
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 mechanism that…
Chad Kymal
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 management…
Erwin Miller
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 transporters to…
Jonathan Jacobi
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 people, and…
ISO
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 something we tend…
NIST
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 measurement…
Sam Manzello
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 devastating effects.…
Jon Speer
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 as a pile of “stuff”…
Howard Sklamberg
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 shipments of FDA-…
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
James Olthoff
I’m a physicist, and as anyone who watches the popular TV series The Big Bang Theory knows, it’s a commonly held conception that there is a strong connection between being a scientist and being enthralled with all things science fiction, fantasy, and superheroes. Anyone who walks into my office at…
NIST
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 Institute of…
Brian Stanton
Doors that are obviously meant to be pushed not pulled, footprints painted on the floor telling you where to stand at the airport—these are examples of good design and usability. You don’t have to think too hard about what to do because someone else put a lot of thought into how to get across the…
Chad Kymal
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 IAQG decided…
Harry Hertz
I recently read an HBR blog by Sunnie Giles that reported the results of a study of 195 leaders representing 30 global organizations. The leaders were asked to identify the most important competencies for leadership. The study reminded me of a complementary article in Forbes, written by Glen…
Jennifer Marshall
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 the back are…
Mark Esser
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, during the 1990s,…
Grant Ramaley
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 are shared…
Richard Gates
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, wear down,…
Jennifer Lauren Lee
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 method for…
Jeffrey Eves
Sponsored Content
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 employees’ dependence on fossil fuels, and buildings…
NIST
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 inexpensively detect…
Eric Gasper
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 17025, ISO/…
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
NIST
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 horizontal, and…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
NIST
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 MRIs of breast…
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts…
NIST
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 common antibiotics…
John Nolan
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
NIST
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 shorting…
ISO
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,…
Stephen Mundwiller
One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality…
Donald J. Wheeler
Here we look at a simple example to discover the commonalties of various data analysis techniques widely used in industry today. Careful consideration of the following may result in insights that were not part of your introductory class in statistics.
Our example uses the gate oxide thicknesses…
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
Dawn Bailey
Dorothy: Now which way do we go? Scarecrow: Pardon me, this way is a very nice way. Dorothy: Who said that? Toto barks at the scarecrow. Dorothy: Don’t be silly, Toto. Scarecrows don’t talk. Scarecrow: [points other way] It’s pleasant down that way, too. Dorothy: That’s funny. Wasn’t he pointing…
Mark Esser
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 Kilogram as well…
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 manufacturing problems…
NIST
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 based on how…
Mark Esser
Maintaining a social media account involves keeping track of the many random celebrations that can provide an excuse to post a story that otherwise might not have a timely hook. National Peanut Butter Day (Jan. 24 for the uninitiated) is just such a day.
While NIST chemist Carolyn Burdette spent…
Kevin McKinley
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 leading…
Chad Kymal
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 their…
Lawrence Livermore National Laboratory
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 written by…
Grant Ramaley
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 countries: the…
NIST
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 efforts…
Miriam Boudreaux
Before 2015, many of us rode one of the largest waves of success in the history of the oil and gas industry. Everything was booming—companies, salaries, bonuses, cities, services, etc. Then 2015 came and crashed the party, leaving us all a bit uncertain.
Now, entering 2016, you may have some your…
Christine Schaefer
A question for devotees of the Baldrige Excellence Framework: Do people who passionately promote continuous improvement within organizations also tend to make New Year’s resolutions to improve their own well-being?
Seriously, I’m wondering if those who fully appreciate the framework’s value in…
Grant Ramaley
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS) certifications should be created.
The intent of the…
Mike Micklewright
I’ve made the point many times that the quality function and the lean/continuous improvement/kaizen function within an enterprise are really one and the same. Treating them as separate value streams with their own documentation, procedures, and goals is wasteful, short-sighted, and disrespectful…
TÜV SÜD America
Sponsored Content
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 delegate certain responsibilities which can help maintain…
Dawn Bailey
Losing can actually have its benefits. For Baldrige users, however, it’s a common saying that everyone is a winner who takes that first step.
The most important reason for using the Baldrige Excellence Framework is not to win an award but to improve financial and business performance, says Joseph…
Christine Schaefer
Being a Baldrige examiner: What is the experience like? Some have compared the work—especially during the final phase of an evaluation—to being in a rigorous MBA program. Others may find it’s like being part of a dispersed but highly engaged task force, as teams collaborate online and on the phone…
Peter Holtmann
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 affecting the…
Craig Cochran
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 to read it…
Jeffrey Eves
Sponsored Content
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 14001—“Environmental management systems—…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
TÜV SÜD America
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 years ago,…
Mika Javanainen
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 synonymous…
Donald J. Wheeler
When industrial classes in statistical techniques began to be taught by those without degrees in statistics it was inevitable that misunderstandings would abound and mythologies would proliferate. One of the things lost along the way was the secret foundation of statistical inference. This article…
NIST
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 the constants…
Patrick Runkel
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
ISO
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 ISOfocus,…
Craig Cochran
ISO 9001:2015 does a lot of things right, but using clear language isn’t one of them.
One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That's right, the standard’s updaters took one word and turned it into three. And the three…
Harry Hertz
Business schools today have a renewed emphasis on teaching leadership. Dawn Bailey explored this topic in a recent Blogrige post. One of the principles behind this shift, she explained, is intended to cause a deep dive into values. And values-centered leadership is, in my opinion, a critical…
Randall D’Amico
Sponsored Content
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 together to find ways to create a win-win outcome, buyers use their…
Donald J. Wheeler, Henry R. Neave
In theory, there is no difference between theory and practice. In practice, there is. During the past three months we have looked at three families of probability models and found that they share some remarkable properties. These properties provide a theoretical explanation of how and why process…
Christine Schaefer
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 Criteria…
Mike Micklewright
Finally... the new version of ISO 9001:2015 has been released. I can hear many of you screaming, “Hurray!” Or not. More realistically, I’m sure many of you living in the kaizen world are thinking, “Yeah, so what? This stuff has nothing to do with real kaizen, and in fact, it often creates…
Chad Kymal
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).
Setting the strategic direction
An organization uses its…
Arun Hariharan
In my previous article, “Is Poor Quality ISO 9001’s Fault?” I shared the example of the chairman of a large company who ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified. And we all know how bad the municipality is. I don’t believe ISO 9001 can do my…
Arun Hariharan
The chairman of a large company once ridiculed ISO 9001, saying, “Even the municipal office of this city is ISO 9001-certified, and we all know how bad the municipality is. I don’t believe ISO 9001 can do my business any good.”
The chairman had similar uncharitable things to say about other…
Tim Lozier
Sponsored Content
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 organization, whether to products, processes, or…
Gurdeep Mahal
Sponsored Content
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 ISO are generic by design so that they may be applied to businesses of any size, type, and product line. As…
Dawn Bailey
As a writer for the Baldrige Program, I have a lot of fun learning about how various people and organizations use the Baldrige Excellence Framework to guide, focus, and improve their operations.
I recently had the pleasure of conversing with Shannon Block, the president and CEO of the Denver Zoo…
Mika Javanainen
The recently released final draft of the ISO 9001:2015 standard for quality management systems has now been voted on by members of both the ISO and CEN standards bodies. The latest version still targets the same goal—to help organizations improve overall performance—while addressing the profound…
Grant Ramaley
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 cover ISO…
Denise Robitaille
OK, so “cool” probably isn't the precise term—unless you happen to be a standards uber-geek. But there are definitely some enhancements to the 2015 revision of ISO 9001 that are worth getting a little excited about.
The final draft international standard (FDIS) is finally out for ballot, so most…
Ryan E. Day
Sponsored Content
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 of implementing it. On the other hand, the rising price of energy and…
Chad Kymal, R. Dan Reid
Sponsored Content
Risk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition indicates that risk is the “effect of uncertainty on an expected result.” Risk is now addressed by…
Arun Hariharan
Peter Drucker once said, "The most important, and indeed the truly unique, contribution of management in the 20th century was the fifty-fold increase in the productivity of the manual worker in manufacturing. The most important contribution management needs to make in the 21st century is similarly…
Randall D’Amico
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…
Mary McAtee
Everyone is gearing up for the challenge of updating their compliance to the requirements of the 2015 version of ISO 9001. Most quality professionals I speak with seem to have digested the new requirements as something very different than past versions. Personally, I don’t see it in quite the same…
Ulrich Wegner
The new ISO 9001, scheduled for publication in late 2015, introduces the term “knowledge.” As knowledge was not addressed by the previous version of ISO 9001, the depth of this topic and the approach to it are new.
The international standard ISO/DIS 9001:2015—“Quality management systems—…
Harry Hertz
Every year, I return from the Baldrige Program’s Quest for Excellence Conference energized and full of pride in the success that can be achieved by people working together. And every year, I try to synthesize what I’ve heard into some key themes that reflect the best practices of the United States…
Donald J. Wheeler
While the computations for a process behavior chart are completely general and very robust, the secret to using a process behavior chart effectively lies in the art of rational sampling and rational subgrouping. Rational subgrouping has to do with organizing your data so that the chart will answer…
Chad Kymal
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 of…
Richard DeRisio
Editor’s note: Quality Digest will present Richard DeRisio’s webinar, “Effective Strategies for Complaint Handling” on May 19, 2015, at 2 p.m. Eastern, 11 a.m. Pacific. DeRisio will be a guest on Quality Digest Live on Friday, May 15, also at 2 p.m. Eastern, 11 a.m. Pacific, to preview the webinar…
Bud Weightman
The fifth edition of ISO 9001, which is slated for publication in late 2015, has some good ideas regarding improvement and harmonization with other management system standards such as ISO 14001. However, ISO/Draft International Standard (DIS) 9001:2015 has taken away prescriptive language for a…
Nicola Wilson
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 between life…
Christine Schaefer
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, said, “If we’re…
Strahinja Stojanovic
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 certification audit.…
Calin Moldovean
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.
In today’s…
Dawn Bailey
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 Baldrige…
Harry Hertz
Before you read further, get your tissues out. I’ve had many memorable moments over the years at Quest for Excellence conferences. And I’ve never left an annual conference without some immediate action items and feeling inspired that excellence is achievable in every type of organization. But…
Peter Theobald
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 through 14…
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 sobering…
Timothy Lozier
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 article we’ll…
Paula Oddy, Jeffrey Eves
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…
Denise Robitaille
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 standard is still on track to…
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and thinking. They put us on autopilot as we toil in our everyday work. The first step to change that is to…
Dawn Bailey
According to a recent IndustryWeek article, the 2015 edition of ISO 9001, the standard on quality management systems, is nearing completion.
The new version of IOS 9001 will have three areas of focus:
1. The process approach will be strongly emphasized; that is, the quality management system has…
Andy Nichols
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, and we’re sharing with you…
Christine Schaefer
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 Malcolm Baldrige…
Rick Calabrese
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 of…
Ryan E. Day
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 too quiet.…
NIST
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.
The 2014…
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 gained…
Dan Nelson
ISO 9001 certification is like a driver’s license test. To prepare for a driver’s license test, a new, unlicensed driver requests a booklet from the state. This booklet explains the laws and conventions of driving in that state. From ISO, a new, unregistered company receives two booklets…
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a standard reference human.
Having started working for the (then) National Bureau of Standards (NBS) almost…
Quality Digest
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 adoption of their first…
Quality Digest
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 lethality…
Paula Oddy
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 getting or…
NIST
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 double today’s…
Denise Robitaille
Unless you’ve been hiding under a rock for the last two years, you can’t help to have noticed that the ISO 9001 standard is in the middle of its revision process. Seems like people have been talking about this revision for ages. And, it’s not even a whole new standard. They’re not starting from…
Whitney Andrews
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 internationally recognized quality…
NIST
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 microscopy (…
Rick Gehrke
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 organizations…
Gary Phillips
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 specialized…
Rob Fenn
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 years, we have moved the…
Gurdeep Mahal
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 version. The…
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term marketplace success. The related self-assessment questions cover how your organization listens to the voice…
Dawn Bailey
Much has been discussed about the value of tomorrow’s leaders learning about the Baldrige Criteria for Performance Excellence while still in school. As an example, I remember listening to a presentation by Bruce Kintz, president of Concordia Publishing House, a 2011 Baldrige Award recipient, about…
Maria Lazarte
Everyone has a passion, whether it involves biking the toughest roads or collecting Star Wars figurines. Mine is travel.
My love of travel has taken me far and wide. I have been thrown into a river by an elephant in Malaysia and attended a four-day traditional wedding in Sudan. I have swum with…
Dan Nelson
Editor's note: This is part two of a series about customer-centric quality management systems. Read part one here.
Bob’s Machine Shop has been satisfying customers with good parts delivered on time for more than 20 years. Bob has satisfying customers down pat—it doesn’t happen day in and day out…
NIST
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 value…
Christine Schaefer
How is a company to decide whether to use the Baldrige Criteria for Performance Excellence, the ISO 9001 quality management system, or both? To explore some key distinctions between the comprehensive business model provided by the Baldrige framework and the quality management system provided by…
Umberto Tunesi
In my August 2013 column titled “Beethoven’s Fifth and ISO 9001:2015,” I commented on the ISO 9001 Committee Draft (CD). As is typical of me, I wasn’t soft. Now the interim draft international standard (DIS) is available for voting on by ISO members, and I’d like to offer my opinion about this…
Jeffrey Eves
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 being released in the…
Miriam Boudreaux
Sometimes interpreting ISO 9001 or API Q1/API Q2 requirements seems to force us to agree to things we won’t be able to do, or to sustain for more than a few months, let alone days. So how do we write our policies and procedures to explain our approach while avoiding being boxed in by our own words…
David Lawson
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 (DIS) of the…
Dan Nelson
Editor's note: This is part one of a serios about customer-centric quality management systems. Read part two here.
A document review is supposed to be conducted as part of stage one of the ISO certification process. For the uninitiated looking into certification—maybe you—that statement often…
Michael A. Hughes
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.
As auditors and quality…
Kelly Kuchinski
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 and beverage…
Mark Schmit
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 that products and…
ISO
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 reliable…
Paula Oddy
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 language and…
Ryan E. Day
Last month I, along with millions of other people around the world, celebrated Easter. For myself, a religious observance, for others a celebration of seasonal renewal. I think for most people, Easter is a time that elicits reflection on what matters most in the world. The state of the global…
David Fenn
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 such times I like to…
NIST
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 will benefit…
Patti Arms
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 performance…
Dave K. Banerjea
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 accreditation is…
Christine Schaefer
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 are: • Pewaukee School District in Pewaukee…
Miriam Boudreaux
In part one of this series I described how many auditors want your quality manual to repeat what is in ISO 9001, API Spec Q1, or API Spec Q2. Since auditors don’t always make the connection between how you wrote the quality manual (in a way that’s useful for you) and the standards in question, your…
Dan Nelson
Why is internal auditing important to your quality management system (QMS)? To ensure that processes conform to ISO 9001 requirements, or to ensure that the company conforms to management’s own defined plans? Although audits can be done for both reasons, the second choice is more important.…
David Muil
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 they think…
Mike Micklewright
Editor’s note: This article discusses topics covered at greater length in episodes 19–23 of a new streaming video training series, Creating and Sustaining Lean Improvements—Integrating Principles, Culture, and Tools by the author and 360 Performance Circle, a sister company to Quality Digest.…
NIST
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, these virtual…
MassMEP
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 takes members through…
ISO
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 numbers—and among the…
Dan Nelson
Editor's note: Dan Nelson will be a guest on Quality Digest LIVE Friday March 14, 2014, at 11 a.m. Pacific.
Bill Cosby once did a routine about a funny aspect of human nature: How we all seem to have a hard time believing the obvious.
So Cosby pulls some milk out of the fridge. He sniffs it. It’s…
Dan Nelson
On June 23, 2013, Simon Feary, executive director of the Chartered Quality Institute, delivered the welcome speech at the International Register of Certificated Auditors’ (IRCA) 12th annual forum held in Japan. Feary made several bold statements, including, “Something isn’t working when auditors…
David Muil
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 do little…
Mike Figliuolo
PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give presentations in some form or fashion at various points in our careers. If you’d like to succeed in those efforts, there are three things you should never…
Rob Fenn
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 stakeholders the…
Dirk Dusharme @ Quality Digest
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 opportunity to meet…
Harry Hertz
The results are in for the annual Best Places to Work in the Federal Government. The overall survey results are not surprising based on history, the current environment, and where many organizations—both government and business—have been challenged during recent years in the area of workforce…
Cognex Corp.
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 currently used to…
Christine Schaefer
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 that have…
Dan Nelson
Paul Batalden, M.D., professor at The Dartmouth Institute for Health Policy and Clinical Practice, once said, “Every system is perfectly designed to get the results it gets.” This idea seems applicable to any system of human design. Phrased slightly differently using ISO 9001 parlance, “Every…
Rob Fenn
So, you’ve decided that you really need to embark upon ISO 9001 registration. Perhaps it’s being requested by a client, or you’ve worked at a company before that had implemented it to great effect. Or maybe you’ve just been convinced by the numerous studies that have elucidated the strong benefits…
Shimadzu
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 stress rate…
Dan Nelson
Nobody likes to be told they’re doing something wrong. But if you were doing something wrong due to a misunderstanding, and it was actually hindering your operations while adding unnecessary cost, wouldn’t you want to know?
For example, let’s assume that you are using a tool consistently with…
Dan Nelson
Based on a reading of the ISO 9001:2015 Committee Draft (CD), the 2015 standard will further clarify and emphasize the requirement to apply a process approach. Although the requirement has been resident in the standard since 2000, this fundamental requirement has been overlooked often enough to…
Gurdeep Mahal
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 improvements is…
Ryan E. Day
It’s a funny spot I find myself in. I’ve been very vocal within Quality Digest about the need for, and virtues of, innovation as it pertains to our company. Very vocal. So much so, that the bosses have put me in a position to cash the checks my mouth has been writing.
I’ve written about…
Chris Carson, Lindsey Waddell, Marilyn Platt, Steve Holladay
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 increased…
Ryan E. Day
‘We call them unscheduled (vs. surprise) audits, in that they are not part of the originally planned, annual first-party audit plan.”
“We sometimes need to have unscheduled audits, but they are normally not intended as surprise audits. The auditor may agree with the auditee on an unscheduled…
Mary McAtee
It was the end of a long day. While sitting over dirty martinis with extra olives, my long-time colleague, Tisha Tomlinson, and I were discussing a situation and trying to plan a strategy that met the needs of all involved. We had spent the day with various quality and environmental, health, and…
Grant Ramaley
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,…
NIST
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 standard—a culmination…
Arun Hariharan
Taiichi Ohno, the father of the Toyota Production System, once said, “Where there is no standard [process], there can be no kaizen [improvement].”
In an earlier column, I wrote about how we used the customer-output-process-input-supplier (COPIS) method, which is a customer-first or an outside-in…
LRQA Business Assurance
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 reviewing…
Quality Digest
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, 2013, interview on Quality Digest’s…
Umberto Tunesi
First published Oct. 1, 2013, on the CERM Risk Insights blog. © Umberto Tunesi and CERM Risk Insights.
It isn’t Beethoven’s Fifth Symphony. I wish it were. It’s the committee draft (CD) of ISO 9001:2015, or model No. 5, if you prefer. No connection whatsoever to that lady-loved scent, Chanel No. 5…
Denise Robitaille
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 have made…
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
Dawn Bailey
A recent article in The Washington Post, “Company Town’s Decline Reflects New Mantra: Shareholders First,” got me thinking. The article begins with a look at Endicott, New York, where, during the 1980s, 10,000 IBM workers kept the upstate town thriving. Today, after years of layoffs and jobs…
Miriam Boudreaux
If your company is ISO-certified or thinking about becoming so, you may already know that meeting customer requirements and achieving customer satisfaction is paramount to the certification. However, it’s not always clear who should be in charge of determining whether customer satisfaction has been…
Umberto Tunesi
Stone Age men, so the story goes, got the wheel inspiration by observing trees rolling downhill. So they sliced trees and fit the rounds they got to their sleds, to move them faster and with less effort. In so doing, they also invented carts while expediting transportation.
But friction’s thermal…
Jerry Wilson
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 example.…
ISO
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…
James Lamprecht
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 process monitoring or…
NIST
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 tomography (CT…
Denise Robitaille
What’s Happening With ISO 9001? Stakeholders have offered suggestions for the upcoming revision
Committee Draft of ISO 9001 Is OutChanges include genuine improvement; some will make implementation more difficult
Denise Robitaille
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.
The first…
Stacey Jarrett Wagner
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 colleges…
Michael Ray Fincher
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 asked to join the…
Bull Wranglers
There are more than 1,100 textbooks referring to “short-term process capability,” as distinct from “long term.” Surely 1,100 textbooks can’t be wrong? Let’s apply the first Bull Wrangler test. Does short- and long-term process capability make common sense?
What is capability?
According to ISO…
Denise Robitaille
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 most…
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
Oscar Combs
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 often been amazed…
Randy Dougherty
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). According to ISO/IEC 17000…
Mike Micklewright
Got your attention by what seems a bizarre claim? Yes, you can significantly reduce the number of procedures you maintain by converting your ISO 9001 quality management system (QMS) to one that is also certified to the medical device standard ISO 13485 and the aerospace standard AS9100.
I am…
George Anastasopoulos
In July 2008, the Council of the European Union and the European Parliament agreed to provide a legal framework that creates one monopoly in each member state of the European Union (EU) for the provision of accreditation services across Europe.
This action could be understood (but even then that’s…
NIST
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.
These…
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 the best known program.
When consumers see…
NIST
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…
NIST
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 more than…
Umberto Tunesi
I recently bought myself an almost-latest-version smartphone. It was intended to celebrate my 62nd birthday; replace my present, obsolete portable phone; and be reliable and not too expensive.
Well, its “Quick Reference Guide” consists of 34 pages, three of which are blank, five give generic,…
ISO
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…
Umberto Tunesi
I wrote what follows with ISO 9001 and its derivatives in mind because these are the standards I’m most familiar with. Yet even before writing, I realized, at least from my experience, that the following points can be shared by most management system consultancy projects. Especially when the…
Miriam Boudreaux
Deciding how to control your documents can be difficult. ISO 9001, the quality management system (QMS) standard from the International Organization for Standardization (ISO), requires you maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between…
NIST
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-generation…
ISO
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 community as…
Paul Naysmith
These days quality professionals have shifted away from actually writing procedures to helping others develop documentation to describe the businesses they are in. Although I live in hope, I still see many poor attempts at “procedures”—or at least failures in their facilitation.
I have a simple…
Stewart Anderson
The production and provision of any product or service requires many activities to be performed. The pattern of activities that a firm adopts to create and deliver value to customers is commonly called the value chain (or value stream). A key issue in competitive strategy is how to organize a value…
William A. Levinson
People often ask for examples of benefits from implementing ISO 9001-compliant quality management systems (QMS). Such examples are often difficult to provide, at least in terms of immediate results. The reason is that the effects of ISO 9001 and its automotive counterpart ISO/TS 16949 are largely…
Umberto Tunesi
Back in the early 1990s, there was a saying, loudly heralded by one global registrar: “Certify your company, and the export markets will open their doors to it.” Well, the actual wording was a bit more rude, to get the message across to small companies.
I guess this slogan still holds true,…
Stanley H. Salot Jr.
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.
We…
NIST
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) Fluid…
NIST
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 government…
ASQ
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 organizations…
Jim Tennermann
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…
To remain the valuable business system that it currently is, ISO 9001 needs to continue to evolve, ensuring that organizations of all sizes, complexities, and locations see a clear connection between their strategic objectives and their quality management system (QMS). It is not just about meeting…
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,…
Christine Forcier
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…
Tim Lozier
You’ve heard the phrase, “Get it off your plate—delegate!” It’s a nice phrase for those of us to justify passing off work, isn’t it? However, in an organization, delegation is a much more serious challenge. Market demand dictates that no deadlines can be missed; you miss a deadline, and it may…
Lisa Greenleaf
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. Whether from…
William A. Levinson
Compliance is an unfortunate word in connection with standards because it suggests something arduous, unpleasant, costly, and annoying that one must do to “get the certificate.”
It’s true that organizations must meet certain requirements to register to a standard like ISO 9001, ISO 14001, and the…
NIST
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…
Jonathan Chowdhury
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…
Dale Hallerberg
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 will affect…
NIST
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…
Denise Robitaille
The ISO 9001 requirements pertaining to preventive action would get a lot more attention if people grasped the very simple fact that this is all about managing risk—which is really about managing the consequences of change. Whenever we change something, even for the better, there are…
NIST
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).
The act…
ASQ
(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 experience…
ISO
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 establishes…
TÜV Rheinland of North America
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 mode…
ISO
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…
ISO
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…
ISO
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 such…
Imagine a world where shoe sizes were not standardized, or where golf balls came in a variety of sizes and weights. What if your favorite CDs didn’t fit in your friend’s CD player? None of these things are problems today, thanks to an army of unsung heroes known as standards.
Standards—agreed…
NIST
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 extremely…
ISO
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…
American Association of Advanced Metrology
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…
ISO
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 goal of 99.…
Davis Balestracci
Any improvement effort ultimately faces the issue of standardizing processes, in many cases under the intense pressure of an impending certification audit. Ask yourself: Is your rationale for standardization merely to pass the audit, or is it a serious effort to improve quality? If it’s the former…
Davis Balestracci
Because many organizations are trying for formal certification, the pressure is on to standardize and document processes. This is also true for any robust improvement effort. Organizations are currently drowning in processes that have evolved over time and consequently become rife with…
Management system standards trace their beginnings to the use of simple preventive practices that were developed and used at the beginning of the industrial revolution. These preventive practices included responses to common problems, for example, ensuring changes are communicated to everyone…
In part one of this two-part article, we looked at the history of management system standards. Part two details some of the evidence that supports the assertion that these standards add value to organizations.
A 2008 detailed study published by the Harvard Business School provides real data,…
More than ever, businesses need ways to improve their operations to better gain, serve, and retain customers while reducing costs and improving margins. Implementing management systems and attaining third-party accredited certification can help businesses achieve success on all of these fronts…
NIST
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…
Ryan E. Day
Standard: “A document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context” (ISO/IEC Guide 2:2004—“…
Miriam Boudreaux
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 is…
Steven Ouellette
Although we may use the define, measure, analyze, improve, control (DMAIC) mnemonic to help guide us through our problem solving, that doesn’t really give us a lot of specific direction (as I bemoan in my Top 10 Stupid Six Sigma Tricks No. 4). Good experimental design technique is critical to being…
Robert Parsons
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), that…
British Assessment Bureau BAB
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…
NIST
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…
Mike Richman
Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief Dirk Dusharme and I also covered this story on the April 29th edition of Quality Digest Live (QDL). QDL, by the way, is our live video show wrap-up of the week’s top industry news and…
Denise Robitaille
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 complexity…
Cor Groenveld
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…
Mike Richman
Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which we first launched nearly two years ago. I hope you notice that we’ve added more video content to the newsletter as well as greater editorial…
Lisa Lupo
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…
Miriam Boudreaux
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 do…
Danita Johnson Hughes Ph.D.
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 time.…
Miriam Boudreaux
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 one…
Miriam Boudreaux
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 one…
Denise Robitaille
Every once in a while when I’m conducting training, I have the good fortune to have someone ask a particularly atypical question that gets me thinking and helps me to develop more tools and techniques. This serves to not only augment my own bag of tricks but also increases my capacity to serve my…
Denise Robitaille
Every once in a while when I’m conducting training, I have the good fortune to have someone ask a particularly atypical question that gets me thinking and helps me to develop more tools and techniques. This serves to not only augment my own bag of tricks but also increases my capacity to serve my…
American National Standards Institute ANSI
(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 seemed…
Denise Robitaille
I’ve been working with a client on implementing an ISO 9001-compliant quality management system. As always it’s a unique and interesting project, since organizations have different cultures, processes, products, and customers. No two quality management systems are quite the same. Documentation…
Mike Richman
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 of…
Pierre Huot
If a manufacturer were to ask its clients how they evaluated goods or services, the three most common metrics would be goods at a fair price, on-time delivery, and quality. Ask which could be most valuable and in all likelihood the most significant response would be quality. When included in the…
Dirk Dusharme @ Quality Digest
For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being…
Mike Richman
Yes, it happened again. According to a recent Associated Press story, drinking glasses produced in China, featuring comic and superhero characters, have been discovered to contain extremely high levels of lead. Excessive amounts of cadmium were revealed in the glasses as well.
This has been a…
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 editors of…
Thomas R. Cutler
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-…
The QA Pharm
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 nothing less…
Denise Robitaille
Election time is once again upon us. And, like a bumper crop of kudzu run amok, campaign ads have besieged local broadcasts with the tenacity of an unrelenting pestilence. My mailbox is equally stuffed with innuendo-laden campaign fliers. A horrific waste of paper.
The malicious tone of the…
Mike Richman
Did you know that World Standards Day (being celebrated today) and Earth Day both began in the year 1970? How about the fact that Oct. 14 was chosen as the date because that was the day in 1946 when the delegates of what was to become the International Organization for Standardization (ISO) first…
Andrew Reich
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 and goals…
Miriam Boudreaux
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 Standardization (ISO),…
Denise Robitaille
Trepanning is the process of drilling a hole in the skull. It was practiced as far back as 10,000 years ago. Archaeological artifacts lend credence to the lore that the process was used by some cultures to expel evil spirits. Apart from that occult-ish application, the process has been used for…
Robert Parsons
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 has…
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…
Oriel STAT A MATRIX
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…
Xia Enyu
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…
Denise Robitaille
As the universe of quality management systems expands, it’s interesting to observe the increasing variables that constitute the concept of applicability. Let’s take maintenance of records as an example.
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Twenty years ago, the records that were kept and the method of keeping…
Sal Lucido
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…
Standards Council of Canada
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 most…
Thomas R. Cutler
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 practice…
Gene Rider
Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…
Paul Scicchitano
The billowing cloud of volcanic ash spewing from Iceland may have been a major pain for air travel, but it also had a positive side. It served up a gentle reminder for me to find out what the heck is going on with AS9100 certification.
Faster than I could say Eyjafjallajökull, I was on the…
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 shared…
NIST
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 nonprofit…
Denise Robitaille
ISO 9001 makes multiple references to the need to understand customer requirements and to monitor the extent to which those requirements have been fulfilled. In fact, the scope of the standard clearly indicates that its focus is primarily on ensuring that an organization has the processes that…
Jon Miller
Facilitation is the art of guiding but not leading, bringing learning but not lecturing, engaging but not directing. Coming from the Latin facilitar, meaning, “to make easy,” the role of the facilitator is not to do for others, but to bring out the ability of a group to accomplish a goal. There are…
Paul Leavoy
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 integrity…
Akhilesh Gulati
Toyota’s name has been plastered in the headlines providing it the publicity no organization would wish for.
Historically, Toyota had achieved a global reputation for the production of very high quality vehicles. The Toyota Production System, or the Toyota Way, is being taught, learned, and…
Denise Robitaille
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 spouse’s…
Robert Parsons
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 out…
Paul Scicchitano
Some experts could barely hide their disappointment when the total number of ISO 9001 certificates recently failed to break the long-awaited million-certificate mark—as if it isn’t enough to have the world’s most widely used voluntary quality standard of all time.
With 982,832 third-party…
National Standards Authority of Ireland NSAI
(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”…
The Un-Comfort Zone With Robert Wilson
On a summer weekend in 1977, my friend Tony and I made plans to go water-skiing. When he picked me up there were two people in the car that I did not know. He introduced his new girlfriend, Sue, and her brother, Bubba.
Bubba was the quintessential redneck. Within minutes of getting on the boat…
Miriam Boudreaux
When a quality management system (QMS) is implemented, results are evident immediately: reduction in warranty cost, reduction in rework, reduction in scrap, higher profit margins, etc. Would you agree that ISO 9001 and other quality initiatives such as lean, Six Sigma, and 5S can significantly…
Jennifer Simcox
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 risks…
Denise Robitaille
The new revision to ISO 9004 came off the press in the last quarter of 2009. It is significantly different from its predecessor. ISO 9004:2009 embodies the quality management principle relating to continual improvement. The technical experts made bold strides in their quest to address market…
Stephen J. Marshall
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…
Miriam Boudreaux
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. …
Paul Scicchitano
If you’re like the vast majority of readers, your company has probably gotten certified to one or more management system standards because someone told you to do so.
While certification is considered to be a cost of doing business these days, companies that invest in becoming certified to a…
Mike Micklewright
Can you imagine producing products with a tremendous amount of variation? I’m sure many of you know this all too well. I mean, here you’re trying to produce the same products, trying to ensure consistency, and many of the products you produce have different shades of color, many function…
Michael Jovanis
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…
Stacey Corbin
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 sometimes,…
Denise Robitaille
T
was the night before Christmas and all through the plant
Not a technician was stirring, no quality rants.
Performance charts were pinned to the cork board with care,
In hopes that, their progress, people would share.
The micrometers were nestled, all snug and encased
Protected from…
BSI
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…
Paul Scicchitano
I
f you’ve been sweating what to get your quality colleagues this holiday season, you might want to pass up that tin of gooey chocolate in favor of a new international self-help standard.
Published on Nov. 1 by the Geneva-based International Organization for Standardization (ISO)—the same…
David Roberts
This article is temporarily unavailable
--Editors
Mike Richman
Here at Quality Digest, we get a lot of mail: Some of it’s critical, some of it’s praiseworthy, some of it’s cantankerous, and some of it’s challenging. All of it is insightful. And then, every once in awhile, something comes along that simply... well...
The following was sent to us from a…
“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 and Fang…
Denise Robitaille
There have been a couple of great columns in recent weeks in Quality Digest Daily dealing either directly or indirectly with the subject of root cause analysis. Mike Micklewright gave us his spin on medical consequences of inadequate root cause analysis and Dirk Dusharme illustrated the pitfalls…
BSI
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 of…
Craig Cochran
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 the…
Steve Arbogast
A quality management system is a framework of processes and procedures that are used to ensure that an organization can fulfill all tasks required to achieve its goals, strategies, and objectives.
The majority of businesses around the world have some sort of well-defined quality management…
Denise Robitaille
It was the great W. Edwards Deming who first applied this tenet, “Drive out fear,” to quality management in his book Out of the Crisis (Massachusetts Institute of Technology, 1982) It’s one of his 14 Points for Management.
Over the last two decades, more than a million organizations have…
Sidney Vianna
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.
During the…
Paul Gay
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.
Wireless…
Miriam Boudreaux
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 the…
Bill Kalmar
The band “Chicago” sang those words about "time" decades ago. The second line “Does anybody really care?” seems to sum up what is still in vogue today, especially in the workplace. Just as with vacations where workers are reluctant to leave for fear that someone will discover that their job is…
Denise Robitaille
The final draft of the revised ISO 9004 standard is out for ballot. This means that it will hopefully be available before the end of this year. It’s radically different from the last version. For one thing, the title has changed. It’s now: “Managing for the sustained success of an organization—A…
Miriam Boudreaux
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…
International Electrotechnical Commission IEC
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 capacity
Wind turbines are…
Miriam Boudreaux
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 organization is…
IBS America
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 management…
Geoff Bilau
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” aerospace…
Esteve Garriga
Real estate bubble, subprime mortgages, financial system, stock markets, and finally, Main Street. The deepest crisis in decades is here, monopolizing media’s headlines, freezing our economies and strongly affecting us not only as citizens (or should I say consumers?) but also as quality…
William Tandler
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
1. Introduction
In March 2009 the ASME released a new…
Miriam Boudreaux
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…
Stacey Corbin
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 it…
Denise Robitaille
A father and his son were going to market. Their donkey was laden with the vegetables from their garden and assorted wares they were going to sell. The young son became tired and so his father lifted him up onto the donkey so that he could ride for a while. Shortly thereafter, they passed through…
Richard A. Vincins
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) were…
Thomas Hinton
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…
H. James Harrington
I often get assignments at organizations where I am required to take aside a group of people, either within the building facility or off campus, to focus on issues or problems. Typically these groups spend a considerable amount of time to summarize and present a well-defined problem. The next step…
David C. Crosby
The most important element in producing a quality product or service is the attitude of the people doing the work—not only the worker—but the attitude of all levels of management. Employee attitude about the product, about the work, about the boss, and about the company will pretty well determine…
Dale Hershfield
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?
The…
Denise Robitaille
"The only man who behaved sensibly was my tailor: he took my measure anew every time he saw me, whilst all the rest went on with their old measurements and expected them to fit me.”
—George Bernard Shaw
Can you think of a more rousing or appropriate quotation to justify the ISO 9001…
Craig Cochran
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
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
I
t was…
James Odom
Charles Kettering, the famous inventor, once said: “A problem well stated is a problem half solved.” This implies that a good portion of problem solving should be devoted to a thorough understanding of what’s going on before any corrective action steps are taken.
In many cases, too much time is…
David Millar
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 gases…
Arshad Hafeez
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,…
Stanley Cherkasky
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:…
Dan Seal
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 not…
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…
Thomas R. Cutler
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 litigation is…
Thomas R. Cutler
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 litigation is…
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…
Kurt Boveington
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…
Richard Strouse
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 growth…
Denise Robitaille
Isn’t it annoying when you call a company to complain about a problem and they won’t even give you the chance to describe what’s wrong? They take down the information that they think is important or whatever the generic form directs them to record. You hang up thinking, “They couldn’t even give me…
Denise Robitaille
E
mpowering people is a cool idea. Giving individuals authority and responsibility has many benefits. It fosters accountability and communicates confidence. It avails people the opportunity to contribute in a manner that allows their voices to be heard. They experience the self-satisfaction of…
Denise Robitaille
A few months back, I wrote about the choices an organization makes regarding its quality management system (QMS). At that time, I talked about the overall system, with particular focus on management’s investment and support.
Today I’d like to spend some time talking about the choices within the…
Denise Robitaille
I recently had a client who went through a pre-assessment in anticipation of his company’s certification audit. It’s kind of like a dress rehearsal for the real thing. Over the years, I’ve discovered that organizations tend to garner more value from pre-assessments than I had originally thought…
Denise Robitaille
Unlike many other requirements in ISO 9001, the subclause dealing with the ISO management representative is rarely the subject of debate. In fact, it doesn’t get nearly as much consideration as it deserves.
Traditionally, it’s assumed that the quality manager gets the job by default. If the…
Denise Robitaille
A farmer was experiencing a serious problem with cranes eating his seed, so he decided to cast a net upon his fields in an attempt to capture the cranes. Along with the cranes, he snared a stork. The stork pleaded for his life saying, "Honorable farmer, I am not like these others who came to steal…
Denise Robitaille
Recently I became aware that the ISO 9001 requirements pertaining to preventive action are sometimes referred to as the “fortune-telling clause.” The deprecating implication is that attempting to implement preventive actions is as silly as relying on a two-bit sideshow palm reader to help you make…
Denise Robitaille
Every once in a while, when I’m doing an audit someone will ask me—in a whiney voice—about some ISO 9001 requirement. The whine sounds something like, “Do we really have to ________?” Fill in the blank with any of a number of “shalls” from the standard. They know they have to, but they’re hoping…
Denise Robitaille
There’s a great scene in The Agony and the Ecstasy where Pope Julius, played by Rex Harrison, reacts to the paint dribbles from Michelangelo’s perpetual work on the Sistine Chapel. He’s processing out of the chapel after Mass and Charlton Heston, in his role as the great artist, has unceremoniously…
Denise Robitaille
Many of us quality professionals have been teased by our families on more than one occasion for applying quality principles to everyday life. “I know you said you did your homework, but I’d like to see the evidence.” Admit it; many of you have been caught using quality speak around the house.…
Martin Zwilling
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…
Denise Robitaille
Last month’s column dealt with how to effectively communicate a finding of nonconformity in an audit report. It’s pretty straightforward: Here’s the requirement; there’s the evidence. They don’t match. Observations, which are now often called opportunities for improvement (OFIs), aren’t so cut and…
Denise Robitaille
“Nonfulfillment of a requirement.” That’s the clear and concise definition of a nonconformity offered up by ISO 9000:2005–“Quality management systems—Fundamentals and vocabulary.” The definition leaves little room for ambiguity. A nonconformity is the identification of an incident involving either…
Girdhar J. Gyani
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.…
Denise Robitaille
Control of quality records: Can there possibly be a more boring requirement? You can feel the yawn coming on as you read through the requirements of ISO 9001 subclause 4.2.4.
Not only are you required to keep records, you’re required to have a documented procedure that describes how you maintain…
In last month’s column, I postulated that the hazardous-substance-free movement represents a major paradigm shift and creates demanding requirements for industry, creating a much higher bar of performance for business. QC 080000 IECQ HSPM can be a help.While the increasing demand for business…
Denise Robitaille
What data are the best to gather? What processes should you be tracking? What are your metrics telling you? In observing various organizations’ attempts to fulfill ISO 9001 requirements around subclause 8.4—“Analysis of data,”–I’ve noticed a recurring problem. Companies allow the requirements of…
Last month, I shared some perspectives about the current state of the hazardous-substance-free movement and trends that are propelling its influence. This month I’d like to discuss what I think these trends mean to industry and the potential usefulness of QC 080000 IECQ HSPM.The European RoHS and…
This column and the next two take stock of the current state and future of the hazardous-substance-free (HSF) movement and its effects on industry, and share my perspectives on the potential effects of QC 080000 IECQ HSPM. A vision of the future: The industry will forevermore be held…
Denise Robitaille
Subclause 6.2.2 of ISO 9001 is ubiquitously referred to as the training clause. That unfortunately narrows the focus to only one aspect of the requirement. The subclause is situated in the section of the standard that relates to provision of resources. It doesn’t simply require that training be…
Denise Robitaille
Three blind men sat in the market place. One said to the others: ‘Would it not be a wondrous thing to know the nature of an elephant?’ His companion agreed, ‘Yes, it would indeed be wondrous.’A merchant standing nearby overheard the men’s conversation. He went over to the trio and said, ‘I…
This month we provide the basics for compliance with the European Union’s Directive 2002/95/EC—“On the restriction of the use of certain hazardous substances in electrical and electronic equipment.” This directive is commonly referred to as “RoHS,” for Reduction of Hazardous Substances…
Denise Robitaille
Many of you have probably had the occasional insane day when you thought: “This job would be so much easier if we didn’t have customers to deal with.” Apart from the demands for price concessions and the requests for unreasonable deliveries, there are a whole group of customer traits that can drive…
Dennis Bradley
Europe’s Reduction of Hazardous Substances (RoHS) directive identifies six hazardous substances and their maximum permissible levels within electrical and electronic equipment. RoHS imposes upon producers of such goods responsibility for knowing whether their finished products contain…
Denise Robitaille
How do we conclude that a nagging, recurring blip has become serious enough to justify taking action? How do we assess the significance of anomalies—isolated occurrences and scattered, seemingly unrelated events? Can we objectively distinguish those factors that suggest an escalating…
In a previous column, we discussed the importance of the IECQ quality assessment systems for electronic components, a certification scheme of the International Electrotechnical Commission. The IECQ mission is to provide a business-to-business quality certification scheme that serves industry by…
Dennis Bradley
Previous columns have addressed some of the topics that provide a foundation for understanding the scope and complexity of the worldwide movement to achieve hazardous-substance free (HSF) products and production processes. This month, let’s take a look at how people have been behaving and why they’…
Denise Robitaille
Auditing clause 7.3 of the design and development section of ISO 9001 can be a challenge for the auditor and the auditee. Unlike purchasing, manufacturing, shipping or order processing, it’s rarely carried out on a regular or consistent schedule. The level of activity ranges from the…
Denise Robitaille
Years ago, when my kids were in middle school, I volunteered as a coach for the Future Problem Solvers, a competitive academic program designed to help young people develop the creative thinking skills they will need as tomorrow’s leaders.While the bulk of the time was spent teaching…
QC 080000 IECQ HSPM calls for a process management approach to the management and reduction of hazardous substances in products and processes. It utilizes familiar conventions from the ISO standards world, while calling for a full review and understanding of the technical issues that…
Denise Robitaille
The adage “The pen is mightier than the sword.” is hackneyed, accurate and profound. I’ve done several pieces on the influence of words. The simple fact is that how we say something often matters as much as what we’re saying. It’s a wondrous phenomenon, one that is too often taken for…
Last month’s column provided background on the International Electrotechnical Commission, one of only three standards-setting bodies recognized by the World Trade Organization. Readers may have asked, “So what?” The answer is that one of the three “schemes” within the IEC has provided…
Denise Robitaille
Surely you remember the tale of the emperor’s new clothes, a wonderful story filled with multiple quality training opportunities.
There was an emperor who was pompous and vain. One day, two scoundrels came to the palace, presenting themselves as tailors from a distant land. They said they had woven…
Dennis Bradley
In March 2005, EIA/ECCB-954, "Electrical and Electronic Components and Products Hazardous-Substance-Free Standard and Requirements" was developed and released as a U.S. national standard. In April 2005, the IECQ management committee agreed at its annual meeting in the United Kingdom to…
Denise Robitaille
Blame is one of the most useless, albeit pervasive, reactions that surround problem solving. For many people, the initial reaction when something goes wrong is: “Who did this?” The less-than-subtle implication underlying this question is: “I want to know who screwed up.” Some may even…
Last month’s SBGi on HSF column, “Now What?,” focused on the emergence of RoHS and WEEE as part of the global hazardous-substance-free (HSF) movement. This month, we’ll look at what has been happening in the electrical and electronics equipment industries and in the European Union…
Brandon Kerkstra
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 worse…
Denise Robitaille
I was recently asked to comment on the ISO 9001 requirements regarding external documents. My first reaction was to point out a distinctive subtlety in the actual text of the requirement. Many users have gotten into the habit of referring to this category as “external documents” when in fact, the…
Chip Evans
This is the first of a series of articles intended to share with Quality Digest’s readers key aspects of the global movement toward hazardous substance–free (HSF) products and processes and how they affect organizations. SBGi helps producers of electronic and electrical products prepare…
Denise Robitaille
Don’t you love it when you go to the store and they have a “BOGO” sale? BOGO, as in buy one, get one. Who can resist the attraction of being able to get two things for the price of one? I once had a client who was going through the company’s registration assessment for ISO 9001. The client…
Denise Robitaille
I have long maintained that renumbering procedures from the defunct ISO 9001:1994 standard to reflect the numerical scheme of ISO 9001:2000 is an exercise of questionable value. After all, aren’t they just numbers? What difference can it possibly make if your purchasing procedure is…
Denise Robitaille
"For want of nail a shoe was lost For want of a shoe a horse was lost For want of horse a rider was lost For want of a rider a battle was lost For loss of a battle a kingdom was lost And all because of a horseshoe nail." In researching the origins of this familiar cautionary maxim, I…
Denise Robitaille
A few months ago, I wrote about the importance of understanding your customers’ requirements. We looked at requirements that exceed the traditional scope of product specifications such as labeling, packaging and documentation.This month, we’ll take a look at how we communicate our…
Denise Robitaille
As an auditor, I have a hard time maintaining my composure when individuals tell me they’re unhappy with their registrar and yet have taken no action to address the matter. If clients are dissatisfied with the conduct of an auditor or service they’re getting from their certification…
Denise Robitaille
It’s the week after the huge annual trade show—the opportunity for you and the rest of your industry to showcase your companies and to rollout your latest, greatest blow-the-competition-out-of-the-water product offerings. Unfortunately, instead of having a working model to demonstrate—…
Denise Robitaille
Part of the problem with corrective actions has long been the proliferation of requests for things that just don’t meet the criteria. Significant progress toward selecting the problems that warrant corrective action has been made in recent years. This has improved the image of corrective actions…
Denise Robitaille
Some ISO 9001 requirements simply don’t get as much attention as others. One such example is found in clause 6.4, which relates to work environments. It states: “The organization shall determine and manage the work environment needed to achieve conformity to product requirements.” What…
Denise Robitaille
Time is arguably one of the most precious and least quantified resources that organizations possess. It’s a uniquely intangible, yet indispensable, feature of any process or activity. Things occur over a span of time. It’s an indisputable characteristic of our universe and is so self-evident that…
Denise Robitaille
It’s been my experience as an auditor and as a consultant that the overwhelming majority of corrective actions originate from customer returns. The good news is that the corrective action request (CAR) process is being utilized to address the cause of these problems. Unfortunately, CARs that arise…
Denise Robitaille
How is it possible to ship customers the right product, on time, and still fail to fulfill their requirements? Most organizations do a pretty good job of determining what product the customer wants. Based on what I’ve observed during surveillance audits, they’ve also improved their processes for…
Denise Robitaille
A recurrent theme that dominates discussion on the establishment of corrective action programs is the practice of channeling problems through multiple conduits for assessment and resolution. Organizations inadvertently fragment their corrective action process by trying to address problems and…
Denise Robitaille
I’ve long been a proponent of involving as many individuals as possible in corrective action, both during the root cause analysis phase and during the development of the action plan. Middle managers, supervisors, machine operators, customer service representatives, shippers, software test engineers…
Denise Robitaille
Have you ever wondered how to demonstrate to a manager the rationale behind the ISO 9001 requirements for competence and training? It isn’t uncommon to find quality managers, consultants or auditors sputtering through an explanation of this requirement, trying to describe to others what seems…
Denise Robitaille
Perhaps one of the hardest persisting sells for the average quality professional is the challenge of effectively communicating the benefits of preventive action to senior management. The sales pitch is twofold: 1) defining the concept and 2) providing concrete examples that are applicable to the…
Denise Robitaille
I often get asked: “What’s the best software package?” Individuals are usually looking for guidance in selecting a program to manage corrective actions, facilitate document revisions, track equipment maintenance or handle transfer of information about some other processes. With our increased…
Denise Robitaille
The Abbott and Costello routine “Who’s on First?” is one of the greatest comic treasures of our time. Bud Abbott begins listing the improbable names of his team players: Who, What and I Don’t Know (the three basemen), while a befuddled and increasingly frustrated Lou Costello tries to nail down the…
Paula Esty
This article reviews management review in the latest ISO 14001 standard revision, including the management review requirement update and system recommendations for ISO 14001:2004 compliance. The updated ISO 14001 environmental management system (EMS) standard includes a clarification to the…
Denise Robitaille
It’s logical to expect the purchasing process to fall under the purview of the purchasing department. However, the reality is that in most organizations there are people from different departments who generate purchase orders and sign contracts. Not all procurement is done by the purchasing…
Denise Robitaille
Occasionally, when I’m waiting for a flight, the small talk with fellow travelers will meander into discussions about the purpose of our respective trips. When I tell them that I’m on my way to conduct an audit, they immediately jump to the conclusion that I’m a certified public accountant (CPA)…
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,…
David Parlagreco
The concept of establishing goals and flowing them throughout an organization isn’t new in business or in quality management system standards. In ISO 9001:1994, the establishment of goals was done via the quality policy, following a review of effectiveness in meeting these management goals. QS-9000…
Denise Robitaille
I was channel surfing the other day, looking for some local news that would tell me why I had woken up to a power outage that had lasted the better part of the morning. I don’t usually watch TV during the day, so I had no idea what stations carried noon time news broadcasts. As I was flipping…
Robert Kozak
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…
Denise Robitaille
Good morning, everyone. On behalf of Galactic Registrars Interstellar Network (GRIN), I’d like to express our appreciation to your organization for selecting us as your ISO 9001 registrar. Before we begin the audit, there are a few items we need to cover. This is standard auditing protocol. Certain…
Denise Robitaille
I was recently asked to write about the ISO 9001:2000 requirements that are still giving folks a hard time. Recent audits that I’ve conducted have led me to conclude that there are several clauses that continue to give us heartburn.
The issue that seems to come up most frequently relates to…
Denise Robitaille
I’ve long been frustrated, both as an auditor and as a consultant, by the unique exemption most organizations extend to distributors. It’s a common practice for purchasing personnel to excuse distributors from the vendor qualification requirements they apply to most of the other companies they do…
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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 companies…
Denise Robitaille
Perhaps the single most pervasive reason top management resists the implementation of a quality management system relates to our failure, as quality professionals, to demonstrate the return on investment. We do a less-than-stellar job of demonstrating to executives the financial value implicit in…
Michael Stanleigh
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…
Denise Robitaille
There’s a marauding infestation of adverbs and adjectives that infiltrate the text of quality documents and operating procedures, wreaking havoc wherever they are found. The leader of this menacing bunch is called “All.” Among his compatriots you’ll find “Never,” “Always,” “Every” and “None.”
When…
Craig Cochran
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 exploring…
Denise Robitaille
We all love exceptions. They afford us unfettered permission to break the rules. They are the vehicles we use to get around “things”—whatever those things happen to be.
For those of us who attended elementary school in the sixties, the tradition of exceptions reaches deep down to our grammatical…
Denise Robitaille
Do not ever, ever, do anything just to please an auditor. This is quickly becoming one of my new favorite mantras. For many individuals, this statement would seem to be self-evident, and yet there are instances when an organization has felt compelled to change a process or implement a new practice…
Ronald J. Bowen
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 doing…
Craig Cochran
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 elements…
Denise Robitaille
When is faster not better? In our warp-speed, 21st-century lives, getting the task completed on time--or ahead of time or before the competition--has become a goal in itself. We want this project done so we can move on to the next big thing. We tick things off our to-do list and gauge each day’s…
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…
Craig Cochran
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 experienced…
Jim Mroz
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…
Robert H. King Jr.
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.…
Frank Holland
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…
