All Features
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…
jeffdewar
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…
