All Features
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system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.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…
