All Features
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…
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
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…
Oihab Allal-Chérif
In just five short months, two Boeing 737 Max 8 airliners crashed, killing a total of 346 passengers and crew members. Both crashes occurred shortly after takeoff, and the similarities between the two catastrophes raised fundamental questions about the aircraft’s safety. It was grounded by nation…
Claire Harbour, Antoine Tirard
Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer. After four years of higher education, Megha found a job in the booming…
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…
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling…
Knowledge at Wharton
Many people work on their goals by engaging in positive actions—hitting the gym, planning a trip, or taking guitar lessons. But they may be overlooking one of the most important tools for effecting change: the power of thought.
Harvard Business School professor emeritus Gerald Zaltman recommends…
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.…
Nicole Radziwill, Graham Freeman
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths.
Although a burger is only required by law in that region to contain 47-percent…
Kelly Kuchinski
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
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…
NIST
Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the digital thread, so they turned to the new kid on the block... blockchain, that is.
According to a new NIST report, the security system better known for underpinning…
Knowledge at Wharton
In the 1999 film Office Space, a dark comedy about the mundane conventionality of work, disgruntled software engineer Peter Gibbons tells his new love interest, Joanna, that he hates his job and doesn’t want to go anymore.
When Joanna, played by actress Jennifer Aniston, asks Peter whether he is…
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…
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
Laurel Thoennes @ QD
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
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…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
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…
Chip Bell
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage.
What do Bill Marriott, Ray Kroc, and Al Hopkins have in common?
No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Dirk Dusharme
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…