All Features
Jenna Gallegos, Jean Peccoud
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…
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…
Bhargav Mitra, Robert McCausland
Google might be in trouble for collecting the personal data of its users, but many companies have a growing incentive to rid their hands of the data that users entrust them with. This is because of growing costs of holding onto it.
A major cause is the rising number of cyber attacks where hackers…
Scott Berkun
On Tuesdays I write about the top-voted question on “Ask Berkun.” This week’s question came from J.R., who wrote: “What is a favorite theory that you wish more people understood?”
A favorite theory that I wish was more well-known is the Satir Change Model. It’s popular in some circles, but often…
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…
William A. Levinson
ISO 9001:2015, Clause 6.1—“Actions to address risks and opportunities,” relates to Clause 4.1—“Understanding the organization and its context.” The external context includes the social environment, which in turn includes social networking, a potentially devastating vehicle for the delivery of “…
Peter J. Strauss
The recent spate of natural disasters that devastated parts of North America included a violent variety of events. There were three major hurricanes—Harvey, Irma, and Maria—wildfires in California, an earthquake in Mexico, and tornadoes in Oklahoma.
One thing these calamities have in common: They…
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…
Rob Magee
I have a friend who owns a hardware store. One morning during the 1980s, he strolled into his back-room office to start his day. He was shocked to discover his safe was missing—along with a lot of cash inside.
The thing is, when he’d arrived a few moments earlier, all the doors had been locked,…
Tab Wilkins
There’s no question the digital manufacturing revolution is racing at us. As a small or medium-sized manufacturer, how close are you to already being “smart?” Here are five steps in the journey to becoming a smarter digital enterprise.
First and foremost, be cybersecure. Cybersecurity is an…
Dirk Dusharme
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…
William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
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…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
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…
Scott Shackelford
Hackers around the world are attacking targets as diverse as North Dakota’s state government, the Ukrainian postal service, and a hospital in Jakarta, Indonesia. Unfortunately, many governments—in the developing world, and even cash-strapped states and local communities in the United States—lack…
Jason Furness
You have defined what you want as an outcome of the change program; you have looked at how to understand your financial statements and how to use them to assess options. You have looked at the obstacles that lay in your path. Now we are going to start to look at your business, specifically.
Why…
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…
Fred Schenkelberg
The term “Weibull” in some ways has become a synonym for reliability. Weibull analysis = life data (or reliability) analysis. The Weibull distribution has the capability to describe a changing failure rate, which is lacking when using just mean time between failures (MTBF). Yet, is it suitable to…
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…
Jeremy Straub
Some people are afraid that heavily armed artificially intelligent robots might take over the world, enslaving humanity—or perhaps exterminating us. These people, including tech-industry billionaire Elon Musk and eminent physicist Stephen Hawking, say artificial intelligence technology needs to be…