All Features
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,…
