All Features
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to…
Jack Dunigan
The concept of leading from behind appears in the news fairly often. The term has found expression via academia, in an idea put forth by Linda Hill of the Harvard Business School. She claims it originated from a reading of Nelson Mandela’s autobiography, in which he likened leaders to shepherds…
(9001Academy: Zagreb, Croatia) -- The experts at 9001Academy have produced a matrix to help address some of the questions and confusion stemming from the soon-to-be-released ISO 9001:2015 update to the ISO 9001:2008 quality management systems standard. The matrix can be downloaded in PDF form here…
Matthew Barsalou
I see a weakness in management models. It’s not the models themselves that are the problem, but rather their application in smaller organizations. Those of us with either business experience or a business-related degree can be expected to have an understanding of at least a few management models,…
Annette Franz
A couple weeks ago, I participated in a webinar with Kyle Antcliff of Intradiem. We talked about the employee experience, employee journey mapping, and solutions that drive or affect workforce efficiency. During the presentation, a lot of employee experience terms were used, and I attempted to…
ISO
(ISO: Geneva) -- Voting has begun on the draft version of ISO 45001, which sets the requirements for an occupational health and safety management system.
ISO 45001 is currently at the committee draft stage of development, the first consultation phase. During this stage, the countries (ISO members…
Alan Nicol
There are a great many risk management tools available, in a variety of forms. Most of us are familiar with failure mode and effects analysis (FMEA) for design risk management, or some other form of risk matrix for project risk planning.
But what do we use for real-time decision making? Our…
Rob Harrison
Organizations face multiple challenges when selecting a vendor and planning the implementation of enterprise quality management system (EQMS) software. The potential for failure (assuming that all the functional and nonfunctional, usability, deployment model, and support requirements are…
Bob Emiliani
In a recent article in the Dec. 28, 2014, issue of The Wall Street Journal, “Colleges Need a Business Productivity Audit,” authors Frank Mussano and Robert Iosue argue that colleges should be audited, as business are, “to identify unprofitable practices.”
Audits are the answer to structural…
(ZenQMS: Conshohocken, PA) -- Join ZenQMS and BioProcess Technology Consultants (BPTC) on April 15, 2015, for food, drinks, and learning at the CIC in Kendall Square from 4:30 p.m. until 6:30 p.m.
Taylor Burtis from BPTC will offer a presentation “What Works and What Doesn’t in QMS Document…
Kelly Kuchinski
Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will…
Society of Manufacturing Engineers
(SME: Dearborn, MI) -- Continuing to set the standard for operational excellence and an improved workforce, the Lean Certification Alliance has introduced customer-driven improvements to its Lean Certification program, a globally recognized standard for lean principles and practices.
Lean…
Larry Maggiano
Creating quality coordinate measuring machine (CMM) measurement programs takes time, and production cycles are often delayed while waiting for the measurement programs to be created. But software that works directly from model-based definitions can drastically decrease that time.
The move from 2D…
Jim Benson
Modern business drowns in overhead it can’t even see. I’ve seen companies spend hours denying an expense request on a $20 book. I’ve seen teams spin for weeks planning projects that change dramatically in the first week due to a simple implementation lesson. I’ve seen people overworked and…
Alexandra Brown
Hospital leaders are feeling increasing pressure to find ways to thrive in our changing healthcare system. A C-suite that is removed from daily hospital operations is a liability in this era of process improvement and hands-on progress.
Here are four characteristics hospital leaders need to move…
Phillips Precision Inc.
(Phillips Precision: Boylston, MA) -- Phillips Precision Products Division has designed a work-holding kit for Vision Inspection that complements its Open-Sight LEAN, fast-swap fixture plate system. The work-holding kit includes trigger-finger and trigger-point hold downs, a clear acrylic platform…
Jack Dunigan
When I was last in Africa, I found a book in the library of the home I stayed in about the early days of safari hunting. The industry is tightly regulated these days and was, to a certain degree, even during the early part of the 20th century. The hunters and guides were a hardy and courageous lot…
William A. Levinson
Two recent “Consumer Watchdog” articles in the Wilkes-Barre, Pennsylvania, Times Leader, as well as reports of General Motors’ ignition switch problem, give the perception that GM’s position on ISO/TS 16949 is “Do as we say, not as we do.” If a major automaker that requires its suppliers to meet…
Thomas R. Cutler
Much has been written about the different styles of management between the genders. Although there are still few women in top leadership, particularly in manufacturing, learning from them, even anecdotally, can provide insight into the current state of leadership and a future where more women are…
Jeffrey Phillips
After posting “Don't rock the boat innovation,” I was asked by a few folks a very interesting question. It was: What does it take to be a good innovator in a corporation?
It’s fairly easy to be an innovator in a small company or as an entrepreneur. In fact, you need to rock the boat in small…
The QA Pharm
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”
Having procedures is certainly…
Women in Manufacturing
(WiM: Cleveland, OH) -- Women in Manufacturing (WiM) invites interested parties to submit an application to speak at SUMMIT 2015, scheduled for Sept. 23–25, 2015, in Minneapolis, Minnesota.
This annual event is geared toward women who have chosen careers in manufacturing and want to share…
Bill Kalmar
D uring the last year or so we’ve been subjected to automotive recalls and government mismanagement. There’s a distinct difference in how these incidents are handled. In the corporate world, people who have been responsible for misconduct or malfeasance are, in general, summarily fired. In…
Bill Reilly
I have heard people say that geometric dimensioning and tolerancing (GD&T) is a black art, and I agree—it can almost seem that way sometimes. My experiences in coordinate metrology throughout the past 20 years demonstrate a widespread lack of understanding, confusion, and even resentment for…
Mary McAtee
In almost everything in quality there are multiple facets of responsibility. The same applies when we talk about cybersecurity and threat assessment.
The last time I spoke about this topic I addressed our responsibility for protecting our own organization’s intellectual property and security.…