All News
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster,…
(Quality Digest -- Chico, CA) Quality Digest, for more than 30 years the leading source for quality news and resources, is now available on mobile devices. Check out our website on your smartphone or tablet for exclusive content, in-depth articles and columns, industry news, webinars, and more.…
We all face adversity in our lives. The difference is in how you approach it. If you’re willing to look past the challenge and have the determination to overcome it, you can achieve more than you ever dreamed was possible.
In 1986 I lost my vision due to a pediatric brain tumor. I lost my vision…
Reducing waste, implementing efficiency-promoting practices, and continuously improving operations are the main goals of lean manufacturing ideology. These tasks may seem daunting for a manufacturer at the start of an improvement program, but there are many concrete steps that can be taken to…
As a project manager, you’re most likely familiar with the five project phases outlined in the Project Management Body of Knowledge (PMI, 2013): initiating, planning, executing, monitoring and controlling, and closing. However, do you know the 47 project management “processes” that these five…
(Frost & Sullivan: London) -- Increasing procedure volumes have been fuelling the adoption of custom procedure trays and packs (CPTP) in Western and Eastern Europe. In part, the expanding aging population, which is more likely to develop chronic wounds as they have more medical issues…
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The…
(METTLER-TOLEDO: Columbus, Ohio) -- The latest addition to the METTLER TOLEDO CI-Vision portfolio is the newly developed Label Check Station (LCS), which prints and verifies labels automatically. Food manufacturers can use the LCS to print high-quality, product-specific labels at a rate of up to…
Sometimes we receive unreasonable and confusing directions, and sometimes we give them.
As in the short video clip below, even if the systems behind this confusion are sound and the motivations reasonable, when you put them together they can create a frustrating no-win situation:
Here are a few…
Business runs on estimates. “How long do you think that might take?” we naively ask. Then when someone tells us how long they think something might take, we write that down and hold them to it.
Merriam-Webster’s says the very word “estimate” means to roughly calculate or judge the value, number,…
(Hexagon Metrology: North Kingstown, RI) -- Hexagon Metrology has released the RS3 upgrade package, delivering a dramatic performance improvement for the ROMER Absolute Arm with integrated laser scanner. The RS3 doubles the scan rate of the previous RS2 integrated scanner, enabling users to…
Regular readers of my column, as well as my Twitter and LinkedIn feeds, will know that in recent months I have posted many critiques on various aspects related to the products, promotion, and practice of lean management. Why now? The reason is that 20 years of engagement in lean offers the unique…
A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the certification audit.…
Management systems programs such as ISO 9001 and ISO 14001 were originally implemented to help organizations gain market access, satisfy mandatory customer requirements, streamline processes, manage growth, drive continual improvement, and generally keep up with the competition.
In today’s…
As a member of Minitab’s technical support team, I get the opportunity to work with many people using design of experiments (DOE).
People often will call after they’ve already chosen their design, run the experiment, and identified the important factors in their process. But now what? They have…
(ANSI: Washington, D.C.) -- World Standards Day is celebrated annually around the world to increase awareness of the role that standards play in the global economy. The World Standards Day Paper Competition is co-sponsored by The Society for Standards Professionals (SES) and the U.S. Celebration…
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons.
Many hospital systems don’t know their real costs
It’s been said that the first step in fixing a problem is realizing…
Magline is a leading manufacturer of route distribution solutions. Back in 1947, the company was founded to “make things out of magnesium” because such products offered unrivaled strength and lightness. Magline’s first product was a modular magnesium hand truck that caught on rapidly. That was a…
Have you heard the one about the robot that hops a train down to the brewery? It may not seem likely that robots, beer, and high-speed trains have much in common, but the industrial quest to coax more output from no more input (translate that to efficiency) can make for some unlikely bunkmates.…
There are many techniques to visualize your work. Obviously, our most popular is Personal Kanban. The way the human brain is constructed, we’re very sensitive to the content of visual information, and we quickly assimilate it. Just walking down the street, we’re exposed to different buildings with…
The future of retailing is in upheaval, and the country’s malls top the list of potential collateral damage. Tenants are pulling out as chains scale back and retailers continue to struggle with how to adapt to the rise of e-commerce and other changes in shopping behavior, and to better target a…
(ECM: Topsfield, MA) -- ECM Global Measurement Solutions (ECM) is a satisfied user of SpatialAnalyzer (SA) software from New River Kinematics (NRK). Ray Ryan, vice president of operations for ECM, will present a paper at the 2015 SA User Conference titled “Evolutionary Approach to Automation.”…
(SME: Dearborn, MI) -- With manufacturing a driving force of economic growth in the Northeast, as well as the United States, more than 12,000 business owners, engineers, designers, production managers and purchasing executives will gather May 12–14, 2015, at EASTEC, the East Coast’s premier…
Good data collection requires eight questions to be addressed. The first four involve designing the collection.
Most of these issues were discussed in my last column. To summarize:1. Why collect the data? • Is there a clear objective for this collection?
2. What method(s) will be used for the…
The more strategy development work I do with organizations, the more I’m becoming aware of a prevalent pattern, one that I find counterproductive, even detrimental. It concerns the starting point for their strategy work: In nearly every case, they begin with convergent thinking, the polar opposite…
