Content By Quality Digest

Yosef Ayzencot’s picture

By: Yosef Ayzencot

Starting a business is a costly investment. According to U.S. Bureau of Labor statistics, more than half of businesses fail within the first five years of opening. Adding to this pressure were the nationwide staffing challenges during the “Great Resignation” and then the “Great Reshuffle.” This type of workforce back and forth leaves business owners and human resource managers with constant whiplash while the needs of the business continue to go unmet. The problem is finding quality employees and keeping them engaged.

As a co-founder of 26 Motors, a full-service and independent pre-owned car dealership, I can only speak from experience within the niche car sales market. Still, the principles should be much the same no matter what your business sells or provides.

Grant Ramaley’s picture

By: Grant Ramaley

The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.

But by 2003, ISO 13485 had changed so significantly that the FDA QSR was no longer aligned. Now the FDA wants to update the QSR to align it with ISO 13485:2016. But will that solve the problem? Can the FDA and industry use the new QSR in a cooperative way?

Why the FDA needs to cooperate better with industry

A 2008 U.S. Government Accountability Office (GAO) report indicated that foreign manufacturers see an FDA inspector about once every 26 years, unless they make high-risk devices. Overseas high-risk device makers are visited perhaps once every six years. These numbers haven’t significantly changed. A review of foreign inspections saw a bump in 2012, but a small bump—not one that would satisfy the mandate to audit all manufacturers, worldwide, every two years.

The issue is manpower: To say the FDA has “capacity issues” and is unable to meet its congressional mandate to inspect every two years is an enduring and extreme understatement.

John Courtney’s picture

By: John Courtney

Customers are the lifeblood of any business. Without them, there would be no profits to distribute, no people to serve, and no reason to continue operating. To keep your business running on a path to growing success, you need to offer a customer experience that will make customers choose your brand every time.

The importance of customer experience

When a customer interacts with your brand, whether they’re simply browsing through your website, buying a product, or creating a review of your service, this is already part of the customer experience. What they feel, do, and think at that moment affects their whole perception of your brand. Their impression of it, whether positive or negative, can make or break your business.

Customer experience is also a way for businesses to communicate with their customers on a deeper level. What you do matters more than what you say. Giving a great customer experience demonstrates that you prioritize customers’ needs and wants, which leads them to prefer your brand over others.

Dawn Bailey’s picture

By: Dawn Bailey

According to a survey of a broad cross-section of CEOs, the Foundation for the Malcolm Baldrige National Quality Award noted that “deploying strategy is three times more difficult than developing strategy. If deployment is so challenging, the questions [should be], Are you making progress? How do you know?”

Understanding perceptions that lead to engagement

This introduction was part of the initial publication of the Baldrige self-assessment tool “Are We Making Progress?” and its companion document, “Are We Making Progress As Leaders?” Now in their fifth revisions, these tools were designed to help leaders understand the perceptions that provide insights about deployment and engagement across an organization. Such perceptions can help decision makers focus resources on key areas of improvement and communication efforts that will have the most impact, as well as recognize opportunities for innovation.

Quality Digest’s picture

By: Quality Digest

(Tooling U-SME: Chicago, IL) -- Continuing its decades-long tradition of harnessing technology to advance manufacturing training, Tooling U-SME, the leading provider of manufacturing training solutions, is showcasing its new Virtual Labs at the International Manufacturing Technology Show (IMTS), Sept. 12-17, 2022.

This innovative, immersive virtual reality training curriculum bridges the gap between learning and doing to enhance productivity, increase safety, lower costs, and engage a younger workforce. IMTS visitors may experience the Virtual Labs by visiting Tooling U-SME in Booth 431678, the SME Education Foundation in Booth 215100, or the SME Technology Hub in Booth 236900, where live, hands-on demonstrations will be taking place throughout the event.

Using a Meta Quest 2 headset or through their desktop or laptop computer, trainees tap into applied learning through virtual reality. By providing realistic, immersive experiences for learners to work with simulated equipment, Tooling U-SME Virtual Labs accelerate competency for real-world manufacturing situations.

Prashant Kapadia’s picture

By: Prashant Kapadia

Workforce scarcity and remote employment made it challenging to maintain industrial machinery during and after the Covid-19 epidemic. With the global industrial automation market expected to nearly double in the next six years, maintaining an increasing number of assets will result in more unscheduled downtime, higher production losses, and detrimental effects on long-term machine health. Many firms have switched to calendar-based maintenance to avoid this.

Quality Digest’s picture

By: Quality Digest

(Omnex: Ann Arbor, MI) -- Omnex has announced its latest webinar, “Automotive SPICE for Cybersecurity,” scheduled for Aug. 25, 2022, at 3 p.m. Eastern. 

With vehicles increasingly software-defined in development, along with V2X communication and over-the-air (OTA) communication, cybersecurity has become central to automotive product design. ISO/SAE 214—“Road Vehicles—Cybersecurity engineering” specifies engineering requirements for cybersecurity risk management of concept, product development, production, operation, maintenance, and decommissioning of electrical and electronic (E/E) systems in road vehicles, including their components and interfaces. Moreover, the UNECE R155 regulation requires, among other things, that vehicle manufacturers identify and manage cybersecurity risks in the supply chain.

Automotive SPICE is a recommendation of the VDA (German automotive industry) to identify process-related product risks. To incorporate cybersecurity-related processes into the recommendation, additional processes have been defined in Automotive SPICE.

Quality Digest’s picture

By: Quality Digest

(GBMP: Plymouth, MA) -- The Greater Boston Manufacturing Partnership conference is coming Sept. 28–29, 2022, to Springfield, Massachusetts, and will focus on identifying and sharing the causes of successful lean transformation as well as overcoming constraints to collaboration.

“It’s hard to argue with the ideal of everyone working together to achieve a common purpose, but true collaboration is a catalyst seen in very few organizations; we call it the collaboration effect,” says GBMP president Bruce Hamilton. “Respect for people and human development cannot be truly realized without it. Business results, too, will be limited. Lacking a spirit of collaboration, persons are marginalized in their own work groups, departments work at cross-purposes, managers compete for resources, and customers and suppliers intentionally operate at arm’s length.”

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