The National Institute of Standards and Technology (NIST) was directed by the federal government to define cloud computing to assist federal agencies in implementing cloud architectures.

In 2011, NIST published NIST SP 800-145—“The NIST Definition of Cloud Computing” and defined cloud computing as: “A model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction. This cloud model is composed of five essential characteristics, three service models, and four deployment models.”¹

There’s much to learn about the benefits that this business model can bring to organizations. Cloud computing will transform how you do business. This article explains the benefits of using a cloud architecture for calibration management software systems. The following benefits and topics will be discussed: work from anywhere, always on, reduced IT costs, scalability, automatic updates, reduced coordination costs, improved quality control, disaster recovery, environmental sustainability, increased competitiveness, stronger security, and compliance considerations.²

A manufacturer of the fabric used to reinforce car tires might not seem an obvious source of innovation inspiration. But in just a few years, Kordsa, a part of the Turkish industrial conglomerate Sabancı Group, transformed itself from a price-driven maker of commodity products into a provider of innovative solutions to clients across multiple industries.

Although there are many reasons for Kordsa’s remarkable success, the process began with senior executives giving permission to everyone in the organization to innovate.  

Of course, most organizations recognize the importance of encouraging innovation. Good ideas can streamline production processes, help save money and open up potential new markets. Yet despite the compelling evidence, it’s not always obvious what steps are needed to integrate innovative practices and thinking across an organization.

Three years’ worth of new graduates have entered the workforce entirely remote due to the changing atmosphere of the work world, and more companies than ever are fully remote. Millions of employees have experienced remote work for the first time and don’t plan to go back to brick-and-mortar offices. After Covid hit, it became clear that remote isn’t just a trend; it’s the future.

Although many of the world’s most forward-thinking organizations have adapted to remote, achieving excellence with that format requires more than just a Zoom license and permission to work from home. Remote success requires policies, benefits, leadership, and processes to be effective and inclusive. With or without the existence of Covid, these are transformative shifts that aren’t going away. Remote HR needs and development are now an asset to every company. It’s no longer enough to address remote effectiveness. In order for companies to thrive and grow, effective remote leadership from human resources departments is a mission-critical element of any competitive business.

Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.

The FDA’s requirement of an annual water-risk assessment by farms to “determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination” arguably creates a hazard analysis and critical control point (HACCP) for produce. This requires that produce growers take stock of what pathogen risks surround them on nearby lands, like cattle operations or wild animal populations, that might impact water quality, and take measures to protect produce consumers from possible infection from a deadly pathogen.

With respect to risky adjacent land operations, it’s unclear at this point what a grower can do to mitigate those risks short of relocating, or treating or testing water. However, this rule seems to remove certain water-testing requirements. One method of confirming if HACCP is working is science-based  testing to help understand if the mitigation measures are in fact working.

If you’re looking for information on medical-device design controls and product development, you can find a practically endless number of articles, videos, and podcasts with a few quick online searches. Yet with so much out there on these topics, there’s a glaring omission of a closely related subject: design transfer.

Not only is design transfer left out of many guides and overviews of the product life cycle, it’s also relegated to just a single sentence in 21 CFR Part 820: “Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.”

If that sounds too vague to be of much help, you’re not alone. With so much uncertainty around design transfer, let’s take a closer look at the process, when it should happen, and what it should entail.

What happens during design transfer?

The basic definition of design transfer is the process by which a medical device’s design is transferred to production. However, this is a deceptively simple way of explaining a much more complex and ongoing process.

The ISO 9001 standard talks about the relationship between the company and the customer in a couple of places. First is management’s responsibility to make sure that customers’ needs are a top consideration, and that their requirements are met. Then that customer satisfaction is improving, and customer satisfaction data are analyzed.

Many books deal with improving customer satisfaction, and a few focus on loyalty. Loyalty is a topic unto itself because it’s significantly different from satisfaction and is inherently measurable through behaviors that customers exhibit. In many organizations these three topics are treated as separate entities that don’t connect with each other. Many companies have siloed customer requirements from customer satisfaction measurement, and many don’t even look at customer loyalty. However, these three things are innately related to each other. One cultural development has enabled a strong connection among the three: social media.

You may recognize the following quote from Friedrich Nietzsche, or more recently from Kelly Clarkson: “What doesn’t kill you makes you stronger.” I’ve thought about this often during the last 22 months in context of the horrible pandemic and, more parochially, in relation to the efforts of many client organizations to sustain continuous improvement in a period of great uncertainty. There are more than a few parallels.

Here are some that occur to me.

Burning platforms are finite

The 17th-century playwright Samuel Johnson said, “When a man knows he is to be hanged in a fortnight, it concentrates his mind wonderfully.” The sense of urgency generated by immediate threats, commonly referred to as burning platforms, has kick-started many a lean transformation, including at Toyota. There, as Taiichi Ohno noted, “The oil crisis opened our eyes,” and it was the event that kicked the Toyota Production System (TPS) into high gear during the 1970s.

The manufacturing industry was thrown into the spotlight early in the pandemic as consumers rushed to stores, panic-buying everything from canned goods to water bottles. Since then, the industry has had more than its fair share of challenges, including the critical ramp-up of vaccine and pharmaceutical production, supply chain disruptions, and more. All these factors have helped usher in a period of rapid digital transformation across the sector.

The pandemic has supercharged AI investment and adoption by manufacturers and other industrial sectors. Across the board, we’re hearing from customers that they have accelerated their digital strategy plans, many of which revolve around AI adoption, by years as a result. Below are a few key trends and predictions on how AI’s role will impact and evolve within the industrial sector over the next year.

AI will help address a growing skills gap

For the manufacturing industry, which has already been experiencing a talent gap and an aging workforce, an acceleration of AI adoption will help recruit new talent. As innovation speeds up, industrial markets and applications will be responsible for some of the biggest AI breakthroughs of 2022 and beyond. This will draw new tech talent into the industry that wants to be at the forefront of this innovation.

With membership in ASQ down, ISO 9000 series certifications down, and an unnerving reduction in quality management staff in many companies during the pandemic, today’s quality professionals are justifiably concerned about their future and career choice.

Here’s my take on the future of quality: It has never been a more needed and noble profession. There has never been a time in industry when the tools, strategies, and hard-earned wisdom of a quality professional has been more valuable. The degree of complexity of some of our production and service processes is astounding; couple that with the zero-defect expectations of customers as well as those of your own CFOs as they guard the company coffers from liability lawsuits.

At Quality Digest we see an increasing number of areas that need the expertise of quality professionals. In my 2021 interview with Ann Jordan, CEO of ASQ, she said:

“The pandemic, as horrible as it is, has put quite a spotlight on how critically important quality processes are. One perfect example is in the development, storage, transportation, and distribution of the Covid-19 vaccines. It has been nothing short of amazing how this has brought C-suite awareness of the critical importance of quality processes and the professionals who manage them.”