According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12 months. These statistics are important to take note of and address because the U.S. food supply also represents a huge economic asset, contributing almost $1 trillion to the national gross domestic product (GDP) each year.

How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions? Quality Digest editor in chief Dirk Dusharme and Mike Richman, principal at Richman Business Media Consulting, point out that most manufacturers already recognize that waste, including waste of energy as represented by carbon emissions, costs the supply chain money.¹ This leads to my conclusion that withdrawal from the agreement will not have any significant effect on U.S. carbon emissions.

Involving relevant interested parties

It is a basic principle of ISO 9001:2015 that organizations must identify the needs and expectations of their relevant interested parties, but not all interested parties are relevant. The Paris Agreement offers little identifiable value to organizations, so it is not a relevant stakeholder. Neither are investment banks that had hoped to profit from cap-and-trade mandates.² The supply chain should contain nothing that does not deliver value to the other supply chain participants.

Much has been written about the challenges associated with AI-based decisions. Some documented failures include gender and race biases in recruiting and credit approval software; chatbots that turned racist, and driverless cars that fail to recognize stop signs due to adversarial attacks; inaccuracies in predictive models for public health surveillance; and diminished trust because of the difficulty we have interpreting certain machine-learning models.

When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges, missions, and leaderboards, they achieved a 37-percent increase in participation.

And when Ford Canada gamified its sales and service training, platform usage jumped a massive 417 percent, with big gains in engagement among younger employees.

Saying gamification makes work a game is an oversimplification. In reality, it’s all about leveraging proven psychological principles around our motivation to compete, encouraging habits and behavior that improve business performance.

These principles can also be used in manufacturing to increase engagement in audits, which are critical to quality but often suffer from low participation. Key gamification tools and techniques to consider include mobile apps, competitions, and recognition programs.

Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device quality management systems. ISO 13485:2016 has been adopted by regulatory agencies around the world as a universally harmonized standard.

However, the International Organization for Standardization itself is not a governing regulatory agency; unlike government agencies, ISO does not publish reports to the public of violations during audit findings. This fact makes it nearly impossible for device makers in this market to research and learn from others’ mistakes.

With more than 20 years of experience working in the medical device industry, I’ve seen my fair share of mistakes made during ISO 13485 implementation, with six mistakes in particular that commonly trip up device makers. You can learn from these missteps of others and avoid making them yourself:

In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization. But when you have multiple, disparate plants around the country or the globe, standardization can seem unattainable, as each site operates more like an island with its own way of doing things.

I previously worked with one company that had numerous plants throughout the United States and Europe. Over time, each site had developed unique practices. One specific issue that came up was whether to use the metric system for quality data collection. Unfortunately, the company did not standardize. So, when it was time to run cross-plant reports, the results were in different units, presenting a challenge to comparative analysis.

In contrast, I worked with a separate organization that was very adamant about using a standardized approach and implementing the same quality management system at every site. Standardization made it easy to deploy the system to approximately 80 plants in merely 18 months. In addition to streamlining deployment, standardization enabled the company to perform enterprisewide reporting for better decision-making.

The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities that IATF 16949 covers explicitly, such as six of the Toyota Production System’s (TPS) Seven Wastes as well as crippling supply-chain interruptions, inadequate metrology systems, and more.

IATF 16949 is actually ISO 9001:2015 plus additional requirements, which makes it easy for ISO 9001 users to implement relevant clauses of IATF 16949. ISO 9001 users don’t need to implement all the additional clauses—if they did, they might as well register to IATF 16949—but many of IATF 16949’s key clauses are as relevant to nonautomotive applications as they are to automotive ones. This article will cover what look like the most important ones, although others also might be helpful.

Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug Administration (FDA) announced its intention to adopt the internationally recognized quality management standard ISO 13485:2016 for medical devices. According to the FDA, the revisions are intended to modernize and reduce compliance and record-keeping burdens on device manufacturers by harmonizing current domestic and international requirements.

For FDA-regulated manufacturers, the required actions to close the gap between the FDA’s existing Quality System Regulation (QSR) 21 CFR part 820 and ISO 13485:2016 should not increase manufacturers’ regulatory administration significantly. However, it is important that manufacturers are aware of and prepared for these changes, and they understand what the changes will mean for their businesses. They can do this by seeking industry insight on best practices.

Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published.

Innovation is an increasingly important contributor to the success of an organization, enhancing its ability to adapt in a changing world. Novel and innovative ideas give rise to better ways of working, as well as new solutions for generating revenue and improving sustainability. It is closely linked to an organization’s resilience, in that it helps stakeholders understand and respond to challenging contexts, and seize the opportunities that might bring and leverage the creativity of both its own people and those it deals with.

Ultimately, big ideas and new inventions are often the result of a long series of little thoughts and changes, all captured and directed in the most effective way. One of the most efficient ways of doing just that is through implementing an innovation management system.

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.