Risk Management Article

Lee Seok Hwai’s picture

By: Lee Seok Hwai

Hong Kong scientists teaching a panicked populace to make their own surgical masks with paper towels and metallic wire must surely rank as one of the most Kafkaesque moments of the new coronavirus disease outbreak. But the worst is yet to be if global medical supply chains, already stretched in parts to breaking point, are not shored up to cope with the pandemic.

A desperate shortage of surgical masks, the most visible symbol of the epidemic since China began fighting it at the start of the year, underscores the scale of the problem. The country made five billion masks last year and supplied about half of the global market. But with its people churning through tens of millions of masks every day, China is cranking up domestic production even as it imports medical gear from the West.

Ken Maynard’s picture

By: Ken Maynard

When educational and public sectors consider applying a proven method like lean Six Sigma, the perception persists that this “manufacturing program” will not work in a nonmanufacturing environment. Along with that limiting assumption, there is an underlying expectation within the service industry that it requires a substantially customized approach.

This makes perfect sense. It’s logical. If I’m not making the proverbial “widget”—if I’m processing transactions, delivering services, or providing a learning environment—then how do I use lean Six Sigma? It’s got a proven track record of success in manufacturing, but this success can morph into a hindrance when considering spreading the gains in nonmanufacturing.

If a different approach is necessary to successful lean Six Sigma implementation in the public sector, then how do we adapt the approach without compromising the fundamentals that lead to success?

Sophia Finn’s picture

By: Sophia Finn

Effective and efficient supplier management is possible, but not when we’re still using old tools and expecting different outcomes.

Emailing suppliers to communicate product specs, corrective action requests, or audit reports may be “the way it’s always been done,” but that doesn’t mean it isn’t inefficient and risky. The email black hole is a real thing, and busy quality professionals cannot be expected to remember every supplier correspondence and response. Excel spreadsheets are a favorite for many of us, but how can you ensure data accuracy and accessibility when spreadsheets are stored on someone’s computer or on a shared drive?

When you think about it, using yesterday’s tools to manage suppliers infuses uncertainty, inefficiency, and a lack of traceability and transparency at every step. “The way it’s always been done” introduces a level of risk entirely unnecessary, given the availability of modern, cloud-based supplier quality management solutions.

Jennifer Grant’s picture

By: Jennifer Grant

With Covid-19 continuing to impact many businesses, lead time as well as sourcing new suppliers is increasingly difficult. If you currently outsource manufacturing overseas, it is likely you have encountered some turbulence to your supply chain.

Rapid prototypes and large-quantity production of special precision parts and components are key to many business’s operations. Along with this, an agile business strategy that enables the sourcing of verified suppliers, as well as maintaining production-line efficiency, are critical. With travel to Asia currently stalled, and many factories presently closed or operating at low capacity, this strategy is not easily executed for many companies worldwide. Although engineers have a wide array of companies to choose from to get their machining parts manufactured, the turnaround time can be weeks from order to delivery.

Quality Digest’s picture

By: Quality Digest

This is supposed to be trade-show season. The time when companies send their employees to industry tech shows and user-group meetings to see and experience the latest offerings in their field. A time when companies expend a good portion of their budget on booth space, shipping costs, and hotel and travel expenses to get their products and employees in front of thousands of people.

This year, however, due to concerns about the Covid-19, conferences are being cancelled left and right. From fashion to food to finance, show websites are plastering “cancelled” notices across their home pages. Design News  lists dozens of tech shows around the world that have shuttered or postponed. These include shows from Apple, Facebook, Google, Gartner, and both the China and Korea Semicon shows.

David Pride’s picture

By: David Pride

‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States with the coronavirus outbreak.

I am a physician scientist who practices infectious disease medicine and runs a research laboratory that specializes in viruses. I spend much of my time directing a clinical microbiology laboratory for a large academic medical center. If you’ve ever had a doctor tell you that they are going to test you for a virus, it’s teams like mine that develop and run that test.

When I first heard about the coronavirus outbreak in China, I had no idea I would soon be on the front lines of dealing with this outbreak.

Sean Spence’s picture

By: Sean Spence

The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally. This is a result of the increasing importance of critical infrastructure (CI).

In order to mitigate these negative consequences to organizations—like lost revenue, lost customers and reputational damage—they must have well-structured and defined contingency plans in place to meet operational objectives.

What’s known as critical infrastructure has many different definitions within academic literature and among different governments worldwide. But essentially, CI can be defined as infrastructure so vital that its incapacity or destruction would have a debilitating impact on the economy or the defense of the country and therefore becomes a national security issue.

William A. Levinson’s picture

By: William A. Levinson

The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.1 The reaction to this outbreak, as driven by corrective and preventive action (CAPA), may however save thousands of lives not only this year but in the future. It should also initiate serious thought as to the desirability of reshoring U.S. manufacturing capability that should have never been sent offshore in the first place, and generate new opportunities in distance networking technologies.

The Automotive Industry Action Group’s Effective Problem Solving manual (CQI-20) defines an outstanding nine-step CAPA process that is applicable to almost any problem a manufacturer might encounter. These are essentially:

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at demonstrating and establishing various subclauses of Clause 5—Leadership, to build organizational excellence and assess risk.

Clause 5—Leadership

Words have meaning. Throughout the history of ISO 9001, the terms “top management” or “senior management” have been used to describe an organization’s decision and policy makers. These individuals are ostensibly those who are accountable to themselves or to a board of directors for the company’s success. They have the power to hire and fire, and to establish the organization’s operational infrastructure.

In work with more than 700 companies, the term “management” was most often appropriate because those in charge were directors and benevolent dictators. Very few were true leaders of people who created an environment where everyone could achieve their highest level of success and excellence.

Nico Thomas’s picture

By: Nico Thomas

Each new year brings about a period of reflection, where one can think back on the path that the previous year took us on. 2020 represents an even larger opportunity for reflection as the world enters a new decade. Reflection provides an opportunity to learn and improve, and extends beyond just an individual to include industries and businesses. As a U.S. manufacturing enthusiast, I’m looking back over the past 10 years at how manufacturing has changed, evolved, and innovated so that I can continue to support that evolution.

The U.S. manufacturing industry is entering this new decade in a much different state than when it entered the last. The industry is no longer shaking off the aftereffects of the Great Recession, but it is still grappling with the economic uncertainty that comes with new trade deals, tariffs, and other global uncertainties. There is also the need to keep pace with the ever-increasing speed of technological change. Industry 4.0 and its adoption by U.S. manufacturers has begun to pick up steam, and manufacturing’s digitization is only going to increase. Things like 3D printing, advanced robotics, artificial intelligence, and smart factories are becoming more commonplace in the U.S. manufacturing industry, emphasizing a deepening need for stronger cybersecurity.

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