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AssurX GDPR Compliance: Benefits and Lessons Learned
AssurX
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU) by making companies more accountable for how…
The American Chamber of Horrors
Vanessa Burrows, Suzanne Junod, John Swann
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods. A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact…
Loose Lips Sink Companies
Dirk Dusharme @ Quality Digest
If asked whether you guard your company’s secrets, most of us would say, “Well, of course I do.” But I’m guessing that if you are a remote worker, or do any work while on the road, you are blithely handing out company secrets and don’t even know it. If nothing bad has happened yet, it’s only…
Electronic Work Instructions Address Manufacturing Employee Retention, Quality
Thomas R. Cutler
Although automation has been successful in replacing repetitive, simple tasks, the human workforce still plays a critical role in manufacturing. Even the most sophisticated and automated manufacturing operations rely on human operators to configure, run, and properly maintain production equipment…
Consider the Decision Making First
Fred Schenkelberg
Reliability activities serve one purpose: to support better decision making. That is all they do. Reliability work may reveal design weaknesses, which we can decide to address. Reliability work may estimate the longevity of a device, allowing decisions when compared to objectives for reliability.…
Sharing Lessons Learned Improves Quality and Operational Excellence
Aiman Sakr
Does your organization benefit from lessons learned? Does it learn from previous quality issues? A vast amount of learning takes place every day in every manufacturing facility. Do global manufacturing companies share experiences gained from resolving quality issues between overseas plants? And…
ROI Is Important, But...
Rick Barker
Return on investment (ROI) is the subject of many discussions about ergonomics, and rightfully so. Musculoskeletal disorders are an expensive and preventable workplace injury, with total costs averaging nearly $30,000 per case, according to data from the Occupational Safety and Health…
What Do You Look for in a Mobile Quality Management System?
Richard Wilson
According to the Verdantix global survey of 382 EHS decision-makers, 57 percent  expect to use mobile apps in 2018 either widely across all their facilities, at multiple facilities, or as a pilot project at one facility. Mobile has become a game changer for modern quality management systems (QMS).…
Connected Cars Can Lie, Posing a New Threat to Smart Cities
Qi Alfred Chen, Z. Morely Mao
The day when cars can talk to each other—and to traffic lights, stop signs, guardrails, and even pavement markings—is rapidly approaching. Driven by the promise of reducing traffic congestion and avoiding crashes, these systems are already rolling out on roads around the United States. For…
Drug Shortages Pose a Public Health Crisis in the U.S.
Sharona Hoffman
On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans. The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a…
Three Things Medical Marijuana Startups Need to Thrive Despite Regulatory Uncertainty
Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this mean…
Cybersecurity for Manufacturers
Steven Brand
Many consider 2017 the “worst year ever” for data breaches and cyber attacks, largely due to the rise in ransomware, and IT experts predict it’s only going to get worse. According to the Online Trust Alliance (OTA), a nonprofit that works to develop tools and best practices that enhance internet…
Inside Quality Digest Live for June 15, 2018
Dirk Dusharme @ Quality Digest
In our June 15, 2018, episode of QDL, we get a field report from the HxGN LIVE user conference, examine the “story of quality,” and consider the importance of experience. HxGN Live recap Mike Richman went to HxGN LIVE... but I didn’t. I relive it vicariously through Mike’s field report. “A…
Building the Story of Quality
Tim Lozier
Quality management systems (QMS) have become strategic components that touch more and more of the business today. With new versions of QMS standards, and the enrollment of all people in the quality management effort, the need for cohesion from one system to the next is becoming critical.   Let’s…
NIST Updates Risk Management Framework to Incorporate Privacy Considerations
NIST
Augmenting its efforts to protect the nation’s critical assets from cybersecurity threats as well as protect individuals’ privacy, the National Institute of Standards and Technology (NIST) has issued a draft update to its Risk Management Framework (RMF) to help organizations more easily meet these…
Sino-U.S. Trade: Truth From the Shop Floor
Ryan E. Day
With the threat of a trade war between China and the United States looming, business relations between Asia and the West have not been this hot a topic since the Japanese Economic Miracle that was birthed shortly after WW II. Today, it is China’s turn on center stage as its soaring economic growth…
Made in China: From Scary Bad to Scary Good
Dirk Dusharme @ Quality Digest
In part one we saw that China has made great strides in terms of product quality, notably in the tech sector. But it still has a long way to go in other products. Driven by the growing middle class, who like all middle class buyers want value for their money, and by the Chinese government’s desire…
Made in China: From Scary Bad to Scary Good
Dirk Dusharme @ Quality Digest
Back in the 1950s and 1960s, Japanese products were synonymous with cheaply made. Anyone over the age of 50 probably remembers cheap Japanese transistor radios when they were a kid. We all believed, in the day, that the more transistors a radio had, the better. That wasn’t necessarily true, but try…
Use Comprehensive Process Assessment to Support ISO 45001
William A. Levinson
A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001. The concept can be carried even…
Defending Hospitals Against Life-Threatening Cyberattacks
Mohammad Jalali
Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They…
Boot Your Root (Cause)
Matthew E. May
Process improvers the world over rally around root cause analysis as if it were the holy grail of all things organizational. But is it? Understanding the root cause of a problem certainly makes sense in the context of a present day situation carrying the potential for a correct answer or solution…
Brightstarr Bolsters Data Security Confidence With ISO/IEC 27001 Certification
Ryan E. Day
Unily is a leading digital workplace platform designed by BrightStarr to improve engagement, productivity, and efficiency for global enterprises. Unily is also a SaaS solution. That is, it’s served up via the cloud. Meaning that—with more than a million users, including the likes of Shell, Hershey’…
The Clock Is Ticking on the Transition to IATF 16949:2016
Terry Onica
The new automotive quality management system (QMS), IATF 16949:2016, was released in October 2016, and it officially went into effect on Jan. 1, 2017, along with revisions to IATF Rules for Achieving and Maintaining IATF Recognition, Fifth Edition. Starting Oct. 1, 2017, all automotive QMS audits…
The Fear of Reliability
Fred Schenkelberg
Mean time between failures (MTBF) is a symptom of a bigger problem. It’s possibly a lack of interest in reliability (which I doubt is the case). Or it’s a bit of fear of reliability. Many shy away from the statistics involved. Some simply don’t want to know the currently unknown. It could be the…
ISO 45001: Understanding the New International Standard for Occupational Health and Safety
BSI
Organizations worldwide recognize the need to provide a safe and healthy working environment, reduce the likelihood of accidents, and demonstrate they are actively managing risks. ISO 45001 will provide an internationally accepted framework that will help protect employees as well as protect the…

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