Risk Management Features

Winnie Ip's picture
Winnie Ip
You may have heard that it takes 21 days to form a new habit. Well, it turns out that’s just a myth. Researchers found that, on average, it takes people more than two months before a new behavior...
AssurX's picture
AssurX
A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at...
DNV GL's picture
DNV GL
The internet of things (IoT), robotics, augmented reality, 3D printing... look at megatrends, and despite their unique attributes and myriad differences, you’ll find that they all have one thing in...
Mark Bartholomew's picture
Mark Bartholomew
Ethics lawyers and historians have argued that Donald Trump has blurred the line between his public office and private business interests in an unprecedented fashion. In another sense, it’s part of...
William A. Levinson's picture
William A. Levinson
Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and...
Ryan E. Day's picture
Ryan E. Day
I like my job in journalism. I get some interesting invitations from some interesting people. Last Friday my inbox greeted me with “The American Homebrewers Association (AHA) is throwing a rally in...
Volodymyr Bilotkach's picture
Volodymyr Bilotkach
On April 9, 2017, a passenger was forcibly removed from a United Airlines flight from Chicago O’Hare to Louisville after the carrier was unable to find volunteers to accommodate four of its...
Knowledge at Wharton's picture
Knowledge at Wharton
The mismanagement of bet-the-company business crises has become pandemic. Consider just the most recent examples. In December 2016, Yahoo disclosed that three years earlier hackers had stolen...
Fred Schenkelberg's picture
Fred Schenkelberg
A conversation the other day involved how or why someone would use the mean of a set of data described by a Weibull distribution. The Weibull distribution is great at describing a dataset that...
Gleb Tsipursky's picture
Gleb Tsipursky
Let’s say you’re interviewing a new applicant for a job, and you feel something is off. You can’t quite put your finger on it, but you’re a bit uncomfortable with this person. She says all the...
Michael Causey's picture
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the...
Chad Kymal's picture
Chad Kymal
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment....
Michael Jovanis's picture
Michael Jovanis
Sponsored Content Particles of metal in children’s medicine. Adulterated baby formula. Spontaneously combusting smartphones. When scandal is only a tweet away, companies can’t hide from quality...
Ryan E. Day's picture
Ryan E. Day
Sponsored Content My wife and I purchased a new car this year. The employee handling the closing paperwork gave a compelling presentation concerning the extended warranty, which we also purchased....
Inderjit Arora's picture
Inderjit Arora
Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check,...
Timothy Lozier's picture
Timothy Lozier
Compliance is a common term that is very broad, and many companies interpret compliance as a host of different items. It can be related to quality, safety, or operations, but it encompasses a long...
Greg Anderson's picture
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital...
Jeffrey Phillips's picture
Jeffrey Phillips
The attempt to eliminate noise from an operating system or a business process is an interesting and perhaps worthwhile challenge, until one considers the question: What is the real signal? What is...
Jon Speer's picture
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not...