Standards Features

John Flaig's picture
John Flaig
In a similar vein to Donald Wheeler’s excellent article on process capability confusion I would like to submit the following example of thinking that you are doing the math right and getting an...
AssurX's picture
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to...
Ellen Kominars's picture
Ellen Kominars
While Hank Matousek Sr. was perfectly content in his position as quality control manager at a bearing company during the late 1960s and early 1970s, he had no idea that his employer’s growing...
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...
Inderjit Arora's picture
Inderjit Arora
Certifications often drive the implementation of a system approach, based on ISO standards. The primary implementation demand is for ISO 9001. Certifications do have initial costs and then...
Shobhendu Prabhakar's picture
Shobhendu Prabhakar
Whenever the term “nonconformance report” (NCR) comes into project home offices or construction and fabrication sites, it is often seen as a negative, and personnel are typically reluctant to...
Sandrine Tranchard's picture
Sandrine Tranchard
Depression and mental health conditions are on the rise globally. Affecting more than 300 million people of all ages across the world, depression causes immense suffering to people and their...
Barbara A. Cleary's picture
Barbara A. Cleary
Complying to requirements and standards is sufficient to meet the objectives of injury and accident prevention, and ensure the health and safety of all employees—right? In his article, “We’re...
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...
Mike Richman's picture
Mike Richman
In our latest episode of QDL from this past Fri., April 21, 2017, we examined the importance of the various steps in the plan-do-check-act (PDCA) cycle, considered what United Airlines could have...
Laurie Locascio's picture
Laurie Locascio
Like a lot of scientists, I am very goal-oriented, so after I got my Ph.D. in toxicology, I set out to become a leader in my field by the time I was 40. To get there, I knew I had to be...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In last week’s Quality Digest Live: Enterprise quality management vs. integrated quality management. Our deteriorating U.S. infrastructure. Stress testing composites. The Fowler Precision Mobile Tech...
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....
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....
David Sefcik's picture
David Sefcik
Believe it or not, I love to grocery shop. Besides getting to pick all my favorite foods, I love the challenge of getting the best deals—and a challenge it can sometimes be. Without a doubt, I have...
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,...
Mike Richman's picture
Mike Richman
The March 24 episode of QDL offered a potpourri of topics, including news and features from the realms of academia, corporate culture, and politics. Here’s a quick recap: “Winners Selected for the...