AssurX’s picture

By: 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 medical device manufacturers.

Ellen Kominars’s picture

By: 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 financial woes and a pending layoff would become his surprise catalysts to found Grind All Inc. Not surprising, though, was that Matousek’s background as a quality leader would lead him to place value and excellence above all in his new enterprise.

DNV GL’s picture


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 common: time—or more precisely, the fact that there’s always less of it.

Inderjit Arora’s picture

By: 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 recurring costs for surveillance and recertification visits. This is a responsive approach to business requirements, invariably driven by a forthcoming contract that mandates the system approach. Prudent businesses appreciate the risk of not having a process-based system.

Shobhendu Prabhakar’s picture

By: 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 accept it as a positive and powerful tool to improve. Perhaps, the “non” in nonconformance is the reason for this. This article explains why NCRs should be seen as friends rather than a foes, and how they can be used to improve a company’s projects, products, and services as well as its overall performance.

Sandrine Tranchard’s picture

By: 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 families, as well as placing a great economic cost on society. Its consequences and solutions were highlighted on World Health Day, April 7, 2017.

Mike Richman’s picture

By: 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 done differently to avoid its latest public relations fiasco, and conversed with Mike McLean of ISO’s Technical Management Board’s task group.

Here’s a closer look:

Dirk Dusharme @ Quality Digest’s picture

By: 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 Center.

“Save Costs When Implementing Enterprise Quality Systems”

Taran March @ Quality Digest’s picture

By: 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 loosely regulated wilds of global competition. Quality control now requires a sense of how different cultures perceive the art of doing business. (Hint: It’s not always about teamwork and doing the right thing.)

Chad Kymal’s picture

By: 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. Why is this a good idea? Because it saves money.

Figure 1 illustrates how enterprise quality takes many isolated management systems and transforms them into a common one.

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