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New Language in AS9100 Revision D
Intertek
Sponsored Content For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations; and AS9120 for aerospace warehouse and distribution operations—is a necessity for doing business.…
Transition Planning for AS9100 Revision D
Intertek
Sponsored Content Organizations that build, supply, design, or maintain products, parts, or services for the aerospace industry generally must be certified to the AS9100 family of standards (including AS9110, which is specifically for aerospace maintenance, repair, and overhaul [MRO] organizations…
Same Old Routine With FMEA?
Michael Ray Fincher
To meet the 2018 deadline for becoming certified to ISO 9001:2015, organizations are scrambling to overhaul their quality management systems. One major revision to ISO 9001 is the requirement to identify, evaluate, and address risks. Unfortunately, a tool most appropriate for these actions has…
How Your Personal Relationships Impact Your Professional Ones
Roger Lehman, Julius Koh
Lucy felt hollow and dissatisfied. She was a star performer and had just helped her team clinch a large government deal that they had been working on for months. At the celebration that evening, Lucy was forced to put on a smile and a dynamic front. She had good relationships with her team members…
Replacing the Risk Priority Number
William A. Levinson
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when all…
Risk-Based Thinking in Planning (6.0): Using the Business Operating System Approach
Chad Kymal
In the 1990s, Omnex worked with Ford Motor Co. to develop the Ford quality operating system methodology, which with maturity and broad experience has evolved into Omnex’s business operating system (BOS) process. The quality operating system promised and has delivered the following: • Cross-…
Inside Quality Digest Live for June 16, 2017
Mike Richman
The June 16, 2017, episode of QDL included my hot take on Hexagon’s ginormous user conference as well as interviews with two of our favorite guests, Chad Kymal of Omnex and Kelly Graves of Internal Business Solutions. Take a look: “Field Report: Hexagon Live 2017” I and more than 3,000 of my…
Why Banning Laptops From Airplane Cabins Doesn’t Make Sense
Cassandra Burke Robertson, Irina Manta
Recent reports suggest that terrorists can now create bombs so thin that they cannot be detected by the current X-ray screening that our carry-on bags undergo. In an effort to protect against such threats, the United States is considering banning laptops and other large electronic devices in the…
Lessons Learned From the WannaCry Ransomware Attack
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile manufacturers, and government systems. The worm’s ominous red ransom screen, informing the user that…
Building Team Resilience on Social Media
Iffet Turken
The world faces a new crisis situation more or less every day—be it political, economic, or humanitarian. Wherever a crisis is experienced, echoes are felt around the globe. In the digital age, social media conveys crises in real time, resulting in rich portfolios of pictures, videos, written…
Tides of Change at Ford Motor Co.
Ryan E. Day
I remember my first trip to Michigan in 2012. I was covering the Ford Motor Co.’s annual Trend Conference and had the opportunity to meet Alan Mulally, who gave a compelling presentation explaining the vision, strategy, and implementation of the One Ford plan. I was impressed more with the man…
Process Capability Confusion Caused by Skewed Distributions
John Flaig, Jack Ren
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 answer that can get you into real trouble. Consider the following capability assessment problem. The…
Quality Management Insights for Medical Device Manufacturers
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. The CDRH continues to put a premium on quality when it assesses a…
Solving Compliance and International Manufacturing Challenges
Ryan E. Day
Sponsored Content Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
Shared Vehicles Head Toward a Healthier Future
UC Davis
Three transportation revolutions are in sight, and together they could help reduce traffic, improve livability, eventually save trillions of dollars each year, and reduce urban transportation carbon dioxide (CO2) emissions by 80 percent or more worldwide by 2050. That’s according to a report…
Learn-Do-Manage
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 becomes automatic. So what does that have to do with your office ergonomics process? A lot, especially…
High-Quality Equipment a Must for Quality Certification
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…
Prioritize a QMS Process Automation or Risk Failure
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 once and streamline the entire eQMS process in one giant undertaking. However, real-world experience…
Wasting Time Is the Biggest Risk of All
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 common: time—or more precisely, the fact that there’s always less of it. No matter how long your…
Is There Any Way to Stop Ad Creep?
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 a much larger social trend. Commercial entreaties, whether in the form of magazine ads, radio…
The Cost of Certification
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…
Nonconformance Reports: Friends, Not Foes
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…
A Better Designed Workplace With ISO Standards
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…
Checking Off the Box
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 blinded by compliance bias,” health and safety consultant Dan Markiewicz says no, citing data indicating…
Use a SIPOC Matrix to Deploy ISO 9001:2015 Clause 4.4
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 interaction of these processes, noting that handoffs between processes often create risks; and identify the…

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