All Features
NIST
Story update 7/13/2018: This story was updated with a link to the released version of standard E3125–17.
Large-volume 3D laser scanners play an essential role in manufacturing large products (e.g., airplane wings), making measurements for large-scale construction (e.g., bridges), and other…
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…
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
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…
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…
Tom Middleton
Markets and manufacturing practices continue to evolve, and companies now outsource to an increasing number of global manufacturing and supply partners. As companies have pursued this broadened supply chain strategy, the ability to manage both business and quality risks has become more challenging…
Mike Richman
On the May 4 episode of QDL, we discovered that love is a key component to winning a Baldrige Award, learned how to be more efficient at work, and discussed how great art helps us to really see our processes. Here is an up-close look:
“Undersecretary of Commerce and NIST Director Walter Copan…
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’…
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…
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…
Harry Hertz
The greatest challenge I have each year when I return from the Baldrige Program’s annual Quest for Excellence Conference is prioritizing the most important messages for me and my organization, whether that is my work organization, volunteer organization, or—yes—my family (this one might be stealth…
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….”
That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars…
Sal Lucido
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Policies are dynamic and require a system to manage their creation, documentation, distribution, and management. Here’s…
Bruce Bolger
Grace Swanson, vice president of human capital at Accumold, a leading micro-molding plastics injection company located just outside Des Moines, Iowa, knows the field of standards well. Her company has certifications in ISO 9001 for quality management, ISO 14001 for environmental management, and ISO…
Richard Harpster
The AIAG-VDA FMEA Handbook committee and everyone who responded to the request for comment on the proposed AIAG-VDA failure mode and effects analysis (FMEA) manual must be applauded for their efforts. Harmonizing the VDA and AIAG FMEA methods is not an easy task. According to industry sources,…
Mike Richman
During this past Friday’s episode of QDL, we presented two great interviews, both revolving around standards and certification, plus a piece about analytics, and a lively off-script about the responsibilities of media companies like Facebook when it comes to protecting user data. Here’s a closer…
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a…
Karl Kleinkauf
If you’ve been thinking about software as a service (SaaS) for your quality management system (QMS) and trying to justify the “why,” here’s a quick case supporting SaaS. Although not for everyone, it certainly makes more sense than it used to. There will always be the detractors who are not…
Kyle Rose
As I’m sure many of you know, the ISO 13485 standard for medical devices was updated in 2016, which means the time to transition your quality management system (QMS) is now. Most auditing organizations have either cut off ISO 13485:2003 recertifications or will be doing so very soon.
I was…
Dirk Dusharme @ Quality Digest
In our March 16, 2018, episode of QDL, we looked at universal basic income, management status quo, ISO 10018, and how a community college is teaching cutting-edge metrology skills.
“Public Split on Basic Income for Workers Replaced by Robots”
Gallup asks Americans if they would support a universal…
Eric Stoop
If you had your AS9100 transition audit tomorrow, could you say right now whether you would pass? More important, do you know where the gaps are in your processes that could trigger nonconformities?
AS9100 is the leading standard for aerospace management systems, required by original equipment…
Violet Masoud
Imagine going to work, motivated to meet all your goals and deadlines, only to find you need a different computer for each of the applications you use: Microsoft Word on the laptop in your office; the customer database solution on the tower PC in the conference room; and email on the desktop in…
Bruce Bolger
Many quality professionals remain unaware that a systematic approach to human resources is now a requirement in ISO 9001:2015. These new requirements are based on the principles considered by the International Organization for Standardization (ISO) to be essential to quality management success.…
Harry Hertz
The Baldrige Excellence Framework encourages organizations to create an environment for innovation by pursuing intelligent risks. How do you know whether a new idea is an intelligent risk, and therefore worth pursuing? How do you know if the resulting change is an innovation? An experience from my…
Martin R. Voelk
In just a few short months, the European Union’s General Data Protection Regulation (GDPR) will take effect. The regulation, which replaces the EU’s 20-year-old Data Protection Directive, imposes new and more rigorous requirements on any entity that collects or maintains personal consumer data,…
