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Quickest Way to Effective AIAG-VDA-Harmonized FMEAs
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,…
Inside Quality Digest Live for April 6, 2018
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…
First ISO Health and Safety Management System Standard Is Released
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…
Three Reasons to Consider SaaS for Quality Management Software
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…
Understanding QMS Software Validation Requirements in ISO 13485:2016
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…
Inside Quality Digest Live for March 16, 2018
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…
AS9100 Transition
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…
Primetime for Integrated Management Systems
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…
Human Capital Is Critical to ISO 9001:2015 Success
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.…
On Innovation, Intelligent Risks, and Leaking Sinks
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…
Are You Ready for the EU’s General Data Protection Regulation?
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,…
The Case Against the AIAG-VDA DFMEA
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
Fresh Changes in the Pipeline
ISO
Ageing wastewater systems are under threat from growing populations, urbanization, pollution. and climate change, not to mention human behavior. However, despite these challenges and fears for health and safety, the new ISO 24516 series is playing a key role in turning what many consider a burden…
The Importance of Documenting Enterprise QMS Process Requirements
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
ISO 9001:2015 and ISO 10018: Developing People Engagement In a QMS
Bruce Bolger
HighlightsThe New Focus on People Overview of ISO 9001:2015 Standards and the ISO 10018 Certification How This Microsite Helps Quality Management, Auditors, and Solution Providers Articles ResourcesOther Articles In This Series This Month's Featured ArticleAccumold Starts With the Why  Can the…
Inside Quality Digest Live for Jan. 19, 2018
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
Five Key Standards Trends to Watch in 2018
Miriam Boudreaux
If you are a manufacturing company or a service provider, there is a good chance that you have heard about standards such as ISO 9001. In fact, you may already be certified. But whether you are certified or not, read on for some of the expected trends in the world of standards and certification…
Transitioning to ISO 45001
Ismael Belmarez
Workplace safety is a vital concern for every organization. According to the U.S. Bureau of Labor Statistics, 2.9 million nonfatal workplace injuries and illnesses were reported by private industry employers in 2016, costing employers tens of billions of dollars. In March of this year, the leading…
Inside Quality Digest Live for Jan. 12, 2018
Dirk Dusharme @ Quality Digest
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Impatient With Colleges, Employers Design Their Own Courses” Microsoft, Amazon, and others are teaming up with third-party online courseware providers to…
The Test of Time: NIST’s Wall of Many Stones
Jason Stoughton
Frequented by more deer than people, the NIST stone test wall lives a fairly isolated existence. Out among the trees and the grass on the south end of the Gaithersburg, Maryland, campus, it cuts an imposing and visually bizarre figure. Set in the mortar of its technicolor face are more than 2,000…
Top 10 Things You Need to Know About Implementing Risk-Based Thinking
Richard Harpster
The concept of risk-based thinking has been implicit in previous editions of ISO 9001 through requirements planning, review, and improvement. But ISO 9001:2015 requires companies to use risk-based thinking to manage their business. If you want to implement an ISO 9001:2015-compliant quality…
Inside Quality Digest Live for Dec. 15, 2017
Mike Richman
Last Friday’s episode of QDL was our final show of the year, and we’re leaving 2017 on a high note! We brought you two great interviews and a terrific Tech Corner, not to mention some advice on increasing your productivity in 2018. Let’s take a look: “AIAG and VDA Release Draft of Harmonized FMEA…
AIAG and VDA Release Draft of Harmonized FMEA Manual
Chad Kymal, Gregory F. Gruska
The Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry, or VDA (Verband der Automobilindustrie), have been cooperating in automotive quality management systems since the advent of the second edition of ISO/TS 16949 in 2002. The integration work that…
Inside Quality Digest Live for Dec. 8, 2017
Dirk Dusharme @ Quality Digest
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Smart Manufacturing Trends in 2017” The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds, and is spurred on by…
DNV GL Healthcare and CoxHealth Partnership for Improvement
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines. Readmissions cost hospitals $…

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