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Stepping Into Cloud-Based Quality Control
Abdallah Samaha
Lin Engineering is a California-based manufacturer of hybrid step motors that was founded in 1987 as a consulting company specializing in step-motor applications. Today, Lin Engineering is the largest manufacturer of 0.9-degree step motors in the motion control industry. As the quality and custom-…
Count Data: Easy as 1-2-3?
Davis Balestracci
Author's note: To my non-U.S. readers, I apologize for using the sport of baseball to make my points today—and during the World Cup, no less! It’s a perfect context, however, and I hope you will be able to understand the main points. In my last column, I talked about the different types of control…
Learning Lean at Lunch
Peter J. Sherman
Who says business luncheons are a waste of time? Recently, I enjoyed one of the most productive business luncheons of my career. In February, I was dining with two senior-level professionals at an IT staffing firm. After the usual chitchat about the recent snowstorms and traffic snarls, we started…
The Truth About Acceptance Sampling,
Part 1
Donald J. Wheeler
One of the common tools of quality assurance is acceptance sampling. Acceptance sampling uses the observed properties of a sample drawn from a lot or batch to make a decision about whether to accept or reject that lot or batch. Textbooks are full of complex descriptions of various acceptance…
Snowballs to Soot
NIST
Particles of soot floating through the air and comets hurtling through space have at least one thing in common: 0.36. That, reports a research group at the National Institute of Standards and Technology (NIST), is the measure of how dense they will get under normal conditions, and it’s a value…
Risk Assessment and the Quality Management System
Hermann Ries
In the world of quality management systems (QMS), the nature of the relationship between risk management and preventive actions is often confused and misunderstood. Indeed, some believe that a thorough risk assessment process replaces the need for preventive action. In fact, risk management and…
Baldrige and ISO 9001: A Complementary Relationship
Christine Schaefer
How is a company to decide whether to use the Baldrige Criteria for Performance Excellence, the ISO 9001 quality management system, or both? To explore some key distinctions between the comprehensive business model provided by the Baldrige framework and the quality management system provided by…
Deconstructing ISO/DIS 9001
Umberto Tunesi
In my August 2013 column titled “Beethoven’s Fifth and ISO 9001:2015,” I commented on the ISO 9001 Committee Draft (CD). As is typical of me, I wasn’t soft. Now the interim draft international standard (DIS) is available for voting on by ISO members, and I’d like to offer my opinion about this…
Fearful Features: Making Risk Explicit
Jim Benson
Sometimes work is terrifying. We’re asked to do something that we know, or at least strongly suspect, won’t work. Maybe we’re asked to do several things, some of which are are simple, but one or two make us uncomfortable. We might even place a hard estimate on a task (“It’ll take six hours!”), but…
Why Is This Yorkie So Irritated?
Patrick Runkel
You know what really gets on my nerves? A lot of things. That slow, slinky way that cats walk by. Grrrr. The rude, abrupt arrival of delivery persons in their obnoxiously loud trucks. (Why do they always pull up just as I'm settling down for a nap?) Grrrr. Total strangers who reach…
Visualizing Delay, Waste, and Nonvalue-Added Work
Jay Arthur—The KnowWare Man
When looking at any existing process, people often have a hard time visualizing the enormous amount of delay, waste, and nonvalue-added work involved. That’s where a time value map comes in; it makes the invisible waste visible. A time value map shows value-added and nonvalue-added activities and…
Are You Ready for ISO 14001:2015?
Jeffrey Eves
ISO 14001 is the world’s best-known environmental management system standard, and it provides a systematic framework to help organizations protect the environment through balanced socio-economic means. In conjunction with an updated ISO 9001, a new version of ISO 14001 is being released in the…
QMS Documentation: Don’t Get Trapped by Your Words
Miriam Boudreaux
Sometimes interpreting ISO 9001 or API Q1/API Q2 requirements seems to force us to agree to things we won’t be able to do, or to sustain for more than a few months, let alone days. So how do we write our policies and procedures to explain our approach while avoiding being boxed in by our own words…
An Analysis of ISO/DIS 9001:2014
David Lawson
Story update 6/18/2014: In an earlier version of this article the editors changed ISO/DIS 9001:2014 to ISO/DIS 9001:2015. The error was ours, not the author's. The correct name of the document is ISO/DIS 9001:2014, as now shown. The publication of the draft international standard (DIS) of the…
A System for Satisfying Customers, Part 1
Dan Nelson
Editor's note:  This is part one of a serios about customer-centric quality management systems.  Read part two here. A document review is supposed to be conducted as part of stage one of the ISO certification process. For the uninitiated looking into certification—maybe you—that statement often…
I Think I Can, I Know I Can
Eston Martz
Remember The Little Engine That Could, the children’s story about self-confidence in the face of huge challenges? In it, a train engine keeps telling itself, “I think I can” while carrying a very heavy load up a big mountain. Next thing you know, the little engine has done it, but until that…
What Is an Alpha-Level?
Donald J. Wheeler
One thing burned into the brains of those who survive a statistics class is that you have to specify an alpha-level before you do anything statistical. And when it comes to statistical inference, they are correct. But just what does the alpha-level represent? What does it mean in practice? Read on…
Streamlining Your QMS
Michael A. Hughes
Your quality management system (QMS) documents for AS9100, ISO 9001 or any other standard for that matter, do not have to be complicated. Why create volumes of wordy procedures that employees will probably never read? And even if they do, they certainly won’t understand. As auditors and quality…
The Journey Toward Excellence
David Schwinn
This month’s column is about a recent trip to New York and what I learned along the way. About a month ago, we attended the National Band and Orchestra festival at Carnegie Hall. The high school orchestra our granddaughter, Claire, plays in was invited to participate, and we were not about to miss…
Are Your Processes ‘Too Variable’ to Apply Statistical Thinking?
Davis Balestracci
My recent columns have emphasized the need for critical thinking to understand the process that produces any data. By just plotting data in their naturally occurring time order, many important questions arise about the data’s “pedigree” (a term coined by my respected colleagues Roger Hoerl and Ron…
Recipe for Success: Food Safety Regulations and the Role of Quality Management
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here. Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
What Are Good Measurements?
Donald J. Wheeler
Who could ever be against having good measurements? Good measurements are like apple pie and motherhood. Since we all want good measurements, it sounds reasonable when people are told to check out the quality of their measurement system before doing an experiment or putting their data on a process…
Things Could Get Risky
Mark Schmit
ISO 9001 has been the quality management standard, with almost a million businesses certified around the world. It has been through many revisions, in 1994, 2000, and 2008, but the 2015 revision has an added element to consider—risk. ISO international standards help to ensure that products and…
Dear Elected Official: Let’s Talk Quality...
ISO
Governments—local or otherwise—are under increasing pressure around the world to provide results that matter to the public, often within severe resource constraints. Now they are taking pointers from the private sector by using ISO 9001 for quality management to provide efficient and reliable…
Getting Ready for ISO 9001:2015
Paula Oddy
The 2015 version of ISO 9001 is still more than a year away from publication, but ISO/TC 176, the technical committee responsible for the standard, has been hard at work on the revision since 2012. Registrants to the current version, ISO 9001:2008, are wondering about changes to the language and…

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