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Document Center's Standards Forum

ISO/IEC 19592-1 – Sharing Secrets!

ISO/IEC 19592-1, “Information technology – Security techniques – Secret sharing – Part 1: General,” has just been released.  This is a new IT security standard, the first of two standards on the subject.  The second is still in draft format and will be titled R

New Food Safety Standards

The FDA has recently released new food safety standards.  So since it’s Thanksgiving, I thought we’d take a look at them today!  Since all FDA regulations are in response to legislation, the new standards support the Food Safety Modernization Act.  It is part of the effort to crea

Medical Device Reporting

FDA Guidance on Medical Device Reporting for Manufacturers has been updated. The Guidance was originally issued in 1997. This recent 2016 Edition provides manufacturers with insight into the 21 CFR Part 803 regulation's requirements. It is organized as a series of questions and answers.

ANSI C84.1 2016

ANSI C84.1 has just been updated. This standard is titled "American National Standard for Electric Power Systems and Equipment - Voltage Ratings (60 Hz)." The new 2016 Edition replaces the previous revisions, including the 2011 Edition. This standard establishes nominal voltage ratings and op

ISO/TR 18196 – Measuring Nano-Objects

ISO/TR 18196, "Nanotechnologies - Measurement technique matrix for the characterization of nano-objects," has just been released. This new 66 page technical report is a useful tool for identifying the relevant information for measuring nano-objects. It connects the nano-object parameters you'l

ASTM F3184 – Stainless Steel for Additive Manufacturing

ASTM F3184, "Standard Specification for Additive Manufacturing Stainless Steel Alloy (UNS S31603) with Powder Bed Fusion," has just been released. This new standard provides information on the additive manufacturing of UNS S31603 stainless steel components. These components are made using lase

ISO 20581 – Workplace Air Quality

ISO 20581, "Workplace air - General requirements for the performance of procedures for the measurement of chemical agents," has just been released. This new ISO standard is based on EN 482 (including Amendment 1 from 2015). It provides you with information on how to measure for chemical age

IATF 16949 Rules is here!

IATF 16949 "RULES-5; Automotive certification scheme for IATF 16949, Rules for achieving IATF recognition" has been released. You'll use this new publication to help you meet the IATF 16949 2016 Edition requirements. The Rules include the criteria for certification body recognition, the audit

New ISO/TS 9002 2016!

ISO/TS 9002, "Quality management systems - Guidelines for the application of ISO 9001:2015," has just been released. This new 1st Edition from 2016 revives the document which was cancelled in 2000. It is a Technical Specification, which means that it is a guidance document. You'll use it when

JESD 31 for Semiconductor Distributors has been updated!

Standard JESD 31 from JEDEC has been updated. Its full title is "General Requirements for Authorized Distributors of Commercial and Military Semiconductor Devices". The new Revision E will replace Revision D, which is now obsolete. It's available now from Document Center in hard copy format or

Quality Forum - All Forums

Get Work Done and Stay Healthy

Get Work Done and Stay Healthy Develop healthy habits to keep from burning out

A Short Piece on Tom’s Cass Event

A Short Piece on Tom’s Cass Event <p>Following Tom's appearance there, a member of the Cass Business School staff composed a short version of his masterclass for posting on their website. It seems that both Tom and Cass B-school

Podcast #268 – @TomEhrenfeld, on #Lean Books & #LeanStartup

Podcast #268 – @TomEhrenfeld, on #Lean Books & #LeanStartup My guest for Episode #268 is a long-time friend of mine in the Lean community and Lean Enterprise Institute circles, Tom Ehrenfeld (@tomehrenfeld). Tom is a writer and editor living in

Subaru Steps Up Quality Control After Stumbles

Subaru Steps Up Quality Control After Stumbles Subaru is feeling the burn of its red-hot sales. With the brand stung by a spate of U.S. recalls that undercut earnings this year and an embarrassing tumble in its cherished Consumer Re

Interview on the David Pakman Show on the Future of Manufacturing

Interview on the David Pakman Show on the Future of Manufacturing Recently I had the exciting opportunity to be interviewed on the David Pakman Show on American TV, where I talked about the future of manufacturing, especially in America. Our subj

Napoleon’s Defeat Made Visual

Napoleon’s Defeat Made Visual One picture represents 410,000 lives

On-Demand Learning from IIL: Project Management Day 2016

On-Demand Learning from IIL: Project Management Day 2016 <p>Another opportunity to hear Tom speak is coming in November. He'll be one of the keynote online speakers at the International Project Management Day presentation, produced

What the Books Don't Tell: Explaining the Financial Benefits of Lean

What the Books Don't Tell: Explaining the Financial Benefits of Lean It's a curious fact that very few books about lean address the topic of finance. Questions about lean's financial benefits are often the first that leaders skeptical about launc

Software Fix Didn’t Work on Some Fiat Chrysler Gearshifts

Software Fix Didn’t Work on Some Fiat Chrysler Gearshifts Software designed to fix confusing gear shifters on 1.1 million Fiat Chrysler vehicles didn't work on 29,000 of them. Now the owners are being asked to take the vehicles back to dealers f

ISO/IEC 19592-1 – Sharing Secrets!

ISO/IEC 19592-1 – Sharing Secrets!

ISO/IEC 19592-1, “Information technology – Security techniques – Secret sharing – Part 1: General,” has just been released.  This is a new IT security standard, the first of t

Driving the Quality Initiative

Driving the Quality Initiative Become an effective change agent

Tom’s Talk on Sirius Radio

Tom’s Talk on Sirius Radio <p>If you missed Tom's radio spot originally aired September 7th on Channel 111 of SiriusXM, Business Radio Powered by The Wharton School, you have an opportunity to listen via this link to the Wharton

Updated W. Edwards Deming Institute Web Site

Updated W. Edwards Deming Institute Web Site We have launched an updated web site for The W. Edwards Deming Institute. The new site offers much better usability when using a smart phone and has an updated design. We have added several new feature

What Do Incorrect Election Predictions Mean for Consumer Research?

What Do Incorrect Election Predictions Mean for Consumer Research? How did so many pollsters get the presidential election so wrong? The answer could have implications for research firms and brand marketers who rely on their methodologies.

How to Handle Bad Online Reviews

How to Handle Bad Online Reviews Many consumers begin their search for products and services online. Since most consumers trust recommendations, online reviews can influence where they buy. What should you do if you get a bad onli

Quality Digest - Management Column

Get Work Done and Stay Healthy

Develop healthy habits to keep from burning out

Napoleon’s Defeat Made Visual

One picture represents 410,000 lives

The Lost Art of Saying, ‘I Don’t Know’

Although leaders must be decisive, they can’t be omniscient

How to Persevere When Facing a Work Grind

Six tips for getting out of the rut

It’s called “work” for

Driving the Quality Initiative

Become an effective change agent

Weology, Part 1

We comes before me

A Perspective of the Manufacturing Future, Part 3

Inventory management

Inside Quality Digest Live

Recapping our show of Nov. 11, 2016

Put a Surprise Inside: the Cracker Jack Principle

Foster a spirit that customers can’t wait to narrate

‘Which of Deming’s 14 Points Should I Start With?’

Answer: none of them

Quality Digest - Six Sigma Column

‘Which of Deming’s 14 Points Should I Start With?’

Answer: none of them

Safety and the Gemba Walk

Lean safety goes beyond human error and OSHA compliance

Doormats

In defense of engineers

A Black Belt Is a White Belt Who Never Quit

You can achieve real and sustainable transformation

Some Final Thoughts on DOE—for Everyone

It’s all in the planning

C

Kaizen—Can It Go Wrong?

Change for the better must be better for everyone

Quality Transformation

A journey toward truth

Peripheral Discoveries

‘The best place to look for improvement is in an area where it is thought not to exist’

Lean Management Is Illegitimate. Or Is It?

The methodology still waits for acceptance in traditional management models

Information at the Gemba

Data input doesn’t output knowledge

Quality Digest - CMSC Column

Moving CMSC Forward with Education and STEM

Do You Have a Measure of Your Metrology Skills?

World Metrology Day Celebrates a Link That Binds Humanity

Welcome to the World of Metrology

Updates and Outlooks for CMSC 2016

Setting Expectations for Your Next Metrology Job

The “Light of My Life”: World Metrology Day Sheds Light On Industry Advances

Life’s a Beach!

Hardware vs. Software: The Knockout Round?

Top Reasons to Outsource 3D Metrology

Quality Digest - FDA Compliance Column

The Patient’s Voice Enhances FDA’s Approach to Drug Review and Development

Public meetings helped fulfill an FDA commitment one year ahead of schedule

The Evolving Regulatory Landscape of 3D-Printed Medical Products

The concept of making personalized devices doesn’t require new regulatory processes

The Real Reason the EpiPen and Other Off-Patents Are So Expensive

The FDA’s unique position

FDA Introduces the Pre-RFD Process

Making continuous improvements in the combination products program

Six Tips to Make Sure Your 510(k) Submission Is Accepted

Planning and organization will help you avoid the FDA’s refusal

Modernizing the Pharmaceutical Manufacturing Base

Continuous manufacturing has a strong impact on drug quality

The Rise and Fall of Theranos

So many lessons in a drop of blood

Why FMEA Is Not ISO 14971

Medical device risks aren’t solely a function of failure

Addressing Human Factors Relating to Combination Products

FDA seeks comments on new draft guidance

Border Crossings

Working with partners to verify the safety of imported produce

Quality Digest - Standards Column

Inside Quality Digest Live

Recapping our show of Nov. 11, 2016

Safety and the Gemba Walk

Lean safety goes beyond human error and OSHA compliance

Heads Up, OED

10 suggestions for the venerable lexicon

What Does That Have to Do With the Baldrige Excellence Framework?

Excellence can turn up in the oddest places

The Evolving Regulatory Landscape of 3D-Printed Medical Products

The concept of making personalized devices doesn’t require new regulatory processes

Mylan’s Self-Created Risks

Beginning by bluster

FDA Introduces the Pre-RFD Process

Making continuous improvements in the combination products program

Six Tips to Make Sure Your 510(k) Submission Is Accepted

Planning and organization will help you avoid the FDA’s refusal

A ‘Certified’ Stamp for the Smart Grid

Creating the standard for wi-fi interoperability

Science, Science Fiction, and Superheroes

Feeling fascinated just may encourage a young person to do something great

Software Testing Help

3 Worst Defect Reporting Habits and How to Break Them

Defects are serious business and small mistakes can be expensive. You know what to do when you find a defect. You report it; either in a Defect Tracker/Defect Management tool or in an Excel sheet. The underlying principles are the same for both methods. Defect Management tools don’t guarantee be

The Complete Beginner’s Guide to Responsive Web Design Testing

Beginner’s guide to Test Responsive Website Designs: In today’s age, the use of mobile devices to access internet has grown and become quite popular. Almost every internet user desires a mobile version of the website. However, most websites are not as optimized as they should be for mobile

10 Worst Things a Critic Would Say About Your Software

It is a typical practice to include the list of known issues with the QA sign off an email. This helps teams make the right decisions as to: Let the end-users know the problem areas Plan for training accordingly Work on Change Management Include these issues in the help files or documentation, so

TestLodge Tutorial – How to Organize Your Software Testing Projects Using TestLodge Test Management Tool

Organizing, storing and updating testing documents takes time. A good test management tool can make this easier. A few years ago, we wrote this review on the TestLodge Test Case Management tool. Since then, TestLodge has gotten a lot of feedback from users and they’ve made several changes and imp

How Do You Decide Which Defects are Acceptable for the Software to Go-live?

Software Go-Live is always a big event for any software product. It is important to absolutely make sure that everything works and that we are releasing quality software to the users. A bad or premature or unstable or difficult to use product can cause a lot of losses financially and could also ma

James Bach’s Blog

Rethinking Equivalence Class Partitioning, Part 1

Wikipedia’s article on equivalence class partitioning (ECP) is a great example of the poor thinking and teaching and writing that often passes for wisdom in the testing field. It’s narrow and misleading, serving to imply that testing is some little …

Accountability for What You Say is Dangerous and That’s Okay

[Note: I offered Maaret Pyhäjärvi the right to review this post and suggest edits to it before I published it. She declined.] A few days ago I was keynoting at the New Testing Conference, in New York City, and I … Continue reading

How Michael Bolton and I Collaborate on Articles

(Someone posted a question on Quora asking how Michael and I write articles together. This is the answer I gave, there.) It begins with time. We take our time. We rarely write on a deadline, except for fun, self-imposed deadlines … Continu

CC to Everyone

I sent this to someone who’s angry with me due to some professional matter we debated. A colleague thought it would be worth showing you, too. So, for whatever it’s worth: I will say this. I don’t want anyone to … Continu

The Bestselling Software Intended for People Who Couldn’t Use It.

In 1983, my boss, Dale Disharoon, designed a little game called Alphabet Zoo. My job was to write the Commodore 64 and Apple II versions of that game. Alphabet Zoo is a game for kids who are learning to read. … Continue reading

QA Intelligence

Are you the Signal or the Noise?

There is an ongoing theme around Signal vs Noise in the organization, that originates from the Signal to Noise ratio in radio signals, and tells us about the problem of having too much noise hampering the effectivity of the signal. I think many testers should try to understand this principle (t

Why you should NOT be a tester!

If you are not passionate about testing let me give you a word of advice, you better not be a tester.  There are plenty of other things you can be doing for a living, go and choose another one. Testing is really a grueling job, not because it requires tons of physical work but because […]

Why You Need to be a Testing Evangelist!

Have you ever been told the annoying phrase: “You’re preaching to the choir.” I’ve been on the receiving end of it a number of times, and it is always a source of frustration. Why so? Because most times it just indicates that there is something important (maybe even logic

Even Messi sometimes needs to start from scratch

What does Messi’s hair, a megaphone, getting fired, and repositioning your desk have in common…? If I got your attention come on in and read this blog post 🙂

The post Even Messi sometimes needs

Testing Under Stress

Dealing with the stressful reality of testing in today’s fast paced development cycles Our lives are full of stress both at work and at home. Is seems at times that there aren’t enough hours in the day, and everyone around us has their demands for our time, which is forever limited.

Association for Software Testing

Mum’s the Word (Hiccupps)

Rethinking Equivalence Class Partitioning, Part 1 (James Bach’s Blog)

Wikipedia’s article on equivalence class partitioning (ECP) is a great example of the poor thinking and teaching and writing that often passes for wisdom in the testing field. It’s narrow and misleading, serving to imply that testing is some little …

A RubyGems SSL cerificate solution (Chris Kenst's Blog)

The Problem Early last month I was trying to update some gems on my MBP and ran into an SSL error: ERROR: While executing gem ... (Gem::RemoteFetcher::FetchError) SSL_connect returned=1 errno=0 state=SSLv3 read server certificate B: certificate verify failed (https://api.rubygems.org/specs.4.8.gz)

Outlook broke important business feature (zagorski software tester)

TL;DR This post is about Outlook broken business feature, carbon copy recipients. In e-mail, the abbreviation CC indicates those who are to receive a copy of a message addressed primarily to another (CC is the abbreviation of carbon copy). The list of recipients in copy is visible to all other reci

Cambridge Lean Coffee (Hiccupps)

This month's Lean Coffee was hosted by Abcam. Here's some brief, aggregated comments and questions  on topics covered by the group I was in.Suggest techniques for identifying and managing risk on an integration project.Consider the risk ...

Developsense Blog

Very Short Blog Posts (30): Checking and Measuring Quality

This is an expansion of some recent tweets. Do automated tests (in the RST namespace, checks) measure the quality of your product, as people sometimes suggest? First, the check is automated; the test is not. You are performing a test, and you use a check—or many checks—inside the test.

s/automation/programming/

Several years ago in one of his early insightful blog posts, Pradeep Soundarajan said this: “The test doesn’t find the bug. A human finds the bug, and the test plays a role in helping the human find it.” More recently, Pradeep said this: Instead of saying, “It is programmed&

The Honest Manual Writer Heuristic

Want a quick idea for a a burst of activity that will reveal both bugs and opportunities for further exploration? Play “Honest Manual Writer”. Here’s how it works: imagine you’re the world’s most organized, most thorough, and—above all—most honest documenta

Testers Don’t Prevent Problems

Testers don’t prevent errors, and errors aren’t necessarily waste. Testing, in and of itself, does not prevent bugs. Platform testing that reveals a compatibility bug provides a developer with information. That information prompts him to correct an error in the product, which prevents t

Is There a Simple Coverage Metric?

In response to my recent blog post, 100% Coverage is Possible, reader Hema Khurana asked: “Also some measure is required otherwise we wouldn’t know about the depth of coverage. Any straight measures available?” I replied, “I don’t know what you mean by a ‘straight’

Quality Progress

A Better Way

Multiple approaches to root cause analysis (RCA) are available, but the common focus is correction rather than identification of a problems root cause. The plan-do-check-act (PDCA) cycle is widely used to structure a failure investigation, but it does not identify a root cause without support. To p

Fresh Faces

The 46 up-and-coming quality professionals presented for 2016 constitute a group of outstanding young standard-bearers for quality across a wide range of industries and across the globe. Though their backgrounds and accomplishments vary widely, they share a drive toward quality leadership which is

Understanding Variation—26 Years Later

A Quality Progress article published in 1990 stressed the importance of understanding variation when interpreting data and the high costs of failure to appreciate and account for both common and special variations. Since that time, data sources have multiplied and data sets have grown vastly larger

Diving Deeper

The LEARN process is an alternative statistical method that delivers valuable information about a process without the need for heavy duty math. By following its stages--look, examine, assign, regression and natural selection (LEARN)--one can compile a rich set of input data to deliver valuable outp

Elephant in the Room

The old tale of six blind men reporting dissimilar descriptions of an elephant is comparable to auditors' coming to different conclusions about quality management systems. Careful preparation, an organized plan and comprehensive data collection are essential. Establishing audit criteria sets out st

Coordinate, Collaborate and Consolidate

Considerable effort goes into reviews and audits within an organization, but often with little coordination. Better oversight results in more effective knowledge sharing, appropriate staffing and team leadership, and more efficient work by those teams. Necessary information and procedures relating

Leading the Way

The 2015 revision of ISO 9001 prioritizes quality in management systems without specifying how quality is realized, whether as monetary gain, asset retention or nonmonetary achievement. It stresses the important role of management providing a clear purpose and foundation for strategic direction. Th

Handling Handoffs

Patient transfers are a critical point in the care continuum. If done poorly, they can jeopardize patient care and treatment outcomes. Proper handoffs require systematic communications of specific patient information to avoid negative results. Analysis of transfers within a 450-bed hospital complex

Home Improvement

A survey of 21 U.S. residential builders highlighted the use of quality management methods and opportunities for cost savings. The cost of quality can be as high as eight to 15% of residential constructions costs, and preventing issues can yield a 6-to-1 return in investment. The survey examined is

Buying Into Quality

Quality tools are effective methods organizations can use to improve their purchasing processes. The tools facilitate performance evaluation, benchmarking of key performance indicators and pointing out improvement opportunities, helping to lower costs and boost efficiency through the entire supply

Knowledge Center

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Ask the Experts: Standard vs. Specification and Guidance Documents

In this recent Ask the Experts question, learn the difference between a standard and a specification. For more answers, visit the Ask the Experts page.

Is the Workplace a Zombie Breeding Ground? - ASQ

In this Journal for Quality and Participation article (open access), learn how creating an environment that fosters the development of spiritual intelligence can be a key leadership strategy for encouraging individuals to not choose to become zombies.

Benchmarking - ASQ™ TV

This ASQ TV episode covers the basics of benchmarking, reviews the recommended six phases of a benchmarking process, and explains one vital ingredient in benchmarking: metrics.

ASQ: Handbook of Investigation and Effective CAPA Systems, Second Edition

In understanding and improving the CAPA system as a whole, this book reflects the importance of the investigation/root cause analysis stage as the necessary step of any effective corrective and preventive action system

Using Six Sigma in Your Personal Life - Quality for Life - ASQ

In this Quality for life video, Kevin Holston, a certified Black Belt, shares how he uses Six Sigma tools in his everyday life, including providing humorous examples of how keeps his life in order and on track.