Quality Management 2.0 Blog

Quality Management Systems as a Preventive Mechanism

Posted by Mary McAtee on Oct 06, 2015 @ 11:30 AM

Transparency as a Corporate Imperative

Unless you have been climbing Mount Everest or spending time in an isolation tank, you have been painfully and repeatedly made aware of current issues at Volkswagen. It is early in the feeding frenzy but as we step through the debris and past the first of what will likely become a steady stream of exiting Management, there is sobering fallout that should have us all paying attention.

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Topics: Quality Management Software, QMS, Tisha Tomlinson

Pushing the Frontier of Risk Assessment and CAPA

Posted by Mary McAtee on Sep 03, 2015 @ 02:00 PM

Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the invention of the steam engine and powered flight, as literal moments in time. The reality is that the invention of the steam engine by Fulton was only possible because of a long sequence of successive inventions he was able to capitalize on to change the world. If the ability to cast and temper Iron had not been improved on over the ages, Fulton could not have repurposed the concept used to pump water and compress air into the piston, cylinder and crankshaft. Fulton’s brilliance was harnessing known physical laws to use steam to develop and transfer energy into work.

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Topics: CAPA, FMEA

ISO 9001: 2015 Customer Requirements

Posted by Mary McAtee on Jul 02, 2015 @ 10:00 AM

ISO 9001: 2015 Customer Requirements: The Challenges of Just Saying “No”

Everyone is gearing up for the challenge of updating their compliance to the requirements of ISO 9001:2015. Most of the Quality professionals I speak with seem to have digested the new requirements as something very different than past versions. Personally, I don’t quite see it the same way as most of my contemporaries. After careful review, I see the new revision increasing emphasis on long standing requirements and adding measurable controls to help assure attention and accountability.

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Topics: ISO 9001 Quality Management System, ISO 9001

Document Control, Document Management & Content Managment

Posted by Mary McAtee on Jun 25, 2015 @ 10:04 AM

Document Control, Document Management and Content Management, Interchangeable terms?

There is a wonderful Indian Poem about a group of blind men describing an elephant. One man grabs the writhing trunk and exclaims that it is like a snake. Another man puts his arms around the massive leg of the animal and confidently describes it as a tree trunk. The last man runs his hands along the large flapping ears and declares that the other two men are clearly wrong and the elephant is birdlike with wings. They were all feeling the same animal; the only thing that differed for each of them was perspective. This similarity always comes to mind when I find myself discussing the differences between document control, document management and content management with other quality and business professionals. In these discussions the differentiator is almost always perspective. Opinions and definitions run the gamut from no discernible difference to resolute beliefs that each of these are mission critical systems that do different but equally important functions. In most cases, I see clusters of systems that address different elements of what is required but in a very constrained fashion resulting in silos of information that do not communicate with each other. On the other end of the scale, I see companies doggedly attempting to utilize massive systems that are frequently difficult to navigate. These implementations can easily result in the users that most need to locate information to reliably do their job, becoming mired in a navigation nightmare, sometimes giving up and working around system controls to print and develop local shortcuts creating their own web of compliance issues and risk.

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Topics: Document Management Systems, Document Control Systems

Your Quality Management system as a Hedge against Irrelevance

Posted by Mary McAtee on May 06, 2015 @ 09:04 AM

Unrecoverable Errors in more than Baseball

Spring is my favorite time of the year. It is so green and full of promise and new beginnings. The big issue for me is how easily distracted I am during those first few warm days. I fall into a sort of stream of consciousness thought drift. The crack of the bat from baseball practice in the park across the canal is one of my favorite sounds. I then start thinking about a whole string of baseball related thoughts. Just when and how quickly my Mets will self-destruct? What is used to give the infield that beautiful red clay contrast against the perfect green of the outfield grass? It turns out to be something called “Soil Master Red Clay”. It was specially developed to drain and not form mud or produce excessive airborne dust. This leads to thoughts of great base runners which leads me to thoughts of Pete Rose. This, of course leads to musings about the warm welcome A-Rod received after sitting out a piddly year for alleged steroid use while Pete remains banned for life for betting on his own team. This of course, is a natural Segway to thoughts about Ted Williams and the image of Teddy Ballgame shooting annoying seagulls off of the light stanchions in Fenway Park after he was robbed of a homerun by a gull colliding with his perfectly hit ball. I can just imagine how that would play in the media today. This completes the circle back to thoughts of how much company behaviors are driven by public perceptions of their brand.

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Topics: quality management

Assuring your Quality Management System Leaves Nothing Behind in 2015

Posted by Mary McAtee on Apr 22, 2015 @ 04:00 PM

Preventive Actions: Have they evolved out of existence?

One of the most interesting fallouts of the final draft of the 2015 ISO 9001 Standard proposed revision is a contextual change in “continual Improvement”. The intent to preemptively address likely issues before they manifest as problems has not changed. If anything, there is an explicit toughening of the language and intent to clarify what is expected. Some organizations are choosing to interpret the updated language to significantly reduce the effort they are applying to prevention. It is my opinion that this will prove to be a tactical mistake.

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Topics: Enterprise Risk Management

Cyber Threat Risk Assessment for Products and Consumers

Posted by Mary McAtee on Mar 17, 2015 @ 03:00 PM

Understanding your Role and Responsibility for Risk Assessment and Controls

In almost everything in Quality there are multiple facets of responsibility. The same applies when we talk about cyber security and threat assessment. The last time I spoke about this topic I addressed our responsibility for protecting our own organization’s intellectual property and security. This time I am concerned with how we protect those who depend on the products and services we provide. Market demands for increasingly intelligent products coupled with rapidly evolving software and wireless technology provides the means for companies to deliver exactly what the market demands. What is equally clear is that the ability of companies to assess the risk for the user and their privacy is not coming close to keeping pace with these advances. Just because the capability for smart devices is more readily available is no guarantee that prudent product management decisions are being made. The media is filled with stories about misuse of everything from baby monitors to auto-assist parking in late model vehicles.

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Topics: Risk Management, Risk Assessment & Analysis, quality and compliance, Risk assessment, Mitigation and Controls

Training and Qualification: Work Smarter, Not Harder

Posted by Mary McAtee on Feb 19, 2015 @ 04:38 PM

One of those pronouncements that I have no idea of factual basis or origin concerns developing proficiency. “They” say it takes repeating a task a thousand times before you become an expert. I guess I can understand why they might take this position. Clearly repetition fixes memory. I am trying to think of things I have repeated that many times and it is a short list.

I recently heard a master sushi chef interviewed about his apprenticeship program in Japan. An aspiring chef must study with him for ten years at minimum. They must not marry, they must live at the school and they work for free during their apprenticeship. The jaded New Yorker in me thinks that this master chef has developed a great source of cheap and extremely dedicated labor.  Others will look at this model and point to it with Zen-like certainty that this is how excellence must be cultivated. In practical business terms, training is undeniably invaluable on many levels. It assures competency and consistency that is important for quality and bench marking best practice. In addition to the positive impact on quality it is also fertile ground for identifying opportunities for improvements. It can even serve as the incubator for new ideas and technological advances.

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Topics: Employee Training Software, CompliantPro Training and Qualifications

Cyber Security and Threat Assessment for Risk Assessment

Posted by Mary McAtee on Jan 22, 2015 @ 09:00 AM

One of the positive peripheral results from the flurry of reactions to the movie, “The Interview” was a short-lived media focus on cyber-terrorism.  The recognition of cyber-attacks has been slow to evolve but is gaining traction. In the last major threat assessment document, prepared during the final year of the Bush Administration, the term Cyber Threat was mentioned by name less than ten times. Last year’s assessment prepared by the Obama Administration mentioned Cyber Terrorism less than 100 times. The current joint intelligence threat assessment document just released mentioned Cyber Terrorism more than 1000 times. C-SPAN recently televised the briefing to the House Intelligence committee by the NSA and CIA. As redacted as I am sure it was it was still chilling. Malware (most likely introduced by China years ago) has been identified in several locations in the infrastructure for the nation’s power grid and water purification and delivery systems. While this specific threat has been neutralized, the idea of a foreign government or other groups planting a latent threat that can be activated when and if the mood strikes is very unsettling. These are not simple annoying denial of service attacks. One of the municipal power generation facilities cooperated with the NSA and permitted activating the malware on one turbine generator control system. The program once activated, took control of the turbine and forced it to run out of safe operating limits until it self–destructed. One can easily imagine the impact on a major city and the entire economy if this or similar incidents were to happen.

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Topics: Risk Assessment & Analysis

Leveraging Risk Assessment to Avoid Crisis

Posted by Mary McAtee on Jan 16, 2015 @ 11:33 AM

People who know me are very aware of how much I love boats and getting out on the water. My father was a Merchant Seaman and my spouse and close friends tend to all have seawater in their veins.  This love of the water includes a deep respect for the power and unpredictable nature of the ocean. Most misadventures at sea seem to be a case study in the precise definition of a “Cluster F&$@”.  Every major and even minor disaster at sea seems to always involve several of the fates conspiring together to allow the progress of a bad situation to become worse. Let’s take just one recent example from the news. Rob Konrad, a former player for the Miami Dolphins, was several miles offshore on his 36 foot fishing boat. He fell overboard and ended up swimming over 9 miles through shark infested waters to reach shore in Palm Beach. Several contributing factors put him in that water swimming for his life. Almost any other person would have become another sad obituary but his physical conditioning overcame some really bad decisions on his part:

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Topics: Risk Management, Risk Assessment Software

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