Quality Management 2.0 Blog

Quality Management System Tools that Keep Growing and Evolving Companies on Track

Posted by Mary McAtee on Oct 28, 2015 @ 01:08 PM

How Truly Great Companies Maintain Excellence

If I were to pose the questions:

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Topics: QMS, FMEA

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

Risk Assessment - What Could Possibly Go Wrong?

Posted by Mary McAtee on Oct 22, 2014 @ 04:00 PM

Like pretty much everyone else with a pulse I have watched the sad spectacle of Ebola marching into my living room on every news outlet. Much like an anvil hitting a cartoon character repeatedly, I am gob smacked by the cascading series of lousy decisions made at every level.

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Topics: CAPA, APQP, Risk Management Software, FMEA, Risk Assessment & Analysis

FMEA as a Business Process Tool

Posted by Mary McAtee on Oct 03, 2014 @ 12:00 PM

More and more industries are discovering what the Automotive and Heavy Equipment companies have known for years. The same tools they use and trust to define, quantify and control risk around manufacturing design and associated processes can be used for defining, analyzing and controlling risk for any business process. Investing in the education, structure and discipline of a Design and process centric approach to developing and refining your company’s strategy to almost anything you need to do reliably and repeatedly can yield huge and immediate benefits.

If the entire concept of Design and Process FMEAs (Failure Mode Effects Analysis) is new to you here is the Cliff Notes explanation of the basics.

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Topics: IBS America, CAPA, Mary McAtee, APQP, FMEA

Risk Management - Depend on your QMS Tools

Posted by Mary McAtee on Jul 02, 2014 @ 03:15 PM

Risk Management as a Career Tool

In the last blog I vented my most annoying compliance issue. This week I thought I would switch gears to my most amusing and embarrassing Quality moments.

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Topics: Quality Management Software, QMS, Mary McAtee, Corrective Actions and Preventive Actions, Risk Management Software, Risk Management, FMEA, Risk Assessment Software, Risk Assessment & Analysis

Applying Risk Management to Supplier Qualification

Posted by Mary McAtee on May 21, 2014 @ 12:00 PM

A couple of blog posts ago I wrote about a warning I had once received to carefully distinguish between fads and fashion versus legitimate innovations and quality tools that stand the test of time. Risk Assessment is certainly not new but it seems to currently be the popular kid in the class. The idea of risk analysis as part of Design and Process FMEAs have been the standard within the Auto Industry for many years. Likewise, Risk Assessment is and has been an important element of Environmental Risk Management.  

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Topics: Supply Chain Management, IBS America, CompliantPro, Mary McAtee, APQP, Risk Management Software, EH&S, Supply Management Software, Risk Management, FMEA

FMEA - An Underestimated Tool

Posted by Daniel Schmitt on Jan 27, 2014 @ 11:00 AM

Failure Mode and Effects Analysis (FMEA) is very often underutilized in many companies.  The key is to catch failures before they happen, thus reducing costs in the long run.  And in today’s world reducing costs while keeping quality up is an indicator for success in this global economy.  A lot of companies I visited recently have need for a tool that helps them manage their FMEA process.  But sometimes they just do it because they “have to” – their customer requires it, government regulations require it or it’s just to simply please someone else’s needs.  A more functional approach would be to use software solutions to help manage their overall process. Microsoft Excel is great and probably the most commonly used tool but it has its limitations.  Using a more sophisticated software solution gives you additional tools to grow the use of FMEA throughout your company. Leveraging parent-child relationships between FMEAs, the ability to report with a one click on Risk Priority Numbers (RPN), visualize defect nets and accessing libraries of data points gives you the edge in growing a foundation of thought leadership and lessons learned within your company.  Following an Automotive Industry Action Group (AIAG) approach utilizing both Design Failure Mode Effects Analysis (DFMEA) and Process Failure Mode Effects Analysis (PFMEA) referencing both is crucial for successful FMEA implementation.

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Topics: IBS America, Daniel Schmitt, APQP, FMEA, Risk Priority Numbers, Failure Mode and Effects Analysis, DFMEA, PFMEA, Design Failure Mode Effects Analysis, Process Failure Mode Effects Analysis

The Human Side of Product Recalls and CAPA

Posted by Mike Richman on May 08, 2013 @ 11:11 AM

As publisher of Quality Digest, I often take a somewhat dispassionate view of process and performance errors. After all, our typical reader is a quality professional whose job, in part, is to figure out why something went wrong and prevent it from occurring again.

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Topics: Automotive Quality Management, Quality Management Systems, Process Control, IBS America, CAPA Software, CAPA, Guest Blog on Quality Management, Corrective Actions and Preventive Actions, Food and Beverage Control, Quality, Risk Management, FMEA, Product Quality Control, Automotive, Cost of Quality, Continuous Improvement, NC/CAPA, Mike Richman, Quality Digest

Significance of Automotive Quality Management

Posted by Daniel Schmitt on Oct 12, 2012 @ 11:00 AM

I've been a sales engineer here at IBS for over five years now. I've witnessed firsthand the impact the financial crisis has had on companies. Recent events seem to be indicating a change for the better. Over the last year my trips to Detroit have quadrupled. As the health of the economy has begun showing signs of improvement, many of our customers, especially from the automotive industry, are significantly increasing production and sales. Every day I talk to customers who see the need for a quality control and for whom a quality management system becomes of significant importance. They believe that having a good QMS in-place is an important distinguisher from competitors. People are becoming more and more aware that Quality is not just a “service” that needs to be addressed but that it actually increases revenues and profit in the long run. Customer retention is continues to be recognized as critical to business health. A robust quality management system is recognized as the best safeguard of long term business relationships.

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Topics: Automotive Quality Management, Production Quality Control, Quality Management Systems, Quality Management Software, SPC, CAPA, Quality Control in Manufacturing, FMEA, Automotive, Traceability, Warranty, Detroit, Track & Trace, Receiving Inspection, AIAG

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