Quality Management 2.0 Blog

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

4 Key Concepts for Supplier Quality Management

Posted by Ashley Osgood on May 18, 2012 @ 09:41 AM

"Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."

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Topics: Quality Management Systems, Guest Blog on Quality Management, Customer Management Software, Enterprise Risk Management, Supply Management Software

Reshoring Initiative Harry Moser Named Quality Professional 2012

Posted by Ashley Osgood on Apr 19, 2012 @ 09:40 AM

As a proud sponsor of the Reshoring Initiative, IBS America would like to congratulate guest blogger Mr. Harry Moser on his 2012 Quality Professional of the Year Recognition from Quality Magazine.

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Topics: Quality Management Systems, Document Management Software, Electronic Document Management, Guest Blog on Quality Management

OH&S Management: 5 Key Safety Measures Titanic Taught Us

Posted by Ashley Osgood on Apr 14, 2012 @ 02:01 PM

A hundred years ago today, on April 14, 1912, the RMS Titanic collided with an iceberg on her maiden voyage. Travelling from Southhampton to New York with over 2,200 people onboard (including 900 staff), the ship sank within three hours. Around 1,517 people died, with only 710 surviving. The main reason so many died was that the ship only had lifeboats to save 1,178 people, due to outdated maritime OH&S regulations at the time.

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Topics: CompliantPro, Guest Blog on Quality Management, Health and Safety Software

Who makes the best SME During an FDA inspection?

Posted by Ashley Osgood on Mar 22, 2012 @ 09:46 AM

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Topics: Process Management Software, Guest Blog on Quality Management, Audit Management, Food and Beverage Control

New Whitepaper: Getting Management Buy-In for Quality Initiatives

Posted by Ashley Osgood on Mar 19, 2012 @ 09:26 AM

A large number of Quality practitioners describe their #1 problem as “Getting Management to Buy In to Quality Programs.” I have seen this show up consistently during my career. I experienced it personally on numerous occasions when I was employed as a Quality manager, and later at many companies after I became a consultant.

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Topics: Quality Management Systems, Guest Blog on Quality Management, IBS Quality Whitepapers

Value and Quality through Compliance

Posted by Ashley Osgood on Mar 12, 2012 @ 10:30 AM

Compliance management stretches far beyond the scope of industry and likely finds genesis in daily living. I find it of peculiar note when specific technical directives distill to fundamental kindergarten tenets. While presenting universal mandates in an arduous set of documents, compliance is a human endeavor. Every assertion that is more than a thought requires authority, and authoritative assertions about a project are stakeholder voices. Ultimately, value and quality within an effort are measured by business goals. Assumptions at iteration zero are vital but not relevant when stakeholders do not share context. A litmus test in a vacuum is a technique.

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Topics: Guest Blog on Quality Management, Compliance Software, Risk Management Software

Are you ready when the FDA shows up at your door?

Posted by Ashley Osgood on Mar 05, 2012 @ 09:13 AM

When was the last time an inspector from the FDA showed up at your site? While many FDA inspections are scheduled with some advance notification, there is always a possibility that an inspector from the agency could show up at your door any time. Are you prepared?

It is a standard practice to have a Standard Operating Procedure (SOP) defining what your organization should do when the FDA (or other government agency) shows up at your site. When was the last time your SOP was reviewed and updated? Are the key quality assurance management players the same? Some of the specific areas that you should consider as part of that procedure should include:

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Topics: Production Quality Control, Quality Management Systems, Document Management Software, Quality Assurance Management, Guest Blog on Quality Management

Making Change Work: Practical Ways for Overcoming Human Resistance to Change

Posted by Ashley Osgood on Jan 30, 2012 @ 09:36 AM

We all know that many quality assurance management  changes—introduced with great fanfare—fail to meet the goals that their sponsors envisioned.

Changes that fail usually do not do so because of technical reasons: that is, because there was something inherently flawed about the change itself. They usually fail because of human reasons: that is, because the promoters of the change did not attend to the healthy, real, and predictable reactions of normal people to disturbances in their routine.

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Topics: Quality Assurance and Quality Control, Quality Assurance Management, Guest Blog on Quality Management

Total Cost of Ownership: See Your Gap in Local VS Offshore Costs

Posted by Ashley Osgood on Jan 03, 2012 @ 09:03 AM

First, thanks to IBS for the chance to speak at the September 2011 User Forum. Great attendees and informative content!

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Topics: Guest Blog on Quality Management, Environmental Quality Management, Compliance Software, IBS User Forum 2011

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