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.
Quality Management 2.0 Blog
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
"Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."
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.
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 The main reason so many died was that the ship only had lifeboats to save 1,178 people, due to outdated maritime OH&S regulations at the time.
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.
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.
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:
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.
First, thanks to IBS for the chance to speak at the September 2011 User Forum. Great attendees and informative content!