Okay, I am officially outing myself as an old fart! I knew what I wanted to talk about this week but no matter what title or description I came up with it screamed crotchety old person. The subject this week is personal investment and responsibility in one’s job. In my opinion, based on decades of walking shop floors and talking to all kinds of people, I’ve reached the following conclusions. In general people have a real and significant investment and pride of accomplishment in their job. This seems to remain a truism no matter how dirty, dangerous and thankless the job appeared to me. It was still “their job”. Formal education seemed to have little or nothing to do with the work ethic and pride of accomplishment demonstrated by the people I have encountered.
Quality Management 2.0 Blog
Documentation and Training as a Means to Assure Continuous Improvement
“If you don’t know where you’re going any road will take you there”. This is a quote from a keen observer of human nature, the great Yogi Berra. I quote him frequently and in this particular observation he is totally on point. One of the keys to identifying and correcting issues is removing as many variables as possible in order to zero in on what works and what doesn’t. If you can’t reliably baseline a process you get trapped into either a false sense of security that everything is fine or you get entangled in chasing false issues.
Topics: IBS America, Document Management Software, Mary McAtee, Document Management Systems, Employee Training Software, document control, document management solutions, document management, product and process waivers
How Education is Ruining Your Compliance Initiatives - And What You Can Do About It
Over the last several weeks we dove into a series on “3 Keys to a Successful Integrated Management System,” and one of the sections focused on cooperation. A key part of cooperation is letting creativity flourish. Today, we will dive into both creativity and collaboration (in our school days known as cooperation).
Topics: Document Management Solution, Jim Verzino, IBS America, Document Management Software, CAPA Software, CAPA, Corrective Actions and Preventive Actions, Document Management Systems, Compliance Software, document control, corrective and preventative actions, compliance
Here's a quick example of how easy it is to change the messages sent by IBS software. Suppose you want to change how the email-message that is sent when a Training Record is coming up for renewal. For this example, suppose you would like to indicate in the Subject line the name of the person whose record this refers to.
Topics: Document Management Solution, Document Management Software, CompliantPro, Document Management Systems, Compliance Software, Complaint Management, Employee Training Software, CompliantPro Tips and Tricks, CompliantPro Training and Qualifications
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.
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:
IBS America, Inc. queried some of our customers that have been using the CompliantPro document management software to gain insight on our products and services. This month, customers were asked to respond with their top features of the CompliantPro product. We've highlighted one of our customers' responses here.
We are all aware that the FDA is taking a much stronger position in the world of enforcement and inspection activity. While many of us have had good relationships with our District office over the years (and work hard to maintain those relationships) we should always make certain we are well prepared when the agents show up at our door. Maybe it’s time for a brief refresher with the latest whitepaper now available for download, "Key Strategies to Succeed at your Next FDA Inspection"
The IBS America, Inc. Document Management Solution is a tightly integrated part of our enterprise compliance management software, CompliantPro.
Now that Q4 is coming to a close and you are wrapping up end-of-year business and setting fresh quality management goals for the year ahead, there is still time left (about 30 days) to make a valuable investment that will pay for itself in 2012. Let me explain.