Michael Rennell joins IBS with a focus on maximizing sales and new business development.
Quality Management 2.0 Blog
As a resource for quality and compliance professionals, the Quality Management 2.0 blog would be remiss to make our subscribers aware of the sophisticated, all-inclusive tool that organizations can utilize to help solve their business problems: CompliantPro.
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.
Working in quality for your organization, you may be aware of the OHSAS 18001 occupational health and safety management standard. But what does this mean for the young OH&S professional looking to get started in their career, or just getting started with health and safety software systems? IBS has researched and compiled the following selections as a basic go-to glossary guide for organizations required to adhere to this standard.
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.