Six Sigma is a powerful tool used to solve a problem or improve a process. The company (one of the 4 big defense companies) I worked for over 20 years lived, breathed and ate it every day. I became a six sigma specialist. For those readers not familiar with six sigma, I offer the following example to hopefully provide some insight into how it works and the benefits it offers. Continue reading
Ah, the job search.
Rejection isn’t meant for the faint of heart and in a job search one must have a bullet proof ego to withstand hours of searching for the right job, applying, networking, re-writing the resume – and other mind numbing tasks in order to do one simple thing – replace an income. Continue reading
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SO 31000 is 23 pages long, but these pages provide an entry level Enterprise Risk Management (ERM) guideline.
Why is this important?
An organization develops ISO 31000 ERM capabilities to provide a structured, consistent, disciplined, and achievable approach to risk management that facilitates Risk Based Thinking throughout the organization. Risk Based Thinking is composed of 1. Risk based, problem solving (RB – PS) and 2. Risk based, decision making (RB –DM). Both RB – PS and RB – DM are the basis for all management and supervision. We discuss this in our new book: ISO 31000: Enterprise Risk Management. Continue reading
As 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard. Continue reading
As stated in our CERM article 127, highly effective safety initiatives are not a short list of “Do’s” and “Don’ts” but include a complex mix of integrated and interacting best safety practices as shown in Figure 1. In this article, we will focus on one of the 7 critical ingredients of an effective Cascading Safety Management System: The Elimination of Biased Thinking and Mental Blocks highlighted with the arrow in Figure 1. Continue reading