FDA shares inspections database
Curious as to where FDA inspections have been the last 10 years? Checkout the inspections database: https://www.fda.gov/ICECI/Inspections/ucm222557.htm
Two Harbors Supports the Voluntary Maturity Model Pilot Program for Medical Devices
Two Harbors Consulting has been working closely with partners in industry, the Medical Device Innovation Consortium, the Food & Drug Agency, and the CMMI Institute to further the Case for Quality program leveraging the CMMI Maturity Model as a framework to assess and drive quality improvements in medical device firms. As background, please review FDA Director of CDRH, Dr. Jeff Shuren describes the Case for Quality here. The CMMI Institute has provided a comprehensive FAQ […]
Robin Newman provides background on CfQ
A good set of background information related to the Case for Quality and the voluntary maturity model program … really reflecting how the FDA is taking a different approach: https://www.youtube.com/watch?v=JCZcxaTf1pQ
Surprising business lessons I (re)learned while college shopping with my daughter
written by George Zack: I’d like to share with you a story comparing some of the experiences our daughter had in her college search. I think the different experiences with some of her “top choice” universities provide possible learning opportunities for business organizations. Our daughter had done well in high school and determined she wanted to continue her education after graduating. Like millions of kids each year, she started the search for a school that would be […]
Seeking Healthcare Services Providers for VSM Research
Wanted: Several healthcare departments or organizations to participate in research leveraging a lean assessment technique evaluating how value flows through their services organization. You will receive: An electronic copy of the value stream map A common understanding of actual current state Prioritized target areas; and Clear, quantifiable metrics for demonstrating impact The market value of this work is $10,000. This workshop is provided free of charge. Asking for 2-4 hrs. phone time with executive sponsor […]
Monitor and control your process
Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail. In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process. The goal of this series is to provoke thought […]
How do you tell a good drummer from a bad one?
Dave Grohl once said, “I love being a drummer. Everyone thinks you’re dumb. What they don’t realize is that if it weren’t for you, their band would suck.” Contrary to what Dave believes the rhythmically-challenged think, I have great admiration for percussionists. The things some drummers can do with a drum kit seems, frankly, impossible to me. The speed of their hands…the fact that they are often doing four separate things with their hands and feet (five if you count […]
Identify and Involve Relevant Stakeholders
Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail. In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process. The goal of this series is to provoke thought […]
Control work products
Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail. In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process. The goal of this series is to provoke thought […]
Training People
Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail. In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process. The goal of this series is to provoke thought […]
